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2021_conversational · 35.8k rows

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35,800	[ { "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 Training on Brain Activity During Postural Tasks in Older Adults\n\nClinical Trial Summary:\n\nOlder people show deficits in dynamic weight-shifting, as the investigators found that more\r time is needed to perform weight-shifts and the movements became less fluent and accurate in\r older versus younger adults. Deficits with weight-shifting in the mediolateral (left-right)\r direction have been linked to balance and falls in ageing. Balance control can be improved\r with training. Virtual reality (VR) based training programs for improving balance are gaining\r ground, as it can provide both fun and challenging balance tasks, enhancing motivation. The\r investigators demonstrated earlier that older adults show an overloaded neural activation\r pattern compared to young adults when performing the same VR-based mediolateral\r weight-shifting task (wasp game). What is yet unclear, is whether improved balance capacity\r can be gained with training and whether such an intervention impacts the underlying neural\r mechanisms. Using a combination of behavioral assessments and functional Near-Infrared\r Spectrocopy (fNIRS), the primary aim of this study is to investigate the effects of a\r VR-based weight-shift training and its underlying neural imprint in older adults. Next to the\r wasp game, a mediolateral tracking task will be used to standardize weight-shifting speed to\r allow a comparison of fNIRS data during stable weight-shifting performance. Furthermore, as a\r previous study done by the investigators also showed that adding an extra cognitive task in a\r so-called dual-task (DT) negatively affects weight-shifting performance, a secondary aim will\r be to test whether weight-shift training will enhance performance during such DT conditions.\r The results of this study may contribute to the future design of technology-based\r rehabilitation programs.\n\nClinical Trial Detailed Description:\n\nFor this study, 40 healthy older adults will be included. A previous fNIRS study done by the\r investigators (unpublished) revealed that our primary outcome, weight-shifting speed,\r improved from 0,0668 ± 0,0255 m/s to 0,0916 ± 0,0350 m/s. Based on Caljouw et al. (2016), the\r investigators expect a training effect size of 20%, resulting in a weight-shifting speed of\r 0.1094 ± 0,0418 m/s. Applying a power of 80% and alpha of 0.05 for a repeated measures ANOVA\r with a within-between interaction design (within: pre vs post; between: training vs control)\r the investigators calculated a total sample size of 40 participants (20 per group).\r Considering possible data exclusion due to fNIRS measurements, the collected fNIRS data will\r be monitored during recruitment, and more participants will be recruited if necessary.\r\n\r Prior to training on day 1, participants will be screened for inclusion based on the Montreal\r Cognitive Assessment (MoCA). Other cognitive assessments include the Flanker (inhibition),\r Set-Shifting (shifting attention), and Benton Judgement of Line Orientation (visuospatial\r ability) test, which will be administered on day 2. The Falls Efficacy Scale International\r (FES-I), a sarcopenia questionnaire (SARC-F), and the Pittsburgh Sleep Quality Index (PSQI)\r will also be administered on day 2 to assess fear of falling, sarcopenia, and the quality of\r sleep of the night between day 1 and day 2 of the experiment, respectively.\r\n\r For both weight-shifting assessment and training, the VR-based Wasp Game will be used. Before\r starting the Wasp Game, functional limits of stability (fLOS) will be assessed by asking the\r participant to move the Centre of Mass (CoM) as far as possible over its base of support in\r eight different directions by pushing a virtual bar away from the center position. Maximum\r CoM shifts will be calculated and used for personalized scaling of the Wasp Game. The Wasp\r Game was developed and piloted to meet the requirements for balance training for older people\r and can capture weight-shifting speed and accuracy as learning outcomes. In the Wasp Game,\r the player is in the middle of an area infested by wasps. By moving the CoM towards a\r pre-defined 80% of the fLOS, a water stream will come on to hit the wasp. The Wasp Game\r single-task (WASP-ST) involves hitting wasps in the mediolateral (ML) direction only. During\r the Wasp Game dual-task (WASP-DT), a serial subtraction task is added as the secondary task,\r whereby the red ball (representing the CoM) will change color from red to white and white to\r red within a random interval between 2-5 seconds. A starting number will appear on the screen\r for 1.5 seconds at the beginning of each trial. Every time the ball changes its color,\r subtractions have to be made in threes. Subjects will indicate the correct number afterward,\r so as not to disturb the fNIRS recording.\r\n\r During training on day 1, participants will perform 10 blocks of 2.5 min weight-shifting\r within the WASP-ST. Before, after, and 24h after training, balance performance will be\r assessed with the Mini Balance Evaluation Systems Test (MiniBEST), and weight-shifting\r ability with the fLOS, the WASP-ST, and WASP-DT. During the WASP-ST and WASP-DT, oxygenated\r (HbO2) and deoxygenated hemoglobin (HHb) will be assessed simultaneously by means of\r functional Near-Infrared Spectroscopy (fNIRS). To be able to compare HbO2 and HHb levels\r relative to a baseline, both the WASP-ST and WASP-DT will be offered in a block design of 20\r sec standing still and looking at a screen capture of the Wasp Game and 20 sec of\r weight-shifting within the Wasp Game, alternating in 10 trials. In addition, weight-shifting\r speed will be standardized by implementing a white ball that participants have to track in\r the ML direction, to be able to compare fNIRS data on similar behavioral performance. The\r same block design will be implemented for this task. Cortical regions assessed with fNIRS\r include the prefrontal cortex (PFC), frontal eye fields (FEF), premotor cortex (PMC),\r supplementary motor area (SMA), and supplementary sensory cortex (SSC). To ensure similar\r fNIRS recording on all test moments, only the optodes will be removed between pre and\r post-testing while the cap stays in place. Between post and retention testing, certain spots\r on the head (i.e. Cz) will be marked to guide cap placement on day 2. In a recent study,\r fNIRS was found to have adequate test-retest reliability.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Being able to independently stand upright > 5min\r\n\r Exclusion Criteria:\r\n\r - Visual impairment precluding following the targets on the screen\r\n\r - Cognitive impairment (MoCA<24/26?) / (MMSE<24)?\r\n\r - History of neurological disorders\r\n\r - Balance impairments (i.e. vestibular disorders)\r\n\r - Chronic musculoskeletal, cardiovascular and respiratory conditions\r\n\r - Diabetes related polyneuropathy\n\nPatient 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
35,801	[ { "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\nTelerehabilitation for Parkinson's Disease\n\nClinical Trial Summary:\n\nOur primary objective in this 10-week pilot study is to demonstrate the feasibility of using\r videoconferencing technology to provide Parkinson's Disease (PD) patients, alongside their\r supervising care partners, specialized physical and occupational therapy (PT/OT) focused on\r neurorehabilitation that ultimately aims to reduce fall risk. This therapy is similar to what\r a PD patient could receive in-person with neurologic-certified physical therapists and\r occupational therapists with significant experience working with PD patients and addressing\r their needs, but it is delivered through a virtual platform. Feasibility is defined by\r measures of adherence, retention, and safety.\r\n\r The specialized PT and OT measurement tools and strategies used in this study are in-line\r with the most current formal evidence-based guidelines/recommendations available for therapy\r in PD: European Physiotherapy Guideline for Parkinson's Disease, Parkinson Evidence Database\r to Guide Effectiveness (PD-EDGE) Task Force and Guidelines for Occupational Therapy in\r Parkinson's Disease Rehabilitation.\r\n\r The study duration is approximately 10 weeks of the primary telerehabilitation intervention\r and a 2 follow-up phone calls at the 3- and 6-month timepoints. There will be one baseline\r in-person evaluation and one final in-person evaluation following the completion of all\r televists. The enrollment target is up to 15-20 patient and care partner (P+CP) pairs,\r meaning 30-40 subjects total. There are no controls for this study.\n\nClinical Trial Detailed Description:\n\nGait dysfunction, postural instability, and freezing-of-gait (FOG) ultimately develop in\r about 80% of PD patients, which lead to falls and advancing disability. This is significant\r because the consequences of falls are far-reaching: accelerating immobility due to heightened\r fear-of-falling, reducing quality of life and independence, and increasing healthcare\r utilization and costs. Thus, there is an urgent need to expand evidence- based outpatient\r neurologic-PT/OT services to community-dwelling PD patients to reduce fall risk.\r\n\r This research proposal will address this unmet need by determining whether\r tele-neurorehabilitation is a care model that can be executed safety for PD patients to\r provide these services from well-trained therapists who are not easily accessible otherwise.\r This feasibility data is critical in the development of a novel tele-neurorehabilitation\r protocol and randomized-controlled efficacy trial thereafter.\r\n\r The impact of the intended research is to demonstrate the feasibility and preliminary\r efficacy of this novel teleconferencing-based delivery of gait and balance\r exercises/strategies with guided instruction much like one would receive in-person but in the\r comfort of one's own home. By demonstrating the feasibility and preliminary efficacy of this\r pilot program, subsequent long-term goals are to apply for larger sources of funding to\r sustain the program. By leveraging the data gained from these studies it is anticipated the\r practice of telerehabilitation will be expanded and improved; and ultimately its efficacy to\r health care policy providers and insurers for potential reimbursement will be demonstrated.\r\n\r The researchers intend to enroll 15-20 individuals with mild-moderate PD into our proposed\r novel telerehabilitation program, where patients will receive tele-PT/OT home visits and\r home-safety surveillance with neurologic-specialized therapists who are experienced with the\r core problem areas seen in PD patients. The intended clinical impact is to improve\r gait/balance function and postural stability, and thus reduce falls in patients with PD. With\r the remote telecommunications intervention, we aim to enable the additional clinical impact\r of expanding access to therapy for people with PD that otherwise would have significant\r difficulty obtaining this type of multiple-visit, individually-tailored, and specialized\r therapy care due to travel burden and cost.\r\n\r References:\r\n\r 1. Marras C, Beck JC, Bower JH, et al. Prevalence of Parkinson's disease across North\r America. NPJ Parkinsons Dis. 2018 Jul 10;4:21.\r\n\r 2. Macht M, Kaussner Y, Moeller JC, et al. Predictors of freezing in Parkinson's disease: a\r survey of 6,620 patients. Mov Disord. 2007; 22:953-956.\r\n\r 3. Hely MA, Morris JG, Reid WG, et al. Sydney Multicenter Study of Parkinson's disease:\r non-L-dopa-responsive problems dominate at 15 years. Mov Disord. 2005; 20:190-199.\r\n\r 4. Poewe W. The natural history of Parkinson's disease. J Neurol. 2006 Dec;253 Suppl\r 7:VII2-6.\r\n\r 5. Low V, Ben-Shlomo Y, Coward E, et al. Measuring the burden and mortality of\r hospitalization in Parkinson's disease: A cross-sectional analysis of the English\r Hospital Episodes Statistics database 2009-2013. Parkinsonism Relat Disord. 2015\r May;21(5):449-54.\r\n\r 6. Wielinski Cl, Erickson-Davis C, Wichmann R, et al. Falls and injuries resulting from\r falls among patients with Parkinson's disease and other Parkinsonian syndromes. Mov\r Disord. 2005;20:410-415.\r\n\r 7. Pressley JC, Louis ED, Tang MX, et al. The impact of comorbid disease and injuries on\r resource use and expenditures in parkinsonism. Neurology. 2003 Jan 14;60(1):87-93.\n\nClinical Trial Eligibility Criteria:\n\nSubject Inclusion Criteria:\r\n\r 1. Subject's age is greater than or equal to 18.\r\n\r 2. Subject has a diagnosis of Idiopathic Parkinson's Disease according to established\r criteria and this has been confirmed by a Movement Disorders Neurologist.\r\n\r 3. Subject's Movement Disorders Neurologist believes he/she would benefit from\r specialized physical and occupational therapy to reduce fall risk.\r\n\r 4. Subject's Idiopathic Parkinson's Disease is Hoehn and Yahr stage 2 or 3 in the\r \"OFF\"-medication state (stage 2 defined by bilateral or midline symptoms with less\r than or equal to 2 steps back on the pull test with self-recovery; stage 3 is defined\r by more than 2 steps back on the pull test with or without self-recovery, or no steps\r back and requiring assistance to recover).\r\n\r 5. Subject demonstrates the ability to utilize the virtual platform at their initial\r in-person evaluation.\r\n\r 6. Subject has been on a stable medication regimen for the treatment of Idiopathic\r Parkinson's Disease for the month preceding the baseline in-person visit, and has the\r ability to maintain stable dosing for the duration of the 10-week primary\r intervention.\r\n\r 7. Subject has home Wi-Fi access for the tele-neurorehabilitation home visits and a\r personal tablet with Wi-Fi connectivity.\r\n\r Care Partner Inclusion Criteria:\r\n\r 1. Care partner's age is greater than or equal to 18.\r\n\r 2. Care partner has been the primary caregiver for >6 months and will remain so for at\r least 10 weeks to the study subject.\r\n\r 3. Care partner has the ability and desire to participate in all of the study visits with\r the study subject, including the tele-neurorehabilitation home visits.\r\n\r 4. Care partner has the ability and desire to provide stand-by assistance, but in the\r setting of a gait belt, to the study subject during tele-neurorehabilitation home\r visits.\r\n\r Subject Exclusion Criteria:\r\n\r 1. Subject is non-English speaking.\r\n\r 2. Subject has only a provisional diagnosis of Idiopathic Parkinson's Disease or atypical\r features suggestive of an alternative diagnosis.\r\n\r 3. Subject has and additional significant neurologic diagnosis that may render him/her\r with neurologic deficits that may affect gait and balance.\r\n\r 4. Subject has another destabilizing chronic medical condition which may warrant frequent\r hospitalization or render the patient unable to participate in physical activity.\r\n\r 5. Subject requires more than just stand-by assistance for gait and balance.\r\n\r 6. Subject is reliant on mobility devices to walk (walkers, cane, walking sticks,\r motorized scooter, etc).\r\n\r 7. Subject is receiving physical therapy elsewhere during the month preceding the study\r and during the duration of the study.\r\n\r 8. Subject has no care partner available to participate in all of the study visits.\r\n\r 9. Subject is unable to follow direction or consent to research.\r\n\r 10. Subject is unable to commit to the study-related activities and/or schedule of events.\r\n\r Care Partner Exclusion Criteria:\r\n\r 1. Care partner is non-English speaking.\r\n\r 2. Care partner is unable to follow direction or consent to research.\r\n\r 3. Care partner is unable to commit to the study-related activities and/or schedule of\r events.\n\nPatient 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
35,802	[ { "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\nOnline Motor Control in People With Parkinson's Disease\n\nClinical Trial Summary:\n\nThis study aims to better understand how people with Parkinson's control reaching movements.\r Specifically, we are asking how these individuals respond to different environmental\r perturbations. Testing includes reaching movements made within a virtual reality set-up.\n\nClinical Trial Detailed Description:\n\nParkinson's disease (PD) is the second most common neurodegenerative disease, affecting\r approximately up to 10 million people worldwide and with 60,000 new cases diagnosed annually\r in the U.S. alone. Some of the most common signs and symptoms in individuals with PD are\r slowed and small movements and difficulty in movement initiation. The ability to correct\r movements online in response to environmental changes is an important part of daily living.\r Online movement corrections in reaching refer to the ability to smoothly change how and where\r you reach in response to a change in the environment. For example, one can adjust the\r position of the hand and arm when trying to catch a butterfly flying in the air. Generally\r speaking, online movement corrections can happen in response to visual perturbations (e.g.,\r trying to catch a butterfly) or to force perturbations (e.g., someone knocks your hand while\r you're holding a coffee mug). Since individuals with PD have trouble with movements, it\r stands to reason that they may have problems with online movement corrections. Surprisingly,\r very little is known about online movement corrections in individuals with PD. The current\r evidence suggests that individuals with PD can make online movement corrections to small\r visual perturbations, but whether they can successfully respond to large visual perturbations\r is debatable. Furthermore, whether individuals with PD can make online movement corrections\r to force perturbations has not been studied. The aim of this project is to investigate if\r individuals with PD can make online movement corrections during reaching to visual and/or\r force perturbations. We will test both individuals with PD and age-matched healthy controls.\r They will perform reaching movements while visual or force perturbations are applied. We will\r use various perturbation strengths in order to test for potential differences in responses to\r small and large perturbations. Results from this study will provide new information on how\r individuals with PD make online movement corrections, and possibly provide insight to\r improving rehabilitation for PD.\n\nClinical Trial Eligibility Criteria:\n\nInclusion criteria (all participants):\r\n\r - Age 18-85 years\r\n\r - Able to perform reaching movements of ~20 cm (8 inches)\r\n\r - MMSE score ≥ 26/30\r\n\r - Willing and able to attend all testing sessions\r\n\r Inclusion criteria (PD group only):\r\n\r - Diagnosis of idiopathic Parkinson's disease per self report\r\n\r - Currently taking dopaminergic/dopamine agonist medication\r\n\r Exclusion criteria (all participants):\r\n\r - Any chronic or recent upper extremity musculoskeletal conditions that affects reaching\r\n\r - Any neurological disorders other than Parkinson's disease (e.g., seizure disorders,\r closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm,\r history of stroke)\n\nPatient 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
35,803	[ { "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\nAssessing the Polygenic Burden of Rare Disruptive Mutations in Parkinson's Disease\n\nClinical Trial Summary:\n\nThe project intends to assess the polygenic burden of rare disruptive mutations in\r Parkinson's disease (PD) and how they influence the phenotype/pathological heterogeneity of\r disease.\n\nClinical Trial Detailed Description:\n\nThe investigators intend to extend the genetic analysis to a cohort of 300 PD cases and 300\r healthy subjects (wife / husband of the patients) that will be recruited at Scientific\r Institute for Research, Hospitalization and Healthcare (IRCCS) Neuromed.\r\n\r After signed informed consent patients will be assessed for disease progression (Hoehn and\r Yahr stadium, Movement Disorder Society-Unified Parkinson's Disease Rating Scale part III\r (MDS-UPDRS), Montreal Cognitive Assessment (MoCA) test, no motor symptoms, therapy and\r levodopa induced Dyskinesia (LID) occurrence). Each patient and control will be subjected to\r peripheral blood sampling for the isolation of DNA, RNA, plasma and serum. The investigators\r will use a disease-specific gene panel including about 100 genes related to Parkinson's\r Disease, autophagy and levodopa induced Dyskinesia (LID).\r\n\r Bioinformatics analysis will allow to catalog in a database the identified variants/mutations\r according to their frequency and characteristics.\r\n\r The investigators will specifically assess if the inheritance of multiple rare deleterious\r variants in Parkinson's Disease genes is predictive of disease risk.\r\n\r The presence of one or more variants will be tested for association with phenotypic\r manifestation of Parkinson's Disease (motor, non-motor, and cognitive signs, as well as age\r at onset, LID and neuroimaging changes) to assess the variant burden effect on progression,\r and prognosis of the disease.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Presence of at least two out the following cardinal signs: resting tremor, cogwheel\r rigidity, bradykinesia, asymmetrical onset of symptoms and symptomatic response to\r L-dopa (levodopa).\r\n\r Exclusion Criteria:\r\n\r - Previous thalamotomy on the implanted sides;\r\n\r - Significant brain atrophy or structural damage seen on CT or MRI;\r\n\r - Marked cognitive dysfunction;\r\n\r - Active psychiatric symptoms;\r\n\r - Concurrent neurological disorders;\r\n\r - Other uncontrolled medical disorders.\n\nPatient 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
