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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nFludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia\n\n**Clinical Trial Summary:**\n\nThe goal of this research is to test if the conditioning regimen, fludarabine and total body\r irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment\r regimen for ALL patients older than 40 years of age and/or younger patients with high risk\r medical conditions. The primary objective is to establish the efficacy of allo HCT in older\r ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also\r assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative\r FluTBI conditioning regimen.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Disease Criteria:\r\n\r - ALL in complete remission (CR) at the time of transplant. Remission is defined as\r \"less than 5.0% bone marrow lymphoblasts by morphology,\" as determined by a bone\r marrow aspirate obtained within 2 weeks of study registration.\r\n\r - Philadelphia chromosome positive ALL is allowed.\r\n\r - Lymphoid blastic crisis of CML will be included (provided that patients achieve\r CR).\r\n\r - Age Criteria: Equal or above age 40 and up to 65 years. If younger than 40, there must\r be comorbidities which preclude the patient to undergo CyTBI conditioning regimen.\r\n\r - Organ Function Criteria: All organ function testing should be done within 28 days of\r study registration.\r\n\r - Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated\r Acquisition) scan or echocardiogram.\r\n\r - Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity)\r ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for\r hemoglobin) ≥ 50% of predicted.\r\n\r - Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60\r mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula:\r\n\r CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL).\r\n\r - Hepatic:\r\n\r - Serum bilirubin 2.0 g/dL\r\n\r - Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN\r\n\r - Alkaline phosphatase 2.5 ULN\r\n\r - Performance status: Karnofsky ≥ 70%\r\n\r - Consent: Patient must be informed of the investigational nature of this study in\r accordance with institutional and federal guidelines and have the ability to provide\r written informed consent prior to initiation of any study-related procedures, and\r ability,in the opinion of the principal investigator, to comply with all the\r requirements of the study.\r\n\r - Presence of a willing adult HLA-matched sibling (excluding identical twin) or\r HLA-matched unrelated donor meeting all the criteria for routine allo HSCT. All donors\r will be evaluated for eligibility and suitability per the standard of care according\r to the FACT and NMDP guidelines.\r\n\r Exclusion Criteria:\r\n\r - Non-compliant to medications.\r\n\r - No appropriate caregivers identified.\r\n\r - HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive\r\n\r - Active life-threatening cancer requiring treatment other than ALL\r\n\r - Uncontrolled medical or psychiatric disorders.\r\n\r - Uncontrolled infections, defined as positive blood cultures within 72 hours of study\r entry, or evidence of progressive infection by imaging studies such as chest CT scan\r within 14 days of registration.\r\n\r - Active central nervous system (CNS) leukemia\r\n\r - Preceding allogeneic HSCT\r\n\r - Receiving intensive chemotherapy within 21 days of registration. Maintenance type of\r chemotherapy will be allowed.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,501
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nBreast Cancer Toxicity\n\n**Clinical Trial Summary:**\n\nThe aims of the cohort will be to quantify impact of cancer treatments toxicities , and to\r generate predictors of chronic toxicity in patients with non-metastatic breast cancer.\r\n\r The project will include four specific aims :\r\n\r 1. To develop a database of chronic treatment related toxicity in a cohort of 13250 women\r with stage I-III breast cancer (= non metastatic), whatever these treatments are\r (surgery; radiation therapy; chemotherapy …)\r\n\r 2. To describe incidence, clinical presentation, and outcome of chronic toxicities over a\r maximum of 8 years.\r\n\r 3. To describe the psychological, the social and the economic impacts of chronic\r toxicities.\r\n\r 4. To generate predictors for chronic toxicities in order to prevent them, based upon\r biological criteria.\r\n\r The expected impact of these toxicities, when identified, will be to improve quality of life\r and to decrease health cost, by the early identification of patients at high risk of\r toxicity. Such early identification could lead to prevent toxic effect by: a. developing\r prevention strategies, b. substituting toxic treatment by a non (less) toxic one.\r\n\r Also, such cohort will offer a quantification of the impact of treatment toxicity, that could\r be further used to quantify medical usefulness of strategies that aim at decreasing treatment\r toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen\r etc…)\n\n**Clinical Trial Detailed Description:**\n\nSPECIFIC AIM I: TO DEVELOP A TOXICITY DATABASE ON A COHORT OF 20,000 WOMEN WITH STAGE I-III\r (NON METASTATIC) BREAST CANCER\r\n\r Selection criteria The cohort will include female patients with non-metastatic breast cancer\r (stage I-III) without any selection based on their characteristics (except stage) or\r treatment. They may be included in other concomitant clinical studies.\r\n\r Patients will have to sign informed consent and will have to benefit from social security.\r\n\r The lack of selection criteria is related to the fact that the cohort aims at investigating\r toxicity in the whole population of breast cancer from a public health perspective.\r\n\r Sample size The cohort plans to include 13250 women in 13 years. A cohort of 13250 patients\r will allow to detect a two fold increased in the risk of a specific toxicity in a homogenous\r subgroup.\r\n\r As illustration, the study present a 90% power to detect whether a variable (age as example)\r observed in 50% of patients is associated with an increased risk of toxicity (heart toxicity)\r in a specific subgroup (Her2+++).\r\n\r Development of the cohort The13250 patients will be recruited in 20 cancer centers, maximum\r in France. The project will start with 14 centers and will further be expanded to 6\r additional centers. These patients will be followed for at least 5 years in the context of\r the cohort. After 5 years, additional specific data will then be captured each year.\r\n\r Patients will be included at the time of diagnosis, before any cancer specific treatment.\r After having signed informed consent, the patient will fill a first questionnaire for\r demographics (adapted from French DREES reference study) and living conditions, and a set of\r validated questionnaires related to QoL (BR 23) and special psychological dimensions. In\r addition, blood samples will be collected at baseline.\r\n\r The toxicities (events) will start to be collected 3 months after the end of \"acute\"\r treatment (surgery/adjuvant/chemotherapy/radiation therapy). Toxicity data will also be\r collected at the time of the last chemotherapy. Toxicities will be collected each 6 months,\r alternatively by a dedicated nurse and by the patient herself. Three sets of toxicities will\r be collected.\r\n\r - First, predefined and previously described toxicities will be collected on dedicated\r items in the case report form.\r\n\r - Second, unknown toxicities will be captured by the use of a patient's notebook where\r each patient will collect events and doctor' visits (general practitioner or organ\r specialist). This will allow capturing events that have not previously been associated\r with cancer treatment toxicities.\r\n\r - Finally, objective measurements by paraclinic exams will be done. This includes yearly\r blood tests and a heart ultrasonography at 1 and 5 years.\r\n\r In addition to the data collection, a baseline blood sample for genetic analyses will be\r done, and serum samples will be collected at baseline and yearly during 5 years (serum).\r\n\r Outcome data will also be collected and will include metastatic relapse (+ site),\r locoregional relapse (+ site) and death.\r\n\r SPECIFIC AIM II: TO DESCRIBE INCIDENCE, CLINICAL PRESENTATION, BIOLOGICAL CHARACTERISTICS AND\r OUTCOME OF CHRONIC TOXIC EVENTS\r\n\r This specific aim will follow three goals :\r\n\r - First, the investigators will describe the incidence of predefined chronic toxicities\r according to the treatment received.\r\n\r - Second, the investigators will aim at identifying new treatment-related toxicities. This\r information will be captured through a dedicated notebook where each patient will report\r all health and social related events.\r\n\r - Finally, the investigators will also assess the outcome of each adverse event, and try\r to develop some hypotheses to be addressed in further clinical trials.\r\n\r SPECIFIC AIM III: TO DESCRIBE THE PSYCHOLOGICAL AND THE SOCIAL IMPACTS OF TOXIC EVENTS This\r specific aim will be split in two parts: a. to describe the psychological and the social\r impact to the patient, b. to describe the impact at the population level.\r\n\r To describe psychological and social impact for the patient\r\n\r Using robust well validated methods, subjective and objective dimensions of wellbeing will be\r investigated, that is: a. Quality of life b. Living conditions c. Psychosocial issues.\r\n\r Quality of life Global perception of quality of life will be assessed through both SF-36,\r QLQ-C30 and BR 23.\r\n\r Social impact Living conditions will be assessed through a questionnaire derived from the\r French DRESS reference study on living conditions. The initial questionnaire was designed by\r DRESS to investigate the social, economical, professional condition two years after the\r diagnosis of cancer: back or abandonment of the initial professional/social activity,\r conversion, income trends, etc.\r\n\r Psychological impact This part will focus on psychological functioning, including\r psychological impact of chronic toxicities and psychological impact of cancer itself.\r Psychological impact is mainly expected on emotional issues, cognitive disorders, body image\r and sexual disorders.\r\n\r To describe the impact on the society This sub-aim will mainly focus on medico-economics and\r will assess the global impact of treatment toxicity on health economy. The quantification of\r costs related to toxicities is a major challenge since it could allow to identify avoidable\r major source of expenses and could allow better tailoring treatment accordingly. Specific\r partnerships are being developed with the French social security and other public/private\r partners in order to accurately quantify toxicity-related cost.\r\n\r SPECIFIC AIM IV TO DEVELOP PREDICTORS FOR CHRONIC TOXICITIES In the present specific aim, the\r goal will be to develop molecular/biologic predictors for toxic events. In as many cases as\r possible, the investigators will split the cohort into a discovery set and a test set, or\r will identify a cross-validating series before doing analyses.\r\n\r Ultimately, the goal is to develop multiparametric scores to predict the occurrence of\r toxicity.\r\n\r Regarding molecular predictors, it is planned that 20 ml blood will be collected yearly. One\r sample at baseline will be dedicated to single nucleotide polymorphism (SNP) arrays and\r validation of candidate genetic variants.\r\n\r A number of tests are already planned. First, we will investigate conventional biological\r parameters including endocrine tests (cortisolemia, TSH, estradiol levels, mullerian\r hormone…), metabolic test (including lipidemia), hematologic tests, liver function, immune\r function (assessed by lymphocyte counts). Second, more recent and under investigation tests\r will be added including troponin (heart failure), mullerian hormone, bone resorption markers\r (bone loss), RANK / RANKL, osteoprotegerin (bone loss).\r\n\r Finally, it is planned to use the baseline sample for the discovery of genetic tests and to\r use the serum for the discovery of biochemical predictors.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Women,\r\n\r - Aged 18 years and over,\r\n\r - With an invasive breast cancer diagnosed by cytology or histology,\r\n\r - Tumors cT0 to cT3, CN0-3,\r\n\r - No clinical evidence of metastasis at the time of inclusion,\r\n\r - Untreated including scored for breast cancer surgery in progress,\r\n\r - Patient receiving a social security system,\r\n\r - Patient mastering the French language,\r\n\r - Free and informed consent for additional biological samples, different questionnaires\r and collecting information on resource usage.\r\n\r Exclusion Criteria:\r\n\r - Metastatic breast cancer,\r\n\r - Local recurrence of breast cancer,\r\n\r - History of cancer within 5 years prior to entry into the trial other than basal cell\r skin or carcinoma in situ of the cervix,\r\n\r - Already received treatment for breast cancer ongoing,\r\n\r - Blood transfusion performed for less than six months,\r\n\r - Persons deprived of liberty or under supervision (including guardianship).\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,502
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nDeveloping and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients\n\n**Clinical Trial Summary:**\n\nWhile thyroid cancer is generally associated with a favourable prognosis, there is a\r discrepancy with how important if not traumatic its impact can be on patients. Quality of\r life (QoL) decreases in the year following a thyroid cancer diagnosis, constituting an\r optimal period for a preventive intervention. The goal of this study is to evaluate the\r impact of offering an interdisciplinary team-based care approach for newly diagnosed thyroid\r cancer patients, including a dedicated nurse who will provide important psychoeducational\r elements identified in previous focus group studies of thyroid cancer patients, i.e.,\r information on: the physical illness; the emotional impact of being newly diagnosed with\r thyroid cancer; surgery and its' short- and long-term consequences; radioactive iodine\r treatments and its associated safety precautions, nutrition and dietary considerations; and\r how the cancer diagnosis can be an opportunity to make important lifestyle changes and\r establish new life-priorities.\n\n**Clinical Trial Detailed Description:**\n\nThe investigators will conduct a 2-arm Randomized Controlled Trial comparing an\r Interdisciplinary Team-Based Care Approach to usual care.\r\n\r The primary research question will be: Does adding the Interdisciplinary Team-Based Care\r Approach (ITCA-ThyCa) to usual care (EG) increase levels of overall QoL among newly diagnosed\r thyroid cancer patients, compared with those receiving usual care (UC), at 9 months\r post-randomization (i.e., after all of the dedicated-nurse meetings are administered) as\r judged by scores on the Functional Assessment of Chronic Illness Therapy-General (FACT-G)?\r Primary hypothesis: The EG will report higher scores of overall QoL on the FACT-G than the UC\r at 9 months post-randomization.\r\n\r Secondary research questions: The investigators plan to evaluate ITCA-ThyCa effects on\r secondary outcomes such as level of: physical health (SF-36 Physical Health subscale), mental\r health (SF-36 Mental Health subscale), fatigue (Functional Assessment of Chronic Illness\r Therapy-Fatigue; FACIT-F), anxiety and depression (Hospital Anxiety and Depression Scale;\r HADS), and negative illness perception (Illness Perception Questionnaire - Revised (IPQ-R).\r The investigators also plan to explore ITCA-ThyCa effects on satisfaction with care (16\r questions of the NRC Picker satisfaction survey measuring patient satisfaction with care) and\r healthcare service use (types of professionals consulted, frequency of visits, and time\r elapsed between referral and first consultation). Hypotheses: The EG will report a higher\r level of physical and mental health on the SF-Physical and Mental Health subscales,\r respectively; and a lower level of fatigue on the FACIT-F, anxiety and depression on the\r HADS, and negative illness perception on the IPQ-R; compared with the UC at 9 months\r post-randomization.