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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nCost-effectiveness of Nursing Interventions for Patients With PD\n\n**Clinical Trial Summary:**\n\nBackground: Current guidelines recommend that every person with Parkinson's disease (PD)\r should have access to Parkinson's Disease Nurse Specialist (PDNS) care. Thus, hospitals\r increasingly offer PDNS care to their patients with PD. However, there is currently little\r scientific evidence on the cost-effectiveness of PDNS care. Consequently, many hospitals lack\r the nursing capacity to offer PDNS care to all patients, which creates unequal access to care\r and possibly avoidable disability and costs.\r\n\r Objective: The investigators aim to study the (cost-)effectiveness of specialized nursing\r care provided by a PDNS as compared to no PDNS care for people with PD in all disease stages.\r To gain more insight into the used interventions and their effects, a subgroup analysis will\r be performed based on disease duration (diagnosis made <5, 5-10, or >10 years ago).\r\n\r Methods: The investigators will perform an 18-month, single-blind, randomized controlled\r clinical trial in eight community hospitals in the Netherlands. A total of 240 people with\r idiopathic PD that have not been treated by a PDNS over the past two years will be included,\r independent of disease severity or duration. In each hospital, 30 patients will randomly be\r allocated in a 1:1 ratio to either PDNS care according to the Dutch Guideline on PDNS care or\r no nursing intervention (continuing usual care). For the allocation of participants, a\r computer-generated list of random numbers will be used. The co-primary outcome measures are\r Quality of Life (QoL) and motor symptoms. Secondary outcomes include PD symptoms, mobility,\r non-motor symptoms, health-related quality of life, experienced quality of care,\r self-management, medication adherence, caregiver quality of life, coping skills and caregiver\r burden. Data will be collected after 12 months and 18 months. A healthcare utilization and\r productivity loss questionnaire will be completed every 3 months by both the patient and the\r caregiver.\r\n\r Hypothesis: The investigators hypothesize that, by offering more patients access to PDNS\r care, QoL will increase with equal healthcare costs. Increasing direct medical costs (for\r nurse staffing) will be offset by a reduced number of consultations with the general\r practitioner and neurologist. If these outcomes are reached, wide implementation of PDNS care\r is needed.\n\n**Clinical Trial Detailed Description:**\n\n1. Background The Parkinson's Disease Nurse Specialist (PDNS) can fulfill a pivotal role in\r the multidisciplinary team of people with PD. The PDNS was introduced in 1989 in the\r United Kingdom to bridge the gap between medical management and the unique personal\r needs of patients. To obtain greater uniformity in care delivery by a PDNS and to\r facilitate the efficacy of nursing care in PD, the Dutch Guideline 'Nursing care in\r Parkinson's disease' was published in 2016. The main roles of the PDNS are clearly\r described in the Guideline, and include 1) providing information, education and\r instruction; 2) supporting the patient and caregiver in the promotion of\r self-management; 3) supporting psychosocial care questions; 4) prevention; 5)\r specialized diagnostic strategies and therapeutic nursing interventions; and 6)\r multidisciplinary collaboration.\r\n\r Based on expert opinion from healthcare professionals, the Dutch guideline advises that\r every person with PD could benefit from PDNS care, including those in early-stage\r disease where delivery of information, education about medication compliance and support\r in self-management are critical. So far, only three studies have evaluated PDNS care and\r they have found inconsistent results. Overall, they indicate that PDNS care may improve\r patient wellbeing, physical functioning and general health status and reduce anxiety and\r depression, but definite conclusions could not be drawn. Moreover, there is little\r evidence that shows that quality of life actually improves with PDNS care and to date,\r no studies have been performed that evaluated the cost-effectiveness of PDNS care.\r\n\r Currently, most hospitals in The Netherlands offer PDNS care, since it is advised in the\r Dutch Multidisciplinary Guideline. However many centers still lack the nursing capacity\r to offer PDNS care to all patients because the scientific evidence is inconclusive. This\r situation creates an undesirable inequality in access to care and presumably leads to\r avoidable disability and costs (e.g. from early admissions to nursing homes or crisis\r admissions to the hospital). Therefore, the investigators aim to study the\r cost-effectiveness of specialized nursing care provided by a PDNS as compared to no PDNS\r care for people with PD.\r\n\r 2. Study design The NICE-PD study is an 18-month, single-blind randomized controlled\r clinical trial that will be performed in eight community hospitals in the Netherlands. A\r total of 240 people with PD will be included (120 in each group) and equally distributed\r over the participating hospitals. The investigators have selected hospitals where, due\r to lack of sufficient PDNS staff, only a proportion of PD patients currently has access\r to PDNS care. This provides the investigators with a unique opportunity to identify\r patients who at present have no access to PDNS care, and to randomize them within\r hospitals (at the patient level) between PDNS care and no nursing intervention.\r\n\r Eligible patients will be allocated randomly to either PDNS care or usual care in a 1:1\r ratio, using a computer-generated list of random numbers. To ascertain an equal\r representation of patients, the investigators will stratify for disease duration\r (according to pre-defined subgroups, i.e. disease duration <5 years, 5-10 years and >10\r years). The PDNS intervention will be carried out according to the Dutch 'Guideline\r Nursing care in PD'. A blinded researcher will perform the clinical assessments at\r baseline (t0), after 12 months (t1) and after 18 months (t2). Patients and caregivers\r will also be asked to complete a set of questionnaires at t0, t1 and t2. Finally, every\r three months patients and their caregivers will complete an online questionnaire about\r healthcare utilization, costs and productivity loss.\r\n\r 3. Intervention\r\n\r The PDNS intervention will be performed according to the Dutch 'Guideline Nursing care\r in PD' published in 2015. The intervention is not standardized, but tailored to the\r patients' and caregivers' needs. This includes the following:\r\n\r - Assessment of individual care needs of people with PD and their caregivers. The\r PDNS performs a specific nursing assessment related to the medical, physical,\r psychological and social domains.\r\n\r - Development of a patient-centered treatment plan that supports the patient and\r caregiver in self-management. The PDNS composes a multidisciplinary plan, based on\r the results of the individual assessment, and as prioritized by the patient and\r caregiver (shared decision making). The treatment plan is developed according to\r the national self-management framework.\r\n\r - Specific nursing interventions. The intervention varies across disease stages and\r is tailored to the specific problems and needs of individual patients and their\r caregivers. The Guideline on PDNS care describes general- and specific nursing\r interventions. General interventions consist of providing information and\r education, disease management (e.g. considering advanced treatment options such as\r DBS) and monitoring (e.g. of caregiver burden). Specific nursing interventions are\r described for the following areas: mental functions, fatigue, sleep, urogenital\r functions, sexuality, medication adherence, orthostatic hypotension, caregiver\r burden, coping, mobility, self-management and dietary issues (table 2 provides\r examples of such interventions).\r\n\r - Collaboration with other healthcare professionals. The PDNS stimulates and supports\r multidisciplinary collaboration between healthcare professionals based on the\r individual patient-centered treatment plan. The PDNS also plays a pivotal role in\r the timely referral to other healthcare professionals.\r\n\r The PDNS will keep a pre-defined electronic study report according to a structured\r format for each PD patient, documenting the individual care needs, present symptoms,\r performed interventions and (changes in) the individual care plan. This report will be\r started at the initial assessment and updated at every follow-up contact with the\r patient, e.g. at the outpatient clinic, during a telephone consultation or at a home\r visit. This data will be purposefully collected for a possible process analysis at the\r end of the study.\r\n\r Patients will have regular contact with their PDNS about the progress and realization of\r the personal goals, both during face-to-face contacts and by telephone, and sometimes\r during additional home visits. The frequency and type of contact will be optimized for\r each patient depending on disease stage and individual patient needs. The Guideline on\r PDNS care advises that each patient has a minimum of one contact with the PDNS each\r year. Currently in the Netherlands, patients are seen on average twice a year by their\r PDNS, with an additional two interim telephone consultations per year.\r\n\r The control group will receive ongoing/ usual care which is otherwise comparable, but\r without a nursing intervention. This involves regular consultations with a neurologist\r in their own community hospital (typically 2-4 times per year, depending on patient\r preferences and health status). In addition, control patients will have no other\r restrictions considering any other medical treatments (e.g. by a psychologist or social\r worker). Importantly, many important elements of care (including in particular the\r treating neurologist) remain comparable between the two intervention arms because of the\r randomization at patient level within hospitals.\r\n\r 4. Clinical assessments At baseline, t1 and t2 all patients will visit their own hospital\r for the study assessments which are performed by a blinded researcher (PDQ-39,\r MDS-UPDRS, and TUG). Furthermore, the patients and their caregivers will complete\r additional home questionnaires. In addition, every three months, patients will receive a\r questionnaire at home regarding healthcare utilization, costs and productivity loss over\r the past three months. Caregivers will complete a cost questionnaire including\r healthcare utilization, costs and productivity loss specifically related to caregiver\r burden. Patients can choose if they want to fill out digital or paper questionnaires.\r\n\r 5. Data analysis The economic evaluation investigates, alongside the clinical trial, the\r value for money of full implementation of the PDNS into PD care from a societal and\r healthcare perspective. The investigators will take all relevant costs into account. The\r cost-effectiveness timeframe adheres to the clinical study protocol and evaluates\r cost-effectiveness up to 18 months after randomization. Cost will be measured using a\r healthcare utilization questionnaire (e.g. including medical consultations, hospital\r admissions, medication, travel costs, etc.) and a questionnaire measuring productivity\r loss while working of both patients and caregivers. Per item of healthcare consumption,\r standard cost-prices will be determined using the guideline for performing economic\r evaluations. If standardized prices are not available, full cost prices will be\r determined using activity based costing. Costs will be analyzed using a mixed model\r approach or a general linear model approach with a gamma distribution using a log link\r to account for possible skewness of the cost data.\r\n\r The investigators will use a PD-specific quality of life measure (PDQ-39) and a generic\r health-related quality of life scale (EQ5D) to evaluate the quality of the health status\r of patients. The potential difference in Quality-Adjusted Life Years (QALYs) measured\r with the EQ5D will be analyzed with a regression approach. The investigators will use a\r linear mixed model with repeated measurements to test for differences in quality of life\r (measured with the PDQ-39) between both groups. The same analysis will be used to\r measure differences between groups in the secondary outcome measures. The investigators\r will include study center as a random effect and fixed effects for group, time and the\r interaction between group and time. Each of the outcomes will be included as dependent\r variable. Statistical analyses will be performed based on the intention-to-treat\r principle.\r\n\r Besides the overall cost-effectiveness evaluation, the investigators will perform a\r pre-planned subgroup analysis based on disease duration (diagnosis made <5 years, 5-10\r years or >10 years ago) to obtain more insight into the nursing interventions used in\r each disease stage and the effects of PDNS care in these different groups of patients.\r This subgroup analysis will be performed because, for example, for the more severely\r affected patients the nursing intervention is expected to become more intensive and\r possibly more effective, but also more expensive. When different patterns of this kind\r are found, this should be investigated further in future trials that are powered\r adequately to address such group differences.\r\n\r 6. Discussion The investigators hypothesize that offering PDNS care will lead to higher\r quality of life with equal healthcare costs. Increasing direct medical costs (for nurse\r staffing) are expected to be offset by a reduced number of (telephone) consultations\r with the general practitioner and neurologist. These short-term goals are the focus of\r the present NICE-PD proposal. In addition to the short-term effects, the investigators\r also expect long-term benefits, which are out of scope of the present project. Examples\r of potential long-term benefits include a reduction in the number of nursing home\r admissions and fewer emergency visits to the hospital, which would lead to a substantial\r cost reduction.\r\n\r In conclusion, this study will generate new insights into the cost-effectiveness of\r specialized PD nursing interventions for people with PD. If positive results are found, a\r large shift in the organization of PD care is needed to warrant equal access to PDNS care for\r every person with PD.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - A diagnosis of idiopathic PD;\r\n\r - Sufficient knowledge of the Dutch language to fill out questionnaires;\r\n\r - Age 18 years or older at the time of diagnosis;\r\n\r - All disease stages, regardless of disease severity or disease duration;\r\n\r - Not having received care from a PDNS in the past two years;\r\n\r - A score of ≥ 18 on the Mini-Mental State Examination (MMSE13) and ≥ 12 on the Frontal\r Assessment Battery (FAB14).\r\n\r Exclusion Criteria:\r\n\r - A type of atypical parkinsonism caused by medication (e.g. neuroleptics), a metabolic\r disorder (e.g. Wilson's disease), encephalitis or a neurodegenerative disorder (e.g.\r multiple system atrophy, progressive supranuclear palsy, corticobasal syndrome).\r\n\r - Residing in a nursing home or another type of residential care facility (because the\r PDNS is not operational there).\r\n\r - Any other medical or psychiatric disorder that, in the opinion of the researcher, may\r compromise participation in the study.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** possibly relevant"
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possibly relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"content": "**Clinical Trial Title:**\n\nTrial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The \"UP\" Study\n\n**Clinical Trial Summary:**\n\nThe aim of this study is to explore the potential of Ursodeoxycholic acid (UDCA) to slow down\r the progression of Parkinson's Disease (PD) in a randomised, double-blind,\r placebo-controlled, \"proof of concept\" study. The primary objective of the study will be to\r determine the safety and tolerability of this drug in patients with PD. Participants will be\r recruited form a cohort of patients who have been diagnosed with PD within the last 3 years\r and are potentially suitable for this study.\r\n\r There is strong evidence from previous research and the work carried out by other groups that\r UDCA rescues the function of the mitochondria (mitochondria are the \"powerhouse\" of the cell)\r in PD patient tissue and other models of PD. This suggests that UDCA may slow down the\r worsening of PD.\r\n\r UDCA has been in clinical use for the treatment of liver disease (primary biliary\r cholangitis) for over 30 years. The investigators therefore know that it is safe and well\r tolerated in patients with liver disease but the investigators don't know yet whether this is\r also the case in patients with PD. Furthermore, the dose used for patients with liver disease\r (15 mg/kg) is not high enough for UDCA to get into the brain. The investigators therefore\r need to double the dose to 30 mg/kg. This higher dose was also safe in clinical trials for\r liver disease, but is currently not used routinely in clinical practice.\n\n**Clinical Trial Detailed Description:**\n\nThe primary aim of this study is to generate clinical data to examine the safety,\r tolerability & potential effectiveness of 48 weeks exposure to UDCA compared to placebo.\r Furthermore, it will determine the usefulness of novel objective readouts (namely the\r objective sensor based quantification of motor progression & 31P-MRS/imaging-based in vivo\r quantification of ATP) which may allow a reduction of the sample size (& thus cost) of future\r trials.\r\n\r This is double-blind, randomised, placebo-controlled multi-centre parallel group trial in\r patients with PD who have been diagnosed ≤ 3 years ago. 30 patients will be randomised to\r UDCA at a dose of 30 mg/kg or matched placebo using a 2:1 split (20 patients on UDCA, 10 on\r placebo). This will include 48 week exposure period & a subsequent 8 week washout period.\r Detailed evaluations of all patients will take place at Screening, Baseline, 12, 24, 36, 48 &\r 56 weeks. The trial medication will be taken at 3 equal doses per day, to be taken orally\r with food. The dose will be increased gradually by 250 mg (1 capsule) every 3 days until\r patient reaches a dose of 30 mg/kg.\r\n\r Visit Schedule\r\n\r Telephone Contact 1 (Telephone Screening)\r\n\r Subsequent to the site staff having received a reply slip from the patient indicating their\r interest to participate in the study, a suitable time & date will be arranged with the\r respective patient to undergo telephone screening by a member of the research team to check\r potential eligibility, including a brief review of relevant medical history. The Chief\r Investigator (CI)/ Principal Investigator (PI) will check the screening record made after the\r telephone screening call. Any patients not deemed eligible to be invited for their screening\r visit will be contacted by a member of the research team to inform them of this outcome.\r Patients deemed eligible will be invited to a screening visit. The date of diagnosis &\r confirmation of the PD diagnosis & any other uncertainties relating to the\r inclusion/exclusion criteria will be confirmed subsequent to this telephone screening\r assessment for those patients who seem eligible but are outside the Sheffield Teaching\r Hospitals (STH)/ University College London Hospitals (UCLH) geographical area by requesting\r copies of relevant clinic letters or contacting their PD Clinical Consultants directly. The\r telephone screening call will be repeated if the patient cannot attend visit 0 (screening\r visit) within 1-8 weeks to ensure that s/he would still fulfil the telephone screening\r eligibility criteria.\r\n\r The telephone screening call will not be undertaken for study patients who are already\r patients of either site.\r\n\r Visit 0: Screening (Time -1 - 8 weeks prior to baseline visit)\r\n\r At this visit the research team will answer any further questions, check the patient's\r eligibility for the study as far as possible and, if the patient wishes to participate in the\r study, obtain written consent. A clinical diagnosis of PD is based on the opinion of the\r Principal Investigator (PI) after review of the patient's clinical history, examination\r findings & response to PD medication.\r\n\r The written informed consent process will be undertaken by the PI or by an appropriately\r trained member of the research team as delegated by the PI/ CI. This study will not include\r vulnerable patients or patients who lack capacity.\r\n\r Screening procedures\r\n\r The PI (or authorised delegate) will complete the following screening assessments/procedures\r with the patient:\r\n\r - Obtaining consent\r\n\r - Inclusion/Exclusion Review\r\n\r - Demographic information & medical history\r\n\r - Demographic data regarding PD\r\n\r - Past medical history\r\n\r - Medication History\r\n\r - Family history\r\n\r - Previous imaging\r\n\r - Previous genetic tests\r\n\r - Confirmation of eligibility\r\n\r - Confirmation of date for diagnosis of Parkinson's disease by PIs or other experts in\r movement disorders (this may include review of medical records)\r\n\r - Concomitant medication\r\n\r - Physical examination (including assessment of modified Hoehn & Yahr stage), including\r weight, height &vital signs\r\n\r - Montreal Cognitive Assessment (MoCA)\r\n\r - Montgomery-Asberg Depression rating scale (MADRS)\r\n\r - Confirmation of post-menopausal state\r\n\r - Safety bloods (full blood count, urea & electrolytes, liver function tests, blood\r glucose, HbA1C, lipid profile)\r\n\r - Serum sample (approach. 20 ml stored at -80 degrees Celsius)\r\n\r - ECG\r\n\r - Provision of physical activity monitor & activity diary\r\n\r Assuming that the patient fulfils the immediate eligibility criteria, arrangements will be\r made for the patient to attend a baseline appointment approximately 2 to 4 weeks after the\r screening visit. This interval enables review of the patient's blood results to confirm final\r eligibility. If more than 8 weeks have elapsed since the screening visit, the screening visit\r & screening assessments should be repeated before proceeding to the baseline visit.\r\n\r Patients who consent to the study but who are subsequently found not to meet the study\r eligibility criteria will be contacted by the research nurse or other member of the research\r team to inform them that they are not eligible to join the study. If any concerns about the\r patient's health or well-being are identified from out-of-range blood results or abnormal\r assessment scores, a member of the research team will inform the patient's General\r Practitioner (GP).\r\n\r Following written consent, randomisation will take place at the baseline visit. All patients\r will be assigned a unique patient ID number at screening that will link all of the clinical\r information collected for them on the study database, these will be in the format Sxx/nnnn;\r where xx is a unique number assigned to the site by the Trial Manager & nnnn is a unique\r number starting at 0001 &incrementing by 1. Once the patient ID number has been entered, the\r system will supply a randomisation number which will identify the treatment pack to be\r dispensed. The randomisation will be 2:1 in favour of UDCA. The randomization system will\r stratify by site.\r\n\r Site Study Teams\r\n\r The local PI, supported by an appropriate member of the research team will monitor patient\r well-being, record adverse events, titrate &prescribe study medication. Since the 'treating'\r nurse or doctor will review all blood results & be aware of any reported side effects, a\r separate member of the research team will act as a blinded assessor, undertaking the\r MDS-UPDRS & other outcome measures after appropriate training. Ideally the blinded assessor\r will undertake the MDS-UPDRS Part 3 with the patient in the \"OFF\" state, followed by the\r complete MDS-UPDRS, Non-Motor Symptom assessment Scale (NMS-Quest) & MADRS once the patient\r is in the \"ON\" state. The practically defined \"OFF\" medication state refers to the patient\r assessment conducted in the absence of their regular medication with the aim of exposing the\r severity of the underlying PD. Efforts should be made to ensure that the same outcome\r assessor is present at all visits but sites should identify back-up personnel to cover staff\r absences & avoid cross-over of 'assessing' &'treating' team members.\r\n\r Baseline (Visit 1)\r\n\r Eligible patients will attend a further clinic visit where baseline assessments will be\r performed. Results of blood tests & ECG will be reviewed prior to baseline evaluation to\r ensure patient eligibility. They will be asked to attend in the \"practically defined OFF\"\r state. The following assessment will be undertaken in the \"practically defined OFF\" state:\r\n\r - Confirmation of eligibility/inclusion/exclusion review\r\n\r - Medication review\r\n\r - Physical examination\r\n\r - Recording of any Adverse Events (AEs)\r\n\r - MDS-UPDRS part 3 (motor examination)\r\n\r - Optogait &Opals sensor-based objective quantification of motor impairment (Sheffield\r Patients only)\r\n\r They will be invited to take their PD medication following the assessment. The PI or\r authorised delegate will record any reported serious adverse events & changes to concomitant\r medications, including PD medication. In addition, the predicted progression will be\r calculated, following the model developed by Williams-Gray & co-workers. The Prognostic Model\r developed by Williams-Gray &co-workers identified the following three parameters as\r associated with more rapid PD progression: 1. Higher age, 2. Higher UPDRS motor examination\r axial score (items 27-30), 3. Lower animal naming fluency (patients will be asked to name as\r many animals as possible in a 1-minute time frame). The assessor will then complete the\r following procedures with the patient in the \"practically defined ON\" stage (typically 30-60\r min after patient has taken PD symptomatic medication):\r\n\r - MDS-UPDRS\r\n\r - NMS-Quest\r\n\r - PDQ-39\r\n\r - 31P- MRS\r\n\r - Blood sample for genetic analysis\r\n\r - Safety bloods\r\n\r - Serum sample\r\n\r - Provision of patient diary\r\n\r - Return of physical activity monitor &activity diary\r\n\r Patients will be randomised at this visit to receive either active of placebo medication (2:1\r ratio). The PI or appropriately delegated medically qualified member of the study team will\r complete &sign a study-specific prescription form for presentation to pharmacy by the\r patient. The prescription form will details the baseline medication allocation print-out from\r the randomisation computer system.\r\n\r All patients will be provided with a study-specific diary by their local research team at the\r baseline visit, in which to record any alterations in the dose of trial medication or\r concomitant medications taken. Patients should be advised to contact the study team promptly\r should they develop loose stools rather than waiting for the next study visit or scheduled\r telephone call.\r\n\r Visit 2: 12 week follow-up clinic\r\n\r Patients will attend a clinic visit twelve weeks after the baseline visit, having taken all\r medications as usual. The PI or authorised delegate will complete the following procedures\r with the patient in conjunction with study diary review:\r\n\r - Record any AEs & changes to concomitant medications\r\n\r - Assess compliance with study treatment & collect any unused medication\r\n\r - Return of unused medication\r\n\r - Safety bloods\r\n\r - Serum sample\r\n\r - Diary Review\r\n\r Provided that there are no immediate clinical contra-indications, the patient will be\r provided with a further 3 months prescription for the trial medication.\r\n\r Visit 3: 24 week follow-up clinic\r\n\r Patients will attend a clinic visit six months after the baseline visit, having taken all\r medications as usual. The PI or authorised delegate will complete the following procedures\r with the patient in conjunction with study diary review:\r\n\r - Record any AEs & changes to concomitant medications\r\n\r - ECG\r\n\r - Safety bloods\r\n\r - Serum sample\r\n\r - Assess compliance with study treatment & collect any unused medication\r\n\r - Return of unused medication\r\n\r - MDS-UPDRS/part 3 motor assessment in the practically defined \"ON\" stage\r\n\r - Diary Review\r\n\r Provided that there are no immediate clinical contra-indications, the patient will be\r provided with a further 3 months prescription for the trial medication.\r\n\r Visit 4: 36 week follow-up clinic\r\n\r Patients will attend a clinic visit thirty six weeks after the baseline visit, having taken\r all medications as usual. The PI or authorised delegate will complete the following\r procedures with the patient in conjunction with study diary review:\r\n\r - Record any AEs & changes to concomitant medications\r\n\r - Assess compliance with study treatment & collect any unused medication\r\n\r - Return of unused medication\r\n\r - Safety bloods\r\n\r - Serum sample\r\n\r - Diary Review\r\n\r Provided that there are no immediate clinical contra-indications, the patient will be\r provided with a further 3 months prescription for the trial medication.\r\n\r Visit 5: 48 week follow-up clinic\r\n\r Patients will attend a clinic visit 48 weeks after the baseline visit. For this visit,\r patients will be asked to attend on the day of assessment in the 'practically-defined OFF'\r state.\r\n\r The assessor will complete the following procedures with the patients in conjunction with\r study diary review:\r\n\r - Record any AEs & changes to concomitant medications\r\n\r - Assess compliance with study treatment & collect any unused medication\r\n\r - MDS-UPDRS part 3 in the \"practically defined OFF\" state\r\n\r - Opticals/Sensor based gait assessment (Sheffield patients only)\r\n\r - Height & Weight\r\n\r Patients will then be invited to take their routine PD medication. The assessor will then\r complete the following procedures with the patient in the \"practically-defined ON\" state\r (typically 30 - 60 min later):\r\n\r - MDS-UPDRS\r\n\r - NMS-Quest\r\n\r - MoCA\r\n\r - MADRS\r\n\r - PDQ-39\r\n\r - Safety bloods\r\n\r - Serum sample stored\r\n\r - 31P- MRS\r\n\r - Diary review\r\n\r - Return of the physical activity monitor &activity diary\r\n\r Visit 6: 56 week follow-up clinic\r\n\r Patients will attend a clinic visit 56 weeks after the baseline visit. For this visit,\r patients will be asked to attend on the day of assessment in the 'practically-defined OFF'\r state. The PI or authorised delegate will complete the following procedures with the patient:\r\n\r - Record any AEs & changes to concomitant medications\r\n\r - Safety bloods\r\n\r - Serum sample\r\n\r - MDS-UPDRS part 3 motor subscale in the \"practically defined OFF medication state\"\r\n\r Patients will then be invited to take their routine PD medication. The assessor will then\r complete the following procedures with the patient in the \"practically-defined ON\" state\"\r (typically 30 - 60 min later):\r\n\r - MDS-UPDRS\r\n\r - NMS-Quest\r\n\r - MoCA\r\n\r - MADRS\r\n\r - PDQ-39\r\n\r - Diary review\r\n\r - Diary collection\r\n\r For all visits, each procedure is undertaken as part of the study & not part of the patient's\r standard care.\r\n\r Telephone contacts There will be 12 telephone contacts throughout the study, weekly after the\r baseline visit during the dose escalation period &week 8, week 18, week 30, week 42 & week\r 52. Patients will also be contacted via the telephone 2 days prior to their baseline visit,\r visit 5 & visit 6 to remind patients to attend their next visit in the \"practically defined\r OFF medication state\" for their next visit.\r\n\r Sensors At the screening visit, eligible patients will be given the DynaPort Movemonitor to\r wear for 7 days. A text message will be sent to the patients every morning to remind them to\r wear the device. A 2nd DynaPort Movemonitor will be posted to patients 2 weeks prior to their\r 48 week visit with instructions to wear the sensor for 7 days prior to their next visit.\r Patients will then be asked to return this at their 48 week visit.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r • Diagnosis of Parkinson's disease: PD is a clinical diagnosis as defined by the Queen\r Square Brain Bank criteria (bradykinesia defined as slowness of initiation of voluntary\r movement with progressive reduction in speed and amplitude on repetitive actions and at\r least one of the following: Rigidity, 4-6 Hz rest tremor). The diagnosis will have been\r made by the treating clinician and confirmed by the PI on site after review of the clinical\r history, examination findings and response to PD medication.\r\n\r The Queen Square brain bank criteria MAY be used to help assist in the diagnosis although\r this need not be a formal inclusion criteria, and the relevance of a positive family\r history of PD, or a confirmed genetic basis for an individual's symptoms will be evaluated\r in the context of other clinical features in determining diagnosis and eligibility.\r\n\r - Diagnosis of Parkinson's disease ≤ 3 years ago by a clinician with particular\r expertise in the diagnosis and treatment of movement disorders (typically one of the\r PIs or their consultant colleagues). The date of diagnosis will be verified by a\r review of the medical records.\r\n\r - Subjective improvement of motor impairment on dopaminergic medication, confirmed by PI\r through personal examination and/or review of medical records\r\n\r - Hoehn and Yahr stage ≤ 2.5 in the practically defined \"ON\" medication state. This\r implies that all patients will be mobile without assistance during their best \"ON\"\r medication periods.\r\n\r - Ability to take study drug\r\n\r - Ability to communicate in English\r\n\r - Age 18 - 75 yr of any gender\r\n\r - Documented informed consent to participate\r\n\r - Able to comply with study protocol and willing to attend necessary study visits\r\n\r Exclusion Criteria:\r\n\r - Diagnosis or suspicion of other cause of parkinsonism such as Multiple system atrophy\r (MSA) or progressive supranuclear palsy (PSP), drug induced parkinsonism, dystonic\r tremor or essential tremor will not be recruited.\r\n\r - Known abnormality on CT or MRI brain imaging considered likely to compromise\r compliance with trial/protocol/31P-MRS acquisition.\r\n\r - Known claustrophobia or other reasons why patient could not tolerate or be suitable\r for 31P-MR Spectroscopy (31P-MRS)\r\n\r - Current or previous exposure to UDCA\r\n\r - Current or previous diagnosis of liver disease judged to be significant by the\r clinical investigator, in particular Primary Biliary Cholangitis (previously referred\r to as Primary Biliary Cirrhosis, PBC)\r\n\r - Prior intracerebral surgical intervention for PD (including deep-brain stimulation).\r Patients who have previously undergone deep brain stimulation, intracerebral\r administration of growth factors, gene therapies or cell therapies will not be\r eligible.\r\n\r - Already actively participating in a trial of a device, drug or surgical treatment for\r PD\r\n\r - History of alcoholism\r\n\r - Women of child - bearing potential (WOCBP)\r\n\r - Participants who lack the capacity to give informed consent\r\n\r - Any medical or psychiatric condition which in the investigator's opinion compromises\r the potential participant's ability to participate\r\n\r - Concurrent dementia defined by Montreal Cognitive assessment (MoCA) score <25\r\n\r - Concurrent severe depression defined by a score >16 on the Montgomery- Asberg\r Depression Rating Scale (MADRS)\r\n\r - Serum transaminases (such as aspartate transaminase (AST) more than 2 times upper\r limit of normal.\r\n\r - Patients on ciclosporin, nitrendipine or dapsone for the treatment of concomitant,\r general medical conditions.\r\n\r - Participants with previous or current diagnosis of inflammatory bowel disease (i.e.\r ulcerative colitis or Crohn's disease)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,702
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMulti-chip Meta-analysis of Parkinson's Disease for Clinical Validation of Small Samples of Key Genes in Disease\n\n**Clinical Trial Summary:**\n\nThe research team used meta-analytical statistical methods to integrate the results of\r different research groups on Parkinson's disease, using meta-analysis to find key genes\r related to the pathogenesis and development of Parkinson's disease, and to make small\r clinical results. The verification of the sample, the internal mechanism of the pathogenesis\r of Parkinson's disease and provide guidance and reference for subsequent experimental\r research.\n\n**Clinical Trial Detailed Description:**\n\nParkinson's disease (PD) is a relatively common degenerative disease of the central nervous\r system. As society gradually becomes aging, the number of PD patients is increasing, but its\r exact pathogenesis is still not fully understood. May be related to genetic factors,\r environmental factors, immunological abnormalities, mitochondrial dysfunction and oxidative\r stress, ageing, apoptosis and other factors; the current genetic diagnosis is in the\r ascendant, making the understanding of the etiology and pathogenesis of Parkinson's disease\r more In-depth, provide more basis and means for the pathogenesis and development of\r Parkinson's disease, but due to the number of individual samples, operational norms and\r platform differences, different research groups have great differences in the results of gene\r chip research on Parkinson's mechanism, resulting in the reliability is poor; In order to\r improve the credibility of the pathogenesis of Parkinson's disease and the development of\r genetic diagnosis, the investigators use the statistical means of meta-analysis to integrate\r the results of the chip research on Parkinson's disease in different research groups and find\r synaptic correlation function may be closely related to the development of Parkinson's\r disease, PPP2CA, PPP3CB, SYNJ1, NSF, CYCS genes may be key genes in the pathogenesis of\r Parkinson's disease, and the expression of these genes is related to the pathogenesis and\r development of PD patients. the investigators will conduct a small sample validation in the\r clinic to explore the intrinsic mechanism of Parkinson's disease and follow-up experimental\r research provides guidance and reference.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - PD group：\r\n\r - Patients who meet the 2016 China Parkinson's diagnostic criteria and the 2015\r International Parkinson's and Movement Disorders Association (MDS) Parkinson's\r disease diagnostic criteria\r\n\r - Newly diagnosed primary PD patients, diagnosed within 3-6 months\r\n\r - Informed consent to the study\r\n\r - Age > 18 older\r\n\r - Non-PD group:\r\n\r - Age, gender-matched PD group\r\n\r - Non-PD, non-PDS, non-neurological degenerative disease, patients without\r inflammatory disease and related family history\r\n\r - Informed consent to the study\r\n\r - Age > 18 older\r\n\r Exclusion Criteria:\r\n\r - Severe craniocerebral trauma patients\r\n\r - Disturbance of consciousness\r\n\r - Severe organic diseases, cerebral hemorrhage, cerebral thrombosis, severe coronary\r heart disease and lung disease, severe liver and kidney dysfunction, severe diabetes,\r severe hearing And visual impairment\r\n\r - History of severe brain tumors, encephalitis or brain surgery\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,703
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nDietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nIn this prospective, intervention study, participants with diagnosed Parkinson's disease will\r be instructed to follow a Mediterranean diet for five weeks. Gut permeability will be\r assessed using food-grade sugar molecules. Participants will provide urine and stool samples\r to assess gut permeability and microbial communities.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Physician-diagnosed Parkinson's disease aged 21-85 years\r\n\r - Hoehn & Yahr stage <3\r\n\r - Currently living in the same household with a healthy spouse/partner who meets study\r eligibility criteria and is willing to participate\r\n\r - Willing and able to complete informed consent in English\r\n\r - Willing to complete daily and weekly questionnaires and 6 dietary recalls over\r approximately 7 weeks\r\n\r - Willing to avoid beer, wine, and cocktails on the day before and the day of the sugar\r probe tests.\r\n\r - Willing to provide urine and stool samples during the study collection periods.\r\n\r - Willing and able to fast (no food or drink, except water or tea) for a prolonged\r period of time during study urine collections.\r\n\r - Willing to maintain usual diet through the pre-baseline period\r\n\r - Willing to make dietary changes to follow a Mediterranean dietary pattern during the\r intervention period.\r\n\r - Willing to discontinue taking prebiotic, fiber, probiotic, herbal, or high-dose\r vitamin or mineral supplements that may impact inflammation during the pre-baseline\r period and throughout the study protocol.\r\n\r - Willing to limit use of oral laxative medication to an \"as-needed basis\" (i.e. <3\r times per week) during the full length of the study\r\n\r - Willing to avoid high intensity exercises two days prior to and the day of the\r permeability tests. These tests will be done on two occasions.\r\n\r - Willing to provide a social security number to receive study payment.\r\n\r Exclusion Criteria:\r\n\r - Does not meet above criteria\r\n\r - Atypical or secondary Parkinsonism\r\n\r - History of deep brain stimulation\r\n\r - Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior\r to screening.\r\n\r - Daily use of anticholinergics or prokinetic agents\r\n\r - Use of enemas or suppositories to alleviate constipation\r\n\r - Use of another investigational product within 3 months of the screening visit.\r\n\r - Antibiotic use within 2 months from the day of stool collection\r\n\r - Good adherence to the Mediterranean diet during the pre-baseline period (score >6)\r based on the 14-item Mediterranean Diet Assessment Tool\r\n\r - Physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis,\r Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short\r bowel disease, ileostomy, colostomy) other than gastroesophageal reflux or\r diverticular disease\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,704
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPilot Trial of Transnasal Nicotine in Parkinson Disease\n\n**Clinical Trial Summary:**\n\nThe widely observed inverse relationship between smoking and Parkinson's Disease (PD) and the\r results of numerous preclinical studies indicating neuroprotective effects of nicotine,\r suggest a possible novel intervention in PD. In our opinion, an optimal nicotinic therapy in\r PD would consist of pulsatile nicotine delivery (e.g. via nasal spray) similar to pulsatile\r nicotine obtained via smoking. The investigators believe that pulsatile stimulation of the\r central nicotinic receptors (achievable via nasal spray) would affect the dynamic of the\r nicotinic receptors much more desirably and similar to smoking compared to continuous\r nicotine administration via patch, which might result in continuous nicotinic receptor\r desensitization. Thus, this pilot trial seeks to evaluate the efficacy of nicotine nasal\r spray (Nicotrol NS®) in symptomatology of PD. For this purpose, a total of 6 non-smoking\r patients at intermediate disease stages (2-3 of Hoehn and Yahr scale) and receiving\r conventional therapy for PD will be recruited at the \"Instituto Nacional de Neurología y\r Neurocirugía, (Manuel Velasco Suárez)\" in Mexico City. Nicotrol NS® in incremental dosing (up\r to 10 mg/day) regimens will be added to the current medications to each patient during the\r first week. This will be maintained for up to 1 month. Motor and non-motor aspects of PD will\r be evaluated. The investigators expect significant improvement of motor and non-motor\r symptoms in all patients receiving Nicotrol NS® during therapy and a reversal during\r withdrawal.\n\n**Clinical Trial Detailed Description:**\n\nParkinson's disease (PD), the second most common progressive neurodegenerative disorder, is\r associated with loss of dopaminergic neurons in the substantia nigra pars compacta that leads\r to striatal dopamine deficiency. This dopaminergic loss results in motor deficits\r characterized by: akinesia, rigidity, resting tremor and postural instability as well as\r non-motor symptoms that might also involve other neurotransmitter systems. The non-motor\r symptoms may include: cognitive deficits (e.g., mild to severe memory impairment), emotional\r changes (e.g., depression, apathy and anxiety), sleep perturbations (e.g.,\r insomnia/hypersomnia), autonomic dysfunction (e.g., bladder disturbances, orthostatic\r hypotension, sweating), sensory symptoms (e.g., pain, visual and olfactory deficits) and\r gastrointestinal symptoms (e.g., constipation, nausea).\r\n\r Parkinson's disease current treatment of choice is replacement of dopamine with its precursor\r Levodopa (L-Dopa), which unfortunately loses its effectiveness and can cause dyskinesia\r following prolonged usage. This fact motivates the search for new pharmacological strategies\r to better control the symptoms and/or progression of the disease.\r\n\r The inverse relationship between smoking and PD has been confirmed by a number of\r epidemiological studies. Moreover, numerous preclinical studies indicate neuroprotective\r effects of nicotine. Thus, nicotine may offer a novel intervention in PD. Although use of\r nicotine patch has been suggested in some neurodegenerative disorders, including PD, the\r investigators believe that the key for success with nicotinic intervention, particularly in\r PD, relies on mode of nicotine administration. In our opinion, an optimal nicotinic therapy\r in PD would consist of pulsatile nicotine delivery (e.g. via nasal spray) similar to\r pulsatile nicotine obtained via smoking. Pulsatile stimulation of the central nicotinic\r receptors (achievable via nasal spray) would affect the dynamic of the nicotinic receptors\r much more desirably than continuous nicotine administration via patch, which can result in\r continuous nicotinic receptor desensitization. The investigators also believe that nicotine\r delivered via nasal spray, in addition to its potential usefulness for improving motor\r dysfunctions, may also be helpful in non-motor symptoms (e.g. cognitive decline and\r depression) that are commonly associated with neurological disorders such as PD.\r\n\r Thus, this pilot clinical trial seeks to evaluate the efficacy of treatment during one month\r with nicotine nasal spray (Nicotrol NS®) in motor and non-motor aspects of PD.\r\n\r Hypothesis: Scores of the Movement Disorders Society Unified Parkinson Disease Rating Scale\r (MDS-UPDRS) for motor and non-motor symptomatology will decrease after 1 month of treatment\r with nicotine nasal spray (Nicotrol) in patients with PD (stages 2-3 of Hoehn & Yahr).\r\n\r Research question: Can controlled doses of nicotine administered via nasal spray decrease the\r severity of PD (stages 2-3 of Hoehn & Yahr) using MDS-UPDRS scores?\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - Subjects over 60 years of age with a clinical diagnosis of Parkinson's disease\r\n\r - Stages of the disease 2-3 of Hoehn and Yahr\r\n\r - Not exposed to tobacco during any stage of their life\r\n\r - No history of lung diseases\r\n\r - No laboratory abnormalities\r\n\r - No history of adverse reactions to nicotine\r\n\r - Able to use nicotine nasal spray\r\n\r - Residents of Mexico City able to attend for evaluations\r\n\r - Under current treatment with levodopa at a stable dose\r\n\r - Not currently receiving a monoamine oxidase inhibitor treatment\r\n\r Exclusion Criteria\r\n\r - Unable to complete follow-up protocol\r\n\r - Drug adverse reaction\r\n\r - Death\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,705
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nVibrational Therapy to Improve Gait and Balance in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe purpose of this research study is to determine optimum dose of vibration delivered by an\r experimental device called PDVibe2 required to treat freezing of gait in persons with\r Parkinson's disease (PD). The PDVibe2 was developed by Resonate Forward, LLC (RF). This\r PDVibe2 was designed to administer vibration therapy to the wearer to improve gait and\r balance in persons with PD while wearing the device.\n\n**Clinical Trial Detailed Description:**\n\nParticipation will require up to 8 treatment sessions within 5 days (no more than 2 sessions\r in one day) plus an additional day for screening and another for follow-up (7 days total).\r All visits will occur at the Virginia Commonwealth University Parkinson's Movement and\r Disorders Center in Richmond, VA. Participants will be asked to walk for a brief period of\r time while wearing the PDVibe2. The PDVibe2 will provide vibration therapy and study staff\r will measure the number of \"freezes\" before, during and after therapy. Participants will be\r asked to provide feedback on the device, the therapy session and how they are feeling.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - age 21 years or older\r\n\r - PD diagnosed by a movement disorder specialist for 3 months or longer prior to\r recruitment\r\n\r - PD medication regimen is stable over the last 3 months with no changes\r\n\r - Hoehn & Yahr stage 2 (N = 13) and H&Y stage 3 (N=13),\r\n\r - able to walk independently or with a simple assistive device (e.g., cane, walker)\r\n\r - observed by the research team to have PD related gait disturbance such as FOG,\r shortened or irregular stride lengths, irregular step cadence, slowed speed while on\r their regular treatment regimen.\r\n\r Exclusion Criteria:\r\n\r - diagnosed with a known Parkinson plus syndrome\r\n\r - were previously exposed to vibration treatment for gait and balance\r\n\r - presence of dementia (Montreal Cognitive Assessment < 21)\r\n\r - additional disorders (not related to PD)impairing gait, stance, balance or\r coordination (e.g. stroke, leg amputations, or multiple sclerosis)\r\n\r - history of implantable cardiac device or any other implanted electronic device except\r a deep brain stimulator (DBS)\r\n\r - use of braces/orthotics that assist with walking\r\n\r - are currently in physical therapy (PT) treatment for balance or gait\r\n\r - peripheral neuropathy by exam\r\n\r - any condition that, in the opinion of the PIs, would compromise participant safety,\r data integrity, or data interpretation.\r\n\r - Children under the age of 18\r\n\r - Prisoners\r\n\r - Women who are pregnant or may become pregnant during the course of this study since\r the safety of this device for an unborn child is unknown.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
35,706
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nFecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nthis pilot study aims to further explore the potential usage of Fecal microbiota\r transplantation in treating constipation and possibly also motor symptoms in Parkinson's\r disease (PD) patients, and to increase understanding of the potential relationship between\r the identities of intestinal microbial communities and PD.\n\n**Clinical Trial Detailed Description:**\n\nFecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are\r transferred from a healthy donor to the patient, with as primary goal to introduce - or\r restore - a stable and 'healthy' microbial community in the gut.\r\n\r Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms and\r Gastrointestinal dysfunction, in particular constipation, affects up to 80% of PD patients\r and may precede the onset of motor symptoms by years.\r\n\r this study include one group of PD patients that will receive FMT. two other groups will\r serve as controls:\r\n\r 1. PD patients that will not receive FMT\r\n\r 2. healthy people who live with PD patients in the same house and share similar surrounding\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects aged > 50 years, diagnosed as suffering from PD and under follow up of the\r Movement Disorders Clinic in Soroka University Medical Center.\r\n\r - Subjects complaining of constipation .\r\n\r - Subjects who did not perform a screening colonoscopy for colon cancer.\r\n\r - Subjects who are clinically undertreated according to last Movement Disorders\r specialist's impression at the clinic visit.\r\n\r Exclusion Criteria:\r\n\r - Subjects who do not complain of constipation or seem clinically stable properly\r treated pharmacologically.\r\n\r - Subjects who already underwent a screening colonoscopy for colon cancer.\r\n\r - Subjects who suffer from a cognitive decline and could not give their consent, or\r patients who refuse to undergo a colonoscopy.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,707
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPacemaker Effect With Closed Loop Sensor in Neuromodulated Syncope Refractory to Medical Therapy\n\n**Clinical Trial Summary:**\n\nVasovagal syncope is an entity frequently in the emergency services, its treatment includes\r pharmacological and non-pharmacological measures, and in some severe cases, requires the\r implantation of cardiac stimulation devices, specifically, those pacemakers that have\r closed-loop sensors (CLS).\r\n\r This research is an intervention study, multi-institutional, randomized and double blind that\r will be carried out in patients older than 18 years, with a diagnosis of neurally mediated\r type 1, 2A or 2B syncope documented in a tilting table test, who have had at least 2 syncope\r in the last year and that significantly affects the quality of life despite the use of\r pharmacological and non-pharmacological non-interventionist therapy.\r\n\r This study aims to evaluate the effect of cardiac pacing therapy with CLS pacemakers on\r quality of life, recurrence of syncope and pre-syncopal symptoms in patients with a diagnosis\r of neurally mediated syncope in this group of patients.\n\n**Clinical Trial Detailed Description:**\n\nSyncope is defined as a loss of consciousness with inability to maintain the postural tone,\r with subsequent spontaneous recovery and without neurological sequelae. This occurs due to\r cerebral hypoperfusion by two mechanisms: 1) decreased cardiac output, usually due to\r bradycardia, and 2) hypotension due to decreased peripheral vascular resistance. An incidence\r of 6.2 per 1000 persons / year has been calculated, constitutes 2% of the reasons for\r consultation by emergency department and is found in 40% of the hospitalized participants.\r Its prevalence increases with age and is clearly influenced by the presence or absence of\r heart disease. The most frequent etiology is vasovagal, which has a benign course, with a\r mortality that does not exceed the expected for the general population. However, up to 21.6%\r have recurrences, which affects the quality of life and can generate physical injuries,\r especially in the geriatric population. The pathophysiology is not completely clear, it is\r thought that orthostasis has an important mechanism by decreasing the venous return,\r therefore, this leads to a vigorous contraction of the myocardium in the presence of a little\r filled heart chamber, it can stimulate the mechanoreceptors and thus precipitate the Bezold\r Jarisch reflex, which results in paradoxical hypotension and bradycardia.\r\n\r The management can be variable, and will depend on the patient's response, from conservative\r strategies such as changes in lifestyle, avoiding triggers, abortive maneuvers in the case of\r prodromes, and some drugs (fludrocortisone) to cardiac stimulation devices such as\r pacemakers. Cardiac stimulation has been studied in participants with cardioinhibitory\r response in the Tilt test with divergent results, especially with the use of conventional\r pacemakers that monitor the fall in heart rate. Interestingly, an other type of pacemakers,\r those with closed handle sensor (CLS), that measures the impedance through each beat, which\r is related to myocardial contractility, in this way it could detect changes in the\r contractility that precede the cardioinhibitory response, and thus guarantee a good cardiac\r output and avoid syncope.\r\n\r The use of cardiac stimulation therapy has been proposed as an effective strategy in\r participants with recurrent syncope and refractory to pharmacological and non-pharmacological\r measures, a special group are those with a cardioinhibitory response with asystole greater\r than 6 seconds, however, this benefit it could be extrapolated to those of mixed commitment.\r In the world, there is no definitive consensus on the level of recommendation for the\r implantation of pacemakers with CLS in this disease, however, based on the pathophysiology,\r studies of the disease and technical elements on the functioning of these devices, they have\r come implanting in Colombia and in the world with apparent good results in the quality of\r life of the participants, syncope-free event rate, longer time to the first syncope and\r improvement in hemodynamic parameters in the Tilt Test. In Colombia, more research is needed\r to confirm or reject this assertion.\r\n\r General objective: Evaluate the effect of cardiac pacing therapy with CLS pacemakers on\r quality of life, recurrence of syncope and pre-syncopal symptoms of participants with a\r diagnosis of neurally mediated syncope (with mixed response or inhibitory cardio) refractory\r to pharmacological and non-pharmacological management, in six health care centers in the city\r of Medellín.\r\n\r Specific objectives\r\n\r - Sociodemographically and clinically characterize the study population.\r\n\r - Evaluate the impact on quality of life, pre and post implant.\r\n\r - Measure the occurrence of episodes of syncope, pre and post implant.\r\n\r - Assess the reduction of pre-syncopal symptoms.\r\n\r - Evaluate if the mode and programming functions influence the appearance of syncopes and\r recurrences.\r\n\r - Determine the average time that elapses from the implantation of the CLS pacemaker until\r the first episode of syncope.\r\n\r Interventions of participants\r\n\r - A: participants who will be activated the CLS function one month after implantation of\r the pacemaker. They will be reevaluated after 4 months and will be changed to DDD-R mode\r for another 4 months, when the results will be analyzed to define the final form of\r reprogramming.\r\n\r - B: patient to whom, one month after the implantation of the pacemaker, the R function\r will be activated. They will be reevaluated after 4 months and will be switched to\r DDD-CLS mode for another 4 months, when they will be evaluated again and the results\r will be analyzed for define final form of reprogramming.\r\n\r Participants will be contacted through the electrophysiology service of \"CES Cardiology\" in\r Medellín, Colombia.\r\n\r The calculation of the sample size was carried out probabilistically with the following\r parameters and based on the previous studies: Power 80%, confidence: 95%, expected proportion\r of group 1: 72%, expected proportion group2: 99% What gave the following results:\r intervention A: 26 participants, intervention B: 26 participants. Total sample: 52\r participants.\r\n\r Selection of participants All participants will be recruited and who meet all the inclusion\r criteria and none of the exclusion criteria will be selected by one of the members of the\r research team previously trained on the Plan of Clinical Research and that has been\r designated to perform this type of tasks.\r\n\r Estimated time to include participants The inclusion of all participants requires\r approximately 6 months. The anticipated duration of this study is 27 months. This will depend\r on the inclusion rate.\r\n\r Informed consent process: It will be prepared by the principal investigator, with the\r information indicated in article 15 of resolution 8430.\r\n\r - It will be reviewed by the Human Research Ethics Committee of the CES University and can\r only be signed by the patient, researchers and witnesses when it is approved.\r\n\r - Indicate the names and contact forms of the principal investigators and who should be\r contacted in case of any difficulty or adverse event.\r\n\r - It must be signed by two witnesses and by the research subject or his legal\r representative. If the research subject does not know how to sign, he will print his\r fingerprint and in his name he will sign another person that he designates.\r\n\r - It will be prepared in duplicate, leaving a copy in the possession of the research\r subject or his legal representative.\r\n\r Blinding of the study: The programming modes of the intracardiac devices can only be known\r through the use of specific reprogramming equipment provided by each generating company of\r the device. In the case of pacemakers with CLS, their only manufacturer is Biotronik, so they\r provide a device that connects with the device that the patient has implanted. Unless the\r reprogramming card is delivered, neither the patient nor another person will be able to\r establish the programming mode.\r\n\r In this way the people who will be in contact with the programming of the device will be:\r\n\r Electrophysiologist in charge of implanting the device: it could be any of the members of the\r CES Cardiology group with this training, it will implant the device and leave it in DDD-CLS\r mode to start the first month or washing time. This electrophysiologist will not make any\r scheduled visits or reprogram the device in any of his visits.\r\n\r Electrophysiologist commissioned the visit by electrophysiology within each of the visits\r scheduled and listed above: professional in charge of programming the devices as established\r by the paper envelopes generated in the random assignment. It will be the only person who\r will know the way of programming during the 8 months of intervention and will not disclose\r this information to the patient or their relatives.\r\n\r Main co-investigators: they will not know the way of programming the device nor will they\r attend the part of the visit that performs electrophysiology. In another office and before or\r after the program, they will evaluate the patient clinically and ask the questions included\r in the scales of quality of life used.\r\n\r The person who will analyze the information: will know the process. The patient: He will not\r know the programming mode of his device, that is, he will not know if he is in DDD - CLS or\r DDD - R. This study will be double blind.\r\n\r Random assignment Through computer-based randomization programs, 26 participants will be\r assigned to the group of participants who, in the month of implantation, will be programmed\r in DDD-CLS mode and 26 participants who will be programmed in DDD-R mode one month after\r implantation. The randomization will be known by the investigating epidemiologist who will\r activate the randomization program and the electrophysiologist who will program the patient.\r Initial randomized programming modes will be delivered in sealed envelopes to the\r electrophysiologist who will program the patient.\r\n\r Procedures The clinical trial will be conducted in accordance with the Clinical Research\r Plan. All those who participate in the conduct of the clinical study will be qualified by\r training, training or experience to carry out their tasks and this training should be\r documented in an appropriate manner. The clinical study will not begin until it receives\r written approval from the Ethics Committee and the relevant regulatory authorities and all\r necessary documentation has been collected. Procedures during the time of intervention. Once\r the patient enters the health center with criteria to participate in the study, as long as it\r does not meet any of the exclusion criteria and has signed the informed consent (the\r participant or a legal representative in case this is not in conditions to sign).\r\n\r Starting point: Prior to implanting the device. Between the day of implantation and the first\r month (at which time the initial visit will take place) will be the washing or \"wash out\"\r process in which the device will be left in DDD-CLS mode until the start visit.\r\n\r Start visit: One month after implanting the device. It includes two parts: Evaluation by\r electrophysiology and Clinical evaluation.\r\n\r Visit # 1: It will happen 4 months after the start visit. It includes two parts: Evaluation\r by electrophysiology and Clinical evaluation.\r\n\r Visit # 2: Finally, a final check (visit # 2) will be made 8 months after the start visit and\r 4 months after the visit # 1. It includes two parts: Evaluation by electrophysiology and\r Clinical evaluation.\r\n\r Procedures during the time following the end of the intervention: At the end of the 8 months\r in which the information on the mode of reprogramming was recorded and these modes were\r reversed, the follow-up will continue for 12 more months counted from visit # 2 as follows:\r\n\r - Visit # 3: It will take place 6 months after the visit # 2 and 14 months after the\r initial visit. The patient will be evaluated clinically (without pacemaker programming)\r by one of the researchers who will apply the SFSQ and SF-36 quality of life scales.\r\n\r - Visit # 4: It will take place 12 months after the visit # 2 and 20 months after the\r initial visit. The patient will be evaluated clinically (without pacemaker programming)\r by one of the researchers who will apply the SFSQ and SF-36 quality of life scales.\r\n\r After this the study ends.\r\n\r Procedures in case of Adverse Events: In the event of any adverse event related or not to the\r implant or use of the device or any condition of the patient, the patient must notify the\r group of researchers in the contact telephone numbers that are delivered and according to the\r severity and needs of the event will be cited in an additional visit for clinical evaluation\r and / or electrophysiology or will be redirected to the CES Clinic if the event or situation\r requires management in the emergency department or intrahospital service. Each of these\r adverse events must be reported on a form and a communication sent within 72 hours after the\r group of researchers had knowledge of the Human Research Ethics Committee of the CES\r University, making the event known to all. the details.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Over 18 years.\r\n\r - Diagnosis of neurally mediated syncope with a tilting table test (Tilt test) that\r demonstrates a mixed (type 1) or cardioinhibitory response (Type 2A and 2B).\r\n\r - Negative impact on work and social life.\r\n\r - Non-respondent to pharmacological therapy (Fludrocortisone 0.1mg / 24 hours for 3\r months) and non-pharmacological (exercise, hydration and consumption of more than 3\r months) is due to a cardiologist who has performed a strict stricture over time.\r\n\r - At least 2 episodes of syncope in the last year.\r\n\r Exclusion Criteria:\r\n\r - Complete atrioventricular block.\r\n\r - Second degree ventricular atrial block.\r\n\r - Bradycardia syndrome - tachycardia.\r\n\r - Disease of the sinus node.\r\n\r - Arrhythmia (bradycardia or tachycardia that generate syncope and / or low cardiac\r output).\r\n\r - Syncope due to hypersensitivity of the carotid sinus.\r\n\r - Syncope with Tilt Test that demonstrates depressant vasopressor response (type 3).\r\n\r - Refusal of the patient, his relatives or the attending physician to participate in the\r study.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,708