35,804	[ { "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\nDECLIC Patient Education Program : Assessment Through a Population Health Intervention Research Approach (LE DECLIC EPRI)\n\nClinical Trial Summary:\n\nCancer pain is a frequent symptom, reported by 20 to 70% of patients in any stage of the\r cancer disease : 60 to 70% in the advanced stage of the disease and 20 to 40% among the\r survivors. Among patients who report pain, 40% report undertreated pain. Strengthening Pain\r management in cancer is a specific objective of the French Cancer Plan. Providing patient\r education for cancer pain management is recommended since small to moderate efficacy of\r patient education on pain intensity and interference was found in all meta-analysis. An\r effect size comparable with some analgesic agents. However, recommendations suggest\r improvement in order to increase effectiveness and population reach of those interventions.\r The DECLIC EPRI intervention aim at addressing all the issues raised by patient education for\r cancer pain management. It was developed according to the framework of Michie's Behavior\r change wheel theory.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Patient aged over 18.\r\n\r 2. Followed in the participant comprehensive cancer center.\r\n\r 3. All cancer types, location and stage.\r\n\r 4. Patient under any anticancer treatment (including hormonal therapy) and has stopped\r his treatment in less than a year.\r\n\r 5. Patient experiencing cancer pain and/or his treatments for 3 months or more.\r\n\r 6. All previous and concomitant treatments are accepted.\r\n\r 7. Participation to another clinical trial is accepted.\r\n\r 8. Patient has accepted to participate to the study and signed informed consent form or\r his legal representative.\r\n\r 9. Patient affiliated to the social security healthcare.\r\n\r Exclusion Criteria:\r\n\r 1. Cognitive impairment preventing to understand the patient education program.\r\n\r 2. Language barrier preventing to understand the patient education program.\r\n\r 3. Physical impairment preventing patient to attend to the patient education program.\n\nPatient 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
35,805	[ { "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 Role of Glycocalyx Integrity in the Primary Prevention of Major Cardiovascular Events\n\nClinical Trial Summary:\n\nWe intend to recruit individuals who are referred for a routine screening in the primary\r prevention outpatient clinic of Attikon University hospital, Athens According to\r institutional protocols, a detailed medical history for atherosclerotic risk factors and\r current medication is recorded and a baseline clinical examination is performed. Moreover\r fasting blood samples are drawn to diagnose the presence of diabetes mellitus and\r hyperlipidemia. Glycocalyx examination is performed at the same visit. The subjects are\r revaluated at one month and then followed up according to the attending physician's\r instructions. All subjects are followed up for adverse events (death, stroke, myocardial\r infarction, hospitalization for heart failure) for 6 years after enrollment via telephonic\r contact and planned appointment at the outpatient clinic.\n\nClinical Trial Detailed Description:\n\nBlood pressure is measured in each subject with the aid of a digital oscillometric\r sphygmomanometer (TensioMed, Budapest Hungary, Ltd). Each subject rests in a quiet room at\r 25°C for 30 minutes before the examination. The cuff is placed in the right arm, while the\r subject is seated. The diagnosis of hypertension is made on the basis of:1) systolic blood\r pressure ≥140 mmHg/diastolic blood pressure ≥90 mmHg after 3 consecutive measurements or 2)\r the participant is receiving antihypertensive treatment. Moreover fasting blood samples are\r drawn to identify the presence of diabetes mellitus and hyperlipidemia in our sample.\r Specifically, DM is determined by either plasma glucose ≥ 126 mg/dl measured by the enzymatic\r in vitro test (Roche, automatic chemistry clinical analyzer) or treatment with antidiabetic\r agents . Similarly, hyperlipidemia was defined by either Total Cholesterol ≥230 mg/dl, and/or\r LDL ≥160 mg/dl, and /or TGs ≥200 mg /dl measured by the colorimetric spectrophotometry (Roche\r Diagnostics) or the use of lipid lowering agents according to the running guidelines held\r during the initial examination. Additionally, smokers are considered only those participants\r who are actively smoking at the time of enrollment . Also, the presence of positive family\r history of coronary artery disease is defined as coronary disease in a first degree female\r relative before 65 years or a male relative before 55 years of age. BMI is calculated as the\r ratio of weight (kg) to the square of height (m2). Furthermore, we use the SCORE estimation\r system to calculate the 10-year cardiovascular risk for each participant.\r\n\r As far as ethnicity is concerned, an individual is not considered Greek in case he/she was\r born abroad and also has at least a foreigner parent or he/she is born in Greece but both\r parents were foreigners. Inversely, a subject was considered Greek if they and simultaneously\r both parents were born in Greece.\r\n\r Exclusion criteria are the history of Coronary artery disease (CAD), Peripheral Arterial\r Disease (PAD), Heart failure (HF), Stroke, hepatic or renal failure, active neoplasia and\r poorly controlled DM, defined as Hba1C>7%.\r\n\r ENDOTHELIAL GLYCOCALYX EVALUATION We quantify the perfused boundary region (PBR, measured in\r μm) of the sublingual microvasculature by using Sideview Darkfield Imaging (Microscan,\r Glycocheck, Microvascular Health Solutions Inc., Salt Lake City, UT, USA) . Briefly, SDF\r camera utilizes green reflected light emitting diode (LED) light (540 nm) from hemoglobin\r molecules to depict the radial displacements of RBCs within the microvessels . The camera is\r inserted under the tongue and captures more than 3000 vascular segments of vessels with\r diameter ranging from 5 μm to 25 μm. The images are obtained automatically by the Glycocheck\r software . Afterwards the system checks the quality of the recordings and selects the valid\r frames (contrast enhancement greater than 60%), which are going to be further analyzed . The\r RBC column width, as well as the total perfused diameter of microvessels is estimated by the\r software with high accuracy. Then PBR is calculated by the formula [Perfused Diameter- RBC\r column width]/2.The software also provides the PBR of vessels with diameter 5-9μm, 10-19μm,\r 20-25μm and the mean 5-25μm As a result, PBR expresses the outer area of the vessels' lumen\r that is vulnerable to RBC penetration and is consistent with the integrity of glycocalyx\r layer. Thus, high PBR values are considered as indicator of damaged endothelial glycocalyx\r with affected barrier properties, which allows high spatio-temporal distribution of RBCs. On\r the other hand Conversely, low PBR values are associated with robust thick glycocalyx layer.\r The whole procedure lasts for approximately 3 minutes, does not require high expertise, is\r operator independent, has satisfactory reproducibility and thus is highly recommended as a\r validated technique for the assessment of endothelial glycocalyx function . The PBR\r measurements are independent of red blood cell filling of the vessels segments (hematocrit),\r because the software only includes vessel segments that have a filling percentage of more\r than 50%. Hence, vessel segments are only selected when at least 11 of the 21-line markers\r have a positive signal for the presence of an erythrocyte. Thus, PBR values are independent\r of hematocrit, reflecting a damaged glycocalyx that is more accessible for circulating\r erythrocytes .\r\n\r In our study the evaluation of PBR takes place between 9:00 and 11:00, after 8 hours fasting\r and abstinence from alcohol and smoking and temporary discontinuation of medications for 48 h\r before the examination as well.\r\n\r FOLLOW UP We perform a follow up of our study cohort 6 years after the recruitment via\r telephonic contact and planned appointment at the outpatient clinic. Briefly, at the\r reevaluation the participants or their legal representatives - in case of inability or death-\r are asked for the incidence of major cardiovascular events or death attributed to any cause.\r The primary composite outcome of major adverse events consists of death, myocardial\r infarction (ICD-10: DI20-22), stroke (ICD-10: DI60-68; DG45) and hospitalization for heart\r failure (ICD-10: DI50-51; DI42; DI11). Each of the forenamed events is documented by hospital\r medical records or attending phycians' letters and confirmed by the national security\r electronic records using the appropriate ICD10.\r\n\r STATISTICAL ANALYSIS\r\n\r Statistical analysis is performed by SPSS version 25 (IBM SPSS Statistics, Inc., Chicago, IL)\r and Stata version 16 (StataCorp LP, College Station, TX). Scale variables are presented as\r mean ±SD in case of normal distribution, as determined by the normality tests\r Kolmogorov-Smirnov test and Shapiro-Wilk, or as medians and interquartile ranges in case of\r non-normal distribution. Nominal variables are expressed as frequencies and percentages.\r Scale variables are compared using independent samples Student's t tests or Mann-Whitney\r tests as indicated, whereas categorical variables are compared using Chi-square tests or\r Fisher's exact tests, as appropriate. In addition, patients are dichotomized based on the\r mean values of PBR for the sublingual microvessel diameter 5-25μm, 5-9 μm, 10-19 μm, and\r 20-25 μm . Cox proportional hazard models are built for each variable to decide whether any\r of mean values of the above PBR categories can serve as an independent predictor of major\r cardiovascular events or death at a significance level of p value<0.05. Cumulative event\r rates are calculated using the Kaplan-Meier survival analysis for subjects with lower vs\r higher mean PBR value. The log-rank test for time-to-event data with respect to the total\r events is used for comparison of these two groups. Cox proportional hazard models are built\r for each possible risk factor in relation to the study endpoints. Estimated hazard ratios and\r their respective 95% confidence intervals are obtained. P value<0.05 are considered\r significant. Multivariate analysis include factors with proven clinical value or p value ≤0.1\r at univariate analysis. Moreover, we compare chi-square values of multivariate models before\r and after adjusting for PBR. Chi square change with p value<0.05 is considered significant.\r Furthermore, we calculate the net reclassification index (NRI) and Harrell's C to evaluate\r improvement in risk prediction by PBR and p value<0.05 is considered significant.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r We recruit individuals who were referred for a routine screening in the primary prevention\r outpatient clinic of Attikon University hospital.\r\n\r Exclusion Criteria:\r\n\r - History of Coronary artery disease,\r\n\r - History of Peripheral Arterial Disease,\r\n\r - History of Heart failure\r\n\r - History of Stroke\r\n\r - hepatic failure\r\n\r - renal failure,\r\n\r - active neoplasia\r\n\r - poorly controlled DM, defined as Hba1C>7%\n\nPatient 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
35,806	[ { "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\nResearch on the Effect and Mechanism of Aerobic Exercise on PD\n\nClinical Trial Summary:\n\nThis trial is expected to recruit patients with primary Parkinson's disease and give them\r four consecutive weeks of aerobic exercise to observe its effect on Parkinson's disease and\r explore its mechanism\n\nClinical Trial Detailed Description:\n\nThis trial is expected to recruit patients with primary Parkinson's disease who are\r distributed into tremor group and stiff group and give them the same kind of four consecutive\r weeks of aerobic exercise to observe its effect on Parkinson's disease and explore its\r mechanism\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Participants were diagnosed primary PD according to the 2015 MDS diagnostic criteria\r\n\r - Participants are between 55 and 65 years old\r\n\r Exclusion Criteria:\r\n\r - Severe heart\r\n\r - liver dysfunction\r\n\r - kidney dysfunction\r\n\r - severe cognitive dysfunction\r\n\r - severe anxiety and depression\r\n\r - history of mental illness\r\n\r - history of cerebral infarction or ischemic attack in the past three months\r\n\r - acute myocardial infarction or acute coronary in the past three months\r\n\r - Parkinson's Pulse syndrome\r\n\r - medication history (drugs that improve blood circulation in the brain and increase the\r excitability of the nervous system)\n\nPatient 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
35,807	[ { "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\nPatient Perception Between Two Emergency Treatments of Symptomatic Irreversible Pulpitis.\n\nClinical Trial Summary:\n\nTo evaluate in a comparative way the perception of the patient who comes with pain due to\r irreversible pulpitis in a tooth and who receives two types of treatment: complete pulpectomy\r (or control group) or pulpotomy (or experimental group).\r\n\r Prospective randomized and multicenter study. It will be carried out in 4 centers of similar\r socio-professional characteristics, with the same operative protocol. On a significant sample\r of emergency patients with a concrete clinical manifestation of symptomatic irreversible\r pulpitis, one type of intervention or another will be performed randomly. The data will be\r collected by means of a visual numeric scale (NRS).\r\n\r The null hypothesis is that both interventions provide the same reduction of pain in patients\r who present symptomatic irreversible pulpitis.\r\n\r All the patients who come to one of the private centers with irreversible pulpitis and who\r meet the defined criteria for inclusion and exclusion will be selected.\r\n\r The type of procedure that will be performed in the control group will be the complete\r removal of the pulp by means of a defined instrumentation technique, also called Pulpectomy.\r The procedure to be performed in the experimental group will be the removal of the pulp only\r at coronal level, also called Pulpotomy. The interventions will be assigned randomly and the\r \"List Randomizer\" (random.org) will be used for the randomization.\n\nClinical Trial Detailed Description:\n\nClinical procedure will be the same in both groups with regard to the anesthetic technique,\r and the cavity access and provisional closure of the aperture. The characteristics of both\r interventions will be described in detail in order to homogenize the procedures. The patient\r will be conveniently informed before requesting his/her Informed Consent for his/her\r voluntary participation in the study. Their identification data will be treated in accordance\r with the provisions of Regulation (EU) 2016/679 of the European Parliament and Council of\r April 27, 2016, and the Organic Law 3/2018 of 5/12, currently in force, will remain in\r custody at the Center where they receive treatment and will not be shared by the other\r centers of the study.\r\n\r The patient will not be aware of the type of procedure he has been assigned for and will\r express in a numerical scale according to his perception of the pain on 4 occasions: before\r starting treatment, at 8-12, 24 and 72 hours after treatment. Likewise, right after receiving\r the treatment, he will answer some questions related to the degree of comfort during the\r treatment and about his perception of the time of the intervention.\r\n\r Data sheets will be collected and treated statistically.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patient in American Society of Anesthesiologists I or II condition.\r\n\r - Patient who comes to the emergency room with irreversible pulpitis in a single tooth.\r\n\r - Patients of age >20 years.\r\n\r - Positive response to the vitality test and bleeding after pulp exposure.\r\n\r Exclusion Criteria:\r\n\r - American Society of Anesthesiologists patients>II.\r\n\r - Pharmacological allergies that contraindicate the intervention.\r\n\r - Teeth with negative vitality test and no bleeding after pulp exposure.\r\n\r - Signs of concomitant periodontal infection such as swelling or fistula.\r\n\r - Teeth with immature roots.\r\n\r - Patients who are medicated with anxiolytics.\r\n\r - Abuse of psychotropic drugs or medication that may alter the perception of pain 15\r days before the intervention.\r\n\r - Pregnant or breast-feeding women.\r\n\r - Interventions with conscious sedation.\r\n\r - Pathological mental state (dementia, psychosis).\r\n\r - Lack of collaboration or non-acceptance of the consent of the study.\n\nPatient 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
35,808	[ { "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\nLong-term Effects of Combined Balance and Brisk Walking in Parkinson's Disease\n\nClinical Trial Summary:\n\nParkinson's disease (PD) is a progressive neurodegenerative disease characterized with both\r clinical motor and non-motor features, as well as decrease in balance performance and walking\r endurance. The non-motor symptoms such as depression, anxiety, sleep disturbance and fatigue\r wound impose negative impacts on the quality of life of the individuals with PD. Aerobic\r endurance training can improve physical capacity and reduce those non-motor symptoms such as\r mood and sleep disorders. Based on the results of our recent pilot study, brisk walking is a\r safe and moderate-level aerobic walking exercise for improving walking capacity in the PD\r population up to 6 week after treatment ended. Community-based balance training could also\r enhance balance performance and dual-task gait performance up to 12-month follow-up for\r people with PD. The primary purpose of this proposed study is to investigate the short- and\r long-term effects of a 6-month balance and brisk walking programme in alleviating non-motor\r and motor symptoms in people with PD. The secondary objective is to examine the short- and\r long-term effects of a 6-month balance and brisk walking program on enhancing walking\r capacity, balance performance, and quality of life.\n\nClinical Trial Detailed Description:\n\n\n\nClinical 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 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\nPatient 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