\r\n\r All of the abovementioned changes will be present throughout the treatment, namely at 7-10\r days and 5 months post-randomization (i.e., immediately after each of the meetings planned\r with the dedicated nurse).\r\n\r All of the abovementioned changes will persist at 12 months post-randomization (i.e.,\r corresponding to 6 months after all anti-cancer treatments are completed and 3 months after\r all dedicated-nurse meetings have been administered).\r\n\r Feasibility and acceptability (9 first months of the trial):\r\n\r The investigators plan on testing the feasibility and acceptability of the 2-arm RCT of\r ITCA-ThyCa during the first 9 months of the trial (once the investigators start recruiting,\r after the first 3-6 months dedicated to hiring our personnel and developing the manual of our\r approach). During this phase, the investigators will aim to address the following research\r questions:\r\n\r 1. Can the investigators recruit a sufficient number of patients (i.e., a minimum of 60\r patients over 6 months or 10/month) and retain a sufficient proportion of thyroid cancer\r patients (i.e., at least 80% at 7-10 days, 5 months or 9 months post-randomization) in\r both trial arms?\r\n\r 2. Is ITCA-ThyCa acceptable to at least 80% of EG thyroid cancer patients? Secondary pilot\r study questions\r\n\r 3. Which evaluation time should be primary post-randomization, based on an acceptable\r retention rate of 80%?\r\n\r 4. What variance estimates can be used to inform calculation of sample size for the full\r study?\r\n\r If the design remains the same following this pilot, the investigators aim to roll in the\r pilot data in the full trial.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis\r (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary\r type; TNM classification system);\r\n\r - Willing to participate in the EG meetings;\r\n\r - >18 years;\r\n\r - Alert and capable of giving free and informed consent;\r\n\r - Able to speak and read English or French.\r\n\r Exclusion Criteria:\r\n\r - Anaplastic thyroid cancer;\r\n\r - Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC)\r or referring physician) or expected survival <6 months according to clinical judgment.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,503
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPain in Women With Chronic Pelvic Pain\n\n**Clinical Trial Summary:**\n\nChronic pelvis pain is very common between adult women. Significant progress is made in\r clarifying the multifactorial model of chronic pain pathogenesis, but a more complete\r assessment is important in order to improve the therapeutic approach. The purpose of this\r study is stablish a clinical and symptomatological profile of women with chronic pelvic pain.\n\n**Clinical Trial Detailed Description:**\n\nChronic pelvic pain is defined as non-menstrual or noncyclic pelvic pain with duration of at\r least 6 months. This pain interfere with habitual activities and requires clinical or\r surgical treatment. It is a complex interaction between the gastrointestinal, urinary,\r gynecologic, musculoskeletal, neurologic and endocrine systems influenced by psychological\r factors. Its prevalence range between 3 and 8% among women aged 15-73 years, ranging from 14\r to 24% among women of reproductive age. It is very important a multidimensional approach in\r order to stablish a more specific profile.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Women.\r\n\r - Clinical diagnosis of chronic pelvic pain.\r\n\r - More than eighteen years.\r\n\r - Non-menstrual or noncyclic pelvic pain.\r\n\r - Duration of pain of at least 6 months.\r\n\r Exclusion Criteria:\r\n\r - Duration of pain less than 6 months.\r\n\r - Women who were pregnant in the last 12 months\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,504
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAngiography Study of BioNIR Drug Eluting Stent System (NIREUS)\n\n**Clinical Trial Summary:**\n\nThe NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR\r Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison\r to the Resolute zotarolimus-eluting stent (hereafter referred to as Resolute).\r\n\r The trial hypothesis is that the BioNIR is non-inferior to the Resolute for the primary\r endpoint of angiographic in-stent late loss at 6 months.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective, multi-center, single-blind, two-arm, 2:1 randomized clinical trial.\r\n\r Randomization will be stratified by the presence of medically treated diabetes vs. no\r medically treated diabetes and by site. Lesions planned to be treated must be declared and\r recorded at time of randomization.\r\n\r Angiographic follow-up will be performed at 6 months. Clinical follow-up will be performed at\r 30 days, 6 months, and 1, 2, 3, 4, and 5 years post randomization.\r\n\r The Primary Endpoint is in-stent late loss at 6 months as measured by the angiographic core\r laboratory.\r\n\r Angiographic Secondary Endpoints to be evaluated at 6 months are:\r\n\r - In-segment late loss\r\n\r - Follow-up percent diameter stenosis (in-stent and in-segment)\r\n\r - Binary restenosis (in-stent and in-segment)\r\n\r - Length and patterns of angiographic restenosis (Mehran classification)\r\n\r Clinical Secondary Endpoints to be evaluated at 30 days, 6 months, and 1, 2, 3, 4 and 5\r years, except as noted, are:\r\n\r - Device, Lesion, and Procedure Success at time of baseline procedure\r\n\r - Target lesion failure (TLF; the composite of cardiac death, target vessel-related MI, or\r ischemia-driven TLR)\r\n\r - Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or\r ischemia-driven TLR)\r\n\r - Target vessel failure (TVF; the composite rate of death, target vessel-related MI, or\r ischemia-driven TVR)\r\n\r - Overall Mortality\r\n\r - Cardiac Death\r\n\r - Myocardial Infarction\r\n\r - Target Vessel Related MI\r\n\r - Ischemia-driven TLR\r\n\r - Ischemia-driven TVR\r\n\r - Stent Thrombosis (ARC definite and probable)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 18 years\r\n\r - Patient with an indication for PCI including angina (stable or unstable), silent\r ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis\r of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI,\r or recent STEMI. For STEMI the time of presentation to the first treating hospital,\r whether a transfer facility or the study hospital, must be >24 hours prior to\r randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both\r enzyme levels have peaked.\r\n\r - Non-target vessel PCI are allowed prior to randomization depending on the time\r interval and conditions as follows:\r\n\r a. During Baseline Procedure: i. PCI of non-target vessels performed during the\r baseline procedure itself immediately prior to randomization if successful and\r uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI\r Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment\r changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding.\r\n\r b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see exclusion\r criteria #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target\r vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as\r defined above.\r\n\r ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the\r baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12\r hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above\r the local laboratory upper limit of normal, serial measurements must demonstrate that the\r biomarkers are falling.\r\n\r d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed\r greater than 30 days prior to procedure whether or not successful and uncomplicated.\r\n\r - Patient or legal guardian is willing and able to provide informed written consent and\r comply with follow-up visits and testing schedule.\r\n\r Angiographic inclusion criteria (visual estimate):\r\n\r - Treatment of up to three de novo target lesions, maximum of one de novo target lesion\r per vessel\r\n\r - Target lesion(s) must be located in a native coronary artery with visually estimated\r diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100%.\r\n\r - Lesion must be ≤28 mm long and can be covered by a single study stent with maximum\r length of 33 mm (note: multiple focal stenoses may be considered as a single lesion\r and be enrolled if they can be completely covered with one stent).\r\n\r - TIMI flow 2 or 3\r\n\r - If more than one target lesion will be treated, the RVD and lesion length of each must\r meet the above criteria.\r\n\r Exclusion Criteria:\r\n\r - Planned procedures after the baseline procedure in either the target or non-target\r vessels.\r\n\r - STEMI within 24 hours of initial time of presentation to the first treating hospital,\r whether at a transfer facility or the study hospital or in whom enzyme levels (either\r CK-MB or Troponin)have not peaked.\r\n\r - PCI within the 24 hours preceding the baseline procedure and randomization.\r\n\r - Non-target lesion PCI in the target vessel within 12 months of the baseline procedure.\r\n\r - History of stent thrombosis.\r\n\r - Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90\r mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support,\r including IABP.\r\n\r - Known LVEF <30%.\r\n\r - Subject is intubated.\r\n\r - Relative or absolute contraindication to DAPT for 12 months (including planned\r surgeries that cannot be delayed, or subject is indicated for chronic oral\r anticoagulant treatment).\r\n\r - Hemoglobin <10 g/dL.\r\n\r - Platelet count <100,000 cells/mm3 or >700,000 cells/mm3.\r\n\r - White blood cell (WBC) count <3,000 cells/mm3.\r\n\r - Clinically significant liver disease.\r\n\r - Renal disease as defined by an estimated creatinine clearance <40 mL/min using\r Cockcroft-Gault equation.\r\n\r - Active peptic ulcer or active bleeding from any site.\r\n\r - Bleeding from any site within the prior 8 weeks requiring active medical or surgical\r attention.\r\n\r - History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions.\r\n\r - If femoral access is planned, significant peripheral arterial disease which precludes\r safe insertion of a 6F sheath.\r\n\r - Cerebrovascular accident or transient ischemic attack within the past 6 months, or any\r permanent neurologic defect attributed to CVA.\r\n\r - Known allergy to the study stent components, whether in the BioNIR or Resolute, e.g.\r cobalt, nickel, chromium, molybdenum, Carbosil®, PBMA, Biolinx polymer, or limus drugs\r (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or\r any other analogue or derivative or similar compounds).\r\n\r - Known allergy to protocol-required concomitant medications such as aspirin, or DAPT\r (clopidogrel, prasugrel, ticagrelor), or heparin and bivalirudin, or iodinated\r contrast that cannot be adequately pre-medicated.\r\n\r - Any co-morbid condition that may cause non-compliance with the protocol (e.g.\r dementia, substance abuse, etc.) or reduced life expectancy to <24 months (e.g.\r cancer, severe heart failure, severe lung disease).\r\n\r - Patient is participating in or plans to participate in any other investigational drug\r or device clinical trial that has not reached its primary endpoint.\r\n\r - Women who are pregnant or breastfeeding (women of child-bearing potential must have a\r negative pregnancy test within one week before treatment).\r\n\r - Women who intend to become pregnant within 12 months after the baseline procedure\r (women of child-bearing potential who are sexually active must agree to use a reliable\r method of contraception from the time of screening through 12 months after the\r baseline procedure).\r\n\r - Patient has received an organ transplant or is on a waiting list for an organ\r transplant.\r\n\r - Patient is receiving or scheduled to receive chemotherapy within 30 days before or any\r time after the baseline procedure.\r\n\r - Patient is receiving oral or intravenous immunosuppressive therapy or has known\r life-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are\r allowed.\r\n\r Angiographic Exclusion Criteria (visual estimate):\r\n\r - Unprotected left main lesions ≥30%, or planned left main intervention.\r\n\r - Stenting of ostial LAD or LCX lesions (stenting of any diseased segment within 5 mm of\r the unprotected left main coronary artery).\r\n\r - Lesions located within an arterial or saphenous vein graft or distal to a diseased\r arterial or saphenous vein graft.\r\n\r - Moderately or heavily calcified lesions.\r\n\r - Moderately or heavily tortuous or angulated lesions or vessels.\r\n\r - Bifurcation lesions in the presence of a side branch ≥2.0 mm in diameter.\r\n\r - Lesions containing thrombus.\r\n\r - Total occlusions.\r\n\r - In-stent restenotic lesions or lesions present within 10 mm of a previously implanted\r stent.\r\n\r - Lesions requiring pre-dilatation with any device other than simple balloon angioplasty\r (e.g. atherectomy or cutting/scoring balloons).\r\n\r - Another lesion in the target vessel is present that requires or has a high probability\r of requiring PCI during the baseline procedure or within 6 months after the baseline\r procedure.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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35,505
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Role of Aldosterone on Augmented Exercise Pressor Reflex in Hypertension\n\n**Clinical Trial Summary:**\n\nHypertensive patients often show an exaggerated rise in blood pressure during exercise\r through overactivity of the exercise pressor reflex. An increasing body of evidence suggests\r a role for aldosterone in augmenting the exercise pressor reflex in hypertensive humans. We\r hypothesize that this effect of aldosterone is mediated by its direct action on the central\r nervous system and that administration of mineralocorticoid receptor antagonists constitute\r an effective treatment for EPR overactivity in hypertension, independent of reductions in\r resting BP.\n\n**Clinical Trial Detailed Description:**\n\nHypertensive patients are known to display exaggerated rise in blood pressure (BP) during\r exercise but the underlying mechanisms are poorly understood.\r\n\r Traditionally, muscle afferents were dichotomized as metaboreceptors, which are activated\r slowly and only during intense or ischemic muscle contraction, or mechanoreceptors, which\r respond quickly to even mild deformation of their receptive fields. The increase in\r sympathetic nerve activity and BP caused by activation of these receptors, known as exercise\r pressor reflex, is normally buffered by activation arterial baroreceptors, which are reset to\r operate at higher BP range but at the same level of sensitivity. Mechanisms responsible for\r overactive exercise pressor reflex in hypertension remain unknown, but an increasing body of\r evidence suggested a role for aldosterone in regulating resting central sympathetic outflow\r in both hypertensive rats and humans.\r\n\r Experiments will be performed on 3 groups of subjects 1) stage I (140-159/90-99 mmHg)\r subjects with essential hypertension, 2) stage I hypertensive subjects with Primary\r Aldosteronism (PA), and 3) normotensive controls. All participants will attend a baseline\r study visit, which will include a physical examination, a medical history review, vital sign\r measurements, and blood and urine collection. Small electrodes will be used to measure muscle\r nerve activity while the subjects perform a series of exercises that include passive arm\r cycling, active arm cycling, rhythmic hand grip, sustained hand grip and cold pressor test.\r Muscle blood flow will be measured before and after hand grip exercises.\r\n\r A subgroup of subjects with essential hypertension and PA will be assigned to receive\r Eplerenone or Amlodipine on a randomized, double-blinded design. Participants will attend two\r weeks visits over a period of 16 weeks. Study visits include measurement of vital signs and\r blood samples collection. After completing 8 weeks on each medication, muscle nerve activity\r will be measured while performing the same exercises described in the baseline study visit.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Experiments will be performed on 3 groups of nondiabetic human subjects:\r\n\r - 1) stage I (140-159/90-99 mmHg) subjects with essential hypertension.\r\n\r - 2) stage I hypertensive subjects with primary aldosteronism\r\n\r - 3) normotensive controls.\r\n\r Exclusion Criteria:\r\n\r - 1) Any evidence of cardiopulmonary disease, left ventricular hypertrophy or systolic\r dysfunction by echocardiography.\r\n\r - 2) Blood pressure averaging ≥160/100 mmHg\r\n\r - 3) Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2\r\n\r - 4) Diabetes mellitus or other systemic illness\r\n\r - 5) Pregnancy\r\n\r - 6) Hypersensitivity to nitroprusside, phenylephrine, amlodipine or eplerenone\r\n\r - 7) Any history of substance abuse or current cigarette use\r\n\r - 8) Any history of psychiatric illness\r\n\r - 9) History of malignancy\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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35,506