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIntranasal Oxytocin for the Treatment of Alcohol Use Disorder\n\n**Clinical Trial Summary:**\n\nPrimary: The primary objective of the study is to compare the efficacy of intranasal oxytocin\r in reducing the weekly percentage of heavy drinking days over the 12 weeks of treatment among\r subjects with moderate to severe Alcohol Use Disorder (AUD). A \"heavy drinking day\" is 4 or\r more drinks per drinking day for women and 5 or more drinks per drinking day for men.\r\n\r Secondary: Secondary objectives include assessment of other measures of the effects of\r oxytocin compared with placebo on reduction of alcohol use as well as effects on\r psychological assessments, alcohol craving, alcohol-related consequences, cigarette smoking\r and other nicotine use, retention in the study, and safety and tolerability throughout the\r study.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Be at least 18 years of age.\r\n\r 2. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed\r using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity,\r ICD-10-CM Code F10.20 alcohol dependence, uncomplicated).\r\n\r 3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent\r document (either just prior to or immediately after signing consent).\r\n\r 4. Be seeking treatment for problems with alcohol reduction in drinking.\r\n\r 5. Be able to verbalize an understanding of the consent form, able to provide written\r informed consent, verbalize willingness to complete study procedures, able to\r understand written and oral instructions in English and able to complete the\r questionnaires required by the protocol.\r\n\r 6. Agree (if the subject is female and of child bearing potential) to use at least one of\r the following methods of birth control, unless she is surgically sterile, partner is\r surgically sterile or she is postmenopausal:\r\n\r 1. oral contraceptives,\r\n\r 2. contraceptive sponge,\r\n\r 3. patch,\r\n\r 4. double barrier (diaphragm/spermicidal or condom/spermicidal),\r\n\r 5. intrauterine contraceptive system,\r\n\r 6. etonogestrel implant,\r\n\r 7. medroxyprogesterone acetate contraceptive injection,\r\n\r 8. complete abstinence from sexual intercourse, and/or\r\n\r 9. hormonal vaginal contraceptive ring.\r\n\r 7. Be able to take intranasal investigational products and be willing to adhere to the\r investigational product regimen.\r\n\r 8. Complete all assessments required at screening and baseline.\r\n\r 9. Have a place to live in the 2 weeks prior to randomization and not be at risk that\r s/he will lose his/her housing by Study Week 14.\r\n\r 10. Not anticipate any significant problems with transportation arrangements or available\r time to travel to the study site by Study Week 14.\r\n\r 11. Not have any plans to move within Study Week 14 to a location which would make\r continued participation in the study impractical.\r\n\r 12. Not have any unresolved legal problems that could jeopardize continuation or\r completion of the study.\r\n\r 13. Provide contact information of someone, such as a family member, spouse, or\r significant other, who may be able to contact the subject in case of a missed clinic\r appointment.\r\n\r 14. Be someone who in the opinion of the investigator would be expected to complete the\r study protocol.\r\n\r 15. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend\r each scheduled visit, participate in phone visits and that s/he does not have any\r already scheduled events or a job that may substantially interfere with study\r participation.\r\n\r 16. If taking a medication for depression or anxiety, must have been taking a stable dose\r in the 2-months prior to randomization and plan to continue during the study. This\r includes drugs such as the following:\r\n\r - SSRIs\r\n\r - Dual uptake inhibitors\r\n\r - SNRIs\r\n\r - Tricyclic antidepressants\r\n\r - MAOIs\r\n\r - Bupropion\r\n\r 17. Not currently taking oxytocin and agree not to take non-study oxytocin for the\r duration of the study.\r\n\r Exclusion Criteria:\r\n\r Contact study site for exclusion criteria.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,709
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive Impairment in Parkinson's Disease (PD)\n\n**Clinical Trial Summary:**\n\nThis study aims to assess the therapeutic role of rTMS on parkinson's patients with cognitive\r impairment. Patients diagnosed with Parkinson's Disease and cognitive impairment will be\r recruited. All patients will be admitted and will be allocated randomly into two groups one\r of which will receive real sessions of high frequency rTMS for each hemisphere for 10\r consecutive sessions totally over period of 10 days with repeated booster sessions every\r month during the period of follow up. The other will receive sham sessions.\n\n**Clinical Trial Detailed Description:**\n\nThis study aims to assess the therapeutic role of rTMS on parkinson's patients with cognitive\r impairment. Thirty PD patients with cognitive impairment using United Kingdom (UK ) bank\r criteria for PD will be recruited from outpatient clinic in Assiut University. All patients\r will be admitted at Neuropsychiatric Department, Assiut University Hospital/ Assiut,\r Egypt.Each patient fulfilled the inclusion criteria as having score less than 24 on\r Mini-Mental Status Examination will be recruited. The patients will be allocated randomly\r into two groups one of which will receive real sessions of high frequency rTMS (25 HZ), with\r intensity of 80% of resting motor threshold detected from the hand motor area, with total\r 2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days\r with repeated booster session every month during the period of follow up among three months.\r The other will receive sham sessions. All subjects will be followed up by selected clinical\r rating scales at different intervals pre session, post 10 sessions, and after one, two and\r three months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All patients with Parkinson's Disease who were diagnosed according to UK bank criteria\r for PD, Aged 45-75 years, with criteria for cognitive impairment (Mini-Mental Status\r Examination< 24), and consent obtained from the patient or his caregiver.\r\n\r Exclusion Criteria:\r\n\r - History of repeated head injury\r\n\r - History of repeated cerebrovascular strokes\r\n\r - History of defined encephalitis\r\n\r - Oculogyric crisis, supranuclear gaze palsy\r\n\r - Family history of more than one relative\r\n\r - History of drug intake as antipsychotics or\r 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) exposure\r\n\r - Moderate and Severe depression (Hamilton Depression Rating Scale score >16)\r\n\r - severe dysautonomia\r\n\r - Cerebellar signs\r\n\r - Babinski sign\r\n\r - Strictly unilateral features after 3 years\r\n\r - Hydrocephalus or intracranial lesion on neuroimaging\r\n\r - We also excludes patients with intracranial metallic devices or with pacemakers or any\r other device.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,710
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nOptimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe purpose of this research study is to test the safety, tolerability, and the effect of\r vibration (delivered by an experimental device called PDVibe2) on freezing of gait (FOG) in\r persons with Parkinson's disease (PD). The PDVibe2 was developed by Resonate Forward, LLC\r (RF). This PDVibe2 was designed to administer vibration therapy to the wearer to improve gait\r and balance in persons with PD while wearing the device.\n\n**Clinical Trial Detailed Description:**\n\nParticipation will require up to 8 treatment sessions within 5 days (no more than 2 sessions\r in one day) plus an additional day for screening and another for follow-up (7 days total).\r All visits will occur at the Virginia Commonwealth University Parkinson's Movement and\r Disorders Center in Richmond, VA. Participants will be asked to walk for a brief period of\r time while wearing the PDVibe2. The PDVibe2 will provide vibration therapy and study staff\r will measure the number of \"freezes\" before, during and after therapy. Participants will be\r asked to provide feedback on the device, the therapy session and how they are feeling.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - age 21 years or older\r\n\r - PD diagnosed by a movement disorder specialist for 3 months or longer prior to\r recruitment\r\n\r - PD medication regimen is stable over the last 3 months with no changes\r\n\r - Hoehn & Yahr stage 2 (N = 13) and H&Y stage 3 (N=13),\r\n\r - able to walk independently or with a simple assistive device (e.g., cane, walker)\r\n\r - observed by the research team to have PD related gait disturbance such as FOG,\r shortened or irregular stride lengths, irregular step cadence, slowed speed while on\r their regular treatment regimen.\r\n\r Exclusion Criteria:\r\n\r - diagnosed with a known Parkinson plus syndrome\r\n\r - were previously exposed to vibration treatment for gait and balance\r\n\r - presence of dementia (Montreal Cognitive Assessment < 21)\r\n\r - additional disorders (not related to PD)impairing gait, stance, balance or\r coordination (e.g. stroke, leg amputations, or multiple sclerosis)\r\n\r - history of implantable cardiac device or any other implanted electronic device except\r a deep brain stimulator (DBS)\r\n\r - use of braces/orthotics that assist with walking\r\n\r - are currently in physical therapy (PT) treatment for balance or gait\r\n\r - peripheral neuropathy by exam\r\n\r - any condition that, in the opinion of the PIs, would compromise participant safety,\r data integrity, or data interpretation.\r\n\r - Children under the age of 18\r\n\r - Prisoners\r\n\r - Women who are pregnant or may become pregnant during the course of this study since\r the safety of this device for an unborn child is unknown.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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35,711
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nChinese PD Registry\n\n**Clinical Trial Summary:**\n\nThe purpose of the Chinese Parkinson's disease Registry (CPDR) is to develop a database of\r patients with Parkinson's disease in China.\n\n**Clinical Trial Detailed Description:**\n\nParkinson's disease (PD) is the second most common disorder among degenerative neurological\r diseases. PD is a complicated disease which consists of different subtypes. A certain type of\r parkinsonism has its unique clinical feature and genetic basis. Standards of classification\r and prognosis in different PD subtypes are still poorly understood. Investigators aim to\r establish a database of longitudinal recruited PD cohort ,and characterize the clinical\r feature, genetic basis, environmental factors and their interactions among different PD\r subtypes in China, identify natural history of a highly-presentative Chinese PD cohort and to\r discern major milestones in the disease process which indicates disease progression.\r\n\r Data were collected at baseline, 12±1 months during the routine follow-up visits. Information\r about detailed disease history, level of education, significant chronic comorbidities,\r physical examination, medication history, family history, living habits and toxic exposure\r history, which include smoking, drinking tea, alcoholic consumption, drinking coffee,\r exposure to pesticide or occupational solvent, history of carbon monoxide poisoning and\r recurrent head trauma will be recorded at baseline. For each evaluation, the same\r questionnaires will be conducted. A standardized neurological assessment according to the\r recommendation of Consensus on the construction of clinical database of Parkinson's disease\r and movement disorders in China. The Unified Parkinson's Disease Rating Scale (UPDRS) part\r III is conducted for motor assessment, all the patients are evaluated in \"OFF\" state. The\r clinical stage of PD is assessed by Hoehn and Yahr scale (H-Y). The non-motor symptoms are\r evaluated by Non-motor Symptom Scale (NMSS), autonomic symptoms are evaluated by The Scale\r for outcomes in Parkinson disease for Autonomic Symptoms (SCOPA-AUT). Constipation was\r diagnosed by Functional Constipation Diagnostic Criteria Rome Ⅲ. The 39-item Parkinson's\r Disease Qestionnaire (PDQ-39) was used to assess the quality of life. Sleep quality was\r evaluated by Parkinson's Disease Sleep Scale (PDSS) and excessive daytime sleepiness by\r Epworth Sleepiness Scale (ESS). Probable rapid eye movement sleep behavior disorder (p-RBD)\r was diagnosed by rapid eye movement sleep behavior questionnaire-Hongkong (RBDQ-HK). Restless\r leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome\r questionnaire (CH-RLSq). Cognitive assessment was used the previously validated scale, Mini\r Mental State Examination (MMSE). Olfaction test was carried out by Hyposmia Rating Scale\r (HRS), a proportion of patients was also ascertained by Sniffin's Sticks. Depression was\r diagnosed by Hamilton Depression Scale (HAMD). Symptom of fatigue was measured by PD fatigue\r severity scale (PFS). Wearing-off was evaluated by WOQ-9 and freezing gait by new freezing\r gait questionnaire scores (NFOGQ). Dyskinesis was evaluated by Rush Dyskinesia Rating Scale.\r DNA samples extracted from peripheral blood and all the PD patients will be examed by Whole\r Exome Sequencing or Whole-genome sequencing. All the participants are scanned by structural\r MRI to exclude obvious intracranial lesions and other parkinsonism such as MSA, PSP and WD.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients diagnosed with PD by UK Brain Bank Diagnostic Criteria and other standard\r criteria.\r\n\r Exclusion Criteria:\r\n\r - Lack of capacity to consent to participate in the project\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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35,712
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nParkinson's Disease Inpatient Clinical Knowledge and Management\n\n**Clinical Trial Summary:**\n\nThis study will focus on patients with Parkinson's Disease in the adult inpatient units of\r Hackensack University Medical Center. We are measuring the effect of a Parkinson's Disease\r Inpatient Clinical Knowledge and Management Program on adherence to Parkinson's Disease\r medication using a Parkinson's Disease Identification Wrist Band, smartwatch and medication\r schedule card\n\n**Clinical Trial Detailed Description:**\n\nParkinson's Disease (PD), the second-most common neurodegenerative disorder and is ranked the\r fourteenth leading cause of death. PD prevalence rate in the United States is estimated to be\r approximately 0.3% and is ranked the fourteenth leading cause of death (CDC, 2013). Depending\r on the methodology, the national prevalence data on PD is varied and insufficient. PD is\r projected to increase by 4% to 5% in age 65 and over 85 years respectively and is associated\r with high economic burden exceeding $14.4 billion per year.\r\n\r Admission to the hospital is identified as a major risk factor due to imprecise timing of\r medication administration, disruption of sleep pattern, dietary changes, and unfamiliarity of\r the hospital environment which all contribute to exacerbation of PD symptoms. Parkinson's\r disease Foundation, 2015). Hospital length of stay for patient with PD is 1.45 times higher\r in comparison to non- PD patients.\r\n\r A study by Chou et al., (2011) involving 51 worldwide National Parkinson Foundation Centers\r found 94% of centers were not confident in the care and knowledge hospital professionals\r provided specific to: PD medications, complex drug interactions, contraindications and\r precise timing of medication administration. Hospital co-morbidities could be improved or\r prevented by adjustment of PD medication and medication adherence, critical in decreasing\r hospital length of stay.\r\n\r The retrospective phase will be a data collection of adult patients admitted with a primary\r and secondary diagnosis of Parkinson's disease during January - June 2015 (6 month period).\r There will be 150 patients selected by the principal investigator(s) from chart review. In\r addition, the clinicians chosen for the study will complete a Parkinson's Disease Knowledge\r Assessment Survey.\r\n\r The prospective phase will begin after completion of the Parkinson's Disease Inpatient\r Clinical Knowledge and Management Program for staff nurses, advanced practice nurses (APN),\r nursing assistants, patient care technicians, case managers, adult inpatient physician\r assistants, pharmacists, occupational therapists, physical therapists, nurse educators, and\r dietitians. There will be 150 patients selected from the adult inpatient units by the\r principal investigator(s) that meet the inclusion criteria and confirm through an informed\r consent that they will participate in the study.\r\n\r The selected patients will be registered in a Watch Rx interface via website URL by the\r Principal Investigator(s) and the Transition of Care(TC) Pharmacist and required to wear a\r Watch Rx smartwatch for the duration of their hospitalization. The Watch Rx Interface will\r store all medical information, necessary treatments and daily clinical care for the patient\r which is synchronized to the smartwatch on the patient's wrist. The smartwatch will send\r alerts to the patient's assigned nurse's iPad through a Watch Rx app for medication\r administration, missed PD medications, battery conditions, and enables messaging between the\r primary nurse and the patient.\r\n\r The WatchRx smartwatch will remind when it is time to take the medication. If the Parkinson's\r Disease medication is not administered, it sends missed medication reminder alerts to the\r nurse. For fixed time medication, the reminder is every 3 minutes up to 10 minutes.\r\n\r During the prospective phase, the research team will collect data from multiple sources such\r as the Watch Rx system, EPIC Hyperspace, and Case Report forms over a 6 month study period.\r The data will be calculated by using statistical analysis for the continuous variables and\r categorical variables identified from the collection of data. All study data will be imported\r into SAS software where data programming will be utilized to flag and generate queries on out\r of range data issues until they are resolved. All analysis will be performed using SAS\r version 9.4 (SAS Institute Inc. Cary, NC, USA Data will be handled in a confidential manner\r to meet mandated IT Security standards and to prevent loss of privacy. All electronic files\r will be stored in an encrypted and password-protected database on a secure medical center\r server. Only co-investigators, advanced practice nurses and the data coordinator who contact\r the subjects will have access to information linked to subject identifiers.\r\n\r This study will improve timely administration of medications to PD patients. Patients\r enrolled in the study will have direct monitoring of their medication compliance and\r adherence. Patients participating in the registry will be gain information from the current\r research and possibly create a support group amongst themselves. This study will improve\r knowledge of Parkinson's disease amongst clinicians and better medication management of PD\r patients\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adult patients diagnosed with primary and secondary diagnosis of Parkinson's disease\r\n\r - Patient 22 years old and older\r\n\r - Patients admitted to inpatient units\r\n\r - Patient who are verbally informed and agree to participate in the study\r\n\r Exclusion Criteria:\r\n\r - Patients less than or equal to 21 years of age\r\n\r - Patients who refuse to wear the PD wrist band.\r\n\r - Patients who verbally refuse enrollment in the PD registry.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,713
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Trial of CHOP-R Therapy, With or Without Acalabrutinib, in Patients With Newly Diagnosed Richter's Syndrome\n\n**Clinical Trial Summary:**\n\nThe STELLAR trial will assess the effect of acalabrutinib taken in combination with CHOP-R\r compared to taking CHOP-R alone in patients with newly diagnosed Richter's Syndrome (RS). It\r will also be a platform to test other new drugs that show potential for treating RS. Chronic\r lymphocytic Leukaemia (CLL) is the most common blood cancer in adults, usually in their 70s\r or older. In a few patients, CLL can transform from a slow-growing cancer into an aggressive\r lymphoma called Richter's Syndrome. RS is very difficult to treat and patients have a short\r life-expectancy - usually a few months after diagnosis. Treatment for Richter's Syndrome in\r the UK is CHOP (four chemotherapy drugs) plus rituximab ('R' - an antibody treatment). The\r CHOP-R treatment is given as a standard of care for RS but has limited benefit - it is often\r temporary to extend life. Richter's Syndrome returns in most patients who then die from this\r disease. The STELLAR trial will investigate if a new drug called acalabrutinib, which is\r effective used by itself in patients with relapsed CLL and also some with Richter's Syndrome,\r will improve outcomes for newly diagnosed patients with RS. Acalabrutinib blocks a protein in\r CLL which can stop the cancer growing.\r\n\r Participants who have Richter's Syndrome and are suitable for CHOP-R will be recruited by\r specialised hospitals across the UK. People with another cancer, heart problems, or recent\r stroke cannot take part. Participants will have a lymph node biopsy, 3-4 bone marrow\r biopsies, blood samples, and PET-CT and CT scans. CHOP-R is given in a hospital every three\r weeks up to 6 times. All participants will receive CHOP-R; half will also receive\r acalabrutinib. When treatment with CHOP-R ends the patients who had acalabrutinib can\r continue to take it; patients who had CHOP-R alone may have acalabrutinib if their Richter's\r Syndrome returns after CHOP-R.\n\n**Clinical Trial Detailed Description:**\n\nTrial Design:\r\n\r STELLAR is a UK multi-centre trial for patients with newly-diagnosed Richter's Syndrome (RS),\r which is a rare and highly aggressive transformation of another blood cancer, chronic\r lymphocytic leukaemia (CLL). It has two parts: a randomised trial (the main component of the\r trial) which compares the current standard of care with an 'experimental' combination, and a\r platform for trialing single-arm studies investigating new drugs, or new combinations of\r drugs, for treating patients with newly-diagnosed Richter's Syndrome. The first novel\r treatment to be investigated in STELLAR is acalabrutinib which is a 'small molecule' drug\r that targets and blocks one of the pathways that causes the CLL (and by extension Richter's\r Syndrome) cancer cells to grow and multiply. Stopping the proliferation of cancer cells is a\r key aim of cancer treatments. There have been promising studies using acalabrutinib to treat\r patients with CLL and patients with Richter's Syndrome, but so far these are small and have\r not compared acalabrutinib, on its own or in a combination, with the current Standard of Care\r treatment for Richter's Syndrome: CHOP-R chemotherapy (cyclophosphamide, doxorubicin,\r vincristine, prednisolone and rituximab). In the STELLAR trial we will investigate if adding\r acalabrutinib to CHOP-R gives a better outcome for patients than CHOP-R alone. The sample\r sizes described below have been calculated by biostatisticians and are based on the known\r rates of progression, survival, and response rates for patients with Richter's Syndrome. The\r sample sizes given below will enable us to answer the research questions with the appropriate\r number of patients with a strong confidence interval.\r\n\r In the randomised component of STELLAR, 60 eligible patients will be randomised 1:1 between\r the current standard of care for Richter's Syndrome (CHOP-R) and the experimental treatment\r of CHOP-R plus acalabrutinib such that 30 patients are in each of these two sets. The trial\r is not blinded so participants, clinic staff, and trial staff will know which treatment they\r receive after the patient has been randomised. Participants will have frequent assessments,\r which includes assessments after 4 and 6 cycles of treatment to see if the treatment is\r working, and all patients will be followed up for a minimum of 2 years. The primary aim of\r the randomised component is to see if adding acalabrutinib to CHOP-R improves the rate of\r progression free survival (PFS) for RS patients, i.e. if they are in remission from Richter's\r Syndrome for a longer period of time. It is important that this component is randomised so\r that the comparison of the two treatments will be fair and unbiased.\r\n\r In the platform study part of STELLAR, single-arm cohorts (not randomised) will receive\r treatment which will test the activity of novel combinations or treatment. The platform may\r be expanded to test other promising treatments if any are identified whilst the randomised\r trial is open to recruitment. In the first platform study there are two cohorts which will\r answer two different research questions. The platform arms are not randomised or blinded\r because they are not comparable; it is rather that they help us to determine whether these\r treatments may be possible candidates for future therapies.\r\n\r - Cohort 1 (21-30 participants) will be made up of patients whose Richter's Syndrome has\r progressed (their disease has got worse) whilst being treated with CHOP-R (or CHOP +\r another immunotherapy treatment) alone or who have relapsed with Richter's Syndrome\r after completing treatment with CHOP-R. Entry to this cohort will be prioritised for\r patients who have taken part in the STELLAR randomised trial, but will be opened up to\r patients outside STELLAR if fewer than 21 patients from STELLAR take part. In this\r cohort we will investigate if giving acalabrutinib treatment on its own improves\r outcomes for patients who have got worse on or relapsed after the current standard of\r care (CHOP-R).\r\n\r - Cohort 2 (up to 15 patients) are anthracycline-naïve (they haven't received CHOP-R\r before) Richter's Syndrome patients, who have been diagnosed whilst being treated with\r ibrutinib (defined as a diagnosis within 4 weeks of the last dose of ibrutinib).\r Ibrutinib is the same class of drug as acalabrutinib, though acalabrutinib is a newer\r drug. Ibrutinib is often used to treat CLL and it is not known if patients who have been\r treated with ibrutinib will respond to treatment with acalabrutinib if they have\r Richter's Syndrome. Ibrutinib is becoming a routine treatment for CLL, so it is\r important to find out if acalabrutinib will help patients who do not respond to\r ibrutinib. These patients are not included in the randomised trial so that we can\r determine if acalabrutinib will work in these ibrutinib-treated patients.\r\n\r Participants:\r\n\r Participants will be identified at specialist haemato-oncology centres around the UK through\r multidisciplinary team meetings and consultant referral from other centres. Patients will be\r approached by their consultant and other, trained, members of the clinic team to introduce\r and discuss the trial. Patients will receive a patient information sheet and will be given at\r least 24 hours to review the information and ask any additional questions they may have.\r\n\r Patients who have enrolled on STELLAR who are offered entry into Cohort 1 because their\r disease has worsened when treated with CHOP-R alone, will already be familiar with the trial\r processes and systems. They will need to know all of the new information about acalabrutinib\r (the treatment for Cohort 1) and will be provided with a separate patient information sheet,\r clinicians will aim to give patients at least 24 hours to review the information. Because\r these patients are already familiar with the trial and will need urgent treatment they may be\r permitted to consent on the same day that they have received the patient information sheet if\r they have all their questions answered and are happy to proceed.\r\n\r Treatment:\r\n\r Participants randomised to the standard of care arm will receive up to 6 cycles of CHOP-R\r where each cycle is 21 days. Participants will be treated in a hospital day unit on day 1 of\r each cycle and will have tablets to take at home on days 2 to 5. All participants will be\r formally assessed after 4 and 6 cycles of treatment. Participants who have achieved a\r response may continue on to a stem cell transplant if they are suitable. Participants who do\r not achieve a response will be offered entry in to the platform Cohort 1 to receive\r acalabrutinib monotherapy if they are eligible. Entry into Cohort 1 is not mandatory; the\r participant's doctor will discuss all possible treatment options with them.\r\n\r Participants who consent and are registered to Cohort 1 will take 100 mg twice-daily of\r acalabrutinib at home as oral tablets. Treatment is continuous until disease progression,\r unacceptable toxicity or patient choice. Participants will be formally assessed at weeks 12\r and 24 to determine if they are responding to treatment.\r\n\r Participants randomised to the experimental arm of STELLAR and registered to Cohort 2 will\r receive up to 6 cycles of CHOP-R where each cycle is 21 days. Participants will be treated in\r a hospital day unit on day 1 of each cycle and will have tablets to take at home on days 2 to\r 5. Patients will then take 100 mg twice daily of acalabrutinib oral tablets at home on days\r 6-21. All participants will be formally assessed after 4 and 6 cycles of treatment.\r Participants who have achieved a response will continue to take acalabrutinib at home at 100\r mg twice daily, continuously until disease progression, unacceptable toxicity or patient\r choice. These participants may continue on to a stem cell transplant if they are suitable. If\r these patients do not achieve a response, they will discontinue trial treatment.\r\n\r In all cases, if patients do not respond to treatment or wish to withdraw from the trial they\r will be counselled by their medical team on the options available to them.\r\n\r Assessments and visits:\r\n\r Participants in the STELLAR trial will have frequent assessments in the first 4 to 6 months\r of the study so that they are monitored for toxicity and response to treatment. Most of the\r assessments for participants receiving CHOP-R (with or without acalabrutinib) would be done\r as part of their standard of care. Before entering the study each potential participant will\r undergo screening assessments in the 4 weeks before trial entry (date of randomisation or\r registration).\r\n\r Screening assessments:\r\n\r A physical and medical assessment by their doctor to record their: age, medical history,\r blood pressure, pulse, weight, any symptoms of their Richter's Syndrome, ECG (heart trace),\r and any other relevant information. Women who are could become pregnant have to have a\r pregnancy test. Blood samples are taken for local assessments (blood count and other\r haematology tests, biochemistry, virology, immunology) and also for research (these are\r 'extra' samples that are not standard of care). Patients will also have a bone marrow\r assessment, a PET-CT scan, and a lymph node biopsy; these assessments would be done as part\r of the patients' standard of care.\r\n\r Assessments during the trial:\r\n\r All patients will have local assessments carried out whilst they receive CHOP-R, most of\r these assessments are standard of care. Patients will have extra assessments that will help\r us to answer the exploratory questions posed in the trial. Most of these extra assessments\r will be done at the same time as local assessments so that patients don't have lots of extra\r visits to the hospital. Patients in all cohorts will have: a physical assessment by their\r doctor to record their blood pressure, pulse, weight, and any symptoms or side effects they\r may have; blood samples are taken for local assessments, patients receiving acalabrutinib\r will have more blood samples taken for research at the same time as the local ones.\r\n\r All patients will have a lymph node biopsy, bone marrow biopsy and PET-CT scan as part of\r their screening assessments. Some patients may have a bone marrow biopsy at the end of cycle\r 6 (or week 24 for Cohort 1) which would be part of their standard of care. All patients will\r have a CT scan at the end of cycle 4 (week 12 for Cohort 1) and a PET-CT at the end of cycle\r 6 (week 24 for Cohort 1). If a patient has disease progression they will have another PET-CT\r scan and lymph node biopsy, and some patients will have a bone marrow biopsy. All of these\r scans and biopsies would be part of the patient's standard of care.\r\n\r As well as medical assessments, patients will complete validated Quality of Life\r questionnaires at trials visits. There are three multi item scales on fatigue, treatment side\r effects and disease symptoms, infection and social activities and future health worries.\r These questionnaires will be completed at clinic visits.\r\n\r Follow Up:\r\n\r All STELLAR patients will be followed-up for disease status and survival for at least 2 years\r from trial entry to determine the long-term effectiveness of the therapy.\n\n**Clinical Trial Eligibility Criteria:**\n\nEntry criteria for randomised trial component (standard of care and experimental arms):\r\n\r Inclusion criteria for the randomised trial component:\r\n\r - Suitable for anthracycline-containing chemo-immunotherapy.\r\n\r - Patients with CLL and newly diagnosed biopsy proven DLBCL-type RS.\r\n\r - ECOG performance status of 0, 1, 2 or 3.\r\n\r - Age 16 years and over.\r\n\r - Signed written informed consent prior to performing any study-specific procedures.\r\n\r Exclusion criteria for the randomised trial component:\r\n\r - Prior therapy with CHOP or any anthracycline containing treatment at any time prior to\r randomisation. (Please note that pre-treatment with prednisolone up to 2mg/kg is\r allowed for up to 14 days prior to the start of treatment).\r\n\r - Ibrutinib-exposed CLL patients who have been newly diagnosed with RS within four weeks\r of their last dose of ibrutinib. (Ibrutinib-exposed CLL patients who discontinue\r ibrutinib due to toxicity or progressive CLL and later (more than four weeks) develop\r RS are not excluded from the randomised trial component).\r\n\r - Previous acalabrutinib exposure. (Prior exposure to other Bruton tyrosine kinase\r (BTK), phosphoinositide-3-kinase (PI3K), or BCL-2 inhibitors is permitted, with the\r exception of patients who have progressed on ibrutinib - see exclusion criterion\r above).\r\n\r - Known central nervous system (CNS) involvement of CLL or DLBCL.\r\n\r - Any other active malignancy that requires active treatment, with the exception of\r basal cell carcinoma, in-situ cervical cancer, and non-invasive squamous cell\r carcinoma of the skin.\r\n\r - Chronic or ongoing active infectious disease requiring systemic treatment such as, but\r not limited to, chronic renal infection, chronic chest infection with bronchiectasis,\r tuberculosis, and active hepatitis\r\n\r - Positive serology for Hepatitis B (HB) defined as a positive test for HB surface\r antigen (HBsAg). In addition, if negative for HBsAg but HB core antibody (HBcAb)\r positive (regardless of HBsAb status), a HBV deoxyribonucleic acid (DNA) test will be\r performed and if positive the patient will be excluded.\r\n\r - Known human immunodeficiency virus (HIV) positive.\r\n\r - Patients with active bleeding or history of bleeding diathesis (e.g. haemophilia, von\r Willebrand disease).\r\n\r - Patients receiving therapeutic anticoagulation with warfarin or equivalent (e.g.\r phenprocoumon).\r\n\r - Uncorrected prolonged prothrombin time (PT) or an activated partial thromboplastin\r time (APTT) > 2 x the upper limit of normal (ULN).\r\n\r - Major surgery within 30 days prior to randomisation and/or inadequate recovery (at\r Investigators discretion) from any prior major surgery, toxicity or complications.\r\n\r - Patients with malabsorption syndrome or medical conditions significantly affecting\r gastrointestinal function.\r\n\r - Clinically significant cardiac disease including unstable angina, uncontrolled\r congestive heart failure, and unstable arrhythmias requiring therapy, with the\r exception of extra systoles or minor conduction abnormalities. Stable and controlled\r atrial fibrillation is not an exclusion.\r\n\r - Significant concurrent, uncontrolled severe medical condition including, but not\r limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary,\r neurological, cerebral or psychiatric disease.\r\n\r - History of significant cerebrovascular disease in the 6 months prior to randomisation,\r including intracranial haemorrhage.\r\n\r - Known or suspected hypersensitivity to components of the investigational products\r\n\r - Patients who have received treatment with any non-marketed drug substance or\r experimental therapy within 4 weeks prior to proposed start of treatment unless\r discussed and approved by the Chief Investigator or Clinical Coordinator via the\r Trials Office.\r\n\r - Current participation in any other interventional clinical study.\r\n\r - Patients known or suspected of not being able to comply with a study protocol (e.g.\r due to alcoholism, drug dependency or psychological disorder).\r\n\r - Breast feeding women or women with a positive pregnancy test at screening.\r\n\r - Women of childbearing potential and men not willing to use highly effective\r contraception during study and for 12 months after last dose of study therapy. Highly\r effective contraception is defined as abstinence, hormonal birth control, intrauterine\r devices, vasectomy/surgical sterilisation.\r\n\r Entry criteria for single-arm relapsed Cohort 1:\r\n\r Inclusion criteria for Cohort 1 (progressive RS following chemo-immunotherapy):\r\n\r - Patients with relapsed/refractory RS who received anthracycline based chemotherapy\r with anti-CD20 monoclonal antibody If fewer than the expected number of patients from\r the randomised component enter into Cohort 1, patients from outside STELLAR with\r relapsed/refractory RS following chemo-immunotherapy (anthracycline based chemotherapy\r with anti-CD20 monoclonal antibody) will be able to join this cohort if they meet the\r eligibility criteria. The Trials Office will alert sites by email if any slots are\r released for patients outside of STELLAR, these must be booked with the Trials Office\r prior to registration.\r\n\r - ECOG performance status of 0, 1, 2 or 3.\r\n\r - Age 16 years and over.\r\n\r - Signed written informed consent prior to performing any study-specific procedures.\r\n\r Exclusion criteria for Cohort 1 (progressive RS following chemo-immunotherapy):\r\n\r - Previous acalabrutinib exposure. (Prior exposure to other Bruton tyrosine kinase\r (BTK), phosphoinositide-3-kinase (PI3K), or BCL-2 inhibitors is permitted).\r\n\r - Known central nervous system (CNS) involvement of CLL or DLBCL.\r\n\r - Any other active malignancy that requires active treatment, with the exception of\r basal cell carcinoma, in-situ cervical cancer, and non-invasive squamous cell\r carcinoma of the skin.\r\n\r - Chronic or ongoing active infectious disease requiring systemic treatment such as, but\r not limited to, chronic renal infection, chronic chest infection with bronchiectasis,\r tuberculosis, and active hepatitis\r\n\r - Positive serology for Hepatitis B (HB) defined as a positive test for HB surface\r antigen (HBsAg). In addition, if negative for HBsAg but HB core antibody (HBcAb)\r positive (regardless of HBsAb status), a HBV deoxyribonucleic acid (DNA) test will be\r performed and if positive the patient will be excluded.\r\n\r - Known human immunodeficiency virus (HIV) positive.\r\n\r - Patients with active bleeding or history of bleeding diathesis (e.g. haemophilia, von\r Willebrand disease).\r\n\r - Patients receiving therapeutic anticoagulation with warfarin or equivalent (e.g.\r phenprocoumon).\r\n\r - Uncorrected prolonged prothrombin time (PT) or an activated partial thromboplastin\r time (APTT) > 2 x the upper limit of normal (ULN).\r\n\r - Major surgery within 30 days prior to registration and/or inadequate recovery (at\r Investigators discretion) from any prior major surgery, toxicity or complications.\r\n\r - Patients with malabsorption syndrome or medical conditions significantly affecting\r gastrointestinal function.\r\n\r - Clinically significant cardiac disease including unstable angina, uncontrolled\r congestive heart failure, and unstable arrhythmias requiring therapy, with the\r exception of extra systoles or minor conduction abnormalities. Stable and controlled\r atrial fibrillation is not an exclusion.\r\n\r - Significant concurrent, uncontrolled severe medical condition including, but not\r limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary,\r neurological, cerebral or psychiatric disease.\r\n\r - History of significant cerebrovascular disease in the 6 months prior to registration,\r including intracranial haemorrhage.\r\n\r - Known or suspected hypersensitivity to components of the investigational products\r\n\r - Patients who have received treatment with any non-marketed drug substance or\r experimental therapy within 4 weeks prior to proposed start of treatment unless\r discussed and approved by the Chief Investigator or Clinical Coordinator via the\r Trials Office.\r\n\r - Current participation in any other interventional clinical study.\r\n\r - Patients known or suspected of not being able to comply with a study protocol (e.g.\r due to alcoholism, drug dependency or psychological disorder).\r\n\r - Breast feeding women or women with a positive pregnancy test at screening.\r\n\r - Women of childbearing potential and men not willing to use highly effective\r contraception during study and for 12 months after last dose of study therapy. Highly\r effective contraception is defined as abstinence, hormonal birth control, intrauterine\r devices, vasectomy/surgical sterilisation.\r\n\r Entry criteria for single arm Cohort 2\r\n\r Inclusion criteria for Cohort 2 (anthracycline-naïve RS patients, diagnosed while on\r ibrutinib):\r\n\r - Ibrutinib-exposed CLL patients who have developed biopsy-proven DLBCL-type RS within\r four weeks of last dose of ibrutinib.\r\n\r - No previous anthracycline treatment and suitable for anthracycline-containing\r chemo-immunotherapy.\r\n\r - Patients with CLL and newly diagnosed biopsy proven DLBCL-type RS.\r\n\r - ECOG performance status of 0, 1, 2 or 3.\r\n\r - Age 16 years and over.\r\n\r - Signed written informed consent prior to performing any study-specific procedures.\r\n\r Exclusion criteria for Cohort 2 (anthracycline-naïve RS patients, diagnosed while on\r ibrutinib):\r\n\r - Prior therapy with CHOP or any anthracycline containing treatment at any time prior to\r registration. (Please note that pre-treatment with prednisolone up to 2mg/kg is\r allowed for up to 14 days prior to the start of treatment).\r\n\r - Previous acalabrutinib exposure. (Prior exposure to other Bruton tyrosine kinase\r (BTK), phosphoinositide-3-kinase (PI3K), or BCL-2 inhibitors is permitted)\r\n\r - Known central nervous system (CNS) involvement of CLL or DLBCL.\r\n\r - Any other active malignancy that requires active treatment, with the exception of\r basal cell carcinoma, in-situ cervical cancer, and non-invasive squamous cell\r carcinoma of the skin.\r\n\r - Chronic or ongoing active infectious disease requiring systemic treatment such as, but\r not limited to, chronic renal infection, chronic chest infection with bronchiectasis,\r tuberculosis, and active hepatitis\r\n\r - Positive serology for Hepatitis B (HB) defined as a positive test for HB surface\r antigen (HBsAg). In addition, if negative for HBsAg but HB core antibody (HBcAb)\r positive (regardless of HBsAb status), a HBV deoxyribonucleic acid (DNA) test will be\r performed and if positive the patient will be excluded.\r\n\r - Known human immunodeficiency virus (HIV) positive.\r\n\r - Patients with active bleeding or history of bleeding diathesis (e.g. haemophilia, von\r Willebrand disease).\r\n\r - Patients receiving therapeutic anticoagulation with warfarin or equivalent (e.g.\r phenprocoumon).\r\n\r - Uncorrected prolonged prothrombin time (PT) or an activated partial thromboplastin\r time (APTT) > 2 x the upper limit of normal (ULN).\r\n\r - Major surgery within 30 days prior to registration and/or inadequate recovery (at\r Investigators discretion) from any prior major surgery, toxicity or complications.\r\n\r - Patients with malabsorption syndrome or medical conditions significantly affecting\r gastrointestinal function.\r\n\r - Clinically significant cardiac disease including unstable angina, uncontrolled\r congestive heart failure, and unstable arrhythmias requiring therapy, with the\r exception of extra systoles or minor conduction abnormalities. Stable and controlled\r atrial fibrillation is not an exclusion.\r\n\r - Significant concurrent, uncontrolled severe medical condition including, but not\r limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary,\r neurological, cerebral or psychiatric disease.\r\n\r - History of significant cerebrovascular disease in the 6 months prior to registration,\r including intracranial haemorrhage.\r\n\r - Known or suspected hypersensitivity to components of the investigational products\r\n\r - Patients who have received treatment with any non-marketed drug substance or\r experimental therapy within 4 weeks prior to proposed start of treatment unless\r discussed and approved by the Chief Investigator or Clinical Coordinator via the\r Trials Office.\r\n\r - Current participation in any other interventional clinical study.\r\n\r - Patients known or suspected of not being able to comply with a study protocol (e.g.\r due to alcoholism, drug dependency or psychological disorder).\r\n\r - Breast feeding women or women with a positive pregnancy test at screening.\r\n\r - Women of childbearing potential and men not willing to use highly effective\r contraception during study and for 12 months after last dose of study therapy. Highly\r effective contraception is defined as abstinence, hormonal birth control, intrauterine\r devices, vasectomy/surgical sterilisation.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,714
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSensory Motor Lateralization as Handwriting Intervention in School-Based OT\n\n**Clinical Trial Summary:**\n\nChildren who attend School-Based Occupational Therapy (SBOT) show mixed dominance and a\r liable decreased in the structural and functional differentiation between the two\r hemispheres. The lack of right-left disparity has been found to link to mirror invariance,\r poor spatial organization, fragmentary reversals, and handwriting difficulty. This study\r intends to find out, whether, Sensory Motor Lateralization (SML), \"With\" a rightward bias,\r profits handwriting more than the conventional (CON) \"Without\".\n\n**Clinical Trial Detailed Description:**\n\n10 to 30% of school children suffer handwriting difficulty. Many of them are eventually\r referred to SBOT for remedial intervention. Among these children, 70% show mixed dominance in\r their hand and/or leg use, and a likely functional and structural interhemispherical\r asymmetry reduction. This would make them right-left symmetrical. Learning, thus, may be\r challenged, because people who are right-left balanced would not have a consistent reference\r point to process the learning materials regularly in any pre-determined directions. They are,\r thus, prone to suffer mirror invariance, fragmentary reversal errors, and handwriting\r difficulty, especially with the fast and accurate construction of asymmetrical letters from\r memory.\r\n\r To enhance right-left disparity, dispel mirror invariance, and facilitate the automatized\r handwriting, SML preferentially belabors one's right eye, ear, hand and leg in therapy, that\r would greater engage the left hemisphere for its acclaimed vantages over learning. This study\r investigates, whether SML, wielding such a rightward bias, profits handwriting greater than\r CON.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Any Special or Regular Education students with Individualized Education Plans (IEPs),\r OT mandates, and handwriting goals.\r\n\r - Has Intelligence Quotient (IQ) equal to or above 60.\r\n\r - Ambulatory.\r\n\r - Proficient in English, and fluent in naming, identifying, and accessing the sequence\r of letters in the alphabet.\r\n\r - The students who attend Physical Therapy (PT), Adaptive Physical Education (PE), and\r any other programs are included, if the programs being provided are skill-, theme-, or\r task-oriented, not involving any muscle strengthening activities.\r\n\r Exclusion Criteria:\r\n\r - All are excluded, if the study candidates have any medical condition(s) that would\r prohibit them from the full physical participation in school.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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35,715
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Impact of a Diagnosis of Parkinson's on Work\n\n**Clinical Trial Summary:**\n\nParkinson's disease leads to loss of employment on average within less than 10 years of\r disease onset and has been found to be associated with an increased absence from work. This\r combined with hospitalisation; use of secondary health services; drug usage; and caregivers\r needing to give up work contributed to the costs associated with the conditions. It has been\r estimated that early support for working age newly diagnosed would cost the government about\r 1.5 million Euro in the UK but might lead to a potential cost saving of over half a billion\r over 5 years.\r\n\r The study will explore the impact of a Parkinson diagnosis on employment. The study will be\r survey based and will include demographic questions: age, age at diagnosis of PD, educational\r level, and Nationality; questions pertaining to employment type, history, and reasons for\r leaving if this happened; and also general health.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Diagnosis of Parkinson\r\n\r Exclusion Criteria:\r\n\r None\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,716
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia\n\n**Clinical Trial Summary:**\n\nThis phase III trial studies how well blinatumomab works in combination with chemotherapy in\r treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or\r B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as\r blinatumomab, may induce changes in the body's immune system and may interfere with the\r ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine,\r dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine,\r mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to\r stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,\r or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate.\r Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving\r blinatumomab and combination chemotherapy may work better than combination chemotherapy alone\r in treating patients with B-ALL. This trial also assigns patients into different chemotherapy\r treatment regimens based on risk (the chance of cancer returning after treatment). Treating\r patients with chemotherapy based on risk may help doctors decide which patients can best\r benefit from which chemotherapy treatment regimens.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine in a randomized manner if the addition of 2 cycles of blinatumomab to\r standard therapy improves disease-free survival (DFS) in patients with standard risk (SR)\r B-ALL and higher risk features (SR-High), and patients with standard-risk average (SR-Avg)\r B-ALL who are negative for minimal residual disease (MRD) by flow cytometry but have\r detectable or indeterminate MRD as measured by high-throughput sequencing (HTS) at end of\r induction (EOI).\r\n\r II. To confirm that boys in the standard-risk favorable (SR-Fav) subset of B-ALL, with or\r without Down syndrome (DS), will maintain a 5-year DFS of greater than 93% when treated with\r a standard chemotherapy regimen with a treatment duration of 2 years from the start of\r interim maintenance I (IM1).\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To describe the DFS for patients with SR-Avg B-ALL who are negative for MRD measured by\r flow cytometry and HTS at EOI when treated with standard chemotherapy with a treatment\r duration of 2 years from the start of IM1, regardless of sex.\r\n\r II. To describe the DFS for patients with standard-risk favorable (SR-Fav) B-ALL when treated\r with a standard chemotherapy regimen.\r\n\r III. To determine if patients with DS-High achieve a reduction of treatment-related mortality\r (TRM) after replacement of intensive elements of standard chemotherapy (omission of\r anthracyclines in induction, omission of the second month of delayed intensification [DI])\r with 3 cycles of blinatumomab.\r\n\r IV. To describe the DFS characterized by the replacement of intensive elements of standard\r chemotherapy with 3 cycles of blinatumomab in patients with DS-High B ALL.\r\n\r V. To describe the DFS for patients with localized (Murphy stage I and II) B lymphoblastic\r lymphoma (B-LLy) receiving standard risk B-ALL therapy.\r\n\r VI. To compare the change in neurocognitive functioning, as measured by the CogState\r Cognitive Composite, from baseline to end-of-therapy among patients with ALL ages 4- < 10\r years at the time of diagnosis between children from poor families (defined as presence of\r household material hardship [HMH], including either food, housing or energy insecurity) and\r non-poor families (absence of HMH).\r\n\r VII. To describe the impact of blinatumomab on caregiver burden and patient/proxy-reported\r symptoms among a subset of children enrolled in the HMH and neurocognitive outcome study.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To explore adaptive and innate immune functions and host genetic factors associated with\r severe infectious complications in children with DS B-ALL.\r\n\r II. To explore the impact of acute lymphoblastic leukemia (ALL) and its therapy on\r neurocognitive, functional, and quality of life outcomes in patients with DS and ALL, as\r measured by caregiver (parent/legal guardian) questionnaires.\r\n\r III. To define the prevalence of minimal marrow disease (MMD) in B-LLy and to correlate MMD\r at diagnosis with outcome in patients with B-LLy.\r\n\r OUTLINE: All patients are assigned to, and complete an INDUCTION treatment regimen. Patients\r are then assigned to a CONSOLIDATION treatment regimen. Finally, following CONSOLIDATION,\r patients are either assigned or randomized to 1 of 7 arms.\r\n\r NON-DS SR B-ALL INDUCTION: Patients receive cytarabine intrathecally (IT) on day 1,\r vincristine intravenous (IV) push over 1 minute on days 1, 8, 15, and 22, dexamethasone\r orally (PO) or IV twice daily (BID) on days 1-28, pegaspargase IV over 1-2 hours or\r intramuscularly (IM) on day 4, and methotrexate IT on days 8 and 29. CNS2 patients also\r receive cytarabine IT twice weekly except during weeks when days 8 and 29 methotrexate is\r administered. Treatment continues for 35 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r * After Non-DS SR B-ALL INDUCTION, SR-Fav and SR-Avg patients complete SR CONSOLIDATION,\r while patients with SR-High complete high-risk (HR) CONSOLIDATION.\r\n\r DS B-ALL INDUCTION: Patients receive cytarabine IT on day 1, vincristine IV push over 1\r minute on days 1, 8, 15, and 22, pegaspargase IV over 1-2 hours or IM on day 4, methotrexate\r IT on days 8 and 29, and leucovorin PO or IV every 6 hours for 2 doses on days 9 and 30.\r Additionally, patients under 10 years of age receive dexamethasone PO or IV BID on days 1-28,\r and patients 10 years of age or older receive prednisone or prednisolone PO or IV BID on days\r 1-28. CNS2 patients also receive cytarabine IT twice weekly except during weeks when days 8\r and 29 IT methotrexate is administered. CNS3 patients also receive methotrexate IT on days 15\r and 22, and leucovorin PO or IV every 6 hours for 2 doses on days 16 and 23. Treatment\r continues for 35 days in the absence of disease progression or unacceptable toxicity.\r\n\r * After DS B-ALL INDUCTION, patients without high risk features and MRD < 0.01 % complete SR\r CONSOLIDATION. Patients without high risk features and MRD >= 0.01%, OR with high risk\r features and any MRD complete HR CONSOLIDATION.\r\n\r NON-DS B-LLy INDUCTION: Patients receive cytarabine IT on day 1 and twice weekly if CNS2,\r vincristine IV push over 1 minute on days 1, 8, 15, and 22, dexamethasone PO or IV BID on\r days 1-28, pegaspargase IV over 1-2 hours or IM on day 4, and methotrexate IT on days 8 and\r 29. Treatment continues for 35 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r * After NON-DS B-LLy INDUCTION, all B-LLy patients then complete SR CONSOLIDATION.\r\n\r DS B-LLY INDUCTION: Patients receive cytarabine IT on day 1, vincristine IV push over 1\r minute on days 1, 8, 15, and 22, pegaspargase IV over 1-2 hours or IM on day 4, methotrexate\r IT on days 8 and 29, and leucovorin PO or IV every 6 hours for 2 doses on days 9 and 30.\r Additionally, patients under 10 years of age receive dexamethasone PO or IV BID on days 1-28,\r and patients 10 years of age or older receive PO or IV prednisone or methylprednisolone on\r days 1-28. Treatment continues for 35 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r * After DS B-LLy INDUCTION, patients then complete SR CONSOLIDATION.\r\n\r SR CONSOLIDATION: Patients receive vincristine IV push over 1 minute on day 1, mercaptopurine\r PO on days 1-28, and methotrexate IT on days 1, 8, and 15. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on days 2, 9, and 16. Treatment continues for\r 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r * After SR CONSOLIDATION, patients with MRD undetectable are assigned to ARM A, and patients\r with MRD detectable/indeterminate/unavailable are randomized to ARM A or B. Patients with\r SR-Fav and all B-LLy patients are assigned to treatments identical to that in ARM A.\r\n\r HR CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, vincristine IV\r push over 1 minute on days 15, 22, 43, and 50, mercaptopurine PO on days 1-14 and 29-42,\r methotrexate IT on days 1, 8, 15, and 22 , and pegaspargase IV over 1-2 hours or IM on days\r 15 and 43. DS patients also receive leucovorin PO or IV every 6 hours for 2 doses on days 2,\r 9, 16, and 23 (on days 2 and 9 only for DS CNS3 patients). Treatment continues for 56 days in\r the absence of disease progression or unacceptable toxicity. Patients with continued clinical\r evidence of DS or testicular leukemia (from diagnosis through the end of Induction) undergo\r testicular radiation therapy over 12 fractions once daily (QD).\r\n\r * After HR CONSOLIDATION, patients are randomized to ARM C or D. DS B-ALL patients with MRD <\r 1% are assigned to an arm including three blocks of blinatumomab.\r\n\r ARM A:\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 11,\r 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted)\r on days 1, 11, 21, 31, and 41, and methotrexate IT on day 31. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on day 32. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1 and 29, dexamethasone\r PO BID or IV on days 1-7 and 15-21, vincristine IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV push/infusion over 1-15 minutes on days 1, 8, and 15, pegaspargase IV\r over 1-2 hours or IM on day 4, cyclophosphamide IV over 30-60 minutes on day 29,\r thioguanine PO on days 29-42, and cytarabine IV over 1-30 minutes or subcutaneously (SC)\r on days 29-32 and 36-39. DS patients receive leucovorin PO or IV every 6 hours for 2\r doses on days 2 and 30. Treatment continues for 56 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV over 2-5 minutes undiluted or 10-15 minutes diluted\r on days 1, 11, 21, 31, and 41, and methotrexate IT on days 1 and 31. DS patients receive\r leucovorin PO or IV every 6 hours for 2 doses on days 2 and 32. Treatment continues for\r 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Non-DS patients receive methotrexate IT on day 1, vincristine IV push over\r 1 minute on day 1, dexamethasone PO on days 1-5, mercaptopurine PO on days 1-84, and\r methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. DS patients\r receive vincristine IV push over 1 minute on day 1, methotrexate IT on day 1,\r dexamethasone PO on days 1-5, mercaptopurine PO on days 1-84, and methotrexate PO on\r days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78, and leucovorin IV or PO on day 2 if\r DS. Treatment repeats every 84 days until a total duration of therapy of 2 years from\r start of INTERIM MAINTENANCE I is reached in the absence of disease progression or\r unacceptable toxicity.\r\n\r ARM B:\r\n\r - BLINATUMOMAB BLOCK I: Patients receive dexamethasone IV or PO on day 1, methotrexate IT\r on day 1, and blinatumomab IV continuously on days 1-28. DS patients also receive\r leucovorin IV or PO every 6 hours for 2 doses on day 2. Treatment continues for 35 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 11,\r 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted)\r on days 1, 11, 21, 31, and 41, and methotrexate IT on day 31. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on day 32. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK II: Patients receive methotrexate IT on day 1, and blinatumomab IV\r continuously on days 1-28. DS patients also receive leucovorin PO or IV every 6 hours\r for 2 doses on day 2. Treatment continues for 35 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1 and 29, dexamethasone\r PO or IV on days 1-7 and 15-21, vincristine IV push over 1 minute on days 1, 8, and 15,\r doxorubicin IV push/infusion over 1-15 minutes on days 1, 8, and 15, pegaspargase IV\r over 1-2 hours or IM on day 4, cyclophosphamide IV over 30-60 minutes on day 29,\r thioguanine PO on days 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32\r and 36-39. DS patients receive leucovorin PO or IV every 6 hours for 2 doses on days 2\r and 30. Treatment continues for 56 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes\r (diluted) on days 1, 11, 21, 31, and 41, and methotrexate IT on days 1 and 31. DS\r patients also receive leucovorin PO or IV every 6 hours for 2 doses on days 2 and 32.\r Treatment continues for 56 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r - MAINTENANCE: Non-DS patients receive methotrexate IT on day 1 (omit on final 2 cycles),\r vincristine IV push over 1 minute on day 1, dexamethasone PO on days 1-5, mercaptopurine\r PO on days 1-84, and methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71,\r and 78 (omit day 1 on final 2 cycles). DS patients receive methotrexate IT on day 1\r (omit on final 2 cycles), dexamethasone PO on days 1-5, mercaptopurine PO on days 1-84,\r and methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 (omit day 1\r except for final 2 cycles), for DS patients and leucovorin IV or PO every 6 hours for 2\r doses on day 2 (omit on final 2 cycles). Treatment repeats every 84 days until a total\r duration of therapy of 2 years from start of INTERIM MAINTENANCE I is reached in the\r absence of disease progression or unacceptable toxicity.\r\n\r ARM C:\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 15,\r 29, and 43, high dose methotrexate IV on days 1, 15, 29, and 43, mercaptopurine PO on\r days 1-14, 15-28, 29-42, and 43-56, methotrexate IT on day 1 and 29, and leucovorin PO\r or IV on days 3-4, 17-18, 31-32, and 45-46. Treatment continues for 56 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1, dexamethasone PO BID\r or IV on days 1-7 and 15-21, vincristine IV over 1 minute on days 1, 8, 15, 43, and 50,\r doxorubicin IV over 1-15 minutes on days 1, 8, and 15, pegaspargase IV over 1-2 hours or\r IM on days 4 and 43, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on\r days 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39. Treatment\r continues for 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV over 1 minute on days 1, 11, 21,\r 31, and 41, Capizzi style methotrexate IV over 2-5 minutes (undiluted) or over 10-15\r minutes (diluted) on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and\r pegaspargase IV over 1-2 hours or IM on days 2 and 22. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Patients receive vincristine IV over 1 minute on day 1, prednisone or\r prednisolone or methylprednisolone PO or IV on days 1-5, mercaptopurine PO on days 1-84,\r methotrexate IT on days 1 and 29 of cycles 1-2 and on day 1 of subsequent cycles,\r methotrexate PO on days 8, 15, 22, 29 (for cycle 3 and later only), 36, 43, 50, 57, 64,\r 71, and 78. Treatment repeats every 84 days until a total duration of therapy of 2 years\r from start of interim maintenance I is reached in the absence of disease progression or\r unacceptable toxicity.\r\n\r ARM D:\r\n\r - BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or IV on day 1, methotrexate IT\r on day 1, and blinatumomab IV continuously on days 1-28. Treatment continues for 35 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV over 1 minute on days 1, 15, 29,\r and 43, high dose methotrexate IV on days 1, 15, 29, and 43, mercaptopurine PO on days\r 1-14, 15-28, 29-42, and 43-56, methotrexate IT on days 1 and 29, and leucovorin PO or IV\r on days 3-4, 17-18, 31-32, and 45-46. Treatment continues for 56 days in the absence of\r disease progression or unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK II: Patients receive blinatumomab IV on days 1-28 and methotrexate IT\r on day 1. Treatment continues for 35 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1, dexamethasone PO or\r IV on days 1-7 and 15-21, vincristine IV over 1 minute on days 1, 8, 15, 43, and 50,\r doxorubicin IV over 1-15 minutes on days 1, 8, and 15, pegaspargase IV over 1-2 hours or\r IM on days 4 and 43, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on\r days 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39. Treatment\r continues for 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV over 1 minute on days 1, 11, 21,\r 31, and 41, Capizzi style methotrexate IV over 2-5 minutes (undiluted) or over 10-15\r minutes (diluted) on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and\r pegaspargase IV over 1-2 hours or IM on days 2 and 22. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Patients receive methotrexate IT on day 1, vincristine IV over 1 minute on\r day 1, prednisone, prednisolone or methylprednisolone PO or IV on days 1-5,\r mercaptopurine PO on days 1-84, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50,\r 57, 64, 71, and 78. Treatment repeats every 84 days until a total duration of therapy of\r 2 years from start of interim maintenance I is reached in the absence of disease\r progression or unacceptable toxicity.\r\n\r DS-HIGH B-ALL:\r\n\r - BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV\r continuously on days 1-28, methotrexate IT on day 1 (or on day 56 of Consolidation), and\r leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment continues for 35 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE: Patients receive vincristine IV push over 1 minute on days 1, 15,\r 29, and 43, intermediate dose methotrexate IV over 24 hours on days 1, 15, 29, and 43,\r mercaptopurine PO on days 1-14, 15-28, 29-42, and 43-46, methotrexate IT on days 1 and\r 29, and leucovorin PO or IV every 6 hours for 2 doses on days 2-4, 16-18, 30-32, and\r 44-46. Treatment continues for 63 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK II: Patients receive blinatumomab IV on days 1-28, methotrexate IT on\r day 1, and leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment continues\r for 35 days in the absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive vincristine IV over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes on days 1, 8, and 15, dexamethasone PO or IV on\r days 1-7 and 15-21, methotrexate IT on day 1, leucovorin PO or IV every 6 hours for 2\r doses on day 2, and pegaspargase IV over 1-2 hours or IM on day 4. Treatment continues\r for 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK III: Patients receive blinatumomab IV on days 1-28, methotrexate IT\r on day 1, and leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment\r continues for 35 days in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Patients receive vincristine IV push over 1 minute on day 1, prednisone,\r prednisolone or methylprednisolone PO or IV BID on days 1-5, mercaptopurine PO on days\r 1-84, methotrexate IT on day 1, methotrexate PO on days 8, 15, 22, 29 (omit day 29 for\r first 3 cycles for patients who do not receive cranial radiotherapy), 36, 43, 50, 57,\r 64, 71, and 78, and leucovorin PO on days 2 and 30 (day 30 dose is for cycles 1-3 and\r for patients who do not receive cranial radiotherapy). CNS3 patients receive cranial\r radiotherapy during first 4 weeks of cycle 1. Treatment repeats every 84 days until a\r total duration of therapy of 2 years from start of interim maintenance I is reached in\r the absence of disease progression or unacceptable toxicity.