35,809	[ { "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\nAdaptive Deep Brain Stimulation to Improve Motor and Gait Functions in Parkinson's Disease\n\nClinical Trial Summary:\n\nThis is a single-center phase I clinical study aiming to improve gait functions in patients\r with Parkinson's disease (PD) by using adaptive neurostimulation to the pallidum. The\r investigators will use a bidirectional deep brain stimulation device with sensing and\r stimulation capabilities to 1) decode the physiological signatures of gait and gait\r adaptation by recording neural activities from the motor cortical areas and the globus\r pallidus during natural walking and a gait adaptation task, and 2) develop an adaptive deep\r brain stimulation (DBS) paradigm to selectively stimulate the pallidum during different\r phases of the gait cycle and measure improvements in gait parameters. This is the first\r exploration of network dynamics of gait in PD using chronically implanted cortical and\r subcortical electrodes. In addition to providing insights into a fundamental process, the\r proposed therapy will deliver personalized neurostimulation based on individual physiological\r biomarkers to enhance locomotor skills in patients with PD. Ten patients with idiopathic\r Parkinson's disease undergoing evaluation for DBS implantation will be enrolled in this\r single treatment arm study.\n\nClinical Trial Detailed Description:\n\nThis study will allow the investigators to evaluate the efficacy of an adaptive stimulation\r paradigm in deep brain stimulation (DBS) to treat motor-related behaviours and motor skill\r learning in Parkinson's disease (PD). Parkinson's disease patients will be implanted\r unilaterally or bilaterally with a totally internalized bidirectional neural interface,\r Medtronic Summit RC+S.\r\n\r While current DBS therapy improves motor symptoms of PD, it does not address problems with\r acquiring additional motor skills (i.e. adapting gait patterns to avoid falls)) in PD,\r therefore, limiting benefits of physical rehabilitation programs aimed at improving mobility.\r Motor skill learning is critical in acquiring any new behaviors related to motor function.\r The overall objective is to identify personalized electrophysiological signatures of motor\r skill learning in PD patients and use adaptive control algorithms to enhance these\r signatures. The study will discover new ways to rehabilitate the disease brain circuits using\r adaptive neuromodulation.\r\n\r In a small, double-blinded trial, ten patients with idiopathic PD and motor fluctuations will\r be implanted with unilateral or bilateral RC+S devices, each connected to a standard\r quadripolar DBS lead implanted in the basal ganglia, along with a 4-contact paddle type\r electrode placed subdurally over the motor cortex. The investigators will compare the overall\r efficacy of closed-loop and open-loop paradigms in terms of behavioral performance\r improvements in validated motor skill learning tasks and measurements from wearable devices.\r During this chronic adaptive DBS phase, adaptive DBS and open-loop stimulation settings will\r be randomized for 30-day periods and motor skill and gait related measurements will be\r obtained from a combination of computerized motor tasks and wearable devices that track\r movement kinematics. Patients will participate in daily, if possible, motor learning and gait\r tasks at home with triggered stimulation settings and recordings.\r\n\r The investigators expect to successfully develop a prototype adaptive DBS algorithm based on\r cortical and / or basal ganglia LFPs (local field potentials). The investigators hypothesize\r that an adaptive paradigm will provide improvements in motor skilled learning compared to the\r conventional, open-loop paradigm, in which stimulation parameters remain constant until\r changed by the patient or clinician using an external programmer.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Ability to give informed consent for the study\r\n\r - Movement disorder symptoms that are sufficiently severe, in spite of best medical\r therapy, to warrant surgical implantation of deep brain stimulators according to\r standard clinical criteria\r\n\r - Patient has requested surgical intervention with deep brain stimulation for their\r disorder\r\n\r - No movement -elated abnormalities that suggest an alternative diagnosis or\r contraindicate surgery\r\n\r - Absence of significant cognitive impairment (score of 21 or greater on the Montreal\r Cognitive Assessment (MoCA),\r\n\r - Signed informed consent\r\n\r - Ability to comply with study follow-up visits for brain recording, testing of adaptive\r stimulation, and clinical assessment.\r\n\r - Age 21-75\r\n\r - Diagnosis of idiopathic PD with duration of motor symptoms for 3 years or greater\r\n\r - Patient has undergone appropriate therapy with oral medications with inadequate relief\r as determined by a movement disorders neurologist.\r\n\r - UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in\r the baseline UPDRS-III on medication score, compared to the baseline off-medication\r score, and motor fluctuations with at least 2 hours per day of on time without\r dyskinesia or with non-bothersome dyskinesia. OR Patients with tremor-dominant PD (a\r tremor score of at least 2 on a UPDRS-III sub-score for tremor), treatment resistant,\r with significant functional disability despite maximal medical management\r\n\r - Patients with gait impairments: slowed gait, shuffling steps, postural instability, or\r freezing of gait off medication.\r\n\r - Ability of patient and/or caregivers to recharge the system evaluated by all\r clinicians and study personnel.\r\n\r - Geographical proximity and/or ability to travel to study sites for patient to receive\r re-programming via investigational devices (e.g. Summit Research Laboratory\r Programmer).\r\n\r Exclusion Criteria:\r\n\r - Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of\r seizures, heart disease, or other medical conditions considered to place the patient\r at elevated risk for surgical complications\r\n\r - Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion\r or \"while unobserved\", symptoms that are inconsistent over time or incongruent with\r clinical condition, plus other manifestation such as \"false\" signs, multiple\r somatizations, or obvious psychiatric disturbance.\r\n\r - Pregnancy: all women of child bearing potential will have a negative urine pregnancy\r test prior to undergoing their surgical procedure.\r\n\r - Significant untreated depression (BDI-II score >20). History of suicidal attempt or\r active suicidal ideation (Yes to #2-5 on C-SSRS)\r\n\r - Any personality or mood symptoms that study personnel believe will interfere with\r study requirements.\r\n\r - Subjects who require electroconvulsive therapy (ECT), repetitive transcranial magnetic\r stimulation (rTMS) or diathermy\r\n\r - Implanted stimulation systems such as; cochlear implant, pacemaker, defibrillator, or\r neurostimulator\r\n\r - Previous cranial surgery\r\n\r - Drug or alcohol abuse\r\n\r - Meets criteria for Parkinson's disease with mild cognitive impairment (PD-MCI). These\r criteria are: performance of more than two standard deviations below appropriate\r norms, for tests from two or more of these five cognitive domains: attention,\r executive function, language, memory, and visuospatial tests.\r\n\r - Known allergies to the implantable device components including titanium, polyurethane,\r silicone, and nylon.\n\nPatient 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
35,810	[ { "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 the Cognition in People With Parkinson's Disease\n\nClinical Trial Summary:\n\nParkinson's disease (PD) is the second most common neurodegenerative disease. The cardinal\r symptoms of PD are tremor, rigidity, bradykinesia and postural instability. Cognitive\r impairment and dementia are also one of the key features of the non-motor symptoms of PD. At\r present, the mainstream treatment of PD-dementia is the dopaminergic rivastigmine. Repetitive\r transcortical magnetic stimulation (rTMS) is a novel non-invasive intervention. Through the\r magnetic stimulation, brain neurons could be activated by the electrical current. The\r application of rTMS had been approved by US FDA for the treatment of depression. The possible\r effect of rTMS may result from the stimulation-related neuronal plasticity. Regarding PD,\r rTMS also had been found to had some effect on different motor symptoms and cognition. The\r present study would like to test the accumulative effect of rTMS on cognition of PD. All the\r study subjects will receive rTMS under intermittent theta burst stimulation (iTBS) mode at\r supplementary motor area (SMA). Cognitive bahevorial tests and other motor/depression\r assessments will be assessed before and after the intervention.\n\nClinical Trial Detailed Description:\n\nThe present trial is designed as an open-label, uncontrolled pilot study for evaluating the\r effect of rTMS on cognitive function in people with Parkinson disease (PD). The primary\r endpoint is the change of cognitive function, and the secondary endpoint is the improvement\r of motor symptoms. All participants need to complete the informed consent before they are\r enrolled into the trial. Preliminary data including age, sex, education, employment, medical\r history, drug history, disease duration, modified Hoehn-Yahr stage, and UPDRS score are\r collected. Cognitive function including mini-mental state examination (MMSE), clocking\r drawing test, Wechsler memory scale (WMS)-world list test and spatial span test, trial making\r test A and B, category fluency test (animal naming), and beck depression inventory-II are\r tested by trained neuropsychiatrists. Gait function are evaluated with time up and go (TUG),\r freezing of gait questionnaire (FOG-Q), and Gait-up device analysis before trial starting.\r Pre-treatment brain image examined by magnetic resonance image (MRI) and blood sampling for\r synapse protein level are performed. The participants are then arranged to receive theta\r burst stimulation for 5 days by using Magstim machine (Super Rapid 2) equipped with air\r cooled coil (D70), stimulating on supplementary motor area (SMA). After the intervention,\r post-treatment evaluation including cognition, motor symptoms, gait function, brain MRI, and\r blood sampling will be performed again with the same methods at 1 month later. Any adverse\r event during the trial period will also be recorded. The trial is expected to be conducted in\r Shuange-Ho hospital, Taipei Medical University.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Fulfill the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's\r disease, age between 45-80 years old.\r\n\r 2. With mild cognitive impairment or dementia (Clinical Dementia Rating Scale >= 0.5)\r\n\r Exclusion Criteria:\r\n\r - People who have\r\n\r 1. pre-existing and active major neurological diseases other than PD\r\n\r 2. with a previous history of seizures\r\n\r 3. with implanted metallic objects that would contraindicate rTMS\r\n\r 4. unable to perform fMRI\r\n\r 5. with skin damage on the stimulation area\r\n\r 6. with multiple sclerosis\r\n\r 7. with large ischemic scars\r\n\r 8. with a family history or medical history of seizures, epilepsy\r\n\r 9. brain damage may affect the threshold for inducing epilepsy\r\n\r 10. taken tricyclic antidepressants, analgesics, or anything that may lower the threshold\r for inducing epilepsy\r\n\r 11. with sleep disorders during the rTMS treatment\r\n\r 12. with severe alcohol abuse or use of epilepsy drugs\r\n\r 13. with severe heart disease or uncontrollable migraine caused by high intracranial\r pressure\r\n\r 14. who are actively suicidal during the trial period, have recurring major medical\r disorders, or with neurological co-morbidities such as space occupying lesions, CVA,\r aneurysms etc\n\nPatient 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
35,811	[ { "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\nUse of the \"Game-Ready\" Splint for Better Recovery in Primary Total Shoulder Arthroplasty\n\nClinical Trial Summary:\n\nThe aim of the study is to compare the level of postoperative pain after fitting the Game\r Ready splint, at 48 hours versus that observed with fitting a standard splint\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. First-line reverse prosthesis\r\n\r 2. Without prosthetic history\r\n\r 3. Patient who has given his consent to participate in the observational study after\r being informed by the surgeon\r\n\r 4. Patient living in France and able to answer the questionnaire alone.\r\n\r 5. Subject affiliated to a social security scheme or beneficiary of such a scheme\r\n\r 6. Lack of participation in another clinical study\r\n\r Exclusion Criteria:\r\n\r 1. Minor patient\r\n\r 2. Major subject protected by law, under curatorship or tutorship\r\n\r 3. Anterior prosthesis\r\n\r 4. Infection\r\n\r 5. Parkinson's, degenerative neurological disease\r\n\r 6. Pregnant or breastfeeding woman\n\nPatient 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
35,812	[ { "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\nInfant Mortality Reduction by the Mass Administration of Azithromycin\n\nClinical Trial Summary:\n\nThis trial will investigate the supplementation of azithromycin distribution to the \"Child\r Health Days\" platform in Burkina Faso for child mortality reduction. This distribution will\r pair door-to-door administration of vitamin A and azithromycin or placebo with acute\r malnutrition screening among children 1-11 months old.\n\nClinical Trial Detailed Description:\n\nThe MORDOR clinical trial funded by the Bill & Melinda Gates Foundation in Malawi, Tanzania,\r and Niger demonstrated that biannual oral azithromycin distributions to children aged 1-59\r months significantly reduced child mortality. The investigators hypothesize that biannual\r administration of azithromycin to children aged 1-11 months will reduce mortality in this age\r group. The aim of the project is to demonstrate that this intervention can be scaled up and\r produce the same benefits on mortality as those documented in smaller, more controlled\r studies. Since 1986, to reduce child mortality, Burkina Faso has been administering high-dose\r vitamin A supplementation to children aged 6-59 months on a biannual basis through the \"Child\r Health Days\" platform. The \"Child Health days\" are a door-to-door distribution of vitamin A\r coupled with screening for acute malnutrition in children aged 6-59 months and deworming of\r children aged 12-59 months. This approach has been successful but expensive. A new strategy\r implemented since September 2017 relies on community-based health workers (CBHWs) to\r distribute Vitamin A in rural areas, and on community-based distributors (CDs) in urban\r areas. Based on expert opinion and the preliminary findings of formative research conducted\r by the Ministry of Health and Helen Keller International, it was agreed that the Child Health\r Days platform was the most appropriate platform to implement the biannual administration of\r azithromycin to children aged 1 to 11 months.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r Community eligibility criteria:\r\n\r - Located in one of the three selected regions: SudOuest, Centre-Ouest, Hauts-Bassins)\r\n\r - Verbal consent of the community leader is obtained\r\n\r Inclusion criteria for children:\r\n\r - Aged 1 to 11 months\r\n\r - Living in one of the communities participating in the study\r\n\r Exclusion Criteria:\r\n\r Community exclusion criteria:\r\n\r • Inaccessible or unsafe for the study team\r\n\r Exclusion criteria for children:\r\n\r • Known allergy to macrolides\n\nPatient 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
35,813	[ { "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 Kinesthetic Stimuli During XBOX Kinect Training on People With Parkinson's Disease\n\nClinical Trial Summary:\n\nA single-blind, parallel-group, randomised trial will be conducted in Sao Paulo, Brazil.\r People with Parkinson's Disease (PD) will be recruited at \"Brazil Parkinson Association\"\r (BPA), a non-governmental association of PD care, and randomly allocated in two groups: the\r Movement Guidance Group (MVG) and NO-MVG Group. Both groups will perform XBOX Kinect training\r for balance and gait. However, the MVG will receive kinesthetic stimuli manually by the\r physiotherapist (PT) to improve the participant movements while the NO-MVG Group will not,\r the presence of the PT will be restrict to only guarantee the participant safety.\n\nClinical Trial Detailed Description:\n\nBACKGROUND: Despite evidences indicate the benefit of motor interventions based on video\r games in people with Parkinson's Disease (PD), practice guidelines for the therapeutic use in\r physiotherapy were still not established. Although visual and auditory stimuli provided by\r video games are pointed as one of the main advantages for their therapeutic use, the effects\r of kinesthetic stimuli offered through physical therapist manual intervention during this\r type of training in people with PD have not been investigated yet. The answer to this\r question is relevant to guide the physical therapist (PT) conduct during this kind of\r intervention.\r\n\r PURPOSE: To compare the effects of motor training using video games with and without\r kinesthetic stimuli offered by physical therapist manual guidance during intervention on the\r functionality of people with PD.\r\n\r METHODS: A blind randomized clinical trial in people with idiopathic PD, staging of 1 to 3\r according to disability scale of Hoehn and Yahr, will be performed. Participants will be\r randomized into two groups: the Movement Guidance Group (MVG) and NO-MVG Group. Both groups\r will receive 8 individual sessions, twice a week, for 4 weeks. Each session consist of 10\r minutes of warm-up and 40 minutes of XBOX Kinect training for balance and gait. In the MVG\r Group, the PT will provide kinesthetic stimuli by assisting manually the participant\r movements. In the NO-MVG Group, the involvement of the PT will be restricted to ensure\r participant safety. The two groups will be evaluated before (BT) and after (AT) training and\r after 60 days (follow-up). A blind physiotherapist will conduct the assessments. Measurements\r are categorized according to the International Functioning Classification (ICF), those\r associated with the activity level were established as primary measures: Balance Evaluation\r Systems Test (BESTest); International Falls Effectiveness Scale (FES-I); 30-second Gait Test;\r Six Minute Walk Distance (6MWD); Five Times Sit to Stand Test (FTSTS) and Unified Parkinson's\r Disease Rate Scale (UPDRS) session II. Secondary measures were the evaluation of function\r using UPDRS session III; Rapid Turns Test (RTT); Montreal Cognitive Assessment (MOCA);\r Geriatric Depression Scale (GDS-15), and participation using the Parkinson's Disease Quality\r of Life Questionnaire (PDQ-39).\r\n\r STATISTICAL ANALYSIS: An ANOVA to repeated measures will be use, having as factors: group\r (MVG Group and NO-MVG Group) and evaluations (BT, AT and FU). Followed by post hoc Tukey Test\r to the significance factors. A significance of 5% will be considered.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Idiopathic Parkinson's disease diagnosis according to Parkinson's Disease Society\r Brain Bank of London criteria\r\n\r - Active treatment with levodopa\r\n\r - Stages 1, 2, and 3 according to Hoehn and Yahr Classification\r\n\r Exclusion Criteria:\r\n\r - Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment\r\n\r - Score greater than or equal to 6 on the geriatric depression scale\r\n\r - Severe respiratory and / or cardiovascular conditions\r\n\r - Visual and / or auditory deficit that cannot be corrected with glasses or a hearing\r aid;\r\n\r - Other previously detected orthopedic or neurological diseases, other than Parkinson's\r Disease, that may interfere with the individual's performance\r\n\r - Previous experience with Microsoft XBOX Kinect® games\r\n\r - And being in rehabilitation in another location concomitant to this training.\n\nPatient 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
35,814	[ { "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\nMicrobiota Modification for the Treatment of Motor Complication of Parkinson´s Disease\n\nClinical Trial Summary:\n\nIn recent years, abnormalities in gut microbiota have been identified in patients with\r Parkinson´s disease having a possible role in motor manifestations. Among 80 patients with\r PD, we selected 14 with LID and motor fluctuations with limited response to pharmacological\r therapy to receive treatment with sodium phosphate enema, oral rifaximin and polyethylene\r glycol to improve motor complications.\n\nClinical Trial Detailed Description:\n\nWe studied consecutive patients diagnosed with PD according to the Queen Square Brain Bank\r Criteria [Hughes et al 1992] in a tertiary care center for movement disorders, from June 2018\r to March 2020.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - patients aged 18-years old or older with moderate to severe dyskinesia and/or motor\r fluctuations with incomplete or poor response to adjustments in time and dose of levodopa\r and other anti-parkinsonian agents such as entacapone, rasagiline, dopamine receptor\r agonists and amantadine in 1-2 months prior to enrollment; defined by a Movement Disorders\r Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) part IV score equal or higher\r than 8 following pharmacological adjustments.\r\n\r Exclusion Criteria:\r\n\r - patients with chronic renal failure, decompensated heart failure, colonic\r abnormalities precluding the use of evacuating enema, known allergies to prescribed\r medications to reduce microbiota load and patients who declined to participate in the\r study.\n\nPatient 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
35,815	[ { "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\nVideo-oculography and Parkinson's Disease\n\nClinical Trial Summary:\n\nThis study aims to study, in patient with Parkinson's disease, mild to moderate stage\r (according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease,\r Postuma et al., 2015):\r\n\r - the evolution of oculomotricity markers over time.\r\n\r - the correlation between neurological evaluations (motor and non-motor scores),\r neuropsychological evaluations (cognitive disorders) and oculomotricity evaluation, over\r a follow-up period of 7 years.\r\n\r - the impact of antiparkinsonian drugs on the evolution of oculomotricity assessment by\r video-oculography.\r\n\r - the value of oculomotricity assessment by video-oculography as an evolutionary marker of\r the disease.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Male or Female;\r\n\r 2. Clinically defined idiopathic Parkinson's Disease (PD);\r\n\r 3. Brain MRI performed in routine care in the 12 months preceding inclusion;\r\n\r 4. Cerebral DaTSCAN or cerebral PET with F-DOPA, performed as routine care before\r inclusion (no time limit), confirming presynaptic dopaminergic denervation;\r\n\r 5. Hoehn & Yahr score: 1 to 3;\r\n\r 6. Normal clinical examination of oculomotricity (slight impairment of smooth pursuit\r accepted);\r\n\r 7. Neuro-cognitive disorders: absent or minor (according to DSM5);\r\n\r 8. Sufficient written and oral expression in French;\r\n\r 9. Covered by a health insurance system;\r\n\r 10. Written informed consent signed by the patient;\r\n\r 11. Presence of a caregiver.\r\n\r Exclusion Criteria:\r\n\r 12. Psychiatric comorbidity (except anxiety or mild to moderate depression);\r\n\r 13. Neurological comorbidity, if significant;\r\n\r 14. Brain MRI showing:\r\n\r 1. significant cerebrovascular pathology (Fazekas I admitted),\r\n\r 2. another brain disease, including stroke.\r\n\r 15. Major cognitive impairment;\r\n\r 16. Absolute exclusion criteria and \"Red flags\" of the 2015 criteria orienting towards\r another degenerative pathology of the extrapyramidal system:\r\n\r - Cerebellar syndrome\r\n\r - Vertical oculomotricity disorders on clinical examination\r\n\r - Motor symptoms restricted to the lower limbs\r\n\r - Bilateral and perfectly symmetrical parkinsonism\r\n\r - Early dystonia\r\n\r - Clinical profile suggestive of behavioral variant frontotemporal dementia (bvFTD)\r\n\r - Progressive aphasia or apraxia\r\n\r - Moderate or severe postural instability and / or early falls\r\n\r - Early bulbar dysfunction (dysarthria, swallowing disorders)\r\n\r - Ventilatory dysfunction (inspiration)\r\n\r - Severe dysautonomia\r\n\r - DOPA-resistance\r\n\r - Neuroleptic treatment or related\r\n\r 17. Normal MIBG myocardial scintigraphy (if performed).\n\nPatient 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