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nErythromycin in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nGastroparesis (slow stomach emptying) is a common feature of Parkinson's Disease. Levodopa\r (Sinemet), a common medication for Parkinson's Disease, can make gastroparesis worse.\r Gastroparesis effects how the levodopa is absorbed and used by the body. This study will\r explore the possibility of using Erythromycin, a drug commonly used (off label) for\r gastroparesis, along with levodopa to determine if there is improved levodopa absorption and\r motor function.\n\n**Clinical Trial Detailed Description:**\n\nParticipants will be required to make four visits for evaluation. Visit 1 is a screening\r visit, participants will receive the study drug or a placebo during visits 2 and 3, and visit\r 4 is a follow up visit. Participants will provide blood and urine samples during the visits.\r Participants will also be required to complete questionnaires and a series of motor tests.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects must have a definitive diagnosis of Parkinson's Disease (per United Kingdom\r brain bank criteria), Hoehn and Yahr stage 1-3,\r\n\r - must exhibit unequivocal levodopa responsiveness\r\n\r - must be able to distinguish between the \"off\" versus \"on\" state\r\n\r - Subjects must be on a stable dose of levodopa for at least 28 days prior to enrollment\r and should be anticipated to maintain a stable dose throughout both study periods\r\n\r - Subjects may be on concomitant therapy with Monoamine oxidase B inhibitors,\r entacapone, and amantadine, though the doses of these medications must have remained\r stable for at least 28 days prior to enrollment and must be expected to remain stable\r throughout both study periods.\r\n\r Exclusion Criteria:\r\n\r - History of deep brain stimulation for Parkinson Disease\r\n\r - History of ablative (tissue removal) surgery for Parkinson Disease\r\n\r - Presence of dementia (MMSE<25)\r\n\r - Presence of active psychosis\r\n\r - History of any chronic gastrointestinal diseases\r\n\r - History of any prior gastrointestinal surgeries except for appendectomy,\r cholecystectomy, and hysterectomy\r\n\r - Any gastrointestinal surgeries in the past 3 months\r\n\r - Severe dysphagia (difficulty swallowing) to pills or food\r\n\r - History of physiological or mechanical gastrointestinal obstruction\r\n\r - History of strictures or fistulae (abnormal or narrow connections) along the\r gastrointestinal tract\r\n\r - History of gastric bezoars (undigested mass)\r\n\r - Allergy to wheat, soy, milk, or nuts\r\n\r - Presence of portable electromechanical devices such as pacemaker, defibrillator, or\r infusion pump\r\n\r - Female subjects who are pregnant or lactating\r\n\r - Symptomatic orthostatic hypotension (low blood pressure)\r\n\r - Diabetes\r\n\r - Presence of symptomatic anemia\r\n\r - Abnormal liver or kidney function\r\n\r - Cardiac arrhythmia (past or present) or abnormal QT interval on entrance EKG\r\n\r - Known hypersensitivity to any of the study drugs\r\n\r - Subjects receiving certain medications during specified time frames\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,507
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory\n\n**Clinical Trial Summary:**\n\nThe investigators hypothesize that ten sessions of repetitive transcranial magnetic\r stimulation yield ability to upregulate the function of primary motor cortex and prefrontal\r cortex that play key roles in motor and frontal memory processing.\n\n**Clinical Trial Detailed Description:**\n\nExcitatory (>3Hz) rTMS could facilitate the brain cortex and neuroplasticity that benefits\r motor control and working memory when the coil is applied over primary motor cortex or\r dorsolateral prefrontal gyrus.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Ischemic or hemorrhagic cerebrovascular lesion,\r\n\r 2. Parkinson's disease\r\n\r Exclusion Criteria:\r\n\r - Seizure\r\n\r - With metal implantation\r\n\r - Dementia or severe cognitive impairment\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,508
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nProgression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach\n\n**Clinical Trial Summary:**\n\nMSA is a rapidly progressive disorder with an average survival time of about 7 years after\r the first clinical manifestation. No potent symptomatic treatment is currently available. A\r disease-modifying therapy does not exist either. The growing understanding in recent years of\r the underlying pathological mechanisms of the disease allows the development of new treatment\r options that have a modifying effect on the disease progression. Therefore, treatments are\r urgently required that effect the central underlying pathological mechanism, which appears to\r be the intracellular aggregation of toxic oligomers of α-synuclein.\r\n\r EGCG, a polyphenol found in green tea, has shown to inhibit the formation of toxic\r α-synuclein oligomers in vitro and has shown to transform α-synuclein-oligomers in non-toxic\r oligomer species. There is also evidence for a neuroprotective effect in MPTP-mouse models of\r PD and is an antioxidant and iron chelator. There are currently 63 clinical studies\r (http://clinicaltrial.gov) in which EGCG was applied for various indications, such as\r Multiple Sclerosis, various forms of cancer and Huntington's disease. All of which have shown\r good tolerability and safety with the applied doses of EGCG of up to 1200 mg per day,\r demonstrating the safety of the drug under controlled clinical conditions (see 5.3.1 for\r hepatotoxicity in uncontrolled conditions).\r\n\r These data provide a solid rationale for testing in a clinical trial if supplementation of\r EGCG can interfere with the core disease mechanism in MSA and consequently retard the\r clinical progression of the MSA-related disability.\n\n**Clinical Trial Detailed Description:**\n\n5 Introduction Multiple System Atrophy (MSA) is a slowly progressing neurodegenerative\r disease that is characterized by i) a hypokinetic movement disorder which defines MSA of the\r parkinsonian type (MSA-P) or by ii) cerebellar symptoms which define MSA of the cerebellar\r type (MSA-C). In both types the movement disorder can be accompanied by vegetative symptoms\r such as orthostatic hypotension. In contrast to Parkinson's disease (PD), the effect of\r dopaminergic medication on the parkinsonian symptoms is very limited. In spite of several\r efforts, no disease modifying therapy has been identified so far. Several lines of evidence\r including epidemiological, in vitro, and in vivo data, suggest that Epigallocatechin gallate\r (EGCG) might be able to delay disease progression of MSA by modifying several aspects in the\r pathogenesis of MSA such as protein aggregation, oxidative stress and iron accumulation.\r Therefore, this study is designed to investigate the influence of EGCG on disease progression\r in patients with MSA. To assess the effect on disease progression, clinical evaluation and\r MR-imaging will be applied in a bi-center, prospective, placebo-controlled, double-blind\r randomized phase III trial. The primary outcome measure will be the change in motor symptoms\r from V1 to V7 measured by the UMSARS-ME comparing placebo- vs. verum-treated patients. The\r secondary efficacy endpoint will be the change from V1 to V7 in the total UMSARS score, in\r the CGI score and in MRI parameters (global and regional atrophy / iron deposition) comparing\r placebo- vs. verum-treated patients.\r\n\r 5.1 Background The disease: MSA is a synucleinopathy that is suitable for various reasons as\r a model disease to investigate disease-modifying effects in α-synuclein (aSyn)-dependent\r neurodegeneration. The disease progression is more rapid compared to PD and therefore allows\r the observation of clinically relevant effects in shorter observation periods. As no potent\r symptomatic treatment of MSA is currently available, the influence of symptomatic active\r substances on clinical data is limited and placebo can be used as comparator. This solves the\r potential ethical problem of having to deprive patients of such symptomatic treatment during\r the study and underlines the high medical need for a symptomatic treatment. Another important\r argument for neuroprotection studies in MSA is that in three independent studies EMSA,\r NNIPPS, MEMSA a very similar disease progression was observed over a defined period of time,\r which enables a precise power analysis with sample sizes and follow-up periods that are\r suitable for an investigator initiated trial (IIT).\r\n\r The therapeutic target: An increasing amount of data suggests that toxic oligomers from\r misfolded, disease-specific proteins play a potentially important role in the neuronal cell\r death in neurodegenerative diseases. Specifically in MSA, oligomeric aSyn aggregate species\r appear to be crucially involved in the pathogenetic mechanisms.\r\n\r The pharmacological compound: Epidemiological data suggest that ingredients in tea may be\r neuroprotective for synucleinopathies in man. Regular consumption of tea reduces the risk of\r contracting PD by about 50%. Also for MSA, a clear trend in the sense of a positive effect of\r tea consumption on the risk of disease development was observed (OR = 0.5, 95% CI: 0.22-1.5,\r p = 0.09). EGCG, a polyphenol that is for example found in green tea, inhibits the formation\r of toxic aSyn oligomers in vitro and transforms aSyn oligomers by direct interaction in\r alternative, non-toxic oligomer species. Furthermore, EGCG shows a neuroprotective effect in\r the 1-Methyl-4-phenyl-1,2,3,6-tetrahydropyridin (MPTP) mouse model of PD. In addition, EGCG\r is an antioxidant and an iron chelator and therefore has more potential beneficial effects on\r synucleinopathies.\r\n\r The pharmacokinetic properties of EGCG were tested in humans in the serum and in rodents in\r serum and organs, including the brain in detail. It was found that repeated oral application\r of doses of EGCG result in a significant increase in serum levels in healthy adults compared\r to a single dose. The proposed daily dose of 1200 mg of EGCG is comparable to about 15 to 30\r cups of green tea (depending on the mode of preparation) (Prof. F. Paul, Berlin, pers.\r comm.). Animal experiments in rodents have shown that after a single i.v. dose of EGCG, the\r substance is found in the brain in significant quantities.\r\n\r 5.2 Trial Rationale MSA is a rapidly progressive disorder with an average survival time of\r about 7 years after the first clinical manifestation. No potent symptomatic treatment is\r currently available. A disease-modifying therapy does not exist either. The growing\r understanding in recent years of the underlying pathological mechanisms of the disease allows\r the development of new treatment options that have a modifying effect on the disease\r progression. Therefore, treatments are urgently required that effect the central underlying\r pathological mechanism, which appears to be the intracellular aggregation of toxic oligomers\r of aSyn.\r\n\r EGCG, a polyphenol found in green tea, has shown to inhibit the formation of toxic aSyn\r oligomers in vitro and has shown to transform aSyn-oligomers in non-toxic oligomer species.\r There is also evidence for a neuroprotective effect in MPTP-mouse models of PD and is an\r antioxidant and iron chelator. There are currently 63 clinical studies in which EGCG was\r applied for various indications, such as Multiple Sclerosis, various forms of cancer and\r Huntington's disease. All of which have shown good tolerability and safety with the applied\r doses of EGCG of up to 1200 mg per day, demonstrating the safety of the drug under controlled\r clinical conditions.\r\n\r These data provide a solid rationale for testing in a clinical trial if supplementation of\r EGCG can interfere with the core disease mechanism in MSA and consequently retard the\r clinical progression of the MSA-related disability.\r\n\r 5.3 Side effects and Risk Benefit Assessment 5.3.1 Side effects In all clinical trials\r investigating the oral intake of green tea/EGCG in various doses and pharmacological forms,\r EGCG has shown a good safety and tolerability in daily doses of up to 1200 mg over a period\r of 6 months. Side effects that have been reported after application of EGCG were usually mild\r and did not occur more often than under placebo (flatulence, headache, nausea, vertigo,\r abdominal cramps and muscle pain). Other reported side effects (arterial hypertension,\r palpitations, headache, polyuria, tremor, sleep disorders, nausea/vomiting) are due to the\r caffeine part in green tea and are not due to EGCG, as all studies using pure EGCG have not\r reported such side effects.\r\n\r No relevant or persistent changes in the extensive clinical serum tests have been found so\r far; also no influence on vital parameters have been reported after using EGCG. Only minimal\r and transient changes of the blood pressure, echocardiography, liver function tests and serum\r lipids have been reported. In a study of Chow et al. healthy subjects were given 800 mg EGCG\r or Polyphenon E (a mixture of several green tea extracts with a 50-75%share of EGCG) once\r daily or 400 mg twice daily versus placebo over a period of 4 weeks. Only mild side effects\r occurred in several subjects (flatulence, abdominal pain, nausea, headache, dizziness and\r muscle pain) that were not occurring more often than under placebo.\r\n\r The SuniMS study, NCT ID: 00525668, recorded no SUSAR in 120 patients with\r remitting-relapsing MS, who were administered 800 mg Sunphenon/ EGCG per day. They also were\r able to show an excellent tolerability. Only 15 patients showed mild, clinically\r insignificant elevations of liver function tests, which are not necessarily caused by the\r study medication. The ongoing SUPREMES study, NCT ID: 00799, has so far not recorded any\r SUSAR in 60 patients with progressive MS who have been on up to 1200 mg EGCG/day for up to 48\r months.\r\n\r In a study by Chen et al a significant protective effect of orally applied EGCG could be\r demonstrated in mice with a toxic liver failure caused by tetrachlorohydrocarbons. Otherwise,\r single cases of hepatotoxicity following application of various forms of green tea\r polyphenols are known. In the period between 1999 and 2008, 34 such case reports have been\r published, 29 of which have shown a positive de-challenge and 7 have shown a positive\r re-challenge. The clinical and pathological symptoms included mild elevations of liver\r function tests, cholestasis, cholangitis, hepatocellular inflammation and hepatocellular\r necrosis. The symptoms were usually completely reversible after stopping the medication. One\r patient died of liver failure. Signs of liver toxicity were recorded between day 9 up to 5\r months after beginning a therapy with doses of 187,5 -468,75mg EGCG/day).