\r\n\r All B-LLy patients:\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 11,\r 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 (diluted) on days\r 1, 11, 21, 31, and 41, and methotrexate IT on day 31. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on day 32. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive vincristine IV push over 1 minute on days 1, 8\r and 15, doxorubicin IV over 1-15 minutes on days 1, 8, and 15, dexamethasone PO or IV on\r days 1-7 and 15-21, methotrexate IT on days 1 and 29, pegaspargase IV over 1-2 hours or\r IM on day 4, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days\r 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39. DS patients\r additionally receive leucovorin PO or IV every 6 hours for 2 doses on days 2 and 30.\r Treatment continues for 56 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes\r (diluted) on days 1, 11, 21, 31, and 41, and methotrexate IT on days 1 and 31. DS\r patients also receive leucovorin PO or IV every 6 hours for 2 doses on days 2 and 32.\r Treatment continues for 56 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r - MAINTENANCE: Patients receive vincristine IV push over 1 minute on day 1, dexamethasone\r PO on days 1-5, mercaptopurine PO on days 1-84, methotrexate IT on day 1, and\r methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. DS patients also\r receive leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment repeats every\r 84 days until a total duration of therapy of 2 years from start of interim maintenance I\r is reached in the absence of disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed up every 4 weeks until complete\r blood count(CBC)/differential/platelet count recovery, then every 3 months for the first 2\r years, then every 4-6 months for the 3rd year, and every 6-12 months for the 4th and 5th\r years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All B-ALL patients must be enrolled on APEC14B1 and consented to Eligibility Screening\r (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement\r for B-LLy patients. B-LLy patients may directly enroll on AALL1731.\r\n\r - Age at diagnosis:\r\n\r - Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS).\r\n\r - Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS).\r\n\r - Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or\r without DS).\r\n\r - B-ALL patients without DS must have an initial white blood cell count < 50,000/uL\r (performed within 7 days prior to enrollment).\r\n\r - B-ALL patients with DS are eligible regardless of the presenting white blood cell\r count (WBC) (performed within 7 days prior to enrollment).\r\n\r - Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on\r a bone marrow (BM) aspirate;\r\n\r - OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis\r can be established by a pathologic diagnosis of B-ALL on a BM biopsy;\r\n\r - OR a complete blood count (CBC) documenting the presence of at least 1,000/uL\r circulating leukemic cells;\r\n\r - OR patient has newly diagnosed B-cell LLy Murphy stages I or II, with or without\r Down syndrome.\r\n\r - Note: For B-LLy patients with tissue available for flow cytometry, the criterion\r for diagnosis should be analogous to B-ALL. For tissue processed by other means\r (i.e., paraffin blocks), the methodology and criteria for immunophenotypic\r analysis to establish the diagnosis of B-LLy defined by the submitting\r institution will be accepted (diagnostic biopsy for B-LLy must be performed\r within 14 days prior to enrollment).\r\n\r - All institutional, Food and Drug Administration (FDA), and National Cancer Institute\r (NCI) requirements for human studies must be met.\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent.\r\n\r Exclusion Criteria:\r\n\r - Patient must not have secondary ALL that developed after treatment of a prior\r malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior\r history of transient myeloproliferative disease (TMD) are not considered to have had a\r prior malignancy. They would therefore be eligible whether or not the TMD was treated\r with cytarabine.\r\n\r - With the exception of steroid pretreatment or the administration of intrathecal\r cytarabine, patients must not have received any prior cytotoxic chemotherapy for\r either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to\r initiation of protocol therapy on AALL1731.\r\n\r - For patients receiving steroid pretreatment, the following additional exclusion\r criteria apply:\r\n\r - Non-DS B-ALL patients must not have received steroids for more than 24 hours in\r the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to\r initiation of the steroids.\r\n\r - DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV\r steroids within 4 weeks of diagnosis.\r\n\r - Patients who have received > 72 hours of hydroxyurea.\r\n\r - B-ALL patients who do not have sufficient diagnostic bone marrow submitted for\r APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted\r containing > 1,000/uL circulating leukemia cells.\r\n\r - Patient must not have acute undifferentiated leukemia (AUL).\r\n\r - Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be\r known prior to enrollment).\r\n\r - Note: DS patients with CNS3 disease are eligible but will be assigned to the\r DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior\r to administration of any systemic or intrathecal chemotherapy, except for steroid\r pretreatment.\r\n\r - Non-DS B-ALL patients with testicular leukemia. (Note: DS patients with testicular\r disease are eligible but will be assigned to the DS-High B-ALL arm).\r\n\r - For LLy patients, the following additional exclusion criteria apply:\r\n\r - T-Lymphoblastic Lymphoma.\r\n\r - Morphologically unclassifiable lymphoma.\r\n\r - Absence of both B-cell and T-cell phenotype markers in a case submitted as\r lymphoblastic lymphoma.\r\n\r - CNS positive disease or testicular involvement.\r\n\r - M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow.\r\n\r - Patients with known Charcot-Marie-Tooth disease.\r\n\r - Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,\r regardless of blast immunophenotype.\r\n\r - Patients requiring radiation at diagnosis.\r\n\r - Female patients who are pregnant since fetal toxicities and teratogenic effects have\r been noted for several of the study drugs. A pregnancy test is required for female\r patients of childbearing potential.\r\n\r - Lactating females who plan to breastfeed their infants.\r\n\r - Sexually active patients of reproductive potential who have not agreed to use an\r effective contraceptive method for the duration of their study participation.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"content": "**Clinical Trial Title:**\n\nPhysical Functions in Allogeneic-HSCT Candidates\n\n**Clinical Trial Summary:**\n\nPhysical inactivity and impairments in physical functions have been observed in patients due\r to hematological malignancy itself and treatments of chemotherapy, radiotherapy,\r corticosteroids. However, no study investigated relationship of physical activity with\r pulmonary and physical functions in allogeneic hematopoietic stem cell transplantation (HSCT)\r candidates. Therefore, investigation of the relationship among outcomes in allogeneic HSCT\r candidates was aimed.\n\n**Clinical Trial Detailed Description:**\n\nHematological malignancies arise from deficiencies in blood cell lineage which represent a\r heterogeneous group including leukemias, lymphomas, myelomas, myeloproliferative diseases and\r myelodysplastic syndromes. In recent years, a great majority of patients with hematological\r malignancies often experience side effects of disease related treatments such as chemotherapy\r with multiple agents, radiotherapy, corticosteroids, combination of medical drugs, autologous\r and/or allogeneic hematopoietic stem cell transplantation (HSCT) throughout their remaining\r lives. Furthermore, there are substantial outcomes regarding the initial time of diagnosis\r that pulmonary function involvements, sedentary life style (39%), decreased exercise capacity\r and lower extremity muscle weakness have been present in patients with lymphoma even before\r first cycle of chemotherapy is administered to patients. During the period of or after\r chemotherapy, patients have suffered from decreased maximal oxygen uptake, advanced muscle\r weakness, decreased hemoglobin levels and evident fatigue, as well.\r\n\r As the treatment process continues for patients with hematological malignancies, HSCT is\r begun to schedule for almost all patients which has a significant potential for good clinical\r outcomes along with longer life expectancy. However, especially allogeneic-HSCT is a quite\r aggressive treatment option due to serious complications such as graft versus host disease,\r long term severe treatments of these complications and severe immune suppression related\r infections. Moreover, patients have already been exposed to immobility condition, low level\r of physical activity, pulmonary functions involvements, respiratory and peripheral muscle\r weakness as well as exercise intolerance before HSCT. In addition, the outcomes obtained from\r candidates just before HSCT have indicated that quadriceps femoris muscle strength, exercise\r capacity evaluated with 6-minute walk test, inspiratory and expiratory muscle strength are\r decreased respectively in 23%, 58%, 42% and 89% of candidates. Sarcopenia (50.6%), reduction\r in hip flexor, hip abductors and ankle flexors muscles strength and decreased diffusing\r capacity of the lung for carbon monoxide (78%) have also been mostly observed in HSCT\r candidates. In a study, candidates who were evaluated using a metabolic holter device are\r inactive (average 2180 steps/day) before HSCT. In another study, number of steps evaluated\r using a pedometer which provides only one output about step count are approximately 201.1\r steps per a day for HSCT candidates. Accuracy of pedometers can be reduced at slow walking\r speeds so that pedometers may not be suitable for cancer patients. On the other hand,\r metabolic holter devices use pattern recognition technology to evaluate physical activity\r level that may produce more accurate estimation of energy expenditure in cancer population.\r Besides, it has also been stated that quadriceps femoris muscle weakness is related to\r reduced daily number of steps, therefore if the muscles are strengthened, number of steps may\r be increased at the process of HSCT.\r\n\r Physical activity is any bodily movement which is produced by skeletal muscles concluded\r energy expenditure. While total daily energy expenditure demonstrates all types of energy\r costs including resting, diet-induced and activity-induced energy expenditures within 24\r hours, active energy expenditure related with physical activity is produced by daily living\r activities such as employment, sport and any other activities. Activity energy expenditure\r also decreases with excess body weight, older age, female gender, loss of muscle mass and\r diseases throughout life span . On the other hand, Canadian Academy of Sports and Exercise\r Medicine recommends that people prefer moderate-to-vigorous physical activity (>3.0 metabolic\r equivalents (METs)) including brisk walking, aerobic and resistance exercises, jogging,\r hiking, swimming and field games with ball or racquet for 150 min/week and a total\r sustainable activity duration from 30 min to 60 min per practice rather than sedentary\r behavior (<1.5 METs) in order to decrease risk of most major chronic disease by 25-50%.\r Moreover, a 15 min/d or 75 min/week of moderate-to-vigorous physical activity is also\r recommended as about 15% mortality risk reduces in diseases and benefits increase . Given the\r importance of physical activity assessment and counseling in people with/without chronic\r disease, according to literature, studies objectively investigating either detailed physical\r activity condition rather than number of steps or relations of physical activity with\r pulmonary and physical functions in allogeneic-HSCT candidates are scarce. Therefore, primary\r aim of the current study was to exhibit possible all detailed aspects of physical activity\r outcomes evaluated with a metabolic holter, an objective measurement device, secondary aim\r was to investigate relationship among physical activity parameters, pulmonary functions and\r physical functions in allogeneic-HSCT candidates and as finally, to identify independent\r predictors of physical inactivity in candidates was aimed.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - being 18-65 years of age,\r\n\r - having a diagnosis with hematologic malignancy\r\n\r - being clinically stabile,\r\n\r - being an allogeneic-HSCT candidate\r\n\r - receiving optimal standard medical therapy including antibiotics, supplements and\r other drugs.\r\n\r Exclusion Criteria:\r\n\r - having cooperation problems,\r\n\r - having orthopedic or neurological disease with a potential to prevent assessment of\r exercise capacity,\r\n\r - having comorbidities such as chronic obstructive pulmonary disease, cardiac diseases,\r\n\r - acute infections and/or hemorrhage.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,718
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nClinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients\n\n**Clinical Trial Summary:**\n\nThis 8 weeks, prospective, single center, randomized, open-label, parallel-group,\r non-inferiority study was performed from October 2015 to April 2018. This study as designed\r to evaluate the efficacy and safety of 10mg of the generic formulation (rosuvastatin,\r ROVASRO®) compared to the reference formulation (rosuvastatin, CRESTOR®) in patients with\r primary hypercholesterolemia and complex dyslipidemia.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Individuals aged between 19 and 80 years old.\r\n\r 2. The following patients who belong to the low-risk group to the very-high risk group\r according to 2015 Korean guidelines for the management of dyslipidemia (Committee, KCJ\r 2016).\r\n\r - Very high risk group (coronary artery disease, ischemic stroke, peripheral\r vascular disease) were not receiving lipid-lowering agents (statins) within 4\r weeks of the screening, regardless of LDL-C levels\r\n\r - High risk group (carotid artery disease, abnormal aneurysm, diabetes)* : LDL-C ≥\r 100 mg/dl\r\n\r - Moderate risk group (2 or more major risk factors)* : LDL-C ≥ 130 mg/dl\r\n\r - Low risk group (less than 1 major risk factors)* : LDL-C ≥ 160 mg/dl\r\n\r - If the patients taka a lipid-lowering agents (statin) within 4 weeks of\r screening, enrolled them after wash-out for 4 weeks or more.\r\n\r 3. Patients who voluntarily participated in the trial and obtained document consent.\r\n\r Exclusion Criteria:\r\n\r 1. a history of acute arterial disease (patients with unstable angina myocardial\r infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass\r graft or percutaneous transluminal coronary angioplasty within 3 months prior to study\r enrollment)\r\n\r 2. uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood\r pressure ≥100mmHg)\r\n\r 3. uncontrolled diabetes (hemoglobin A1c ≥9% or fasting glucose ≥160mg/dl)\r\n\r 4. uncontrolled thyroid dysfunction (thyroid stimulation hormone ≥1.5 times the upper\r limits of normal (ULN))\r\n\r 5. usage of antihyperlipidemic drugs (bile acid sequestrants, fibrates, niacin, etc.)\r within 4 weeks before enrollment\r\n\r 6. a history of myopathy, rhabdomyolysis or elevated serum creatinine kinase (CK) more\r than 2 times the ULN\r\n\r 7. chronic kidney disease (serum creatinine ≥2 times the ULN)\r\n\r 8. elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase\r (ALT) ≥2 times the ULN)\r\n\r 9. a history of drug or alcohol abuse\r\n\r 10. a history of gastrointestinal surgery or gastrointestinal tract disorders\r\n\r 11. hypersensitivity to the components of this drug\r\n\r 12. those who disagree with contraception\r\n\r 13. pregnancy and/or lactation.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,719
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nComparison of Bonding Failure Rates of Fixed Lingual Mandibular Retainers in a French Sample Aged 11 or Older, Comparing Prior Enamel Sandblasting With Conventional Pumice Polishing\n\n**Clinical Trial Summary:**\n\nAt the completion of orthodontic treatment, the position of the mandibular canines and\r incisors is being maintained on a routine basis by bonding a multi-braided wire retainer onto\r their lingual surfaces. One of the adverse events that might occur with time is the debonding\r of the wire from one or several lower anterior teeth . This event which can unfortunately get\r unnoticed by the patient can lead to unwanted tooth displacement. When the practionner\r detects such a debonding, he has to go through a laborious and lengthy procedure to rebond\r the wire. When on the other hand the patient notices himself such a debonding, he is to call\r in emergency his practitioner to get his retainer repaired. This leads to emergency visits\r that are susceptible to affect adversely his timetable. The prevalence of these bonding\r failures is estimated at 37% at 18 month follow-ups. It has been reported that with prior\r enamel sandblasting, bonding failure rate is reduced to 8% at 24 month follow-ups. However,\r no study has reported yet the debonding rate of lower fixed, comparing wires that have been\r bonded after prior enamel pumicing to those that were put in place after prior enamel\r sandblasting.\r\n\r The expected result of this trial is a significantly decrease in bonding failure rate of\r mandibular lingual retainer when enamel surfaces are initially sandblasted compared to the\r ones which are pumiced. This reduction would lower the risk of unwanted tooth movement of\r mandibular incisors and canines after orthodontic treatment and decrease the number of\r emergency appointments for the patient and the practitioner.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Minimum of 11 years of age\r\n\r - At completion of fixed orthodontic therapy\r\n\r - Presence of all 6 mandibular canines and incisors\r\n\r Exclusion Criteria:\r\n\r - Active decay\r\n\r - Presence of dental restorations\r\n\r - Tooth fracture\r\n\r - Periodontal disease\r\n\r - Structural anomalies affecting the lingual side of the mandibular incisors and canines\r\n\r - Cleft lip and palate\r\n\r - Cranio-facial syndrome\r\n\r - Inability to obtain the patient informed consent\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,720
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study in Parkinson's Disease in paTients With mOderate to seveRe dyskInesiA\n\n**Clinical Trial Summary:**\n\nThe current study will explore the efficacy, safety and tolerability of 2 dose combinations\r of JM-010 to determine the optimal doses of each component to be studied in confirmatory\r clinical trials.\n\n**Clinical Trial Detailed Description:**\n\nThis is a Phase 2, double-blind, double-dummy, placebo-controlled, randomized, parallel\r group, multicentre study.\r\n\r Subjects with a diagnosis of moderate to severe dyskinesia in Parkinson's disease (PD) will\r complete a Screening Visit to assess eligibility to participate in the study.\r\n\r Subjects will continue with their usual levodopa treatment regimen for the duration of study\r participation.\r\n\r The screening assessment period will be a minimum of 1 week up to a maximum of 6 weeks.\r Subjects deemed to be eligible at the end of the Screening Visit will be randomly assigned in\r a 1:1:1 ratio to receive either 1 of the 2 dose combinations of JM-010 and 1 placebo, or 2\r placebos as per the double-dummy study design. The randomized subjects will be followed\r treatment periods for 12 weeks and safety follow periods for 2 weeks, including\r pharmacokinetic (PK) sub-study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Is able to read, understand, and provide written, dated informed consent prior to\r Screening Visit.\r\n\r - Is male or female, between 18 and 80 years of age at Screening Visit.\r\n\r - Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS)\r Brain Bank Clinical Diagnostic Criteria and requires treatment with and shows\r responsiveness to levodopa.\r\n\r - Has experienced dyskinesia over a period of at least 3 months prior to Screening Visit\r\n\r - Has stable peak-effect dyskinesia\r\n\r - Has more than one hour of \"ON\" time with troublesome dyskinesia during daily waking\r hours on a 24-hour PD subject diary\r\n\r - Is on a stable levodopa dosing regimen requiring at least 3 dose administrations but\r no more than 6 dose administrations per day\r\n\r Exclusion Criteria:\r\n\r - Has undergone surgery for the treatment of PD\r\n\r - Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse or\r Dependence, as defined by Diagnostic and Statistical Manual, Fifth Edition [DSM 5]),\r\n\r - Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses\r\n\r - Has a significant risk for suicidal behaviour in the opinion of the investigator\r during the course of their participation in the study\r\n\r - Has current seizure disorders (other than febrile seizures in childhood) requiring\r treatment with anticonvulsants.\r\n\r - Has known serious ongoing symptomatic cerebral disease or cerebrovascular disease or\r any acute brain trauma requiring treatment with anti-convulsant therapy within 5 years\r prior Visit 2, Week 0 (Baseline Visit).\r\n\r - Has a history of exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic\r dyskinesia without peak-dose dyskinesia.\r\n\r Other criteria related to other medical conditions to be referred to the protocol.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,721
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Alouette Test in Parkinson Disease\n\n**Clinical Trial Summary:**\n\nReading disorders in Parkinson's Disease (PD) are poorly evaluated due to the lack of\r validated tests to screen for them. They are often attributed to hand tremors associated with\r the disease. In this study, the investigating team evaluated the \"alouette test\" validated\r for dyslexia screening, in PD by comparing the results to healthy patients.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with Parkinson's Disease\r\n\r - Montreal Cognitive Assessment (MoCA) test > 20\r\n\r Exclusion Criteria:\r\n\r - Patient's with supranuclear Palsy\r\n\r - Other neurologic disease\r\n\r - Any ophthalmologic disease\r\n\r - Presence of a nystagmus\r\n\r - Visual acuity < 0.6\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,722
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nInotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy\n\n**Clinical Trial Summary:**\n\nThis phase III trial studies whether inotuzumab ozogamicin added to post-induction\r chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves\r outcomes. This trial also studies the outcomes of patients with mixed phenotype acute\r leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without\r inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab,\r linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in\r a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy\r regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin,\r methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and\r pegaspargase work in different ways to stop the growth of cancer cells, either by killing the\r cells, by stopping them from dividing, or by stopping them from spreading. This trial will\r also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and\r disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.\r\n\r The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard\r of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic\r Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy:\r Induction and Consolidation. This part will collect information on the leukemia, as well as\r the effects of the initial treatment, in order to classify patients into post-consolidation\r treatment groups. On the second part of this study, patients will receive the remainder of\r the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance\r II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this\r study include investigating whether treating both males and females with the same duration of\r chemotherapy maintains outcomes for males who have previously been treated for an additional\r year compared to girls, as well as to evaluate the best ways to help patients adhere to oral\r chemotherapy regimens. Finally, this study will be the first to track the outcomes of\r subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute\r Leukemia (MPAL) when treated with B-ALL chemotherapy.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVE:\r\n\r I. To determine in a randomized manner if the addition of 2 blocks of inotuzumab ozogamicin\r to modified Berlin-Frankfurt-Munster (mBFM) chemotherapy will improve 5-year disease-free\r survival (DFS) in children and young adults with high-risk B-cell acute lymphoblastic\r leukemia (HR B-ALL).\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To describe the 5-year DFS for a favorable risk subset of National Cancer Institute (NCI)\r HR B-ALL (HR-Fav) when treated with mBFM chemotherapy with a single high-dose methotrexate\r (HD-MTX) interim maintenance (IM) phase and treatment duration of 2 years from the start of\r IM regardless of sex.\r\n\r II. To determine the toxicity and tolerability of inotuzumab ozogamicin integrated into the\r mBFM chemotherapy backbone in HR B-ALL.\r\n\r III. To describe the 5-year event-free survival (EFS) for patients with mixed phenotype acute\r leukemia (MPAL) receiving mBFM HR B-ALL therapy that includes a second IM phase with Capizzi\r escalating intravenous (IV) methotrexate (MTX) without leucovorin rescue plus pegaspargase\r (C-MTX).\r\n\r IV. To describe the 5-year EFS for patients with disseminated (Murphy stage III-IV) B-cell\r lymphoblastic lymphoma (B-LLy) receiving mBFM HR B-ALL therapy that includes a second IM\r phase with C-MTX.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To describe the therapy administered, disease response, and survival outcomes of patients\r with MPAL who come off protocol therapy due to poor disease response to ALL therapy either\r during Induction, at end of induction (EOI), or at end of consolidation (EOC).\r\n\r II. To define the prevalence and significance of minimal marrow disease (MMD) at diagnosis\r and bone marrow minimal residual disease (MRD) at EOI in disseminated B-LLy.\r\n\r III. To determine the impact of proposed adherence-enhancing interventions on adherence to\r oral 6-mercaptopurine in patients with ALL.\r\n\r OUTLINE: All patients receive the same Induction and Consolidation chemotherapy. Patients\r with HR-Fav B-ALL are assigned to Arm I. Patients with HR B-ALL are randomized to Arm II or\r III. Patients with MPAL are assigned to Arm IV, and patients with B-LLy are assigned to Arm\r V.\r\n\r All patients with B-ALL receive Induction and Consolidation therapy:\r\n\r INDUCTION: Patients receive cytarabine intrathecally (IT) on day 1 and central nervous system\r (CNS)2 patients also receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also\r receive vincristine intravenously (IV) or IV push over 1 minute on days 1, 8, 15, and 22,\r daunorubicin IV over 1-15 minutes days 1, 8, 15, and 22, pegaspargase intramuscularly (IM) or\r IV over 1-2 hours on day 4, and methotrexate IT on days 8 and 29 (and on days 15 and 22 for\r CNS3 patients). Patients < 10 years old receive dexamethasone orally (PO) twice daily (BID)\r or IV on days 1-14; patients >= 10 years old receive prednis(ol)one PO BID or IV on days\r 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39,\r mercaptopurine PO once daily (QD) on days 1-14 and 29-42, and methotrexate IT on days 1, 8,\r 15, and 22 (CNS3 patients receive methotrexate IT on days 1 and 8). Patients also receive\r vincristine IV or IV push over 1 minute on days 15, 22, 43, and 50, and pegaspargase IV over\r 1-2 hours or IM on days 15 and 43. Treatment continues for 8 weeks in the absence of disease\r progression or unacceptable toxicity. Additionally, patients with testicular disease at\r diagnosis that does not resolve by the end of induction will undergo radiation therapy over\r 12 once daily fractions.\r\n\r POST-CONSOLIDATION THERAPY: After Consolidation, based on clinical features and response,\r patients with B-ALL are designated as HR-Fav or HR B-ALL. Patients with HR-Fav B-ALL are\r assigned to Arm I. Patients with HR B-ALL are randomized to Arm II or III. Patients with MPAL\r and B-LLy are assigned to therapy arms (Arms IV and V) that are identical to Arm II. Patients\r that are < 10 years, have CNS1, no testicular leukemia, with favorable cytogenetics (ETV6\r RUNX1 fusion or double trisomies [4 and 10]), =< 24 hours of steroids in the two weeks prior\r to diagnosis, and EOI MRD < 0.01% are assigned to Arm I. Patients with HR B-ALL who are\r surface CD22 positive at diagnosis and have MRD < 0.01% by the end of Consolidation, are\r randomized to either Arm II or III.\r\n\r ARM I: HR-FAV B-ALL (Patients that are < 10 years, have CNS1 status, no testicular leukemia,\r with favorable cytogenetics (ETV6 RUNX1 fusion or double trisomies [4 and 10]), =< 24 hours\r of steroids in the two weeks prior to diagnosis, and EOI MRD < 0.01%)\r\n\r INTERIM MAINTENANCE: Patients receive vincristine IV or IV push over 1 minute on days 1, 15,\r 29, and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO\r or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO QD on days 1-14, 15-28, 29-42,\r and 43-56, and methotrexate IT on days 1 and 29. Treatment continues for 9 weeks in the\r absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r MAINTENANCE: Patients receive methotrexate IT on days 1 and 29 for cycles 1-4, and day 1 for\r subsequent cycles. Patients also receive vincristine IV or IV push over 1 minute on day 1,\r prednisolone PO BID or IV on days 1-5, mercaptopurine PO QD on days 1-84, and methotrexate PO\r on days 8, 15, 22, (29 excluded in cycles 1-4), 36, 43, 50, 57, 64, 71, and 78. Cycles repeat\r every 12 weeks for up to 2 years in the absence of disease progression or unacceptable\r toxicity.\r\n\r Patients with HR B-ALL who have MRD < 0.01% by the end of Consolidation, and leukemic blasts\r positive for surface CD22 at diagnosis are randomized to Arm II or Arm III.\r\n\r ARM II: HR B-ALL (CONTROL) INTERIM MAINTENANCE I: Patients receive vincristine IV or IV push\r over 1 minute on days 1, 15, 29 and 43, high dose methotrexate IV over 24 hours on days 1,\r 15, 29 and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, 45-46, mercaptopurine PO QD on\r days 1-14, 15-28, 29-42, and 43-56, and methotrexate IT on days 1 and 29. Treatment continues\r for 9 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r INTERIM MAINTENANCE II: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 11, 21, 31 and 41, methotrexate IV over 2-15 minutes or 10-15 minutes on days 1, 11, 21, 31,\r and 41, methotrexate IT on days 1 and 31, and pegaspargase IV over 1-2 hours or IM on days 2\r and 22. Treatment continues for 8 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r ARM III: HR B-ALL (EXPERIMENTAL) INOTUZUMAB OZOGAMICIN (InO) BLOCK 1: Patients receive\r inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15 and methotrexate IT on day 1.\r Treatment continues for 4 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r INTERIM MAINTENANCE I: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 15, 29 and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin\r PO or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO on days 1-14, 15-28, 29-42,\r and 43-56, and methotrexate IT on days 1 and 29. Treatment continues for 9 weeks in the\r absence of disease progression or unacceptable toxicity.\r\n\r InO BLOCK 2: Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15.\r Treatment continues for 4 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r INTERIM MAINTENANCE II: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV on days 1, 11, 21, 31, and 41, methotrexate IT on days 1\r and 31, and pegaspargase IV over 1-2 hours or IM on days 2 and 22. Treatment continues for 8\r weeks in the absence of disease progression or unacceptable toxicity.\r\n\r ARMS II AND III: HR B-ALL MAINTENANCE: Patients receive vincristine IV or IV push over 1\r minute on day 1, prednisolone PO BID or IV on days 1-5, mercaptopurine PO on days 1-84,\r methotrexate PO on days 8, 15, 22, 29 (excluded in cycles 1 and 2), 36, 43, 50, 57, 64, 71\r and 78, and methotrexate IT on days 1 (and 29 of cycles 1-2 for patients who do not receive\r cranial radiation). Cycles repeat every 12 weeks for up to 2 years in the absence of disease\r progression or unacceptable toxicity. Patients with CNS3 disease undergo cranial radiation\r therapy over 10 fractions during the first 4 weeks.\r\n\r ARM IV: MPAL INDUCTION: Patients receive cytarabine IT on day 1 and CNS2 patients also\r receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also receive vincristine IV or\r IV push over 1 minute on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes days 1, 8,\r 15, and 22, pegaspargase IM or IV over 1-2 hours on day 4, and methotrexate IT on days 8 and\r 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone\r PO BID or IV on days 1-14; patients >= 10 years old receive prednisolone PO BID or IV on days\r 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO\r on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 (excluded on days 15 and 22\r for CNS3 patients), vincristine IV or IV push over 1 minute on days 15, 22, 43, and 50, and\r pegaspargase IV over 1-2 hours or IM on days 15 and 43. Treatment continues for 8 weeks in\r the absence of disease progression or unacceptable toxicity. Patients with testicular disease\r at diagnosis that does not resolve by the end of induction will and continued evidence of\r testicular disease at end of induction undergo testicular radiation over 12 once-daily\r fractions.\r\n\r ARM V: B-LLY INDUCTION: Patients receive cytarabine IT on day 1 and CNS2 patients also\r receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also receive vincristine IV or\r IV push over 1 minute on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes days 1, 8,\r 15, and 22, pegaspargase IM or IV over 1-2 hours on day 4, and methotrexate IT on days 8 and\r 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone\r PO BID or IV on days 1-14; patients >= 10 years old receive prednisolone PO BID or IV on days\r 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO\r on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 (excluded on days 15 and 22\r CNS3 patients), vincristine IV or IV push over 1 minute on days 15, 22, 43, and 50, and\r pegaspargase IV over 1-2 hours or IM on days 15 and 43. Treatment continues for 8 weeks in\r the absence of disease progression or unacceptable toxicity. Patients with testicular disease\r at diagnosis that does not resolve by the end of induction will and continued evidence of\r testicular disease at end of induction undergo testicular radiation therapy over 12\r once-daily fractions.\r\n\r ARM IV AND V: MPAL AND B-LLY (Post-Consolidation Therapy) INTERIM MAINTENANCE I: Patients\r receive vincristine IV or IV push over 1 minute on days 1, 15, 29, and 43, high dose\r methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO or IV on days 3-4,\r 17-18, 31-32, and 45-46, methotrexate IT on days 1 and 29 and mercaptopurine PO QD on days\r 1-14, 15-28, 29-42, and 43-56. Treatment continues for 9 weeks in the absence of disease\r progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r INTERIM MAINTENANCE II: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV or infusion over 2-15 minutes or 10-15 minutes on days 1,\r 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase IV over 1-2 hours or\r IM on days 2 and 22. Treatment continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r MAINTENANCE: Patients receive vincristine IV or IV push over 1 minute on days 1, prednisolone\r PO BID or IV on days 1-5, mercaptopurine PO on days 1-84, methotrexate PO on days 8, 15, 22,\r 29 (excluded in cycles 1 and 2), 36, 43, 50, 57, 64, 71, and 78, and methotrexate IT on days\r 1 (and 29 of cycles 1-2 for patients who do not receive cranial radiation). Cycles repeat\r every 12 weeks for up to 2 years in the absence of disease progression or unacceptable\r toxicity. Patients with CNS3 disease at diagnosis undergo cranial radiation therapy for 10\r fractions over 4 weeks.\r\n\r After completion of study treatment, patients are followed up at 4 weeks, then every 3 months\r for 2 years, every 4-6 months for the third year, then every 6-12 months for years 4-5.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility\r studies (Part A) prior to treatment and enrollment on AALL1732. Note that central\r confirmation of MPAL diagnosis must occur within 7 business days after enrollment for\r MPAL patients. If not performed within this time frame, patients will be taken off\r protocol.\r\n\r - APEC14B1 is not a requirement for B-LLy patients but for institutional compliance\r every patient should be offered participation in APEC14B1. B-LLy patients may directly\r enroll on AALL1732.\r\n\r - White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to\r the start of protocol-directed systemic therapy):\r\n\r - Age 1-9.99 years: WBC >= 50,000/uL\r\n\r - Age 10-24.99 years: Any WBC\r\n\r - Age 1-9.99 years: WBC < 50,000/uL with:\r\n\r - Testicular leukemia\r\n\r - CNS leukemia (CNS3)\r\n\r - Steroid pretreatment.\r\n\r - White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to\r the start of protocol-directed systemic therapy):\r\n\r - Age 1-24.99 years: any WBC.\r\n\r - Patient has newly diagnosed B-ALL or MPAL (by World Health Organization [WHO] 2016\r criteria) with > 25% blasts on a bone marrow (BM) aspirate;\r\n\r - OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the\r diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM\r biopsy;\r\n\r - OR A complete blood count (CBC) documenting the presence of at least 1,000/uL\r circulating leukemic cells if a bone marrow aspirate or biopsy cannot be\r performed.\r\n\r - Patient has newly diagnosed B-LLy Murphy stages III or IV.\r\n\r - Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.\r\n\r - Note: For B-LLy patients with tissue available for flow cytometry, the criterion for\r diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e.,\r paraffin blocks), the methodology and criteria for immunophenotypic analysis to\r establish the diagnosis of B-LLy defined by the submitting institution will be\r accepted.\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent.\r\n\r - All institutional, Food and Drug Administration (FDA), and NCI requirements for human\r studies must be met.\r\n\r Exclusion Criteria:\r\n\r - Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL\r are eligible for AALL1731, regardless of NCI risk group).\r\n\r - With the exception of steroid pretreatment or the administration of intrathecal\r cytarabine, patients must not have received any prior cytotoxic chemotherapy for the\r current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to\r initiation of protocol therapy on AALL1732.\r\n\r - Patients who have received > 72 hours of hydroxyurea within one week prior to start of\r systemic protocol therapy.\r\n\r - Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow\r submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted\r containing > 1,000/uL circulating leukemia cells.\r\n\r - Patients with acute undifferentiated leukemia (AUL) are not eligible.\r\n\r - For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid\r pretreatment, the following additional exclusion criteria apply:\r\n\r - T-lymphoblastic lymphoma.\r\n\r - Morphologically unclassifiable lymphoma.\r\n\r - Absence of both B-cell and T-cell phenotype markers in a case submitted as\r lymphoblastic lymphoma.\r\n\r - Patients with known Charcot-Marie-Tooth disease.\r\n\r - Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,\r regardless of blast immunophenotype.\r\n\r - Patients requiring radiation at diagnosis.\r\n\r - Female patients who are pregnant, since fetal toxicities and teratogenic effects have\r been noted for several of the study drugs. A pregnancy test is required for female\r patients of childbearing potential.\r\n\r - Lactating women who plan to breastfeed their infants while on study and for 2 months\r after the last dose of inotuzumab ozogamicin.\r\n\r - Sexually active patients of reproductive potential who have not agreed to use an\r effective contraceptive method for the duration of study participation. For those\r patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the\r last dose of inotuzumab ozogamicin for females and 5 months after the last dose of\r inotuzumab ozogamicin for males.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,723
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations\n\n**Clinical Trial Summary:**\n\nCODY (co-design for you) is a Virtual Reality (VR) tool and Application Programming Interface\r (API) which uses an immersive, interactive environment for using, experiencing and\r co-designing home alterations. The aim of this research is to assess the efficacy of using\r CODY to aid and enhance the ability of adults with Parkinson's disease (PD) to experience and\r choose appropriate home modifications.\n\n**Clinical Trial Detailed Description:**\n\nAccessible housing is a widespread need in this country. This is particularly true among\r those persons with mobility impairments and movement disorders. While design and construction\r guidebooks exist for modifying homes for people with disabilities, there are also many\r documented instances where a standard, \"by-the-book\" alteration or assistive technology did\r not support the need or condition of the particular individual it was intended for. Just as\r occupational therapists recognize that a critical component of successful rehabilitation\r assistance is a person-centered plan that facilitates individualized solutions, likewise\r diverse design (or home alterations/modification, referred here as HM) approaches which\r approximate a person-centered plan also provide a more effective fit for persons with\r disabilities. A \"one-size-fits-all\" approach is not comprehensive for the diverse disability\r community.\r\n\r This research entails the design and development of CODY (co-design for you), a Virtual\r Reality (VR) tool and Application Programming Interface (API), which uses an immersive,\r interactive environment for using, experiencing and co-designing home alterations. The\r 'co-design' nature of CODY denotes that persons with movement disorders, such as Parkinson's\r disease can: virtually interact with and experience a home alteration/modification (HM) in a\r virtual, simulated environment; have multiple variations of a HM that the user can choose\r from; and is able to assess and manipulate the HM for appropriateness to one's need and\r circumstances before actually installing devices or making modifications to one's own home.\r As such, CODY is a new assistive technology that aids and enhances the ability of individuals\r with disabilities to live in adapted homes that supports their needs.\r\n\r This study focuses on movement disorders faced by persons with Parkinson's disease (PD) to\r demonstrate how effective CODY may be for those with major movement challenges, characterized\r by tremor, bradykinesia, postural instability, and freezing of gait (FoG). Collectively,\r these symptoms increase fall risk, fear of falling and impact the quality of life when\r compared to other age-matched non-PD adults. While clinical observations suggest that\r attributes of the physical interior environment may make daily activities easier or harder\r for persons with PD, few studies have actually examined the impact of specific changes in\r interior design on an individual's performance. One research study revealed that FoG, one of\r the major contributors to falls, was induced by doorways. Another study similarly revealed a\r significant increase in doorway-provoked FoG indicators by decreasing doorway width.\r\n\r The aims of this research are: (1) To develop the Virtual Reality-based CODY tool and\r corresponding API; and (2) To assess the efficacy of using CODY to aid and enhance the\r ability of persons with PD to experience and choose appropriate home modifications. The\r underlying purpose of CODY is to provide opportunities for the growing population of persons\r with movement disabilities and disorders to actively engage in decisions affecting their\r living environment. Although VR games have been used for rehabilitation and therapy purposes,\r no research studies exist that demonstrate the use or effectiveness of integrated VT\r simulations in allowing persons with disabilities to interactively design residential\r alterations. The study team's expectation is that CODY will not only be successful in this\r short-term pilot study, but will lead to further refinement, development and, potentially, a\r commercial product. The investigators envision CODY's integrated, immersive, and interactive\r simulation will be used by neurologists, rehabilitation specialists, and occupational\r therapists for working with consumers to assess and determine optimal home modifications for\r those with ambulatory and other movement impairments.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria: Parkinson's Disease participants\r\n\r - Patients with a mild-to-moderate diagnosis of PD, evaluated using the Unified\r Parkinson's Disease Rating Scale (UPDRS) and the Modified Hoehn and Yahr stages I-III,\r by a fellowship trained neurologist, arriving at the diagnosis by applying strict UK\r Brain Bank criteria\r\n\r - Disease duration is less than 5 years\r\n\r - With phone area code of 352; 904\r\n\r - Currently on their medications Inclusion Criteria: Healthy participants\r\n\r - Individuals who indicated they would like to be contacted for future research\r opportunities.\r\n\r - Age-matched (+ or - 5 years) healthy participants without PD\r\n\r - No history of neurological or orthopedic problems that could impair walking function\r or upper extremity mobility\r\n\r Exclusion Criteria:\r\n\r - Individuals with atypical features of PD, peripheral neuropathy, vestibular\r dysfunction, and medications affecting balance or alertness/ attention\r\n\r - Individuals with the presence of active unstable medical, diabetes, or any orthopedic\r conditions\r\n\r - Individuals who have previously undergone any brain surgeries\r\n\r - Individuals who take any anti-psychotic medications\r\n\r - Individuals with dementia as reflected by performance on the Mini-Mental State\r Examination (MMSE) (score < 24)\r\n\r - Individuals with elevated scores on the Beck Depression Inventory-II (I.E., ≥20), the\r recommended cut-off for depressive symptoms in PD by the task force for the Movement\r Disorders Society or history of severe pre-existing psychiatric difficulties (i.e.,\r schizophrenia)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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35,724
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe primary objective of this study is to evaluate the safety and tolerability of single and\r multiple doses of BIIB094 administered via intrathecal (IT) injection to participants with\r Parkinson's Disease (PD). The secondary objective of this study is to evaluate the\r pharmacokinetic (PK) profile of BIIB094.The study is open for PD patients with verified\r presence or absence of variations in the leucine-rich repeated kinase 2 (LRRK2) gene, but\r also for patients without any verified PD-related genetic variant.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nKey Inclusion Criteria:\r\n\r - Ability to understand the purpose and risks of the study and provide signed and dated\r informed consent and authorization to use confidential health information in\r accordance with national and local participant privacy regulations.\r\n\r - Diagnosed with PD in the last 7 years, without major motor fluctuations or dyskinesia\r that may interfere with study treatment and assessments in the opinion of the\r investigator after consultation with the Sponsor.\r\n\r - Modified Hoehn and Yahr Stage ≤ 3.\r\n\r Key Exclusion Criteria:\r\n\r - Montreal Cognitive Assessment (MoCA) score less than (<) 23, dementia, or other\r significant cognitive impairment that, in the opinion of the Investigator, would\r interfere with study evaluation.\r\n\r - History of any brain surgery for PD or a history of focused ultrasound treatment at\r any time; or history of neuromodulation procedures.\r\n\r - Transient ischemic attack or stroke or any unexplained loss of consciousness within 1\r year before Screening.\r\n\r - History of unstable angina, myocardial infarction, chronic heart failure, or\r clinically significant conduction abnormalities within 1 year before Screening.\r\n\r - Poorly controlled diabetes mellitus, as defined by having dosage adjustment of\r diabetic medication within 3 months before dosing (Day 1) or glycosylated hemoglobin\r value greater than or equal to (≥) 8 percent (%) at Screening.\r\n\r - History or positive test result at Screening for human immunodeficiency virus.\r\n\r - History or positive test result at Screening for hepatitis C virus antibody.\r\n\r NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,725
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nClinical Outcomes for Deep Brain Stimulation\n\n**Clinical Trial Summary:**\n\nThe object of this study is to longitudinally collect clinical outcomes of patients receiving\r deep brain stimulation for movement disorders with the objective of making retrospective\r comparisons and tracking of risks, benefits, and complications.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Levodopa responsive Parkinson disease OR\r\n\r - Medically refractory Essential Tremor OR\r\n\r - Medically refractory Dystonia\r\n\r Exclusion Criteria:\r\n\r - Dementia (Mattis Dementia Rating Scale <130)\r\n\r - Structural abnormalities precluding intracranial surgery\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,726
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSafety and Initial Effectiveness of Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nSafety and Effectiveness in ExAblate Neuro treatment of medication-refractory tremor in\r subjects with idiopathic Parkinson's disease.\n\n**Clinical Trial Detailed Description:**\n\nThe goal of this prospective, single-arm, multi-site, feasibility study is to develop data to\r evaluate the safety and effectiveness of unilateral focused ultrasound thalamotomy using this\r ExAblate Transcranial System in the treatment of medication-refractory tremor resulting from\r idiopathic Parkinson's disease.\r\n\r The Indications for Use claim for this system is: treatment of medication-refractory tremor\r in subjects with idiopathic Parkinson's disease.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Men and women, age 30 years and older\r\n\r 2. Subjects who are able and willing to give informed consent and able to attend all\r study visits through 3 Months\r\n\r 3. Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and\r examination by a movement disorder neurologist at the site\r\n\r 4. All subjects included in this study will have a TD/PIGD ratio > 1.15 in the medicated\r [ON] state as calculated from the UPDRS formula as described by S, et. al., [74].\r\n\r Note: Ratios for TD/PIGD that are greater than or equal to 1.15 are defined as TDPD.\r PIGD includes those with a ratio of less than or equal to 0.9. Scores of greater than\r 0.9 and less than 1.15 are considered a mixed subtype.\r\n\r 5. Subject demonstrates a resting tremor severity score of greater than or equal to 3 in\r the hand/arm as measured by the medicated (ON) MDS-UPDRS question 3.17 or a\r postural/action tremor greater than or equal to a 2 for question 3.15 or 3.16.\r\n\r 6. Significant disability due to PD tremor despite medical treatment (CRST score of 2 or\r above in any one of the items 16-23 from the Disability subsection of the CRST:\r [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing,\r writing, working, and social activities])\r\n\r 7. Tremor remains disabling when medical therapy is optimal or not tolerated for the\r treatment of other cardinal signs of PD (bradykinesia, rigidity, etc), as determined\r by a movement disorders neurologist at the site\r\n\r 8. Subjects should be on a stable dose of all PD medications for 30 days prior to study\r entry.\r\n\r 9. The thalamus must be apparent on MRI such that targeting of the Vim nucleus can be\r performed indirectly by measurement from a line connecting the anterior and posterior\r commissures of the brain.\r\n\r 10. Subject is able to communicate sensations during the ExAblate Transcranial procedure.\r\n\r Exclusion Criteria:\r\n\r 1. Subjects with unstable cardiac status including:\r\n\r 1. Unstable angina pectoris on medication\r\n\r 2. Subjects with documented myocardial infarction within six months of protocol\r entry\r\n\r 3. Significant congestive heart failure defined with ejection fraction < 40\r\n\r 4. Subjects with unstable ventricular arrhythmias\r\n\r 5. Subjects with atrial arrhythmias that are not rate-controlled\r\n\r 2. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as\r defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the\r following occurring within the preceding 12 month period:\r\n\r 1. Recurrent substance use resulting in a failure to fulfill major role obligations\r at work, school, or home (such as repeated absences or poor work performance\r related to substance use; substance-related absences, suspensions, or expulsions\r from school; or neglect of children or household).\r\n\r 2. Recurrent substance use in situations in which it is physically hazardous (such\r as driving an automobile or operating a machine when impaired by substance use)\r\n\r 3. Recurrent substance-related legal problems (such as arrests for substance related\r disorderly conduct)\r\n\r 4. Continued substance use despite having persistent or recurrent social or\r interpersonal problems caused or exacerbated by the effects of the substance (for\r example, arguments with spouse about consequences of intoxication and physical\r fights).\r\n\r 3. Severe hypertension (diastolic BP > 100 on medication)\r\n\r 4. Subjects with standard contraindications for MR imaging such as non-MRI compatible\r implanted metallic devices including cardiac pacemakers, size limitations, etc.\r\n\r 5. Significant claustrophobia that cannot be managed with mild medication.\r\n\r 6. Current medical condition resulting in abnormal bleeding and/or coagulopathy\r\n\r 7. Patient with severely impaired renal function with estimated glomerular filtration\r rate <30 mL/min/1.73m2 (or per local standards should that be more restrictive) and/or\r who is on dialysis;\r\n\r 8. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within\r one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage\r (e.g. Avastin) within one month of focused ultrasound procedure\r\n\r 9. Subjects with risk factors for intraoperative or postoperative bleeding as indicated\r by: platelet count less than 100,000 per cubic millimeter, a documented clinical\r coagulopathy, or INR coagulation studies exceeding the institution's laboratory\r standard\r\n\r 10. History of intracranial hemorrhage\r\n\r 11. History of multiple strokes, or a stroke within past 6 months\r\n\r 12. Subject who weigh more than the upper weight limit of the table or subjects who will\r not fit into the MR scanner\r\n\r 13. Subjects who are not able or willing to tolerate the required prolonged stationary\r supine position during treatment.\r\n\r 14. Are participating or have participated in another clinical trial in the last 30 days\r\n\r 15. Subjects unable to communicate with the investigator and staff.\r\n\r 16. Presence of central neurodegenerative disease, including but not limited to\r Parkinson-plus syndromes, suspected on neurological examination. These include:\r multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia\r with Lewy bodies, and Alzheimer's disease.\r\n\r 17. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic\r medications.\r\n\r 18. Presence of significant cognitive impairment as determined with a score ≤ 24 on the\r Mini Mental Status Examination (MMSE)\r\n\r 19. Unstable psychiatric disease, defined as active uncontrolled depressive symptoms,\r psychosis, delusions, hallucinations, or suicidal ideation. Subjects with stable,\r chronic anxiety or depressive disorders may be included provided their medications\r have been stable for at least 60 days prior to study entry and if deemed appropriately\r managed by the site neuropsychologist\r\n\r 20. Subjects with significant depression as determined following a comprehensive\r assessment by a neuropsychologist. Significant depression is being defined\r quantitatively as a score of greater than 14 on the Beck Depression Inventory.\r\n\r 21. Legal incapacity or limited legal capacity as determined by the neuropsychologist\r\n\r 22. Subjects with a history of seizures within the past year\r\n\r 23. Subjects with brain tumors\r\n\r 24. Subjects with intracranial aneurysms requiring treatment or arterial venous\r malformations (AVMs) requiring treatment.\r\n\r 25. Any illness that in the investigator's opinion preclude participation in this study.\r\n\r 26. Pregnancy or lactation.\r\n\r 27. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the\r basal ganglia\r\n\r 28. Subjects with remarkable atrophy and poor healing capacity of the scalp (> 30% of the\r skull area traversed by the sonication pathway) will be excluded from this study\r\n\r 29. Subjects who have an Overall Skull Density Ratio of 0.30 (±0.05) or less as calculated\r from the screening CT.\r\n\r - It should be noted that for those candidates whose SDR ratio score is within the\r standard deviation, full technical assessment should be performed and reviewed by\r study investigator with the support of the sponsor.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,727
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nNocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai\n\n**Clinical Trial Summary:**\n\nThis is a cross-sectional, retrospective clinical observation study focusing on the incidence\r and influencing factors of nocturnal symptoms in patients with Parkinson's disease.\n\n**Clinical Trial Detailed Description:**\n\nThis study was a cross-sectional, retrospective clinical observation study investigating the\r incidence and influencing factors of nocturnal symptoms in patients with Parkinson's disease\r through the Parkinson's disease sleep-related scale. At the same time, the effects of\r nocturnal symptoms on the quality of life of patients with Parkinson's disease were studied.\r About 1,500 Parkinson's patients will be recruited into the study who come from Shanghai,\r China.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS\r\n\r 2. Signing informed consent\r\n\r Exclusion Criteria:\r\n\r 1. clinically suspected Parkinson's disease, has not been diagnosed;\r\n\r 2. suspected or diagnosed as secondary Parkinson's syndrome (vascular, drug, traumatic,\r encephalitis, toxic, etc.);\r\n\r 3. suspected or diagnosed as atypical Parkinson's syndrome (progressive supranuclear\r palsy, multiple system atrophy, cortical basal ganglia degeneration, etc.);\r\n\r 4. There is a clear history of stroke, moderate to severe traumatic brain injury,\r hydrocephalus, brain surgery or history of brain tumors;\r\n\r 5. severe cognitive impairment or psychiatric symptoms;\r\n\r 6. Can not cooperate with the completion of the study.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,728
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Effact of Helicobacter Hylori Eradication on the Development of Gastric Mucosa Pathology\n\n**Clinical Trial Summary:**\n\nSubjects who are included will recieve Hp eradication therapy based on antimicrobial\r susceptibility test. After the therapy, the subjects will be divided into two groups, the\r successful group and the failure group. And then they wiil be followed up to observe the\r development of the gastric mucosa pathology.\n\n**Clinical Trial Detailed Description:**\n\nSubjects who are included will recieve Hp eradication therapy based on antimicrobial\r susceptibility test. After the therapy, the subjects will be divided into two groups, the\r successful group and the failure group. The subjects who fail to eradicate the Hp after\r initial treatment and rescue treatment will go into the failure group. Otherwhile, they will\r go to the successful group.And then they wiil be followed up to observe the development of\r the gastric mucosa pathology. For mild atrophy gastritis, non- intestinal metaplasial\r gastritis, follow-up is performed every 2-3 years.For severe atrophy gastritis, intestinal\r metaplasial gastritis, follow-up is performed every 1-2 years. For patients wth high-grade\r intraepithelial neoplasia, they can be included 3 months after the endoscopic treatment, and\r the follow up will be performed at 6, 12 months after the treatment and then the follow up\r will be carried out every 1 year. For non-atrophic gastritis, no follow-up will be performed.\r All included patients will recieve a follow-up at the endpoint of 5 years. The follow-up\r includes endoscopy examination and serum test of PG I,PG II and gastrin 17.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients, aged between 18 and 70 years old, with positive H. pylori infection that was\r not eradicated by previous therapies are included. The H. pylori infection is\r confirmed by the positive rapid urease test or 13C-breath test.\r\n\r Exclusion Criteria:\r\n\r - Patients with significant underlying disease including liver, cardiac, pulmonary, and\r renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric\r surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, patients with\r peptic ulcer, the use of PPI, NSAID or antibiotics during the 4 weeks prior to\r enrolment, and previous history of allergic reactions to any of the medications used\r in this protocol. Patients previously treated with H. pylori eradication regimens or\r those unwilling to participate in the study were also excluded.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,729
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nParkinson's Disease and Digestive Health\n\n**Clinical Trial Summary:**\n\nThis study focuses on the relationship between the brain and the gut, and additionally will\r foster collaboration between Movement Disorder experts and Neurogastroenterologists to\r provide critical information and lead to innovative therapies in the future to treat GI\r dysfunction of Parkinson's Disease.\n\n**Clinical Trial Detailed Description:**\n\nParkinson's disease affects 1 million people in the US with a rising prevalence. In addition\r to neurological problems, patients with Parkinson's Disease often suffer from debilitating\r gastrointestinal (GI) symptoms related to delayed stomach emptying, gas/bloating, and\r constipation. GI complaints of patients suffering from Parkinson's Disease are poorly\r understood. This proposal aims to characterize GI disturbance in patients with Parkinson's\r Disease and provide deeper understanding by investigating symptoms, regional and whole gut\r transit, anorectal physiology, and the brain-gut axis. The investigator believes patients\r with Parkinson's Disease will show altered GI sensation, slower GI motility and demonstrate\r deranged regulation of the brain-gut axis correlated to severity of Parkinson's disease.\r Results from this study of GI motility and brain-gut axis will define a subset of Parkinson's\r Disease patients that can benefit from tailored treatment. This study will foster\r collaboration between Movement Disorder experts and Neurogastroenterologists to provide\r critical information and lead to innovative therapies in the future to treat GI dysfunction\r of Parkinson's Disease.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Presence of 2 of 3 cardinal features of PD (resting tremor, bradykinesia, and\r rigidity)\r\n\r - Hoehn and Yahr Scale stage I-IV\r\n\r - Men or women aged 18+\r\n\r - Stable dopaminergic treatment for ≥4 weeks.\r\n\r - Women of childbearing potential must agree to a urine pregnancy test at screening and\r to avoid pregnancy throughout the study.\r\n\r Exclusion Criteria:\r\n\r - Secondary parkinsonism.\r\n\r - Parkinson-plus syndromes.\r\n\r - Montreal Cognitive Assessment score <17.\r\n\r - Unstable dosage of drugs active in the cns (e.g., anxiolytics, antidepressants) during\r the 60 days before the visit.\r\n\r - Participation in drug studies within 30 days of screening.\r\n\r - Structural brain disease.\r\n\r - Women who are pregnant or likely to conceive (women with potential for pregnancy must\r use contraceptive measures to be included);\r\n\r - Active or personal history of epilepsy.\r\n\r - Acute illness or active, confounding medical, neurologic, or musculoskeletal\r conditions.\r\n\r - Alcoholism or other forms of drug addiction.\r\n\r - Significant prior gastrointestinal surgery.\r\n\r - Ongoing chemotherapy or other treatment for cancer.\r\n\r - Dysphagia\r\n\r - implanted or externally worn medical device such as, but not limited to, a pacemaker.\r (gastric stimulators, bladder stimulators, spinal stimulators, medication infusion\r devices, insulin pumps, continuous glucose monitors are permitted).\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,730
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nHand Rehab Using AMADEO in PD Patients\n\n**Clinical Trial Summary:**\n\nHand movements are particularly impaired in Parkinson's Disease (PD) patients contributing to\r functional disability and difficulties in activities of daily living. AMADEO®. is an\r end-effector system enables intensive training with frequently repeated gripping movements.\r It offers the possibility to select from between passive, assistive and active modes using\r exercise of finger strength, finger movement, movement control and a selective activation of\r the fingers.Aim of this study is to evaluate the efficacy of the end-effector finger system,\r AMADEO®, on hand-finger movements in PD patients evaluating the improvement on finger tapping\r and agility of hand movement item scores on the MDS-UPDRS, variation on the active finger\r strengths and the active and passive Range of Motion (ROM); variation on Electromyographic\r (EMG)-parameters.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria\r\n\r - Idiopathic PD diagnosed according to the Gelb's criteria;\r\n\r - Hoehn-Yahr stage 1- 3\r\n\r - \"On\" state\r\n\r - MMSE score ≥ 24\r\n\r - Willing and able to give written informed consent;\r\n\r - Willing and able to comply with the study procedures.\r\n\r Exclusion Criteria\r\n\r - A specific kind of fluctuation: Sudden on-off fluctuations\r\n\r - History sign or symptoms suggesting the diagnosis of atypical or secondary\r Parkinsonisms;\r\n\r - History of stereotaxic brain surgery for PD;\r\n\r - Mini-mental examination (MMSE) score less than 24 at screening;\r\n\r - Changes in Levodopa (DA) dose in any time within 4 week prior to baseline;\r\n\r - Changes in Dopamine Agonists (DA) in any formulation in any time within 4 week prior\r to baseline;\r\n\r - Presence of severe dyskinesia prior to baseline;\r\n\r - Any other medical or psychiatric condition that may compromise the patient's\r participation in this study;\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,731