35,816	[ { "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\nReal-Time Levodopa Level Monitoring in Parkinson Disease\n\nClinical Trial Summary:\n\nThis project aims to develop a minimally invasive microneedle sensor to monitor levodopa\r levels in real time. We will test the accuracy, tolerability, and safety of this device in\r people with Parkinson disease.\n\nClinical Trial Detailed Description:\n\nPeople with Parkinson disease (PD) lack the chemical dopamine, which is important for\r movement. Levodopa replaces dopamine and restores normal motor function in PD. Early in the\r disease stages, people with PD benefit significantly from levodopa. However, as PD\r progresses, the brain loses more dopamine-producing cells, which causes motor complications\r and unpredictable responses to levodopa. To maintain control of symptoms over time, levodopa\r doses must be increased and given at increasingly shorter intervals. The optimal levodopa\r regimen is different for each person and may vary from day-to-day, depending on a variety of\r internal and external factors including meal consumption, activity level, and other lifestyle\r variances. Currently, clinicians assess levodopa's benefit by the patient's testimony and by\r clinical exam. However, these methods may not adequately represent the severity or range of\r complications experienced by the PD patient. Thus, it can be difficult to determine the\r optimal levodopa treatment regimen, which can cause suboptimal disease management and side\r effects.\r\n\r This project aims to develop a continuous, minimally invasive microneedle device placed on\r the skin (the \"Levodopameter\") designed to continuously measure levodopa levels in real time,\r with the future goals of identifying an individualized treatment regimen for people with PD\r to improve disease management. We will compare levodopa levels measured by the Levodopameter\r to the impractical and expensive \"gold standard\" high-performance liquid chromatography\r (HPLC) analysis of plasma levodopa levels. We will first test the device after administering\r oral carbidopa/levodopa in 10 participants with PD. After that portion of the study is\r completed and safety confirmed, we will test the device in 10 participants with PD after\r administering carbidopa and intravenous levodopa. We will also evaluate the device's safety\r and tolerability.\r\n\r The long-term goal of this device is to allow PD patients to take proactive measures to\r assess and maintain an optimal, personalized levodopa regimen, similar to diabetes care in\r which diabetic patients periodically self-monitor their glucose and adjust their insulin\r regimen accordingly.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Participants must meet the Movement Disorders Society (MDS) diagnostic criteria for\r clinically established Parkinson disease.\r\n\r 2. Able to provide signed informed consent (in English or Spanish)\r\n\r 3. Mild, moderate, or severe Parkinson disease, able to ambulate (Hoehn and Yahr stages\r I-IV)\r\n\r 4. Taking instant release oral carbidopa/levodopa therapy\r\n\r 5. Either not taking, or on stable doses of any of the following antiparkinsonian\r medications: dopamine agonists, monoamine oxidase B (MAO-B) inhibitors or\r catecholamine O-methyl transferase (COMT) inhibitors\r\n\r Exclusion Criteria:\r\n\r 1. Other neurological conditions including but not limited to stroke, dementia (including\r Parkinson disease dementia), or traumatic brain injury\r\n\r 2. Co-existent major psychiatric disease\r\n\r 3. Uncontrolled, active medical conditions (e.g., heart, kidney, or liver failure,\r diabetes, etc.)\r\n\r 4. Status post deep brain stimulation (DBS) device placement\r\n\r 5. Any other condition, that in the opinion of the investigators, would place the\r participant at risk.\n\nPatient 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
35,817	[ { "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 Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease\n\nClinical 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 will assess how safe and\r effective ABBV-951 is in adult participants with PD. Adverse events and change in disease\r activity is evaluated.\r\n\r ABBV-951 is an investigational (unapproved) drug containing levodopa/carbidopa (LD/CD) given\r as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants\r with advanced PD and who have completed M15-736 study will be enrolled. Approximately 130\r participants will be enrolled in the study in approximately 80 sites in the United States and\r Australia.\r\n\r Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of\r ABBV-951 for 96 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 and remote\r telephone assessments, blood tests, checking for side effects, and completing questionnaires.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Completion of the parent study, Study M15-736.\r\n\r Exclusion Criteria:\r\n\r - Participant considered by the investigator to be an unsuitable candidate to receive\r ABBV-951 for any reason.\n\nPatient 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
35,818	[ { "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\nHB-adMSCs for the Treatment of Parkinson's Disease\n\nClinical Trial Summary:\n\nThis Individual Patient Expanded Access IND has been created as requested by an 83-year-old\r man who suffers Parkinson's disease and for which the drugs currently approved are not\r providing an improvement over the progression of this disease.\n\nClinical Trial Detailed Description:\n\nThis is an Individual Patient Expanded Access IND with the primary goal of treatment for an\r individual with Parkinson's Disease. There are no FDA approved, fully restorative treatments\r for Parkinson's Disease. The subject will receive a total of twelve autologous HB-adMSCs\r infusion of 200 million cells.\r\n\r Primary Objective:\r\n\r 1. To evaluate the efficacy of HB- adMSCs by improving activities of daily living in a\r subject with Parkinson's Disease.\r\n\r Secondary Objective:\r\n\r 1. To evaluate the efficacy of HB- adMSCs by improving quality-of-life in a subject with\r Parkinson's Disease.\r\n\r 2. To assess the safety of multiple administrations of HB-adMSCs in a subject with\r Parkinson's Disease\r\n\r 7.3. Statistical Measures\r\n\r Data analysis will be limited to descriptive statistics of the following:\r\n\r - Incidence and severity of adverse events as measured by CBC, CMP, coagulation panel.\r\n\r - C-reactive protein and Sedimentation rate will be measured to evaluate the ability of\r HBadMSCs to alter Parkinson's Disease related inflammation.\r\n\r - Changes in brain and dopamine availability reflected in PET Scan results.\r\n\r - Changes in motor function as measured by the UPDRS score.\r\n\r - Changes in motor function as documented in video records\r\n\r - Changes in function abilities as measured by the Schwab and England Activities of Daily\r Living score.\r\n\r - Changes in quality-of-life scores as measured by the subject evaluations in the \"Social\r Roles and Activities\" surveys.\r\n\r 7.4 Measurement Tools\r\n\r - UPDRS\r\n\r - Neuro-QOL Scale v1.0\r\n\r - Schwab and England Activities of Daily Living score.\r\n\r - Video recordings\r\n\r - Writing Samples\r\n\r - Modified Hoehn and Yahr Staging score\r\n\r - Schwab and England Activities of Daily Living score.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Adult individual at least 18 years old\r\n\r 2. Clinical diagnosis Parkinson's Disease\r\n\r 3. Subject has provided informed consent before initiation of any study procedure.\r\n\r 4. Subject has mesenchymal stem cells banked at Hope Biosciences\r\n\r Exclusion Criteria:\r\n\r 1. Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or\r endocrine disease or any other acute or chronic medical condition that, in the opinion\r of the investigator, may increase the risks associated with study participation.\r\n\r 2. Chemical or ETOH dependency that in the opinion of the investigator would preclude\r participation in the study\r\n\r 3. Participation in concurrent interventional research studies during this trial\r\n\r 4. Unwillingness to return for follow-up visits.\n\nPatient 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
35,819	[ { "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\nAssessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa Via the DopaFuse® Delivery System in Parkinson's Disease Patients\n\nClinical Trial Summary:\n\nThe purpose of this study is to evaluate whether the DopaFuse System can reduce the\r fluctuation of plasma levodopa levels compared to participants' standard intermittent doses\r of oral LD/CD tablets (background treatment). It will also assess whether the system is safe,\r well tolerated, and can relieve motor symptoms.\n\nClinical Trial Detailed Description:\n\n\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Diagnosis of Parkinson's Disease consistent with UK Brain Bank Criteria\r\n\r 2. Age at least 30 years old at time of consent\r\n\r 3. Male and Female participants (Women of child-bearing potential (WOCB) are eligible for\r participation if they are not pregnant or breastfeeding and agree to follow the\r contraceptive guidance in Appendix 3 during the treatment period and for at least 30\r days after the last dose of study treatment)\r\n\r 4. Suitable for oral retainer wear\r\n\r 5. A good response to Levodopa, as assessed by the Investigator\r\n\r 6. At least 2 hours of wearing OFF time per day, as reported by the participant\r\n\r 7. Predictable early morning OFF periods, in the judgement of the participant and the\r Investigator\r\n\r 8. Taking 400-1,200 mg of LD/CD per day in at least 4 doses, with stable dosing for the\r last 28 days prior to screening.\r\n\r 9. A modified Hoehn and Yahr of ≤ 3 in the ON state at screening\r\n\r 10. A stable regimen of anti-PD medications for the last 28 days prior to Screening\r\n\r 11. A Mini-Mental State Examination (MMSE) Score ≥26\r\n\r 12. Capable of giving signed informed consent\r\n\r 13. Approved for entry into the study by the Enrollment Authorization Committee (EAC)\r\n\r Exclusion Criteria:\r\n\r 1. Atypical or secondary Parkinson's Disease\r\n\r 2. Severe Dyskinesia that might interfere with study performance in the judgement of\r Investigator\r\n\r 3. Clinically significant dysphagia or sialorrhea that might interfere with\r administration of study intervention in the judgement of the Investigator\r\n\r 4. Use of extended release levodopa within 28 days prior to screening\r\n\r 5. Any clinically significant medical, surgical, or psychiatric condition; laboratory\r value or ECG result which, in the opinion of the Investigator, makes the participant\r unsuitable for study entry or potentially unable to complete all aspects of the study.\r\n\r 6. Presence of clinically significant orthostatic hypotension at screening, in the\r opinion of Investigator or the EAC\r\n\r 7. Suicidal ideation within 1 year prior to the Screening Visit as evidenced by answering\r \"yes\" to Questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide\r Severity Rating Scale (C-SSRS) or attempted suicide within the last 5 years.\r\n\r 8. History of psychosis or hallucinations in the past six months\r\n\r 9. Any malignancy in the past 5 years (excluding basal cell carcinoma of the skin or\r cervical carcinoma in situ that have been successfully treated.)\r\n\r 10. Current or previous diagnosis of malignant melanoma or the presence of any suspicious\r skin lesion based on physical exam findings\r\n\r 11. Unable to give blood required for the study\r\n\r 12. History of allergic reaction to plastics\r\n\r 13. LD infusion therapy (i.e. Duodopa); current or previous continuous apomorphine\r infusion treatment.\r\n\r 14. Participation in any other clinical trial <30 days prior to screening visit.\r\n\r 15. Presence of two third molars (\"wisdom teeth\") on the upper dentition\r\n\r 16. Participants who, for any reason, are judged by the Investigator or the EAC to be\r inappropriate for this study, including participants who are unable to communicate or\r cooperate with the Investigator or who have/had a clinically significant illness or\r abnormal physical examination that may compromise safety of the participant during the\r trial or affect ability of the participant to adhere to study procedures.\r\n\r 17. Participants taking non-selective monoamine oxidase (MAO) inhibitors\r\n\r 18. Participants with known hypersensitivity to the active ingredients (levodopa,\r carbidopa) or excipients (Benzoic Acid, Disodium Edetate, Medium Chain Triglycerides,\r Poloxamer 188) of the drug paste\r\n\r 19. Participants with narrow-angle glaucoma\n\nPatient 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
35,820	[ { "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\nEffect of a Boxing Program on People With Parkinson Disease\n\nClinical Trial Summary:\n\nThis study is investigating the impact of a boxing training program on people with Parkinson\r Disease. The investigators were provided data for the intervention group retrospectively by\r the organizers of the boxing club to assess participants' benefit from participation. The\r outcome measures were selected to measure different aspects of functional mobility. Of\r particular interest is the impact of challenging whole-body activities designed for boxing\r and their impact on turning speed and gait. The second phase of the study will gather control\r group information from people with Parkinson Disease who have not participated in a boxing\r program to compare differences in pre-test and post-test data over a period of 12 weeks. The\r specific population and study design are currently pending global pandemic restrictions.\r Subject recruitment will involve people who have never had access to a program of this\r nature. An alternative population for recruitment may involve the same participants from the\r boxing club in a crossover study format since the boxing club has been suspended for over a\r year due to health and safety concerns during the pandemic. The control group of either\r situation would be instructed to carry on with their daily activities as usual without\r changing their physical activity. We hypothesize that the intervention group would show\r greater improvements in functional mobility compared to the control group.\n\nClinical Trial Detailed Description:\n\nThe effects of Parkinson Disease are progressive and cause limitations in functional mobility\r and quality of life. This is a disease that greatly impairs the motor system with key\r presentation of resting tremors, rigidity and bradykinesia. These impairments cause further\r deficiencies in gait and postural stability. Most notable is festinating gait that is\r exacerbated by direction changes and becomes a fall risk for patients. These physical\r limitations can manifest fear and avoidance behaviors in people that ultimately decrease\r quality of life. Activities that can improve balance, strength and coordination allow people\r to gain confidence in their ability to participate in their daily activities. The purpose of\r this study is to investigate the impact of a boxing training program on lower extremity\r functional strength, fall risk, gait speed, and turning speed for people with Parkinson\r Disease compared to a control group.\r\n\r Data for the intervention group has been provided retrospectively by the organizers of the\r boxing club. This initial data was collected by volunteers of the club at the initial session\r and then at 12 weeks for purposes of progress reporting to the members. Data was\r de-identified prior to receipt by the investigators. The next phase of this study will\r involve recruitment of participants for a control group from areas that do not have\r established boxing programs. Pre- and post-tests will be conducted over a span of 12 weeks.\r Outcome measures for the future control group will be the same as the original tools provided\r by the boxing club. These measures will assess lower extremity functional strength, fall\r risk, gait speed and turning speed. Baseline data will be taken using 30-second sit to stand,\r Timed Up-and-Go, 180° turning speed, and gait speed. During the 12 week period, participants\r will be instructed to avoid changing their physical activity. At the end of 12 weeks the\r post-testing will be completed. Those participants in the control group will receive a gift\r card for participation in the study.\r\n\r If pandemic concerns prevent the recruitment of new participants for a control group, an\r alternative approach will involve a cross-over design in which the original participants from\r the intervention group will serve as the control group. The boxing club will be approached to\r contact the twelve participants who provided intervention data. The boxing club has not been\r held since March, 2020 due to the pandemic restrictions. A control period for this group will\r be established over a twelve week period where they do not participate in any new changes to\r their physical activity. The same outcome measures will be collected at pre-test and twelve\r weeks later for post-testing.\r\n\r Due to the nature of the in-person testing, extra precautions regarding Covid-19 have been\r implemented including a Covid-19 and Other Communicable Disease consent form outlining\r expectations of the participants as well as precautions by the investigators. These extra\r initiatives include appropriate facial masks and face shields by everyone involved at all\r times at the study site, physical distancing between investigators and participants with\r exceptions made for safety reasons, and any other procedures established by the study site.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Diagnosis of Parkinson Disease\r\n\r Exclusion Criteria:\r\n\r - Inability to walk without physical assistance\n\nPatient 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
35,821	[ { "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\nMultidisciplinary Health Educational Program Based on Centered People Care Model in Parkinson's Disease\n\nClinical Trial Summary:\n\nThe objective of this study is to compare the effects of two similar long-term\r interprofessional programs, one of them delivers by in-person classes, and another delivers\r by online classes on the quality of life of people with Parkinson's.\r\n\r Method: People with PD will be randomized into 3 groups: (1) Face-to-face group, in which\r participants, in groups of 10 persons, followed a multidisciplinary health education program\r composed of 10 monthly face-to-face lectures; (2) Remote group, in which individuals followed\r the same lectures delivered by online; and (3) Control group, in which participants followed\r no lecture. The participants will be evaluated before (BED) and after (ABP) the education\r program conclusion (10 lectures). Health quality of life was adopted as a primary outcome.\r Independence in daily living activities, motor and non-motor symptoms severity, and global\r cognitive capacity was adopted as secondary measures, Besides, all participants will be asked\r to answer a survey to evaluate the knowledge improvement of key learning points of lectures.\r The results will be analyzed by ANOVA for repeated measures.\n\nClinical Trial Detailed Description:\n\nParkinson's disease is a large cause of disability worldwide. The complex combination of\r motor and non-motor symptoms brings an increasing impairment in functionality and,\r consequently, a progressively decrease in the quality of life of the people living with PD\r and their families. The World Health Organization (WHO) recommends that for health care,\r especially in chronic diseases, care should be centered on the person (people-centered care).\r This model enlarges the focus on biological aspects, including psychological and social\r aspects, building a multidimensional perspective on an individual, which can only be reached\r by integrated and interprofessional care.\r\n\r According to this model, education is crucial to empower the person to occupy an active role\r in the health process, gaining greater control over decisions and actions affecting their\r health. Patient empowerment has been associated with positive health and clinical outcomes,\r including improved disease management, effective use of health services, improved health\r status, and medication adherence. However, there are several barriers for participants to\r attending this kind of program. Reasons for nonparticipation include mobility-reducing\r physical health issues, time constraints, distance, insufficient funds, lack of respite care\r if caring for someone else, and transportation. Thus, using a home-based video class may be\r one opportunity to reduce these known barriers and improve the accessibility of education\r programs. This delivery strategy can be beneficial for no high-income countries.\r\n\r Objective: The objective of this study is to compare the effects of two similar long-term\r interprofessional programs, one of them delivers by in-person classes, and another delivers\r by online classes on the quality of life of people with Parkinson's.\r\n\r Method: People with a confirmed diagnosis of Idiopathic Parkinson's disease, in stage 1-4 of\r disease evolution according to Hoehn and Yahr classification will be randomized into 3\r groups: (1) Face-to-face group (FFG), in which participants, in groups of 10 persons,\r followed a multidisciplinary health education program composed of 10 monthly face-to-face\r lectures; (2) Remote group (RG), in which individuals followed the same lectures delivered by\r online; and (3) Control group (CG), in which participants followed no lecture. People who\r have severe cognitive decline and uncorrected visual or hearing impairment will be excluded.\r Participants from both groups will be instructed to follow their usual routine for the\r treatment of the disease. The lectures on the management of motor and non-motor alterations\r associate with PD will be offered by a nurse, physiotherapist, occupational therapist, speech\r therapist, neurologist, lawyer, nutritionist, and psychologist. The participants will be\r evaluated before (BED) and after (ABP) the education program conclusion (10 lectures). Health\r quality of life, adopted as a primary outcome, will be evaluated by Parkinson´s disease\r questionnaire 39 (PDQ-39). The independence in daily living activities, motor and non-motor\r symptoms severity, and global cognitive capacity, adopted as secondary measures, will be\r evaluated by Unified Parkinson´s disease rating scale (UPDRS) and Montreal Cognitive\r Assessment (MoCA), respectively. Besides, all participants will be asked to answer a survey\r to evaluate the knowledge improvement of key learning points of lectures. The survey\r consisted of 20 questions (2 per lecture) where the minimum level (score 0) indicated the\r absence of knowledge and maximal level (score 5) indicated the full understanding of\r lectures' key points. The results will be analyzed by ANOVA for repeated measures considering\r as factor group (FFG, RG, CG) and assessment points (BED, AEP).\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r Clinical diagnosis of Idiopathic Parkinson's disease Must have acess to internet.\r\n\r Exclusion Criteria:\r\n\r Severe cognitive decline Severe visual impairment Severe hearing impairment\n\nPatient 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