\r\n\r The withdrawal of a green tea extract in Spain and France (Exolise®) a couple of years ago\r needs to be mentioned. After application of this medication some cases of severe\r hepatotoxicity were reported. Symptoms like icterus, massive elevation of transaminases\r occurred not later than 12 weeks after beginning the treatment with the extract in capsules\r and were completely reversible few weeks after stopping the medication. The exact underlying\r mechanisms have not been completely worked out. Possibly these are due to a SAE that is\r specific for Exolise®, and is connected with the manufacturing process (hydro-alcoholic\r extraction techniques). For this reason, only the distribution of Exolise® has been stopped\r by the respective authorities, but not the distribution of other green tea extracts (see also\r the following publications by the WHO):\r www.who.int/entity/medicines/publications/restrictedpharm2005.pdf It has not yet been found\r out which parts of the polyphenols and their metabolites are responsible for the hepatotoxic\r effects. Even though in most cases mixtures of green tea and polyphenols have been\r administered it is suspected, that EGCG as a main component of the green tea extracts shows\r hepatotoxic potential. In favor of this hypothesis is the fact, that there have been reports\r of elevated transaminases under treatment with EGCG in man and interactions with other\r substances. EGCG is known to bind to α- and β-estrogene receptors and increases 17\r β-estradiol-induced reactions in mice. EGCG is a known inhibitor of the\r Catechol-O-methyltransferase (COMT) that catalyses the degradation of exogenous and\r endogenous substances.\r\n\r It is suspected, that for the biotransformation of green tea catechines, COMT plays an\r important role. COMT polymorphisms with low activity of COMT could result in elevated plasma\r levels of toxic EGCG metabolites.\r\n\r The cytotoxicity of EGCG in hepatocytes seems to be low in vitro and only doses that are\r higher by a multiple compared to the doses used in clinical studies lead to liver necrosis in\r animal models. Also, the extremely low bioavailability in man has to be considered.\r\n\r On the basis of all recent studies using green tea extract and EGCG there are no reports of\r persistent and severe influence on the physiological systems (blood circulation, respiratory\r system, central nervous system and urinary tract). Still there are singular case reports of\r hepatotoxic effects in the context of intake of green tea extracts/ EGCG.\r\n\r As a conclusion, all data are in favor of a good tolerability of the substance. For further\r details see the investigator's brochure (Polyphenon E).\r\n\r 5.3.2 Risk Benefit Assessment The reported data suggest a safe pharmacological profile apart\r from individual cases of hepatotoxicity which can be controlled for by routine serum liver\r parameters. The preclinical data suggest a molecular mode of action for EGCG which appears to\r target core pathological mechanisms active in MSA. In absence of any effective symptomatic,\r protective or curative intervention in this devastating disorder, the risk benefit evaluation\r justifies the conduct of the proposed clinical trial.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. \"clinical possible\" or \"clinical probable\" MSA (Gilman et al., Neurology, 2008\r 26;71:670-6)\r\n\r 2. Hoehn & Yahr stage I - III\r\n\r 3. A stable regimen for at least 1 month prior to V1 and willingness / no fore-seeable\r need to change the regimen throughout the 52 week follow-up pe-riod for\r\n\r 1. drugs acting against Parkinsonism (e.g. Levodopa, Dopamine-Agonists, Amantadine\r and MAO-B-Inhibitors)\r\n\r 2. drugs acting against autonomic dysfunction (e.g. ephedrin, midodrin,\r fludrucortison, octreotide, desmopresin, oxybutinine)\r\n\r 3. antidepressant and antidementive drugs.\r\n\r 4. No regular consumption of EGCG, green tea, or more than two cups of black tea per day\r\n\r 5. Capability and willingness to give written informed consent indicating that the\r subject has been informed of and understood all aspects pertinent to the study\r\n\r 6. Capability and willingness to comply with the procedures of the study\r\n\r 7. Contraception by adequate contraceptive methods (oral, injected or im-planted hormonal\r contraceptive methods, intrauterine pessar, sterilisation or real abstinence) in all\r female patients with childbearing potential\r\n\r 8. Absence of liver disease documented by transaminases and bilirubin below 2-folds of\r the upper normal level.\r\n\r Exclusion Criteria:\r\n\r 1. Hoehn & Yahr stage > III (loss of postural reflexes, no independent walking possible,\r inability to stand unassisted, wheelchair-bound).\r\n\r 2. Neurodegenerative diseases other than MSA\r\n\r 3. Severe liver disease with elevation of transaminases and bilirubin above 2-folds of\r the upper normal level or regular intake of hepatotoxic drugs\r\n\r 4. Known hypersensitivity to EGCG or to drugs with similar chemical structure\r\n\r 5. Participation in another clinical trial involving administration of an investigational\r medicinal product within 1 month prior to V1\r\n\r 6. A physical or psychiatric condition, which at the investigator's discretion may put\r the subject at risk, may confound the trial results, or may interfere with the\r subject's participation in this clinical trial\r\n\r 7. Persistent abuse of medication, drugs or alcohol\r\n\r 8. Consumption of > 500 ml grapefruit juice per day (leading to inhibition of cytochrome\r P-450 isoenzyme 3A4, which may be involved in degradation of EGCG).\r\n\r 9. Current or planned pregnancy or breast feeding in females\r\n\r 10. Females of childbearing potential, who are not using medically reliable methods of\r contraception for the entire study duration (such as oral, inject-able, or implantable\r contraceptives, or intrauterine contraceptive devices).\r\n\r 11. Intake of COMT-inhibitors (e.g. Entacapone, Tolcapone)\r\n\r 12. Current or planned therapy with Bortezomib and/ or history of plasmocytoma.\r\n\r 13. Anemia at Screening (Hb < 10g/dl)\r\n\r 14. Other severe medical conditions upon discretion of the LKP\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nGenetic Characterization of Movement Disorders and Dementias\n\n**Clinical Trial Summary:**\n\nBackground:\r\n\r There are two basic types of movement disorders. Some cause excessive movement, some cause\r slowness or lack of movement. Some of these are caused by mutations in genes. On the other\r hand, dementia is a condition of declining mental abilities, especially memory. Dementia can\r occur at any age but becomes more frequent with age. Researchers want to study the genes of\r families with a history of movement disorders or dementia. They hope to find a genetic cause\r of these disorders. This can help them better understand and treat the diseases. This study\r will not be limited to a particular disorder, but will study all movement disorders or\r dementias in general. This study will perform genetic testing to identify the genetic causes\r of movement disorders and dementia. Today, genetic testing can be done to analyze multiple\r genes at the same time. This increases the chances of finding the genetic cause of movement\r disorders and dementias.\r\n\r Objectives:\r\n\r To learn more about movement disorders and dementia, their causes, and treatments.\r\n\r Eligibility:\r\n\r Adults and children with a movement disorder or dementia, and their family members.\r\n\r Healthy volunteers.\r\n\r Design:\r\n\r Participants will be screened with medical history and blood tests. Some will have physical\r exam.\r\n\r Participants will give a blood sample by a needle in the arm. This can be done at the clinic,\r by their own doctor, or at home. Alternatively, a saliva sample may be provided if a blood\r sample cannot be obtained.\r\n\r Participants can opt to send an extra blood sample to a repository for future study. Genetic\r test will be done on these samples. The samples will be coded. The key to the code will\r remain at NIA. Only NIA investigators will have access to the code key. Participants can\r request to receive results of the tests.\r\n\r Participation is generally a single visit. Participants may be called back for extra\n\n**Clinical Trial Detailed Description:**\n\nObjective\r\n\r The objective of this study is to ascertain individuals with a clinical diagnosis of a\r movement disorder or dementia, their affected and unaffected family members, and unrelated,\r healthy individuals (to provide control samples); to characterize their phenotypes; and to\r identify and further characterize genetic contributions to etiology by collecting blood\r samples, and/or saliva samples on these individuals for DNA and induced Pluripotent stem\r (iPs) cell line preparation.\r\n\r Study population\r\n\r Up to 10,000 persons with a diagnosis of a movement disorder or dementia, 1,000 asymptomatic\r persons who are family members/related to individuals with a diagnosis of movement disorder\r or dementia, and 1,000 unrelated, healthy control individuals.\r\n\r Design\r\n\r This study usually requires one outpatient visit to the NIH Clinical Center. Participant\r visits may also take place when they are an inpatient at the NIH Clinical Center. Those who\r are unable to travel to NIH may have study procedures performed at a site near their\r\n\r home, such as hospital facilities, private physician offices, nursing homes, assisted living\r facilities, local community centers, or participant homes. Participants will undergo medical\r record review, a physical examination and biospecimen collection including\r\n\r blood draw and/or saliva collection at the enrollment visit.\r\n\r Additional visits may be scheduled to collect additional phenotype information or to collect\r additional biospecimens.\r\n\r Outcome measures\r\n\r The primary outcome measure of this study is the identification of pathogenic genetic\r variants that are causative for the movement disorder or dementia that the patient has been\r diagnosed with. These disease-causing variants are often inherited.\r\n\r The secondary outcome measure of this study is the identification of genetic variants that\r alter susceptibility/risk for the movement disorder or dementia that the patient has been\r diagnosed with. These genetic risk factors are associated with disease that can be apparently\r sporadic in nature.\n\n**Clinical Trial Eligibility Criteria:**\n\n- INCLUSION CRITERIA\r\n\r For Patients:\r\n\r - Diagnosis of a movement disorder or dementia by a neurologist or other qualified\r professional and accompanied by sufficient clinical and/or laboratory evidence to\r support the diagnosis\r\n\r - Confirmation of a movement disorder or dementia by study investigators or a qualified\r clinician by physical examination and/or review of medical records\r\n\r - Ages 18 and above\r\n\r - Able to provide consent or, in the case of minors, or cognitive impairment, have a\r legally-authorized representative to provide consent\r\n\r - Able to understand and participate in study procedures or for those without consent\r capacity, able to participate in study procedures AND has a legally authorized\r representative that understands the study procedures and can consent on their behalf.\r\n\r For unaffected family members of patients:\r\n\r - Unaffected relative of a patient diagnosed with a movement disorder or dementia\r enrolled in this protocol. For these purposes, we define a family member as an\r individual for which there is a demonstrable relationship with the proband in the\r pedigree. This is a standard approach used in family-based studies. Furthermore, the\r related patient (defined as a family member diagnosed with the disease of interest)\r must be enrolled in the study.\r\n\r - Ages 18 and above\r\n\r - Able to provide consent\r\n\r - Able to understand and participate in study procedures\r\n\r For unrelated healthy control individuals:\r\n\r - Be in good general health\r\n\r - Have no known movement disorder or dementia, or family member with a movement disorder\r or dementia\r\n\r - Age 18 and above\r\n\r - Able to provide consent\r\n\r - Able to understand and participate in study procedures\r\n\r EXCLUSION CRITERIA\r\n\r For patients:\r\n\r -An identifiable, non-genetic etiology for the movement disorder or dementia, such as a\r specific environmental exposure, birth injury, metabolic disorder, or brain infection such\r as encephalitis\r\n\r For all participants:\r\n\r - Clinically significant anemia that would make phlebotomy unsafe, and participant\r unwilling to provide saliva sample.\r\n\r - Clinically significant bleeding that would make phlebotomy unsafe, and participant\r unwilling to provide saliva sample.\r\n\r - Any medical condition that would make phlebotomy unsafe or undesirable, such as a\r serious medical illness like unstable heart disease, or unstable chronic obstructive\r pulmonary disease, and participant unwilling to provide saliva sample.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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35,510
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nGlutamine Challenge as Predictor of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt (TIPS)\n\n**Clinical Trial Summary:**\n\nTransjugular intrahepatic portosystemic shunt (TIPS) is the first-line therapy for patients\r with cirrhosis and refractory ascites. However, mental changes known as hepatic\r encephalopathy (HE) frequently occur after TIPS. There is no effective method to predict HE\r after TIPS. Oral glutamine challenge (OGC) and psychometric tests have been used to assess\r the risk for HE, but never in patients undergoing TIPS. Severe muscle loss may also\r predispose patients to HE. The aim of the present study is to assess if both the OGC and\r psychometric tests can accurately predict the development of overt HE after TIPS. Patients\r will be studied before TIPS and followed after TIPS for the development of HE. The role of\r muscle loss in favoring HE, as well as is possible reversibility after TIPS will also be\r investigated.\n\n**Clinical Trial Detailed Description:**\n\nIn cirrhosis, up to 10% of patients develop refractory ascites. TIPS (transjugular\r intrahepatic portosystemic shunt) is the first-line therapy for these patients. However, 30%\r will go on to develop hepatic encephalopathy (HE) as a consequence of TIPS, and there is no\r effective method to predict this outcome. Oral glutamine challenge (OGC) is used to\r functionally assess ammonia metabolism, and the severity of porto-systemic collateralization,\r and it has been used to predict overt HE. Psychometric tests (i.e. Psychometric Hepatic\r Encephalopathy Score [PHES] and inhibitory control test) allow the identification of covert\r forms of HE and can also predict overt HE. Severe sarcopenia may also predispose patients to\r HE. The aim of the present study is to assess if both the degree of impairment in ammonia\r metabolism as estimated with the OGC, and cognitive status as determined by psychometric\r tests, can accurately predict the development of overt HE after TIPS. Patients will be\r studied before TIPS and followed after TIPS for the development of overt HE. The role of\r sarcopenia in favoring HE, as well as is possible reversibility after TIPS will also be\r investigated.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Cirrhosis (any etiology)\r\n\r - Refractory ascites or hepatic hydrothorax and plan for TIPS placement\r\n\r Exclusion Criteria:\r\n\r - Well-documented overt hepatic encephalopathy, either persistent or at the time of\r screening\r\n\r - Any contraindication for TIPS placement\r\n\r - Except for coagulopathy and thrombocytopenia (decided on an individual basis)\r\n\r - Uncontrolled depression/anxiety disorder or use of antipsychotic drugs\r\n\r - Active use of alcohol or illicit drugs\r\n\r - History of dementia\r\n\r - TIPS planned for another indication.\r\n\r - Active alcoholic liver disease.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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35,511