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEfficacy of Brisk Walking in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nParkinson's disease (PD) is the second most common neuro-degenerative disease in older\r people. Falls are common among people PD with the incidence rate up to 70% and have strong\r associations with the severity of the disease, balance impairment, and freezing of gait.The\r abnormal gait characteristics include reduction in stride length, gait speed and arm swing,\r and increase in cadence. Gait training, balance training, aerobic training, Tai chi and dance\r training are common types of physical rehabilitation for PD. Brisk walking is a way of\r walking with a pace faster than normal, and it can improve dynamic balance for senior men and\r balance function for chronic stroke clients.\r\n\r Brisk walking also promotes cardiopulmonary fitness and walking endurance in elderly women,\r healthy middle-age and older adults, active elderly men and chronic stroke clients. Our\r previous pilot randomized controlled trial on the effects of a 6-week home-based brisk\r walking program indicates that it is feasible and safe for the early PD population with\r improved walking capacity measured by 6-minute walk distance. The positive effects could\r carry over to 6 weeks after treatment completion. Up-to-date, the short- and long-term\r effects of brisk walking in improving balance and gait performance, and functional capacity\r in people with PD have not yet been well investigated. In order to promote their balance and\r functional capacity in longer term, more sustained training and better exercise adherence may\r be necessary.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Parkinson disease diagnosed by neurologist with Hoehn & Yahr stage 2 or 3\r\n\r - Having a 30-meter walking ability\r\n\r Exclusion Criteria:\r\n\r - Significant neurological condition (other than Parkinson's disease)\r\n\r - Musculoskeletal conditions affecting gait, balance or upper limb functions\r\n\r - Had received deep brain stimulation surgery\r\n\r - Cognitive impairment with Montreal Cognitive Assessment score <24\r\n\r - Present with on-off motor fluctuations.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
35,732
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEvaluation of Anticholinergic Load\n\n**Clinical Trial Summary:**\n\nDrugs with anticholinergic properties may cause central and peripheral side effects. Several\r scales have been developed to evaluate the anticholinergic effect of drugs. Numerous studies\r have been published, showing a link between the anticholinergic load and the occurrence of\r adverse effects in the elderly.\r\n\r Anticholinergic Cognitive Burden is a scale that identifies the severity of adverse effects\r of anticholinergic drugs specifically on cognition including cognitive decline, mental\r confusion, mild cognitive impairment, and dementia. It was developed from reviews of the\r medical literature and the calculation of drug affinities for muscarinic receptors. This list\r of drugs was presented to a team of experts including geriatricians, psychogeriatrists\r geriatric nurses and pharmacists, who assigned these drugs three scores ranging from 1 to 3:\r\n\r - score 1: drugs with a possible anticholinergic effect on cognition demonstrated in vitro\r by its affinity for the muscarinic receptor or by calculation of the ASA level\r (anticholinergic activity of the serum), but without relevant clinical evidence of\r cognitive adverse effects;\r\n\r - scores 2 and 3: drugs whose moderate or severe anticholinergic effect on cognition has\r been clearly established clinically. The drugs of scores 2 or 3 are differentiated by\r their ability to cause confusion and their properties to penetrate or not the\r blood-brain barrier.\r\n\r The sum of the scores of the different drugs taken by the patient determines the cumulative\r cognitive risk score related to anticholinergics.\r\n\r This ACB scale seems to be the most relevant in Parkinsonian patients.\r\n\r Parkinson's disease (PD) is described for the first time in 1817 by an English doctor who\r gives it his name.\r\n\r Parkinson's disease is a chronic, slowly progressive condition defined by the presence of\r motor symptoms (resting tremor, slowness and difficulty of movement or bradykinesia, muscle\r rigidity, equilibrium disorders) associated with variable non-motor symptoms ( such as\r constipation, fatigue, depression and anxiety, sleep disorders, impaired sense of smell,\r cognitive disorders). Age is the main risk factor for the disease (?).\r\n\r There is a significant increase in the number of cases due to the aging of the population and\r the improvement in life expectancy.\r\n\r By 2030, the number of Parkinson's patients could increase by 56% with 1 in 120 people over\r 45 with the disease.\r\n\r Parkinsonian patients are subjected to a higher anticholinergic load, by the therapeutics\r used in their pathologies (antidepressants, neuroleptics, antiparkinsonians, etc ...).\r\n\r These central and peripheral anticholinergic effects may add to the symptomatology in\r Parkinson's patients and aggravate their pathology.\r\n\r My study project aims to improve the management of elderly patients with Parkinson's disease.\r\n\r Hypothesis: People involved in the management of Parkinson's patients are not always aware of\r the potential anticholinergic effects of drugs. Indeed, anticholinergic effects can be\r responsible for many hospitalizations in the elderly.\r\n\r This is why we want to make an inventory of treatments in Parkinson's patients at the\r entrance of hospitalization by evaluating the anticholinergic load using the ACB scale and\r the hospitalization exit in order to know if this score changed after informing the doctors\r responsible\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Parkinson's disease\r\n\r Exclusion Criteria:\r\n\r - age < 18 years\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Trial of tPCS on Parkinson's Disease OFF State\n\n**Clinical Trial Summary:**\n\nA significant number of patients with Parkinson's disease (PD) face motor fluctuations even\r after repeated titration of the dosing of Levodopa. Dealing with OFF state really becomes\r problematic for them. Aggravation of bradykinesia, rigidity, tremor and gait difficulty are\r the common problems in OFF state. Studies are going on drugs like Apomorphine as rescue\r therapy in OFF state. Recently there are studies with Noninvasive brain stimulation, as an\r evolving therapeutic option in different neurodegenerative diseases. In this study, the\r investigators are to evaluate the efficacy of transcranial pulsed current stimulation (tPCS)\r in the OFF state in PD patients. The investigators will give stimulation via tPCS\r (active/sham). EEG, Kinematic measurement of upper limb movement via KinArm, Unified\r Parkinson's Disease Rating Scale (UPDRS) scoring will be done and gait will be assessed via\r Gait Carpet - pre and post-stimulation. The investigators will evaluate the effectiveness of\r tPCS as a single modality or in combination with Levodopa in managing OFF state of PD.\n\n**Clinical Trial Detailed Description:**\n\nThis will be a randomized sham-controlled trial. The investigators have planned to study the\r efficacy of Transcranial pulsed current stimulation (tPCS) in patients of Parkinson's disease\r (PD) in their OFF state. Each patient will come in 3 separate days in OFF state. They will\r first receive either active tPCS or sham tPCS or 3 tabs of Levodopa (100/25) in OFF state.\r Pre and post intervention analysis will be done. In those, who are receiving tPCS\r (active/sham), the investigators will give them Levodopa (100/25) after post stimulation\r assessment done. The patients will be assessed clinically by UPDRS III. EEG (for\r electrophysiological analysis), Gait Carpet (for Gait analysis) will also be done - before\r and after a single session of 20 min stimulation via tPCS. The investigators will also\r compare the effect of tPCS in OFF state, with that of Levodopa in OFF state.\r\n\r The assessment will be done by-\r\n\r 1. Unified Parkinson's disease rating scale III (UPDRS III)\r\n\r 2. Gait via Gait Carpet\r\n\r 3. Quantitative Electroencephalography (qEEG)\r\n\r 4. KinARM\r\n\r Transcranial pulsed current stimulation (tPCS) will be delivered through a pair of\r saline-soaked (0.9% NaCl) surface sponge electrodes. For this experiment, 20 minutes of\r stimulation will be performed. The stimulation would be done to the motor cortex (M1) or\r supplementary motor area (SMA), based on quantitative electroencephalography (qEEG) findings.\r For the sham stimulation, the electrode placement will be same, but the electric current will\r be ramped down 5 seconds.\r\n\r Zeno Walkway is a pressure sensitive electronic roll-up walkway that measures the temporal\r and spatial parameters of gait which could in turn help in identifying any abnormalities in\r the gait. The patient walks on the Zeno Walkway mat before and after the tPCS stimulation to\r find the difference in the gait motion. The Zeno walkway will be used in conjunction with the\r ProtoKinetics Movement Analysis Software (PKMAS). These data will be captured and collated\r via the PKMAS software, resulting in numerous spatial, temporal and pressure-related gait\r parameters. Timed-up-and-go (TUG) (1-5minutes per trial) will be performed. The test consists\r of rising from chair, walking across the 20-foot gait carpet, turning around off the carpet,\r walking back and sitting down. This will be performed over 3 trials. Gait analysis provides\r various additional parameters as output such as stride length, line of progression, step\r length, toe-offs and other temporal and spatial parameters for analysis.\r\n\r Quantitative EEG signals will be recorded, eyes-closed, no-task, using g.Nautilus g.tec\r wireless system. The g.tech system uses earclip reference sensors. The patient will be in a\r quiet place with less light or electromagnetic perturbations. During the resting state\r recordings, patients are seated in a comfortable arm chair and will be instructed to keep\r relaxed, with their eyes closed for 5 min.\r\n\r Kinarm will be used to measure the kinematics of upper limb movements, via Reaching tasks.\r This is basically mechanical handle driven by multiple actuators. A software named BKIN will\r be used to setup this hardware. The Kinarm initially provides the patients with multiple\r points to reach in the screen and the patients would try to reach these points using the\r kinarm handle. The motion of the patients when trying to reach for these points is analysed\r by kinarm and the data would be provided to us based on this analysis.\r\n\r An paired t test will be used to compare baseline data and post tPCS data. Descriptive\r analysis of the neurological examination findings will be provided. The output from the\r KinARM, gait carpet, EEG will be used for further analysis to build a descriptive machine\r learning model.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients diagnosed with Idiopathic Parkinson's disease (IPD).\r\n\r Exclusion Criteria:\r\n\r - Parkinson plus syndromes.\r\n\r - Drug-induced parkinsonism.\r\n\r - Patients who cannot walk independently or wheelchair-bound.\r\n\r - Patients who are not able to provide informed consent.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,734
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPDGeneration: Mapping the Future of Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nTo assess the feasibility, impact, and participant satisfaction of offering Clinical\r Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care\r for People with Parkinson's disease (PWP).\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of this study is to evaluate how offering Clinical Laboratory Improvement\r Amendments (CLIA) certified genetic testing for Parkinson's Disease (PD) genes to people with\r Parkinson's Disease impacts clinical care and potential enrollment in clinical trials. This\r multi-center study will assess the impact and satisfaction of the mode of genetic counseling\r by comparing counseling conducted by a clinician versus centralized genetic counseling\r conducted through Indiana University. The study will also assess knowledge gained by\r administering a knowledge survey pre- and post-genetic testing. All genetic test results will\r be returned to participants through a genetic counseling visit.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's\r Disease: probable diagnosis.\r\n\r 2. Willingness to undergo genetic testing, and choose to be informed of genetic testing\r results for Glucosylceramidase Beta (GBA), LRRK2 and 5 additional PD related genes\r (SNCA, VPS35, PRKN, PINK-1, PARK7).\r\n\r 3. Capacity to give full informed consent in writing, and have read and signed the\r informed consent forms (ICFs) based on clinician's determination.\r\n\r 4. Able to perform study activities (including completion of either online, in-person or\r paper surveys).\r\n\r 5. Individuals must speak and understand the language of the informed consent.\r\n\r Exclusion Criteria:\r\n\r 1. Diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy,\r progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome),\r including that due to medications, metabolic disorders, encephalitis, cerebrovascular\r disease, or normal pressure hydrocephalus.\r\n\r 2. Individuals who have received a blood transfusion within the past 3 months.\r\n\r 3. Individuals who have active hematologic malignancies such as lymphoma or leukemia.\r\n\r 4. Individuals who have had a bone marrow transplant within the past 5 years.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,735
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nNeurophysiological, Behavioral, and Cognitive Networks in Movement Disorders\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to investigate the brain activity associated with motor and\r non-motor symptoms of movement disorders, including Parkinson's disease (PD) and essential\r tremor. These movement disorders commonly have significant non-motor features, such as\r depression, cognitive and memory impairment, decreased attention, speech and language\r disturbances, and slower processing speeds. The investigators are interested in the brain\r activity associated with these motor and non-motor symptoms, and propose to investigate\r changes in brain activity while the investigators perform recordings of the surface and deep\r structures of the brain, in addition to the typical recordings the investigators perform,\r during routine deep brain stimulation (DBS) surgery.\n\n**Clinical Trial Detailed Description:**\n\nMovement disorders are a prominent cause of disability worldwide. In the United States, it is\r estimated that more than 4 million people suffer from Parkinson's disease (PD), essential\r tremor (ET), and dystonia, making them some of the most prevalent of neurologic disorders. Of\r these, PD is the most common, and is primarily characterized by tremor, rigidity, and\r bradykinesia. However, though primarily characterized by motor symptoms, many patients also\r have prominent non-motor features, including depression and cognitive impairment, with\r deficiencies in processing speed, memory, attention, and learning. Some of the most\r debilitating cognitive deficiencies include deficits in goal-directed response selection and\r response inhibition, language, and/or speech difficulties, all of which substantially\r contribute to reduced quality of life.\r\n\r Unfortunately, these features of movement disorders are less well-studied and lack effective\r treatment options, necessitating that new treatments be investigated. Deep brain stimulation\r (DBS), while a highly effective treatment for the cardinal features of PD, is essentially\r ineffective for, and can even worsen other cognitive domains, and there are few studies\r currently investigating how different parameters of DBS may improve these symptoms. In\r addition, speech abnormalities are common with Parkinson's disease and DBS can sometimes\r worsen speech problems. These impairments consists primarily of hypophonia, but cognitive\r deficits can result in actual language disturbance. It is often difficult to know whether the\r speech problems are related to language processing or articulation (related to the movement\r disorder). In an effort to begin addressing these questions, we propose to study motor and\r non-motor symptoms in patients with movement disorders, and to correlate movement and\r cognition with underlying neural electrophysiology.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Eligible for DBS surgery based on multi-disciplinary consensus review\r\n\r - Have a diagnosis of Parkinson's disease or Essential Tremor\r\n\r - A minimum of 18 years of age\r\n\r - Willingness to participate in the paradigms described in the protocol\r\n\r Exclusion Criteria:\r\n\r - Inability to provide full and informed consent\r\n\r - Are not surgical candidates due to co-morbid conditions or pregnancy\r\n\r - Have not undergone an adequate trial of conservative medical management\r\n\r - Have a clinical presentation for which DBS surgery is not indicated\r\n\r - Are not able to participate in study-related activities\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,736
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIndividual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe drug for this submission is Hope Biosciences' autologous, adipose-derived\r culture-expanded mesenchymal stem cells (HB-adMSC's) for the treatment of a single patient\r with Parkinson's Disease (PD). PD is an aggressive neurodegenerative disease that attacks\r neurons, specifically dopaminergic neurons, in regions of the brain associated with movement.\r Accumulation of alpha-synuclein develop Lewy bodies, which aggregate in the brain. Patient's\r experience tremor, bradykinesia, rigid muscles, impaired posture and balance, and changes in\r speech and writing ability. Other physiological symptoms include cognitive decline,\r depression, difficulty chewing and swallowing, sleep disorders, bladder and bowel issues,\r changes in blood pressure and olfaction, as well as significant pain and fatigue. There is no\r cure for PD.\n\n**Clinical Trial Detailed Description:**\n\nOnce the eligibility is confirmed, approximately 1-3 after the screening/baseline visit, the\r subject will return for the first infusions. Subsequent treatments will occur 2 weeks apart\r for two infusions and then monthly for 6 additional infusions. Total number of infusions will\r be eight.\r\n\r On each of these visits, the subject will receive one autologous HB-adMSC infusion of 200\r million (2 x 10^8 cells) total cells suspended in 250 mL normal saline for IV infusion. Every\r infusion visit will include the following procedures:\r\n\r 1. Interval H&P and concomitant medications update,\r\n\r 2. Unified Parkinson's Disease Rating Scale exam (UPDRS),\r\n\r 3. Hoehn and Yahr score\r\n\r 4. Schwab and England Activities of Daily Living Scale\r\n\r 5. Subject will complete a quality of life survey \"Social Roles and Activities\"\r\n\r 6. A video documenting subject walking, standing from sitting, writing a paragraph of 3\r lines and drawing a spiral will be recorded at each visit beginning with the first\r infusion visit.\r\n\r 7. Vital signs monitoring will be initiated (Heart Rate, BP, Resp., Temp., SpO2),\r\n\r 8. A peripheral IV line will be inserted,\r\n\r 9. *A blood and urine sample for clinical labs (CBC with Platelets, CMP, PT, PTT, complete\r Urinalysis as well as baseline TNF-a, IL6 and CRP)\r\n\r 11. A \"time out\" verification of patient/consent/procedure/cell product will be performed,\r 12. The HB-adMSC infusion will be given by through the peripheral IV, infused over 1 hour at\r a rate of 250ml/hr (83gtts/minute) 13. Assessment for Infusion Related AE/SAEs\r\n\r Follow-up Visits Week 4, 32, 36, 40, 44, 48, and 52\r\n\r The subject will undergo the following procedures at each follow-up visit without infusion:\r\n\r 1. Interval H&P and concomitant medications update,\r\n\r 2. Unified Parkinson's Disease Rating Scale exam (UPDRS),\r\n\r 3. Hoehn and Yahr score\r\n\r 4. Schwab and England Activities of Daily Living Scale\r\n\r 5. Subject will complete a quality of life survey \"Social Roles and Activities\"\r\n\r 6. A video documenting subject walking, standing from sitting, a handwriting sample of one\r sentence and drawing a spiral will be recorded at each visit beginning with the first\r infusion visit.\r\n\r 7. Vital signs monitoring will be initiated (Heart Rate, BP, Resp., Temp., SpO2),\r\n\r 8. A blood and urine sample for clinical labs (CBC with Platelets, CMP, PT, PTT, complete\r Urinalysis as well as baseline TNFa, IL6 and CRP)\r\n\r 9. Assessment for Infusion Related AE/SAEs\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. adult individual at least 18 years old\r\n\r 2. clinical diagnosis of Parkinson's disease\r\n\r 3. capable and competent to provide informed consent -\r\n\r Exclusion Criteria:\r\n\r 1. Prior history of:\r\n\r 1. Recent or ongoing clinical infection indicated by WBC>13,000 and/or temperature\r >102.\r\n\r 2. Clinically significant cardiovascular, lung, renal, hepatic, or endocrine disease\r or any other acute or chronic medical condition that, in the opinion of the\r investigator, may increase the risks associated with study participation,\r\n\r 3. Chemical or ETOH dependency that in the opinion of the investigator would\r preclude participation in the study\r\n\r 2. Participation in concurrent interventional research studies during this trial\r\n\r 3. Unwillingness to return for follow-up visits.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,737
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nHow \"Shared Decision Making Decision-aid\" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan\n\n**Clinical Trial Summary:**\n\nShared decision-making helps patients to establish a treatment plan with clinicians together.\r Our goal was to determine if the tools we developed could reduced decisional conflict for\r patients with obstructive sleep apnea.\n\n**Clinical Trial Detailed Description:**\n\nShared decision-making helps patients to establish a treatment plan with clinicians together.\r Our goal was to determine if the tools we developed could reduced decisional conflict for\r patients with obstructive sleep apnea.\r\n\r Inclusion criteria: include obstructive sleep apnea patient from the outpatient clinic of\r Dean Wu, the sleep center of Shuang-He Hospital, 20-80 years old, polysomnography showed\r moderate severity (AHI ≥ 15), can communicate in Chinese.\r\n\r Exclusion criteria: dementia, mental illness, language difficulties.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Include obstructive sleep apnea patient from the outpatient clinic of Dean Wu, the\r sleep center of Shuang-He Hospital, 20-80 years old, polysomnography showed moderate\r severity (AHI ≥ 15), can communicate in Chinese\r\n\r Exclusion Criteria:\r\n\r - Exclude dementia, mental illness, language difficulties\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,738
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nNovel Tools for the Delivery and Assessment of Exercise Programs Adapted to Individuals With Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe study will aim to determine whether a technology-based personalized home exercise program\r delivered asynchronously and supervised remotely by a kinesiologist is more effective in\r improving gait than a similar home-based exercise program without technology nor remote\r supervision. The main hypothesis is that the proposed intervention with the technology will\r provide significant improvements in gait performance and higher adherence/satisfaction over\r the non-supervised exercise program.\r\n\r Both groups will be composed of people with Parkinson's disease. They will have the same\r evaluation pre and post intervention, the same number of visits from the kinesiologist to\r deliver the exercise program at home. The difference is the information gathered from the\r technology; for example, the completion level of each training, success or failure of\r selected exercises, connection to exercise session, etc. In addition, kinesiologist can\r remotely adjust difficulty of exercise and take action quickly if the participant hasn't\r logged in the training system.\r\n\r Total duration for a participant is 16 weeks: pre-evaluation at home and at lab, 12 weeks\r home-based exercise program, post-evaluation at home and lab (same as before exercise\r program).\r\n\r Pre- and post-evaluation: 7 days wearing an Apple watch to measure mobility in participant\r environment (participant is met at home and continues normal activities), than comes to lab\r to undergo physical and balance tests, and scans to analyse body composition (fat, muscle and\r bone structures). Participant needs to be in \"off\" state when arriving at the lab; not have\r taken the morning PD medication. Will take it at the lab with breakfast, after the first\r tests.\n\n**Clinical Trial Detailed Description:**\n\nThe specific aims of this project are: a) to determine whether a technology-based\r personalized home exercise program delivered asynchronously and supervised remotely by a\r kinesiologist is more effective in improving gait than a traditional home-based exercise\r program, b) to assess the system acceptability and satisfaction, c) to examine and compare\r the impact of both approaches on several secondary outcome measures related to mobility, PD\r symptom, and quality of life. This study is a prospective randomized controlled\r single-blinded clinical trial of efficacy of a technology asynchronous assisted supervised\r tele-exercise program compared to an a traditional home-based exercise program with a\r booklet.\r\n\r Interventions:\r\n\r Control group (CONT): The participants (n=21) included in control group will follow a\r non-supervised home-based exercise program (booklet format). The exercise program will\r include 3 physical activity sessions per week for 12 consecutive weeks. This exercise regimen\r has been shown to be adequate to improve functional capacities in elderly and feasible. Each\r exercise session will last 40-45 minutes and includes: 1) 5 minutes of warm-up exercises; 2)\r 15-18 minutes of mobility and balance exercises (e.g. high knees, lateral launches, side\r steps); 3) 15-18 minutes of strengthening and coordination exercises (e.g. weight transfer\r and squats, leg extension and balance, lateral shifting, horizontal flexion and extension)\r and; 4) 5 minutes for cool down/stretching. This exercise protocol was developed based on\r general guidelines for the prescription of exercises to older adults and, validated in a\r previous study. The exercise booklet will be introduced and supervised for the first sessions\r by a trained kinesiologist. Follow-ups by phone will happen at sessions 6, 12 and 18. During\r these follow-up calls, if the answers are \"yes\" to the 3 following questions (1. Did the\r participant perform during the last weeks all the exercise sessions? 2. Did the participant\r feel safe when performing exercises? 3. Did the participant find easier to perform the\r exercises compared to the last contact?), then the participant will be invited, but not\r obligated, to increase the level of difficulty using the option indicated in the booklet.\r\n\r JIN Group (n=21): The JIN group (n=21) will receive an individualized asynchronous supervised\r home-base exercise program using the Jintronix System, 3 times/week for 12 weeks (36\r sessions). This exercise regimen has shown to be adequate to improve functional capacities in\r elderly. Briefly, the Jintronix Rehabilitation System (JRS) uses Microsoft Kinect cameras to\r track patient's movements in 3D during exercises. They are programmed as games that are\r visualized on a television and for which performance feedback is provided to the participant.\r Developed by Jintronix system designers in partnership with researchers, the system provides\r an interactive exergame environment to execute, specialized exercises through specific\r instructions and real-time feedback. The Jintronix system which includes a computer, the\r software and a motion capture device will be installed at participants' homes on their own\r television. A trained kinesiologist will install the system and supervise the exercise\r program. Participants will be trained to use the system with help of the kinesiologist during\r the visits. Each exercise session will last 40-45 minutes and includes: 1) 5 minutes of\r warm-up exercises; 2) 15-18 minutes of mobility and balance exercises (e.g. high knees,\r lateral launches, side steps); 3) 15-18 minutes of strengthening and coordination exercises\r (e.g. weight transfer and squats, leg extension and balance, lateral shifting, horizontal\r flexion and extension) and; 4) 5 minutes for cool down/stretching. Based on the Web-portal\r daily reports on the performance of the exercise program, the kinesiologist will do online\r adjustment of the degree of difficulty of the individualized exercises by increasing the\r number of repetitions, number of series, intensity and range of motion and provide feedback\r to the participant. This will ensure individualized adaptations and progress throughout the\r 12-week intervention.\r\n\r The JIN group will use the Jintronix rehabilitation software to exercise at home whereas the\r CONT group will use an exercise booklet. Both groups will be free to exercise on the 3 days\r and times that best suit their schedule, with a mandatory minimum of one day off between\r sessions. In addition, to counteract human interaction bias, both exercise groups will have\r the same number and type of contact. The first weeks following the baseline evaluation, 3 to\r 4 in-person home visits are required to ensure proper and safe execution of exercise protocol\r (both groups) and the capacity to use the technology (JIN group only). In addition to these\r visits, 3 follow-up phone calls will be given to allow the kinesiologist to ensure safety and\r adherence. An emergency contact number will be given to participants for any questions\r regarding the exercise regimen during the 12-week intervention.\r\n\r Study workflow and monitoring: After a phone screening to ensure eligibility and obtaining an\r oral consent to participate, participants will follow 2 baseline visits: 1 at their home and\r 1 at the \"Université du Québec à Montréal\" (UQAM). Before the home visit, subjects will be\r randomized into control (CONT) or Jintronix® (JIN). During the first visit at home,\r participants will sign an informed consent form. Afterward, the visit will be divided in 2\r parts. The first part will serve to complete validated questionnaires (Parkinson's Disease\r Questionnaire, Short Falls Efficacy Scale-International and Life Space Assessment). The\r second part is to install the wearable equipment for mobility assessment (Apple watch® and\r location beacons). Participants will wear the sensor for at least 7 consecutive days.\r Afterwards, participants will return wearable sensors and location beacons at the UQAM visit.\r They will arrive in the morning in \"off\" state (abstinence of medication 12h before\r appointment) to undergo the motor evaluation, which is the 6-minute walk test, and the Short\r Physical Performance Battery test. After these, participants will take their medication with\r a breakfast at the lab. While waiting to be \"on\" state, investigators will perform the body\r composition (DEXA) and muscle composition scans (Ct-scan). When the medication is fully in\r effect, functional capacity and 6-min walk tests will be re-assessed. This will provide us\r comparison measures. All evaluations will be repeated at the end of the exercise intervention\r using the same sequence.\r\n\r Power analysis:\r\n\r Sample size: Primary outcome measure is the average gait speed assessed during a 6-minute\r walk test. Based on previous studies, obtaining clinically significant improvement in gait\r speed needs to show a gain of 0.2m/sec after intervention. Data using the proposed technology\r yielded significant improvement (JIN:+0,2±0,12m/s vs CONT:0,05 ±0,09m/s; p=0.025). Thus,\r obtaining a power of 0.80, an alpha of 0.05, with an effect size of 0.5 (which is\r significantly smaller that the investigators previously obtained (1.37)), this project would\r need a total sample size of 28 participants (14 per group) to detect clinically significant\r differences in gait speed changes between two groups. However, considering an attrition rate\r of 20% (3 out of 14 in each group) and to improve chances to achieve adequate power for\r secondary outcomes, a sample of 21 participants per group (n=42) will be used. Even if\r adequate power is not achieved for the secondary outcomes' measures, sample sizes between 24\r and 50 are sufficient to calculate the standard deviation of outcome measures gathered during\r a feasibility study, to estimate the sample size required for hypothesis testing in a\r randomized control trial (RCT). Thus, calculations will ensure a sufficient power analysis\r for the primary outcome measure and position the investigators to establish the variability\r on secondary measures for a larger RCT.\r\n\r Statistical analyses: Descriptive statistics (means, standard deviations, ranges, normality,\r and proportions) will be determined for all study variables. The primary outcome, gait speed,\r will be assessed using a two-way mixed model analysis of variance (ANOVA) where group is the\r between factor and time is the within factor. Tukey post hoc or Friedman test will be used\r based on data characteristics. Categorical variables related to the outcome measures (i.e.\r clinical scales and diary) will be analyzed using χ2 or Fisher exact tests for baseline\r comparisons. The change in each outcome variable (before and after training) will be modeled\r in an unadjusted 1-factor (group) analysis of variance, to investigate the effect of\r interventions. Wearable sensor data will be averaged over multiple days and compared using a\r two-way mixed model ANOVA as described above, similar to other secondary outcome measures\r (i.e. DEXA, CT-Scan, etc.). Tukey post hoc or Friedman test will be used based on data\r characteristics. To examine changes in variability, standard deviations will be averaged over\r multiple days and compared using the same approach. Finally, exploratory analyses will be\r performed to examine 1) if the JIN intervention allows to improve on/off periods, 2) the\r possible effect of age, sex or medication dose on exercise adaptations.\r\n\r Innovation: Patients with PD are likely to experience a decrease in their daily physical\r activity (PA) because of physical impairments, fatigue, and apathy. PA is a complement to\r pharmacological interventions to manage the inherent decline in function associated with the\r disease. It is well known that PA interventions induce positive effects on physical\r capacities and more specifically on gait, mobility, posture and balance. However, engaging\r older adults in PA through different modalities of exercise programs to obtain these benefits\r is a challenge, as more than half of older adults are inactive physically and patients with\r PD are even more than older adults. Supervised exercise programs are needed to motivate and\r engage patients with PD in becoming more physically active in structured and safe ways.\r Providing access to supervised exercise programs for patients is difficult as they have\r mobility constrains and they rely on others for their travel. Home Exercise Programs (HEPs)\r offer potential benefits but are often lacking close supervision and interaction with a\r healthcare professional. The use of a supervised in-home PA program driven and supported by\r an exergame such as Jintronix© has the potential to be more impactful and meaningful to\r patients than traditional HEPs. It can be used independently by them in their own home and do\r not require the presence of a professional to perform physical activity training. This allows\r patients to perform exercise as they wish (schedule, day, on/off period etc.) which overall\r will increase their adherence to the PA program and promote self-engagement and\r self-management of their PD. The technology provides a unique way to engage patients in PA\r while ensuring supervision and communication with a health care professional. The proposed\r works will also innovate by using an ecological mobility measurement approach based on\r wearable sensors to capture gait and activity metrics under real life conditions for\r multiples days and link this to medication use. The combination of sensors used (inertial\r sensor at the ankle, and interior and exterior location sensors) and their packaging into\r highly usable and wearable form factors is highly innovative and unique. The proposed\r instrumentation for the measurement approach offers a lot of potential to study the impacts\r of pharmacological and non-pharmacological interventions on real life functions and\r activities of patients. It could be of interest to other parties involved in clinical trials\r on interventions for PD.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of PD from a neurologist based on the clinical diagnostic criteria for PD\r based on the recent work of Postuma and colleagues\r\n\r - Hoehn and Yahr stages 1 to 3\r\n\r - lives on the island of Montreal\r\n\r Exclusion Criteria:\r\n\r - Unstable medical/psychiatric comorbidities\r\n\r - History of other movement disorders\r\n\r - Orthopedic conditions restricting exercise\r\n\r - Already performing more than 20 minutes of aerobic exercise more than 3 times per week\r (to avoid prior training effect)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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35,739
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study\n\n**Clinical Trial Summary:**\n\nA new Neuro-Immersion system based on virtual reality and 3D motion tracking has been\r developed recently, allowing to evaluate and record the spatial localization performance of\r cochlear implant (CI) users. This system allows to highlight localization deficits in\r three-dimensional space for all CI patients. Unfortunately, there is currently no suitable\r postoperative management for these localization problems. However, the discomfort felt by\r patients is clearly verbalized. Thanks to the new virtual reality system, it is now possible\r to develop a rehabilitation protocol adapted to each patient. This project will focus on the\r evaluation of a spatial auditory rehabilitation, based on unisensory (visual) or multisensory\r (auditory and visual) feedback, for bilateral CI adults.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age between 18 and 75 years inclusive\r\n\r - Use of the second CI for at least 1 year\r\n\r - Regular follow-up in the Ear Nose and Throat department of Edouard Herriot Hospital in\r Lyon\r\n\r - Post-lingual deafness\r\n\r - Average voice recognition over 80% with 2 Cochlear Implants\r\n\r - Normal vision (with or without correction)\r\n\r - Able to understand the experimental instructions\r\n\r - Affiliated to a social security scheme\r\n\r Exclusion Criteria:\r\n\r - Oculomotor disorder\r\n\r - Bilateral vestibular areflexia\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,740
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nUsing DBS to Probe Basal Ganglia Dysfunction\n\n**Clinical Trial Summary:**\n\nThis study will probe the function of collections of neurons deep in the brain termed the\r basal ganglia It will investigate the role of the basal ganglia in how and why movement is\r disrupted in conditions like Parkinson's disease, Dystonia and Essential Tremor. Deep brain\r recording and stimulation will be used to probe the basal ganglia's contribution. Patients\r with relatively severe movement disorders may have electrodes implanted in the basal ganglia\r so that stimulation can be delivered chronically as a form of therapy. Studying these\r patients allows researchers (a) to record brain activity from these electrodes in the basal\r ganglia during symptoms related to abnormal motor control and (b) to stimulate the same\r electrodes while patients experience symptoms. Like this they can see what aspects of the\r activity of groups of nerve cells in the basal ganglia are associated with which symptoms and\r also establish that these aspects of activity help cause linked symptoms. This means studying\r patients just after electrode implantation, while the leads from the electrodes may still be\r available for hooking up to external recording and stimulating devices. Understanding how the\r activity of groups of nerve cells in the basal ganglia controls movement may help us develop\r improved treatments.\n\n**Clinical Trial Detailed Description:**\n\nThis study investigates how the basal ganglia contribute to motor symptoms like tremor,\r bradykinesia and muscle spasm. The basic research approach is to record from sites in the\r basal ganglia whilst patients are symptomatic, so that brain waves can be correlated with\r symptoms/signs. Once a brain wave is implicated in an aspect of abnormal movement, the\r researchers can try and confirm its central role in function or dysfunction by triggering\r stimulation whenever the brain wave is picked up. For stimulation the researchers will use\r the same high frequency stimulation (130 Hz) as used clinically, as this is thought to\r effectively suppress neural activity at the stimulation site. Thus, if a given brain wave is\r important in, for example, slowing movement, then by triggering stimulation whenever this\r brain wave is big it can be expected that movement speed will be increased.\r\n\r The investigators hope to follow this two-stage procedure to document the role of the\r different brain activities picked up from basal ganglia sites in driving tremor, muscle spasm\r and slowness of movement in patients with Parkinson's disease, dystonia and essential tremor.\r This study is important, as if the researchers can alter brain function and specific symptoms\r with stimulation they can use the same form of feedback-controlled stimulation as a\r potentially efficient form of treatment. Conventional deep brain stimulation delivers fixed\r stimulation all of the time. For example, researchers are beginning to see that stimulation\r control based on feedback from beta activity in the basal ganglia may have advantages over\r conventional continuous deep brain stimulation in treating Parkinson's disease.\r\n\r The current study is particularly interested in the processes contributing to slowness\r (bradykinesia) and rigidity (stiffness) in patients with Parkinson's disease, tremor in\r patients with Parkinson's disease and Essential Tremor, and muscle spasms in patients with\r dystonia.\r\n\r 1. Bradykinesia and Rigidity in patients with Parkinson's disease Here there is already\r evidence that these impairments are associated with beta frequency band activity\r (~20Hz). Such activity is exaggerated in patients with Parkinson's disease in whom it\r comes in bursts lasting several hundred milliseconds or even longer. The investigators\r have already shown that by triggering stimulation when bursts of beta activity occur\r they can speed up movement and reduce rigidity. In the present study they are interested\r in (a) determining whether it is necessary to trigger off beta bursts or whether it is\r sufficient to trigger off the general level of beta activity (ie averaged over long\r periods), (b) whether if it is necessary to trigger off all beta bursts, or is it just\r the long bursts that need to be triggered off, and (c) whether triggered stimulation is\r also sufficient to control tremor where this is a co-existent symptom. Exploration of\r these issues requires the investigators to record basal ganglia activity (the feedback)\r and to deliver stimulation, whilst varying how the feedback is processed before driving\r the stimulation. In engineering terms the investigators vary the signal processing and\r control policy details, but the net result is feedback-controlled deep brain\r stimulation. Note that the investigators only control the amplitude of stimulation\r within a clinically determined range that goes no higher than the threshold for\r eliciting side-effects. All the remaining stimulation parameters, e.g. frequency and\r pulse width, are set to standard clinical settings.\r\n\r 2. Tremor in patients with Parkinson's disease or Essential Tremor Here the evidence that\r tremor is associated with a discrete brain activity is less robust, although\r oscillations at tremor frequency (and twice this) are suspected of playing a role. In\r conditions where the investigators are unsure of the exact nature of the factors\r contributing to a state, in this case tremor, they often use machine learning to find\r the relevant factors. Here the investigators propose to record both basal ganglia\r activity and tremor in the limbs and then use these with machine learning algorithms to\r point out the relevant combination of signals associated with tremor. The investigators\r can then use machine learning outputs to tell them how to control tremor with\r stimulation, whilst interrogating the weights of the inputs to the machine learning\r algorithms to deduce the important relationships. As above, they will explore the\r optimal signal processing and control policy details, but the net result is\r feedback-controlled deep brain stimulation. Note that they only control the amplitude of\r stimulation within a clinically determined range that goes no higher than the threshold\r for eliciting side-effects. All the remaining stimulation parameters, e.g. frequency and\r pulse width, are set to standard clinical settings.\r\n\r 3. Involuntary muscle spasms in patients with Dystonia Here the evidence that muscle spasms\r are associated with a discrete brain activity is also relatively weak, although\r oscillations at theta-alpha frequencies (5-12 Hz) are suspected of playing a role. The\r investigators propose to record both basal ganglia activity and muscle spasms in the\r body and then use these with machine learning algorithms to point out the relevant\r combination of signals associated with muscle spasms. They can then use machine learning\r outputs to tell them how to control muscle spasms with stimulation. As above, the\r investigators will explore the optimal signal processing and control policy details, but\r the net result is feedback-controlled deep brain stimulation. Note that they only\r control the amplitude of stimulation within a clinically determined range that goes no\r higher than the threshold for eliciting side-effects. All the remaining stimulation\r parameters, e.g. frequency and pulse width, are set to standard clinical settings.\r\n\r Techniques to be used\r\n\r Our study involves several techniques:\r\n\r 1. Evaluation of symptoms using standard clinical rating scales e.g Part III motor UPDRS,\r Unified dyskinesia rating scale and speech intelligibility test in patients with\r Parkinson's disease; essential tremor rating assessment scale (TETRAS) for patients with\r essential tremor; Burke Fahn Marsden dystonia rating scale (BFMDRS) for patients with\r dystonia. The performance of these rating scales will also be videoed for off-line\r review.\r\n\r 2. Recording of peripheral symptoms like movement speed, tremor or spasm with standard\r techniques e.g. recording joystick movement speed, recording tremor and other movements\r with the bradykinesia akinesia incoordination test, skin mounted accelerometers and skin\r mounted electromyographic (EMG) electrodes. These are standard, non-invasive techniques\r that do not involve any side-effects of discomfort.\r\n\r 3. Recording of EEG using scalp mounted electrodes. This is a standard, non-invasive\r technique that does not involve any side-effects or discomfort. However, there is an\r important caveat here that as these patients will have recent surgical scars on their\r scalps these will avoided so that no electrode is applied to the scalp within 4 cm of\r any wound. EEG electrodes are applied to the scalp with a conductive paste which helps\r hold them in place. Sometimes, where lack of hair allows, the investigators bolster that\r attachment with some tape. There is no increase in infection risk due to recordings in\r patients with externalised deep brain stimulation leads.\r\n\r 4. Recordings of depth EEG from the deep brain stimulation electrodes implanted in to the\r brain by the surgeon for standard clinical therapy. As these are passive recordings\r there are no side-effects or risks. Recordings in 2-4 will be performed using an\r amplifier that holds a certification mark that indicates conformity with health, safety,\r and environmental protection standards for products sold within the European Economic\r Area.\r\n\r 5. Stimulation of the deep brain stimulation electrodes implanted in to the brain by the\r surgeon for standard clinical therapy. Stimulation can cause side-effects, so\r importantly the investigators will only deliver stimulation in the form and range used\r clinically, taking care to always remain below the threshold for side-effects.\r Stimulation will be delivered through an in-house, custom-built, battery-supplied,\r bilateral stimulator that does not hold a certification mark that indicates conformity\r with health, safety, and environmental protection standards for products sold within the\r European Economic Area. Nevertheless, it has been fully safety tested. The stimulator is\r an updated version of that used for several past studies that have been reviewed and\r approved by the United Kingdom National Research Ethics Service Committee South Central.\r To allow for stimulation return, the amplifier is connected to a conducting pad placed\r over the neck. Periodic impedance checks will ensure this connection is robust through\r the course of the experiment.\r\n\r Participants will be given the choice to undergo the study without their usual medication for\r their motor symptoms or with such medication. The former state is preferred to facilitate the\r demonstration of a link between neural activities and symptoms, but the final decision will\r be down to the participant. Symptoms may be worse with the temporary withdrawal of\r medication, but most participants will be familiar with this as a result of forgetting their\r medication in the past or because their medication was temporarily withdrawn as part of a\r clinical test like the levodopa challenge.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Participant is willing and able to give informed consent for participation in the\r study.\r\n\r - Male or Female, aged 18 to 80 years old.\r\n\r - Diagnosed with Parkinson's disease, Essential Tremor or Dystonia.\r\n\r - Undergoing two-stage surgery for deep brain stimulation as therapy for their movement\r disorder.\r\n\r Exclusion Criteria:\r\n\r - Cognitive impairment (judged by the clinician on the care team or in the research team\r as a participant not having sufficient mental capacity to understand the study and its\r requirements). This includes anyone who, in the opinion of clinicians on the care team\r or clinicians in the research team, is unlikely to retain sufficient mental capacity\r for the duration of their involvement in the study.\r\n\r - Intracranial bleeding, confusion, cerebrospinal fluid leak or any other complication\r after the first stage of surgery.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,741
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Natural History of Parkinson's Disease-associated Spinal Disorders\n\n**Clinical Trial Summary:**\n\nThis is a prospective single-institution longitudinal study to access quality of life and\r serial imaging and biodynamic testing to assess spinal disorders associated with Parkinson's\r disease patients.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective single-institution longitudinal study to access quality of life with\r PROMIS testing, ODI, NDI, VAS and short form 36 health physical component score. The study\r will also include serial radiographic assessments and biodynamic force plate and hand\r dynamometer testing. This study will follow for five years post-consent.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of Idiopathic Parkinson Disease Early to mid-disease course (Hoehn and Yahr\r scale 1-3) Age 18-75\r\n\r Exclusion Criteria:\r\n\r - Prior spinal fusion Diagnosis of ankylosing spondylitis, diffuse idiopathic spinal\r hyperostosis (DISH), or other systemic condition that affects spinal function\r Inability to consent Current incarceration Presence of other medical condition or\r neurologic condition that would hinder ability to perform biodynamic testing\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
35,742
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nInteractive Stepping Exercise on Memory\n\n**Clinical Trial Summary:**\n\nThis is a randomized controlled trail. A total of 28 individuals with aMCI will be randomly\r assigned to either the ISE group or control group. The ISE intervention conducts three times\r a week for 16 weeks. Outcomes are measured at baseline and after intervention. The primary\r outcomes are the Chinese version verbal learning test (CVVLT), selective reminding test\r (SRT), and logic memory test (Wechsler Memory Scale). The secondary outcomes are Montreal\r Cognitive Assessment (MoCA) for cognitive function, and trail making test Part A & B (TMT-A &\r B), Stroop test, and 25-item Executive Interview (C-EXIT 25) for executive function.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age≥50 years\r\n\r - Complained of memory impairment\r\n\r - Chinese Version Verbal Learning Test 10-minute delays ≤ 6 words\r\n\r - MMSE score≥24 and CDR score=0.5\r\n\r - Activities of daily living are intact\r\n\r - DSM-IV criteria for the diagnosis of dementia is not met\r\n\r Exclusion Criteria:\r\n\r - Any significant neurologic disease other than suspected incipient Alzheimer's disease\r\n\r - Psychotic features, contraindication of exercise... which could lead to difficulty\r complying with the protocol\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
35,743
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEvaluating the Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects\n\n**Clinical Trial Summary:**\n\nThis study's primary objective is to determine the ability of Kombucha to impact blood sugar\r levels in patients with diabetes mellitus type II. The secondary objective is to determine\r the ability of Kombucha to impact blood pressure, and quality of life measures as measured by\r uniform questionnaire that includes: gut health, colds, infections, headaches, sleep, anxiety\r (GAD2), depression (PHQ2), skin health.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. S/he is above the age of 18\r\n\r 2. S/he has the ability to read, speak and write English\r\n\r 3. S/he has telephone access\r\n\r 4. S/he is diabetic and willing to check blood sugar levels every day\r\n\r 5. Hb A1c >7%\r\n\r 6. Possesses a glucometer\r\n\r Exclusion Criteria:\r\n\r 1. Allergy to kombucha ingredients\r\n\r 2. Drinks kombucha regularly (>3time per week)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
35,744
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAssessment of Pupil Light Responses in Patients With Parkinson Disease\n\n**Clinical Trial Summary:**\n\nParkinson diseases (PD) is the second most common degenerative disease of the central nervous\r system. The development of early diagnostic biomarkers may help identify at-risk individuals\r and allow precocious interventions at the onset of disease and more precise monitoring of\r therapies that may slow disease progression.\r\n\r Proof of concept studies indicated significant differences in pupil light response between PD\r patients and healthy controls. The feasibility of using pupillometry for assesment of PD will\r be examined.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - General inclusion criteria\r\n\r 1. Age 30-75 years old\r\n\r 2. Signed written informed consent\r\n\r 3. Gender: Both (Male and Female)\r\n\r 4. Pupillary reflex to light.\r\n\r 5. Clear ocular media\r\n\r Patients' Inclusion Criteria:\r\n\r Patients with clinical presentations of the neurodegenerative forms of parkinsonism\r (bradykinesia, extrapyramidal rigidity, tremor, postural instability and gait disturbance)\r including: idiopathic Parkinson disease (PD), Lewy body disease (LBD), progressive\r supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD)\r and secondary parkinsonisms.\r\n\r Control group- inclusion criteria\r\n\r 1. Normal eye examination\r\n\r 2. Best-corrected visual acuity (BCVA) of 20/20\r\n\r 3. Normal color vision test (Farnsworth/Lanthon D-15 Test)\r\n\r 4. No present ocular disease\r\n\r 5. No past ocular disease or surgery within last 6 months\r\n\r 6. No use of any topical or systemic medications that could adversely influence efferent\r pupil movements\r\n\r 7. Normal 24-2 Humphrey visual field and\r\n\r - Short duration (≤10 minutes)\r\n\r - Minimal fixation losses, False positive errors and False negative errors (less\r than 30% for each one of reliability indices)\r\n\r Exclusion Criteria:\r\n\r 1. Diagnosis of dementia.\r\n\r 2. Cognitive decline that may impair obtaining informed consent.\r\n\r 3. Tremor or dyskinesia that could interfere with ophthalmic evaluation\r\n\r 4. History of past (last 3 months) or present ocular disease or ocular surgery\r\n\r 5. Use of any topical or systemic medications that could adversely influence pupillary\r reflex\r\n\r 6. Psychiatric illness, active psychosis.\r\n\r 7. Previous neurosurgical interventions, including stereotactic neurosurgical procedures.\r\n\r 8. Past or current strokes or brain injury and other brain disorders (except\r PD/parkinsonism for patient group)\r\n\r 9. Anti-dopaminergic drugs.\r\n\r 10. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tomometry or\r other schedule study procedure.\r\n\r 11. Visual media opacity including cloudy corneas.\r\n\r 12. Any condition preventing accurate measurement or examination of the pupil.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
35,745
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\ntaVNS in Mild to Moderate Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to find out whether a non-invasive form of nerve stimulation\r called transcutaneous vagus nerve stimulation (taVNS) is safe and effective in people with\r Parkinson's Disease.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age: 40-79 y\r\n\r - Idiopathic Parkinson's Disease Diagnosis\r\n\r - Disease Stage: Hoehn and Yahr stage 2-3\r\n\r - Patient requires a minimum of 3 doses of levodopa daily\r\n\r - Willingness to be videotaped\r\n\r Exclusion criteria:\r\n\r - Dementia or Montreal Cognitive Assessment score <24\r\n\r - Parkinson's Disease psychosis\r\n\r - Ear trauma\r\n\r - Facial pain\r\n\r - Traumatic Brain Injury or clinical history of stroke\r\n\r - Metal implants above the shoulders\r\n\r - History of myocardial infarction or arrhythmia, bradycardia\r\n\r - Active respiratory disorder\r\n\r - Alcohol or substance use disorders\r\n\r - History of Deep Brain Stimulation (DBS) or other brain surgery\r\n\r - Epilepsy\r\n\r - Pregnancy\r\n\r - B-Blockers, dopamine blocking agent, antiarrhythmic medication, acetylcholine esterase\r inhibitor, midodrine, florinef, droxidopa, or anticholinergic drugs\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
35,746
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPhase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy\n\n**Clinical Trial Summary:**\n\nEvaluation of the clinical profile (lipid efficacy, safety and PK) across a number of doses\r of CIVI 007, a PCSK9 inhibitor. Patients to be evaluated will be on a stable background of\r statin therapy with or without ezetimibe.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nKey Inclusion Criteria:\r\n\r 1. Body mass index (BMI) between 18.0 and 40.0\r\n\r 2. Stable (>4 weeks prior to the Screening Visit) dose of statin therapy with or without\r ezetimibe\r\n\r 3. Fasting low-density lipoprotein cholesterol (LDL-C): ≥100 mg/dL for those without\r cardiovascular disease, or ≥70 mg/dL for those with cardiovascular disease.\r\n\r 4. Fasting triglycerides (TGs) <400 mg/dL\r\n\r Key Exclusion Criteria:\r\n\r 1. Women who are pregnant, nursing or breast feeding\r\n\r 2. Currently prescribed a lipid lowering agent other than a statin or ezetimibe.\r\n\r 3. Clinically significant disorder or laboratory abnormality that could contraindicate\r the administration of study drug, affect compliance, interfere with study evaluations,\r or confound the interpretation of study results\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
35,747
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEffects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe aim of this study is to further evaluate the effects of seasonal variation and the\r aquatic thermal environment of hyperthermic baths (HTB) on the Motor Symptoms (MS) of\r Parkinson's Disease (PD), and whether the environmental temperature is associated with these\r effects.\n\n**Clinical Trial Detailed Description:**\n\nAfter being informed about the study and potential risks, all participants will give written\r informed consent. All participants who meet the inclusion criteria will undergo a complete\r history and physical examination, including an assessment using the Movement Disorder\r Society-United Parkinson's Disease Rating Scale (MDS-UPDRS), H&Y stage, MMSE and MOCA. Each\r participant will receive two subjective measures (the Movement Disorder Society-United\r Parkinson's Disease Rating Scale part III motor examination total scores and the modified\r Webster Symptoms Score) nine times in an open medication state (open state). Each participant\r will take hyperthermic baths (HTB) at the same time on the first, third and fifth days. The\r participants will receive subjective measures before and after the HTB. The time at which the\r subjective measures begin after the HTB will be recorded. In the second week, no participants\r accept any intervention. To avoid the effects of fluctuations in dopaminergic drugs\r concentrations, subjective measures will be given without HTB at the recorded times on the\r fifteenth, seventeenth and nineteenth days.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - ≥ 18 years of age\r\n\r - Diagnosis of Idiopathic Parkinson's Disease（IPD）based on the Movement Disorder Society\r clinical diagnostic criteria for Parkinson's Disease\r\n\r - Subjective feeling that Motor Symptoms（MS）of Parkinson's Disease （PD） were affected by\r seasonal variation (i.e., MS were more severe in winter than in summer) and improved\r after HTB\r\n\r - No change in the patient's PD medication regimen during the study\r\n\r Exclusion Criteria:\r\n\r - Symptomatic bradycardia, severe postural hypotension, symptomatic coronary\r insufficiency, severe organic heart damage, severe cerebrovascular disease, and active\r psychosis\r\n\r - Dementia (Mini-Mental State Examination (MMSE) < 24 and Montreal Cognitive Assessment\r (MOCA) < 26)\r\n\r - Failure to cooperate with the study requirements and poor compliance\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
35,748
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSystem for Quantifying the Functional Strength of the Grip and Pinch Movements\n\n**Clinical Trial Summary:**\n\nThis study developed a system to quantify the functional strength of young adults without\r motor impairment during grip and pinch movement. Making it possible to know the accuracy of\r the value of these strength, the range of motion performed and whether the grip force was\r maintained throughout the range of motion. In addition to checking the functionality,\r reliability and reproducibility of the system.\n\n**Clinical Trial Detailed Description:**\n\nQuantifying grip and grip movement is essential as it allows for a basis in upper limb\r functionality. However, when there is access, it causes changes in the hands and changes the\r motor in relation to the force and range of motion, or generates changes in activities of\r daily living. Thus, a system with 5 devices, where each one the devices were prints in\r three-dimensional, and instrumented with force sensor for static-dynamic force analysis e\r potentiometer for analysis range of motion, during the execution of movements cylindrical\r grip, spherical grip, hook grip, pulp-pulp pinch, and pulp- side pinch in different\r activities of daily living. Elaborated a data storage interface through MATLAB® software that\r allows recording the data of each device. For the system functionality tests, 30 volunteers\r were selected for both sexes, young adults between 20 and 39 years old, students of the\r Physiotherapy and Graduate courses of the University of Mogi das Cruzes. The tests are\r divided into two sessions and are repeated after 7 days of the first test\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - only right-handed individuals,\r\n\r - male and female,\r\n\r - have preserved cognitive functions,\r\n\r - absence of neurological disorder\r\n\r - who present minimum grip strength by the Jamar ® dynamometer, in the age group of\r 20-29 years men 45.08 ± 0.67 kg and women of 27.2 ± 0.46 kg, who present minimum grip\r strength by the dynamometer Jamar ®, aged 30 to 39 years old men 46.05 ± 0.47 kg and\r women 28.0 ± 0.39 kg, using the mean minus the standard deviation.\r\n\r Exclusion Criteria:\r\n\r - Injury to upper limbs such as amputation, recent surgery (6 months), fractures,\r bruising, pain and musculoskeletal disorders.\r\n\r - Do not accept to participate in the survey.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
35,749
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMonitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial\n\n**Clinical Trial Summary:**\n\nWhen Parkinson Disease is mild, it responds well to treatment with drugs (L-Dopa and dopamine\r antagonists). However, as the disease progresses, the effect of the drugs diminishes and\r lasts for a shorter time (wearing-off), which require physicians to progressively increase\r and/or break up the dosage of dopamine drugs, to control symptoms over the course of the\r entire day. Despite this, most patients present motor fluctuations after 10 years. These\r fluctuations consist of changes between what are known as Off periods, when the medication\r does not produce an effect and mobility is hindered, and On periods when patients can move\r smoothly, with the medication producing its best effect.\r\n\r The timeline of these motor fluctuations over the course of the day and also on different\r days is very valuable to precisely adjust the medication. Nevertheless, neurologists do not\r currently have detailed information on the timeline of the symptoms of their patients, which\r means that they have serious difficulties to obtain good results with the adjustment of\r medication. Currently, the neurologist's information on the time progression of the motor\r fluctuations is drawn from what the patient indicates in the office visit, or in the best\r case, from diaries that the patient fills out at home, periodically (e.g. every hour) noting\r the motor state (On or Off). Although the latter method is still the gold standard in\r research and in care, it has serious limitations, because patients often forget to record the\r information (especially when they are in Off), many do not recognize their motor states well,\r and few can maintain adherence to such a laborious system for more than a few days.\r\n\r The Parkinson Holter (STAT-ON ®) is a wearable device, which objectively measures and records\r the motor fluctuations of the patients. It does not require intervention by the patient, and\r can, therefore, be used in daily life, long term if necessary. However, the concept that\r detailed knowledge of motor fluctuations of patients will lead to better control of the\r disease, thanks to optimisation of the therapeutic regimen, is still a hypothesis. To\r demonstrate or refute this hypothesis, we are now conducting a clinical trial, with this\r medical device, to study the clinical effectiveness in patients with moderate Parkinson's\r disease and motor fluctuations. This trial will show whether using the Parkinson Holter is\r better than the clinical interview used in traditional clinical practice (primary objective),\r and whether it is not inferior to the On-Off diary recorded by the patients at home\r (exploratory objective)\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Ideopathic Parkinson's Disease\r\n\r - Disease in the moderate-severe phase (Hoehn & Yahr ≥ 2 en Off)\r\n\r - Motor fluctuations (with at least 2h/day in Off)\r\n\r - Agree to participate voluntarily and will sign a written consent form\r\n\r Exclusion Criteria:\r\n\r - Incapable of walking independently or H&Y=5\r\n\r - Participating in another clinical trial\r\n\r - Patients with acute intercurrent disease\r\n\r - Psychiatric or cognitive disorders that prevent collaboration (MMSE <24)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,750