35,822	[ { "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\nMiro-randomized Trial for Optimizing a JITAI to Reduce Dietary Lapses in Obesity Treatment\n\nClinical Trial Summary:\n\nThis project targets dietary lapses (instances of nonadherence to dietary goals), a major\r cause of poor outcomes during behavioral obesity treatment, which is a recommended first-line\r intervention for cardiovascular disease. The investigators propose to conduct a\r micro-randomized trial (MRT) to empirically optimize a smartphone-based just-in-time adaptive\r intervention (JITAI) that monitors risk and intervenes on lapses as needed. By evaluating the\r immediate, proximal effect of four theory-driven interventions on lapse behavior, the project\r will: (a) produce a scalable, finalized JITAI that has the greatest potential to show clear\r clinical impact in future trials; and (b) inform the development of more sophisticated\r theoretical models of adherence behavior more broadly. Therefore, this study has three goals.\r First the investigators aim to compare the effects of delivering any intervention to no\r intervention on the occurrence of lapse. Second, the investigators aim to compare the effects\r of specific theory-driven interventions to one another to determine which ones are best for\r preventing lapses. Within this second aim, the investigators also aim to examine other\r factors that may influence the effectiveness of interventions (e.g., time, location). Lastly,\r the investigators will use the data from this MRT to customize intervention delivery in\r future versions of this JITAI\r\n\r Patients will be recruited through various methods including advertisements in local media,\r targeted online advertising, advertisements in medical and minority communities, and direct\r mailers. All participants will receive a well-established 3-month online obesity treatment\r program, with 3 months of no-treatment follow-up. In conjunction, they will use a\r smartphone-based JITAI consisting of: 1) repeated daily surveys assess lapses and relevant\r triggers; 2) a machine learning algorithm that uses information from the surveys to determine\r real-time lapse risk; & 3) interventions to counter lapse risk. When an individual is at risk\r for lapsing she will be randomly assigned to no intervention, a generic risk alert, or one of\r 4 theory-driven interventions with interactive skills training. The outcome of interest will\r be the occurrence (or lack thereof) of dietary lapse, as measured both subjectively (i.e.,\r reported by the participant in the daily surveys) and objectively (i.e., via wrist-based\r intake monitoring), in the hours following randomization initiated by heightened lapse risk.\n\nClinical Trial Detailed Description:\n\nThe purpose of the 6-month micro-randomized Trial (MRT) is to optimize a just-in-time\r adaptive intervention (JITAI) for dietary lapses by evaluating the effects of 4 theory-driven\r interventions on the proximal outcome of dietary lapse as compared to active and inactive\r comparators. The proposed JITAI has been extensively piloted, and will now be executed using\r a well-known NIH-funded mobile platform (PiLR Health). Prior to commencement of the main\r trial, a small group of participants will be recruited to iteratively pilot the\r below-described procedures for 3 months. These data are for piloting/testing only and will\r not be used in the analysis of primary outcomes. Participants in the main trial (N=159) will\r receive 3 months of online behavioral obesity treatment (BOT) + JITAI followed by 3 months of\r JITAI-only. The MRT includes sequential randomization to intervention options each time the\r JITAI identifies heightened lapse risk. The primary outcome is dietary lapse (assessed via\r repeated surveys called ecological momentary assessments [EMA]). The secondary outcome is\r objectively-measured eating characteristics (via wrist-watch device at assessments). The\r investigators will also assess contextual moderators (i.e., location, time of day, active\r BOT/follow-up, trigger type) for the study's exploratory aim. JITAI engagement, satisfaction,\r and weight will be used for descriptive purposes.\r\n\r Participants will be recruited on a rolling basis (~6-7 participants/month) until the target\r N=159 is reached. Participants will be recruited via advertisements in local media (e.g.\r newspapers, radio) and targeted online advertising (e.g., Google AdWords); flyers and\r advertisements posted in waiting rooms and exam rooms in primary care offices, informational\r materials made available as part of the health and wellness program for employees in the\r Lifespan heath system and hospital network (an approach used in a previous trials); and\r direct mailings. Minority participation will be increased via ads in newspapers with high\r circulation in minority communities. Recruitment flyers will also be sent to agencies serving\r minority groups. The investigators will use online advertisements on local websites that are\r popular with men and minority groups. The investigators consistently find that these\r approaches maximize minority and male recruitment.\r\n\r All following procedures described will be offered both in-person at the research center, or\r remotely via the video chat forum Zoom. The remote option is in response to the COVID-19\r pandemic. Participants who choose to attend in-person assessments will use self-report\r screening procedures consistent with hospital policy to ensure that the participant has not\r been recently or is currently ill. Rigorous sanitization procedures will be used for\r equipment and office space pre- and post-assessment.\r\n\r Interested individuals will be initially screened for eligibility via REDCap, a Lifespan\r secure website. If a participant appears to be eligible based on their survey responses, they\r will receive a follow-up call from the research team to confirm eligibility, describe the\r study in more detail, and schedule an orientation meeting. If they are not eligible, they\r will receive a message indicating that they are not eligible for the study and directed to\r contact us if they wish to receive referrals for other weight loss programs. Those who are\r eligible will be invited to an orientation, either in-person at the research center or via\r the online video chat forum Zoom, where the study will be described and informed consent\r obtained. Individuals who decide to complete the orientation via Zoom will be sent a consent\r form to their home address before the call. Only after the consent form is signed and\r returned will any further study procedures be completed. If consent is not given, participant\r contact information will be immediately removed from the system. After consent is obtained,\r participants will complete baseline questionnaires, either by paper surveys or using\r Lifespan's secure REDCap website, and they will complete self-reported logs of what they eat\r and drink and EMA for 1 week before their baseline assessment. If a participant elects to use\r a paper questionnaire and does not wish to be present at the research center, the\r questionnaire will be sent to the participant's home address. Participants must complete >70%\r of EMA surveys and 7 days of dietary self-monitoring to move forward with the remainder of\r study procedures.\r\n\r Following consent and successful completion of baseline procedures, participants will attend\r a \"kick-off\" session (either in-person or remotely) to assist them in using the intervention\r tools. Participants will be given access to an online BOT (described further in the\r Intervention section) for 3 months, with an additional 3-month no treatment follow-up. They\r will also be asked to use the JITAI for the entire 6-month study period. The JITAI operates\r through PiLR Health, and will utilize ecological momentary assessment (EMA) to repeatedly\r assess lapse triggers and dietary lapses. The EMA survey responses are immediately uploaded\r to a HIPAA-compliant server, where a previously-validated predictive algorithm determines if\r the participant may be at risk for a lapse based on what they reported. When a participant is\r determined to be at risk for a lapse after completing an EMA survey, the PiLR Health system\r server will micro-randomize the delivery of intervention. The randomization is independent of\r prior randomizations and the participants' responses to previously delivered interventions\r for lapse. Based on the investigator's prior research developing this JITAI, the algorithm\r predicts heightened states of lapse risk approximately once per day. The once/day estimate is\r representative of an average across participants and the investigators have demonstrated\r there is substantial individual variability to these data; heightened states of lapse risk\r can range from 2.75/week to 12/week and fluctuate over time. As such, while the estimated\r average is once per day, the prediction algorithm within the proposed JITAI ensures that\r intervention is provided in exact moments of individual need - which is not static within or\r between individuals - thus reducing participant burden and improving potency of intervention.\r The study methods are therefore a considerable improvement to providing general daily\r reminders. Based on these data, intervention options will be randomized an average of 180\r times for each participant. The theory-driven intervention conditions, which have empirical\r support, include: (a) education to promote awareness of lapse triggers; (b) self-efficacy;\r (c) motivation; & (d) self-regulation skills. Given the primary aim of comparing the\r immediate, proximal effect of intervention (as compared to no intervention), interventions\r will be randomized based on the following probabilities: 0.4 no intervention (inactive\r control), 0.12 to generic risk alerts (active control), 0.12 to Enhanced Education, 0.12 to\r Self-efficacy, 0.12 to Autonomous Motivation, and 0.12 to Self-regulation. As such, a given\r participant will receive no intervention at approximately 72 randomization points over the\r study and 107 (~21-22 each) randomization points will be divided equally among the remaining\r 5 intervention options. All JITAI interventions are described in the Intervention section\r\n\r In addition to data they are providing through the JITAI, participants will complete 3 total\r assessments with a research assistant (who does not need to be blinded due to sequential\r randomization) at baseline, 3, and 6 months. During the baseline assessment, height, weight,\r demographic information and weight history will be collected either by a study staff,\r cellular scale, or self-report. Objective data collection will be the priority, so if a\r participant elects to attend their assessment via Zoom, cellular scales may be mailed to the\r participant's home address. Participants will be asked to wear a wrist-watch device (called\r an Actigraph) to measure eating behavior for two weeks following the baseline appointment.\r The participant will be given the Actigraph device in-person during the baseline assessment,\r or by mail to their home address if they choose to attend the assessment via Zoom (the device\r will be mailed back to the study team or dropped off in-person). Also, during the baseline\r assessment, participants will be provided with a calorie and physical activity goal, overview\r of the program, and tutorial for using the smartphone app and online program. The\r participants will be asked to complete similar assessments at 3 months and 6 months.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Age 18-70\r\n\r - Body mass index (BMI) between 25 and 50 kg/m-squared\r\n\r - Diagnosis of one or more cardiovascular disease risk factors (prediabetes, type 2\r diabetes, hypercholesterolemia, or hypertension)\r\n\r - Able to walk 2 city blocks without stopping\r\n\r Exclusion Criteria:\r\n\r - Currently participating in another weight loss program\r\n\r - Currently taking weight loss medication\r\n\r - Lost > 5% of their body weight in the 6 months prior to enrolling\r\n\r - Has been pregnant within the 6 months prior to enrolling\r\n\r - Plans to become pregnant within 6 months of enrolling\r\n\r - Has chest pain during periods of activity or rest, or loss of consciousness in the 12\r months prior to enrolling\r\n\r - Has any medical condition that would affect the safety of participating in\r unsupervised physical activity\r\n\r - Has history of bariatric surgery\r\n\r - Has any condition that would result in inability to follow the study protocol,\r including terminal illness, substance abuse, eating disorder (not including Binge\r Eating Disorder) and untreated major psychiatric illness.\n\nPatient 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
35,823	[ { "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\nLeap Motion Controller on the Functionality of Upper Limbs in Parkinson's Disease\n\nClinical Trial Summary:\n\nIs treatment with the Leap Motion Controller device effective for upper limb functionality in\r individuals with Parkinson's Disease?\r\n\r The present study presents two hypotheses:\r\n\r True hypothesis: There is an improvement in the functionality of MMSS after intervention with\r virtual reality? Null hypothesis: There is no improvement in the functionality of MMSS after\r intervention with virtual reality? The proposed work will be characterized as a Randomized\r Clinical Trial, with evaluators outside the experimental groups (single-blind). The sample\r will be probabilistic, from individuals diagnosed with Parkinson's disease.\n\nClinical Trial Detailed Description:\n\nSTUDY METHODOLOGY\r\n\r 1. RESEARCH DESIGN: The proposed work will be characterized as a Randomized Clinical Trial,\r with evaluators outside the experimental groups (single-blind). The sample will be\r probabilistic, from individuals diagnosed with Parkinson's disease.\r\n\r 2. TYPE OF STUDY: Randomized Clinical Trial.\r\n\r 3. AREA OF SCOPE: Major area: Health Sciences. Area: Physiotherapy and Occupational\r Therapy.\r\n\r 4. LOCATION: The place where the entire study will be carried out will be in the home\r environment of each research participant.\r\n\r 5. PARTICIPANTS: Participants will be recruited from an existing pre-existing list of\r research conducted on individuals with Parkinson's Disease from the UFCSPA. Individuals\r who: - are diagnosed with Parkinson's disease; - Classified as I-III on the Hoehn & Yahr\r motor staging scale; - Are over 18 years old (above this, without age restriction). -\r Residents in the city of Porto Alegre / RS. - Have signed the informed consent form\r (Appendix A). Individuals who: - Do not show the understanding of the games on the first\r day of familiarization; - Have a cerebral pacemaker implant; - Have recent injuries or\r limitations that make the MMSS impossible. - Do not perform / abstain from two\r appointments out of the 16 proposed in the intervention protocol, regardless of the\r group that will be allocated. The study will consist of two groups: intervention group\r (IG), which will receive treatment with Leap Motion Controller; and the control group\r (CG), who will receive treatment with conventional physiotherapy.\r\n\r 6. EVALUATION INSTRUMENTS: A participant identification form will be filled out, containing\r full name, date of birth, gender, address, telephone number, education, diagnosis, time\r of diagnosis, onset of symptoms (laterality), associated diseases, PD subtype and\r medicines. Individuals will be assessed for: the motor aspects of experiences and\r activities of daily living using the TEMPA test and the Unified Assessment Scale for\r Parkinson's Disease (MDS-UPDRS) part II; Motor Assessment and subtype of the disease,\r using the MDS-UPDRS scale III; motor staging of PD using the Hoehn & Yahr scale; muscle\r strength and endurance, using the handgrip dynamometer (TEMPA test); manual dexterity,\r through the Box and Block test and the Nine Hole Peg test; cognitive issues through the\r Montreal Cognitive Assessment (MoCA); and quality of life, through the Questionnaire on\r Parkinson's Disease (PDQ-39).\r\n\r 7. EXPECTED DURATION: The present research project contemplates different objectives, this\r being a study proposal to be developed during four years.\r\n\r 8. PROCEDURES: The formation of each of the groups will be done through the generation of a\r random sequence through the tool available at http://www.randomize.com. Therefore,\r individuals will be divided into two groups: Intervention Group and Control Group.\r Subsequently, the initial assessment will be made,TEMPA, MDS-UPDRS-II e III, motor\r staging of the disease (H&Y), Box and Block Test, Nine Hole Peg Test), MoCA and\r PDQ-39.The IG will carry out a 2-month intervention protocol, with 16 40-minute\r interventions, twice a week. The CG will perform a conventional physiotherapy protocol\r for the same period as the IG. Therefore, all groups will receive the same evaluation\r procedures that will be performed before the intervention (PRE), after the intervention\r (POST) and, finally, 30 days after the intervention (follow-up). The researchers\r responsible for the intervention will not be aware of the evaluations carried out and\r the evaluators will not be aware of the group to which the participant will belong. Both\r groups will be able to follow their routine activities (physical and / or physical\r therapy) and all procedures will be performed in the home environment of each research\r participant.\r\n\r 9. ETHICAL AND LEGAL PROCEDURES The study project in question will be submitted to the\r Research Ethics Committee of the Federal University of Health Sciences of Porto Alegre\r (UFCSPA) and will only be applied after due approval. All participants will be informed\r about the procedures, objectives, justifications, potential risks and benefits of their\r participation in the study. The research will not present risks to the participant, but\r if there is any discomfort during any activity, the treatment will be stopped\r immediately and the necessary measures taken. In addition, all participants must sign\r the informed consent form and receive a copy of it. The use of any type of image will\r not identify the participant and will only be used with written consent. The data in the\r medical record (name, telephone and address) will be used for screening in the\r identification and contact of individuals and stored in a database that will be accessed\r only by researchers.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Parkinson's disease diagnostic;\r\n\r - Classified as I-III on the Hoehn & Yahr motor staging scale;\r\n\r - Are over 18 years old (above this, without age restriction).\r\n\r - Residents in the city of Porto Alegre / RS.\r\n\r - Have signed an informed consent form.\r\n\r Exclusion Criteria:\r\n\r - Do not show the understanding of the games on the first day of familiarization;\r\n\r - Have a cerebral pacemaker implant;\r\n\r - Have recent injuries or limitations that make the MMSS impossible.\r\n\r - Do not perform / abstain from two appointments out of the 16 proposed in the\r intervention protocol, regardless of the group that will be allocated.\n\nPatient 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