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Effects of Auditory Cueing on Rhythmic Movement and Cortical Excitability in Patients With Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nParkinson's disease (PD) is a progressive degenerative disease of central nervous systems\r deficit. The clinical symptoms of Parkinson's disease include the following motor tasks:\r difficult in initiating movement, performing rhythmic movement or serial movement, the\r ability of learning motor movement is also affected. The primary treatment for Parkinson's\r disease is medical treatment; surgery is used if in need. Rehabilitation such as physical\r therapy, which aims to improve patient's quality of life and functions, is a non-invasive\r treatment and value for PD patients. Auditory cue is a technique that widely applied on\r training patients with Parkinson's disease, and some researches revealed that auditory cueing\r could improve motor performance. However, the mechanism under this treatment technique is\r still unknown.\r\n\r This study is to investigate the effect of auditory cueing on rhythmic finger movement in\r patients with Parkinson's disease. To investigate the mechanism under auditory cueing,\r neurophysiological data such as motor cortex excitability and blood flow in cortical cortex\r will be obtained by using Transcranial magnetic stimulation (TMS) and near infrared\r spectroscopy (NIRS).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Clinical diagnosis of Parkinson disease\r\n\r Exclusion Criteria:\r\n\r - Clinical diagnosis of other neurological diseases\r\n\r - Dementia\r\n\r - Been diagnosed with any mental illness\r\n\r - History of seizures\r\n\r - Brain trauma\r\n\r - Body with a pacemaker or other electrical stimulator\r\n\r - Pregnancy\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,512
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTemporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine the temporal relationship between motor\r fluctuations and non-motor fluctuations in persons with Parkinson's disease.\r\n\r Observational study case-only\n\n**Clinical Trial Detailed Description:**\n\nObjectives\r\n\r 1. how many patients will experience motor or nonmotor fluctuation during follow-up period?\r\n\r 2. in how many patients, does motor fluctuation precede nonmotor fluctuation?\r\n\r 3. in how many patients, does nonmotor fluctuation precede motor fluctuation?\r\n\r Participants: persons with Parkinson disease in early stage who does not have motor or\r nonmotor fluctuation\r\n\r Recruitment period: 3 years from the commencement of the study Follow-up period: 3 years for\r each participants\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - clinical diagnosis of Parkinson disease by United Kingdom Parkinson's Disease Society\r Brain Bank criteria\r\n\r - early stage\r\n\r Exclusion Criteria:\r\n\r - dementia (MMSE<26)\r\n\r - persons who refuse participating\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,513
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure\n\n**Clinical Trial Summary:**\n\nThe aim of the current study is to determine whether rifaximin or lactulose is more effective\r in preventing the development of severe hepatic encephalopathy in hospitalized patients with\r cirrhosis and new onset kidney failure.\r\n\r Subjects will be randomly assigned to one of two treatment groups:\r\n\r Group A: Lactulose 20g dose titrated to 2-3 soft-formed bowel movements per day Group B:\r Rifaximin 550mg tablet twice daily.\r\n\r Subjects will be followed daily for two weeks or until hospital discharge. Treatment success\r is defined as prevention of grade 3 or 4 HE during hospitalization.\n\n**Clinical Trial Detailed Description:**\n\nHepatic Encephalopathy (HE) is a reversible neuropsychiatric syndrome that develops in\r patients with cirrhosis due to the accumulation of a variety of toxic substances that are\r produced from bacteria in the gastrointestinal tract. It is characterized by slowing of\r function of the brain function and ranges in severity from mild cognitive impairment (grade\r 1), presence of a shaking tremor called asterixis (grade 2), lethargy but arousable state\r (grade 3), and coma (grade 4). Decreased kidney function exacerbates the condition, and\r hospitalized patients with cirrhosis with new onset kidney failure are at risk for the\r development of severe HE.\r\n\r Possible treatments for HE include lactulose and antibiotics. Lactulose reduces the\r production of many of the toxins by the bacteria, and antibiotics work by reducing the number\r of bacteria in the gastrointestinal tract. Rifaximin is an antibiotic that is an antibiotic\r that is not absorbed, possesses a wide antibacterial spectrum, and was approved by the Food\r and Drug Administration in 3/2010 for prevention of relapse for patients with recurrent\r severe hepatic encephalopathy. The aim of the current study is to determine whether rifaximin\r or lactulose is more effective in preventing the development of severe hepatic encephalopathy\r in hospitalized patients with cirrhosis and new onset kidney failure.\r\n\r To determine whether rifaximin or lactulose is more effective in preventing severe HE,\r seventy consecutive hospitalized patients with cirrhosis and new onset kidney failure will be\r recruited. New onset kidney failure will defined as a progressive and sustained increase in\r serum creatinine >0.5mg/dl from baseline to a value of 2.0mg/dl or greater within 3 days.\r Subjects will be randomly assigned to one of two treatment groups:\r\n\r Group A: Lactulose 20g dose titrated to 2-3 soft-formed bowel movements per day Group B:\r Rifaximin 550mg tablet twice daily. Subjects will be followed daily for two weeks or until\r hospital discharge. Severity of hepatic encephalopathy will be graded by physical\r examination, review of hospital chart, and performance of standard paper and pencil tests\r that evaluates the ability to concentrate. In addition, approximately one tablespoon will be\r drawn twice a week at every 3 to 4 day for ammonia level and other toxins. A sample of breath\r will also be collected by having the subjects breathe into a collection bag to measure\r substances that determine whether there are bacteria present in the small intestine.\r Treatment success is defined as prevention of grade 3 or 4 HE during hospitalization.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age 18 years or older\r\n\r 2. Cirrhosis of the liver based on biopsy or clinical and radiographic criteria\r\n\r 3. Ability to provide informed consent (Grade 0 to 1 HE)\r\n\r 4. Acute renal failure (increase in baseline creatinine of 0.5mg/dL to a value of >2.0\r mg/dL within 3 days).\r\n\r 5. Absence of improvement in renal function after adequate fluid resuscitation using\r either normal saline or blood products (25% salt poor albumin, fresh frozen plasma, or\r packed red blood cells)\r\n\r Exclusion Criteria:\r\n\r 1. Previous history of sensitivity/allergy to lactulose or rifaximin or rifampin\r\n\r 2. Pregnancy\r\n\r 3. Inability to obtain informed consent\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,514
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nHallux Mobilization in Patients With Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nParkinson's disease is a degenerative disorder of the central nervous system. The motor\r symptoms of Parkinson's disease result from the death of dopamine-generating cells in the\r substantia nigra, a region of the midbrain; the cause of this cell death is unknown. Early in\r the course of the disease, the most obvious symptoms are movement-related; these include\r shaking, rigidity, slowness of movement and difficulty with walking and gait. A\r multidisciplinary intensive rehabilitation treatment (MIRT) is able to improve different\r parameters in PD that are poorly responsive to dopaminergic therapy. In this study, we aim to\r understand whether the passive mobilization of the metatarsophalangeal joint of the hallux\r determines an increase in the joint range in this district, allowing to improve, at least,\r the gait.\n\n**Clinical Trial Detailed Description:**\n\nParkinson's disease is a degenerative disorder of the central nervous system. The motor\r symptoms of Parkinson's disease result from the death of dopamine-generating cells in the\r substantia nigra, a region of the midbrain; the cause of this cell death is unknown. Early in\r the course of the disease, the most obvious symptoms are movement-related; these include\r shaking, rigidity, slowness of movement and difficulty with walking and gait. The main\r families of drugs useful for treating motor symptoms are levodopa dopamine agonists and\r Monoamine oxidases-B inhibitors.A multidisciplinary intensive rehabilitation treatment (MIRT)\r is able to improve different parameters in PD that are poorly responsive to the\r pharmacological therapy. In this study, we aim to understand whether the passive mobilization\r of the metatarsophalangeal joint of the hallux determines an increase in the joint range in\r this district, allowing to improve, at least, the gait in patients with PD. In this course,\r we will evaluate whether passive mobilization of this joint, lead to positive effects on the\r freezing of gait and on the festination.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r PD patients stage 3 H&Y with FOG\r\n\r Exclusion Criteria:\r\n\r we excluded patients with atypical parkinsonism, with other concomitant neurological\r conditions (with cerebrovascular etc.), with joint disorders, muscle disorders or with\r other orthopedic conditions.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,515
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEffects of a Rehabilitation Treatment on Balance in PD Evaluated With a Stabilometric Platform\n\n**Clinical Trial Summary:**\n\nPharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide\r significant improvements in postural instability in Parkinson's disease, whereas previous\r reports of physical interventions have suggested promising results. The investigators want to\r study the effects of the multidisciplinary intensive rehabilitation treatment (MIRT) on\r balance disorders in Parkinson Disease (PD).\n\n**Clinical Trial Detailed Description:**\n\nPharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide\r significant improvements in postural instability in Parkinson's disease, whereas previous\r reports of physical interventions have suggested promising results. The investigators want to\r study the effects of our multidisciplinary intensive rehabilitation treatment (MIRT) on\r balance disorders in PD.\r\n\r PD patients in stage 3 of Hoen & Yahr will undergo clinical and instrumental evaluations at\r the beginning (T0) and at the end (T1) of the MIRT. Berg Balance Scale (BBS) will be\r performed to assess static and dynamic balance abilities. In order to determine some\r variables as index of postural stability, the investigators will use a stabilometric\r platform. With respect to the average centre of gravity the standard deviation (SD) of trunk\r sway will be calculated: total, in antero-posterior (AP) and in medio-lateral (ML) direction.\r The investigators can obtain a statokinesigram, that is the layout of a line connecting the\r successive positions of the center of pressure during the recording, and the area of the\r ellipse containing 90% of the sampled positions of the center of pressure. These measurements\r will be calculated with open eyes (OE), and while the patient was performing a cognitive task\r (open eyes counting [OEC]).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - patients diagnosed with PD in stage 3 of Hoen & Yahr according to the United Kingdom\r Brain Bank criteria.\r\n\r Exclusion criteria:\r\n\r Atypical parkinsonisms, patients with osteoarticular and muscular pathologies, PD patients\r with Mini Mental State Examination < 26, patients with other disorders of balance.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,516
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPrimary Premature Ejaculation Genetics\n\n**Clinical Trial Summary:**\n\nThe main objective of our study is to identify the first genetic etiology of primary\r Premature Ejaculation (PE). We will test and evaluate the existence of genetic determinism\r conferring susceptibility to a life-long syndrome (primary premature ejaculation) in some\r patients. To this end, we plan to establish a collection of biological samples and a database\r of patients with this extreme syndrome, which we will analyze by Genome Wide analysis. This\r will lead to improvements in the biological understanding, the \"knowledge\" of physicians of\r the disease, and should improve the patients' quality of life. Not all PE cases have the same\r physiopathology and treatment efficiency, which depend on the specific mechanism involved in\r the clinical context. Our work will make it possible to develop new therapeutic approaches\r suitable for a large proportion of individuals presenting PE. This integrative approach\r combining researchers, patients and ethics committees will facilitate profound reflection,\r promoting the creation of suitable structures capable of receiving patients for appropriate\r consultations. This unique study of PE should also favor industrial partnerships.\n\n**Clinical Trial Detailed Description:**\n\n2.1 Main Objective\r\n\r - To identify the molecular basis of primary premature ejaculation (PPE) in humans for the\r development of new adapted therapy.\r\n\r - Check and confirm the genetic hypothesis of PPE to fill the void of genetic knowledge\r about this syndrome.\r\n\r - Improve knowledge of physicians on this disease to increase the comfort of life of\r patients.\r\n\r 2.2 Secondary Objectives\r\n\r - Provide the basis for new therapeutic approaches.\r\n\r - Expanded knowledge of the aetiology of PE and allow better management of patients.\r\n\r - Develop strategies to prevent the consequences, sometimes severe , of this condition on\r the intimate, personal, social and professional life of these patients. Because all the\r PE do not have the same pathophysiology and treatment success depends on its relevance\r to the specific mechanism of the clinical form concerned.\r\n\r - Increase the comfort of life of the patients.\r\n\r - Eliminate public prejudice based on misconceptions.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. . Patients (index cases ) Prospective and retrospective cases\r\n\r - Man aged over 18 years\r\n\r - signing the informed consent\r\n\r - Presenting primary PE\r\n\r - have an affiliation to a social security system\r\n\r 2. . Related\r\n\r - Male or female over 18 years\r\n\r - be related to the index case\r\n\r - signing the informed consent\r\n\r - have an affiliation to a social security system\r\n\r Non Inclusion Criteria:\r\n\r 1. . Patients ( index case ) :\r\n\r - Be aged under 18\r\n\r - have known genetic variations that predispose or can promote psychological\r disorders that can lead to PE ( eg: Kallman 's Syndrome , micropenis , testicular\r dysgenesis , Klinfelter syndrome, Leydig cell hypoplasia )\r\n\r - have had psycho- social and psycho- traumatic factors in childhood\r\n\r - Inability to receive clear information on the protocol\r\n\r - Person deprived of liberty by judicial or administrative decision\r\n\r - Major Person subject of legal protection or unable to consent\r\n\r - Refusal to be informed of an abnormality detected after genetic testing\r\n\r - History of allergies to lidocaine or other anesthetic agent used during puncture\r or blood sample\r\n\r 2. . Related :\r\n\r - Age <18 years\r\n\r - Inability to receive clear information about the protocol . Unable to participate\r in the entire study.\r\n\r - No coverage by the social security system\r\n\r - Absence of signature of consent or refusal of the related party\r\n\r - Person deprived of liberty by judicial or administrative decision\r\n\r - Major Person subject of legal protection or unable to consent\r\n\r - Refusal to be informed of a genetic abnormality detected\r\n\r - History of allergies to lidocaine or other anesthetic agent used during puncture\r or blood sample\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,517