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAction Observation Treatment in Parkinson's Patients\n\n**Clinical Trial Summary:**\n\nThe aim of the study is to assess the role of Action Observation Treatment (AOT) and Motor\r Imagery (MI) in the rehabilitation of Parkinson's disease patients, as compared to a control\r condition. Main outcome measures will be the results in two functional scales (FIM, UPDRS)\r and kinematics parameters obtained from gait analysis. Data at two months and six months\r follow up, respectively, will be also collected.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Parkinson disease patients on Hoehn and Yahr 3-4\r\n\r Exclusion Criteria:\r\n\r - Mini-Mental State Examination < 24\r\n\r - Fluent aphasic patients\r\n\r - Apraxia\r\n\r - Neglect\r\n\r - major neuropsychiatric disorders\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,751
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMachine Learning in Quantitative Stress Echocardiography\n\n**Clinical Trial Summary:**\n\nGreater diagnostic accuracy is required to find out who is at risk of a heart attack as this\r can reduce the requirement of more invasive downstream tests and thereby improve the patient\r experience and also reduce their exposure to risk. Stress echocardiography is a routine\r clinical test that involves using ultrasound to image the heart whilst it is under stress to\r assess the risk of a heart attack.\r\n\r This study will focus on developing more accurate analysis tools to interpret the results of\r these stress echocardiographic scans. New methods will be tested to measure the function of\r each part of the heart muscle, using advanced analysis of the information obtained when\r high-frequency sound waves are bounced off the heart inside the chest. The researchers will\r measure and report exact heart function during stress, so that they will be able to recognise\r normal hearts and those with any disease. New computer methods will be developed to display\r any abnormality, which will make it easier for doctors to choose the best treatment for\r patients who are at risk.\r\n\r The goals and potential benefits of this research proposal are to update the interpretation\r of a routinely used clinical test (stress echocardiography) to produce a reliable new method\r for diagnosing the precise effects of diseased arteries on the function of the heart muscle;\r to develop new computer graphics that adapt to show individual risks for each patient; and to\r implement new computer models that can be constantly updated\n\n**Clinical Trial Detailed Description:**\n\nNew onset chest pain is a common presenting complaint and can be a marker of significant\r cardiovascular disease and risk of myocardial infarction and death; therefore obtaining an\r accurate diagnosis is critical to guide patient management. It is noteworthy that only 40-50%\r of patients who have invasive arteriography subsequently undergo revascularisation. This\r underscores the imprecision of the initial tests employed prior to arteriography.\r\n\r Historically electrocardiographic stress testing during exercise has been used to detect\r inducible myocardial ischaemia but its diagnostic sensitivity and specificity are low (about\r 65%). Diagnostic accuracy can be improved by by incorporating echocardiography or single\r photon emission computed tomography. Current NICE guidelines recommend that patients with\r chest pain of recent onset should be investigated with CT coronary angiography as a first\r line, and if this reveals a significant stenosis then a functional imaging test should be\r performed.\r\n\r The Myocardial Doppler in Stress Echocardiography (MYDISE) study assessed the diagnostic\r value of quantitative stress echocardiography during the infusion of dobutamine, a\r short-acting synthetic catecholamine that acts on β-1 adrenergic receptors to increase heart\r rate and myocardial contractility. Measuring the systolic velocities of LV long-axis function\r at peak stress had good reproducibility (coefficients of variation in basal segments 9-14% at\r rest and 11-18% at peak stress) and similar sensitivities and specificities (about 70%) to\r published studies in which expert observers reported wall motion scores. When adjusted for\r the independent effects of age, gender and heart rate, however, diagnostic accuracy increased\r significantly with C statistics (area under receiver-operator curves) up to 90%.\r\n\r Visual analysis of stress echocardiography to detect myocardial ischaemia depends on\r qualitative assessment of multiple parameters. Major studies of quantitative stress\r echocardiography have been limited to identifying the single best echocardiographic variable,\r and they have used diameter stenosis as the reference criterion. Progressive subclinical\r reductions of regional (long-axis) myocardial function have been demonstrated in subjects\r with cardiovascular risk factors, affecting myocardial deformation (strain and strain rate)\r as well as velocities. Ischaemia changes the timing of events during the cardiac cycle - for\r example prolonging pre-ejection and post-ejection phases. These factors confirm the clinical\r need for objective measurement of regional myocardial function throughout the cardiac cycle.\r\n\r It is now possible to create algorithms that are based not just on a single time point (e.g.,\r peak velocity) but instead rely on analysis of the whole of the velocity trace. This concept\r can also be extended to include strain and strain rate curves. Investigators at Universitat\r Pompeu Fabra, Barcelona, have developed this approach to create a statistical atlas of the\r heart to detect dyssynchrony. A similar concept has been applied using multiple kernel\r learning to patients with dyspnoea who have undergone exercise stress testing to identify\r those with evidence of diastolic heart failure.This has enabled velocity traces taken from\r the whole of the cardiac cycle to be compared and discriminated between control subjects\r (with and without dyspnoea) and those diagnosed with heart failure with preserved ejection\r fraction (HFpEF); the major differences observed are in early diastolic function. This\r application has not previously been used to explore inducible myocardial ischaemia in stress\r echocardiography, but similar findings might be expected, as changes during diastole are\r amongst the earliest and most sensitive indicators of myocardial ischaemia. Individuals at\r the University of Leuven (Prof Jan D'hooge) have recently developed supervised\r machine-learning methods that allow for automatic classification of myocardial segments based\r on their local mechanical behaviour (i.e. velocity/strain/strain rate) after going through a\r training phase; the proposed machine-learning approach outperforms expert wall motion\r readings as well as expert interpretation of segmental strain (rate) traces in classifying\r ischemic segments.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Clinically suitable for stress echocardiography examination\r\n\r Exclusion Criteria:\r\n\r - None\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,752
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSelectively Modulating Pathophysiological Biomaker to Improve Freezing of Gait in Parkinson' s Disease by Adaptive Subthalamic Stimulation\n\n**Clinical Trial Summary:**\n\nFreezing of gait (FoG) is defined as a brief, episodic absence or reduction of forward\r progression of the feet despite the intention to walk. It is one of the most disabling and\r intractable motor symptoms in patients with Parkinson's disease (PD) as it often causes falls\r and loss of independence. The pathophysiology of FoG remains unclear but it seems differ from\r other cardinal motor symptoms in PD. The therapeutic efficacy of medical and surgical\r treatments for FoG are usually suboptimal. Deep brain stimulation (DBS) in the subthalamic\r nucleus (STN) is a well established treatment for advanced PD with motor fluctuation. It\r alleviates tremor, bradykinesia and rigidity and improved the quality of life. However, the\r therapeutic effects of DBS are impeded by high cost of device, stimulation induced adverse\r effects and partial treatment for some parkinsonism symptoms, particular gait disturbance and\r FoG. Recently, a new mode of stimulation is proposed. Differing from the conventional DBS\r which is operated in open loop so that stimulation remains fixed over time and is delivered\r at regular and high frequencies, the new adaptive DBS (aDBS) detects the pathological\r activities and only deliver stimulation when it is necessary. Recent studies in MPTP-primate\r and patients with PD demonstrate that the aDBS is superior to standard continuous DBS.\r However, the therapeutic efficacy is only shown in \"appendicular symptoms\" such as\r bradykinesia, rigidity and tremor. There is no report about the effect of aDBS on gait\r disturbance, particular FoG in PD so far.\r\n\r The aim of the current project is to test whether the therapeutic efficacy of aDBS is\r superior to conventional DBS in PD patients with FoG. To this end, 20 advanced PD patients\r who undergo STN DBS implantation for the treatment of their disorders will be examined. The\r gait of patients will be assessed during conventional open loop stimulation and aDBS and the\r therapeutic efficacy for FoG will be defined. The results of this study will also contribute\r to better understanding of pathophysiology of FoG and to future development of embedded aDBS\r system for PD.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients' age between 20 and 75 years old\r\n\r 2. Idiopathic PD with cardinal motor impairment (bradykinesia, rigidity, tremor and\r postural instability\r\n\r 3. Advanced PD as determined by Hoehn and Yahr stage or UPDRS part III motor score\r\n\r 4. Levodopa responsive\r\n\r 5. Disabling Parkinson's symptoms or drug side effects (dyskinesia, motor fluctuation or\r disabling \"off\"period) despite the best medical therapy.\r\n\r 6. Willingness and ability to cooperate during conscious operative and experimental\r procedure.\r\n\r 7. Normal MRI\r\n\r Exclusion Criteria:\r\n\r 1. Non-idiopathic parkinsonism or \"Parkinson's plus syndrome\"\r\n\r 2. Impaired cognitive dysfunction (MMSE<26)\r\n\r 3. Moderate to severe depression (BDI≧30)\r\n\r 4. Depression (BDI≧30), or psychiatric disorder\r\n\r 5. Structure lesion such as stroke, tumor or severe brain atrophy revealed by MRI\r\n\r 6. Major medical disorders, such as hematological, heart disease or malignancy\r\n\r 7. Significant medical, surgical or neurological co-morbidities contraindicating DBS\r surgery or stimulation\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,753
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nChinese ET Registry (CETR)\n\n**Clinical Trial Summary:**\n\nThe purpose of the Chinese Essential Tremor Registry (CETR) is to develop a database of\r patients with Essential tremor in China.\n\n**Clinical Trial Detailed Description:**\n\nEssential tremor (ET) is one of the most common movement disorders and affects approximately\r 1% of the population worldwide. Twin and family history studies show a high heritability for\r essential tremor. The molecular genetic determinants of essential tremor are unknown. Some\r mutations have been found in ET families but have not been validated in others. The\r pathophysiological basis of ET remains unknown. In 2017, a task force of the International\r Parkinson and Movement Disorder Society proposed a new formal definition of essential tremor\r as a syndrome of isolated tremor of both upper limbs with a duration of at least 3 years,\r with or without tremor in other locations, such as head, larynx (voice tremor), or lower\r limbs. Defining essential tremor as a syndrome and not as a single disease, while\r concomitantly narrowing its phenotypic scope to increase its homogeneity, recognizes that\r there are multiple possible causes, which may facilitate progress in understanding the\r pathogenesis. Investigators aim to establish a database of longitudinal recruited ET cohort,\r and characterize the clinical feature, genetic basis, environmental factors and their\r interactions among different ET subtypes in China, identify natural history of a\r highly-presentative Chinese ET cohort and to discern major milestones in the disease process\r which indicates disease progression.\r\n\r Data were collected at baseline. Information about detailed disease history, level of\r education, significant chronic comorbidities, physical examination, medication history,\r family history, living habits and toxic exposure history, which include smoking, drinking\r tea, alcoholic consumption, drinking coffee, exposure to pesticide or occupational solvent,\r history of carbon monoxide poisoning and recurrent head trauma will be recorded at baseline.\r For each evaluation, the same questionnaires will be conducted. A standardized neurological\r assessment according to the recommendation of Consensus on the construction of clinical\r database of Parkinson's disease and movement disorders in China.\r\n\r The Essential Tremor Rating Assessment Scale (TETRAS) includes both performance and\r Activities of Daily Living (ADL) subscales. It is conducted for the clinical measurement of\r ET severity and tremor's impact on ADL. The non-motor symptoms are evaluated by Non-motor\r Symptom Scale (NMSS).Functional constipation was diagnosed by the Rome III diagnostic\r criteria. Excessive daytime sleepiness was evaluated by Epworth Sleepiness Scale (ESS).\r Probable rapid eye movement sleep behavior disorder (p-RBD) was diagnosed by rapid eye\r movement sleep behavior questionnaire-Hongkong (RBDQ-HK). Restless leg syndrome (RLS) was\r diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire (CH-RLSq). Cognitive\r assessment was used the previously validated scale, Mini Mental State Examination (MMSE).\r Olfaction test was carried out by Hyposmia Rating Scale (HRS), a proportion of patients was\r also ascertained by Sniffin's Sticks. Depression was diagnosed by Hamilton Depression Scale\r (HAMD).DNA samples extracted from peripheral blood and all the ET patients will be examed by\r Whole Exome Sequencing or Whole-genome sequencing. All the participants are scanned by\r structural MRI to exclude obvious intracranial lesions and other metabolic disorders, etc.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients diagnosed with ET by the Consensus Statement on the Classification of\r Tremors,From the Task Force on Tremor of the International Parkinson and Movement\r Disorder Society.\r\n\r Exclusion Criteria:\r\n\r - Lack of capacity to consent to participate in the project.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,754
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMicrobiome of the Ageing Gut and Its Effect on Human Gut Health and Cognition.\n\n**Clinical Trial Summary:**\n\nThe investigators aim to undertake a 49-month longitudinal study in a cohort of 360 healthy\r individuals of 60 years and older, living in East Anglia to understand the role of gut\r microbes (the microbiome) in healthy ageing. The investigators also aim to identify changes\r in the structure and function of the gut microbe populations that are associated with\r deteriorating mental health and cognitive function. Using clinically validated cognitive\r assessments and tests, study participants will be stratified in to one of three risk groups\r for developing dementia:-\r\n\r Cohort 1 - low (n=120). Cohort 2 - medium (n=120). Cohort 3 - high (n=120).\r\n\r Participants will be recruited from three streams - Primary Care, The NHS Bowel Cancer\r Screening Programme (BCSP) and the Norfolk & Suffolk Foundation Trust (NSFT).\r\n\r Following initial Telephone Contact and the Pre-Study Visit, all participants will be\r required to attend the Quadram Institute Clinical Research Facility (QI CRF) every 6 months\r over 4 years. At each of these follow-up visits, the participant will provide a stool sample\r (collected at home) and at differing time points, provide a blood sample and undergo a series\r of physical measurements, cognitive tests/questionnaires and complete a health questionnaire.\r All participants will undergo Optical Coherence Tomography scans at the Beccles & District\r War Memorial Hospital.\r\n\r There will be 2 subgroups in this study.\r\n\r Subgroup 1 - at least 30 participants from each cohort (n= at least 90) will undergo colonic\r tissue biopsies as part of routine clinical care using the NHS BCSP.\r\n\r Subgroup 2 - 30 participants from Cohort 3 will undergo brain imaging at the Norfolk &\r Norwich University Hospital (NNUH) Imaging Department.\r\n\r The results of the study will provide new insights into the gut-brain axis and the\r relationship between age-associated changes in gut microbe populations and declining mental\r health. Such insights will be of enormous value in developing new microbe-based strategies to\r improve lifelong health and wellbeing that impact on dementia development.\n\n**Clinical Trial Detailed Description:**\n\nHumans have co-evolved with populations of colonising microbes and their genomes to establish\r a mutually beneficial relationship. The gut microbiome represents the largest population of\r resident microbes in humans and is highly diverse and plays essential roles in digestion and\r pathogen protection. Perturbations in populations of gut bacteria (dysbiosis or\r dysbacteriosis) in response to, for example, infections or drugs, have been associated with\r an increased risk of various chronic diseases including obesity, cancer and inflammatory\r bowel disease (IBD).\r\n\r In older individuals an array of complex and characteristic clinical changes that includes a\r basal proinflammatory state (so called \"inflammaging\"), can directly interface with gut\r microbes of older adults that can enhance susceptibility to diseases accompanying aging, and\r reduce healthy lifespan. Studies in older adults demonstrate that the makeup and functional\r attributes of the intestinal microbiota correlates with lifestyle (e.g. diet and location of\r residence) and behaviour (e.g. medications), and basal level of inflammation. Links exist\r between the intestinal microbiota and a variety of clinical problems plaguing older adults,\r including physical frailty, Clostridium difficile colitis, vulvovaginal atrophy, colorectal\r carcinoma, and atherosclerotic disease. These links are however, principally associative with\r very little evidence of causality.\r\n\r The gut microbiome establishes a mutualistic relationship with its host and contributes to\r maintaining homeostasis. Its composition can be influenced and changed by numerous host (e.g.\r genome, age), environmental (e.g. diet, medicines, infections), and lifestyle and behavioural\r factors (e.g. travel, habitat). Changes in the structure and/or function of the microbiome\r (dysbiosis) can result in damage to, or infection of, barrier epithelial cells enabling\r microbes and microbial products to cross the compromised barrier and gain access to\r underlying tissues and immune cells, leading to immune activation and (chronic) inflammation.\r\n\r Age is a major risk factor for the development of cognitive dysfunction with dementia being\r one of the most common disorders linked to ageing. Dementia affects an estimated 47 million\r people worldwide and is projected to affect over 131 million people by 2050. Cognitive\r function declines with age, ranging from relatively minor everyday slips of action, through\r subjective cognitive decline, mild cognitive impairment (MCI), then to major or mild\r neurocognitive disorder/dementia in some instances. Up to 50% of those with MCI are predicted\r to develop dementia within 5 years.\r\n\r The development of new treatments to prevent dementia is hindered by a lack of predictive\r biomarkers. The gut microbiome is a potential marker for progressive declining intrinsic\r capacity, which is a composite of all the physical and mental attributes on which an\r individual can draw, not only in older age but across their lives. Evidence of age-associated\r changes in the gut microbiome comes from population-based studies, one of the largest and\r most comprehensive was ELDERMET, a study that examined the faecal microbiome of elderly\r individuals living in the community or in care homes in Ireland. The results identified\r differences in the composition of the gut microbiome of elderly individuals compared with\r younger individuals, and that these differences were associated with poorer health status in\r the elderly (e.g. poor dentition, dysphagia, loss of salivation, decreased physical activity\r and constipation).\r\n\r However, in relying on data from samples taken at a single timepoint, this study provides\r only a 'snapshot' of what is happening but little insight into the dynamics or stability of\r any changes in the gut microbiome over time in different individuals or groups of\r participants. It is also impossible to determine whether the changes noted are drivers or\r consequences of unhealthy ageing. In addition, this study did not include assessments of\r mental health and cognitive function, which are major comorbidities associated with ageing.\r The fact that structural changes within the gut microbiome occur during ageing is a\r consistent finding across different studies. However, the scale and nature of the changes\r noted vary considerably between studies, and amongst individuals within the same study.\r Larger longitudinal studies with sequential (serial) sampling of the gut microbiome during\r ageing would provide a clearer picture of how the gut microbiome changes during ageing, and\r whether it is a contributing factor to declining health in old age and/or in the development\r of neurodegenerative disorders and dementia.\r\n\r The link between potentially pathogenic changes in the gut microbiome (dysbiosis) in\r individuals with neurodegenerative disorders comes mainly from observational studies in\r patients with Alzheimer's (AD) or Parkinson's disease (PD), and from animal (rodent) models.\r Analysis of the faecal microbiome of dementia patients has identified an increased prevalence\r of Prevotellaceae and Enterobacteriaceae species in PD, and an increased prevalence of\r Clostridia, Bacteroides and Verrucomicrobia species in AD patients. compared with healthy\r individuals. In addition, many PD and AD patients reported gut symptoms including irritable\r bowel syndrome prior to neurological symptoms developing. Furthermore, antibiotic treatment\r to eradicate gut pathogens (e.g. H. pylori) can improve L-dopa action and reduce clinical\r symptoms in PD patients. Perhaps the most compelling evidence for a causal link between gut\r microbes and neurodegenerative disease comes from the finding that, when faecal microbiomes\r from PD patients are transferred into PD-susceptible mice, symptom development accelerates\r and the mice suffer greater motor dysfunction than control mice receiving faecal microbiomes\r of healthy individuals. Although collectively these findings implicate the gut microbiome in\r the pathogenesis of neurodegenerative disorders, the studies carried out to date have failed\r to identify which species of bacteria (or any other member of the gut microbiome; viruses,\r archaea, fungi, protozoa) are critically important for mental health and in the development\r of dementia, when during ageing do changes in the population size and/or function of critical\r species occur, and once established how do these critical species influence brain signalling,\r neuroinflammation and pathology?\r\n\r Subgroup 1 - Colon tissue biopsy (n= at least 90). Microbe populations that are specifically\r and intimately associated with the lining of the gut wall are ideally situated to influence\r the host and intestinal cells, but they can be underrepresented or absent in stool samples.\r For this reason, colon tissue samples are important to: 1) fully identify the microbes that\r are in most intimate contact with the host 2) identify and analyse how the cells within the\r tissue respond and react to these microbes and their products.\r\n\r 6-8 pinch biopsies each measuring 3mm cubed will be taken for research biopsies from the\r large bowel during the routine care colonoscopy (these will taken in addition to routine care\r biopsies). The research biopsies are taken to examine the microbiome that is adhering\r directly to the mucosal lining of the colon.\r\n\r Subgroup 2 - Brain MRI scans (n=30 from cohort 3). Scans will be performed to allow for the\r cognitive and behavioural data collected at the previous visits to be related to\r neuroanatomical changes. The 60-minute scan will capture both structural and functional\r sequences. Structural sequences will allow measurement of grey and white matter integrity in\r participants, whereas functional sequences will allow measurement of brain connectivity and\r perfusion changes. We hypothesize that medial temporal structures will be intact in low risk\r participants but those in the medium risk group might already show subtle structural and\r functional changes.\r\n\r Another screening test with potential as a biomarker for ageing and dementia development is\r retinal morphometry. The retina is the only part of the central retinal nervous system that\r can be directly visualized. Optical Coherence Tomography (OCT) is a rapid, non-invasive\r imaging tool that can produce 3- dimensional cross-sectional images of the retina, and\r permits precise and accurate measurement of the thickness of individual retinal components.\r The retinal nerve fiber layer (RNFL) is the innermost layer of the retina and is comprised of\r the retinal ganglion cell axons, which link the outer neuroretina to the dorsal lateral\r geniculate nucleus, where synaptic connections lead to the visual cortex. In a very recent\r multi-centre study of individuals aged between 40 and 69 years of age, OCT imaging revealed\r that a thinner RNFL was associated with worse cognitive function in individuals with no\r neurodegenerative disease; it was also associated with a greater likelihood of subsequent\r cognitive decline. This makes a strong case for regarding retinal anatomical measures as a\r potentially useful screening marker to identify those at risk of developing dementia.\r\n\r The studies carried out to date highlight the need to develop a more holistic and integrated\r understanding of human ageing: There is a need to understand how (or whether) changes in one\r organ system (e.g. the gut) are related to changes occurring elsewhere in the body (e.g. in\r the brain). In order to begin to answer these fundamentally important questions, the\r investigators have designed the MOTION study to obtain a clearer picture of how the gut\r microbiome changes during ageing in a cohort over the age of 60 years without existing\r serious medical conditions at the point of study consent, and how these changes relate to\r declining intrinsic capacity and increasing cognitive impairment.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or female aged at least 60 years.\r\n\r - Must be able to provide informed consent.\r\n\r - Must be able to complete the Cognitive Tests/Questionnaires, Health Questionnaires by\r themselves and be familiar with using an ipad/tablet.\r\n\r Exclusion Criteria:\r\n\r - Currently taking part in an interventional study.\r\n\r - Living with or related to any member of the research team.\r\n\r - Have a diagnosis of Dementia, Parkinson's Disease, Alzheimer's Disease,\r Creutzfeldt-Jakob disease (CJD), Picks Disease.\r\n\r - Bipolar Disorder.\r\n\r - Obsessive Compulsive Disorder.\r\n\r - Untreated current clinical depression.\r\n\r - Have irreversible brain injury.\r\n\r - Have had a stroke.\r\n\r - Have epilepsy.\r\n\r - Take more than a daily dose of probiotics.\r\n\r - Have a long-standing gastrointestinal or liver function abnormality requiring on-\r going medical management or medication.\r\n\r - History of cancer within the last 5 years except for squamous or basal cell carcinomas\r of the skin that have been medically managed by local excision.\r\n\r - Unstable dietary history as defined by major changes in diet during the previous\r month, where a major food group in the diet has been stopped or significantly\r increased, for example become vegetarian, vegan or stopped eating red meat.\r\n\r - History of alcohol, drug or substance abuse. History of Hepatitis B or Hepatitis C.\r\n\r - Major surgery of the gastrointestinal tract, apart from gall bladder or appendix\r removal, in the past five years.\r\n\r - Any major bowel resection at any time.\r\n\r - History of Ulcerative Colitis, Crohn's Disease or Diverticulitis.\r\n\r - Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic\r diarrhoea of unknown cause, Clostridium difficile infection (recurrent) or\r Helicobacter pylori infection (untreated).\r\n\r - Constipation.\r\n\r - Regular use of laxatives.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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35,755
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nGrowing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Health\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to test the effect of group-based nutrition advice plus\r gardening (intervention) versus group-based nutrition advice alone on dietary intake of\r fruits and vegetables, physical activity, and lifetime risk for cardiovascular disease (CVD).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Are at least 20 years old\r\n\r 2. Have transportation and are willing to travel to the Hershey Community Garden\r\n\r 3. Have any two health conditions or risk factors for CVD. These include, but are not\r limited to:\r\n\r 1. Any history of cardiovascular disease\r\n\r 2. Any family history of premature cardiovascular disease\r\n\r 3. Any history of stroke\r\n\r 4. High cholesterol\r\n\r 5. High blood pressure\r\n\r 6. Overweight/obesity (BMI >=25)\r\n\r 7. Diabetes\r\n\r 8. Current or past Tobacco use\r\n\r Exclusion Criteria:\r\n\r 1. Currently tends a vegetable garden\r\n\r 2. Moving out of the area in the next 4 months\r\n\r 3. Non-English speaking\r\n\r 4. Pregnant women\r\n\r 5. Participation in a past gardening study\r\n\r 6. Medical conditions or medications that limit ability to freely increase dietary intake\r of fruits and vegetables (e.g., kidney failure, dialysis)\r\n\r 7. A medical condition that precludes safe pursuit of gardening, i.e., recent heart\r conditions (e.g., heart failure, stroke, heart attack), recent or pending surgery,\r severe orthopedic conditions, pending hip/knee replacement, paralysis, dementia,\r blindness, unstable angina or uncontrolled arrhythmias, or uncontrolled asthma or\r allergies.\r\n\r 8. History of difficulty obtaining blood samples or fear of needles\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,756
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nLIPAD - LRRK2 International Parkinson's Disease Study\n\n**Clinical Trial Summary:**\n\nThe study aims to identify and systematically characterize Parkinson's patients with\r mutations in the LRRK2 gene. In about 90% of Parkinson's patients the cause of the disease is\r unclear. Based on current knowledge, it can be assumed that there are several causes and that\r the causes may be differ between patients; this makes research into the pathogenesis and\r possible therapies very difficult. In the case of monogenic Parkinson's diseases, which are\r due to changes in one gene (e.g. LRRK2), the function of the gene and possible disease\r mechanisms can be investigated. LRRK2-associated Parkinson's syndrome is clinically\r indistinguishable from idiopathic Parkinson's disease. It is inherited autosomal dominant,\r that means if one of the two gene copies is altered, the disease occurs. However, the disease\r does not occur in every mutation carrier, the penetrance is reduced and the mechanisms for\r that are still unclear. Ideally, knowledge of what influences penetrance could make it\r possible to exert targeted influence and prevent the disease. The comprehensive investigation\r of mechanisms of reduced penetrance but also of the effects of the mutation itself requires\r systematic investigations of as many affected persons as possible. We therefore aim to\r identify 4,000 people internationally, of them 1,500 with LRRK2-associated Parkinson's\r syndrome, 500 with LRRK2-mutations but without Parkinson's symptoms, 500 without mutations\r and without Parkinson's symptoms, 500 Parkinson patients with mutations in other genes than\r LRRK2 and 1,000 patients with idiopathic Parkinson's disease from the same populations. The\r participants will undergo a comprehensive survey on Parkinson's symptoms, concomitant\r diseases, environmental factors and medication and there is the possibility of more detailed\r genetic examinations. Participants will be asked to donate samples of blood, urine and\r household dust.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Informed consent is obtained from the participant.\r\n\r - The participant is clinically diagnosed with Parkinson's disease or the individual is\r a family member of a participant with LRRK2 parkinsonism or is a member of a high risk\r population with an early PD onset.\r\n\r - The participant is equal to or older than 18 years old.\r\n\r Exclusion Criteria:\r\n\r - Inability to provide informed consent.\r\n\r - The participant is not suffering from Parkinson's disease or the individual is not a\r family member of a participant with LRRK2 parkinsonism or is not a member of a high\r risk population.\r\n\r - The participant is younger than 18 years old.\r\n\r - Previously enrolled in the study.\r\n\r - Participant in custody.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,757
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nDeep Brain Stimulation of the Cuneiform Nucleus for Levodopa-resistant Freezing of Gait in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe purpose of this research study is to determine if DBS is a safe and effective therapy for\r severe freezing of gait in patients with Parkinson's Disease. Freezing of gait (FOG) is a\r particularly debilitating motor deficit seen in a subset of patients with Parkinson's Disease\r (PD).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion:\r\n\r 1. Confirmed Parkinson's Disease according to movement disorder neurologist with\r documented exclusion of other disorders such as fronto-temporal dementia (FTD)/\r frontal gait disorder/normal pressure hydrocephalus (NPH)/progressive supranuclear\r palsy (PSP)\r\n\r 2. PD stage3 ON medication, with severe gait dysfunction and predominant axial symptoms:\r Movement Disorder Society-Unified Parkinson's Disease Rating Scale Tremor Dominant\r (MDS-UPDRS TD), Postural Instability Gait Difficulty (PIGD) ratio ≤ 0.90 and Freezing\r Of Gait Questionnaire (FOGQ) score > 12.\r\n\r 3. Age 40-75 with good response to Levodopa (defined as greater than 20% improvement in\r UPDRS score)\r\n\r 4. FOG refractory to LEVODOPA>600 mg\r\n\r 5. Insignificant tremor, bradykinesia, and rigidity symptoms, and poor candidate for Sub\r Thalamic Nucleus (STN) or Globus Pallidus Interna (GPi) DBS\r\n\r Exclusion:\r\n\r 1. Individuals with major executive dysfunction\r\n\r 2. Individuals with dementia, as defined by the Mattis Dementia Rating Scale-2 (DRS-2)\r score ≤ 130\r\n\r 3. Individuals with other neurocognitive impairments\r\n\r 4. Individuals who have depression, as defined for example by the Beck Depression\r Inventory II (BDI-II) > 25\r\n\r 5. Presence of major medical co-morbidities and other surgical contra-indications such as\r coagulopathy\r\n\r 6. Individuals who require diathermy, transcranial magnetic stimulation (TMS), or\r electroconvulsive therapy (ECT)\r\n\r 7. Individuals with a history of prior intracranial surgery\r\n\r 8. Individuals with a metallic implant in their head that is not MRI compatible (e.g.,\r aneurysm clip, cochlear implant)\r\n\r 9. Individuals with active implantable devices anywhere in the body (e.g. cardiac\r pacemaker, defibrillator, spinal cord stimulator, implanted medication pump)\r\n\r 10. Individuals who are pregnancy or desire to become pregnant during the study\r\n\r 11. Individuals who are breastfeeding12.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,758
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTES Artemether-lumefantrine for Pf and Chloroquine (CQ) for Pv\n\n**Clinical Trial Summary:**\n\nPurpose: To assess the efficacy of the current first line of treatment policy.\r\n\r Objectives:\r\n\r To assess the safety and efficacy of Artemether-lumefantrine for the treatment of\r uncomplicated P. falciparum infections in the Philippines.\r\n\r To assess the efficacy of Artemether-lumefantrine for the treatment of P. vivax infections in\r the Philippines.\r\n\r Study Sites:\r\n\r Rural Health Unit, Bataraza, Palawan Rural Health Unit, Rizal, Palawan\r\n\r Study Design: one-arm, prospective study\r\n\r Patient Population: Febrile patients aged > 6 months to 59 years old, with confirmed\r uncomplicated P. falciparum infection only or P. vivax infection only, and non- pregnant\r and/or breastfeeding for female.\r\n\r Sample Size: A minimum of 50 and maximum of 75 patients will be enrolled for both Plasmodium\r falciparum and Plasmodium vivax malaria.\r\n\r Treatments and follow-up: Clinical and parasitological parameters will be monitored over a\r 28/34 day follow-up period to evaluate drug efficacy.\r\n\r Primary endpoints: The proportion of patients with early treatment failure, late clinical\r failure, late parasitological failure or an adequate clinical and parasitological response as\r indicator of efficacy. Recrudescence will be distinguished from re-infection by polymerase\r chain reaction (PCR) analysis.\r\n\r Secondary endpoints: The frequency and nature of adverse events.\r\n\r Optional exploratory endpoints: to determine the polymorphism of molecular markers for name\r of the antimalarial drug(s) resistance.\n\n**Clinical Trial Detailed Description:**\n\n1. BACKGROUND In 2002, the Philippines changed its antimalarial drug policy to the\r combination treatment, CQ+ Sulphadoxine-pyrimethamine (SP) as 1st-line treatment and\r artemether-lumefantrine as 2nd-line treatment. The Department of Health (DOH) prescribed\r the use of artemether-lumefantrine (AL) combination as the second line drug, limiting\r its use only in the treatment of confirmed Plasmodium falciparum, until further study on\r its efficacy were done before making it as the first line treatment. Consequently, AL\r became the first-line drug for falciparum malaria in the 2009 revised drug policy. The\r DOH in the past 6 years (2002-2007) adopted the use of AL in the highly endemic areas of\r the country and conducted therapeutic efficacy studies (TES) in 3 sentinel sites:\r Kalinga-Isabela, Palawan and several Mindanao provinces, showing 97-100% efficacy.\r Whereas, CQ+SP showed variability and declining efficacy, results ranged from 70%-95%\r (CARAGA region). In Sultan Kudarat province, results in 2006-2007 showed 90% efficacy of\r CQ+SP and 96% for AL for falciparum malaria.\r\n\r In the 2018 drug policy, chloroquine was replaced by artemether-lumefantrine as the\r primary treatment for P. vivax (Pv) malaria, with primaquine as anti-relapse drug. The\r last TES of AL as firstline drug of choice for falciparum malaria was made in 2017 and\r this will be the first time that AL will be assessed as treatment for uncomplicated\r vivax malaria. Monitoring of antimalarial drug efficacy through molecular analysis of\r known drug resistance associated genes can also provide complementary information.\r Previous analysis of drug resistance markers for CQ, SP and artemisinin (pfcrt, pfdhps,\r pfdhfr, pfmdr1, Kelch13 for Pf, and pvcrt, pvmdr, pvdhps, pvdhfr for Pv) of Philippine\r TES samples revealed variations in genotypes that can be assessed in relation to TES\r clinical outcomes. These information are relevant baseline information that have future\r use in determining parasite lineage during post malaria-elimination status, in addition\r to the crucial monitoring for drug resistance.\r\n\r The results of this study will be used to assist the Department of Health of Philippines\r in assessing the current national treatment guidelines for uncomplicated P. falciparum\r and P. vivax malaria, and to update the policy if necessary.\r\n\r 2. OBJECTIVES The general objective of this study is to assess the therapeutic efficacy and\r safety artemether-lumefantrine for the treatment of uncomplicated P. falciparum\r infections and of P. vivax infections in the Philippines.\r\n\r The primary objectives are:\r\n\r To measure the clinical and parasitological efficacy of artemether-lumefantrine (AL)\r among patients aged between > 6 months and 59 years old suffering from uncomplicated\r falciparum malaria, by determining the proportion of patients with Early Treatment\r Failure (ETF), Late Clinical Failure (LTF), Late Parasitological Failure (LPF), or with\r an Adequate Clinical and Parasitological Response (ACPR) as indicators of efficacy; To\r measure the clinical and parasitological efficacy of Chloroquine among patients aged\r between > 6 months and 59 years old suffering from uncomplicated vivax malaria, by\r determining the proportion of patients with Early Treatment Failure (ETF), Late Clinical\r Failure (LTF), Late Parasitological Failure (LPF), or with an Adequate Clinical and\r Parasitological Response (ACPR) as indicators of efficacy; To differentiate\r recrudescences from new infections by the Polymerase Chain Reaction (PCR) analysis;\r\n\r The secondary objectives are:\r\n\r To evaluate the incidence of adverse events; To formulate recommendations to enable the\r Department of Health to make informed decisions about the possible need for updating of\r the current national antimalarial treatment guidelines.\r\n\r The exploratory objective:\r\n\r To determine the polymorphism of molecular markers for artemether-lumefantrine and\r chloroquine resistance.\r\n\r 3. INVESTIGATIONAL PLANNING 3.1. Study Design The design of this surveillance study is a\r one-arm, prospective evaluation of the clinical and parasitological response to directly\r observed treatment for uncomplicated falciparum malaria and vivax malaria. Individuals\r with uncomplicated malaria who meet the study inclusion criteria will be enrolled,\r treated on site with AL and monitored for a period of 28 days if they have falciparum\r malaria, and with chloroquine if with vivax malaria for a period of 34 days. The\r follow-up will consist of a fixed schedule of check-up visits and corresponding clinical\r and laboratory examinations. Study patients will be classified as therapeutic failures\r (early or late) or adequate responders based on the results of these assessments. The\r proportion of patients experiencing therapeutic failure during the follow-up period will\r be used to estimate the efficacy of the study drug(s). Polymerase Chain Reaction (PCR)\r analysis will help distinguish between a true recrudescence due to treatment failure and\r episodes of reinfection.\r\n\r 3.2. Study site The study site will be conducted in the Rural Health Unit in selected\r municipalities of Palawan. Several factors influenced the selection of sites were:\r adequate numbers of patients with symptomatic, uncomplicated P. falciparum or P. vivax\r malaria; willingness and availability of the selected health care facility staff to\r participate in the surveillance study and to support the work with laboratory space;\r access of patients to the health facility for weekly follow-ups; availability of the\r Municipality Health Officer (MHO), the nurse and a trained Medical Technologist to take\r responsibility for conducting the study, and security.\r\n\r 3.3. Timing and duration of study The study will be conducted from September 2019 to\r September 2020.\r\n\r 3.4. Study population The study population will consists of patients aged between > 6\r months to 59 years old diagnosed with uncomplicated falciparum and vivax malaria\r attending the study health clinic, and having given, or whose parents or legal guardians\r have given an informed consent for study inclusion and assent in children as\r appropriate. All adult patients who are 18 years, age of majority in this country, will\r sign an informed consent form for participation. Parents or guardians will give informed\r consent on behalf of children who have not reached 18 years of age. Children aged 12 to\r 17 years old will be required to consent for participation by signing an informed assent\r form.\r\n\r 3.5. Inclusion criteria Above 6 months old to 59 years old;\r\n\r Mono-infection with P. falciparum or P. vivax, with parasitemia of:\r\n\r - P. falciparum: 1000-100 000 asexual forms per µl; P. vivax : ≥ 250 per µl Axillary\r temperature ≥37.5 °C or oral/rectal temperature of ≥38 °C; Ability to swallow\r medication; Ability and willingness to comply with the study protocol for the duration\r of the study and to comply with the study visit schedule; Informed consent from the\r patient or from a parent or legal guardian in the case of children less than 18 years\r old; Informed assent from any minor participant aged 12 - 17 years; and Consent for\r pregnancy testing from female of child-bearing potential and from their parent or\r guardian if under 18 years old.\r\n\r 3.6. Exclusion criteria Presence of general danger signs among children <5 years old or\r other signs of severe and complicated falciparum malaria according to World Health\r Organization (WHO) definitions; Severe malnutrition Mixed Plasmodium species detected by\r microscopy; Presence of severe malnutrition (defined as a child whose weight-for-height\r is below -3 standard deviation or less than 70% of the median of the National Center for\r Health Statistics (NCHS)/WHO normalized reference values, or who has symmetrical oedema\r involving at least the feet or who has a Mid Upper Arm Circumference Mid-Upper arm\r circumference [MUAC] <110 mm); Presence of febrile conditions due to diseases other than\r malaria (measles, acute lower tract respiratory infection, severe diarrhea with\r dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac,\r renal, hepatic diseases, HIV/AIDS); Regular medication, which may interfere with\r antimalarial pharmacokinetics; History of hypersensitivity reactions or\r contraindications to any of the drug(s) being tested or used as alternative treatment;\r Positive pregnancy test or breastfeeding; and Unable to or unwilling to take pregnancy\r test or to use contraception for women or child-bearing age and who are sexually active.\r\n\r 3.7. Loss to follow-up Loss to follow-up occurs when, despite all reasonable efforts\r within 48 hrs period of the visit, an enrolled patient that does not attend the\r scheduled visits cannot be found. No treatment outcome will be assigned to these\r patients. These patients will be classified as lost to follow-up and excluded from the\r per protocol analysis. Patients who are lost to follow-up, but who subsequently come\r back to the study site before day 28 for participants with Plasmodium falciparum and\r before day 34 for Plasmodium vivax participants, will not be turned away and will also\r be encouraged to return for check-up visits. Nevertheless, these patients will also be\r classified as lost to follow-up. Every effort must be made to schedule a follow-up visit\r for patients who fail to return to the study site especially during or but also after\r administration of the study drug.\r\n\r 3.8. Patient discontinuation or protocol violation Study patients meeting any of the\r following criteria classified as withdrawn.\r\n\r Withdrawal of consent A patient may withdraw consent at any time, without prejudice for\r further follow up or treatment by the study site.\r\n\r Failure to complete the treatment due to either:\r\n\r Persistent vomiting of the treatment. A patient who vomits twice study medication will\r be withdrawn from the study and given rescue treatment.\r\n\r Failure to attend the scheduled visits during the first 3 days; Serious adverse events\r necessitating termination of the treatment before the full course of the treatment is\r completed. A patient can be discontinued from the study if the principal investigator\r decides that a patient should be withdrawn for safety reasons due to an adverse event of\r such a nature or intensity to recommend withdrawal from the study. In this case,\r information concerning the adverse event and symptomatic treatment given must be\r recorded on the case record form (CRF). If the adverse event is serious, the principal\r investigator must notify the sponsor or its designee immediately and the reporting\r procedures described in the safety section must be followed.\r\n\r Enrolment Violation Severe malaria on Day 0; Erroneous inclusion of patient who does not\r meet the inclusion criteria.\r\n\r Voluntary protocol violation Self or third party administration of antimalarial (or\r antibiotics with antimalarial activity) (see Annex 2)\r\n\r Involuntary protocol violation Severe malaria occurring on Day 0 Occurrence during the\r follow-up of concomitant disease that would interfere with a clear classification of the\r treatment outcome Detection of another malaria species during the follow-up Erroneous\r inclusion of a patient who do not meet the inclusion criteria Misclassification of a\r patient due to a laboratory error (parasitaemia) leading to the administration of the\r rescue treatment\r\n\r Patients who are withdrawn will nevertheless be follow-up until day 28 for Plasmodium\r falciparum and until day 34 for Plasmodium vivax or until recovery, if possible.\r However, no treatment outcome will be assigned to these patients and excluded from the\r per protocol analysis. The reason for discontinuation or protocol violation will always\r be recorded on the CRF.\r\n\r 4. TREATMENT 4.1. Antimalarial treatment P. falciparum: artemether-lumefantrine will be\r administered for 3 days according to body weight (Days 0, 1 and 2). Correct drug dosage\r will be determined using the dosing chart (in accordance with national treatment\r guidelines, details provided in Annex 3). Primaquine 0.75 mg/kg body weight single dose\r will be given on Day 3 (in accordance with national treatment guidelines, details\r provided in Annex 3).\r\n\r P. vivax: Chloroquine will be administered according to body weight at a total dose of\r 25mg base/kg over 3 days (10mg base/kg on Day 0; 10mg base/kg on Day 1 and 5mg base/kg\r on Day 2) Primaquine will be withheld for 28 days. It will be given after Day 28\r follow-up, at 0.25 mg base/kg per day for 14 days.\r\n\r Quinine, doxycycline, tetracycline, clindamycin and primaquine (15 mg base per tablet)\r as well as other anti-malarial drugs for rescue treatment will be sourced from the\r Department of Health.\r\n\r All doses of drugs including rescue treatment will be administered under the supervision\r of Municipal Health Officer and Public Health Nurse, and/ or Project Staff Nurse\r designated by the principal investigator. Study patients will be observed for 30 minutes\r after drug administration for adverse reactions or vomiting. Any patient who vomits\r during this observation period will be retreated with the same dose of drug and observed\r for an additional 30 minutes. If the patient vomits again he/she will be withdrawn and\r offered rescue therapy. The study patients will be required to return to Rural health\r unit (RHU) for each dosing dosing day.\r\n\r 4.2. Concomitant treatments and forbidden medication Treatment of fever over 38 °C is\r permitted with paracetamol or acetaminophen. Parents/guardians will be instructed in the\r use of tepid sponging for children <5 years old.\r\n\r Prior treatment with antimalarial drugs will not be considered as an exclusion\r criterion. But, during the follow-up, if infections other than malaria require the\r administration of drugs with antimalarial activity, the patient will be withdrawn from\r the study. Patients given tetracycline as eye ointment will not be excluded (see Annex\r 2). Similarly, patients will be withdrawn from the study in case of self-medication or\r if an antimalarial drug or antibiotics with antimalarial activity is administered by a\r third party.\r\n\r Adverse events requiring treatment will be checked and treated by the municipal heath\r officer and inform Principal Investigator within 24 hours of occurrence of the event.\r Should there be a clinical indication for any additional medication during the course of\r the study including medication given to treat an adverse event related to the study\r drug, the name of the drug, the dosage, and the date and time of administration must be\r recorded in the CRF.\r\n\r 4.3. Rescue treatment If the patient vomits twice he/she will receive parenteral therapy\r with quinine at 10mg/kg bw every 8 hours for 2-3 days, followed by AL for 3 days when\r he/she can tolerate oral meds, and he/she will be withdrawn from the study.\r\n\r For any sign of severe Pf or Pv malaria, the study patient will be hospitalized and\r receive parenteral therapy with Quinine at 10mg/kg bw every 8 hours for 2-3 days,\r followed by AL for 3 days, as well as relevant supportive treatments.\r\n\r If a patient meets one of the criteria for therapeutic failure, he/she will receive oral\r Quinine at 10mg/kg bw every 8 hours for 7 days, in combination with tetracycline (250 mg\r 4x/ day for 7 days), clindamycin (10 mg/kg twice a day for 7 days) or doxycycline (3\r mg/kg once a day for 7 days) for Pf patients and Pv patients + Primaquine for 14 days\r for Pv patients, according to the current national recommendations. If the patient is\r re-infected with another malaria species he/she will receive treatment according to the\r current national recommendations.\r\n\r 5. Evaluation criteria Valid end-points of the study include completion of the follow-up\r period without treatment failure, treatment failure, and loss to follow-up, and\r withdrawal from study (voluntary or involuntary, and voluntary or involuntary protocol\r violation). At all times, the well-being of the study patient will take priority over\r the continuation of the involvement of that patient in the study.\r\n\r 5.1. Efficacy and safety evaluation 5.1.1. Classification of treatment outcomes The\r classification of treatment outcomes will be based on an assessment of the\r parasitological and clinical outcome of antimalarial treatment according to the latest\r guidelines of WHO. Accordingly, all patients will be classified as having an Early\r Treatment Failure, a Late Clinical Failure, a Late Parasitological Failure, or an\r Adequate Clinical and Parasitological Response, as defined in Annex 4.\r\n\r As parasitological cure is the goal of antimalarial therapy, all study subjects who\r present with a treatment failure will be treated with the rescue treatment and dropped\r from further follow-up.\r\n\r 5.2. Clinical evaluations\r\n\r Clinical evaluations will be undertaken in all patients using the following parameters:\r\n\r 5.2.1. Physical Examination A standard physical examination will be performed at\r baseline (Day 0 pre-dose) as well as on days 1, 2, 3, 7, 14, 21, 28. A complete medical\r history, demography and location of contact address and details will be taken at\r baseline.\r\n\r 5.2.2. Weighing and presence of edema Body weight will be recorded at day 0. Weight will\r be measured at to the nearest kg on a Salter scale or some other hanging scale for\r weighing young children properly calibrated with only undergarments kept on the patient.\r The screening weight will be used to satisfy the inclusion/exclusion for nutrition\r status as well as to calculate the dose (number of tablets) to be administered. The\r reliability of scales will be verified using known standard weights prior to\r commencement of study and will be checked at regular intervals.\r\n\r MUAC will be measured on the left arm, at the mid-point between the elbow and the\r shoulder and will be recorded to the nearest 0.2 cm. Edema will be assessed by thumb\r pressure for 3 seconds on the dorsal part of both feet.\r\n\r 5.2.3. Measurement of body temperature Axillary temperature will be performed at\r baseline (Day 0 pre-dose) as well as on Days 1, 2, 3, 7, 14, 21,and 28. Temperature will\r be measured using a thermometer with a precision of 0.1°C. Temperature will additionally\r be measured as clinically indicated. If the result is <36.0°C, the measurement will be\r repeated.\r\n\r Quality of temperature-taking technique and thermometers should be regularly tested in a\r water-bath of known temperature prior to study commencement and at regular intervals\r during study.\r\n\r 5.2.4. Microscopic blood examination A pair of Giemsa-stained thick and thin blood films\r will be obtained from each patient and examined at a magnification of 1000x to identify\r parasite species and to determine the level of parasitemia at screening on Day 0 to\r confirm inclusion/exclusion criteria. Thick and thin blood films will be also examined\r on Days 1, 2, 3, 7, 14, 21 and 28 or on any other day if the patient spontaneously\r returns and parasitological reassessment is required. Specimens will be labelled\r anonymously (study number, day of follow-up, date taken). The other pair of blood film\r will be kept in a separate box as back-up blood films. The study number of the patient,\r the date and day of follow-up will be recorded on the frosted edge of the slide.\r\n\r The second blood smear (Days 0, 1, 2, 3, 7, 14, 21, and 28,) will be used to calculate\r the parasite density, by counting the number of asexual parasites in a set number of\r white blood cells (typically 200) with a hand tally counter. Once a field has been\r started, it must be counted to completion; the final number of white blood cells will\r therefore rarely be exactly 200. If more than 500 parasites have been counted before 200\r white blood cells have been reached, the count will be stopped after the reading of the\r last field has been completed. Parasite density, expressed as the number of asexual\r parasites per µl of blood, will be calculated by dividing the number of asexual\r parasites by the number of white blood cells counted and then multiplying by an assumed\r white blood cell density (typically 6000 per µl).\r\n\r The same technique will be used to establish the parasite count on each subsequent blood\r film. When the number of asexual parasites is less than 100 per 200 white blood cells in\r follow-up smears, counting will be done against at least 500 white blood cells (i.e. to\r completion of the field in which the 500th white blood cell is counted).\r\n\r 5.2.5. Genotyping of malaria parasites In order to differentiate a recrudescence (same\r parasite strain) from a newly acquired infection (different parasite strain), a\r genotypic analysis based on the extensive genetic diversity displayed by the malaria\r parasite genes, msp1, msp2 and glurp will be performed. Genotypic profiles of the pre-\r and post parasite strains will be compared.\r\n\r 5.2.6. Pregnancy test Female patients of child-bearing age (≥ 12 years), defined as\r those who menstruate and who are sexually active, will be asked to take a urine\r pregnancy test before enrolment in the study, because name of the antimalarial drug(s)\r or drug combination(s) is contraindicated during the first trimester. They will also be\r asked to take a urine pregnancy test on day 28 or on early withdrawal from the study.\r\n\r 5.2.7. Haematological assessment Hemoglobin will be determined at Day 0, Day 3, Day 7,\r Day 14 (optional) follow-up among patients enrolled in the Pf study and on Day 0, Day 3,\r Day 7, Day 14 (optional), Day 28, Day 31, and Day 34 among enrolled Pv patients using\r the Hemocue method, requiring 60 ul from a finger-prick blood sample.\r\n\r 5.3. Safety assessment Safety will be assessed by recording the nature and incidence of\r adverse events and serious adverse events. Adverse events will be assessed by direct\r questioning. An adverse event is defined as any unfavourable, unintended sign, symptom,\r syndrome or disease that develops or worsens with the use of a medicinal product,\r regardless of whether it is related to the medicinal product. All adverse events must be\r recorded on the case report form.\r\n\r 6. STUDY ASSESSMENTS 6.1. Screening and enrolment procedures All patients meeting the basic\r enrolment criteria (age, fever or history of fever, presence of symptoms of malaria,\r absence of signs of severe malaria, absence of severe malnutrition, pregnancy, etc)\r during the screening procedure will be assigned a consecutive screening number and\r evaluated in greater depth by clinical staff. Special care will be taken to detect the\r presence or early signs of febrile diseases other than malaria, as these will probably\r necessitate exclusion of the patient from the evaluation. Among paediatric populations,\r the most frequent confounding condition is lower respiratory tract infections: cough or\r difficult breathing, together with fast breathing, is an indicator for identifying and\r excluding patients suffering from such conditions. Fast breathing is defined as a\r respiratory frequency >50/minute in infants under 12 months of age and >40/minute in\r children aged 12-59 months. Other relatively common febrile conditions are otitis media,\r tonsillitis, measles and abscesses. Patients with these conditions will not be enrolled,\r but obviously need to be treated both for malaria (if they have parasitaemia) and the\r other infection as appropriate. Patients will be screened and enrolled at the Rural\r Health Unit and required to return for follow-up visits.\r\n\r 6.2. Follow-up procedure Patients meeting all enrolment criteria will be given a\r personal identification number and receive treatment only after they have had the study\r fully explained to them and have willingly provided their informed consent. Any subject\r who decides not to participate in the study will be examined and treated by the health\r facility staff as usual. They will be treated and followed-up according to the standard\r of care established by the Department of Health.\r\n\r The day that the patient is enrolled and receives the first dose of drugs is designated\r as \"day 0\". All antimalarial treatment will be given by a study team member under\r supervision. Enrolled patients will be observed for at least 30 minutes after treatment\r to ensure that they do not vomit the medicine. If vomiting occurs within 30 minutes of\r treatment, the full treatment dose will be repeated. Ancillary treatments, such as\r antipyretics, may be required and will be provided to patients by the study team and\r documented on the CRF. Patients with persistent vomiting (i.e. necessitating more than a\r single repeat dose) will be excluded from the study and immediately referred to the\r health facility staff for appropriate management.\r\n\r 7. DATA MANAGEMENT The principal investigator will ensure that the study protocol is\r strictly adhered to throughout, and that all data are collected and recorded correctly\r on the CRF. Laboratory and clinical data will be recorded on a daily basis in the CRF\r designed for the study. Data that are derived from source documents should be consistent\r with the source documents or the discrepancies should be explained. Any change or\r correction to a CRF should be dated, and explained and should not obscure the original\r entry. All CRF will be checked for completeness.\r\n\r After the study has been completed, data will be entered onto a database using double\r independent data entry. The data will be stored in a computer database maintaining\r confidentiality in accordance with the national data legislation.\r\n\r The principal investigator is responsible for keeping all the screening forms, the CRF\r and the completed subject identification code list in a secure location.\r\n\r 8. STATISTICAL METHODS 8.1. Minimum sample size Treatment failure to AL in the area being\r 0-5 %, 5% has been chosen as the estimated therapeutic failure rate of the drug. At a\r confidence level of 95% and with a precision around the estimate of 10%, 18 patients\r will be needed. With a 20% increase to allow losses to follow-up and withdrawals during\r the 28-day follow-up period, 22 patients need to be included. But in order for the\r sample to be representative, a minimum of 50 P. falciparum and 50 P.vivax patients need\r to be included and maximum of 75 patients for both P. falciparum and P. vivax will be\r enrolled.\r\n\r 8.2. Analysis of data The Epidemiology-information (EPI-INFO) 6.0 software from USA and\r Excel sheet program (designed from WHO Headquarter [HQ] for monitoring P. falciparum and\r P.vivax resistance to antimalarial drugs) will be used for data entry, management and\r analysis. Data will be analysed by two methods: the Kaplan-Meier method and per-protocol\r analysis (including those who were withdrawn from the study or who were lost to\r follow-up). In addition to the reasons for withdrawal listed in section 3.8, patients\r will be considered withdrawn from the analysis if the PCR results are unclassifiable or\r if the results of PCR indicate that the failure is due to reinfection with P.\r falciparum.\r\n\r The final analysis will include:\r\n\r The description of all the patients screened as well as the distribution of the reasons\r for non-inclusion in the study The description of all the patients included in the study\r The proportion and/or percentage of adverse events and serious adverse events for all\r the patients included in the study The proportion and/or percentage of patients who are\r lost to follow-up or withdrawn with 95% confidence intervals and a list of reasons for\r exclusion The proportion and/or percentage of Early treatment failure (ETF), late\r clinical failure (LCF) and late parasitological failure (LPF) and adequate clinical\r parasitological failure (ACPR) on day 28 with 95% confidence intervals using both\r methods of analysis Guidelines on calculating the cumulative success or failure rate,\r the proportion of adequate clinical and parasitological response and treatment failure\r are given in Annex 9.\r\n\r 8.3. Dissemination of results At the end of the study, the principal investigator will\r submit a report on the study and the main outcome. This report will be shared with the\r National Malaria Program of Department of Health, Philippines and will allow to\r formulate recommendations and enable to make informed decisions about whether the\r current national anti-malarial treatment guidelines should be updated.\r\n\r The patient data will be included in the global database. The results will also be\r presented during the scientific meeting and also be disseminated to the study sites.\r\n\r 8.4. Amendments to the protocol Before the study, official approval to conduct the study\r will be obtained from RITM institutional review board. After the protocol has been\r accepted, no change may be made without the agreement of the principal investigator, the\r sponsor(s), and the Institutional Review Board (IRB).\r\n\r 9. ETHICAL CONSIDERATIONS 9.1. Approval by the national ethical committee Prior to the\r study, official approval to conduct the study will be obtained from Research Institute\r for Tropical Medicine Institutional and Ethical Review Board.\r\n\r 9.2. Patient Information Sheet and Informed consent Inclusion in the study will occur only if\r the patient or the parent/guardian of the child gives an informed consent and informed assent\r from any minor participant aged 12 - 17 years. The consent request, available in English and\r Tagalog, will be read entirely to the patient or the parents/guardians. The Patient\r Information Sheet, available in English and in Tagalog, showing the details about the trial\r and its benefits and potential risks will be explained, and after answering to any potential\r questions, signature on the document will be requested (Annex10). If the patient is\r illiterate, a literate witness must sign (if possible, this person will be selected by the\r participant and will have no connection to the research team). The principal investigator\r must also obtain the assent of children over the age of 12 years, but their assent should\r normally be completed by the permission of a parent or guardian.\r\n\r 9.3. Confidentiality All information regarding the patients will remain confidential within\r the study team. Unique numerical identifiers will be used for the computer-based data entry\r and blood samples. In all cases, principal investigator will seek to ensure that screening\r forms, CRF and completed subject identification code list are kept in locked files.\r\n\r 9.4. Health care services Free health care during the duration of the follow-up for illness\r related to malaria will be provided to the study patients regardless of treatment outcome;\r this includes any necessary expenses related with hospital admission and to adverse drug\r reactions, if required.\r\n\r When prospective or actual subjects are found to have diseases unrelated to malaria, the\r principal investigator should advise them to obtain, or refer them for medical care.\r\n\r Any subject who decides not to participate or cannot be enrolled in the study because they do\r not meet the criteria, will be referred to the health facility staff. They will be treated\r with and followed-up according to the standard of care established by the Department of\r Health. The principal investigator must ensure that this antimalarial drug is available at\r the health center. If a patient is withdrawn from the study before the full course of the\r treatment is completed, the physician must make all necessary arrangements to provide the\r patient with the full dose of the drug currently tested or with a full course of Quinine\r 10mg/kg bw every 8 hours for 7 days, as recommended by the national policy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Above 6 months old to 59 years old;\r\n\r - Mono-infection with P. falciparum or P. vivax, with parasitemia of: P. falciparum:\r 1000-100 000 asexual forms per µl; P. vivax : ≥ 250 per µl\r\n\r - Axillary temperature ≥37.5 °C or oral/rectal temperature of ≥38 °C;\r\n\r - Ability to swallow medication;\r\n\r - Ability and willingness to comply with the study protocol for the duration of the\r study and to comply with the study visit schedule;\r\n\r - Informed consent from the patient or from a parent or legal guardian in the case of\r children less than 18 years old;\r\n\r - Informed assent from any minor participant aged 12 - 17 years; and\r\n\r - Consent for pregnancy testing from female of child-bearing potential and from their\r parent or guardian if under 18 years old.\r\n\r Exclusion Criteria:\r\n\r - Severe malnutrition\r\n\r - Mixed Plasmodium species detected by microscopy;\r\n\r - Presence of severe malnutrition (defined as a child whose weight-for-height is below\r -3 standard deviation or less than 70% of the median of the NCHS/WHO normalized\r reference values, or who has symmetrical oedema involving at least the feet or who has\r a Mid Upper Arm Circumference [MUAC] <110 mm);\r\n\r - Presence of febrile conditions due to diseases other than malaria (measles, acute\r lower tract respiratory infection, severe diarrhea with dehydration, etc.), or other\r known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases,\r HIV/AIDS);\r\n\r - Regular medication, which may interfere with antimalarial pharmacokinetics;\r\n\r - History of hypersensitivity reactions or contraindications to any of the drug(s) being\r tested or used as alternative treatment;\r\n\r - Positive pregnancy test or breastfeeding; and\r\n\r - Unable to or unwilling to take pregnancy test or to use contraception for women or\r child-bearing age and who are sexually active.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nInFocus France Epidemiological Study of Health Burden in Major Hypertriglyceridemia\n\n**Clinical Trial Summary:**\n\nFCS and MCS patients recruited from 7 academic reference centers were invited to answer a\r paper or a web questionnaire. Questions encompassed demographics, physical, cognitive and\r mental symptoms, health care circuit, past and current disease management, satisfaction\r regarding healthcare providers and impact on daily life.\n\n**Clinical Trial Detailed Description:**\n\ncross-sectional study involving a sample of FCS and MCS patients in 1:1 ratio. The study was\r run in seven academic reference centers in France. Adult patients with documented history of\r fasting TG > 10 mmol/L (885 mg/dL) were recruited. Patients had to be genetically\r characterized or MCS patients had a MCS score ≤ 9 [11]. Group sample sizes of 19 FCS and 19\r MCS have been calculated to achieve an at least 80% power to detect a 40% difference in the\r frequency of abdominal pain assuming that 90% of FCS patients would complain about abdominal\r pain.\r\n\r The study protocol was approved by a nationally appointed ethics committee (Comité de\r Protection des Personnes - Ile de France 5) under number 18040. The study protocol complied\r with the ethical guidelines of the Declaration of Helsinki and the French Bioethics Law\r Jarde. The data management complied with the CNIL requirement. Each patient was informed\r about the aims and constraints of the study and signed a non-opposition form prior to any\r study procedure.\r\n\r Health Burden assessment The French IN-FOCUS study was designed to capture current and\r retrospective data in FCS or MCS. Patients were called by the participating centers and were\r proposed to answer a paper questionnaire or to connect to a web-based questionnaire The\r questionnaire was divided into sections specifically assessing various domains of their\r experience: demographic data, signs, symptoms and complications of the disease, healthcare\r circuit, management, relationship with healthcare providers, and burden of the disease on\r daily life. (Details are available as supplementary material S1). The questionnaire focused\r on symptoms because the interest of quality of life assessment tools is debated in rare\r diseases with episodic manifestations. Indeed, most of these tools refer to a limited recall\r period.\r\n\r Data analysis The statistical analysis was performed by Soladis (Lyon, France) using the\r Statistical Analysis System (SAS) software 9.4 (SAS Institute, Cary, NC, USA). Continuous\r variables were summarized by the number of observed data, mean, standard deviation (SD),\r median, first and third quartiles. Categorical variables were described as numbers and\r percentages calculated on the number of observed data. FCS and MCS subjects were compared\r using Student's t test or U Mann-Whitney's test. Categorical variables were compared by the\r chi squared test or the Fisher's exact test. Tests were two-sided and the significance\r threshold was set at 5%. No adjustment of the Type 1 error risk was made for multiplicity.\r Impact of history of AP was evaluated in a multivariable model (logistic regression for\r binary variables, ordinal logistic regression for ordinal variables) including the type of\r disease (FCS or MCS), history of AP and the interaction between these two predictors.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - any adult FCS patient genetically documented any adult MCS patient genetically or\r phenotypically documented\r\n\r Exclusion Criteria:\r\n\r - legal restrictions\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,760