35,824	[ { "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\nSTEM-PD Randomized Controlled Trial\n\nClinical Trial Summary:\n\nThis is a double-blinded, controlled, randomized clinical trial (RCT) to establish the safety\r and efficacy of a non-invasive neuromodulation device for treating symptoms associated with\r PD.\n\nClinical Trial Detailed Description:\n\nUp to 220 participants will first enter the double-blinded, controlled, randomized clinical\r trial (RCT) and will self-administer treatments twice daily in the home setting over a period\r of 12 weeks (84 days). The RCT will have 6 study visits completed at both the study center\r and the participant's home by video call.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Adult participants (aged 18 - 85 years inclusive)\r\n\r - Have been diagnosed with PD according to the UK Brain Bank Criteria\r\n\r - Participants must have demonstrated a positive response to medications to treat the\r motor symptoms of PD and have been treated with these medications for minimum of three\r years prior to the screening visit.\r\n\r - Report limitation to activities of daily living\r\n\r - Participants must be able and willing to consent to participate in the study.\r\n\r - Participants must be willing and able to comply with study requirements.\r\n\r - Participants and investigators must expect that the participant will be able to remain\r on a stable regimen of concomitant therapies used for the management of PD motor and\r non-motor symptoms and not to introduce new medications used to treat motor or\r non-motor symptoms associated with PD during the trial.\r\n\r - Participants must have at minimum a moderate burden of NMS.\r\n\r - Participants must have a study partner (defined as someone who sees the participant\r for more than one hour a day, 3x per week) that is willing to consent and participate\r in the trial.\r\n\r - Participants must have capabilities to use and access smartphones and or tablets for\r the collection of some study data.\r\n\r - Must be willing to answer questions related to sexual interest, arousal and\r performance in an interview with study staff.\r\n\r Exclusion Criteria:\r\n\r - Participant anticipates being unable to attend all visits and complete all study\r activities.\r\n\r - Women of child-bearing potential who are pregnant or plan to become pregnant during\r the course of the study trial. Women of child-bearing potential (i.e., are not yet 3\r years removed from their first menopausal symptom), who are not abstinent or\r exclusively in same sex relationships must:\r\n\r 1. Test negative for pregnancy as indicated by a negative urine pregnancy test\r\n\r 2. Agree to use an approved contraception method for the entirety of the trial\r\n\r - Have a history or prior diagnosis of dementia.\r\n\r - Have experienced a myocardial infarction, angina or stroke within the past 12 months.\r\n\r - Are receiving deep brain stimulation therapy.\r\n\r - Are treated with a pump for continuous delivery of dopamine replacement medication.\r\n\r - Use apomorphine rescue.\r\n\r - Have received MRI guided high intensity focused ultrasound within the past 12 months.\r\n\r - Experience frequent falls.\r\n\r - Work night shifts\r\n\r - Use a hearing aid that is implanted or that cannot be easily removed and replaced.\r\n\r - Have a cochlear implant.\r\n\r - Have chronic (>3 months) tinnitus.\r\n\r - Have previously been diagnosed with traumatic brain injury with ongoing sequalae.\r\n\r - Have been diagnosed with a co-morbid neurological disorder that may present with\r symptoms overlapping with PD (e.g., stroke, brain tumor, epilepsy, Alzheimer's\r disease, multiple sclerosis, amyotrophic lateral sclerosis, atypical Parkinsonism or\r aneurysm)\r\n\r - Have been previously diagnosed with vestibular dysfunction.\r\n\r - Have active ear infections, perforated tympanic membrane or labyrinthitis, as\r identified by a general ear examination performed by medically qualified\r Investigators.\r\n\r - Have a recent history of frequent ear infections (≥ 1 per year over the past two\r years)\r\n\r - Are currently enrolled or have participated in another interventional clinical trial\r within the last 30 days.\r\n\r - Have had eye surgery within the previous three months or ear surgery within the\r previous six months.\n\nPatient 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
35,825	[ { "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\nSTEM-PD Open Label Extension (OLE)\n\nClinical Trial Summary:\n\nThis study seeks to establish the safety and efficacy of extended twice daily treatments for\r treating symptoms associated with PD. Only participants who completed the STEM-PD RCT trial\r are eligible for the OLE.\n\nClinical Trial Detailed Description:\n\nUp to 220 participants will enter an open label extension (OLE) study during which all study\r participants will receive treatment for 12 weeks (84 days). Study participants will be\r followed for 16 weeks (112 days) post treatment-cessation and then the twice daily treatments\r will be re-introduced for the final 8 weeks (56 days).\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Completion of the study activities in the STEM-PD RCT trial. l.\r\n\r - Participants must be willing and able to give consent to participate in the study\r trial.\r\n\r Exclusion Criteria:\r\n\r - Participant anticipates being unable to attend all visits and complete all study\r activities in both the RCT and OLE study trial.\r\n\r - Women of child-bearing potential who are pregnant or plan to become pregnant during\r the course of the RCT or OLE study trial.\n\nPatient 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
35,826	[ { "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 Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension\n\nClinical Trial Summary:\n\nMinimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the\r mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of\r cirrhosis and is responsible of severe complications such as HE. The consequence of portal\r hypertension is the formation of the spontaneous portosystemic shunts (SPSS). The\r relationship between the SPSS and their characteristics and the prevalence of MHE in patient\r with cirrhosis is poorly known. The main objective of this study is to evaluate the MHE in\r patients with cirrhosis and portal hypertension.\n\nClinical Trial Detailed Description:\n\nMinimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the\r mildest type of hepatic encephalopathy (HE). It is a frequent complication of the liver\r disease, affecting up to 80% of tested patients. MHE affects severely the lives of patients\r by altering their quality-of-life and their socioeconomic status and is strongly associated\r to the development of overt HE. Portal hypertension is the main complication of cirrhosis and\r is responsible of severe complications such as HE. The consequence of portal hypertension is\r the formation of the spontaneous portosystemic shunts (SPSS). Their presence has been\r associated with recurrent or persistent HE. The relationship between the SPSS and their\r characteristics and the prevalence of MHE in patient with cirrhosis is poorly known.\r\n\r Patients with compensated cirrhosis and portal hypertension will be considered for inclusion.\r After written inform consent, the serum ammonia, psychometric hepatic encephalopathy score\r (PHES) and the animal naming test (ANT) will be performed to evaluate the presence of MHE.\r Patients diagnosed with MHE will be treated and a new evaluation will be performed 6 months\r later.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Patient with cirrhosis and portal hypertension older than 18 old\r\n\r - Patient who underwent a CT scan or MRI in the last 3 months\r\n\r - The Mini-Mental State (MMS) test >25.\r\n\r - Patient capable of receiving and understanding information relating to the study and\r of giving his written informed consent.\r\n\r - Patient affiliated to the French social security system\r\n\r Exclusion Criteria:\r\n\r - Cirrhotic patient with overt HE or history of persistent or recurrent HE.\r\n\r - Hepatocellular carcinoma beyond Milan criteria.\r\n\r - Portal vein thrombosis.\r\n\r - Previous transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt.\r\n\r - Presence of neurological or psychiatric disorder.\r\n\r - Patient with treatment by benzodiazepines or opioid substitution.\r\n\r - Pregnant or nursing women\r\n\r - Patient in exclusion period of a previous study\r\n\r - Patient under guardianship, trusteeship or the protection of justice or incapable of\r giving their own informed consent\n\nPatient 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
35,827	[ { "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 With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug\n\nClinical Trial Summary:\n\nTo test for the first time the potential of a nicotinic agonist on cognitive symptoms in\r people with mild cognitive impairment (MCI) in Parkinson's disease (PD), referred to as\r PD-MCI.\n\nClinical Trial Detailed Description:\n\nThere is an unmet clinical need to treat PD-MCI. As outlined previously, PD-MCI is common,\r has important clinical consequences, and there is currently no available treatment. Moreover,\r the underlying pathology of cognitive impairment in PD indicates that nicotinic agonists may\r be particularly relevant for this condition. This is a randomised, double-blind,\r placebo-controlled, parallel-group, phase 2a study of AZD0328, a selective α7 nicotinic\r receptor agonist, in PD-MCI. The study is an international, multi-centre study, which will\r take place across sites in Europe.\r\n\r PD-MIND will for the first time test the potential of a nicotinic agonist on cognition in\r PD-MCI. The primary outcome is attention, as it is a key cognitive domain in the PD-MCI\r profile and most likely to be affected by a α7 nicotinic agonist. Exploratory outcome\r measures will guide decisions on the design and conduct of future larger Phase 3 trials.\r Qualifying participants will be randomly assigned at baseline to either receive 0.5mg twice a\r day (bis in die, BID) of AZD0328 or placebo for 12 weeks. A total of 160 participants with\r PD-MCI will be enrolled to the study: 80 in the active (AZD0328) group and 80 in the control\r (placebo) group. Participants will undertake face-to-face assessments at screening, baseline,\r and then 3- 6- and 12- weeks after beginning study treatment (see Figure 2 for trial design\r overview). A subset of 90 participants will also undergo an MRI biomarker component prior to\r study drug administration and at study end.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Aged between 50 to 80 years (inclusive) at time of consent\r\n\r - Duration of motor symptoms of at least 1 year\r\n\r - Hoehn and Yahr stage between 1 and 3 (inclusive) in ON state\r\n\r - Diagnosis of PD according to United Kingdom (UK) Brain Bank criteria\r\n\r - Score on Clinical Dementia Rating (CDR) scale = 0.5\r\n\r - Diagnosis of PD-MCI according to MDS PD-MCI, Level I criteria\r\n\r - Duration of cognitive impairment of at least 3 months (to distinguish from mild\r delirium)\r\n\r Exclusion Criteria:\r\n\r - Insufficient fluency in English or local language to complete assessments\r\n\r - Severe visual or auditory impairment that may interfere with participant's ability to\r complete assessments\r\n\r - Unable to provide informed consent at screening visit\r\n\r - Participation in a clinical study involving an investigational drug within 4 months\r prior to screening\r\n\r - Smoking (cigarettes, pipes, cigars, e-cigarettes etc.) or use of smokeless tobacco\r products (chewing / dipping tobacco, snuff etc.) or anti-smoking nicotine containing\r products (patches/gum/sprays etc.), within the last 12 weeks\r\n\r - HADS depression subscale score ≥ 11\r\n\r - History of deep brain stimulation or other neurosurgical procedure\r\n\r - Diagnosis of dementia, including Parkinson's disease dementia (PDD) or Dementia with\r Lewy Bodies (DLB).\r\n\r - Diagnosis of schizophrenia, bipolar disorder or other psychotic disorder\r\n\r - Malignant neoplasms within 3 years of screening (except for basal or squamous cell\r carcinoma of the skin); or had curative surgery/treatment and has been free of\r malignancy for at least 12 months)\r\n\r - Any medical condition that in the opinion of the investigator may be contributing to\r cognitive impairment, above and beyond that caused by the participant's PD,\r\n\r - Current evidence of any other medical condition not stably or adequately controlled,\r and which in the opinion of the investigator may affect participant safety or study\r participation\r\n\r - Using any prohibited medications or permitted medications that do not meet stable\r dosing regimen requirements, as specified in section 5.7\r\n\r - Clinically significant vital sign or ECG measure at screening or baseline visit, that\r in the opinion of the investigator would prevent participant from safely participating\r in this study\r\n\r - Clinically significant clinical laboratory result from screening visit, that in the\r opinion of the investigator would prevent participant from safely participating in\r this study\r\n\r - Significant renal function impairment as indicated by estimated glomerular filtration\r rate (eGFR) < 45ml/min); Note: The eGFR is calculated using a formula derived from the\r Modification of Diet in Renal Disease Study (MDRD formula): eGFR= [186.3 x\r (Creatinine/88.4)-1.154 x (Age)-0.203] x [0.742 if female] x [1.210 if black]\r\n\r - Unable to complete computerised cognitive test battery\r\n\r - Marked cerebrovascular disease from MRI or CT scan within last 12 months (defined as\r Fazekas scale ≥ grade 3)\r\n\r - Females who are breast-feeding\r\n\r - Female participants assessed as being of child-bearing potential that have a positive\r pregnancy test at screening or baseline\r\n\r - The participant does not understand or agree to comply with the contraception or\r reproductive requirements of the study\n\nPatient 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
35,828	[ { "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\nVigor and the LDR in Parkinson Disease\n\nClinical Trial Summary:\n\nParkinson disease (PD) is a common disorder in which reduced speed of movement results from\r inadequate brain production of the chemical dopamine. The most effective treatment for PD is\r the drug levo-dopa, which partially replaces brain dopamine. Despite decades of successful\r use, how levo-dopa improves speed of movement in PD is not understood. This observational\r study recruits participants who have been prescribed levo-dopa by their treating physicians.\r Before their first dose, immediately after their first dose and later, when their dose has\r been stabilized, they will engage with the research team to participate in a few simple\r experiments to measure speed, grip strength, tremor, and stability (on and off of treatment).\r The purpose of these experiments is to understand how levo-dopa treatment in Parkinson\r disease enhances movement speed. An important but not understood component of levo-dopa\r action, the Long Duration Response (LDR), lasts for days to weeks. A basic function of\r dopamine signaling in the brain is modulation of motivation - the coupling between effort and\r action values. These experiments will determine if the LDR is associated with relative\r normalization of motivation function in the brain. The motivation behavior of recently\r diagnosed PD participants will be examined before and after treatment with levo-dopa to\r determine if the magnitude of the LDR is correlated with improvements in motivation behavior.\n\nClinical Trial Detailed Description:\n\nDopamine replacement therapy (DRT) is the standard symptomatic treatment for early to\r moderate Parkinson disease (PD). In early to moderate PD, the most important DRT component is\r the Long Duration Response (LDR), a pharmacodynamic effect that builds up over the course of\r days-weeks and can be induced by dopamine agonists. Despite its effectiveness, DRT actions\r are poorly understood and the basis of the LDR is unknown. As the LDR wanes in advancing\r disease, PD patients develop troublesome motor fluctuations and increasing disability.\r Improved understanding of the LDR has the potential to prolong the duration of its effects\r and could have a significant positive effect on clinical practice.\r\n\r The kinetics of the LDR suggest long-term plastic changes in striatal function. Recent\r studies of striatal dopamine actions in PD subjects and experimental animals indicate that\r striatal dopaminergic neurotransmission regulates \"vigor,\" the force, velocity, or amplitude\r of actions. Vigor is closely allied to the concept that striatal dopaminergic\r neurotransmission mediates motivation, which involves the assessment of act utility and the\r appropriate scaling of actions to perceived rewards. Recent theoretical and experimental\r results suggest that tonic striatal dopamine signaling, mimicked by dopamine agonist\r administration, is a key determinant of movement vigor. Convergent clinical pharmacologic and\r experimental data lead to a strong hypothesis that the LDR results from chronic DRT partially\r restoring motivational coupling of effort to perceived reward and movement vigor. Prior\r experiments examining vigor in PD subjects did not take the LDR into account, resulting in\r incomplete examinations of the role of vigor deficits in PD.\r\n\r Recent non-human primate work on the control and vigor of saccadic eye movements indicates\r the existence of basal ganglia circuit changes that stably encode motor action values for\r prolonged periods. Striatal dopaminergic neurotransmission is critical for establishing this\r remarkably stable form of value-action coupling. This phenomenon is a plausible circuit level\r mechanism underlying the LDR.\r\n\r Our long-term goal is to understand the clinically relevant actions of DRT. The primary\r objective of our proposal is to test the hypothesis that the LDR results from partial\r restoration of normal action vigor by reinstating the link between motivation and effort. Our\r secondary objective is to explore potential mechanisms underlying the LDR. The rationale for\r these experiments is that better understanding of the LDR, a clinically crucial component of\r DRT action, will lead to improved symptomatic therapy.\r\n\r We will study recently diagnosed PD subjects. All subjects will undergo standard evaluations\r of clinical, cognitive, and motivational features. Subjects will perform incentive motivation\r tasks assessing movement vigor in response to monetary incentives. Two complementary tasks,\r one based on modulation of movement velocity and one based on modulation of grip strength,\r will be employed. To assess whether the recently described stable action-value coupling for\r saccades is relevant to the LDR, subjects will perform a task that measures saccadic eye\r movement vigor in response to stable value signals learned prior to LDR induction. Subjects\r will perform all tasks before and after LDR induction in both the \"practical off\" and\r post-acute treatment states.\r\n\r Specific Aim 1: To use incentive motivation tasks to evaluate the coupling between motivation\r and movement vigor in recently treated PD subjects before and after LDR induction.\r\n\r Hypothesis 1A: LDR induction will result in partial restoration of movement vigor in response\r to monetary incentives in PD subjects in the \"practical off\" state.\r\n\r Hypothesis 1B: The magnitude of partially restored movement vigor in response to monetary\r incentives will correlate with reduced bradykinesia in PD subjects in the \"practical off\"\r state.\r\n\r Hypothesis 1C: Identical effects will be found with an incentive motivation task based on\r movement amplitude and one based on grip strength.\r\n\r Specific Aim 2: To use a saccadic eye movement task to assess saccadic eye movement vigor in\r response to stable value signals in recently treated PD subjects before and after LDR\r induction.\r\n\r Hypothesis 2: LDR induction will result in partial restoration of saccadic eye movement vigor\r in response to previously learned stable value signals in PD subjects in the \"practical off\"\r state.\r\n\r Validation of our hypotheses would have considerable impact by identifying a specific\r functional process underlying the LDR and a potential mechanism of the LDR. This will\r facilitate research into LDR mechanisms, provide a rational basis for developing valid animal\r models of the LDR, and open a new path towards improved symptomatic management of PD.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Diagnosis of Parkinson Disease\r\n\r - Previously Untreated or treated for <4 weeks\r\n\r - Mild to Moderate Parkinson disease (Hoehn & Yahr Stages I-II)\r\n\r - About to start treatment with a L-Dopa preparation (Sinemet)\r\n\r Exclusion Criteria:\r\n\r - The presence of other neurologic disease or findings on examination\r\n\r - Depression: Geriatric Depression Scale score >11\r\n\r - Use of dopamine agonists or stimulants\r\n\r - Evidence of a stroke or mass lesion on prior structural brain imaging (MRI or CT)\r\n\r - Evidence of any confounding medical or psychiatric problem that would preclude task\r participation.\r\n\r - Participants with cognitive impairment that might impair their capacity to provide\r informed consent.\n\nPatient 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