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nLFP Correlates of Movement Disorders\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to record electrical brain activity during DBS surgery and after\r DBS surgery using the Medtronic Activa PC+S deep brain stimulation (DBS) system, a modified\r DBS pulse generator. The goal of the study is to investigate if the electrical brain activity\r can help customize DBS therapy.\n\n**Clinical Trial Detailed Description:**\n\nThe Activa PC+S system will be implanted and programmed under the same clinical procedures\r and standard of care as the Activa PC system. After implantation and standard clinical\r programming, participants in our research study will be asked to return for additional\r research visits where the recording sub-circuit of the device will be activated and local\r field potentials (LFP) will be recorded in the device and transmitted through telemetry to a\r base station for storage and future analysis. The sensing, or recording, sub-circuit will be\r disabled, non-invasively, at the end of each research visit to minimize impact to battery\r life of the device.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Potential participants must be undergoing DBS lead placement for Parkinson's Disease\r that requires them to be awake during microelectrode recording.\r\n\r - Potential participants have been treated with levodopa/carbidopa, and with a dopamine\r agonist, at the maximal tolerated doses as determined by a movement disorders\r neurologist.\r\n\r - Potential participants must have a Hoehn and Yahr stage >= 2 in the medications OFF\r state.\r\n\r - Potential participants must have documented improvement in motor signs on versus off\r dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale\r motor (UPDRS III) score of >= 30% off to on medication. Patients with tremor\r predominant form of PD, quantified as a UPDRS tremor score in any one limb greater\r than or equal to 3 and UPDRS sum of axial score (speech, posture, gait, balance) less\r than or equal to 5, who do not reach the 30% threshold, may be included.\r\n\r - Potential participants must have evidence of complications of medication, e.g.,\r wearing off signs, fluctuating responses and/or dyskinesias, and/or medication\r refractory tremor, and/or impairment in the quality of life on or off medication.\r\n\r - Potential participants must have the ability to understand instructions in English.\r\n\r - Potential participants are males or females between the ages of 21 and 75.\r\n\r Exclusion Criteria:\r\n\r - Individuals who are pregnant, breastfeeding, or are capable of becoming pregnant and\r not using an acceptable method of birth control. Acceptable methods of birth control\r include hormonal contraceptives, intrauterine device, abstinence or spermicide and\r barrier.\r\n\r - Individuals who have magnetic resonance imaging (MRI) scans demonstrating cortical\r atrophy out of proportion to age.\r\n\r - Individuals who have MRI scans showing focal brain lesions that could indicate a\r nonidiopathic movement disorder.\r\n\r - Individuals who have major comorbidity increasing the risk of surgery such as prior\r stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation\r other than aspirin.\r\n\r - Individuals who have had any prior intracranial surgery.\r\n\r - Individuals who have clinically active depression defined according to the Diagnostic\r and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and\r scored on a validated depression assessment scale.\r\n\r - Individuals who have significant cognitive impairment and/or dementia as determined by\r a standardized neuropsychological battery.\r\n\r - Individuals who have a history of seizures.\r\n\r - Individuals who are immunocompromised.\r\n\r - Individuals who have an active infection.\r\n\r - Individuals who require diathermy, electroconvulsive therapy (ECT) or transcranial\r magnetic stimulation (TMS) to treat a chronic condition.\r\n\r - Individuals who have an implanted electronic device such as a neurostimulator, cardiac\r pacemaker or medication pump.\r\n\r - Individuals who, at the discretion of the research team member, lack the cognitive\r ability to understand the instructions and fully participate in research tasks.\r\n\r - Unable to understand written and spoken instructions in English. Individuals who carry\r a concomitant diagnosis that would preclude them from fully participating in the\r research tasks due to difficulties associated with comprehending instructions,\r cooperating with research tasks, or otherwise rendering the individuals incapable of\r participating in the research tasks. Examples could include a visual or hearing\r impairment preventing the individual from viewing a computer screen or hearing\r instructions.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,518
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAmbulatory Parkinson's Disease Dyskinesia Monitor for Drug Therapy Titration\n\n**Clinical Trial Summary:**\n\nThe objective is to assess a compact, portable, wireless movement disorder system with\r continuous monitoring capabilities to detect and quantify the severity of levodopa-induced\r dyskinesia in Parkinson's disease.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of idiopathic Parkinson's disease\r\n\r - Clinical history of levodopa-induced dyskinesia\r\n\r - 21 Years of age or older\r\n\r - Stage 2 - 4 OFF-medication on the Hoehn and Yahr scale\r\n\r Exclusion Criteria:\r\n\r - Dementia (determined by a neuropsychological assessment)\r\n\r - Severe tremor unaffected by levodopa\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,519
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEfficacy of Isradipine in Early Parkinson Disease\n\n**Clinical Trial Summary:**\n\nThe purpose of the study is to determine whether treatment with isradipine is effective in\r slowing the progression of Parkinson disease disability.\n\n**Clinical Trial Detailed Description:**\n\nThe study will enroll 336 participants in this multi-center study at approximately 56 sites\r across the US and Canada. In this study, we are comparing 10 mg of Isradipine to Placebo for\r treatment of newly diagnosed PD patients. Isradipine has been approved by the Food and Drug\r Administration (FDA) to treat high blood pressure but is considered investigational in this\r study, as it has not been approved for use in patients with PD.Isradipine can affect the\r function of specialized channels that are present in the types of brain cells that are\r affected in PD patient. These cells are usually responsible for making dopamine, which is\r depleted in patients with PD. Isradipine may block the damage caused by the flow of certain\r chemicals through these channels. Laboratory data has showed that Isradipine may prevent the\r development of Parkinson-like symptoms in animal studies. Isradipine has been evaluated in\r some patients with PD. The first study with isradipine controlled release (CR) in patients\r with early PD and normal blood pressure found that the drug was reasonably well tolerated and\r safe. The controlled release formulation of isradipine is not available for use and therefore\r this study is using the immediate release formulation. Eligible participants will be followed\r for up to 36 months and will be expected to complete 12 in-person visits and 4 telephone\r visits. The study visits will include clinical assessment of motor, neuropsychiatric and\r cognitive testing as well as collection of blood and urine samples. Study drug will taken\r twice daily, in the morning and in the evening with or without food. Prior to taking study\r drug, study participants will be required to take their blood pressure with a home blood\r pressure device provided to them for use in this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects with early idiopathic PD (presence of at least two out of three cardinal\r manifestations of PD). If tremor is not present, subjects must have unilateral onset\r and persistent asymmetry of the symptoms\r\n\r - Age equal or greater than 30 years at the time of diagnosis of PD\r\n\r - Hoehn and Yahr stage less than or equal to 2\r\n\r - Diagnosis of PD less than 3 years.\r\n\r - Currently NOT receiving dopaminergic therapy (levodopa, dopamine agonist or MAO-B\r inhibitors) and NOT projected to require PD symptomatic therapy for at least 3 months\r from the baseline visit\r\n\r - Use of amantadine and/or anticholinergics will be allowed provided that the dose is\r stable for 8 weeks prior to the baseline visit\r\n\r - If subject is taking any central nervous system acting medications (e.g.,\r benzodiazepines, antidepressants, hypnotics) regimen must be stable for 30 days prior\r to the baseline visit\r\n\r - Women of childbearing potential may enroll but must use a reliable measure of\r contraception and have a negative serum pregnancy test at the screening visit\r\n\r Exclusion Criteria:\r\n\r - Subjects with a diagnosis of an atypical Parkinsonism\r\n\r - Subjects unwilling or unable to give informed consent\r\n\r - Exposure to dopaminergic PD therapy within 60 days prior to baseline visit or for\r consecutive 3 months or more at any point in the past\r\n\r - History of clinically significant orthostatic hypotension or presence of orthostatic\r hypotension at the screening or baseline visit defined as greater than or equal to 20\r mmHg change in systolic BP and greater than or equal to 10 mmHg change in diastolic BP\r from sitting position to standing after 2 minutes, or baseline sitting BP less than\r 90/60\r\n\r - History of congestive heart failure\r\n\r - Clinically significant bradycardia\r\n\r - Presence of 2nd or 3rd degree atrioventricular block or other significant ECG\r abnormalities that in the investigator's opinion would compromise participation in\r study\r\n\r - Clinically significant abnormalities in the Screening Visit laboratory studies or ECG\r\n\r - Presence of other known medical or psychiatric comorbidity that in the investigator's\r opinion would compromise participation in the study\r\n\r - Prior exposure to isradipine or other dihydropyridine calcium channel blockers within\r 6 months of the baseline visit\r\n\r - Subjects on greater than 2 concomitant antihypertensive medications. If a history of\r hypertension, then a maximum of 2 other antihypertensive agents will be allowed\r provided that the dosages of concomitant anti HTN therapy can be reduced/adjusted\r during the study based on the BP readings in consultation with the subject's primary\r care provider or cardiologist. Use of any concomitant calcium channel blockers will\r not be allowed from the baseline visit and for the duration of the study\r\n\r - Use of grapefruit juice, ginkgo biloba, St. John's wort or ginseng will be prohibited\r starting from the screening visit and for the duration of the study (as they interfere\r with the metabolism of isradipine)\r\n\r - Use of clarithromycin, telithromycin and erythromycin will be prohibited starting from\r the screening visit and for the duration of the study as the combination of\r clarithromycin, telithromycin or erythromycin and calcium channel blockers has been\r reported to be associated with increased risk of kidney and heart injury\r\n\r - Presence of cognitive dysfunction defined by a Montreal Cognitive assessment (MoCA)\r score of less than 26 at screening\r\n\r - Subjects with clinically significant depression as determined by a Beck Depression\r Inventory II (BDI) score greater than 15 at the screening visit\r\n\r - History of exposure to typical or atypical antipsychotics or other dopamine blocking\r agents within 6 months prior to the baseline visit\r\n\r - History of use of an investigational drug within 30 days prior to the screening visit\r\n\r - History of brain surgery for PD\r\n\r - Allergy/sensitivity to isradipine or its matching placebo or their formulations\r\n\r - Pregnant or lactating woman\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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35,520
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEvaluation of ETC-1002 in Patients With Hypercholesterolemia and Hypertension\n\n**Clinical Trial Summary:**\n\nThis Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo\r in patients with hypercholesterolemia and hypertension.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg\r\n\r - or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg\r\n\r - Fasting LDL-C between 100 and 220 mg/dL\r\n\r - Fasting triglycerides less than 400 mg/dL\r\n\r - Body mass index (BMI) between 18 and 45 kg/m2\r\n\r Exclusion Criteria:\r\n\r - Known or suspected secondary hypertension or history of malignant hypertension\r\n\r - Taking more than two anti-hypertension medications at the first visit\r\n\r - History or current clinically significant cardiovascular disease\r\n\r - History or current type 1 diabetes or type 2 diabetes\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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35,521