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Longevity of Trichuris Trichiura Colonization\n\n**Clinical Trial Summary:**\n\nThe aim of the study was to study the longevity of Trichuris trichiura colonization\n\n**Clinical Trial Detailed Description:**\n\nThe present study investigates the longevity of Trichuris trichiura colonization in a human\r volunteer as measured by regular fecal sampling.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r The included volunteer is a researcher within parasitology with focus on Trichuris\r trichiura and Trichiura suis. He planned to infect himself under medical supervision. This\r was his third self-infection with Trichuris. The only clinical criterion for his inclusion\r in the study was that he was healthy.\r\n\r Exclusion Criteria:\r\n\r N/A\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,761
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIntervention to Improve Developmental and Health Outcomes for Female Adolescents\n\n**Clinical Trial Summary:**\n\nThe primary goal of this pilot study (R21) is to address the urgent need for theoretically\r and empirically informed interventions that prevent poor female youth's rural-to-urban\r migration for child labor in low and middle-income countries. The study will address the\r following specific aims: Aim 1: Pilot test the (i) feasibility and acceptability of ANZANSI;\r and (ii) preliminary impact of ANZANSI by comparing the control arm to the treatment arm on\r specific child development outcomes; Aim 2: Explore multi- level factors (individual, family,\r and programmatic) impacting participation in and experiences with the ANZANSI.\n\n**Clinical Trial Detailed Description:**\n\nThe primary goal of this pilot study (R21) is to address the urgent need for theoretically\r and empirically informed interventions that prevent poor female youth's rural-to-urban\r migration for child labor in low and middle-income countries. The International Labor\r Organization (ILO) estimates that 11% of children (ages 5 to 17) worldwide are child\r laborers. ILO recently drew attention to migrant child laborers as an underreported, but more\r vulnerable group to adverse outcomes relative to children working locally. Sub-Saharan Africa\r (SSA) continues to be the continent with the highest rates of child labor, with Ghana\r registering one of the highest incidence rates at 22%, including unaccompanied child migrants\r engaged in labor. Adolescent girls make up the majority of unaccompanied rural-to-urban\r migrants in search of better economic opportunities. Studies document the myriad of serious\r threats to health and emotional well-being experienced by female adolescent migrants engaged\r in child labor. These threats underline the urgent need for theoretically-informed preventive\r interventions, specifically tailored to address the root causes of female child migrant labor\r and the needs of girls from economically insecure families and communities. Hence, this\r application titled ANZANSI Family Program focuses on girls before they drop out of school,\r but as they begin exhibiting possibility of dropping out. Specifically, ANZANSI is an\r innovative combination intervention program, combining an evidence-informed family-level\r economic empowerment (EE) aimed at creating and strengthening financial stability through the\r use of matched children savings accounts (CSA) and microfinance in poor households with a\r multiple family group (MFG) intervention addressing family functioning and parental beliefs\r around gender and child labor/ education. Informed by asset theory, parental ethnotheories\r framework; and the investigative team's research in SSA on child-wellbeing and poverty, the\r study uses a cluster randomized control design (N=10 schools; n=100 girls ages 11-14 at risk\r of dropping out of school and their caregivers), assigned to two study conditions (N= 5\r schools; n=50 children at risk of dropping out of school and their caregivers in each\r condition). The control group will receive bolstered usual care, including books and school\r lunch and treatment group will receive a combination intervention (Family EE+MFG) called\r ANZANSI, to address the following specific aims: Aim 1: Pilot test the (i) feasibility and\r acceptability of ANZANSI; and (ii) preliminary impact of ANZANSI by comparing the control arm\r to the treatment arm on specific child development outcomes; Aim 2: Explore multi- level\r factors (individual, family, and programmatic) impacting participation in and experiences\r with the ANZANSI. This study is aligned with NICHD's mission to support research relevant to\r the psychological, behavioral, and educational development and health of children worldwide.\r Ultimately, our findings may guide approaches to address youth's unaccompanied rural-to-urban\r migration and involvement in child labor in SSA, and the associated negative consequences.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Adolescent girls' inclusion criteria are:\r\n\r - Enrolled in school and living within a family (defined broadly -not necessarily\r biological parents)\r\n\r - Ages 11 to 14\r\n\r - Capable of giving assent\r\n\r - Skipping school in the past academic term (with at least 10% of unexcused absences).\r\n\r The caregiver inclusion criteria are:\r\n\r - Self-identified as primary caregiver of the adolescent girl\r\n\r - Capable of providing informed consent.\r\n\r Exclusion Criteria:\r\n\r - Participants (girls and caregivers) that do not meet the criteria or exhibit a lack of\r understanding of the study procedures and hence not able to provide informed consent\r will be excluded.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,762
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSalivary Biomarker Discovery by Raman Spectroscopy in ALS (SalivALS)\n\n**Clinical Trial Summary:**\n\nBACKGROUND/RATIONALE: The paucity of biomarkers for the diagnosis and monitoring of patients\r affected by Amyotrophic Lateral Sclerosis (ALS) is one of the greatest concerns in ALS\r clinics and research. Phenotypic signs, electrophysiological test and clinical scales are\r currently used for ALS diagnosis and follow up before and after treatments. Nowadays, the\r diagnosis and differential diagnosis used to discriminate ALS from other comparable\r neurodegenerative diseases, are time-consuming and complex processes that reduce the time for\r a prompt intervention. Thus, the scientific community is asked to strive for new, measurable,\r fast and objective biomarkers for the diagnosis and stratification of patients. Saliva is a\r complex biofluid composed of bioactive molecules that can be collected by means of a\r non-invasive procedure. The possibility to simultaneously monitor all the variations in the\r endocrine, electrolytic and metabolic messengers in saliva has recently suggested its use for\r the diagnosis of complex diseases, like neurodegenerative diseases, but only limited\r information are available on the potential of saliva as alternative carrier of ALS\r biomarkers.\r\n\r OBJECTIVES: The aim of the present project is to optimize an innovative, non-invasive and\r fast procedure for the ALS onset and for the stratification of ALS patients, taking advantage\r of the sensitivity of Raman Spectroscopy (RS) and of accessible saliva. Fondazione Don\r Gnocchi (FDG) preliminary results on a small cohort of subjects demonstrated the feasibility\r of the methodology and the ability of LABION protocol to obtain a reproducible Raman\r fingerprint of saliva that can be used for the discrimination of healthy subjects, ALS\r patients and subjects affected by other types of neurological diseases.\r\n\r METHODS: Starting from FDG preliminary results, the biochemical composition of saliva in\r patients with diagnosed ALS will be evaluated and statistically compared with the one\r obtained from age and sex-matched healthy subjects and from patients affected by other\r neurological diseases (Parkinson's and Alzheimer's diseases). Moreover, an intra-group ALS\r clustering will be analysed in order to verify a different Raman fingerprint obtained from\r ALS patients with a bulbar or spinal onset. The collected Raman data will be processed using\r a multivariate analysis approach through Principal Component Analysis - Linear Discriminant\r Analysis (PCA-LDA). The classification model will be created using cross-validation and\r subset validation. Thanks to RS, the overall composition of saliva will be established with\r minimal sample preparation, providing comprehensive biochemical fingerprint of the sample. In\r parallel, routine salivary parameters will be measured including viscosity, pH, total protein\r and carbohydrates concentration, amylase and pepsin, cortisol and Chromogranin A.\r\n\r EXPECTED RESULTS: By the end of this study, the investigators expected to verify the\r possibility to use the Raman salivary pattern as new promising biomarker for ALS diagnosis\r and progression to be related with clinical scales for the personalized and fine tuning of\r the therapeutic approach. The intent of this project is to create a classification model able\r to:\r\n\r 1. Determine the ALS onset\r\n\r 2. Discriminate the signal obtained from ALS patients from the one collected from other\r neurodegenerative diseases\r\n\r 3. Stratify ALS patients into bulbar and spinal onset\r\n\r 4. Correlate the Raman data with clinical and paraclinical scales used nowadays for ALS\r diagnosis and monitoring\n\n**Clinical Trial Detailed Description:**\n\nSAMPLE COLLECTION: Saliva collection from all the selected subjects will be performed\r following the Salivette (SARSTEDT) manufacturer's instructions. To limit variability in\r salivary content not related to ALS, saliva will be obtained from all subjects at a fixed\r time, after an appropriate lag time from feeding and teeth brushing. Pre-analytical\r parameters (i.e. storage temperature and time between collection and processing), dietary and\r smoking habit will be properly recorded. Briefly, the swab will be removed, placed in the\r mouth and chewed for 60 seconds to stimulate salivation. Then the swab will be centrifuged\r for 2 minutes at 1,000 g to remove cells fragments and food debris. Collected samples will be\r stored at -80° C.\r\n\r SAMPLE PROCESSING: Before the Raman acquisition, saliva samples will be filtered with\r different cut-off ranges (3, 10 and 30 kDa), collecting and analysing by RS the eluted sample\r and discarding the concentrated counterpart. For the Raman analysis, a drop of each sample\r will be casted on an aluminium foil in order to achieve the Surface Enhanced Raman Scattering\r (SERS).\r\n\r DATA COLLECTION: Raman and SERS spectra will be acquired using an Aramis Raman microscope\r (Horiba Jobin-Yvon, France) equipped with a laser light source operating at 785 nm with laser\r power ranging from 25-100% (Max power 512 mW). Acquisition time between 10-30 seconds will be\r used. The instrument will be calibrated before each analysis using the reference band of\r silicon at 520.7 cm-1. Raman spectra will be collected from 15 points following a line-map\r from the edge to the centre of the drop. Spectra will be acquired in the region between 400\r and 1800 cm-1 using a 50x objective (Olympus, Japan). Spectra resolution is about 1.2 cm-1.\r The software package LabSpec 6 (Horiba Jobin-Yvon, France) will be used for map design and\r the acquisition of spectra.\r\n\r DATA PROCESSING: All the acquired spectra will be fit with a fifth-degree polynomial baseline\r and normalized by unit vector using the dedicated software LabSpec 6. The contribution of the\r substrate will be removed from each spectra. The statistical analysis to validate the method,\r will be performed using a multivariate analysis approach. Principal Component analysis (PCA)\r will be performed in order to reduce data dimensions and to evidence major trends. The first\r 20 resultant Principal Components (PCs) will be used in a classification model, Linear\r Discriminant Analysis (LDA), to discriminate the data maximizing the variance between the\r selected groups. The smallest number of PCs will be selected to prevent data overfitting.\r Leave-one-out cross-validation and confusion matrix test will be used to evaluate the method\r sensitivity, precision and accuracy of the LDA model. Mann-Whitney will be performed on PCs\r scores to verify the differences statistically relevant between the analysed groups.\r Correlation and partial correlation analysis will be performed using the Spearman's test,\r assuming as valid correlation only the coefficients with a p-value lower than 0.05. The\r statistical analysis will be performed using Origin2018 (OriginLab, USA).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of Amyotrophic Lateral Sclerosis (ALS) according to the El Escorial criteria\r and classification based on the main genetic mutations for the ALS group\r\n\r - Diagnosis of Alzheimer's disease according to the ATN criteria for the Alzheimer's\r group\r\n\r - Diagnosis of Parkinson's disease according to the Unified Parkinson's Disease Rating\r Scale and with Hoehn and Yahr scores for the Parkinson's group\r\n\r - Male\r\n\r - Age between 50 and 70 years\r\n\r Exclusion Criteria:\r\n\r - Oncologic Diseases\r\n\r - Immune and hematological diseases\r\n\r - Bacterial or fungal infections in progress (e.g. oral candidiasis)\r\n\r - Female\r\n\r - Age less than 50 years or above 70 years\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,763
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCore Decompression With or Without Cement Packing for ONFH\n\n**Clinical Trial Summary:**\n\nOsteonecrosis of the femoral head (ONFH) is difficult to treat as collapse frequently occurs\r after core decompression (CD). This may be due to the failure to provide structural support\r during revascularization and healing. Reports of polymethylmethacrylate (PMMA) packing of the\r femoral head after CD for ONFH have noted favorable results. This study was undertaken to\r determine whether the addition of PMMA packing to CD provides any benefit to progression-free\r survival (PFS) and conversion to total hip arthroplasty-free survival (CFS). Secondary\r objectives were to assess for differences in functional outcomes and predictive factors for\r progression of the disease.\n\n**Clinical Trial Detailed Description:**\n\nA prospective randomized controlled trial comparing the results of CD vs. CD + PMMA packing\r in pre-collapse ONFH was set up.\r\n\r Consecutive symptomatic patients aged >14 years with Association Research Circulation Osseous\r (ARCO) Stage I and II ONFH diagnosed using MRI and radiographic imaging were enrolled in this\r study.\r\n\r Exclusion criteria were pre-existing collapse, sub-chondral fracture or degenerative changes\r of the hip.\r\n\r After obtaining informed written consent, patients are asked to complete the Harris Hip Score\r (HHS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and a health\r status questionnaire Short Form-36 (SF-36).\r\n\r The femoral heads enrolled into the study are randomized using a computer-generated card draw\r system to one of following: core decompression (CD) or core decompression with PMMA cement\r packing (CD + PMMA).\r\n\r Allocation concealment was practiced with the use of opaque envelopes. Patients with\r bilateral involvement who had been randomized to one treatment modality for one femoral head\r were automatically selected to receive the other treatment modality for the contralateral\r femoral head.\r\n\r Blinding of either surgeon or patient is impossible.\r\n\r The patients were followed up after surgery every 3-4 months for the first 2 years after\r which the patients were seen annually. Completed questionnaires and radiographs were obtained\r at each visit.\r\n\r Statistical Analysis The date of index procedure (CD or CD + PMMA) was used as start date for\r the purpose of statistical analysis. Progression Free Survival was defined as the time to\r radiographic progression and Conversion Free Survival (CFS) as the time to a THA. In case of\r patients who did not have radiographic progression, the date of their last follow up or death\r was used for the analysis. The SAS software will be used for all the analyses. The Log rank\r and Gerhan-Wilcoxon tests were used to compare Kaplan-Meier survival curves for the time from\r the date of the index procedure to radiographic progression (subchondral collapse) or\r conversion to THA for separate groupings based on age at index procedure (<40 , >40 yrs),\r smoking (Y/N), location (central, medial, lateral), percent involvement (<15% [mild], 15% to\r 30% [moderate], or >30% [severe]), index of necrotic extent (<40 or >40), and modified index\r of necrotic extent (<40 or >40). Whenever factors were found to affect the survival curves\r mainly in the initial year the Gerhan-Wilcoxon test was used as the test of significance. The\r Kaplan-Meier curves were also compared for the main cohorts of CD vs. CD + PMMA. Cox\r proportional hazards regression was used to compare factors (age, smoking, location, percent\r involvement, index of necrotic extent, and modified index of necrotic extent) with regards to\r their ability to predict the time to progression or revision to THA. Mixed multilevel\r regression modeling was used to test for group differences in the change in self-rated health\r survey scores over time from baseline over the post-operative period. The hierarchical linear\r modeling approach has a number of advantages over traditional repeated measures approaches\r for modeling change over time, including allowance for missing data and for varying\r measurement times across subjects. Separate models were generated for SF-36, Harris Hip Score\r and WOMAC scores over two-year and over 5-year post-operative time periods.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Association Research Circulation Osseous (ARCO) Stage I and II ONFH diagnosed using\r MRI and radiographic imaging\r\n\r Exclusion Criteria:\r\n\r - pre-existing collapse, subchondral fracture or degenerative changes of the hip\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,764
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nFaecal Microbiota Transplantation (FMT) in Patients With IBSmechanism(s) of Action\n\n**Clinical Trial Summary:**\n\nTwo hundrad patients are randomized to either 90 g transplant, 90 g transplant twice with\r 1week interval into the distal small intestine via working channel of a gastroscope, or to 90\r g transplant into the coecum of the colon via working channel of a colonoscope. The patients\r shall complete 5 questionnaires measuring symptoms, fatigue and quality of life and collect a\r feces sample at 0, 2 weeks, 1 month, and 3 months. Dysbiosis and fecal bacterial are\r determined by using 16S rRNA gene.\n\n**Clinical Trial Detailed Description:**\n\nPatients Two hundrad patients who fulfil Rome IV criteria for irritable bowel syndrome (IBS)\r shall be included in the study. All the IBS subtypes shall be included.\r\n\r Donor Investigators are going to use the same super-donor they used in their previous\r randomised double-blind, placebo-controlled study. The donor is athletic Caucasian man aging\r 36 years. He is non-smoker and is completely healthy without any medication and with a BMI of\r 23.5. He is not relative to any of the patients in the trial. He was borne by vaginal\r delivery and breastfeed. He was treated 3 times with antibiotics during his life. He trains 5\r times weekly an hour each time. He took regularly dietary supplements rich in proteins,\r vitamins, fibres and minerals that made his diet richer than average in these substances. He\r was screened according to the guidelines for donors for FMT. Before he was accepted as a\r donor the microbiota was analysed in a faecal sample using GA-map Dysbiosis test. The\r analysis revealed a dysbiosis index (DI)= 1, indicating normobiosysis. In addition, he had\r excess of bacteria belonging to the Firmicutes. His faeces shall be tested every third moth\r during the trial.\r\n\r Protocol\r\n\r The patients are randomized to either 90 g transplant, 90 g transplant twice with 1week\r interval into the distal small intestine, or to 90 g transplant into the coecum of the colon.\r The patients shall complete 5 5 questionnaires and deliver fecal samples at the baseline, 2\r weeks, 1 month and 3 month after FMT.\r\n\r Faeces collection, preparation and administration Faeces from both the donor and patients\r shall be collected and stored at - 80•. Frozen faeces shall be thawed and each 30 g is\r dissolved in 30 mL of 0.9% sterile saline. The dissolved stool administrated to the patients,\r after overnight fast, through working channel of gastroduodeno-scope in pars descendent\r duodenum distal to the papilla of Vater or to the coecum through working channel of a\r colonoscope.\r\n\r Analysis Questionnaires\r\n\r 1. IBS symptom severity Scale (IBS-SSS).\r\n\r 2. Birmingham Symptom scale.\r\n\r 3. IBS-quality of life (IBSQo) Questionnaire.\r\n\r 4. Short form of Nepean Dyspepsia Index (SF-NDI).\r\n\r 5. Fatigue Assessment Scale (FAS).\r\n\r Microbiome analysis Gut microbiota analysis is performed using the Genetic analysis-mapTM\r Dysbiosis test (Genetic Analysis AS, Oslo, Norway) by algorithmically assessing faecal\r bacterial abundance and profile (dysbiosis index, DI), and potential deviation in the\r microbiome from normobiosis. GA-map test is based on faecal homogenization, mechanical\r bacterial cell disruption and automated total bacterial genomic DNA extraction using magnetic\r beads. DI is based on 54 DNA probes targeting more than 300 bacterial strains based on their\r 16S rRNA sequence in seven variable regions (V3-V9). Twenty-six bacteria probes are species\r specific, 19 detect bacteria on genus level, and 9 probes detect bacteria at higher taxonomic\r levels. Probe labelling is by single nucleotide extension and hybridization to complementary\r probes coupled to magnetic beads, and signal detection by using BioCode 1000A 128-Plex\r Analyser (Applied BioCode, Santa Fe Springs, CA, USA). A DI above 2 shows a microbiota\r profile that differs from that of the normobiotic reference collection (DI 1-2:\r non-dysbiosis, DI: moderate, DI 4-5: severe dysbiosis).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients who fulfil Rome IV criteria for the diagnosis of IBS.\r\n\r 2. Patients were investigated to exclude other gastrointestinal organic cause(s).\r\n\r 3. Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS Severity\r Scoring System (IBS-SSS).\r\n\r Exclusion Criteria:\r\n\r 1. Pregnant or lactating women.\r\n\r 2. The use of antibiotics or probiotics within 1 month prior to FMT.\r\n\r 3. Immunocompromised patients defined as those treated by immune- suppressive\r medications.\r\n\r 4. Patients with co-morbidity such as kidney failure or chronic heart disease.\r\n\r 5. System disease such as diabetes.\r\n\r 6. Patients with serious psychiatric disorders or drug abuse.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,765
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIntravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF\n\n**Clinical Trial Summary:**\n\nThis study analyses the effect of intravenous branched chain amino acids (BCAA) on overt HE\r in patients with ACLF. The investigators plan to study the efficacy of combining intravenous\r BCAA with lactulose versus lactulose alone in the medical management of overt HE in patients\r with ACLF and its impact on overall survival and improvement in grade of HE.\n\n**Clinical Trial Detailed Description:**\n\nAcute on chronic liver failure (ACLF) is a distinct clinical entity in the spectrum of\r chronic liver disease associated with high short term mortality. Hepatic encephalopathy (HE)\r is commonly seen in patients with ACLF and its treatment mainly involves non-absorbable\r disaccharides (lactulose/lactitol).Treatment of HE in ACLF is based on extrapolation of data\r available from cirrhotic patients. No studies have compared different treatment options for\r HE in patients with ACLF.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age 18-75 years\r\n\r 2. Either gender\r\n\r 3. Patients with ACLF (CANONIC definition) of any aetiology with HE ≥grade 2 as per\r West-Haven Criteria\r\n\r Exclusion Criteria:\r\n\r 1. Those who do not consent to participate in the study\r\n\r 2. Patients with structural brain lesions or stroke\r\n\r 3. Inability to obtain informed consent from patient or relatives\r\n\r 4. Severe preexisting cardiopulmonary disease\r\n\r 5. Renal dysfunction (S. Creatinine ≥ 2mg/dL)\r\n\r 6. Pregnancy/Lactation\r\n\r 7. Post liver transplant patients\r\n\r 8. HIV infection\r\n\r 9. Patients who are on psychoactive drugs, like sedatives or antidepressants\r\n\r 10. Patients who are too sick to carry out the protocol\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,766
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEfficacy of Low Dose Naltrexone in Psoriasis\n\n**Clinical Trial Summary:**\n\nObjective of the study is to determine the efficacy of low dose naltrexone in the patients of\r psoriasis, which is a chronic relapsing and remitting disease. A non-randomized clinical\r trial was carried out in the Department of dermatology in Jinnah Postgraduate Medical Center,\r Karachi. All patients with mild, moderate and severe psoriasis with age above 13 years\r without any co-morbid, were prescribed tablet Naltrexone 6 mg daily after assessing PASI, BSA\r and DLQI scores before starting treatment. Patients were called monthly for follow up to\r monitor lipid profiles and liver function tests. After 3 months of treatment, PASI, BSA and\r DLQI scores were assessed again. The results were significant when analysed with paired t\r test in SPSS 23.\n\n**Clinical Trial Detailed Description:**\n\nPsoriasis is a chronic T-cell mediated disorder. The activated T cell secretes cytokines that\r result in keratinocytes hyper-proliferation and abnormal differentiation. These cytokines\r result in chemo-taxis of neutrophils and lymphocytes in skin. It is a multi-factorial\r disease. Individual has genetic susceptibility for psoriasis, but environmental factors\r trigger the disease like infections, drugs, cold, trauma and stress. It is a multi-system\r disease but mainly affects skin, nails and joints. It impacts adversely on patients' quality\r of life, causes embarrassment, limitation in clothing choice, psychological distress which\r further aggravates the disease. It impacts economically due to off days from work as well. In\r its most common form, it presents as salmon pink plaques, covering with thick silver scales,\r mostly on scalp, trunk, buttocks and external surfaces of limbs.\r\n\r In the management of psoriasis, there are multiple treatment options which includes topical,\r systemic and photo-therapy. But all have their side effects and contraindication. Low dose\r naltrexone(LDN) is an attractive emergent therapy with analgesic, anti-pruritic and\r anti-inflammatory properties for various dermatological disorders including psoriasis. In\r this study, the effectiveness of low dose naltrexone in cases of psoriasis was assessed.\r\n\r The study was conducted in the department of dermatology in Jinnah Postgraduate Medical\r Centre, Karachi, after receiving approval letter from the institutional ethical and research\r committee of the hospital.Forty two patients were selected of either gender with age ranging\r from 13-60 years, after excluding hypertension, cardiovascular disorders, pregnancy and\r lactation. The procedure has been explained to each patient & written consent has been taken.\r Before prescribing LDN treatment, Psoriasis area and severity index(PASI), Body surface\r area(BSA) and Dermatology life quality index(DLQI) has been calculated. Each case has\r prescribed tablet naltrexone 6mg daily after checking all baselines investigations of\r complete blood picture , renal and liver function profiles. The cases were asked to follow up\r monthly to observe patient compliance, response of medicine and its side effects. After 3\r months of treatment, PASI, BSA and DLQI have been calculated to assess the effectiveness of\r treatment.\r\n\r PASI score is used to measure the severity and extent of disease, in terms of intensities of\r erythema, induration and scaling of lesion and the area of body involved with disease.\r\n\r Body surface area (BSA) is calculated through 'rule of nine' which is a convenient and rapid\r method of estimating the extent of body surface area affected with disease. If BSA is <3%,\r 3-10%, or >10%, it is categorized as mild, moderate and severe disease, respectively.\r\n\r The dermatology life quality index is a simple questionnaire, that consists of 10 questions\r to assess the impact of disease and its treatment on daily activities and the impact on the\r social behavior of the patients. DLQI scores has been interpreted in terms of effect of\r disease on patients' life as follows:\r\n\r - 0-1 = No effect\r\n\r - 2-5 = Small effect\r\n\r - 6-10 = Moderate effect\r\n\r - 11-20 = Very large effect\r\n\r - 21-30 = Extremely large effect After 3 months, all three scores were assessed again to\r observe the effectiveness of treatment. The evaluation was done by SPSS version 23. The\r side effects were assessed regarding nausea, headache, decreased appetite, dizziness,\r palpitation, liver enzymes level, renal and complete blood profiles.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - minimum age 13 years\r\n\r - maximum age 60 years\r\n\r - both males and females affected with mild, moderate and severe psoriasis.\r\n\r Exclusion Criteria:\r\n\r - hypertension\r\n\r - cardiovascular disorders\r\n\r - pregnancy\r\n\r - lactation\r\n\r - renal failure\r\n\r - liver failure\r\n\r - hypersensitivity to drug\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,767
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIdentification of Biomarkers in Ischemic Stroke - Clinical Trial\n\n**Clinical Trial Summary:**\n\nThe objective of the study is to determine RNA blood biomarker based on 9 genes already\r identified in experimental studies, whose expression would be significantly increased in\r patient with ischemic stroke compared to controls.\n\n**Clinical Trial Detailed Description:**\n\nThis is a monocentric study. It's a case-control study with case being first-ever ischemic\r stroke and controls being healthy (stroke free) subject patients paired for age, sex and\r cardiovascular risk or hemorrhagic stroke paired for age and sex.\r\n\r Patients are followed for one year. Blood samples will be taken at inclusion, 12h, 24h, 48h,\r 7d, 3m and 1y. Microvesicles samples will be taken at inclusion, 7d and 3M.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - For ischemic stroke :\r\n\r - Age > 18-year-old\r\n\r - Ischemic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI\r imaging)\r\n\r - Inclusion inferior to 6 hours from stroke onset\r\n\r - Initial NIHSS score > 0 at the time of clinical examination\r\n\r - Patients with multimodal imaging either through MRI or CT perfusion and supra-aortic\r vessels and intra-cerebral vessels (Willis circle) imaging <0\r\n\r - Procedure of signed consent in situation of emergency : consent of the patient if he\r has the possibility to sign or his representative if he is present\r\n\r - For hemorragic stroke :\r\n\r - Age > 18 year-old\r\n\r - Hemorrhagic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI\r imaging)\r\n\r - Inclusion inferior to 6 hours from stroke onset\r\n\r - Initial NIHSS score > 0 at the time of clinical examination\r\n\r - Hemorrhagic patients are paired for age and sex with ischemic patients\r\n\r - Procedure of signed consent in situation of emergency : consent of the patient if he\r has the possibility to sign or his representative if he is present\r\n\r For healthy controls :\r\n\r - Age > 18 year-old\r\n\r - Stroke-free standardized questionnaire\r\n\r - Initial NIHSS score = 0\r\n\r - Rankin score = 0\r\n\r - High risk cardiovascular subjects\r\n\r - Controls are paired for age, sex and cardiovascular risk measured by a score (European\r Heart Score) with ischemic patients\r\n\r Exclusion Criteria:\r\n\r - Not affiliated to social security\r\n\r - Patient under legal protection or deprived of liberty by a judicial or administrative\r decision\r\n\r - Patient whose follow-up will be impossible\r\n\r - Prior stroke\r\n\r GROUP FOR ISCHEMIC STROKE :\r\n\r - Patients with TIA and a negative cerebral CT or MRI\r\n\r GROUP FOR HEMORRAGIC STROKE :\r\n\r - Cerebral hemorrhage related to subarachnoid hemorrhage\r\n\r - Post-traumatic hemorrhage\r\n\r - Hemorrhagic transformation in patients with ischemic stroke\r\n\r GROUP FOR HEALTHY CONTROLS :\r\n\r - Contraindication MRI\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,768
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nDeep Neural Network Approaches for Closed-Loop Deep Brain Stimulation\n\n**Clinical Trial Summary:**\n\nIn this research study the researchers want to learn more about brain activity related to\r speech perception and production in patients with Parkinson's Disease who are undergoing deep\r brain stimulation (DBS).\n\n**Clinical Trial Detailed Description:**\n\nDeep brain stimulation (DBS) is the gold-standard treatment for patients with medication\r resistant motor complications of Parkinson's disease (PD) and provides the only opportunity\r to record and stimulate in the human basal ganglia. Most recently, the concurrent use of\r research electrocorticography (ECoG) during DBS surgery, including pioneering work from\r Pittsburgh, has further enabled basic neuroscience investigation of human\r cortical-subcortical network dynamics. The discovery that aberrant synchronization of\r rhythmic neuronal activity recorded in PD patients is suppressed by DBS has advanced the\r concept that measures associated with pathological activity may be used as biomarkers to\r control the delivery of DBS therapy. Pilot studies of aDBS in PD have reported promising\r clinical results from triggering DBS stimulation when the signal recorded from the DBS\r electrode showed a high level of oscillatory power in the beta frequency range (13 - 35 Hz).\r That approach, however, has important limitations. Most importantly, beta power recorded from\r the DBS lead is suppressed by movement including PD tremor, its detection is highly dependent\r on lead location and the recording montage needed to record during stimulation is\r incompatible with directional current steering, a recent innovation employing segmented\r stimulation contacts. The inherent complexity of the increased parameter space through DBS\r innovations also overwhelms standard programming techniques. Finally, use of additional\r biomarker signals (e.g., recorded from cortex) is likely to improve the ability to adaptively\r control DBS for disorders marked by complex multidimensional symptomatologies such as PD. The\r current proposal will establish methods for overcoming these limitations by developing\r techniques for multi-feature classification from ECoG recordings, using advanced machine\r learning algorithms.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subjects scheduled for DBS implantation, as determined by the clinical\r multidisciplinary movement disorders board with definitive diagnosis of Parkinson's\r disease\r\n\r 2. Subjects able to provide informed consent and comply with task instructions.\r\n\r 3. Subjects 18-85 years old\r\n\r Exclusion Criteria:\r\n\r 1. Non-English-speaking subjects\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
35,769
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nStudy in Parkinson Disease of Exercise\n\n**Clinical Trial Summary:**\n\nThis study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance\r treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease\r Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson\r disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85%\r HRmax 4 times per week. The primary objective is to test whether the progression of the signs\r of Parkinson's disease is attenuated at 12 months in among persons who have not initiated\r medication for Parkinson Disease (PD) when they perform high-intensity endurance treadmill\r exercise.\n\n**Clinical Trial Detailed Description:**\n\nThis study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance\r treadmill exercise on changes in the MDS-UPDRS Part III score at 12 months. 370 persons\r diagnosed with Parkinson's disease who have not yet initiated dopaminergic therapy, age\r 40-80, will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per\r week. Secondary objectives will test hypotheses related to striatal specific binding ratio\r (SSBR) at 12 months, MDS-UPDRS Part III score, ambulatory mobility (6-minute walk), daily\r walking activity (steps), cognition, quality of life, cardiorespiratory fitness,\r blood-derived biomarkers of inflammation and neurotrophic factors at 12 and 18 months.\r Tertiary objectives will test hypotheses related to 2 characteristics of ambulation at 12 and\r 18 months. Exploratory objectives will test hypotheses related to the effects of removing the\r study support that was provided over 18 months on the sustainability and durability of the\r exercise effects at 24 months. Approximately 29 sites will enroll participants: 27 sites that\r cover all geographic regions of the USA and 2 sites in Canada. All sites will have a\r collaboration between movement disorders and exercise specialists.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - A diagnosis of idiopathic Parkinson Disease based on the modified * United Kingdom\r (UK) PD brain bank criteria and which are consistent with recent criteria proposed for\r clinically established early established Parkinson's disease that no longer exclude\r individuals with a family history of Parkinson's disease.\r\n\r - Hoehn and Yahr stages less than 3\r\n\r - Disease duration: less than 3 years since disease diagnosis\r\n\r - Age 40-80 years\r\n\r - Positive DaTscan™ SPECT by quantitative readout for idiopathic Parkinson disease.\r\n\r Exclusion Criteria:\r\n\r - Currently being treated with PD medications such as levodopa or dopamine receptor\r agonists, monoamine oxidase-B (MAO-B) inhibitors, amantadine, or anticholinergics.\r\n\r - Expected to require treatment with medication for PD in the first 6 months of the\r study.\r\n\r - Use of any PD medication 60 days prior to the baseline visit including but not limited\r to levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline\r (Eldepryl), Artane (trihexyphenidyl).\r\n\r - Duration of previous use of medications for PD exceeds 30 days.\r\n\r - Use of neuroleptics/dopamine receptor blockers for more than 30 days in the year prior\r to baseline visit, or any use within 30 days of baseline visit\r\n\r - Presence of known cardiovascular, metabolic, or renal disease or individuals with\r major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease\r without medical clearance to participate in the exercise program.\r\n\r - Uncontrolled hypertension (resting blood pressure >150/90 mmHg)\r\n\r - Individuals with orthostatic hypotension and standing systolic BP below 100 will be\r excluded. Orthostatic hypotension (OH) is a reduction of systolic blood pressure of at\r least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of\r standing.\r\n\r - Hypo- or hyperthyroidism (TSH <0.5 or >5.0 mU/L), abnormal liver function (AST or ALT\r more than 2 times the upper limit of normal), abnormal renal function (creatinine\r clearance calculated by the Cockcroft-Gault equation <50mL/min, or estimated\r glomerular filtration rate using the MDRD4 equation or the CKD-EPI equation\r <45mL/min/1.73m2 ).\r\n\r - Complete Blood Count (CBC) out of range and physician's judgment that abnormal value\r is clinically significant.\r\n\r - Recent use of psychotropic medications (e.g., anxiolytics, hypnotics, benzodiazepines,\r antidepressants) where dosage has not been stable for 28 days prior to screening.\r\n\r - Serious illness (requiring systemic treatment and/or hospitalization) within the last\r 4 weeks.\r\n\r - Any other clinically significant medical condition, psychiatric condition, drug or\r alcohol abuse, assessment or laboratory abnormality that would, in the judgment of the\r investigator, interfere with the subject's ability to participate in the study.\r\n\r - Montreal Cognitive Assessment (MoCA) score of <26 to rule out mild cognitive\r impairment (MCI).\r\n\r - Beck Depression Inventory II (BDI) score > 16, indicating depression that precludes\r ability to exercise. Any subject with such a score will be referred to a primary care\r physician (PCP) or physician for further evaluation and management of depression.\r\n\r - Individuals participating in 120 minutes or more of moderate intensity exercise per\r week within the last 6 months will be excluded. Moderate intensity is defined as a\r range greater than 60-65% HRmax. These individuals are excluded since their exercise\r activities are equal to or greater than the activities they would experience if they\r were assigned to the 60-65% treatment group.\r\n\r - Use of the following within 90 days prior to the dopamine transporter (DAT)\r neuroimaging screening evaluation: bupropion, modafinil, armodafinil, metoclopramide,\r alpha-methyldopa, methylphenidate, reserpine, any amphetamine or amphetamine\r derivative. These can compromise DaTscan™ SPECT.\r\n\r - Known allergy to iodinated products.\r\n\r - Known hypersensitivity to DaTscan™ SPECT (either to the active substance of\r 123I-ioflupane or any of the excipients.\r\n\r - Prior SPECT scan within 6 months of baseline scan. Recruitment will be delayed for\r individuals who have had a previous SPECT scan within 6 months of the baseline scan.\r\n\r - (For women only) Actively breast-feeding an infant, and/or pregnant, or plan to become\r pregnant in the next 12 months.\r\n\r - Other disorders, injuries, diseases, or conditions that might interfere with ability\r to perform endurance exercises (e.g. history of stroke, respiratory problems,\r traumatic brain injury, orthopedic injury, or neuromuscular disease).\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,770
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCortical-Basal Ganglia Speech Networks\n\n**Clinical Trial Summary:**\n\nIn this research study the researchers want to learn more about brain activity related to\r speech perception and production.\n\n**Clinical Trial Detailed Description:**\n\nSpeech production is disrupted in a number of neurological diseases that involve the basal\r ganglia, including Parkinson's disease (PD) and dystonia. The investigators will use a novel\r experimental approach and combination of analytic techniques to elucidate the contribution of\r neural activity in cortical-basal ganglia circuits to the hierarchical control of speech\r production, in subjects undergoing deep brain stimulation surgery.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subjects scheduled for DBS implantation, as determined by the clinical\r multidisciplinary movement disorders board with definitive diagnosis of Parkinson's\r disease, essential tremor or dystonia.\r\n\r 2. Subjects able to provide informed consent and comply with task instructions.\r\n\r 3. Subjects 18-85 years old\r\n\r Exclusion Criteria:\r\n\r 1. Subjects with reported hearing loss.\r\n\r 2. Non-English-speaking subjects\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,771
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nLu AF28996 in Patients With Parkinson's Disease (PD)\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to investigate the safety of Lu AF28996, how well it is\r tolerated and what the body does to the drug in Patients With Parkinson's Disease\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Men or women diagnosed with idiopathic PD (consistent with the UK PD Society Brain\r Bank Criteria for the Diagnosis of PD), Modified Hoehn and Yahr Staging ≤4 in 'OFF'\r and ≤3 in 'ON' state and a Mini Mental State Examination Score >26.\r\n\r - Patients must currently have a good response to levodopa, and be receiving a stable\r dose of levodopa (>3 doses per day of standard levodopa or >3 doses per day of\r carbidopa and levodopa, or benserazide and levodopa, Extended-Release Capsules) for at\r least 4 weeks prior to screening. If the patient's response to Levodopa has not been\r previously documented in medical records, the patient will be submitted to a Levodopa\r challenge test while in practically defined OFF state prior to enrolment.\r\n\r - Patients must experience recognizable and predictable motor fluctuations (with at\r least 1.5 hours of OFF-periods in the awake time, including predictable morning OFF\r episodes) causing clinically significant disability during the 4-week screening\r period. This will be documented during a defined period of 3 consecutive days prior to\r enrolment, using a patient diary.\r\n\r Exclusion Criteria:\r\n\r - The patient has or has had one or more of the following conditions that are considered\r clinically relevant in the context of the study; other neurological disorder,\r psychiatric disorder, seizure disorder or encephalopathy, respiratory disease, hepatic\r impairment or renal insufficiency, metabolic disorder, endocrinological disorder,\r haematological disorder, infectious disorder, any clinically significant immunological\r condition, elevated intra-ocular pressure or is at risk of acute narrow-angle glaucoma\r\n\r Other in- and exclusion criteria may apply\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,772
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations\n\n**Clinical Trial Summary:**\n\nThis phase III trial compares standard chemotherapy to therapy with CPX-351 and/or\r gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3\r mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab\r ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the\r cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up\r of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone\r marrow longer and could be less likely to cause heart problems than traditional anthracycline\r drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an\r abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that\r carry instructions for development, functioning, growth and reproduction) inside each cell\r that tell the cell what to do and when to grow and divide. FLT3 plays an important role in\r the normal making of blood cells. This gene can have permanent changes that cause it to\r function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function\r of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to\r compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people\r with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or\r bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or\r other FLT3 mutations and 3) to study changes in heart function during and after treatment for\r AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in\r treating patients with acute myeloid leukemia compared to standard chemotherapy alone.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVE:\r\n\r I. To compare event-free survival (EFS) in children with de novo acute myeloid leukemia (AML)\r without FLT3 mutations who are randomly assigned to standard induction therapy on Arm A with\r daunorubicin, cytarabine (DA) and gemtuzumab ozogamicin (GO) (DA-GO) versus Arm B with\r liposome-encapsulated daunorubicin-cytarabine (CPX-351) and GO.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To compare overall survival (OS) and rates of end of Induction 1 (EOI1) minimal residual\r disease (MRD) in children with de novo AML without FLT3 mutations who are randomly assigned\r to standard induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B).\r\n\r II. To estimate the EFS and rate of EOI1 MRD in FLT3 internal tandem duplication mutation\r positive patients (FLT3/ITD+; as defined by allelic ratio > 0.1) without favorable\r cytomolecular characteristics (NPM1 and/or CEBPA) receiving gilteritinib fumarate\r (gilteritinib) in combination with DA-GO (Arm AC).\r\n\r III. To estimate the EFS and rate of EOI1 MRD in patients with non-ITD FLT3 activating\r mutations who receive backbone therapy (DA-GO or CPX-351 and GO) with gilteritinib (Arms AD\r and BD).\r\n\r IV. To determine the feasibility of combining gilteritinib and DA-GO or CPX-351 and GO in\r patients with FLT3/ITD mutations (Arm AC/Arm BC/Arm AD/Arm BD).\r\n\r V. To compare EOI1 MRD and EFS in patients with FLT3/ITD AML+ (allelic ratio [AR] > 0.1)\r without favorable cytogenetic/molecular characteristics treated with DA-GO-gilteritinib\r versus (vs) CPX-GO-gilteritinib (Arm AC vs Arm BC).\r\n\r VI. To compare the incidence of significant left ventricular systolic dysfunction (LVSD) in\r children with de novo AML without FLT3 mutations who are randomly assigned to standard\r induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B).\r\n\r VII. To compare the changes in echocardiography-derived measures of cardiac function,\r including left ventricular ejection fraction (EF) and global longitudinal strain (GLS),\r throughout AML therapy in patients with low and high risk AML without FLT3 mutations\r receiving Arm A vs Arm B.\r\n\r VIII. Determine if early changes in sensitive echocardiographic measures of cardiac function\r (i.e., post-Induction 1 decline in GLS) and elevations in circulating cardiac biomarkers\r (i.e., cardiac troponin T and N-terminal pro b-type natriuretic peptide) are associated with\r subsequent declines in left ventricular ejection fraction in patients with non-FLT3 mutant\r AML receiving therapy on Arms A or B.\r\n\r IX. To compare longitudinal acute changes in neuropsychological functioning and\r neurocognitive late effects between those with central nervous system (CNS) disease and those\r without CNS disease and between those treated with hematopoietic stem cell transplant (HSCT)\r and those treated with chemotherapy only for patients on Arms A and B.\r\n\r X. To compare cardiotoxicity measures (EF, GLS, and cardiac biomarkers) in patients receiving\r standard induction with dexrazoxane hydrochloride (dexrazoxane) vs. CPX-351 in the context of\r gilteritinib therapy and explore whether the differential cardiotoxicity across arms varies\r from that observed in non-FLT3 mutant AML without gilteritinib exposure.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To estimate the EFS and rate of EOI1 MRD in patients with high allelic ratio (HAR)\r FLT3/ITD+ patients, as historically defined by an AR > 0.4, receiving gilteritinib in\r combination with DA-GO (Arm AC with AR > 0.4).\r\n\r II. To estimate the EFS and rate of EOI1 MRD in FLT3/ITD+ patients (as defined by allelic\r ratio > 0.1) with NPM1 and/or bZIP CEBPA mutations receiving gilteritinib in combination with\r DA-GO (Arm AC).\r\n\r III. Compare the changes in high sensitivity troponin and natriuretic peptide elevations\r throughout AML therapy, as measured at the end of each chemotherapy course, in patients with\r low and high risk AML without FLT3 mutations receiving Arm A vs Arm B.\r\n\r IV. Quantify the association of host factors (age, sex, body mass index [BMI], race),\r treatment exposures (cumulative anthracycline dose, anthracycline arm, hematopoietic stem\r cell transplant vs. chemotherapy alone), early declines in GLS, and elevations in cardiac\r biomarkers (cTnT and NT-proBNP) with subsequent LVSD.\r\n\r V. Develop a multi-marker risk prediction model incorporating significant host factors,\r treatment exposures, and echocardiographic predictors for the development of LVSD within 1\r year of completing therapy.\r\n\r VI. To describe the rates of CNS disease utilizing an updated strategy for diagnosing and\r defining CNS disease in pediatric AML.\r\n\r VII. To describe the rates of CNS relapse (both isolated CNS and combined bone marrow/CNS)\r when utilizing this updated strategy as well as changing CNS prophylaxis and treatment to\r include triple intrathecal chemotherapy.\r\n\r VIII. To describe disease-free survival (DFS) and overall survival (OS) in high risk patients\r based on multi-dimensional flow cytometry detection of measurable residual disease prior to\r hematopoietic stem cell transplant (HSCT).\r\n\r IX. To describe plasma metabolomics that may impact efficacy, toxicity, and/or\r pharmacokinetics of allogeneic HSCT.\r\n\r X. To estimate the prevalence of non-risk stratifying cytogenetic/molecular variants and\r assess their impact on outcome in childhood AML.\r\n\r OUTLINE: Patients are randomized to either Arm A or B and assigned to Arm C or D based on\r FLT3 testing results.\r\n\r TREATMENT FOR PATIENTS WITHOUT FLT3 MUTATIONS:\r\n\r ARM A LOW RISK GROUP 1:\r\n\r INDUCTION 1: Patients receive cytarabine intravenously (IV) over 1-30 minutes every 12 hours\r (Q12H) on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes\r on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1\r receive methotrexate intrathecally (IT), therapeutic hydrocortisone (hydrocortisone) IT, and\r cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT once weekly (QW) starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the cerebral spinal fluid (CSF) is clear of blasts (CNS1\r status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 1 for 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30\r minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi intramuscularly (IM) or IV\r over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM B LOW RISK GROUP 1:\r\n\r INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab\r ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM A LOW RISK GROUP 2:\r\n\r INDUCTION 1: Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane\r IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and\r gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30\r minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4 and\r dexrazoxane IV over 5-15 minutes and mitoxantrone hydrochloride (mitoxantrone) IV over 5-15\r minutes on days 3-6.\r\n\r INTENSIFICATION 3: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM B LOW RISK GROUP 2:\r\n\r INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab\r ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4 and\r dexrazoxane IV over 5-15 minutes and mitoxantrone hydrochloride (mitoxantrone) IV over 5-15\r minutes on days 3-6.\r\n\r INTENSIFICATION 3: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM A HIGH RISK GROUP:\r\n\r INDUCTION 1: Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane\r IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and\r gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30\r minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r ARM B HIGH RISK GROUP:\r\n\r INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab\r ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r TREATMENT FOR PATIENTS WITH FLT3/ITD MUTATIONS (ITD AR > 0.1):\r\n\r ARM AC LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via\r nasogastric (NG) or gastronomy (G) tube daily on days 1-365.\r\n\r ARM BC LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or\r G tube daily on days 1-365.\r\n\r ARM AC HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r ARM BC HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r TREATMENT FOR NON-ITD FLT3 ACTIVATING MUTATIONS:\r\n\r ARM AD LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or\r G tube daily on days 1-365.\r\n\r ARM BD LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or\r G tube daily on days 1-365.\r\n\r ARM AD HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r ARM BD HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r NOTE: During Induction 2 or Intensification 2, patients in Arms A and B with left ventricular\r systolic dysfunction receive a replacement course of high-dose cytarabine IV over 3 hours on\r days 1, 2, 8, and 9, and asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9. Patients in Arms AC, BC, AD, and BD\r receive treatment as in Arms A and B and also receive gilteritinib PO QD on days 10-37\r (Induction 2) or days 10-37 (Intensification 2).\r\n\r All treatment continues in the absence of disease progression or unacceptable toxicity.\r\n\r OPTIONAL NEUROCOGNITIVE STUDY:\r\n\r Patients may complete the Cogstate assessment battery at the end of Induction 1, at the end\r of therapy, and at 9 and 60 months post-enrollment.\r\n\r After completion of study treatment, patients are followed up monthly for 6 months and then\r every other month for 6 months (year 1), every 4 months during year 2, every 6 months during\r year 3, then yearly for years 4-10. Patients who undergo HSCT are also followed up at 30,\r 100, and 180 days, 9 months, and 1 year post-HSCT.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part\r A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens\r must be done according to the Manual of Procedures). Risk stratification will not be\r possible without the submission of viable samples. Given there are multiple required\r samples, bone marrow acquisition techniques such as frequent repositioning or\r performing bilateral bone marrow testing should be considered to avoid insufficient\r material for required studies. Consider a repeat marrow prior to starting treatment if\r there is insufficient diagnostic material for the required studies\r\n\r - Patients must be less than 22 years of age at the time of study enrollment\r\n\r - Patient must be newly diagnosed with de novo AML according to the 2016 World Health\r Organization (WHO) classification with or without extramedullary disease\r\n\r - Patient must have 1 of the following:\r\n\r - >= 20% bone marrow blasts (obtained within 14 days prior to enrollment)\r\n\r - In cases where extensive fibrosis may result in a dry tap, blast count\r can be obtained from touch imprints or estimated from an adequate bone\r marrow core biopsy\r\n\r - < 20% bone marrow blasts with one or more of the genetic abnormalities\r (sample obtained within 14 days prior to enrollment)\r\n\r - A complete blood count (CBC) documenting the presence of at least 1,000/uL\r (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a\r WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells\r (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed\r within 7 days prior to enrollment)\r\n\r - ARM C: Patient must be >= 2 years of age at the time of Late Callback\r\n\r - ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular\r Oncology\r\n\r - ARM C: Patient does not have any congenital long QT syndrome or congenital heart block\r\n\r - ARM C: Females of reproductive potential must agree to use effective contraception\r during treatment and for at least 6 months after the last dose of gilteritinib\r\n\r - ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib\r and for 2 months after the last dose of gilteritinib\r\n\r - ARM C: Males of reproductive potential must agree to use effective contraception\r during treatment and for at least 4 months after the last dose of gilteritinib\r\n\r - ARM D: Patient must be >= 2 years of age at the time of Late Callback\r\n\r - ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating\r mutations as reported by Foundation Medicine\r\n\r - ARM D: Females of reproductive potential must agree to use effective contraception\r during treatment and for at least 6 months after the last dose of gilteritinib\r\n\r - ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib\r and for 2 months after the last dose of gilteritinib\r\n\r - ARM D: Males of reproductive potential must agree to use effective contraception\r during treatment and for at least 4 months after the last dose of gilteritinib\r\n\r - NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who\r transfer to Arm C or Arm D are not eligible\r\n\r - NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment\r\n\r - NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking\r\n\r - NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to\r diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental\r retardation)\r\n\r - NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would\r prevent computer use or recognition of visual test stimuli\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent\r\n\r - All institutional, Food and Drug Administration (FDA), and National Cancer Institute\r (NCI) requirements for human studies must be met.\r\n\r Exclusion Criteria:\r\n\r - Patients with myeloid neoplasms with germline predisposition are not eligible\r\n\r - Fanconi anemia\r\n\r - Shwachman Diamond syndrome\r\n\r - Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21\r\n\r - Any other known bone marrow failure syndrome\r\n\r - Any concurrent malignancy\r\n\r - Juvenile myelomonocytic leukemia (JMML)\r\n\r - Philadelphia chromosome positive AML\r\n\r - Mixed phenotype acute leukemia\r\n\r - Acute promyelocytic leukemia\r\n\r - Acute myeloid leukemia arising from myelodysplasia\r\n\r - Therapy-related myeloid neoplasms\r\n\r - Administration of prior anti-cancer therapy except as outlined below:\r\n\r - Hydroxyurea\r\n\r - All-trans retinoic acid (ATRA)\r\n\r - Corticosteroids (any route)\r\n\r - Intrathecal therapy given at diagnosis\r\n\r - In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be\r avoided from the time of enrollment until it is determined whether the patient\r will receive gilteritinib. Patients receiving gilteritinib will be required to\r avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the\r study treatment\r\n\r - Female patients who are pregnant since fetal toxicities and teratogenic effects have\r been noted for several of the study drugs. A pregnancy test is required for female\r patients of childbearing potential\r\n\r - Lactating females who plan to breastfeed their infants\r\n\r - Sexually active patients of reproductive potential who have not agreed to use an\r effective contraceptive method for the duration of their study participation\r\n\r - ARM D: Patients with congenital long QT syndrome or congenital heart block are not\r eligible for this treatment arm\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nA 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThis trial will be a 2-part, adaptive, open label, single and/or multiple oral dose, safety,\r tolerability, food effect trial of CVL-751 in subjects with Parkinson's disease. Part 1 is a\r placebo-controlled, single dose cohort intended for assessment of safety and tolerability. In\r case of intolerable AEs, Part 2 would proceed as a multiple dose titration trial to achieve a\r 15 mg once daily dose while maintaining L-Dopa treatment (Part 2A). In case of a favorable\r tolerability profile in Part 1, Part 2B would proceed as a single dose trial (similar to Part\r 1), with discontinuation of L-Dopa for 24 hours (12 hours pre-Day 1 dose and 12 hours\r post-Day 1 dose).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Male and female subjects, ages 45 to 75 years, inclusive, at the time of signing the\r informed consent form (ICF).\r\n\r 2. Body mass index (BMI) of 17.5 to 38.0 kg/m2 and a total body weight >50 kg (110 lbs).\r\n\r 3. Subjects with a diagnosis of that is consistent with the UK Parkinson's Disease\r Society Brain Bank diagnostic criteria, with bradykinesia and motor asymmetry.\r\n\r 4. Must be modified Hoehn & Yahr (HY) Stage I - III inclusive.\r\n\r 5. Must be on a stable dose of L-Dopa of at least 300 mg daily in conjunction with a\r dopa-decarboxylase inhibitor (eg, L-Dopa/carbidopa or L-Dopa/benserazide) administered\r at least 3 times per day but no more than 6 times per day for at least 2 weeks prior\r to the Day 1 Visit. Must be willing and able to refrain from L-Dopa treatment (in Part\r 1 and Part 2B) as outlined in the schedule of assessments.\r\n\r 6. A female subject of childbearing potential (see Section 10.4, Appendix 4) who is\r sexually active with a nonsterilized male partner or male subject with a pregnant or a\r nonpregnant partner of childbearing potential must agree to use an acceptable or a\r highly effective method of contraception (see Section 10.4, Appendix 4) from signing\r of informed consent throughout the duration of the trial and for 7 days post last\r dose.\r\n\r 7. Capable of giving signed informed consent as described in Section 10.1.3 (Appendix 1),\r which includes compliance with the requirements and restrictions listed in the ICF and\r in this protocol.\r\n\r 8. Ability, in the opinion of the investigator, to understand the nature of the trial and\r comply with protocol requirements, including the prescribed dosage regimens, scheduled\r visits, laboratory tests, and other trial procedures.\r\n\r 9. Capable of consuming the standard high-fat meal.\r\n\r Exclusion Criteria:\r\n\r 1. Any significant Axis I psychiatric disease as defined by the Diagnostic and\r Statistical Manual of Mental Disorders, 5th edition (American Psychiatric\r Association).\r\n\r 2. In the opinion of the investigator (or caregiver, as applicable), has signs/symptoms\r suggestive of clinically significant cognitive impairment that would interfere with\r the ability to comply with trial procedures.\r\n\r 3. Subjects with a Montreal Cognitive Assessment score <26.\r\n\r 4. History or clinical features consistent with an atypical parkinsonian syndrome (eg,\r ataxia, dystonia, clinically significant orthostatic hypotension).\r\n\r 5. Has a history of psychotic symptoms requiring treatment with an antipsychotic\r medication within the 12 months prior to signing ICF.\r\n\r 6. Subjects with epilepsy, or history of epilepsy, or conditions that lower seizure\r threshold, seizures of any etiology (including substance or drug withdrawal), or who\r have increased risk of seizures as evidenced by history of electroencephalogram with\r epileptiform activity.\r\n\r Subjects with a history of febrile seizures only are allowed. Subjects with a history\r of head trauma with loss of consciousness requiring overnight hospitalization will be\r excluded as well.\r\n\r 7. Subjects with a current history of significant cardiovascular, pulmonary,\r gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or\r neurological disease that, in the opinion of the investigator or medical monitor,\r could compromise either subject safety or the results of the trial.\r\n\r Medical conditions that are minor or well-controlled may be considered acceptable if\r the condition does not expose the subject to an undue risk of a significant AE or\r interfere with the assessments of safety or efficacy during the course of the trial.\r The medical monitor should be contacted in any instance where the investigator is\r uncertain regarding the stability of a subject's medical conditions(s) and the\r potential impact of the condition(s) on trial participation.\r\n\r 8. History of substance or alcohol-use disorder (excluding nicotine; Diagnostic and\r Statistical Manual of Mental Disorders, 5th edition criteria) within 2 years prior to\r signing the ICF.\r\n\r 9. History of regular alcohol consumption exceeding 7 drinks/week for females or 14\r drinks/week for males [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of\r beer or 1.5 ounces (45 mL) of hard liquor] within 6 months prior to signing ICF.\r\n\r 10. If a current smoker, is unable to comply with the following guidelines: agrees not to\r smoke on the mornings of trial dosing days and for the entire trial dosing day until\r completion of all trial assessments for that day.\r\n\r 11. Subjects who answer \"Yes\" on the Columbia-Suicide Severity Rating Scale (C-SSRS)\r Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without\r Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4\r occurred within the last 6 months, OR Subjects who answer \"Yes\" on the C-SSRS Suicidal\r Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose\r most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 6\r months OR Subjects who answer \"Yes\" on any of the 5 C-SSRS Suicidal Behavior Items\r (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior)\r and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal\r Behavior Items occurred within the last 2 years, OR Subjects who, in the opinion of\r the investigator, present a serious risk of suicide.\r\n\r 12. Subjects who have attempted suicide in the past.\r\n\r 13. Human immunodeficiency virus seropositive status or acquired immunodeficiency\r syndrome, acute or chronic hepatitis B or C, with HbsAg, or hepatitis C virus\r antibodies at screening.\r\n\r 14. Subjects with a positive drug screen for illicit drugs are excluded and may not be\r retested or rescreened. Subjects with a positive urine drug screen resulting from use\r of marijuana (any cannabinoids), prescription medications, over-the-counter\r medications, or products that, in the investigator's documented opinion, do not signal\r a clinical condition that would impact the safety of the subject or interpretation of\r the trial results may continue evaluation for the trial following consultation and\r approval by the medical monitor.\r\n\r 15. Subjects with a 12-lead electrocardiogram (ECG) demonstrating the following:\r\n\r • QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec.\r\n\r 16. Subjects with any of the following abnormalities in clinical laboratory tests at the\r Screening Visit, as assessed by the central laboratory and confirmed by a single\r repeat measurement, if deemed necessary:\r\n\r - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 × upper\r limit of normal (ULN)\r\n\r - Total bilirubin ≥1.5 × ULN. Subjects with a history of Gilbert's syndrome may be\r eligible provided the direct bilirubin is <ULN.\r\n\r 17. Subjects with other abnormal laboratory test results, vital sign results, or ECG\r findings unless, based on the investigator's judgment, the findings are not medically\r significant and would not impact the safety of the subjects or the interpretation of\r the trial results. The medical monitor should be contacted to discuss individual\r cases, as needed.\r\n\r Tests with exclusionary results should be repeated to ensure reproducibility of the\r abnormality before excluding a subject based on criteria provided in the protocol. For\r ECGs, three consecutive recordings are required and if two of the three remain\r exclusionary, then the subject is not eligible for the trial.\r\n\r 18. Subjects taking other prohibited medication or who would be likely to require\r prohibited concomitant therapy during the trial (see Section 6.5).\r\n\r 19. Female subjects who are breastfeeding and/or who have a positive serum pregnancy test\r result prior to receiving IMP.\r\n\r 20. Any condition possibly affecting drug absorption (eg, gastrectomy).\r\n\r 21. Subjects with difficulty swallowing.\r\n\r 22. Subjects who are known to be allergic or hypersensitive to the IMP or any of its\r components.\r\n\r 23. Subjects who are known to be allergic or hypersensitive to contents of high-fat diet.\r\n\r 24. Subjects who have participated in any clinical trial within 60 days prior to signing\r the ICF or who participated in more than two clinical trials within the year prior to\r signing the ICF.\r\n\r 25. Any subject who, in the opinion of the sponsor, investigator, or medical monitor,\r should not participate in the trial.\r\n\r 26. Subjects who are investigational site staff members directly involved in the conduct\r of the trial and their family members, site staff members otherwise supervised by the\r investigator.\r\n\r 27. Unwilling or unable to comply with the lifestyle modifications described in this\r protocol.\r\n\r 28. Subjects who participated in Part 1 of the trial are ineligible to participate in Part\r 2.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,774