35,829	[ { "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\n\"Individual Patient Expanded Access IND Using HB-adMSCs to Treat of Spinal Cord Injury\"\n\nClinical Trial Summary:\n\nThis Individual Patient Expanded Access IND has been created per the request of a 19-year-old\r man who has been diagnosed with Spinal Cord Injury.\n\nClinical Trial Detailed Description:\n\nSubject is a 19-year-old male who fell approximately 50 feet onto his back during a skiing\r accident. He suffered traumatic anterolisthesis at T10-11 with associated spinal cord\r transection and obliteration of the central canal. He and his family are requesting this\r Individual Patient Expanded Access IND with the purpose of possible restoration of nerve\r transmission and restoring sensation in his lower body using intravenous autologous adipose\r derived mesenchymal stem cells. This study will give 14 infusions of 200 million HB-adMSC's\r over a 52 week period.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Adult individual 18 years of age or older.\r\n\r 2. Cognitively intact and capable of giving informed consent.\r\n\r 3. Clinical diagnosis of Traumatic Spinal Cord Injury.\r\n\r 4. Subject has mesenchymal stem cells banked at Hope Biosciences.\r\n\r 5. The patient accepts to receive treatment and to comply with follow-up visits.\r\n\r Exclusion Criteria:\r\n\r 1. Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or\r endocrine disease or any other acute or chronic medical condition that, in the opinion\r of the investigator may increase the risks associated with study participation.\r\n\r 2. Active Alcohol or Drug addiction.\r\n\r 3. Participation in concurrent interventional research studies during this study.\r\n\r 4. Severe organ failure (heart, kidney or liver), confirmed by additional tests or\r medical history.\r\n\r 5. Unwillingness to return for follow-up visits.\n\nPatient 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
35,830	[ { "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 in Alzheimer's Disease: Biomarkers and Dose Optimization\n\nClinical Trial Summary:\n\nTitle:\r\n\r Deep Brain Stimulation of the Fornix in Alzheimer's Disease: Investigating clinical and\r imaging biomarkers and dose optimization\r\n\r Objective:\r\n\r To evaluate the influence of deep brain stimulation in Alzheimer's Disease (AD)on markers of\r AD pathology in cerebrospinal fluid (CSF) and on neuroimaging with positron emission\r tomography (PET) and to optimize electrical stimulation parameters.\r\n\r Population size:\r\n\r Twelve (12) patients will be recruited and enrolled in this study.\r\n\r Study design:\r\n\r This is a prospective, open-label trial designed to study the effect of brain stimulation on\r CSF and brain amyloid pathology in AD. In addition, patients will undergo neuropsychological\r testing at various stimulation settings to help determine optimal stimulation parameters.\r\n\r Study duration:\r\n\r Patients will complete screening and baseline assessments before undergoing DBS implantation\r surgery, after which they will be followed-up for 12 months.\n\nClinical Trial Detailed Description:\n\nBackground/Rationale:\r\n\r Despite years of recognition and attempts at treatment, Alzheimer's Disease (AD) remains a\r pervasive and challenging condition, with an inexorable progression to severe disability and\r death once a diagnosis is made. The latest attempts at pharmacologic have yielded, at best,\r very modest results. There exists, therefore, no treatment for AD that significantly slows\r down its progression, and alters the metabolic milieu of AD brains.\r\n\r We have conducted and published the world's first phase I safety and feasibility trial of\r deep brain stimulation (DBS) for early Alzheimer's Disease and the first Phase II randomized,\r placebo-controlled study of DBS in the same population. These trials have had the following\r three objectives: 1) establishing the safety of DBS in AD, 2) studying the possible slowing\r of cognitive decline in AD, and 3) studying the relationship between focal brain stimulation\r and metabolic changes in regions known to be affected by AD neurodegeneration.\r\n\r With this background, we now want to continue and expand our DBS for AD trials. The rationale\r of the currently proposed study is to optimize patient selection and stimulation parameter\r dose for DBS for AD. We will measure the effects of DBS on brain amyloid load, on\r cerebrospinal fluid (CSF) Alzheimer protein metabolites and will screen various stimulation\r parameter settings for their acute effects on memory function. The latter will be used in an\r attempt to define the optimal stimulation dose.\r\n\r The significance of this study is two-fold: 1) A possible demonstration that DBS may directly\r influence brain pathology in AD as measured by amyloid imaging and CSF protein changes, hence\r providing a mechanism of action for its clinical effects, and 2) the first study to\r empirically determine, using a memory task, the optimal stimulation parameters for DBS\r patients to improve memory function.\r\n\r Study Objectives:\r\n\r 1. Influence of DBS on AD Pathology\r\n\r Early results suggest that DBS may influence cognitive and memory functions in patients\r with early Alzheimer's Disease (AD). It is not clear, however, whether DBS can directly\r influence pathology in AD, such as CSF protein biomarkers and amyloid plaque load in the\r brain. The objective of this study is to analyze CSF and brain plaque load prior to and\r after surgery to determine whether DBS influences central nervous systems pathology\r associated with AD.\r\n\r 2. Dose Optimization\r\n\r Currently, selecting the optimal stimulation dose for patients with non-motor conditions\r (i.e. Alzheimer's Disease, depression, obsessive-compulsive disorder) is performed largely\r arbitrarily, and borrows heavily from settings used in motor conditions (i.e. Parkinson's\r Disease, Tremor). The objective of this study is to establish a clinically meaningful dose\r optimization test that will use the patients' performance on an experimental memory task to\r determine the optimal stimulation settings.\r\n\r Study Hypotheses:\r\n\r Our study has the following exploratory hypotheses:\r\n\r i. DBS may lead to changes in CSF biomarkers of AD pathology, including tau, phosphorylated\r tau, and beta amyloid, consistent with plaque clearance ii. DBS may lead to reductions in\r plaque burden, demonstrated by amyloid PET imaging iii. The optimal dose of brain\r stimulation, which maximizes benefits and minimizes adverse events, can be selected using an\r acute memory task performed in the post-operative period.\r\n\r Design and Methodology:\r\n\r This is an open-label, prospective trial designed to measure the influence of DBS on AD brain\r pathology and to optimize stimulation parameter selection post-operatively. Twelve (12)\r patients will be enrolled and operated, and followed in an open-label fashion. All subjects\r will be followed to a common closing date, which will be at the time the last subject\r enrolled is followed for 12 months.\r\n\r Patient selection and enrollment:\r\n\r 1. Pre-treatment procedures\r\n\r The schedule for individual subjects is outlined below in table format and is displayed\r in Figure 1 as a flowchart. This study is divided into four phases: screening, baseline,\r surgery, and on-stimulation. All patients will be recruited through the memory clinic at\r Toronto Western Hospital and local advertisements. Patients meeting inclusion/exclusion\r criteria will be approached for participation. There will be two distinct periods of\r informed consent in this study: the first, to allow study investigators to screen\r patients for study inclusion, and the second, to formally enroll patients into the\r study. Figure 1 outlines the process that will take place for identified patients and\r the estimated number of individual subjects at each stage.\r\n\r Once patients are identified by the study neurologist, screening consent will be\r obtained. This consent will signal entrance into the first phase of the study, and\r indicates that the patient meets inclusion/exclusion criteria. During the screening\r visit, patients will undergo a medical history and general physical examination,\r medication screening, electrocardiogram, relevant pre-operative blood work,\r neuropsychological testing and psychiatric screening: the Alzheimer's Disease Assessment\r Scale-Cognitive Subscale(ADAS-Cog) Clinical Dementia Rating (CDR) scale,\r Neuropsychiatric Inventory (NPI), Columbia Suicide Severity Rating Scale (C-SSRS),\r Cornell Scale for Depression in Dementia (CSDD), Young Mania Rating Scale (YMRS), which\r will be used to classify participants by inclusion/exclusion criteria. Once the\r screening is complete, patients will be discussed by the study team to determine whether\r they should continue in the trial, and progress to the baseline stage.\r\n\r The baseline stage will require an additional informed consent, as this stage signals\r entry into the formal trial. Baseline investigations will commence within 2 months of\r signing baseline consent, and can take place up to within 1 day of surgery\r (\"implantation\"). Baseline investigations will include all tests and examinations done\r during Screening (excepting the ECG), with the addition of: the Alzheimer's Disease\r Cooperative Study Activities of Daily Living Inventory 23-item Scale (ADCS-ADL23), the\r Hopkins Verbal Learning Test (HVLT), neuroimaging (MRI and Amyloid PET) as well as a\r lumbar puncture (LP) for AD protein markers. Participants will also complete acute\r experimental memory tasks that will be used in the 'dosing' phase, to familiarize them\r with the procedure. For these memory tasks, patients will view stimuli (e.g., objects,\r faces, scenes, words), and then be asked to remember them. In addition, an experimental\r visual associative recognition task, which is a simplified version of the one that was\r critical in identifying memory-specific effects in the sentinel case (Hamani et al\r 2008), will be introduced at this stage.\r\n\r Once all baseline investigations are complete, patients will be scheduled for surgery\r and implantation.\r\n\r 2. Treatment procedures - DBS surgery\r\n\r DBS surgery will be performed as is done routinely and has been performed on the\r previous 18 patients with AD at our centre. Patients will arrive on the morning of\r surgery at the Toronto Western Hospital medical imaging department. They will have a\r small part of their head shaved and then have a stereotactic frame attached directly to\r their skull, after infiltration with local anaesthesia. The frame allows precise\r co-ordinates to be acquired so that deep brain structures can be targeted with implanted\r electrodes. The patient will then undergo an MRI scan (for surgical planning) with the\r frame in place, followed by transport directly to the operating room. The anaesthesia\r team will insert an intravenous line followed by induction and initiation of general\r anaesthesia (GA). The entire case, including electrode implantation and implantation of\r the pulse generator, will be done under general anaesthesia with the patient fully\r asleep. In the operating room the patient's head, via the frame, will be attached to the\r operating room table, and their scalp infiltrated with additional local anaesthetic. A\r skin incision will be made and two 2.5 mm diameter burr holes drilled through the skull.\r A DBS electrode will be delivered at the fornix target as identified on the MRI scan\r obtained earlier in the morning. The patient will be monitored throughout the entire\r case. Once implanted, the second stage of the operation with begin (about 30 min)\r whereby the electrodes are connected to a battery placed under the right collarbone.\r With the patient asleep, the electrodes are tunneled to the battery, and connected. Both\r the head and chest incisions are then closed and the patient transferred to the recovery\r room. Following surgery, the patient will be transferred to the neurosurgical ward for\r recovery. On the first post-op day, they will undergo an MRI of their brain to confirm\r the electrode location. Should the electrodes be in a suboptimal location (e.g. nearby\r but not within the target), patients will be offered several options: re-operation for\r lead repositioning, leave the system in place and turn device on, leave the system in\r place and keep device off, or removal of the system completely.\r\n\r Recovery following surgery should take 1-2 days, and patients will be discharged home on\r post-op day 2, with the stimulator in the off position. Patients will return to the\r neurosurgical clinic two weeks after discharge to check the wound, remove staples, and\r for routine post-op follow-up.\r\n\r 3. Other Procedures\r\n\r Beta-Amyloid Positron Emission Tomography (PET) scans. Beta-Amyloid PET scans will be used to\r estimate amyloid burden in the brains of the patients and to probe whether DBS has an impact\r on this process. Flutemetamol (GE Healthcare) is an FDA-approved amyloid PET radiotracer that\r has been approved by Health Canada for research use. PET scans will be performed on a Siemens\r HRRT scanner. During radiotracer uptake, patients will be maintained in a quiet, dimly lit\r room, with eyes open and ears unoccluded. Ninety minutes after a 5mCi ± 10% radiotracer\r injection, patients will be positioned in the scanner, and a 20-minute emission scan will be\r obtained, followed by a transmission scan.\r\n\r Lumbar Puncture (LP) for protein analysis. The procedure is done with patients lying on their\r side. The skin is washed with sterilizing solution; 3 ml of local anesthetic is injected in\r the skin and subcutaneous tissue at the lumbar 4/5 level. 6 ml of CSF is removed and\r distributed in aliquots. The samples are immediately frozen and stored at -80C. CSF levels of\r Tau, phosphoTau and beta amyloid are determined by standard protein analysis. The analysis\r will be performed as per the Alzheimer's Disease Neuroimaging Initiative (ADNI) guidelines.\r\n\r Stimulation dose finding studies. At the patient visits, the DBS will be programmed to test\r the effects of various stimulus settings on memory performance. Testing sessions will last up\r to 2.5 hours or less if, the patient becomes tired. Settings will be adjusted to ensure that\r the patients do not feel or experience adverse effects. Heart rate will be monitored during\r programming. Patients will be asked to perform a memory task at each of the tested settings\r to determine optimal setting during subsequent visits. This setting will remain stable until\r the next visit, at which time settings will again be evaluated and may be changed. For the\r memory tasks, patients will view stimuli (e.g., objects, faces, scenes, words), and will then\r be asked to remember the stimuli. Each test will last approximately 5-10 minutes.\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r 1. Informed consent signed by the subject AND a reliable caregiver\r\n\r 2. 45-85 years of age (inclusive)\r\n\r 3. Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's\r disease Association criteria.\r\n\r 4. Clinical Dementia Rating (CDR) global rating of 0.5 or 1 at screening.\r\n\r 5. ADAS-cog-11 score of 12-30 inclusive at screening AND baseline (with a score ≥ 4 on\r ADAS-cog item 1) or a Mini Mental State Examination (MMSE) of 16-28.\r\n\r 6. If female, post-menopausal, surgically sterile or willing to use birth control methods\r for the duration of the study.\r\n\r 7. The patient has an available caregiver or other appropriate knowledgeable informant\r who can reliably report on daily activities and function and signs the informed\r consent for participation as such.\r\n\r 8. Patient is living at home and likely to remain at home for the study duration.\r\n\r 9. General Medical Health Rating (GMHR) ≥ 3 (good or excellent general health).\r\n\r 10. Patient must be a good surgical candidate for placement of a deep brain stimulator as\r judged by the DBS surgical team.\r\n\r 11. Fluency (oral and written) in the language in which standardized tests will be\r administered.\r\n\r 12. The patient is taking a stable dose of cholinesterase inhibitor (AChEI) medication\r (donepezil, galantamine, or rivastigmine) for at least 60 days prior to signing the\r informed consent form and there is no intention to modify the dose over the course of\r the study (NOTE: These medications may NOT be initiated, discontinued or modified\r after study initiation for the length of study participation).\r\n\r Exclusion Criteria:\r\n\r 1. Neuropsychiatric Inventory (NPI) total score ≥ 10 or score ≥ 4 in any NPI domain\r (clinically significant neuropsychiatric symptoms). Apathy score ≥ 4 acceptable.\r\n\r 2. Subjects at risk for suicide in the opinion of the investigator or the subject answers\r \"yes\" to \"Suicidal Ideation\" Item 4 or 5 on the C-SSRS (at time of evaluation) at the\r screening or baseline visit.\r\n\r 3. Cornell Scale for Depression and Dementia (CSDD) score > 10 at the screening visit\r\n\r 4. Young Mania Rating Scale (YMRS) ≥ 11 at the screening visit\r\n\r 5. Current major psychiatric disorder such as schizophrenia, bipolar disorder or major\r depressive disorder based on psychiatric consult at screening visit\r\n\r 6. The subject has attempted suicide in the 2 years prior to signing the consent to\r participate in the study.\r\n\r 7. In the judgment of the investigator, the subject is at significant risk for suicidal\r behavior during the course of his/her participation in the study\r\n\r 8. History of head trauma in the 2 years prior to signing the consent to participate in\r the study\r\n\r 9. History of brain tumor, subdural hematoma, or other clinically significant (in the\r judgment of the investigator) space-occupying lesion on CT or MRI\r\n\r 10. Active psychiatric disorder\r\n\r 11. Mental retardation\r\n\r 12. Current alcohol or substance abuse as defined by Diagnostic and Statistical Manual of\r Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)\r\n\r 13. Contraindications for PET scanning (e.g., insulin dependent diabetes)\r\n\r 14. Contraindications for MRI scanning, including implanted metallic devices (e.g.\r non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins;\r surgical clips; or other implanted metal parts), or claustrophobia or discomfort in\r confined spaces.\r\n\r 15. Radiation exposure in the 1 year prior to signing the informed consent form that, in\r combination with the radiation exposure from this study, would exceed 5 rem.\r\n\r 16. Abnormal lab results that, in the opinion of the investigator and/or enrollment review\r committee, would preclude participation in the study.\r\n\r 17. Abnormal cardiovascular or neurovascular disorder that, in the opinion of the\r investigator and/or enrollment review committee, would preclude participation in the\r study.\r\n\r 18. Unstable dose of any medication prescribed for the treatment of memory loss or\r Alzheimer's disease.\r\n\r 19. Currently prescribed any non-AD medications that, in the opinion of the investigator\r and/or enrollment review committee, would preclude participation in the study.\r\n\r 20. Is unable or unwilling to comply with protocol follow-up requirements.\r\n\r 21. Has a life expectancy of < 1 year.\r\n\r 22. Is actively enrolled in another concurrent clinical trial.\n\nPatient 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