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSingle Dose Administration of Alpha-1 Anti-Trypsin for the Amelioration of Organ Injury in Patients Undergoing Cardiac Surgery\n\n**Clinical Trial Summary:**\n\nProtocol Summary STUDY DESIGN A pilot, prospective, double blind, randomized, placebo\r controlled study.\r\n\r STUDY POPULATION Patients assigned to elective CABG with cardiopulmonary bypass (CPB) at the\r Department of Cardiothoracic Surgery, Soroka University Medical Center.\r\n\r OBJECTIVE To evaluate anti-inflammatory effects, effects on organ function preservation, and\r postoperative blood loss reduction following AAT-1 administration in patients undergoing CABG\r with CPB.\r\n\r PRIMARY ENDPOINT Postoperative organ function preservation and blood loss following\r preoperative single-dose AAT-1 administration.\r\n\r SAMPLE SIZE CONSIDERATIONS A cohort of 20 patients will be recruited. Patients will be\r randomized to receive either AAT-1 or placebo prior to surgery. Whereas this is a proof of\r concept pilot study, statistical significance is not the primary objective.\r\n\r INCLUSION CRITERIA 1. The study population will comprise patients between 40 and 70 years of\r age, irrespective of gender, at low or intermediate operative risk (calculated Logistic\r Euroscore stratification of 5% or less), assigned to elective CABG with CPB. Recruitment\r depending on patients informed consent.\r\n\r EXCLUSION CRITERIA Co-existing conditions including:\r\n\r 1. Coagulation abnormalities\r\n\r 2. Severe pulmonary disease defined by blood oxygen saturation of 90% or less or FEV1 of\r less than 60% of predicted.\r\n\r 3. Renal dysfunction defined be serum creatinine levels higher or equal to 1.8 mg%,\r\n\r 4. Abnormal liver function tests\r\n\r 5. Uncontrolled diabetes mellitus,\r\n\r 6. Severe peripheral vascular disease\r\n\r 7. Prior cerebrovascular neurological event.\r\n\r 8. Abnormal left or right ventricular function.\r\n\r 9. Treatment with warfarin or thienopyridine class of anti platelet agents.\n\n**Clinical Trial Detailed Description:**\n\n3 Background The use of cardiopulmonary bypass (CPB) during cardiac surgery elicits\r generalized non-specific systemic inflammatory response syndrome (SIRS) and subsequent\r activation of the cytokine, complement, and coagulation-fibrinolytic cascades (1). In\r approximately 11% of the patients SIRS may deteriorate to severe multi-organ failure (MOF)\r resulting in mortality rate of 40-98%.\r\n\r Inflammatory modulation by intraoperative administration of anti-inflammatory substances has\r been advocated to attenuate the effects of SIRS. Attempts have subsequently focused on\r aprotinin which inhibits proteases that are key mediators in the complement, coagulation, and\r fibrinolytic system. Related anti-inflammatory properties of aprotinin include the inhibition\r of platelets, neutrophils and kallikrein activation. Reduction in blood loss and reduced need\r for allogenic blood transfusions have been proposed as additional mechanisms by which\r aprotinin limits the inflammatory response (2). The use of aprotinin during cardiac surgery,\r however, was discontinued following alarming results in terms of higher rate of bypass graft\r occlusion and overall inferior postoperative outcome.\r\n\r AAT-1 mechanism of action:\r\n\r Similar to aprotinin, α1-Antitrypsin (AAT) is a 52-kDa circulating serine protease inhibitor\r classified as a SERPIN protein. Besides its ability to inhibit serine proteases, accumulating\r data suggest that AAT-1 possesses independent anti-inflammatory and tissue-protective effects\r (3). AAT-1 modifies dendritic cell maturation and promotes regulatory T-cell differentiation,\r induces interleukin (IL)-1 receptor antagonist and IL-10 release, protects various cell types\r from cell death, inhibits caspases-1 and -3 activities and inhibits IL-1 production and\r activity (4). Contradictory to classic immunosuppressants, AAT-1 allows undeterred isolated\r T-lymphocyte responses (5).These effects have been repeatedly corroborated.\r\n\r Unlike aprotinin, AAT-1 is produced from human plasma, and does not have strong pro coagulant\r characteristics.\r\n\r AAT-1 in different clinical settings:\r\n\r Circulating AAT-1 levels increase by 4-fold during acute-phase response (3). Patients with\r low circulating levels of AAT-1 are at increase risk for lung, liver and pancreatic\r destructive diseases, particularly emphysema (3). Preclinical and clinical studies have shown\r that AAT-1 therapy for non-deficient individuals is safe, and may modify disease progression\r in type 1 and type 2 diabetes, acute myocardial infarction, rheumatoid arthritis,\r inflammatory bowel disease, cystic fibrosis, transplant rejection, graft versus host disease\r and multiple sclerosis (6-17, 32,33,37,38) . AAT-1 treatment has subsequently advanced from\r replacement therapy to potential treatment for a broad spectrum of inflammatory and\r immune-mediated diseases. AAT-1 also appears to be antibacterial and an inhibitor of viral\r infections, such as influenza and human immunodeficiency virus (HIV) (18).\r\n\r Human pharmacokinetic data:\r\n\r In patients with AAT-1 deficiency, intravenous administration of AAT-1 in a dose of 60 mg per\r kg body weight maintain plasma levels resembling acute phase response immediately after\r administration, and retain an appropriate level of serum AAT above the protective threshold\r (50 mg/dl) a week afterwards (39).\r\n\r Rational of AAT-1 dosage:\r\n\r Based on previous studies and clinical practice, the administration of multiple intravenous\r dosage of 60 mg per kg body weight of AAT-1 is safe and is associated with low incidence of\r benign side-effects.\r\n\r Derived from pharmacokinetic studies (39), AAT-1 plasma levels immediately following the\r administration of this external dosage resembles acute phase response. A 30% reduction in\r AAT-1 plasma levels is anticipated with gradual return to preoperative levels after\r termination of CPB (40).\r\n\r Risk/ benefit of the study:\r\n\r The role of AAT-1 in mitigating inflammatory response has been established. CPB is a potent\r stimulator of inflammatory cascades and associated with bleeding diatheses, coagulation\r abnormalities, potentially leading to organ dysfunction. To date, the administration of AAT-1\r in patients undergoing cardiac surgery with CPB has not been explored. It may be postulated\r that inherent AAT-1 effects may offset deleterious CPB effects. This may clinically result in\r improved preservation of organ function, reduced postoperative bleeding and reduced hospital\r stay. The benefits of other protease inhibitors in corresponding settings have been recently\r demonstrated (41-43).\r\n\r As mentioned above, administration of AAT-1 in various clinical settings is considered safe\r with low rate of side effects (see section 6.1 - potential risks).\r\n\r 4 Methods 4.1 Primary Objective\r\n\r 1. To evaluate the efficacy and safety of preoperative AAT-1 administration in patients\r undergoing CABG with CPB.\r\n\r 2. Postoperative blood loss and organ function will be assessed.\r\n\r To date, no data exists with regard to AAT-1 effects in the settings of CPB. The primary\r goals of this study are to evaluate anti-inflammatory effects, organ function preservation\r (1-2) and postoperative blood loss reduction following AAT-1 administration in patients\r undergoing cardiac surgery with CPB.\r\n\r 4.2 Determination of Study Eligibility 4.2.1 Inclusion Criteria\r\n\r 1. Male/female patients 40-70 years of age.\r\n\r 2. Candidates for isolated CABG with CPB.\r\n\r 3. Calculated logistic Euroscore risk stratification of 5% or less.\r\n\r 4. Signed patient's written informed consent.\r\n\r 4.2.2 Exclusion Criteria\r\n\r Co-existing conditions including:\r\n\r 10. Coagulation abnormalities 11. Severe pulmonary disease defined by blood oxygen saturation\r of 90% or less or FEV1 of less than 60% of predicted.\r\n\r 12. Renal dysfunction defined be serum creatinine levels higher or equal to 1.8 mg%, 13.\r Abnormal liver function tests 14. Uncontrolled diabetes mellitus, 15. Severe peripheral\r vascular disease 16. Prior cerebrovascular neurological event. 17. Abnormal left or right\r ventricular function. 18. Treatment with warfarin or thienopyridine class of anti-platelet\r agents. 4.2.3 Withdrawal Criteria Patients will preserve the right to withdraw from the study\r at any time during treatment without prejudice.\r\n\r If medically indicated, the principal investigator or the surgeon poses the right to\r discontinue patient enrollment at any stage of the study.\r\n\r Discontinuation (failure to complete the study) will be documented. The reason for\r discontinuation will be recorded.\r\n\r Potential causes that may lead to discontinuation include:\r\n\r - Adverse event(s)\r\n\r - Protocol violation\r\n\r - Patient withdrew consent\r\n\r - Administrative problems 4.3 Enrollment Prior to participation in this study, the\r Investigator will obtain written appropriate approval for the protocol and the informed\r consent form the Ethics Committee (EC) and other local regulatory organizations. The\r approved consent form will clearly reflect the EC approval date.\r\n\r Failure to obtain a signed and hand dated informed consent prior to the procedure constitutes\r a protocol violation, and subsequently reportable to the EC.\r\n\r 4.4 Subject Screening Patients that have been already scheduled for isolated CABG operation\r will be addressed by a member of the research team during the preoperative waiting period\r (either in the Department of Cardiothoracic Surgery, the Department of Cardiology or the\r Department of Internal Medicine). The goal of the study, procedure and incentive will be\r explained by a research staff member to each potential participant. Consenting subjects will\r be asked to provide written consent.\r\n\r 4.4.1 Randomization The study participants will be randomized to receive either single dose\r AAT-1 60 mg per kg or placebo.\r\n\r 4.4.2 Trial medication administration: Preparation and dosing of AAT-1 will be performed by\r an unblinded pharmacist. The medication will be diluted just prior to administration. The\r placebo solution will comprise human albumin that resembles the color and consistency of\r AAT-1 solution. The medication will be given 3-5 hours prior to surgery (skin incision).\r Administration rate of the drug will not exceed 0.04 ml per kg per minute (approximately\r 60-80 minutes). Vital signs including blood pressure, pulse rate and body temperature will be\r correspondingly monitored.\r\n\r The patients, research staff, laboratory personnel and data analysts will remain blinded to\r the identity of the treatment from the time of randomization and until database lock. Data\r unblinding will commence in the case of patient's emergency.\r\n\r A randomization list will be produced by the pharmacist, however, will be secured and\r confidential until time of unblinding.\r\n\r 4.4.3 Surgical technique Consistent with our routine policy, fentanyl citrate (20-50mcg/kg),\r midazolam (2-3mg) and isoflurane (0.5-2%) will be used for induction and maintenance of\r anesthesia.\r\n\r Standard median sternotomy will be followed by procurement of the conduits. Heparin loading\r dose will be administered to achieve a kaolin activated coagulation time (ACT). Ascending\r aorta - right atrial cannulation will be performed to institute CPB and ACT will be monitored\r at 480 seconds or more. Standard centrifugal pump and a membrane oxygenator will be used for\r extracorporeal circulation (cardiopulmonary bypass). Compatible with the standard technique,\r systemic active cooling will be avoided and patients core temperature will remain range\r between 32 and 37˚C. Distal anastomoses will be performed during single aortic cross-clamp\r and blood cardioplegic arrest. Proximal anastomoses will be performed during aortic\r cross-clamp. Cold (10˚C) blood cardioplegic solution will be delivered in a 4:1 ratio.\r Cardioplegia will be delivered antegrade via the aortic root with or without additional\r retrograde administration via the coronary sinus. After cardioplegic induction (10 ml / Kg),\r intermittent doses (300 - 500 ml) will be administered following completion of each distal\r anastomosis. Heparin will be reversed using protamine sulphate in a ratio of 1:1 after\r weaning from CPB.\r\n\r 4.4.4 Data collection Preoperative data: Demographic, morphological and clinical descriptors\r including age, gender, body mass index (BMI), body surface area (BSA) co-morbidity, Euroscore\r risk-stratification, medication, etc. will be recorded. Preoperative laboratory analysis will\r include complete blood count, coagulation profile, serum creatinine levels and creatinine\r clearance, liver function test and arterial blood gases test and serology for HIV,HCV,HBC.\r Compatible with our routine policy, all patients will undergo preoperative echocardiography,\r coronary angiography, chest x-ray, lung function tests (spirometry) and carotid artery duplex\r study.\r\n\r Study participants will be assigned to undergo preoperative brain MRI; subjected to the\r protocol described below.\r\n\r Intraoperative: The type of surgery will be classified. The following data will be recorded:\r heparin dose given prior to bypass initiation; activated clotting time (ACT) counts during\r the operation (prior, during and after CPB); operative time, cross-clamp time and CPB time;\r number of trials to wean from CPB, type of inotropes and dosage used during weaning from CPB;\r blood products utilization during surgery. Allergic reactions or adverse events observed by\r the surgeon or anesthesiologist will be documented. The individual surgeon's impression\r regarding bleeding tendency will be recorded.\r\n\r Postoperative organ function and blood loss evaluation:\r\n\r The occurrence and magnitude of systemic inflammatory response and organ dysfunction will be\r recorded and quantified by laboratory markers. Related laboratory markers will be monitored\r on a daily basis during the recovery period (in the intensive care unit and at the ward). The\r following organs and corresponding markers will be monitored:\r\n\r Pulmonary function: Pulmonary function will be evaluated by measured overall mechanical\r ventilation time, peak inspiratory pressures (PIP), plateau pressures, physiologic dead space\r and static and dynamic lung compliance. Bronchoalveolar lavage (BAL) will be performed 3\r hours after operation (while the patient is anesthesized and intubated) and extracted fluid\r will be analyzed for inflammatory markers. A-a DO2 calculation [AaDO2 = (713 x FiO2) - (pCO2\r / 0.8) - (paO2)] will be measured daily.\r\n\r Complete pulmonary function test will be performed before and 4 days after the operation.\r Chest radiographs will be evaluated and quantified by an independent radiologist for the\r occurrence of atelectasis, pulmonary edema, or pleural changes.\r\n\r Renal function: Daily measurements of urine output, serum creatinine levels, creatinine\r clearance and urinary albumin levels. Acute kidney injury (AKI) markers will be sampled in\r the ICU.\r\n\r Brain injury assessment: The degree of insult to the brain will be measured by plasma S-100\r proteinlevels. Assessment of damage to the blood-brain barrier (BBB) will be performed by\r magnetical resonance imaging (MRI) modality (see technique protocol below).\r\n\r Hepatic function: Daily measurements of serum hepatic enzymes levels. Cardiac function:\r Monitoring of cardiac enzymes levels; need and magnitude of required inotrope treatment;\r occurrence of low cardiac output syndrome (defined as systolic blood pressure of 90 mmHg or\r less coupled with central venous pressure (CVP) of 15 mmHg or more) and incidence of cardiac\r arrhythmias. Transthoracic echocardiography examination will be performed on postoperative\r day 5 and assessed by an independent cardiologist.\r\n\r Blood loss: Operative and postoperative blood loss will be monitored as well as daily\r hemoglobin levels. Daily platelet counts and thromboelastograms will be performed. The\r distribution of blood products and total administered will be recorded daily. Postoperative\r CRP levels will be evaluated daily.\r\n\r Blood sampling and laboratory analysis methods for cytokine levels:\r\n\r Ten mL whole blood venous EDTA samples will be collected from radial artery catheter at five\r specified occasions: before induction of anaesthesia, 30 minutes after aortic cross-clamp\r positioning and 3, 6, and 9 hours after aortic cross clamp positioning. The blood samples\r will be subsequently centrifuged at 4 °C for 15 min and the serum stored at -70 °C. Samples\r will be analyzed for the following markers: Polimorphonuclear Neutrophil Elastase (PMNE),\r Interleukin-1α (IL-1α), Interleukin-1ß (IL-1ß), Interleukin-2 (IL-2), Interleukin-4 (IL-4),\r Interleukin-6 (IL-6), Interleukin-8 (IL-8), Interleukin-10 (IL-10), Interferon-γ (IFN-γ),\r Tumor Necrosis Factor-α (TNF-α), Vascular Endothelial Growth Factor (VEGF), Monocyte\r Chemoattractant Protein-1 (MCP-1), and Endothelial Growth Factor (EGF).\r\n\r Daily blood samples will be collected postoperatively for platelet count, renal function,\r liver function, CRP levels S-100 protein and troponin.\r\n\r Early postoperative adverse events will be documented. These include 30-day mortality, new\r neurological events, myocardial infarction, renal dysfunction, need for re-exploration for\r bleeding and deep sternal wound infection.\r\n\r Blood-Brain Barrier (BBB) assessment by MRI The imaging modality used for BBB assessment will\r be MRI scanner (Philips 3T or General Electric 1.5T). The examination format will include 24\r cm FOV, 35 contiguous interleaved slices, 3.5-4 mm thick and co-localized across series.\r Trace-weighted DWI images will be obtained at b=1000 from a 13-15 direction DTI sequence with\r an in-plane resolution of 2.5×2.5mm and TR/TE=10s/58ms at 3T or TR/TE=10s/72ms at 1.5T.\r T2-FLAIR images will be obtained with an in-plane resolution of 0.94×0.94 mm, TR/TE=9000/120\r ms and TI=2600 ms at 3T or TR/TE=9000/140 ms and TI=2200 ms at 1.5T. (25)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. The study population will comprise patients between 40 and 70 years of age, irrespective\r of gender, at low or intermediate operative risk (calculated Logistic Euroscore\r stratification of 5% or less), assigned to elective CABG with CPB. Recruitment depending on\r patients informed consent.