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nDifferences Between Patients With Vascular Parkinsonism and Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nVascular parkinsonism (VP) is defined as the presence of parkinsonian syndrome, evidence of\r cerebrovascular disease by brain imaging and an established relationship between the two\r disorders.\r\n\r However, the diagnosis of VP is problematic. This study aims to distinguish VP from\r Parkinson's disease (PD) in multiple aspects including clinical features as motor ,non motor\r symptoms\r\n\r ,response to treatment ,cognitive assessments by using multiple scales, neuro-radiological\r features of magnetic resonance imaging (MRI) and transcranial color-coded duplex (TCCD)\r findings. This differentiation will have therapeutic and prognostic implications .\n\n**Clinical Trial Detailed Description:**\n\nType of Study : case -control comparative study.\r\n\r • Study Setting: Patients with VP and patients with PD from movement disorders and stroke\r outpatient clinics in Ain shams University Hospitals.\r\n\r Sampling Method study of consecutive patients in Ain Shams University clinic, who had been\r regularly followed up in the clinic and already had a diagnosis either VP or PD at the time\r of data collection.\r\n\r Sample Size: 30 patients diagnosed as VP, 50 patients diagnosed as PD, and 30 healthy age and\r sex matched controls. The difference in selected quantitative variables used to evaluate the\r participants is used to estimate the sample size.\r\n\r This study aims to distinguish VP from Parkinson's disease(PD) in multiple aspects including\r clinical features as motor ,non-motor symptoms, response to treatment ,cognitive assessments\r by using multiple scales, neuro-radiological features of magnetic resonance imaging (MRI) and\r transcranial color-coded duplex(TCCD)findings.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients diagnosed with PD or VP, and healthy controls will be included in the study.\r\n\r - PD diagnosis will be based on the Queen Square Brain Bank for Neurological Disorders\r clinical criteria and MDS criteria.\r\n\r - The VP patients will be included if they fulfill the following criteria (Zijlman's\r diagnostic criteria)Parkinsonism presentation (at least two of the cardinal features:\r tremors, bradykinesia, rigidity and postural instability).\r\n\r Cerebrovascular disease, defined as evidence of relevant cerebrovascular disease by brain\r imaging or the presence of focal signs or symptoms consistent with stroke.\r\n\r A relationship between (1) and (2): acute or delayed progressive onset of parkinsonism.\r\n\r Based on the above criteria, two forms of VP are suggested: one with acute onset, and\r another one with insidious progression. The diagnosis will be confirmed by assigning a\r vascular score. Two points or more are essential to diagnose VP. The points will be\r assigned as follows:\r\n\r - Two points: Pathologically or angiographically proven diffuse vascular disease.\r\n\r - One point: Onset of parkinsonism within 1 month of clinical stroke.\r\n\r - One point: History of two or more strokes.\r\n\r - One point: Neuroimaging evidence of vascular disease in two or more vascular\r territories.\r\n\r - One point: History of two or more risk factors for stroke (hypertension, smoking,\r diabetes mellitus, hyperlipidaemia, presence of heart disease associated with stroke\r [coronary artery disease, atrial fibrillation, congestive heart failure, valvular\r heart disease, mitral valve prolapse, and other arrhythmias], family history of\r stroke, history of gout, and peripheral vascular disease)\r\n\r Exclusion Criteria:\r\n\r - PD patients with age at onset less than 40 years.\r\n\r - Any alternative cause that significantly impair gait.\r\n\r - Inability of the patient to undergo neuroimaging.\r\n\r - Patients couldn't perform the test or severely demented.\r\n\r - Atypical and other secondary parkinsonism as patients who had a history of toxin\r exposure.or antipsychotic drugs treatment by history ,neurological examination and\r brain MRI .\r\n\r - Family or patient's refusal to give written consent.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,775
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEarly Postoperative CRRT After Liver Transplantation in ACLF Patients With Overt HE\n\n**Clinical Trial Summary:**\n\nPretransplant hepatoencephalopathy (HE) markedly impacts recipient outcomes after liver\r transplantation. Intraoperative CRRT showed benefits but feasibility was much concerned. This\r study aims to observe the effect on consciousness recovery when initiating CRRT early in the\r post-transplant period in recipients with ACLF and overt HE.\n\n**Clinical Trial Detailed Description:**\n\nHepatoencephalopathy (HE) is a common severe decompensation in end stage liver diseases and\r resulted to the need of liver transplantation (LT). Pretransplant HE markedly impacts\r recipient outcomes after liver transplantation. HE in acute on chronic liver failure (ACLF)\r is categorized to type C HE. Hyperammonemia and systemic inflammation have been reported to\r contribute its development. Continuous renal replacement therapy (CRRT) has been shown great\r benefits in ACLF patients with HE. Intraoperative CRRT in LT also showed benefits but\r feasibility was much concerned. Our preliminary retrospective data showed that early CRRT\r (eCRRT) after LT reduced consciousness recovery time, ventilation days and post-transplant\r infection rate.\r\n\r This open label, parallel randomized trial will observe the effect on consciousness recovery\r when initiating CRRT early (eCRRT) in the post-transplant period in recipients with ACLF and\r overt HE.\r\n\r The CRRT safety and ventilation days, infection, mortality and ICU stay will also be\r measured.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria: Liver transplant recipients who meet all of the following criteria will\r be enrolled\r\n\r 1. Pre transplant liver failure: Total bilirubin over 171μmol/L and prothrombin activity\r (PTA)<40%;\r\n\r 2. Overt hepatic encephalopathy(HE): Grade II or higher HE according West Haven\r classification;\r\n\r 3. HE associated with acute liver failure (Type A) or cirrhosis complicated with portal\r hypertension and/or portal systemic shunts (Type C)\r\n\r Exclusion Criteria:\r\n\r 1. Patients with a previous history of kidney-related diseases and glomerular filtration\r rate <30 millilitre per minute;\r\n\r 2. Patients with acute renal failure need CRRT before transplantation;\r\n\r 3. Patients newly developed acute renal failure need CRRT at the time of randomization;\r\n\r 4. Retransplantation or multiple-organs transplantation;\r\n\r 5. Any ischemic or hemorrhagic stroke co-morbidity;\r\n\r 6. Hemodynamic instability requiring fluid resuscitation or very high dose of\r vasopressors;\r\n\r 7. Extremely moribund patients with an expected life expectancy of less than 24 hours.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,776
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAnxiety Related to the Diagnosis of Alzheimer's Disease or Related Diseases\n\n**Clinical Trial Summary:**\n\nImproving the diagnosis of neurocognitive disorders is a major public health challenge. This\r diagnosis occurs too late in the majority of cases, or is even sometimes non-existent for\r some despite the presence of clinical signs and symptoms. However, the etiological diagnosis\r of a TNC is crucial for the patient and his family to understand the most appropriate\r decisions for the future, to plan the organization of his life as long as he is able to do\r so, to access the clinical research, to promote dialogue between patients and their\r caregivers. On the contrary, a late diagnosis may be responsible for the fact that the\r patient and his / her family are less able to benefit from certain psychosocial\r interventions, services and treatments.\r\n\r But the diagnostic announcement is retained. One of the negative and dreaded effects of such\r an announcement is the negative psychological impact. Some studies show that the diagnostic\r announcement would worsen the level of anxiety or depressed mood and the risk of social\r isolation. On the other hand, other studies show that symptoms such as anxiety, psychic\r distress and depression remain stable, or even decrease slightly after the announcement of\r the diagnosis, in patients and their relatives. However, the literature is questionable\r because the majority of the studies are retrospective, mono-centric, and the patient numbers\r are low. While the first reactions of patients may be negative after the announcement, some\r report resignation experiences, or form of relief, because they have finally found a clinical\r explanation for the symptoms encountered. While doubt or diagnostic uncertainty, as well as\r the feeling of not knowing the truth, seem to have a more damaging psychological impact on\r the patient and those around him, increasing anxiety and confusion.\r\n\r The primary objective is to study if the level of anxiety 2 months after the announcement of\r the diagnosis of Alzheimer's disease or a related disease is not superior to the level of\r anxiety before the announcement with patient / caregiver.\r\n\r This present study aim to explore the feasibility with 14 patients.\n\n**Clinical Trial Detailed Description:**\n\nImproving the diagnosis of neurocognitive disorders is a major public health challenge. This\r diagnosis occurs too late in the majority of cases, or is even sometimes non-existent for\r some despite the presence of clinical signs and symptoms. However, the etiological diagnosis\r of a TNC is crucial for the patient and his family to understand the most appropriate\r decisions for the future, to plan the organization of his life as long as he is able to do\r so, to access the clinical research, to promote dialogue between patients and their\r caregivers. On the contrary, a late diagnosis may be responsible for the fact that the\r patient and his / her family are less able to benefit from certain psychosocial\r interventions, services and treatments.\r\n\r But the diagnostic announcement is retained. One of the negative and dreaded effects of such\r an announcement is the negative psychological impact. Some studies show that the diagnostic\r announcement would worsen the level of anxiety or depressed mood and the risk of social\r isolation. On the other hand, other studies show that symptoms such as anxiety, psychic\r distress and depression remain stable, or even decrease slightly after the announcement of\r the diagnosis, in patients and their relatives. However, the literature is questionable\r because the majority of the studies are retrospective, mono-centric, and the patient numbers\r are low. While the first reactions of patients may be negative after the announcement, some\r report resignation experiences, or form of relief, because they have finally found a clinical\r explanation for the symptoms encountered. While doubt or diagnostic uncertainty, as well as\r the feeling of not knowing the truth, seem to have a more damaging psychological impact on\r the patient and those around him, increasing anxiety and confusion.\r\n\r The primary objective is to study if the level of anxiety 2 months after the announcement of\r the diagnosis of Alzheimer's disease or a related disease is not superior to the level of\r anxiety before the announcement with patient / caregiver.\r\n\r This present study aim to explore the feasibility with 14 patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients :\r\n\r - Man or woman 55 years and over\r\n\r - Patient received for the first time in Memory Consultation and not aware of his\r diagnosis\r\n\r - Patient with a Mini-Mental State Assessment score (MMSE) ≥ 20\r\n\r - Patient accompanied by a primary caregiver\r\n\r - Patient able to provide consent to participate in research\r\n\r Caregiver:\r\n\r - The caregiver accompanies the patient and is considered as the main caregiver during\r the consultation\r\n\r - is able to provide consent to participate in research\r\n\r Exclusion Criteria:\r\n\r - Patient living in a care homes\r\n\r - Patient protected by law (under legal protection, guardianship or trusteeship)\r\n\r - Patient with a hearing or visual impairment that does not allow to carry out\r assessments in Memory Consultation\r\n\r - Patient opposing research\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,777
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nImprovisational Dance for Parkinson Disease\n\n**Clinical Trial Summary:**\n\nThe long-term goal of this work is to maintain or improve daily function of people with PD by\r addressing cognition. The overall objective is to discover interventions that aid in\r cognitive functioning. The central hypothesis is that engagement in an improvisational dance\r (ID) class will benefit cognition among people with PD. Improvisational dance involves\r spontaneously generated movement, similar to how one moves in everyday life. The literature\r shows that ID classes positively impact motor impairments associated with PD, such as\r balance, gait, and functional mobility. Along with being physically demanding, ID requires\r the use and coordination of a number of cognitive capacities to properly execute movements.\r This type of activity challenges, and thus may strengthen, cognitive processes such as motor\r planning, decision making, flexible thinking, initiation, and execution, which may give\r people cognitive based strategies to be utilized in various aspects of daily life. By\r improving motor function and/or cognition, ID may also contribute to improved daily\r functioning, or the ability to perform and participate in daily activities. Despite these\r theoretical links, evidence for the effect of ID on cognition and overall daily function is\r limited. The current project objective is to address this gap and better understand the\r effects of ID for people with PD. Specifically, it will test the effect of IMPROVment®, a\r method of ID designed for people with PD, on cognition and daily function.\r\n\r Participants' cognition will be assessed at baseline (T1) using the NIH Toolbox Cognitive\r Battery, the Alternate Uses Task, and the Weekly Calendar Planning Activity. Global cognition\r will be assessed using the Montreal Cognitive Assessment. They then will be randomly assigned\r to either the immediate intervention (ID) or waitlist-control (WC) group. The ID group will\r start the 12-week IMPROVment® intervention, which consists of weekly ID classes that progress\r according to a standardized method while the WC group will receive no intervention and\r continue with their regular daily routine and activity level. After 12 weeks, both groups\r will complete cognitive testing again (T2). Cognitive test scores will be compared across\r time points and between groups using a mixed model repeated measures ANOVA. The investigators\r hypothesize that IMPROVment® will have positive effects on the cognitive abilities of people\r with PD. Participants will also complete two questionnaires to assess daily function at T1\r and T2: Older Americans Resources and Services Scale- Extended Version and PROMIS\r Satisfaction with Participation in Discretionary Social Activities. These scores will be\r compared similar to the above aim. The investigators hypothesize that IMPROVment® will have\r positive effects on daily function in people with PD.\r\n\r Participant mood will be assessed in two different ways. The first being to investigate the\r immediate effect of participating in an IMPROVment® class on mood, fatigue, and anxiety. The\r investigators hypothesize that mood will positively improve from pre to post of each class.\r To assess this, participants will respond to a scale assessing mood, specifically sadness,\r nervousness, energy, and overall well-being before and after each class every week. The\r second measurement is to investigate the effect of IMPROVment® on anxiety, fatigue, and\r depression. The investigators hypothesize that IMPROVment® class will decrease feelings of\r depression for those with PD. All participants will fill out the Parkinson's Anxiety Scale,\r the Parkinson's Disease Fatigue Scale, and the Geriatric Depression Scale short form before\r and after participating in the 12-week IMPROVment® program.\r\n\r Achievement of these aims will provide further support for the IMPROVment® method for people\r with PD experiencing cognitive deficits. The long-term impact will better cognition and daily\r functioning in people with PD, and thus enhanced everyday lives.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - aged 50 years or older\r\n\r - Parkinson Disease Diagnosis\r\n\r - Hoehn-Yahr score between 1-3\r\n\r - independently walk at least 3 meters\r\n\r - cognitive ability to follow simple commands\r\n\r Exclusion Criteria:\r\n\r - Montreal Cognitive Assessment score less than or equal to 22\r\n\r - diagnosis of other severe comorbidities\r\n\r - contraindications to physical activity\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
35,778
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPimavanserin vs. Quetiapine for the Treatment Parkinson's Psychosis\n\n**Clinical Trial Summary:**\n\nPatients with Parkinson's disease (PD) sometimes experience symptoms affecting their\r movement, such as slowness, tremor, stiffness, and balance or walking problems. Many patients\r also have other symptoms not related to movement, called non-motor symptoms, which may affect\r one's mood or emotions, memory or thinking, or cause one to see or hear things that aren't\r real (hallucinations) or believe things that aren't true (delusions). Hallucinations or\r delusions, together called psychosis, occur in up to 60% of PD patients at some point in\r time. Parkinson's disease psychosis can sometimes be associated with decreased quality of\r life, increased nursing home placement, increased rate of death, and greater caregiver\r burden. There are approximately 50,000 Veterans with Parkinson's disease receiving care in\r the VA, and up to 30,000 (60%) of them will experience psychosis at some point in time.\r\n\r Quetiapine is an antipsychotic drug approved by the Food and Drug Administration (FDA) that\r is the most commonly used medication to treat PD psychosis, but more studies are needed to\r determine if it works for this condition and is also well tolerated and safe. Pimavanserin is\r a newer antipsychotic drug approved by the Food and Drug Administration (FDA) specifically to\r treat PD psychosis, but more studies are needed to determine if it works and its safety.\r\n\r The purpose of this research is to gather additional information on the safety and\r effectiveness of both Quetiapine and Pimavanserin. By doing this study, the investigators\r hope to learn which of these medications is the most effective course of treatment for people\r with PD psychosis. Your individual participation in this research will last approximately 54\r weeks.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Veteran\r\n\r - Diagnosis of idiopathic PD for 2 or more years\r\n\r - Psychosis [with Neuropsychiatric Inventory (NPI) hallucinations (B) or delusions (A)\r score 4 or greater]\r\n\r - Stable dose of PD medications for at least 1 month If on an acetylcholinesterase\r inhibitor (AChEI) initially prescribed at least 3 months prior and stable dose (no\r dose or medication change) for past month Informed other must provide informed consent\r and agree to attend all study visits. The informed other must be at least 18 years of\r age and have regular in-person contact with the patient (at least 5 days per week, and\r at least 4 hours per day that is spent with patient) English-speaking\r\n\r Exclusion Criteria:\r\n\r - Psychosis symptoms severe enough to preclude enrollment in a clinical trial and\r require prompt clinical care instead\r\n\r - Treatment with an antipsychotic, including pimavanserin in the past year, except\r quetiapine <50 mg/day which has been discontinued for at least 1 month prior to study\r enrollment\r\n\r - Deep brain stimulation (DBS) surgery occurring within 6 months prior or having\r unstable stimulator settings in the previous month\r\n\r - History of a psychotic disorder prior to PD, including schizophrenia and bipolar\r disorder\r\n\r - Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB)\r\n\r - Psychosis secondary to other toxic or metabolic disorder\r\n\r - Congestive heart failure\r\n\r - History of stroke within the last 6 months\r\n\r - History of myocardial infarction within the last 6 months\r\n\r - History of long QT syndrome or prolonged QTc [>450ms in men, >470ms in women] at\r screening/baseline (or baseline, if applicable)\r\n\r - Current uncontrolled serious medical illness\r\n\r - Clinically significant hepatic impairment or severe renal impairment (eGFR <30 mL/min)\r\n\r - Currently taking medications that are significant CYP3A4 inhibitors or inducers\r\n\r - Comorbid medical condition determined too severe by SI to allow participation in\r clinical trial\r\n\r - Failure to tolerate quetiapine or pimavanserin previously\r\n\r - Moderate to severe PD dementia (MoCA score <13)\r\n\r - Currently enrolled in another therapeutic or interventional study\r\n\r - Nursing home placement at baseline or planned placement during the study\r\n\r - Active suicidality\r\n\r - Pregnancy/Pregnant, or a female of child-bearing potential who is unwilling to use a\r reliable form of contraception\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
35,779
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nHeparin vs Placebo for Cardiac Catheterization\n\n**Clinical Trial Summary:**\n\nPatients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant,\r low dose anticoagulant and high dose anticoagulant.\n\n**Clinical Trial Detailed Description:**\n\nPatients undergoing diagnostic cardiac catheterization via the trans-radial approach will be\r randomly allocated (1:1:1) to receive either low-dose UFH (25 IU/Kg -maximal dose 3,000 IU),\r high-dose UFH 50 IU/kg -maximal dose 5,000 IU) or N/S 0.9%. After 30 minutes, patients will\r undergo a gradual wrist band release. Hematoma and radial artery occlusion will be assessed.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - diagnostic cardiac catheterization; Small size sheath; patency of the ulno-palmar\r circulation\r\n\r Exclusion Criteria:\r\n\r abnormal ulno-palmar circulation; Prior radial artery thrombosis; Prior surgery close to\r the access site; Emergent cardiac catheterization; History of HIT or allergy to heparin;\r Patients requiring anticoagulation\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,780
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nExtension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nParkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse\r over time, but how quickly it progresses varies a lot from person to person. Some symptoms of\r PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue\r testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's\r disease after completion of the parent study M15-741.\r\n\r ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa\r phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's\r Disease. Participants who have successfully completed M15-741 study will immediately enter\r this study's treatment period to continue receiving ABBV-951. Adult participants with\r advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the\r study at approximately 65 sites worldwide.\r\n\r Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours\r daily for 96 weeks or until premature discontinuation.\r\n\r There may be higher treatment burden for participants in this trial compared to their\r standard of care. Participants will attend regular clinic visits and have remote assessments\r completed via phone calls during the course of the study. The effect of the treatment will be\r checked by medical assessments, blood tests, checking for side effects, and completing\r questionnaires.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Participants who have Parkinson's Disease and who have successfully completed the\r parent study M15-741.\r\n\r - Participants willing and able to comply with procedures required in the protocol.\r\n\r Exclusion Criteria:\r\n\r - Participants, if judged by the investigator to be unsuitable candidates to continue to\r receive ABBV-951 for any reason.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
35,781
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nStudy Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nParkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse\r over time, but how quickly it progresses varies a lot from person to person. Some symptoms of\r PD are tremors, stiffness, and slowness of movement. This study measures the efficacy,\r safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) [LD/CD] in\r advanced PD participants to achieve reduction in motor fluctuations.\r\n\r ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa\r Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's\r Disease. The study has two treatment arms . In one arm, participants will be given ABBV-951\r plus oral placebo (does not contain treatment drug). In the second arm, participants will be\r given placebo solution and LD/CD tablets. Adult participants with advanced PD will be\r enrolled. Approximately 130 participants will be enrolled in the study in approximately 80\r sites across the world.\r\n\r In one arm, participants will receive ABBV-951 solution as a continuous infusion under the\r skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive\r placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules\r containing LD/CD tablets. The treatment duration is 12 weeks.\r\n\r There may be higher treatment burden for participants in this trial compared to their\r standard of care. Participants will attend regular visits during the course of the study at a\r hospital or clinic. The effect of the treatment will be checked by medical assessments, blood\r tests, checking for side effects, and completing questionnaires.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive.\r\n\r - Participants must be taking a minimum of 400 milligrams/day (mg/day) of Levodopa (LD)\r equivalents and be judged by the investigator to have motor symptoms inadequately\r controlled by current therapy, have a recognizable/identifiable \"Off\" and \"On\" states\r (motor fluctuations), and have an average \"Off\" time of at least 2.5 hours/day over 3\r consecutive PD Diary days with a minimum of 2 hours each day.\r\n\r - Participant or caregiver, if applicable, demonstrates the understanding and correct\r use of the delivery system, including the insertion of the cannula into the\r participant's abdomen, as assessed by the investigator or designee during the\r Screening period.\r\n\r Exclusion Criteria:\r\n\r - Clinically significant, unstable medical conditions or any other reason that the\r investigator determines would interfere with the participant's participation in this\r study or would make the participant an unsuitable candidate to receive study drug.\r\n\r - History of allergic reaction or significant sensitivity to LD or constituents of the\r study drug (and its excipients) and/or other products in the same class.\r\n\r - Has known active Coronavirus Disease - 2019 (COVID-19) infection.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,782
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nImproving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia\n\n**Clinical Trial Summary:**\n\nThe investigators will attempt to develop a more accurate equation to estimate eGFR in\r pediatric and adult sickle cell patients\n\n**Clinical Trial Detailed Description:**\n\n200 pediatric and 200 adult SCA participants will undergo mGFR using iohexol at baseline and\r at one year. On the same day, participants will undergo clinical and laboratory variables\r important for developing an eGFR equation. From baseline data, the investigators will perform\r a training and validation cohort of biologically relevant predictor variables to develop a\r novel equation. Then the investigators will compare the novel SCA eGFR equation to the\r established eGFR equation. From one year data, the investigators will determine the\r longitudinal concordance between pediatric and adult novel and standard eGFR equations with\r mGFR and variables that may alter longitudinal inferences.\r\n\r In a subset of 30 adult participants, the investigators will also evaluate the correlation\r between mGFR using iohexol and a novel measure of mGFR that is more time efficient\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - SCA patients (HbSS and SB0 thalassemia)\r\n\r - Age: 5.0-50.0 at enrollment\r\n\r Exclusion Criteria:\r\n\r - Recent SCA complication associated with hospitalization (within 30 days) or ED visit\r (within 14 days)\r\n\r - Current AKI defined as >0.3mg/g increase in SCr from prior visit\r\n\r - Known history of anaphylaxis with contrast agent or known pregnancy\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
35,783
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPsychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection\n\n**Clinical Trial Summary:**\n\nThe hospitalization of a patient in intensive care is a traumatic experience for his family\r members.\r\n\r With the current COVID-19 epidemic, in view of the high risk of contamination, drastic\r measures to limit the transmission are necessary, with the creation of spaces dedicated to\r the care of Covid+ patients, and family are not allowed to visit.\r\n\r At the Strasbourg University Hospital, visits were prohibited from the start of the epidemic.\r Information concerning the patient's state of health is therefore delivered to families by\r telephone, on call by the healthcare team only, every day before 6 p.m. or in the event of a\r serious event at any time.\r\n\r The primary purpose of this project is to assess the psychological impact of the\r hospitalization of a loved one in intensive care for Covid-19 infection at 3 months\r post-hospitalization, in a context of pandemic with ban on visits.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Family member of a Covid-19 positive patient hospitalized in Intensive Care Unit who\r gave his oral agreement following the communication of the notice of non-opposition.\r\n\r - A patient is considered to be Covid + if the RT-PCR is positive OR if characteristic\r images are taken with a chest scanner.\r\n\r - The family member included in the study is preferably the patient's support person. In\r the absence of an expression of the patient's will, he is the close referent\r designated by the family as an interlocutor.\r\n\r Exclusion Criteria:\r\n\r - Difficulties in understanding French\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
35,784
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTemporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThis study will test newly developed stimulation settings called Temporally Optimized\r Patterned Stimulation or TOPS, which can be used with an already implanted deep brain\r stimulation system. The purpose of this study is to determine if TOPS DBS can improve\r Parkinson's symptoms compared to Standard DBS.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nKey Inclusion Criteria:\r\n\r - Diagnosed with Parkinson's disease\r\n\r - Implanted with unilateral or bilateral subthalamic DBS System to treat Parkinson's\r disease at least 6 months prior to the study date\r\n\r - Responds to DBS by having demonstrated a minimum improvement in motor score\r\n\r Key Exclusion Criteria:\r\n\r - Score of <24 on the Mini Mental Status Exam\r\n\r - Abuses drugs or alcohol\r\n\r - Pregnant\r\n\r - History of significant cardiovascular, pulmonary, musculoskeletal, metabolic, or other\r neurological disorders (i.e. epilepsy, stroke)\r\n\r - Prisoners, employees that report to investigators\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
35,785
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nImmunoassay and Regulation of Traditional Chinese Medicine on Cancer Patients\n\n**Clinical Trial Summary:**\n\nThe immune system is our body's defense mechanism, which helps us to resist foreign pathogens\r and cancer cells in the body. However, if the immune system is too weak, too strong, or\r unbalanced, it will be susceptible to get bacterial and viral infections, unable to fight\r cancer, or cause allergies, autoimmune and rheumatic diseases. At present, there is no good\r western medicine to strengthen immunity when the body is insufficient immunity. However,\r strong immunity causes autoimmune diseases and need to be treated by steroids and\r immunosuppressive agents. These drugs have limited efficacy and often have many side effects.\r In the clinical practice of traditional Chinese medicine, tonify qi, supplement blood and\r nourish yin are often used to enhance immunity. However, there is no clinical test to\r demonstrate the modulation of immune response after traditional Chinese medicine treatment.\r\n\r In our preliminary study, the investigators identified that the basic immune response of\r cancer patients is weaker than healthy people by testing the level of IFN-r (promoting T cell\r activity, anti-tumor, anti-viral), TNF-a (promoting B cell proliferation, producing\r antibodies, anti-tumor, anti-viral) and IL-2 (regulate the proliferation and\r differentiation). Besides, some Chinese herbal extracts can significantly stimulate the\r immune response higher than the general average basic immunity of cancer patients. Further,\r we will use the stimulatory Chinese medicine extract to administer to cancer patients and\r examine the immune response of cancer patients after taking them. Therefore, this test can\r provide actual data on the basic immunity of healthy people or cancer patients and the\r modulation of immune response by traditional Chinese medicine treatment. This analysis\r platform provides patients to select the medicines that can enhance the immune response for\r individuals and analyze the changes of the immune response after conditioning with the\r candidate Chinese medicines. Therefore, this test could be applied clinically to validate the\r immunological regulation of Chinese herbal medicine as well as analyze the immunological\r modulation against different cancer by various Chinese herbal medicine.\n\n**Clinical Trial Detailed Description:**\n\nTraditional Chinese medicine (TCM) and dendritic cells (DCs) activation/maturation One of the\r important approaches to successful cancer immunotherapy is generation of specific T cell\r responses by dendritic cells (DCs). DCs are the most potent antigen-presenting cells for\r naive T cells, because their high expression of MHC and co-stimulatory molecules. DCs\r comprise several subsets, and their roles in the presentation of antigens derived from\r pathogens, vaccines and self tissues are now beginning to be elucidated. Immature DCs (iDCs)\r resided in periphery have a high ability to endocytose antigens and become to mature DCs\r (mDCs) upon a variety of stimuli through Toll-like receptors (TLRs). However, iDCs facilitate\r immune tolerance and fully mDCs can promote immune responses. Until now, there are some\r studies have demonstrated that TCM could promote the activation status of DC to enhance\r immune responses through TLR, which are characterized by increased expression of\r co-stimulatory moleculars, MHC class II and several cytokines. Ganoderma lucidum and\r Cordyceps sinensis have been widely used in Asian countries to have beneficial effects on\r human health. Ganoderma lucidum polysaccharides have been reported to induce DCs maturation\r and promote the cytotoxicity of specific CTL. Moreover, Ganoderma lucidum polysaccharides\r were able to induce DC activation markers production and cytokines expression through TLR-4\r signaling pathway. However, this character about TCM acted as TLR agonists could apply to\r develop safe and effective adjuvant in vaccine generation.\r\n\r Traditional Chinese medicine (TCM) and T cell activation T cells are the master regulators of\r adaptive immune responses. Proper T cell responses are essential for the hosts to orchestrate\r sufficient adaptive immunity. Classically, the TH1/TH2 hypothesis has served the immunology\r community well, particularly in understanding infectious and allergic diseases. Regulatory T\r cells (Treg) are suppressive T cells that regulate effector T cell immunity. Nevertheless,\r this model dose not fit all systems when it comes to the study of organ-specific autoimmune\r diseases. It has also become more and more clear, however, that many complicated pathological\r situations cannot be simply explained by the TH1 cell and TH2 cell paradigm. Efforts to\r resolve these issues in recent years have resulted in the discovery of TH17 cells.\r\n\r T cell immunity is crucial for anti-tumor immunity. Given their importance in immune\r responses and diseases, it is important to understand the regulation of T cell immunity. In\r immune system, different lineages of immune cells were conventionally distinguished by the\r morphology and expression of a cluster of differentiation markers on the cell surface. TH1\r cells that make IL-2 and IFN-r are important for delayed-type hypersensitivity reactions,\r whereas TH2 cells that make IL-4 promote IgE production and allergic reaction. The\r differentiation of TH1 and TH2 cells mainly through the induction of distinct transcriptional\r programs. Activation of Signal Transducers and Activators of Transcription 1 (STAT1) by IFN-r\r and STAT4 by IL-12 drives expression of T-bet for TH1 programming. On the other hand,\r activation of STAT6 by IL-4 promotes GATA3 expression in TH2 cells. A revise of the TH1/TH2\r hypothesis was proposed until the discovery and IL-23 and IL-17. TH17 cell is a distinct T\r helper cell population that plays a crucial role in CD4+ T cell-mediated adaptive immunity.\r Commitment to the TH17 pathway requires the presence of both IL-6 and TGF-a during in vitro\r culture. These cells, different from the classical TH1 and TH2 cells, do not produce IFN-r or\r IL-4 but on the other hand express the IL-23 receptor and IL-21, IL-22, and IL-17F. ROR-rt ,\r ROR-rt are also highly expressed in TH17cells and can be induced by TGF-a and IL-6. Our\r previous studies showed for the first time an in vivo requirement for STAT3 in TH17 mediated\r autoimmunity. In addition, the investigators found that STAT3 is required for the maintenance\r of endogenous TH17 cells. In a more recent report, the investigators also found that CD8 T\r cells, like their CD4 counterparts TH17, can be skewed toward IL-17 production in vitro and\r in vitro.\r\n\r Manipulating T cell immunity by Chinese herbs is a promising field to explore. Many herbs\r were reported to regulate the T cell activation. Tanshinlactone A from Salvia miltiorrhiza\r Bunge significantly decreased the IL-2 and IFN-γ gene expression through reduction of MAPK\r activation in phytohemagglutinin-activated peripheral blood mononuclear cells. Periplocoside\r E (PSE) was shown to dose-dependently inhibit anti-CD3 induced primary T cell proliferation,\r activation for IL-2R (CD25) expression, and IFN-γ and IL-2 production at the transcriptional\r level by inhibited the activation of ERK and JNK. Furthermore, kurarinol was reported to\r increase level of HBV specific CTL by down-regulating peripheral blood HBV specific CTL\r surface PD-1 expression of CHB patients.\r\n\r All of these will support investigators' hypothesis that modulation of dendritic cell and T\r cell immunity by Chinese herbs or cytokines may be an applicable intervention to modulate\r immunity, for example, to promote anti-tumor immunity against cancer. The successful\r completion of the proposed studies will provide a strong support for future development of\r anti-cancer immunotherapy by Chinese herbs.\r\n\r Traditional Chinese herbs as a pharmacologic approach to modulate immunity Cancer\r immunotherapy, allergy, and autoimmune diseases are among the chronic illness that accounts\r for the death and economic burdens in Taiwan and other modern countries. Diseases such of\r Rheumatoid arthritis (RA), SLE, multiple sclerosis, ankylosing spondylitis, vasculitis,\r psoriasis and Sjogren's syndrome are common autoimmune diseases that cause not only life-long\r discomfort but also disabilities of the patients. Cancer immunotherapy is promising. Many of\r autoimmune disease and difficult-to-treat allergies are now found to be associated with IL-17\r mediated pathology. However, the current treatment is limited. Recently, targeted therapy\r such as Etanercept (trade name Enbrel), a biopharmaceutical that interferes with tumor\r necrosis factor (TNF; a soluble inflammatory cytokine), has been developed to treat some of\r the autoimmune diseases. However, nhibition of TNF has substantially advanced the treatment\r of inflammatory diseases. Because TNF and IL-17 have shared functions, the rationale for\r testing IL-17 inhibitors in the clinic is often based on the concept that patients who do not\r respond to TNF inhibitors may have an IL-17-driven disease. Autoimmune diseases such of\r rheumatoid arthritis and multiple sclerosis are common autoimmune diseases that cause not\r only life-long discomfort but also disabilities of the patients. The current treatment for\r these autoimmune diseases is limited to analgesia, anti-inflammatory drugs, steroids,\r disease-modifying antirheumatic drugs (DMARDs), and immunosuppressants. Recent studies in\r mouse models and in humans have identified a key role of IL-17 and TH17 cells in the\r pathogenesis of inflammation and autoimmunity as well as in host defense against certain\r pathogens.\r\n\r Meanwhile, there are some studies using Chinese herbs to modulate CD4 TH17 immunity. Compound\r extracted from Chinese herbs, such as berberine exhibited potent efficacy inhibiting TH17 in\r the EAE model. Triptolide also inhibited collagen-induced arthritis (CIA), a model of\r rheumatoid arthritis, through inhibition of CD4 TH17 cells. Periplocoside A was found to\r ameliorate EAE by suppressing IL-17 production and inhibited the differentiation of Th17\r cells in vitro. Eriocalyxin B was also found to be effective to inhibit TH17 and EAE through\r targeting Janus Kinase/Signal Transducer and Activator Of Transcription and Nuclear\r factor-kappaB signaling pathways. TCM formula such as Qingkailing injection was found to\r ameliorate rat experimental autoimmune uveitis (EAU). Qingkailing injection can alleviate\r autoimmune uveitis in rats, inhibit the differentiation toward Th1 and Th17 effector cells\r and the relevant cytokines secretion. Pure compound from Daphne odora var. marginata (D.\r marginata) was also found to inhibit TH17 and thus exhibit inhibitory effects in CIA model.\r\n\r One of the landmark study published in Science and Nature Chemical Biology is the example of\r halofuginone, an active component of traditional Chinese herb hydrangea root (Dichroa\r febrifuga), used to treat malaria for thousands of years. A collaborative research team led\r by Dr. Mark Sundrud at the Department of Pathology, Harvard Medical School and Immune Disease\r Institute, Boston, MA, has reported that halofuginone halted the progression of experimental\r autoimmune encephalomyelitis (EAE) mice and TH17. Importantly, unlike other therapies for\r autoimmune diseases, halofuginone does not have the undesirable effect of suppressing the\r other immune system.\r\n\r The investigators have established some platforms for screening Chinese herbs not only for\r modulating PD-1/PD-L1, IL-17, but also for detection of dendritic cell and T cell activation\r (Immunogen Test Panel).\r\n\r The hypothesis is that modulation of dendritic cells and T cells by traditional Chinese\r medicine may be an applicable intervention to treat some of the immunologic diseases such as\r cancer, allergy, and autoimmune diseases. Studies that can fit the niche, understanding the\r function and mechanism of Chinese herbs on immune cells and its pathway, will have broad\r clinical and immunological significance. The successful completion of the proposed studies\r will provide a strong support for a clinical trial of traditional Chinese medicine to treat\r patients with immunologic diseases.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients diagnosed with ovarian cancer and endometrial cancer (cancer patients treated\r with chemotherapy, radiotherapy, and surgery) can be included.\r\n\r - Breast cancer: Diagnosed by pathological diagnosis of biopsy, without chemotherapy or\r radiotherapy.\r\n\r - Colorectal cancer: Diagnosed by pathological diagnosis of slices, without chemotherapy\r or radiotherapy.\r\n\r Exclusion Criteria:\r\n\r - Pregnant women\r\n\r - Minors under the age of 20.\r\n\r - Those who are currently using traditional Chinese medicine\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEfficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe efficacy and safety of rotigotine in the treatment of patients with early stage of\r primary Parkinson's disease\n\n**Clinical Trial Detailed Description:**\n\nTo evaluate the efficacy and safety of rotigotine sustained release microspheres therapy by\r injection in the treatment of patients with early stage of primary Parkinson's disease\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects or their legal representatives understand and wish to participate in this\r clinical study and voluntarily sign the informed consent dated;\r\n\r - In the investigator's judgment, believe that the subject or his legal representative\r is trustworthy and able to comply with the study protocol, visit plan, or receive the\r study drug treatment as required;\r\n\r - During screening (interview 1) The subjects were older than 30 years old, regardless\r of gender;\r\n\r - The subject had primary Parkinson's disease for 55 years and was diagnosed based on\r major signs such as delayed movement and at least one of the following symptoms:\r quiescence tremor, rigidity or postural reflexes, and no other known or suspected\r cause of Parkinson's disease;\r\n\r - Hoehn-yahr stage 3 in the \"open\" state (excluding phase 0);\r\n\r - Brief mental State examination (MMSE) ≥ 25;\r\n\r - At baseline (visit 2), the exercise score (Part III) of the Unified Parkinson's\r Disease Rating Scale (U PDRS) under the \"open\" condition was greater than or equal to\r 10;\r\n\r - If the subjects are receiving anticholinergic drugs (such as benzalkonium tropic,\r benzene hai suo, diethyl promethazine, its organism and than pp board), monoamine\r oxidase B (MAO B) inhibitors, N - Methyl - d - aspartate (NMDA) antagonist (such as\r amantadine) treatment, must dose before baseline visit (2) is stable at least 28 days,\r and maintain the dose treatment during the study period;\r\n\r - Childbearing age women (such as: no sterilization surgery or postmenopausal women is\r less than 1 year) or male subjects agreed to during the entire study (screening visit\r to the end of the study) and reliable contraceptive measures (birth control pills, use\r a condom, abstinence, etc.), and the screening visit (l) and the baseline visit (2),\r the childbearing age women of pregnancy test results were negative.\r\n\r Exclusion Criteria:\r\n\r - A history of globulin resection, thalamic destruction, deep brain stimulation or fetal\r tissue transplantation;\r\n\r - Dementia, active mental illness or hallucinations, major depression\r\n\r - Those who received dopamine agonist within 28 days before baseline (visit 2);\r\n\r - Those who received levodopa preparations (including levodopa compound preparations)\r within 28 days before baseline (visit 2), or those who received levodopa preparations\r for more than 6 months after diagnosis; Patients who received any of the following\r drugs: amphetamine or alpha within 28 days prior to baseline (visit 2)\r\n\r - Receiving Central nervous system active drug therapy (e.g., tranquilizers, sleeping\r pills, antidepressants, antianxiety medications), except for those who have been on a\r stable dose for at least 28 days prior to baseline (visit 2) and are likely to remain\r stable during the study period;\r\n\r - Atypical Parkinson's disease symptoms caused by the use of drugs (e.g.,\r metoclopramide, flunarizine), hereditary metabolic diseases of the nervous system\r (e.g., Wilson's disease), encephalitis, cerebrovascular diseases, or degenerative\r diseases (e.g., progressive supranuclear palsy);\r\n\r - Patients with a history of epilepsy, or with a history of stroke or transient ischemic\r stroke within 1 year before the visit;\r\n\r - Intolerance or allergy to antiemetic drugs such as domperidone, ondansetron,\r tropisetron, granisetron;\r\n\r - Patients with clinically significant liver function abnormalities are defined as 1.5\r times of the upper limit of the reference range of total bilirubin > or 2 times of the\r upper limit of the reference range of alanine aminotransferase (ALT) or aspartate\r aminotransferase (AST) >;\r\n\r - Abnormal renal function with clinical significance (serum creatinine > 2.0 mg/dL);\r\n\r - Uncontrolled or significant cardiovascular disease, including New York Heart\r Association grade 2 or above congestive heart failure, unstable angina, myocardial\r infarction, or arrhythmias requiring treatment at screening (visit 1) in the 6 months\r prior to first administration of the study drug;\r\n\r - During screening (interview I);\r\n\r - A history of symptomatic postural hypotension; Systolic blood pressure reduction\r greater than or equal to 20 MMHG or diastolic blood pressure reduction greater than or\r equal to 10 mmHg during screening (visit l) and baseline (visit 2) from baseline to\r upright position for 1 or 3 minutes; Or patients with horizontal systolic blood\r pressure < 105 mmHg during screening (visit I) and baseline (visit 2);\r\n\r - Subjects with evidence of impulse control disorder (ICD) during screening (interview\r L);\r\n\r - A history of suicide attempt (including actual attempt, interruption of attempt or\r failure of attempt) or suicidal ideation in the past 6 months, defined as \"yes\" to\r question 4 or 5 on the Columbine Suicide Severity Rating Scale (C-SSRS) at screening\r (interview L); those\r\n\r - Patients with a history of narcolepsy;\r\n\r - Screening (interview L) For those who had a history of alcohol abuse, drug abuse or\r drug addiction in the first 5 years, alcoholism was defined as drinking more than 14\r units of alcohol per week (1 unit = 360 ml beer or 45 ml spirits with 40% alcohol or\r 150 ml wine);\r\n\r - Screening for malignant tumors within 5 years before surgery, except adequately\r treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the\r skin, local prostate cancer after radical surgery, and intraductal carcinoma in situ\r of the breast;\r\n\r - Women during pregnancy or lactation;\r\n\r - Previous participants in the Rotigotine trial were intolerant or had poor efficacy;\r\n\r - Allergic to or known to be allergic to rotigotine or rotigotine microsphere\r preparations;\r\n\r - Those who have participated in other drug clinical trials within 3 months prior to\r screening;\r\n\r - Any other medical condition, mental condition, or laboratory abnormality of clinical\r significance that the investigator determines may interfere with the subject's ability\r to participate in the study.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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35,787
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nNeurodegenerative Diseases Registry\n\n**Clinical Trial Summary:**\n\nWith the increase in life expectancy of our population due to advancement of medical\r diagnosis and treatments, the incidence of age dependent neurodegenerative diseases\r increased, including Alzheimer's disease (AD), parkinsonian syndromes (PS), small vessel\r disease (SVD) and motor neuron disease (MND). In spite of the progress of knowing the\r pathogenesis of various neurodegenerative diseases at molecular and genetic level, they are\r still very incompletely understood and often cause diagnostic and therapeutic challenges to\r physicians. Due to the overlapping presentation and similar brain pathology, especially in\r the early stage of the diseases, it is difficult to differentiate idiopathic Parkinson's\r disease (iPD) from atypical parkinsonian syndromes, such as multiple system atrophy (MSA) and\r progressive supranuclear palsy (PSP). Similarly, distinguishing AD from other dementia\r syndromes including frontotemporal dementia (FTD), dementia with Lewy Bodies (DLB),\r corticobasal degeneration (CBD) and vascular dementia can be difficult. It is necessary to\r develop accurate and comprehensive diagnostic tests to properly prognosticate the diseases,\r start treatments in early stage of the diseases and maximize the accuracy of drug trials for\r more effective preventive and therapeutic measures for these neurodegenerative diseases.\r\n\r Therefore, the registry aims to generate a large database of cognitive, behavioral, lifestyle\r and psychological information of the subjects who suffered from neurodegenerative diseases,\r as well as to examine the genetic basis of neurodegenerative diseases to help decode the\r pathogenic mechanisms of the diseases. The registry may provide important information to\r understand symptom development of the neurodegenerative diseases, in which may help\r physicians to diagnose the diseases more accurately and provide better treatment plans.\n\n**Clinical Trial Detailed Description:**\n\nThis is a cohort study. It involves baseline, 1st follow up visit and 2nd follow up visit. At\r baseline visit, all participants will go through a list of assessments and questionnaires and\r blood taking. Follow-up visit(s) will be scheduled every one to two years, in which the same\r set of assessments and questionnaires will be administered.\r\n\r 1. Clinical assessments and questionnaires\r\n\r Different clinical assessments would be administered depending on the group that the\r participant belongs to:\r\n\r - Hoehn and Yahr Stage and the Unified Parkinson's Disease Rating Scale (UPDRS) for\r iPD, PSP and SVD patients with parkinsonism features\r\n\r - Unified MSA Rating Scale (UMSARS) for MSA\r\n\r - Levodopa Equivalent Dosage for medication burden for parkinsonian syndromes\r patients\r\n\r - Amyotrophic lateral sclerosis functional rating scale revised (ALSFRS-R), body\r weight and forced vital capacity (FVC) for MND group\r\n\r - Montreal Cognitive Assessment Hong Kong version (HK-MoCA), Olfactory Identification\r Test (OIT) and Farnsworth-Munsell 100 Hue test for all groups\r\n\r Video taking would be administered to record participants' eye movement if necessary.\r For example, video of eye movement is useful to rate MSA patients' ocular motor\r dysfunction, such as gaze-evoke nystagmus.\r\n\r Patients with parkinsonian syndromes will fill in a set of questionnaires, including\r demographic information, medical history, history and current medications, wearing-off\r questionnaire, impulsiveness questionnaire, Buss-Perry Aggression Questionnaire (BPAQ),\r rapid eye movement sleep behavior disorder questionnaire (RBDQ), Epworth Sleepiness\r Scale (ESS), Morningness-Eveningness Questionnaire (MEQ), Insomnia Severity Index (ISI),\r Beck's Scale for Suicide Ideation (BSSI), Scales for Outcomes in Parkinson's\r Disease-Autonomic questionnaire (SCOPA-AUT), Hospital Anxiety and Depression Scale\r (HADS), Patient Health Questionnaire (PHQ9), lifestyle and life history, and occupation\r history.\r\n\r 2. Blood sampling Blood taking would be carried out at Prince of Wales Hospital and will be\r processed and transported to the laboratory according to standard procedure.\r\n\r Venous blood samples are collected into 6 EDTA tubes and 1 Heparin tube. The volume of\r total blood samples will not exceed 23ml. Serum is obtained within 1 hour by\r centrifugation at 3,000 rpm for 10 min and stored at -70°C until laboratory evaluation\r for proteomics, SERS and other biochemical and genetics studies.\r\n\r 3. Sub-studies Selected participants in the cohort groups, especially those with early\r disease onset and/or familial cases, would proceed to sub-studies which include brain\r MRI, brain PET, lumbar puncture and/or skin biopsy. Subjects are voluntary to join one\r or more sub-studies.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age should be between 18-80 years old.\r\n\r Exclusion Criteria:\r\n\r - Patients with ongoing central nervous system infection and/or acute stroke or active\r brain tumor.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,788