35,831	[ { "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 Investigate the Effect of Hypoestes Rosea Powder in Parkinson's Disease\n\nClinical Trial Summary:\n\nParkinson's disease (PD) is a progressive neurological disease characterized by resting\r tremors, limb stiffness, impaired balance, and slow movement. There is no known cure for PD\r although levo-3,4 dihydroxyphenylalanine (L-DOPA) and dopamine agonists are effective for\r improving PD symptoms in the early years following diagnosis. Hypoestes rosea is an evergreen\r shrub which has anti-inflammatory, anticancer and antimalarial properties. Recent studies\r showed that the active pharmaceutical ingredient (API) of Hypoestes rosea, Hypoestoxide, was\r effective in modifying disease progression in a transgenic mouse model of PD.\r\n\r The aim of this study is to determine the efficacy of Hypoestoxide, as contained in Hypoestes\r rosea dry leaf powder, in improving motor symptoms in consenting PD patients. The study\r design is a double-blind, placebo-controlled cross-over trial involving 30 patients with mild\r to moderate disease (Stages 1-3 of Hoehn and Yahr scale over an 8-week period. The symptoms\r of the participants will be monitored using mobile phones with an established quantitative\r assessment tool, mPower2.0, which was previously developed for monitoring symptoms and\r disease progression in PD patients. In addition, the motor examination component of the\r International Movement Disorders Society scale will be administered and correlated with the\r finding on the mobile phone. The outcome measure is an improvement in the motor variables of\r the study participants with a 10% change from baseline over the 8 weeks of using Hypoestes.\n\nClinical Trial Detailed Description:\n\nJustification Age-associated disorders are increasing in many low- and middle-income\r countries due to population ageing and changing lifestyles. PD is a devastating condition\r which, in the advanced stages, is associated with immobility and uncontrollable tremors. Life\r then becomes miserable for the sufferers. Unfortunately, there is no cure for the disease\r except control of symptoms with medications. Any treatment combination that leads to better\r symptom control will go a long way in improving the quality of life for PD patients. This\r proof of concept study, if successful will give a new lease on life to PD patients. Hence it\r is considered worthwhile to treat PD patients with a new compound that is contained in a\r local plant that is readily available and holds promise for efficacy based on its mode of\r action specifically in reducing the formation of alpha synuclein which underlies the neuronal\r death in PD.\r\n\r OBJECTIVES OF THE STUDY\r\n\r The aim of this study is to determine the efficacy of Hypoestoxide, as contained in Hypoestes\r rosea dry leaf powder, in improving motor symptoms in consenting PD patients over an 8-week\r period.\r\n\r Specific Objectives:\r\n\r - To determine the efficacy of Hypoestes rosea in improving motor performance of PD\r patients through traditional clinical evaluation, use of the selected components of the\r Motor Examination section of the International Movement Disorders Society Scale and the\r computer software application (mPower2.0 app)\r\n\r - To document the side effect profile of the herbal product\r\n\r Methodology Study site: University College Hospital, Ibadan Study design: Single-center,\r randomized, double-blind, placebo-controlled trial Study Type: Interventional (Clinical\r Trial) Allocation: Randomized Masking: Double Primary Purpose: Treatment Study participants:\r Patients with mild to moderate Parkinson's disease symptoms.\r\n\r Eligibility Criteria Ages eligible for study: 30 years and older (Adult, older adult) Sexes\r Eligible for Study: All Accepts healthy volunteers: No Sample size: Being a proof-of-concept\r study, 30 PD patients will participate in this phase of the study\r\n\r Inclusion criteria:\r\n\r - Willing and able to give informed consent.\r\n\r - Willingness and ability to comply with study requirements.\r\n\r - PD diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs\r (resting tremor, rigidity, postural instability) being present.\r\n\r - Age >30 years\r\n\r - Men and women with mild to moderate PD: Hoehn and Yahr scale stages 1 - 3. Participants\r may be on current therapeutic agents (including levodopa, dopamine agonists,\r anticholinergics, amantadine or selegiline) to treat PD symptoms at the time of\r enrollment and may remain on these agents throughout the 5-month study period.\r\n\r - Women of childbearing potential (i.e., those not postmenopausal or surgically sterile)\r may participate provided that they are using adequate birth control methods for the\r duration of the study. Women of childbearing potential must have a negative pregnancy\r test at baseline and be non-lactating.\r\n\r Exclusion:\r\n\r • Subjects with advanced, severe disease, including those with dementia, severe\r osteoarthritis, allergies, stroke, and visual impairment.\r\n\r - Presence of atypical PD syndromes due to drugs (e.g., metoclopramide, flunarizine),\r metabolic identified neurogenetic disorders (e.g., Wilson's disease), encephalitis, or\r other degenerative diseases (e.g., progressive supranuclear palsy).\r\n\r - Any clinically significant medical condition (e.g., active neoplasm, angina) or\r laboratory abnormality, which would in the judgement of the investigator interfere with\r the subjects' ability to participate in the study or be followed.\r\n\r Study Procedure:\r\n\r In this study, participants with mild to moderate PD, whether treated or untreated, will be\r randomized into one of two study arms following an initial baseline assessment to determine\r motor activity status of each participant as follows:\r\n\r Baseline Determination: Measurement of motor activities of all participants will be\r determined for 3 weeks while on regular PD medication(s). The International Movement\r Disorders Society Scale - Motor Examination (10 selected items on Slowness, Posture, Tremor,\r Rigidity and Gait) will be utilized for the quantitation of the motor activities.\r\n\r Drug arm: 15 patients will receive 4 capsules each containing 350 mg orally twice a day of\r Peko-D Forte for 8 weeks as add-on therapy to patients' regular PD medication(s).\r\n\r Placebo arm: 15 participants will receive 4 capsules orally twice a day of USP-grade starch\r for 8 weeks as add-on to regular PD medication(s).\r\n\r Wash-Out: Wash-out will be for a duration of 4 weeks in which patients assigned to both arms\r will take no capsules.\r\n\r The Switch over: Following the wash-out period, the Peko-D Forte group will receive 4\r capsules of USP-grade starch powder taken orally twice a day for 8 weeks. The placebo group\r will receive 4 capsules of Peko-D Forte taken orally twice a day for 8 weeks.\r\n\r Symptoms of the participants will be monitored using traditional clinical evaluation and\r daily using mobile phones installed with an established quantitative assessment tool,\r mPower2.0, previously developed for monitoring symptoms and disease progression in PD\r patients.26 Once enrolled and given the smartphones and mPower2.0 app, the participants will\r be asked to perform four (4) separate study tasks daily during the baseline determination\r period and throughout the treatment period: gait, tremor, tapping and balance. The\r International Movement Disorders Society Scale (MDS) - Motor Examination (10 selected items\r on Slowness, Posture, Tremor, Rigidity and Gait) will be utilized for the quantitation of the\r motor activities. Data collected using mPower2.0 and the MDS - Motor items will then be\r analyzed for significant changes in symptom severity relative to baseline status.\r\n\r OUTCOME MEASURE: 10% Mean change in motor assessment parameters using the International\r Movement Disorders Society Scale - selected motor examination items while on the Hypoestes.\r This equates to 1- to 2-point improvement in motor performance over a 2-month period on\r Hypoestes in the absence of side effects which will be monitored using pharmacovigilance\r tools.\r\n\r Total duration of study: 5 months (2 months on active drugs, 2 months on placebo with one\r month wash-out period in-between)\r\n\r The protocol for the study:\r\n\r PROOF OF CONCEPT STUDY: to investigate the effect of Peko-D Forte (100% Hypoestes rosea\r powder) in Parkinson's Disease using mPower2.0 as a quantitative assessment tool.\r\n\r Study Protocol\r\n\r Serial Number: Hospital Number:\r\n\r 1. Name:\r\n\r 2. Address:\r\n\r 3. Phone number:\r\n\r 4. Gender: Male Female\r\n\r 5. Age (in years) Date of Birth (if known):\r\n\r CLINICAL DETAILS:\r\n\r 6. Age at diagnosis of PD:\r\n\r 7. DURATION OF DISEASE AT DIAGNOSIS\r\n\r 8. What are the predominant symptoms? (check all that apply) I) Tremor _______ ii)\r Stiffness _______iii) Slowness ______iv) Postural instability_______\r\n\r 9. Stage of the disease (from Hoehn and Yahr Scale): _______________ I Unilateral disease\r only II Bilateral mild disease III Bilateral disease + early impairment of postural\r stability IV Severe disease requiring considerable assistance V Confinement to\r wheelchair or bed unless aided\r\n\r 10. Medical co-morbidities i) Hypertension --------- ii) Diabetes Mellitus________ iii)\r Heart failure_______iv) Chronic lung disease_________ v) Osteoarthritis _______vi)\r Glaucoma______ VII) Others_________________________\r\n\r 11. Current medications and dosages:\r\n\r I) L-Dopa + carbidopa ii) Anticholinesterase iii) DOPA-agonists (specify) iv) Others\r (specify)\r\n\r 12. Medication Side effects (if any)\r\n\r 13. Any major disability experienced - Yes No IF Yes, check where check whichever is\r applicable: Cognitive ______ On and off phenomenon_____ Neuropathic pain_________\r Dyskinesia____________ others______________\r\n\r WILLINGNESS TO PARTICIPATE IN STUDY: Yes No\r\n\r PECKO-D Study\r\n\r Objective assessment of motor and non-motor- features in PD patients\r\n\r The MDS-sponsored Revision of the Unified Parkinson's Disease Rating Scale\r\n\r 1. Posture: Instructions to examiner: Posture is assessed with the patient standing erect\r after arising from a chair, during walking, and while being tested for postural reflexes. If\r you notice poor posture, tell the patient to stand up straight and see if the posture\r improves (see option 2 below). Rate the worst posture seen in these three observation points.\r Observe for flexion and side-to-side leaning.\r\n\r 0: Normal: No problems.\r\n\r 1. Slight: Not quite erect, but posture could be normal for older person.\r\n\r 2. Mild: Definite flexion, scoliosis or leaning to one side, but patient can correct\r posture to normal posture when asked to do so.\r\n\r 3. Moderate: Stooped posture, scoliosis or leaning to one side that cannot be corrected\r volitionally to a normal posture by the patient.\r\n\r 4. Severe: Flexion, scoliosis or leaning with extreme abnormality of posture.\r\n\r 2. Global spontaneity of movement (body bradykinesia) Instructions to examiner: This global\r rating combines all observations on slowness, hesitancy, and small amplitude and poverty of\r movement in general, including a reduction of gesturing and of crossing the legs. This\r assessment is based on the examiner's global impression after observing for spontaneous\r gestures while sitting, and the nature of arising and walking.\r\n\r 0: Normal: No problems.\r\n\r 1: Slight: Slight global slowness and poverty of spontaneous movements. 2: Mild: Mild global\r slowness and poverty of spontaneous movements. 3: Moderate: Moderate global slowness and\r poverty of spontaneous movements. 4: Severe: Severe global slowness and poverty of\r spontaneous movements.\r\n\r 3. Rigidity: Instructions to examiner: Rigidity is judged on slow passive movement of major\r joints with the patient in a relaxed position and the examiner manipulating the limbs and\r neck. First, test without an activation maneuver. Test and rate neck and each limb\r separately. For arms, test the wrist and elbow joints simultaneously. For legs, test the hip\r and knee joints simultaneously. If no rigidity is detected, use an activation maneuver such\r as tapping fingers, fist opening/closing, or heel tapping in a limb not being tested. Explain\r to the patient to go as limp as possible as you test for rigidity.\r\n\r 0: Normal: No rigidity.\r\n\r 1. Slight: Rigidity only detected with activation maneuver.\r\n\r 2. Mild: Rigidity detected without the activation maneuver, but full range of motion is\r easily achieved.\r\n\r 3. Moderate: Rigidity detected without the activation maneuver; full range of motion is\r achieved with effort.\r\n\r 4. Severe: Rigidity detected without the activation maneuver and full range of motion not\r achieved.\r\n\r 4. Finger tapping: Instructions to examiner: Each hand is tested separately. Demonstrate the\r task, but do not continue to perform the task while the patient is being tested. Instruct the\r patient to tap the index finger on the thumb 10 times as quickly AND as big as possible. Rate\r each side separately, evaluating speed, amplitude, hesitations, halts, and decrementing\r amplitude.\r\n\r 0: Normal: No problems.\r\n\r 1. Slight: Any of the following: a) the regular rhythm is broken with one or two\r interruptions or hesitations of the tapping movement; b) slight slowing; c) the\r amplitude decrements near the end of the 10 taps.\r\n\r 2. Mild: Any of the following: a) 3 to 5 interruptions during tapping; b) mild slowing; c)\r the amplitude decrements midway in the 10-tap sequence.\r\n\r 3. Moderate: Any of the following: a) more than 5 interruptions during tapping or at least\r one longer arrest (freeze) in ongoing movement; b) moderate slowing; c) the amplitude\r decrements starting after the 1st tap.\r\n\r 4. Severe: Cannot or can only barely perform the task because of slowing, interruptions, or\r decrements.\r\n\r 5. Toe tapping Instructions to examiner: Have the patient sit in a straight-backed chair with\r arms, both feet on the floor. Test each foot separately. Demonstrate the task, but do not\r continue to perform the task while the patient is being tested. Instruct the patient to place\r the heel on the ground in a comfortable position and then tap the toes 10 times as big and as\r fast as possible. Rate each side separately, evaluating speed, amplitude, hesitations, halts,\r and decrementing amplitude.\r\n\r 0: Normal: No problems.\r\n\r 1. Slight: Any of the following: a) the regular rhythm is broken with one or two\r interruptions or hesitations of the tapping movement; b) slight slowing; c) amplitude\r decrements near the end of the ten taps.\r\n\r 2. Mild: Any of the following: a) 3 to 5 interruptions during the tapping movements; b)\r mild slowing; c) amplitude decrements midway in the task.\r\n\r 3. Moderate: Any of the following: a) more than 5 interruptions during the tapping\r movements or at least one longer arrest (freeze) in ongoing movement; b) moderate\r slowing; c) amplitude decrements after the 1st tap.\r\n\r 4. Severe: Cannot or can only barely perform the task because of slowing, interruptions or\r decrements.\r\n\r 6. Arising from a chair Instructions to examiner: Have the patient sit in a straight-backed\r chair with arms, with both feet on the floor and sitting back in the chair (if the patient is\r not too short). Ask the patient to cross his/her arms across the chest and then to stand up.\r If the patient is not successful, repeat this attempt up to a maximum of two more times. If\r still unsuccessful, allow the patient to move forward in the chair to arise with arms folded\r across the chest. Allow only one attempt in this situation. If unsuccessful, allow the\r patient to push off using his/her hands on the arms of the chair. Allow a maximum of three\r trials of pushing off. If still not successful, assist the patient to arise. After the\r patient stands up, observe the posture.\r\n\r 0: Normal: No problems. Able to arise quickly without hesitation.\r\n\r 1. Slight: Arising is slower than normal; or may need more than one attempt; or may need to\r move forward in the chair to arise. No need to use the arms of the chair.\r\n\r 2. Mild: Pushes self up from the arms of the chair without difficulty.\r\n\r 3. Moderate: Needs to push off, but tends to fall back; or may have to try more than one\r time using the arms of the chair, but can get up without help.\r\n\r 4. Severe: Unable to arise without help.\r\n\r 7. Gait Instructions to examiner: Testing gait is best performed by having the patient\r walking away from and towards the examiner so that both right and left sides of the body can\r be easily observed simultaneously. The patient should walk at least 10 meters (30 feet), then\r turn around and return to the examiner. This item measures multiple behaviors: stride\r amplitude, stride speed, height of foot lift, heel strike during walking, turning, and arm\r swing, but not freezing. Observe posture for item 1\r\n\r 0: Normal: No problems.\r\n\r 1. Slight: Independent walking with minor gait impairment.\r\n\r 2. Mild: Independent walking but with substantial gait impairment.\r\n\r 3. Moderate: Requires an assistance device for safe walking (walking stick, walker) but not\r a person.\r\n\r 4. Severe: Cannot walk at all or only with another person's assistance.\r\n\r 8. Postural Stability Instructions to examiner: The test examines the response to sudden body\r displacement produced by a quick, forceful pull on the shoulders while the patient is\r standing erect with eyes open and feet comfortably apart and parallel to each other. Test\r retropulsion. Stand behind the patient and instruct the patient on what is about to happen.\r Explain that s/he is allowed to take a step backwards to avoid falling. There should be a\r solid wall behind the examiner, at least 1-2 meters away to allow for the observation of the\r number of retropulsive steps. The first pull is an instructional demonstration and is\r purposely milder and not rated. The second time the shoulders are pulled briskly and\r forcefully towards the examiner with enough force to displace the center of gravity so that\r patient MUST take a step backwards. The examiner needs to be ready to catch the patient, but\r must stand sufficiently back so as to allow enough room for the patient to take several steps\r to recover independently. Do not allow the patient to flex the body abnormally forward in\r anticipation of the pull. Observe for the number of steps backwards or falling. Up to and\r including two steps for recovery is considered normal, so abnormal ratings begin with three\r steps. If the patient fails to understand the test, the examiner can repeat the test so that\r the rating is based on an assessment that the examiner feels reflects the patient's\r limitations rather than misunderstanding or lack of preparedness. Observe standing posture.\r\n\r 0: Normal: No problems. Recovers with one or two steps.\r\n\r 1. Slight: 3-5 steps, but subject recovers unaided.\r\n\r 2. Mild: More than 5 steps, but subject recovers unaided.\r\n\r 3. Moderate: Stands safely, but with absence of postural response; falls if not caught by\r examiner.\r\n\r 4. Severe: Very unstable, tends to lose balance spontaneously or with just a gentle pull on\r the shoulders.\r\n\r 9. Rest tremor amplitude Instructions to examiner: This and the next item have been placed\r purposefully at the end of the examination to allow the rater to gather observations on rest\r tremor that may appear at any time during the exam, including when quietly sitting, during\r walking, and during activities when some body parts are moving but others are at rest. Score\r the maximum amplitude that is seen at any time as the final score. Rate only the amplitude\r and not the persistence or the intermittency of the tremor.\r\n\r As part of this rating, the patient should sit quietly in a chair with the hands placed on\r the arms of the chair (not in the lap) and the feet comfortably supported on the floor for 10\r seconds with no other directives. Rest tremor is assessed separately for all four limbs and\r also for the lip/jaw. Rate only the maximum amplitude that is seen at any time as the final\r rating. Extremity ratings\r\n\r 0: Normal: No tremor.\r\n\r 1. Slight: < 1 cm in maximal amplitude.\r\n\r 2. Mild: ≥ 1 cm but < 3 cm in maximal amplitude.\r\n\r 3. Moderate: ≥ 3 cm but < 10 cm in maximal amplitude.\r\n\r 4. Severe: ≥ 10 cm in maximal amplitude.\r\n\r 10. Constancy of rest tremor Instructions to examiner: This item receives one rating for all\r rest tremor and focuses on the constancy of rest tremor during the examination period when\r different body parts are variously at rest. It is rated purposefully at the end of the\r examination so that several minutes of information can be coalesced into the rating.\r\n\r 0: Normal: No tremor.\r\n\r 1. Slight: Tremor at rest is present ≤ 25% of the entire examination period.\r\n\r 2. Mild: Tremor at rest is present 26-50% of the entire examination period.\r\n\r 3. Moderate: Tremor at rest is present 51-75% of the entire examination period.\r\n\r 4. Severe: Tremor at rest is present > 75% of the entire examination period.\r\n\r Total Score: (out of 40)\r\n\r Any abnormality on neurological\r examination?:--------------------------------------------------------------------------------\r ---------------------------------------------------------------------------------------------\r ---------------------------------------------------------------------------------------------\r ---------------------------------------\r\n\r Blood Pressure:\r\n\r Pulse:\r\n\r Weight:\r\n\r Randomization:: A. Active medication: B. Placebo\r\n\r Mobile Phone serial number: __________________\r\n\r Follow up data:\r\n\r I) First review at 8 weeks:\r\n\r Date scheduled and time:\r\n\r Compliance\r\n\r Any reported side effects?: ____________________________________________________\r\n\r Any benefits noted subjectively?__________________________________________________\r\n\r Other comments: ________________________________________________\r\n\r Assess motor performance using the MDS Scale- Record the score_______\r\n\r II) 4-week washout period: (No study medications to be administered)\r\n\r Any comments________________________________________________\r\n\r III) Cross-over for 8 weeks with change of study medications (Placebo to active and vice\r versa)\r\n\r Date scheduled and time:\r\n\r Compliance\r\n\r Any side effects? ____________________________________________________\r\n\r Any benefits noted? __________________________________________________\r\n\r Other comments: ________________________________________________\r\n\r Assess motor performance using MDS scale: Record the score_______\r\n\r Study completed: Yes No (If No, give reasons) _____________________\r\n\r Date completed:\r\n\r Any comments__________________________________________________________\r\n\r Name and signature of investigator_____________________________________\r\n\r Date: ----------------------------\n\nClinical Trial Eligibility Criteria:\n\nInclusion Criteria:\r\n\r - Willing and able to give informed consent.\r\n\r - Willingness and ability to comply with study requirements.\r\n\r - PD diagnosis must be confirmed by bradykinesia plus one of the other cardinal\r signs (resting tremor, rigidity, postural instability) being present.\r\n\r - Age >30 years\r\n\r - Men and women with mild to moderate PD: Hoehn and Yahr scale stages 1 - 3.\r Participants may be on current therapeutic agents (including levodopa, dopamine\r agonists, anticholinergics, amantadine or selegiline) to treat PD symptoms at the\r time of enrollment and may remain on these agents throughout the 5-month study\r period.\r\n\r - Women of childbearing potential (i.e., those not postmenopausal or surgically\r sterile) may participate provided that they are using adequate birth control\r methods for the duration of the study. Women of childbearing potential must have\r a negative pregnancy test at baseline and be non-lactating.\r\n\r Exclusion Criteria:\r\n\r - • Subjects with advanced, severe disease, including those with dementia, severe\r osteoarthritis, allergies, stroke, and visual impairment.\r\n\r - Presence of atypical PD syndromes due to drugs (e.g., metoclopramide,\r flunarizine), metabolic identified neurogenetic disorders (e.g., Wilson's\r disease), encephalitis, or other degenerative diseases (e.g., progressive\r supranuclear palsy).\r\n\r - Any clinically significant medical condition (e.g., active neoplasm, angina) or\r laboratory abnormality, which would in the judgement of the investigator\r interfere with the subjects' ability to participate in the study or be followed\n\nPatient 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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