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPPMI 2.0 Clinical -Establishing a Deeply Phenotyped PD Cohort\n\n**Clinical Trial Summary:**\n\nThe Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) is a longitudinal, observational,\r multi-center natural history study to assess progression of clinical features, digital\r outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression\r in study participants with manifest PD, prodromal PD, and healthy controls\r\n\r The overall goal of PPMI 2.0 is to identify markers of disease progression for use in\r clinical trials of therapies to reduce progression of PD disability.\n\n**Clinical Trial Detailed Description:**\n\nPPMI 2.0 is a broad program, expanding the goals of the original PPMI study (NCT01141023),\r that includes this PPMI 2.0 Clinical protocol, as well as the PPMI 2.0 Remote, PPMI 2.0\r Digital Applications and PPMI 2.0 Online protocols. All participants in PPMI 2.0 will be\r asked to be enrolled in all PPMI 2.0 protocols, but depending on their method of recruitment,\r participants may be enrolled sequentially in varying order, as appropriate. PPMI 2.0\r participants may also be asked to participate in additional PPMI 2.0 companion studies (as\r they are developed), which may only involve a subset of PPMI 2.0 participants based on their\r cohort designation and/or site location.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Parkinson Disease (PD) Subjects:\r\n\r - Male or female age 30 years or older at Screening Visit.\r\n\r - A diagnosis of Parkinson disease for 2 years or less at Screening Visit.\r\n\r - Not expected to require PD medication with at least 6 months from Baseline.\r\n\r - Patients must have at least two of the following: resting tremor, bradykinesia,\r rigidity (must have either resting tremor or bradykinesia); OR either asymmetric\r resting tremor or asymmetric bradykinesia.\r\n\r - Hoehn and Yahr stage I or II at Baseline.\r\n\r - Individuals taking any of the following drugs: alpha methyldopa, methylphenidate,\r amphetamine derivatives or modafinil, must be willing and medically able to hold the\r medication for at least 5 half-lives before DaTscan imaging.\r\n\r - Confirmation that participant is eligible based on Screening DaTscan imaging.\r\n\r - Able to provide informed consent\r\n\r - Woman may not be pregnant, lactating or planning pregnancy during the study.\r ~Including a negative pregnancy test on day of Screening DaTscan imaging test prior to\r injection of DaTscan.\r\n\r Healthy Control (HC) Subjects:\r\n\r - Male or female age 30 years or older at Screening visit.\r\n\r - Individuals taking any of the following drugs: alpha methyldopa, methylphenidate,\r amphetamine derivatives or modafinil, must be willing and medically able to hold the\r medication for at least 5 half-lives before DaTscan imaging.\r\n\r - Confirmation that participant is eligible based on Screening DaTscan imaging.\r\n\r - Able to provide informed consent\r\n\r - Women may not be pregnant, lactating or planning pregnancy during the study. ~\r Includes a negative pregnancy test on day of Screening DaTscan imaging test prior to\r injection of DaTscan™.\r\n\r Exclusion Criteria:\r\n\r Parkinson Disease (PD) Subjects:\r\n\r - Currently taking levodopa, dopamine agonists, MAO-B inhibitors (e.g., selegiline,\r rasagiline), amantadine or other PD medication.\r\n\r - Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days\r of Baseline.\r\n\r - Has taken levodopa or dopamine agonists prior to Baseline for more than a total of 90\r days.\r\n\r - Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine,\r neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or\r degenerative diseases (e.g., progressive supranuclear palsy)\r\n\r - A clinical diagnosis of dementia as determined by the investigator.\r\n\r - Previously obtained MRI scan with evidence of clinically significant neurological\r disorder (in the opinion of the Investigator)\r\n\r - Received any of the following drugs: dopamine receptor blockers (neuroleptics),\r metoclopramide and reserpine within 6 months of Screening visit.\r\n\r - Current treatment with anticoagulants (e.g. coumadin, heparin, oral thrombin\r inhibitors) that might preclude safe completion of lumbar puncture.\r\n\r - Condition that precludes the safe performance of routine lumbar puncture, such as\r prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant\r coagulopathy or thrombocytopenia.\r\n\r - Any other medical or psychiatric condition or lab abnormality, which in the opinion of\r the investigator might preclude participation.\r\n\r Healthy Control (HC) Subjects:\r\n\r - Current or active clinically significant neurological disorder (in the opinion of the\r Investigator).\r\n\r - First degree relative with PD (parent, sibling, child).\r\n\r - Previously obtained MRI scan with evidence of clinically significant neurological\r disorder (in the opinion of the Investigator)\r\n\r - Received any of the follow drugs: dopamine receptor blockers (neuroleptics),\r metoclopramide and reserpine within 6 months of Screening visit.\r\n\r - Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin\r inhibitors) that might preclude safe completion of the lumbar puncture.\r\n\r - Condition that precludes the safe performance of routine lumbar puncture, such as\r prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant\r coagulopathy or thrombocytopenia.\r\n\r - Any other medical or psychiatric condition or lab abnormality, which in the opinion of\r the investigator might preclude participation.\r\n\r Inclusion Criteria:\r\n\r (PD-LRRK2 or GBA) Participants:\r\n\r - Male or female age 30 years or older at Screening visit.\r\n\r - A diagnosis of Parkinson disease for 2 years or less at Screening Visit.\r\n\r - Patients must have a least two of the following: resting tremor, bradykinesia,\r rigidity (must have either resting tremor or bradykinesia); OR either asymmetric\r resting tremor or asymmetric bradykinesia.\r\n\r - Hoehn and Yahr stage I or II at Baseline.\r\n\r - Confirmation of causative LRRK2 or GBA (willingness to undergo genetic testing as part\r of genetic screening and be informed of genetic testing results, or documentation of\r prior genetic testing results).\r\n\r - Individuals taking any of the following drugs: alpha methyldopa, methylphenidate,\r amphetamine derivatives or modafinil, must be willing and medically able to hold the\r medication for at least 5 half-lives before DaTscan imaging.\r\n\r - Confirmation that participant is eligible based on Screening DaTscan imaging.\r\n\r - Able to provide informed consent\r\n\r - Woman may not be pregnant, lactating or planning pregnancy during the study.\r ~Including a negative pregnancy test on day of Screening DaTscan imaging test prior to\r injection of DaTscan™.\r\n\r Exclusion Criteria:\r\n\r PD-LRRK2 or GBA\r\n\r - Received any of the following drugs: dopamine receptor blockers (neuroleptics),\r metoclopramide and reserpine within 6 months of Screening visit.\r\n\r - Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude\r safe completion of the lumbar puncture\r\n\r - Condition that precludes the safe performance of routine lumbar puncture, such as\r prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant\r coagulopathy or thrombocytopenia.\r\n\r - Any other medical or psychiatric condition or lab abnormality, which in the opinion of\r the investigator might preclude participation.\r\n\r Inclusion Criteria:\r\n\r PD-SNCA or rate genetic mutation (such as Parkin or Pink 1))\r\n\r - Male or female age 30 years or older at Screening Visit.\r\n\r - Parkinson disease diagnosis at Screening Visit.\r\n\r - Patients must have at least two of the following: resting tremor, bradykinesia,\r rigidity (must have either resting tremor or bradykinesia); OR either asymmetric\r resting tremor or asymmetric bradykinesia.\r\n\r - Hoehn and Yahr stage I, II or III at Baseline.\r\n\r - Confirmation of causative SNCA or rare genetic mutation (such as Parkin or Pink 1)\r (willingness to undergo genetic testing as part of genetic screening and be informed\r of genetic testing results, or documentation of prior genetic testing results).\r\n\r - Individuals taking any of the following drugs: alpha methyldopa, methylphenidate,\r amphetamine derivatives or modafinil, must be willing and medically able to hold the\r medication for at least 5 half-lives before DaTscan imaging.\r\n\r - Confirmation that participant is eligible based on Screening DaTscan imaging.\r\n\r - Able to provide informed consent\r\n\r - Woman may not be pregnant, lactating or planning pregnancy during the study.\r ~Including a negative pregnancy test on day of Screening DaTscan imaging test prior to\r injection DaTscan™.\r\n\r Exclusion Criteria:\r\n\r PD-SNCA or rate genetic mutation (such as Parkin or Pink 1))\r\n\r - Received any of the following drugs: dopamine receptor blockers (neuroleptics),\r metoclopramide and reserpine within 6 months of Screening visit.\r\n\r - Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude\r safe completion of the lumbar puncture\r\n\r - Condition that precludes the safe performance of routine lumbar puncture, such as\r prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant\r coagulopathy or thrombocytopenia.\r\n\r - Any other medical or psychiatric condition or lab abnormality, which in the opinion of\r the investigator might preclude participation.\r\n\r Prodromal Subjects:\r\n\r Inclusion Criteria For Screening:\r\n\r - Enrolled in PPMI 2.0 Remote and based on risk criteria, or olfaction, and/or other\r assessments in the PPMI 2.0 Online protocol are eligible for PPMI 2.0 Clinical.\r\n\r - Male or female age 60 years or older (except age 30 years or older for SNCA, or rate\r genetic mutations (such as Parkin or Pink1) participants).\r\n\r - Individuals taking any of the following drugs: alpha methyldopa, methylphenidate,\r amphetamine derivatives or modafinil, must be willing and medically able to hold the\r medication for at least 5 half-lives before DaTscan imaging.\r\n\r - Able to provide informed consent\r\n\r - Woman may not be pregnant, lactating or planning pregnancy during the study.\r ~Including a negative pregnancy test on day of Screening DaTscan imaging test prior to\r injection of DaTscan™.\r\n\r Exclusion Criteria : Prodromal\r\n\r - Clinical diagnosis of PD, other parkinsonism, or dementia\r\n\r - Received any of the following drugs: dopamine receptor blockers (neuroleptics),\r metoclopramide and reserpine within 6 months of Screening visit.\r\n\r - Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude\r safe completion of the lumbar puncture.\r\n\r - Condition that precludes the safe performance of routine lumbar puncture, such as\r prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant\r coagulopathy or thrombocytopenia.\r\n\r - Any other medical or psychiatric condition or lab abnormality, which in the opinion of\r the investigator might preclude participation.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,789
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study for the Identification of Biomarker Signatures for Diagnosis of Pulmonary Hypertension (PH) in Participants at Low or Intermediate Probability of PH Undergoing Cardiac Magnetic Resonance Imaging\n\n**Clinical Trial Summary:**\n\nThe primary purpose of this study is to estimate the percentage of participants in the\r population considered clinically as not having pulmonary hypertension (PH) that are positive\r for PH biomarker (micro ribonucleic acid [RNA]); estimate the percentage of participants in\r the population considered clinically as not having PH that are positive for PH by cardiac\r magnetic resonance imaging (MRI) and compare results of the MRI to the biomarker results; to\r determine the performance of the biomarker signatures identified in the CIPHER (NAPUH0001)\r study in terms of sensitivity, specificity, positive predictive value (PPV) and negative\r predictive value (NPV), in a population considered clinically as not having PH.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Referred for diagnostic work-up for pulmonary hypertension (PH)\r\n\r - With low or intermediate (but not high) probability of PH by transthoracic\r echocardiography (TTE) according to European Society of Cardiology (ESC)/ European\r Respiratory Society (ERS) Guidelines if at the time of enrollment Right Heart\r Catheterization (RHC) is not deemed to be clinically indicated\r\n\r - Medically stable on the basis of physical examination, medical history and vital signs\r performed at screening. Any abnormalities must be consistent with the underlying\r illness in the study population and this determination must be recorded in the\r participant's source documents and initialed by the investigator\r\n\r - Must sign an Informed consent (ICF) indicating that he or she understands the purpose\r of, and procedures required for, the study and is willing to participate in the study\r\n\r - Must sign a separate approval in the ICF if he or she agrees to provide an optional\r (DNA) sample for research. Refusal to give consent for the optional (DNA) research\r sample does not exclude a participant from participation in the study\r\n\r Exclusion Criteria:\r\n\r - Undergone RHC within 2 years\r\n\r - Participants requiring renal dialysis\r\n\r - Participants post-lung or heart transplant\r\n\r - Severe left ventricular dysfunction: left ventricular ejection fraction less then (<)\r 35 percent\r\n\r - Ongoing Contagious respiratory disease\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,790
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nUniversity of Delaware Parkinson's Disease Registry\n\n**Clinical Trial Summary:**\n\nThe purpose of this Parkinson's Disease Registry is to assist with recruitment of willing\r participants into future Parkinson's disease research studies at the University of Delaware.\n\n**Clinical Trial Detailed Description:**\n\nThere is an urgent need for Parkinson's Disease research due to its increasing global\r prevalence. Participant recruitment is a significant challenge to the success of Parkinson's\r disease research and we need your help more than ever in moving the field forward and\r improving the lives of people who have Parkinson's disease. Recruitment of study participants\r can be facilitated by maintaining registries of people who agree to be contacted for future\r studies.\r\n\r The purpose of the University of Delaware Participant Recruitment Registry for Parkinson's\r Disease Research is to create a registry that includes the contact information and basic\r health information pertaining the participant's diagnosis of Parkinson's disease. The\r registry will streamline recruitment and enrollment in a variety of research studies focusing\r on topics such as, but not limited to: brain changes in Parkinson's disease, balance and gait\r in Parkinson's disease, exercise and its effect on motor function.\r\n\r To be in the registry individuals must have a clinical diagnosis of Parkinson's Disease, have\r an interest in participating in research studies, and be willing to allow the Parkinson's\r Disease Team access to their medical history from their medical provider(s).\r\n\r To become a member of this registry, primary information including contact information and\r some general medical information from a health provider are needed. Medical information will\r be evaluated to confirm Parkinson's disease diagnosis and to determine if a potential\r participant is eligible to become a member of the registry.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Individual 21 years old or older\r\n\r - A clinical diagnosis of Parkinson's disease\r\n\r - Interest in participating in one or more investigator-led research studies at the\r University of Delaware\r\n\r - Willingness to allow the registry team to access to the medical history from the\r medical provider(s) that would confirm a clinical diagnosis of Parkinson's disease and\r provide basic health information that facilitate participant-study matching\r\n\r Exclusion Criteria:\r\n\r - Individuals with a clinical diagnosis of parkinsonism that is not considered primary\r (e.g. vascular parkinsonism) or an atypical parkinsonian syndrome (e.g., progressive\r supranuclear palsy, multiple system atrophy, corticobasal degeneration etc.)\r\n\r - Clinical diagnosis of dementia\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,791
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nStudy to Assess Participant/Caregiver/Investigator Satisfaction of Video-Assisted Telenursing in Adult Participants With Parkinson's Disease Treated With Levodopa-Carbidopa Intestinal Gel\n\n**Clinical Trial Summary:**\n\nParkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse\r over time, but how quickly it progresses varies a lot from person to person. Some symptoms of\r PD are tremors, stiffness, and slowness of movement. The purpose of this study is to see how\r feasible and how satisfied participants/caregivers/investigators are with video-assisted\r telenursing use in nurse support programs with LCIG.\r\n\r LCIG is an approved drug to treat PD. Approximately 50 adult participants with advanced PD\r will be enrolled in the study at approximately 10 sites across the world.\r\n\r The study has 2 groups. In one group, around 25 participants will receive nurse support using\r video devices. In the second group, around 25 participants will receive nurse support without\r using video devices. All participants will attend a baseline visit and follow up visits at\r Week 4 and Week 12. The planned observation period will be 12 weeks.\r\n\r Participants who are prescribed LCIG by their physicians will have three study related\r visits. Participants, caregivers, and investigators will be asked to complete questionnaires\r for the study.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Eligible for Levodopa-Carbidopa Intestinal Gel (LCIG) therapy in accordance with the\r approved local LCIG label in the participating country\r\n\r - Formerly LCIG-naive participants who have completed an in-hospital titration, have a\r Percutaneous Endoscopic transGastric Jejunostomy (PEG-J) placed and are discharged\r from hospital\r\n\r - Decision to treat with LCIG made by the investigator prior to any decision to approach\r the participant to participate in this study\r\n\r - Owns a telecommunication device equipped for videoconferencing (smart phone, tablet,\r laptop)\r\n\r - Willing and able (based on investigator's judgment) to handle the video functionality\r of the device\r\n\r - Caregiver willing to provide written informed consent\r\n\r Exclusion Criteria:\r\n\r - Any condition included in the contraindications section of the approved local LCIG\r label in the participating country\r\n\r - Lack of caregiver support\r\n\r - Participation in a concurrent interventional clinical trial\r\n\r - Lack of motivation or insufficient language skills to complete the study\r questionnaires\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,792
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nUniversal Familial Hypercholesterolemia Screening in Children\n\n**Clinical Trial Summary:**\n\n30 million individuals globally with undiagnosed familial hypercholesterolemia (FH) are at a\r substantial cardiovascular disease (CVD) risk, which could be normalized by early diagnosis\r and treatment. Effective screening strategies are urgently needed, but the data on universal\r FH screening (uFHs) is scarce.\r\n\r The investigators aim to assess the overall performance of the uFHs program in Slovenia and\r to compare the common elements to the pilot uFHs program in Lower Saxony (LS; Germany).\n\n**Clinical Trial Detailed Description:**\n\nThe study will include pediatric patients (or their siblings and parents in Slovenian cohort)\r undergoing the universal hypercholesterolemia screening; those with elevated cholesterol at\r universal cholesterol screening at primary care level are referred to the lipidology\r specialist at the UMC Ljubljana (Slovenia) or Kinderkrankenhaus auf der Bult (Lower Saxony,\r Germany). For those with elevated cholesterol levels, the familial hypercholesterolemia\r genetic diagnostics is done centrally in UMC Ljubljana.\r\n\r Only those will be included from whom a signed informed consent by themselves or by their\r parents/guardians will be obtained prior to the genetic diagnosis of familial\r hypercholesterolemia.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Elevated total cholesterol (cohort 1) or LDL-cholesterol (cohort 2) at universal\r screening program in children.\r\n\r - Completed FH genetic analysis (cohort 3).\r\n\r - Parent or sibling of child with confirmed familial hypercholesterolemia (cohort 4).\r\n\r Exclusion Criteria:\r\n\r - Children with hypercholesterolemia not referred through the screening program.\r\n\r - FH genetic analysis not completed.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,793
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPrebiotics in the Parkinson's Disease Microbiome\n\n**Clinical Trial Summary:**\n\nThere are about one million Parkinson's disease (PD) patients in America. The risks\r associated with whether or not an individual may develop PD include environment and genetic\r (biologic, hereditary) factors. Studies have show that certain things may be triggers, for\r example cells in the brain that are made active and associated inflammation in the brain. The\r gut is the largest interface between the PD patient and the environment, and it is highly\r thought to be pathway to the environment trigger. Research studies have looked at how\r information is passed back and forth between the brain and the gut.\r\n\r The goal of this study (pilot) is to gather information to conduct a larger clinical trial.\r For this pilot study is to determine if a microbiota-directed (bacteria in the gut)\r intervention (dietary bar) is capable of correcting the bacteria gut balance in PD. This is\r based on the thought that an imbalance of bacteria in the gut of PD patients may lead to the\r gut and intestines working correctly. The long term goal is to see if the intervention has\r the potential to modify the disease or protect the brain in PD. If the intervention\r successfully improves the bacterial imbalance in PD, it will be the first attempt to modify\r the Gut-Brain communication in PD, which can lead to additional studies aimed at improving\r the disease progression or prevention.\r\n\r In this project, the investigators will test how well Parkinson's disease patients tolerate\r changes in the gut and intestines by providing the participants a dietary bar to eat for 10\r days. The investigators intend to conduct this pilot clinical trial in which the\r investigators believe that daily oral intake of a \"prebiotic\" mixture will be safe and well\r tolerated in a small number Parkinson's disease participants prior to a larger clinical trial\r looking at efficacy.\n\n**Clinical Trial Detailed Description:**\n\nIntestinal microbiota, are a dynamic community of commensal bacteria that modulate gut\r homeostasis and systemic biological processes including brain development and function\r through a bidirectional \"Gut-Brain axis\". Recent studies in both rodent models of disease and\r human have shown disrupted intestinal microbiota community in multiple systemic metabolic and\r inflammatory disorders including neurological disease. More specifically emerging evidence\r shows that stool and intestinal mucosal associated microbiota composition and function are\r abnormal in PD patients. Divergence of commensal bacteria composition from the microbial\r communities found in healthy persons (so called \"dysbiosis\"), has been associated with PD in\r early and late stages, as well as in patients with REM sleep behavior disorder (RBD), a group\r that are at high risk of progression to PD.\r\n\r In this project, the investigators will test the tolerability of Parkinson's disease patients\r in modulating the gut microbiota through dietary means. The investigators intend to conduct a\r pilot clinical trial in which the investigators hypothesize that daily oral intake of a\r prebiotic mixture will be safe and well tolerated in a small number Parkinson's disease\r participants prior to a larger clinical trial looking at efficacy.\r\n\r Research design and protocol:\r\n\r The study is an open-label, non-randomized study in 10 Parkinson's disease participants at\r Rush University Medical Center (RUMC) under the supervision of Drs. Hall and Keshavarzian.\r The trial will include 10 PD patients who are de novo (not yet on medication) or moderate\r stage (on medications). Participants will take the prebiotics in a form of a bar (Table 1)\r for 10 days- one bar (10 gram fiber) a day for 3 days and then one bar twice a day for\r additional one week.\r\n\r Each participant will have a baseline visit and a follow up visit after 10 days of the\r intervention (consumption of prebiotic dietary bar). At each visit, participants will\r complete questionnaires regarding adverse events including a questionnaire that rates bowel\r movement, stool consistency, discomfort, flatulence, abdominal pain, and bloating on a scale\r from 1 (best) to 10 (worst). Participants will also complete a Perceived Stress Questionnaire\r (Appendix D) and GI Symptom and Severity Checklist (Appendix A). Participants will be asked\r to fill out a diet record (24ASA diet questionnaire) (Appendix E) during the last 3 days on\r the intervention. Participant will also are asked to self-collect stool at home before\r consuming (eating) the first probiotic bar in the study and during the last day of the study\r at home. Supplies for stool collection (2 stool collection kit) and instructions for specimen\r handling and for completing these tasks will be given at Visit 1 and refreshed before visit\r 2. At visit 1 participants will be provided with 2 stool collection kits. First stool will be\r collected at home about 1 day and participants are asked to mail the stool in a pre-paid Fed\r Ex right after collecting the stool. The second stool collection will be on the last day that\r participants consume the probiotic bars prior to coming to for study visit 2 when the\r participants bring the stool to the study visit. The kit includes supplies to preserve the\r sample with gas packs and collection bag so the sample can be brought with the participant to\r the visits within 24 hours. The self-collected stool samples will be saved by the study team\r and frozen for future use. Participants will be asked to complete several dietary\r questionnaires including a Mediterranean diet screener (Appendix F), food timing screener\r (Appendix B) and food frequency questionnaire (Appendix C). Before Visit 2, each participant\r will collect the stool and complete the 3-day food record; these will be returned at Visit 2.\r At Visit 2, participants will complete a Perceived Stress Questionnaire (Appendix D) and GI\r Symptom and Severity Checklist and associated instructions (Appendix A). Each participant\r will also have blood draw (1 red top to collect serum and 1 EDTA tube to collect plasma) at\r visit 1 (baseline) and at visit 2 (completion of the study) to check for serum short chain\r fatty acids, lipopolysaccharides, interleukins and cytosine monophosphate(check for safety).\r\n\r Participants will provide written informed consent (Visit 1) before any study procedures,\r data or sample collection are performed.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Clinical diagnosis of Parkinson's disease,\r\n\r - >age 30,\r\n\r - Must be able to consent\r\n\r Exclusion Criteria:\r\n\r - prior intestinal resection,\r\n\r - patient history of GI diseases except for hiatal hernia, gastroesophageal reflux\r disease, hemorrhoids,\r\n\r - severe renal disease defined by creatinine more than 2 ½ times normal,\r\n\r - markedly abnormal liver function defined by liver function tests over 4 times normal\r levels or elevated bilirubin,\r\n\r - antibiotic use within the last 12 weeks prior to enrollment,\r\n\r - a plan to have a major change in dietary habit during the study,\r\n\r - consumption of probiotics, prebiotics or synbiotics without an appropriate 2 week\r washout period\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nDetection of A-synuclein Aggregate as Biomarker in Diagnosing Parkinson's Disease at Early Stage by Using Protein Misfolding Cyclic Amplification (PMCA)\n\n**Clinical Trial Summary:**\n\nThe study will investigate the biomarker of a-synuclein aggregate in CSF detected by protein\r misfolding cyclic amplification (PMCA) and its sensitivity and specificity in diagnosing\r Parkinson's disease at H-Y stage I and disease duration less than 1 year, compared with that\r from age-matched controls without neurodegeneration, those with Multiple System Atrophy (MSA)\r as a disease control with a-synucleinopathy, and those with Progressive Supranuclear Palsy\r (PSP) as a control with non-a-synucleinopathy neurodegeneration.\n\n**Clinical Trial Detailed Description:**\n\nThis will be an observational study aiming to develop the protein misfolding cyclic\r amplification (PMCA) technology that detects minute amounts of αSyn aggregates circulating in\r cerebrospinal fluid (CSF) as a novel assay with high sensitivity and specificity for the\r early diagnosis of PD. To achieve this goal, we will apply the PMCA to detect the αSyn\r aggregates in the CSF samples acquired from a discovery cohort that consist of\r well-characterized early PD patients (disease duration ≤1 year and Hoehn and Yahr Stage I,\r and DAT-PET and FDG-PET meet the imaging features of PD, n=75) and gender, age-matched\r healthy controls (n=38). Furthermore, we will confirm the findings in a separate confirmatory\r cohort with well-characterized early PD patients (disease duration ≤1 year and Hoehn and Yahr\r Stage I, and DAT-PET and FDG-PET meet the imaging features of PD, n=75), early multiple\r system atrophy (MSA) patients (disease duration ≤1 year, n=38), early progressive\r supranuclear palsy (PSP) patients (disease duration ≤1 year, n=38) and age-matched healthy\r controls (n=38). The sensitivity, specificity, positive predictive value, negative predictive\r value, and area under curve of the PMCA for the early diagnosis of PD will be calculated in\r the discovery cohort and be confirmed in the confirmatory cohort, respectively. In addition,\r the clinical characteristics, including motor and nonmotor symptoms of early PD, MSA and PSP\r patients in the two cohort will be comprehensively assessed at baseline and during\r followed-up. To assess the value of the PMCA technology in the evaluation of the disease\r severity and progress, we will perform the partial correlation analysis between clinical\r features of early PD patients and the PMCA T50 defined as the time needed to reach 50% of the\r maximum aggregation.\r\n\r Misfolded αSyn aggregates have the potential to serve as a biomarker for early PD. The PMCA\r technology could detect small quantities of misfolded αSyn aggregates by taking advantage of\r their ability to nucleate further aggregation, enabling a very high amplification of the\r signal. This study examines the effectiveness of using the PMCA as a novel technique for\r discriminating early PD from gender, age-matched healthy controls and other early\r parkinsonian disorders (MSA, PSP) by detecting small misfolded αSyn aggregates in CSF.\n\n**Clinical Trial Eligibility Criteria:**\n\nFor early PD patients\r\n\r Inclusion criteria:\r\n\r - Clinical diagnosis of \"probable PD\" by two neurologists specializing in movement\r disorders according to the International Parkinson and Movement Disorder Society (MDS)\r Clinical Diagnostic Criteria for PD (2015);\r\n\r - Age 50-75, disease duration is less than 1 year, and Hoehn & Yahr Stage I;\r\n\r - the dopamine reuptake transporter (DAT) is significantly reduced in striatum on PET\r imaging;\r\n\r - Metabolic brain network detected by\r fluorine-18-labelled-fluorodeoxyglucose-PET(18F-FDG PET) is consistent with\r Parkinson's disease-related pattern (PDRP), with FDG hypermetabolism being in basal\r ganglia and cerebellum;\r\n\r - Good response to anti-PD medications;\r\n\r - Ability of completing questionnaires;\r\n\r - Ability of providing informed consent;\r\n\r - Willingness of being assessed by neurologists during off-medication state defined as\r discontinuing anti-PD medications for at least 12 hours before assessment.\r\n\r Exclusion criteria:\r\n\r - Secondary parkinsonism (ie. drug induced);\r\n\r - Atypical parkinsonisms like MSA or PSP etc;\r\n\r - Presence of any item in 10 red flags of the MDS Clinical Diagnostic Criteria for PD\r (2015) in the comprehensive assessments during follow-up;\r\n\r - History of being diagnosed as any cancer within 5 years;\r\n\r - Presence of any condition risking the procedure of performing lumbar puncture (LP);\r\n\r - Pregnancy;\r\n\r - Inability to comply with study procedures.\r\n\r For early MSA patients\r\n\r Inclusion criteria:\r\n\r - Clinical diagnosis of \"probable MSA\" by two neurologists specializing in movement\r disorders according to the International Parkinson and Movement Disorder Society (MDS)\r second consensus criteria for MSA (2019);\r\n\r - Age 50-75, and disease duration is less than 1 year;\r\n\r - Metabolic brain network detected by\r fluorine-18-labelled-fluorodeoxyglucose-PET(18F-FDG PET) is consistent with MSA\r related pattern;\r\n\r - Ability of completing questionnaires;\r\n\r - Ability of providing informed consent;\r\n\r - Willingness of being assessed by neurologists during off-medication state defined as\r discontinuing anti-PD medications for at least 12 hours before assessment.\r\n\r Exclusion criteria:\r\n\r - Secondary parkinsonism (ie. drug induced);\r\n\r - History of being diagnosed as any cancer within 5 years;\r\n\r - Presence of any condition risking the procedure of performing lumbar puncture (LP);\r\n\r - Pregnancy;\r\n\r - Inability to comply with study procedures.\r\n\r For PSP patients\r\n\r Inclusion criteria:\r\n\r - Clinical diagnosis of \"probable PSP\" by two neurologists specializing in movement\r disorders according to MDS Clinical Diagnostic Criteria for PSP (2017);\r\n\r - Age 50-75, disease duration is less than 1 year;\r\n\r - Metabolic brain network detected by\r fluorine-18-labelled-fluorodeoxyglucose-PET(18F-FDG PET) is consistent with PSP\r related pattern;\r\n\r - Ability of completing questionnaires;\r\n\r - Ability of providing informed consent;\r\n\r - Willingness of being assessed by neurologists during off-medication state defined as\r discontinuing anti-PD medications for at least 12 hours before assessment.\r\n\r Exclusion criteria:\r\n\r - Secondary parkinsonism (ie. drug induced);\r\n\r - History of being diagnosed as any cancer within 5 years;\r\n\r - Presence of any condition risking the procedure of performing lumbar puncture (LP);\r\n\r - Pregnancy;\r\n\r - Inability to comply with study procedures.\r\n\r For controls without diagnosis of neurodegenerative disorders\r\n\r Inclusion criteria:\r\n\r - Age 50-75;\r\n\r - No history of neurodegenerative disease of the central nervous system;\r\n\r - No history of infective disease of the central system;\r\n\r - Ability of completing questionnaires;\r\n\r - Ability of providing informed consent.\r\n\r Exclusion criteria:\r\n\r - With prodromal symptoms of PD, such as rapid eye movement sleep behavior disorder\r (RBD);\r\n\r - History of being diagnosed as any cancer within 5 years;\r\n\r - Presence of any condition increasing the risk of the procedure of performing lumbar\r puncture (LP);\r\n\r - Pregnancy;\r\n\r - Inability to comply with study procedures.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)\n\n**Clinical Trial Summary:**\n\nThis phase II trial studies the effect of nivolumab in combination with blinatumomab compared\r to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL)\r that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in\r this study. Blinatumomab is an antibody, which is a protein that identifies and targets\r specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer\r cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a\r medicine that may boost a patient's immune system. Giving nivolumab in combination with\r blinatumomab may cause the cancer to stop growing for a period of time, and for some\r patients, it may lessen the symptoms, such as pain, that are caused by the cancer.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To compare rate of minimal residual disease (MRD) negative second remission (Rem-2) after\r up to two cycles of reinduction with blinatumomab versus (vs.) blinatumomab/nivolumab in\r Group 1 patients aged >= 1 to < 31 years old with first relapse of CD19+ B-ALL.\r\n\r II. To compare event-free survival (EFS) PI (EFS post-induction) between consolidation with\r blinatumomab vs. blinatumomab/nivolumab in Group 3 patients aged >= 1 to <31 years old with\r first relapse of CD19+ B ALL.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To evaluate the safety and tolerability of blinatumomab/nivolumab in patients aged >= 1 to\r < 31 years old with first relapse of CD19+ B ALL.\r\n\r II. To compare EFS post-induction between blinatumomab vs. blinatumomab/nivolumab in Group 2\r patients aged >= 1 to < 31 years old with first relapse of CD19+ B ALL.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. In Group 1 patients, compare EFS between blinatumomab monotherapy and\r blinatumomab/nivolumab arms as compared to similar patients treated on the predecessor trial\r AALL1331.\r\n\r II. In Group 1 patients, compare toxicity as defined by grade 3 or greater adverse events\r during the first cycle of blinatumomab or blinatumomab/nivolumab to similar patients treated\r with block 1 of cytotoxic chemotherapy on the predecessor trial AALL1331.\r\n\r III. In Group 2 patients with MRD >= 0.1% after vincristine sulfate, dexamethasone, pegylated\r asparaginase, and doxorubicin hydrochloride (VXLD), compare MRD negative second remission\r (Rem-2) rate after the first cycle of immunotherapy between blinatumomab monotherapy and\r blinatumomab/nivolumab arms.\r\n\r IV. In patients with Down syndrome (DS) with first relapse of B-ALL, describe the safety,\r tolerability and efficacy (as defined by MRD negative second remission, Rem-2) after up to\r two cycles of blinatumomab/nivolumab.\r\n\r OUTLINE: Patients >= 18 years old with marrow +/- extramedullary (EM) relapse of any duration\r after initial diagnosis, or patients < 18 years old with marrow +/- EM relapse < 24 months\r after initial diagnosis are assigned to Group 1. Patients < 18 years old with marrow +/- EM\r relapse >= 24 months from initial diagnosis, or all isolated extramedullary (IEM) relapses >=\r 1 to < 31 years old are assigned to Groups 2-3 re-induction. Patients with DS are assigned to\r Arm G. NOTE: Patients in Group 1 and DS patients with white blood cells (WBC) >= 30,000/uL,\r CNS 2/3 disease, or testicular disease must first receive 1 of 3 pre-immunotherapy\r treatments.\r\n\r PRE-IMMUNOTHERAPY TREATMENT FOR PATIENTS WITH WBC >= 30,000/uL: Patients receive methotrexate\r (MTX) intrathecally (IT) or cytarabine IT or intrathecal triple therapy (ITT) consisting of\r MTX, hydrocortisone sodium succinate, and cytarabine IT at the time of diagnostic lumbar\r puncture (LP) or on day 1 (if intrathecal therapy is given with relapse diagnostic LP < 7\r days prior to the start of protocol therapy). Patients also receive dexamethasone\r intravenously (IV) or orally (PO) twice daily (BID) on days 1-5, vincristine sulfate IV push\r over 1 minute or via infusion on day 1. Patients with DS also receive leucovorin calcium PO\r or IV every 6 hours (q6h) for 2 doses on day 2 or at 24 and 30 hours after each MTX or ITT\r dose. Patients should proceed to the next cycle when CNS 1 and no testicular disease is\r present, no sooner than Day 8 and no later than Day 15.\r\n\r PRE-IMMUNOTHERAPY TREATMENT FOR CNS 2/3 DISEASE: Patients receive MTX IT or cytarabine IT\r twice weekly (Q2W) for 5-7 doses or Intrathecal Triple Therapy (ITT) IT Q2W for 3-4 doses\r until patient is CNS 1. Patients with DS also receive leucovorin calcium PO or IV q6h for 2\r doses at 24 and 30 hours after each MTX or ITT dose. Patients should proceed to the next\r cycle when CNS 1 and no testicular disease is present, no sooner than Day 15 and no later\r than Day 24.\r\n\r PRE-IMMUNOTHERAPY TREATMENT FOR TESTICULAR DISEASE: Patients receive MTX IT, cytarabine IT,\r or ITT IT on days 1 and 15 (day 1 may be omitted if intrathecal therapy is given with relapse\r diagnostic LP < 7 days prior to the start of protocol therapy). Patients with DS also receive\r leucovorin calcium PO or IV q6h for 2 doses on days 2 and 16 or at 24 and 30 hours after each\r IT MTX or ITT dose. Males with testicular disease at relapse undergo radiation once daily\r (QD) for a total of 12 fractions over 12 days. Patients should proceed to the next cycle when\r CNS 1 and no testicular disease is present, no sooner than Day 15 and no later than Day 22.\r\n\r GROUP 1: Patients are randomized to Arm A or Arm B.\r\n\r ARM A: Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1, blinatumomab via\r continuous IV infusion on days 1-28 of cycles 1-2, MTX IT, cytarabine IT, or ITT IT on days 1\r and 15 of cycle 1 (MTX on day 1 may be omitted if intrathecal therapy is given with relapse\r diagnostic LP < 7 days prior to the start of protocol therapy), and MTX IT on days 1 and 15\r of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease\r progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop\r study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle\r 1 proceed to cycle 2.\r\n\r ARM B: Patients receive dexamethasone, blinatumomab, and MTX, cytarabine, or ITT as in Arm A.\r Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1\r and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease\r progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop\r study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle\r 1 proceed to cycle 2.\r\n\r GROUPS 2-3 REINDUCTION: Patients receive vincristine sulfate IV push over 1 minute or via\r infusion on days 1, 8, 15, and 22, dexamethasone PO or IV on days 1-14, doxorubicin\r hydrochloride IV over 1-15 minutes on day 1, MTX IT on days 1, 8, and 29 (day 1 may be\r omitted if intrathecal therapy is given with relapse diagnostic LP < 7 days prior to the\r start of protocol therapy) (days 8 and 29 for CNS 1/2 patients at relapse only), pegaspargase\r intramuscularly (IM) or IV over 1-2 hours on days 2 and 16, cytarabine IT on days 4 and 11\r (CNS 2 patients at relapse only), then Q2W until 3 consecutive samples are clear of blasts,\r and ITT IT on days 8, 15, 22, and 29 (CNS 3 patients at relapse only). Treatment continues in\r the absence of disease progression or unacceptable toxicity.\r\n\r GROUP 2: The following patients are randomized to Arm C or Arm D: 1) >= 1 to < 31 years old,\r IEM relapse < 18 months from diagnosis, regardless of MRD after Re-Induction. 2) < 18 years\r old with marrow relapse >= 24 to < 36 months from diagnosis regardless of MRD after\r Re-Induction, 3) >= 1 to < 31 years old, IEM relapse >= 18 months, and MRD >= 0.1% after\r Re-Induction, 4) < 18 years old with marrow relapse >= 36 months, and MRD >= 0.1% after\r Re-Induction.\r\n\r ARM C: Patients receive dexamethasone PO or IV on day 1 of cycle 1, blinatumomab via\r continuous IV infusion on days 1-28 of cycles 1 and 2, and MTX IT on days 1 and 15 of cycles\r 1 and 2 (day 1 may be omitted from cycle 1 if intrathecal MTX is given < 7 days prior to the\r start of cycle 1 ). Treatment repeats every 36 days for 2 cycles in the absence of disease\r progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop\r study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle\r 1 proceed to cycle 2.\r\n\r ARM D: Patients receive dexamethasone, blinatumomab, and MTX as in Arm C. Patients also\r receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle\r 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or\r unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop study treatment\r or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle 1 proceed to\r cycle 2.\r\n\r GROUP 3: The following patients are randomized to Arm E or Arm F: 1) >= 1 to < 31 years old\r with IEM relapse >= 18 months from diagnosis and MRD < 0.1% after Re-Induction, 2) < 18 years\r old with marrow relapse >= 36 months from diagnosis and MRD < 0.1% after Re-Induction.\r\n\r ARM E:\r\n\r IMMUNOTHERAPY CYCLES 1-2: Patients receive dexamethasone PO or IV on day 1 of cycle 1 only,\r blinatumomab IV via continuous infusion on days 1-28, and MTX IT on days 1 and 15 (day 1 may\r be omitted from cycle 1 if intrathecal therapy is given < 7 days prior to the start of this\r cycle).Immunotherapy Cycles 1-2 alternate with Continuation Cycles 1-2.\r\n\r CONTINUATION CYCLES 1-2: Patients receive dexamethasone PO on days 1-5, vincristine sulfate\r IV push over 1 minute or via infusion on day 1, mercaptopurine PO on days 1-42, MTX PO on\r days 8, 15, 29, and 36, cyclophosphamide IV over 15-30 minutes on days 43 and 50, etoposide\r IV over 90-120 minutes on days 43 and 50, thioguanine PO once daily (QD) on days 43-49, and\r cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 44-47 and 51-54. CNS 1/2\r patients at relapse also receive MTX IT on days 1 and 43 and PO q6h for 4 doses on day 22,\r and leucovorin calcium PO q6h for 2 doses on day 24. CNS 3 patients at relapse also receive\r ITT IT on days 1 and 43, intermediate dose MTX IV over 36 hours on day 22, and leucovorin\r calcium IV or PO q6h on days 24 and 25. Treatment repeats every 8 weeks for 2 cycles in the\r absence of disease progression or unacceptable toxicity.\r\n\r IMMUNOTHERAPY CYCLE 3: Patients receive blinatumomab IV via continuous infusion on days 1-28,\r and MTX IT on days 1 and 15.\r\n\r MAINTENANCE: Patients receive dexamethasone PO BID on days 1-5, 29-33, and 57-61, vincristine\r sulfate IV push over 1 minute or via infusion on days 1, 29, and 57, mercaptopurine PO on\r days 1-84, MTX IT on day 1 (CNS 1/2 patients at relapse only), ITT IT on day 1 (CNS 3\r patients at relapse only), and MTX PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.\r Treatment repeats every 12 weeks for 2 years from the start of Re-Induction therapy in the\r absence of disease progression or unacceptable toxicity.\r\n\r MAINTENANCE CHEMORADIATION (FOR CNS 3 PATIENTS ONLY): Beginning between the first and second\r cycles of maintenance therapy, patients receive dexamethasone PO BID on days 1-7 and 15-21,\r vincristine sulfate IV push over 1 minute or via infusion on days 1, 8, and 15, and\r pegaspargase IM or IV over 1-2 hours on day 1. Patients with CNS 3 and isolated CNS relapse\r undergo cranial radiation in the form of 3-dimensional (D)-conformal radiation therapy (CRT)\r over 5 days per week for a total of 10 treatments.\r\n\r ARM F:\r\n\r IMMUNOTHERAPY CYCLES 1-2: Patients receive dexamethasone PO or IV on day 1 of cycle 1 only,\r blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days\r 11-25 of cycle 1 and on days 1 and 15 of cycles 2 and 3, and MTX IT on days 1 and 15 (day 1\r may be omitted from cycle 1 if intrathecal therapy is given with < 7 days prior to the start\r of this cycle). Immunotherapy Cycles 1-2 alternate with Continuation Cycles 1-2.\r\n\r CONTINUATION CYCLES 1-2: Patients receive dexamethasone PO on days 1-5, vincristine sulfate\r IV push over 1 minute or via infusion on day 1, mercaptopurine PO on days 1-42, MTX PO on\r days 8, 15, 29, and 36, cyclophosphamide IV over 15-30 minutes on days 43 and 50, etoposide\r IV over 90-120 minutes on days 43 and 50, thioguanine PO QD on days 43-49, and cytarabine IV\r over 1-30 minutes or SC on days 44-47 and 51-54. CNS 1/2 patients at relapse also receive MTX\r IT on days 1 and 43 and PO q6h for 4 doses on day 22, and leucovorin calcium PO q6h for 2\r doses on day 24. CNS 3 patients at relapse also receive ITT IT on days 1 and 43, intermediate\r dose MTX IV over 36 hours on day 22, and leucovorin calcium IV or PO q6h on days 24 and 25.\r\n\r IMMUNOTHERAPY CYCLE 3: Patients receive blinatumomab IV via continuous infusion on days 1-28,\r nivolumab IV over 30 minutes on days 1 and 15 and MTX IT on days 1 and 15.\r\n\r MAINTENANCE: Patients receive dexamethasone PO BID on days 1-5, 29-33, and 57-61, vincristine\r sulfate IV push over 1 minute or via infusion on days 1, 29, and 57, mercaptopurine PO on\r days 1-84, MTX IT on day 1 (CNS 1/2 patients at relapse only), ITT IT on day 1 (CNS 3\r patients at relapse only), and MTX PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78.\r Treatment repeats every 12 weeks for 2 years from the start of Re-Induction therapy in the\r absence of disease progression or unacceptable toxicity.\r\n\r MAINTENANCE CHEMORADIATION (FOR CNS 3 PATIENTS): Beginning between the first and second\r cycles of maintenance therapy, patients receive dexamethasone PO BID on days 1-7 and 15-21,\r vincristine sulfate IV push over 1 minute or via infusion on days 1, 8, and 15, and\r pegaspargase IM or IV over 1-2 hours on day 1. Patients with CNS 3 and isolated CNS relapse\r undergo cranial radiation in the form of 3D-CRT over 5 days per week for a total of 10\r treatments in the absence of disease progression or unacceptable toxicity.\r\n\r ARM G (DS PATIENTS): Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1 only,\r blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 11\r and 25 of cycle 1 and days 1 and 15 of cycle 2, and MTX IT, cytarabine IT, or ITT IT on days\r 1 and 15 of cycle 1 (MTX on day 1 may be omitted if intrathecal therapy is given with relapse\r diagnostic LP < 7 days prior to the start of protocol therapy), MTX IT on days 1 and 15 of\r cycle 2, and leucovorin calcium IV or PO q6h for 2 doses on days 2 and 16.\r\n\r Patients with MRD < 0.01% are eligible to come off protocol therapy to receive Consolidation\r therapy at the end of Cycle 1, or may choose to proceed to Arm G, Cycle 2.\r\n\r After completion of study treatment, patients are followed up every 3 months for 1 year.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must be >= 1 and < 31 years at time of enrollment\r\n\r - Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in\r one of the following categories:\r\n\r - Isolated bone marrow relapse\r\n\r - Isolated central nervous system (CNS) (excluding known optic nerve/retinal and\r CNS chloromas) and/or testicular relapse\r\n\r - Combined bone marrow with extramedullary relapse in the CNS (excluding known\r optic nerve/retinal and CNS chloromas) and/or testes\r\n\r - Patients with Down syndrome (DS) are eligible in the following categories:\r\n\r - Isolated bone marrow relapse\r\n\r - Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS\r chloromas) and/or testicular relapse\r\n\r - Patients must have a performance status corresponding to Eastern Cooperative Oncology\r Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and\r Lansky for patients =< 16 years of age\r\n\r - Patients must have fully recovered from the acute toxic effects of all prior\r chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n\r - Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in\r the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19\r expression\r\n\r - Radiation therapy (RT): >= 3 months must have elapsed if prior RT. This includes\r any patient requiring urgent radiation to any sites of extramedullary disease\r prior to enrollment (e.g. retinal/optic nerve involvement)\r\n\r - Hematopoietic stem cell transplant (HSCT): Patients must not have had a prior\r hematopoietic stem cell transplant\r\n\r - A single intrathecal chemotherapy at the time of relapse will be allowed. If < 7\r days have elapsed between this intrathecal therapy (IT) and the start of protocol\r therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine,\r or triple intrathecal) may be omitted\r\n\r - In the 28 days prior to enrollment, up to five days of post-relapse,\r pre-enrollment therapy (steroid and/or hydroxyurea only) is permissible\r\n\r - Group 1 and Down syndrome patients who received pre-enrollment therapy and\r have a white blood count (WBC) >= 30,000/ul at the time of enrollment must\r receive protocol specified cytoreductive therapy with vincristine and\r dexamethasone, and no \"washout\" is required\r\n\r - Group 1 and Down syndrome patients who received pre-enrollment therapy and\r have a WBC < 30,000/ul at the time of enrollment must be given a 24 hour\r \"washout\" before starting immunotherapy\r\n\r - Note: There is no waiting period or \"washout\" for patients who relapse while\r receiving upfront therapy\r\n\r - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70\r mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows (within 5\r calendar days prior to enrollment):\r\n\r - Age: Maximum serum creatinine (mg/dL)\r\n\r - 1 to < 2 years: 0.6 (male), 0.6 (female)\r\n\r - 2 to < 6 years: 0.8 (male), 0.8 (female)\r\n\r - 6 to < 10 years: 1 (male), 1 (female)\r\n\r - 10 to < 13 years: 1.2 (male), 1.2 (female)\r\n\r - 13 to < 16 years: 1.5 (male), 1.4 (female)\r\n\r - >= 16 years: 1.7 (male), 1.4 (female)\r\n\r - Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by\r echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram\r\n\r - No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if\r there is clinical indication for determination.\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent\r\n\r - All institutional, Food and Drug Administration (FDA), and National Cancer Institute\r (NCI) requirements for human studies must be met\r\n\r Exclusion Criteria:\r\n\r - Patients with B-lymphoblastic lymphoma (B-LLy)\r\n\r - Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia\r\n\r - Patients with Philadelphia chromosome positive (Ph+) B-ALL\r\n\r - Patients with mixed phenotype acute leukemia (MPAL)\r\n\r - Patients with known Charcot-Marie-Tooth disease\r\n\r - Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,\r regardless of blast immunophenotype\r\n\r - Patients with active, uncontrolled infection defined as:\r\n\r - Positive bacterial blood culture within 48 hours of study enrollment\r\n\r - Receiving IV or PO antibiotics for an infection with continued signs or symptoms.\r Note: Patients may be receiving IV or oral antibiotics to complete a course of\r therapy for a prior documented infection as long as cultures have been negative\r for at least 48 hours and signs or symptoms of active infection have resolved.\r For patients with clostridium (C.) difficile diarrhea, at least 72 hours of\r antibacterial therapy must have elapsed and stools must have normalized to\r baseline.\r\n\r - Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with\r clinical signs of infection. Fever without clinical signs of infection that is\r attributed to tumor burden is allowed as long as blood cultures are negative for\r > 48 hours\r\n\r - A positive fungal culture within 30 days of study enrollment or active therapy\r for presumed invasive fungal infection\r\n\r - Active viral or protozoal infection requiring IV treatment\r\n\r - Patients known to have one of the following concomitant genetic syndromes: Bloom\r syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome\r or any other known bone marrow failure syndrome are not eligible. Of note, patients\r with known human immunodeficiency virus (HIV) infection on effective anti-retroviral\r therapy with undetectable viral load for at least the last 6 months prior to\r enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who\r have been treated and have no viral detectable burden are also eligible\r\n\r - Patients with significant central nervous system pathology that would preclude\r treatment with blinatumomab, including history of severe neurologic disorder or\r autoimmune disease with CNS involvement\r\n\r - Note: Patients with a history of seizures that are well controlled on stable\r doses of anti-epileptic drugs are eligible Patients with a history of\r cerebrovascular ischemia/hemorrhage with residual deficits are not eligible.\r Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible\r provided all neurologic deficits have resolved\r\n\r - Patients with an active known/suspected autoimmune disease are not eligible. However,\r patients with type I diabetes mellitus, hypothyroidism only requiring hormone\r replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring\r systemic treatment, or conditions not expected to recur in the absence of an external\r trigger are permitted to enroll\r\n\r - Group 1 and DS patients with known non-hematopoietic, non-CNS/testicular\r extramedullary disease (i.e., chloromatous disease) are not eligible\r\n\r - Note: Group 2 and 3 patients with known non-hematopoietic, non-CNS/testicular\r extramedullary disease (i.e., chloromatous disease) are eligible provided that\r this is NOT the only site of relapsed disease\r\n\r - Female patients of childbearing potential are not eligible unless a negative pregnancy\r test result has been obtained within 7 days prior to enrollment. Patients who are\r sexually active and of reproductive potential are not eligible unless they agree to\r use an effective contraceptive method for the duration of this study. Men with female\r partners of childbearing potential should use effective contraception during the\r duration of their treatment. The effect of blinatumomab on fertility has not been\r evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing\r potential (WOCBP) not using contraception. Females of reproductive potential must use\r effective contraception during treatment and for at least 48 hours after the last dose\r of blinatumomab. Studies in animal models have shown that nivolumab can adversely\r impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy.\r WOCBP receiving nivolumab must continue contraception for a period of at least 5\r months after the last dose of nivolumab. It is unknown whether nivolumab is present in\r breast milk, thus breastfeeding should be discontinued while a patient is receiving\r nivolumab. Men receiving nivolumab and who are sexually active with WOCBP must\r continue contraception for 7 months after the last dose of nivolumab\r\n\r - Lactating females are not eligible unless they agree not to breastfeed their infants.\r It is unknown whether blinatumomab or its metabolites are excreted in human breast\r milk. Women are not permitted to breastfeed while receiving blinatumomab and for the\r last 48 hours after the last blinatumomab dose. Due to the potential for serious\r adverse reactions in the breastfed infant, women are not permitted to breastfeed\r during treatment and for 5 months after the last nivolumab dose\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,796
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Combination Drug Including Fimasartan and Statins in Patients With Hypertension and Dyslipidemia\n\n**Clinical Trial Summary:**\n\nThe primary objective of this study is to evaluate the effectiveness of a combination drug\r containing fimasartan and statins on the control of hypertension and dyslipidemia, and the\r secondary objective is to evaluate the drug cost reduction effect, patients' satisfaction\r level and safety of the combination drug administration.\n\n**Clinical Trial Detailed Description:**\n\nThis study is designed as a non-interventional, multicenter, prospective observational study\r for patients with hypertension and dyslipidemia. If a patient voluntarily provides written\r consent to provide information for this study, the enrollment number will be assigned to\r subjects who meet the inclusion/exclusion criteria, and follow-up will be conducted for\r approximately 12 weeks. Pre-specified study-related data will be collected in the case report\r form during the observation period.\r\n\r This is an observational study, and the number or interval of subjects' visits to the\r hospital is determined by the investigators' clinical judgment under actual medical\r circumstances in principle. Whether to participate in this study will not affect the\r patients' treatment (physician's prescription or diagnostic, therapeutic decisions).\r\n\r The follow-up time points specified below indicate the time points of data collection. That\r is, the schedule of subjects' visits is freely determined by the investigators based on the\r medical condition of the subjects regardless of the follow-up time points specified in this\r protocol, but data that are generated during the study period and are deemed necessary in\r relation to the study may be collected in the case report form.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Participation in this study is possible only if all of the inclusion criteria below are\r satisfied.\r\n\r 1. Patients who provide written consent on the consent form for use of personal\r information after listening to explanations regarding the purpose, method, etc. of\r this study\r\n\r 2. Adult males and females aged 19 years or above\r\n\r 3. Patients who correspond to one of the following:\r\n\r 1. Patients who are planning to be treated with a combination drug containing fimasartan\r and statins after being newly diagnosed with essential hypertension and primary\r hypercholesterolemia\r\n\r 2. Patients who are planning to switch to a combination drug of fimasartan and statins,\r among those who have been diagnosed with essential hypertension or primary\r hypercholesterolemia and are receiving hypertension treatment that is containing an\r ARB or dyslipidemia treatment that is containing a statin\r\n\r 3. Patients who are planning to switch to a combination drug of fimasartan and statins,\r among those who have been diagnosed with essential hypertension and primary\r hypercholesterolemia and are receiving hypertension treatment that is containing an\r ARB and dyslipidemia treatment that is containing a statin 4. The following test\r results available within 4 weeks prior to the enrollment date\r\n\r - Total Cholesterol (TC)\r\n\r - HDL-C ③ Triglyceride (TG) ④ LDL-C or LDL-C (Friedewald formula*)\r\n\r - non-HDL-C (Total cholesterol - HDL-C (mg/dL)) *LDL-C = Total\r cholesterol - HDL-C - (triglyceride/5) (mg/dL)\r\n\r Exclusion Criteria:\r\n\r Patients cannot participate in this study if any of the following exclusion criteria is\r applicable.\r\n\r 1. Contraindication according to the drug labeling of the combination drug ingredients\r (fimasartan, amlodipine) for hypertension containing fimasartan\r\n\r 2. Contraindication according to the drug labeling of statins (rosuvastatin,\r atorvastatin)\r\n\r 3. Secondary hypertension or suspected secondary hypertension - Aortic coarctation,\r hyperaldosteronemia, renal artery stenosis, renal hypertension, pheochromocytoma,\r Cushing's syndrome, polycystic kidney disease, etc.\r\n\r 4. Secondary dyslipidemia or suspected secondary dyslipidemia\r\n\r - Nephrotic syndrome, dysproteinemia, obstructive liver disease, Cushing's syndrome,\r etc.\r\n\r 5. Patients currently hospitalized or scheduled to be hospitalized\r\n\r 6. If an investigational drug has been administered within 12 weeks of the enrollment\r date, or if participation in another clinical study during this study participation\r period is planned\r\n\r 7. Patients who are deemed ineligible for study participation at the discretion of the\r investigators for other reasons\r\n\r -\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,797
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEvaluation of Lymphedema Patients Status During Covid-19 Pandemic\n\n**Clinical Trial Summary:**\n\nThe pandemic, which started in China at the end of 2019, appeared in our country in a short\r time. Most hospitals and physicians were only concerned with the treatment of these patients.\r One of the most victimized patient groups in this duration was lymphedema patients who were\r in need of continuous follow-up and rehabilitation at necessary periods, but were also at\r risk in terms of covid-19 infection and could not go to hospitals unless necessary. The\r treatment of both primary and secondary lymphedema patients has been interrupted or delayed.\r This process has affected the health status, treatment processes and quality of life of the\r lymphedema patient group. The current situation may have caused them anxiety and depression\r as a result of infection fear. In this study, we aimed to evaluate the treatment processes,\r health status, coronavirus phobia, anxiety, and depression states of the lymphedema patients\r .\n\n**Clinical Trial Detailed Description:**\n\n60 primary and secondary lymphedema male and female patients with stage I,II,III lymphedema\r older than 18 years old over who were followed up in the lymphedema outpatient clinic of the\r Physical Medicine and Rehabilitation Clinic were included in the study.They were called by\r phone. Permission was asked for questioning from the patients reached. A hundred lymphedema\r patients were called and 60 patients were reached or agreed to be interviewed. The questions\r on the form and scales were read clearly to the patients who accepted the interview and were\r asked to be answered by the patient. The health status of the admitted patients during the\r covid-19 pandemic period and the treatment processes were questioned with the form we\r prepared.These forms were included socio-demographic features, physical, and detailed medical\r histories.Edema staging was evaluated by the International Society of Lymphology (ISL)\r lymphedema staging classification.This information was filled in from patients' files. The\r pandemic process was evaluated in the other part of the form. Working status, mobilization\r during the pandemic process, whether he/she or his/her relative was diagnosed with\r coronavirus infection, whether he/she received suplemental treatment, how much he/she paid\r attention to hand-foot hygine, whether his/her swelling increased, whether he/she had a\r cellulite attack, whether he/she regular self-manual lymphatic drainage and/or exercise, It\r was questioned whether there was an increase in a different symptom other than swelling,\r eating habits and weight gain, most recently whether he used pressure stocking regularly.In\r addition, the fear because of the covid-19 virus was questioned with the coronavirus-19\r phobia scale (CP19-S), quality of life with lymphedema quality of life arm / leg (LYMQOL),\r and anxiety and depression with the hospital anxiety and depression scale (HADS).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Primary or secondary lymphedema patients with stage I,II,II stage\r\n\r - Aged over 18 years old\r\n\r - Upper or lower extremity lymphedema\r\n\r Exclusion Criteria:\r\n\r - Patients under the age of 18\r\n\r - Patients who do not accept phone calls.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,798
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTechnology-based Analysis of Movement Disorders\n\n**Clinical Trial Summary:**\n\nObjectives: To generate pilot data to investigate the feasibility and the potential use in\r clinical practice of technology based objective measures of motor performances in patients\r affected by different movement disorders. To correlate kinematics findings with demographic\r and clinical details. Trial design and methods: Participants enrolled in prof. Bhatia's\r movement disorders clinic, will be classifies according to the main movement disorder,\r specifically, tremor, parkinsonism, dystonia, chorea, ataxia. In the study visit (one day\r only), they will undergo a clinical evaluation using the appropriate clinical scales\r (respectively, Fahn-Tolosa-Marin tremor rating scale, MDS-UPDRS Part III, Toronto Western\r Spasmodic Torticollis Rating Scale 2, Unified Hungtington Disease Rating scale and Scale for\r the Assessment and Rating of Ataxia) and a kinematic evaluation, using wearables and an\r infra-red and LED markers system. Then the protocol is concluded and they will continue the\r routine clinical follow-up\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - clinical diagnosis of parkinsonism and/or dystonia and/or tremor due to:\r\n\r 1. idiopatic parkinson's disease\r\n\r 2. atypical parkinsonism\r\n\r 3. sporadic or inherited/genetic dystonia\r\n\r 4. young-onset Parkinson's disease\r\n\r 5. Ataxia syndrome\r\n\r 6. Choereic syndrome\r\n\r 7. Essential tremor\r\n\r 8. Dystonic tremor\r\n\r - 18 to 80 years of age\r\n\r - Willing and able to provide informed consent\r\n\r - able to walk unassisted\r\n\r Exclusion Criteria:\r\n\r - Change in pharmacological therapy in the last 3 months.\r\n\r - Participated in a clinical drug trial up to 3 months before inclusion into the present\r study\r\n\r - Orthopaedical comorbidities affecting gait or posture.\r\n\r - Cognitive deficit\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,799
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAssessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain\n\n**Clinical Trial Summary:**\n\nDecathlon has developed kneeMID500-STRONG700 products which are two medical devices designed\r to be used for sport resumption after knee sprain.\r\n\r kneeMID500 device is intended to be used following a mild knee sprain. STRONG700 device is\r intended to be used following a moderate knee sprain.\r\n\r The difference between these devices is based on the strength of compression and the knee\r maintain.\r\n\r The objective of this multicentre study is to collect data on the related clinical\r complications and clinical outcomes of market-approved Decathlon kneeMID500-STRONG700\r products to demonstrate safety and performance of these devices in a real-world setting.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject is aged ≥18 years old\r\n\r - Subject has a recent mild (grade I) OR moderate (grade II) knee sprain\r\n\r - The current condition of his/her knee allows the subject to resume usual physical\r activity\r\n\r - Subject has been informed and is willing to sign an informed consent form\r\n\r - Subject is willing to comply with protocol requirements and return to the study center\r for all clinical evaluations and required follow-up (18 weeks)\r\n\r - Subject is affiliated to the French social security regime\r\n\r Non-inclusion Criteria:\r\n\r - Subject has conditions that may interfere with his/her ability to understand protocol\r requirements, participate in scheduled visits, or provide his/her informed consent\r\n\r - Subject has worn a support (knee brace or articulated orthosis) since his/her recent\r injury\r\n\r - Subject has resumed regular physical activity since his/her recent injury\r\n\r - Subject has any medical condition that could impact the study at investigator's\r discretion\r\n\r - Subject has a known hypersensitivity or allergy to the components of the device\r (polyamide, elastane, elastodiene)\r\n\r - Adult subject to a legal protection measure\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
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