\r\n\r Exclusion Criteria:\r\n\r Co-existing conditions including:\r\n\r 1. Coagulation abnormalities\r\n\r 2. Severe pulmonary disease defined by blood oxygen saturation of 90% or less or FEV1 of\r less than 60% of predicted.\r\n\r 3. Renal dysfunction defined be serum creatinine levels higher or equal to 1.8 mg%,\r\n\r 4. Abnormal liver function tests\r\n\r 5. Uncontrolled diabetes mellitus,\r\n\r 6. Severe peripheral vascular disease\r\n\r 7. Prior cerebrovascular neurological event.\r\n\r 8. Abnormal left or right ventricular function.\r\n\r 9. Treatment with warfarin or thienopyridine class of anti platelet agents -\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nComplementary & Alternative Medicine in Parkinson's Disease (CAM Care in PD)\n\n**Clinical Trial Summary:**\n\nWe are trying to identify factors associated with improved quality of life and fewer PD\r symptoms. We are attempting to identify practices, beliefs, and therapies used by individuals\r who report excellent quality of life, few PD symptoms, and reduced rates of progression.\r After agreeing to participate, we will ask participants to fill our questionnaires about\r their experience with PD, their health in general, along with their food intake every six\r months for five years.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective, observational study designed to describe disease progression, symptom\r change, quality of life, diet and lifestyle habits among patients with Parkinson's disease\r (PD). This study will identify and describe those individuals with the highest quality of\r life and least amount of disease activity, in order to describe medication, diet, and\r lifestyle patterns associated with a lack of PD disease progression and high quality of life.\r\n\r Participants will be asked to complete online surveys every six months for five years. The\r time requirement is about an hour to an hour and a half every six months. Participants do not\r need to answer questions if they do not feel comfortable answering.\r\n\r At each six month time point we will send participants an email with the link to the CAM Care\r in PD survey, a questionnaire about health and wellbeing (completed in REDCap). After\r participants have completed this survey we will send participants a link to the second\r survey, about dietary intake (completed on ASA24.gov). Because there is a designated window\r of time during which surveys must be completed, participants may receive a gentle reminder\r from us if time is running out.\r\n\r This study is not designed to provide care. Participants are encouraged to consult with any\r providers you wish. Participants will not directly benefit from the study, but information\r gathered during the course of this study may help us begin to assess the longer-term effects\r of complementary and integrative care on health, disease progression and quality of life in\r PD patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Parkinson's disease (PD)\r\n\r - Parkinsonism\r\n\r - Parkinson-plus syndromes (e.g. Multiple System Atrophy (MSA), Progressive Supranuclear\r Palsy (PSP), Corticobasal degeneration (CBGD), Dementia with Lewy bodies)\r\n\r - Must have online access, an email address, basic computer literacy\r\n\r - Must be willing to complete online surveys every 6 months for 5 years\r\n\r Exclusion Criteria:\r\n\r - Inability to read/write English\r\n\r - Inability or unwillingness to complete surveys every six (6) months (~90 min)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nUsing Parkinson's Disease to Study the Role of the Substantia Nigra Pars Reticulata\n\n**Clinical Trial Summary:**\n\nParkinson's Disease (PD) is a movement disorder causing either uncontrolled movement,\r slowness of movement, slowness of initiation of movement or rigidity of muscles. Deep Brain\r Stimulation (DBS) is the FDA-approved method for patients who no longer get effective\r treatment from the best available medication. The location in the brain where the electrode\r is placed during DBS surgery for PD is called the Subthalamic Nucleus or STN. This study aims\r to investigate another location in the brain, the Substantia nigra pars reticulata or SNr.\r The SNr is also known to be involved in motor control of muscles and may be involved in the\r process by which the initiation of movement occurs.\n\n**Clinical Trial Detailed Description:**\n\nParkinson's Disease (PD) is a movement disorder causing either uncontrolled movement,\r slowness of movement, slowness of initiation of movement or rigidity of muscles. One method\r of easing PD symptoms is the FDA-approved method of Deep Brain Stimulation (DBS) for patients\r who no longer get effective treatment from the best available medication. The location in the\r brain where the electrode is placed during DBS surgery for PD is called the Subthalamic\r Nucleus or STN. During placement of the DBS electrode, the patient is awake and is asked to\r do motor tasks to determine the correct placement in the STN and proper functioning of the\r DBS electrode. This study aims to investigate another location in the brain, the Substantia\r nigra pars reticulata or SNr, during the normal placement of the DBS electrode. This location\r is also known to be involved in motor control of muscles and may be involved in the process\r by which the initiation of movement occurs. The path through the brain to the STN used for\r DBS surgery goes into the SNr but currently, no testing of the SNr is performed. We will\r conduct a simple and well documented visual motor test to document the patient's stimulus\r perception and motor intention both at rest and during neural stimulation of the SNr.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Clinical diagnosis of Parkinson's disease\r\n\r - must be able to undergo awake surgery DBS\r\n\r - must have unaided vision to view visual motor task\r\n\r Exclusion Criteria:\r\n\r - corrective eyeglasses or contact lenses\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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[
{
"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\nDabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma\n\n**Clinical Trial Summary:**\n\nThis phase III trial studies how well initial treatment with ipilimumab and nivolumab\r followed by dabrafenib and trametinib works and compares it to initial treatment with\r dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with\r stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by\r surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and\r nivolumab, may help the body's immune system attack the cancer, and may interfere with the\r ability of tumor cells to grow and spread. Dabrafenib and trametinib may block tumor growth\r by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab\r and nivolumab followed by dabrafenib and trametinib is more effective than treatment with\r dabrafenib and trametinib followed by ipilimumab and nivolumab.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVE:\r\n\r I. To determine whether initial treatment with either combination ipilimumab + nivolumab\r (with subsequent dabrafenib mesylate [dabrafenib] in combination with trametinib dimethyl\r sulfoxide [trametinib]) or dabrafenib in combination with trametinib (with subsequent\r ipilimumab + nivolumab) significantly improves 2 year overall survival (OS) in patients with\r unresectable stage III or stage IV BRAFV600 mutant melanoma.\r\n\r SECONDARY CLINICAL OBJECTIVES:\r\n\r I. To evaluate the impact of initial treatment on median OS and hazard ratio for death.\r\n\r II. To determine whether initial treatment choice significantly improves 3 year OS.\r\n\r III. To evaluate the anti-tumor activities (Response Evaluation Criteria in Solid Tumors\r [RECIST]-defined response rate, median progression-free survival [PFS]) and safety profiles\r of ipilimumab + nivolumab and dabrafenib-trametinib in a Cooperative Group trial of patients\r with V600 mutant melanoma.\r\n\r IV. To evaluate the activity (RECIST-defined response rate, median PFS) and safety of\r dabrafenib + trametinib in patients who have had disease progression on ipilimumab +\r nivolumab and in comparison to its activity and safety in ipilimumab + nivolumab naive\r patients.\r\n\r V. To evaluate the activity of ipilimumab + nivolumab (RECIST-defined response rate, median\r PFS) and safety in patients who have had disease progression on dabrafenib + trametinib and\r in comparison to its activity and safety in dabrafenib + trametinib naive patients.\r\n\r VI. To assess the feasibility of crossover to the alternative treatment strategy (percentage\r of patients who are able to crossover from one arm to the other and complete at least an\r initial course [12 weeks] of treatment after cross-over without intervening symptomatic\r disease progression or treatment limiting toxicity).\r\n\r SECONDARY LABORATORY OBJECTIVES:\r\n\r I. Association of inherited variation with immune mediated adverse events and response to\r ipilimumab + nivolumab.\r\n\r Ia. To determine the association of inherited genetic variation and immune-associated adverse\r events in patients with metastatic melanoma treated with ipilimumab containing regimens by\r completing candidate-based gene and pathway analyses of genes involved in lymphocyte\r activation, cytokines, cytokine receptors and within the major histocompatibility complex\r (MHC) region and an agnostic genome-wide single nucleotide polymorphism (SNP)-based approach.\r\n\r Ib. To investigate the association between inherited genetics and survival in patients with\r metastatic melanoma treated with ipilimumab containing regimens by completing candidate-based\r gene and pathway analyses of genes involved in lymphocyte activation, cytokines profile,\r cytokine receptors and within the MHC region and an agnostic genome-wide SNP-based approach.\r\n\r Ic. To replicate genomic markers identified in the above aims in an independent sample set of\r patients treated with ipilimumab containing regimens and preliminarily characterize their\r potential functional role by completing replication of variation as associated with\r immune-related adverse events (irAEs) and survival and bio-informatic assessment of genomic\r markers.\r\n\r II. To determine the utility of circulating BRAF levels in determining the response and\r resistance to either BRAF/MEK directed and/or combination immunotherapy in patients with BRAF\r mutant melanoma.\r\n\r IIa. To determine if changes in blood BRAF levels utilizing peripheral blood BRAFV600\r mutational testing in patients with stage IV BRAF mutant melanoma correlate with response and\r resistance to combination BRAF/MEK directed therapy.\r\n\r IIb. To determine if changes in blood BRAF levels utilizing peripheral blood BRAFV600\r mutational testing in patients with stage IV BRAF mutant melanoma correlate with response and\r resistance to combination immunotherapy.\r\n\r IIc. To compare the kinetics of peripheral blood BRAFV600 levels during response and\r resistance in groups of patients receiving BRAF targeted therapy or combination immunotherapy\r as initial therapy.\r\n\r IId. To compare the kinetics of peripheral blood BRAFV600 levels during response and\r resistance to combination BRAF targeted therapy or combination immunotherapy in individual\r patients (initial treatment versus [vs] crossover treatment).\r\n\r SECONDARY PATIENT REPORTED OUTCOMES OBJECTIVES:\r\n\r I. To evaluate differences in overall health between initial treatment arms (dabrafenib +\r trametinib vs. ipilimumab + nivolumab immunotherapy) at 2 years, accounting for toxicities\r and overall survival. (Primary) II. To assess differences in overall function over 2 years\r between initial treatment with dabrafenib + trametinib vs. ipilimumab + nivolumab.\r (Secondary) III. To document the effects of treatment crossover and treatment administration\r sequence on symptom burden and overall function. (Secondary) IIIa. To compare differences in\r function and symptoms by treatment sequence for ipilimumab + nivolumab (arm A vs. D), and\r dabrafenib + trametinib, (arm B vs. C) at baseline, 6 weeks, 12 weeks, and 6 months after the\r initiation of each treatment.\r\n\r IIIb. To describe the frequency and severity of treatment toxicities at baseline, 6 weeks, 12\r weeks, and 6 months after initiation of each treatment.\r\n\r EXPLORATORY TOBACCO USE OBJECTIVES:\r\n\r I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other\r forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported\r cancer-treatment toxicity (adverse events [both clinical and hematologic] and dose\r modifications).\r\n\r II. To determine the effects of tobacco on patient-reported physical symptoms and\r psychological symptoms.\r\n\r III. To examine quitting behaviors and behavioral counseling/support and cessation medication\r utilization.\r\n\r IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose\r intensity, and therapeutic benefit.\r\n\r EXPLORATORY CORRELATIVE OBJECTIVES:\r\n\r I. To assess serum based biomarkers of efficacy and adverse events due to treatment with\r immune checkpoint inhibitors.\r\n\r II. To monitor tumor response by comparing changes in circulating cell-free mutant tumor\r deoxyribonucleic acid (DNA) (ctDNA) as a readout of tumor burden (a) at week 12 relative to\r baseline before treatment in responders and non-responders; (b) before and during\r immunosuppressive treatment to control irAEs.\r\n\r III. To monitor organ-specific adverse events (irAEs) using circulating cell-free,\r tissue-specific methylated DNA (cmeDNA) as a readout of tissue-specific toxicity (a) at the\r time of grade 3-4 irAE relative to baseline and control patients without irAEs; (b) during\r immunosuppressive treatment for irAEs.\r\n\r OUTLINE: Patients are randomized to 1 of 2 treatment arms (Arm A or Arm B).\r\n\r ARM A:\r\n\r IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab intravenously (IV) over\r 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every\r 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.\r\n\r IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on\r days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of\r disease progression or unacceptable toxicity. Upon disease progression, patients re-register\r and cross over to Arm C.\r\n\r ARM C: Patients receive dabrafenib mesylate orally (PO) twice daily (BID) and trametinib\r dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of\r disease progression or unacceptable toxicity.\r\n\r ARM B: Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily\r on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or\r unacceptable toxicity. Upon disease progression, patients re-register and cross over to Arm\r D.\r\n\r ARM D:\r\n\r IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and\r ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2\r cycles in the absence of disease progression or unacceptable toxicity.\r\n\r IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on\r days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of\r disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed up every 3 months for 2 years and\r then every 6 months for 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - STEP 1\r\n\r - Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1\r\n\r - The effects of dabrafenib and trametinib or ipilimumab and nivolumab on the developing\r human fetus are unknown; furthermore, dabrafenib has been reported to interfere with\r the effect of hormone based oral contraceptives; for this reason and because other\r therapeutic agents used in this trial are known to be teratogenic, women of\r child-bearing potential and sexually active males must agree to use at least two other\r accepted and effective methods of contraception and/or to abstain from sexual\r intercourse for the duration of their participation in the study, and for at least 4\r weeks after treatment with dabrafenib or for 4 months after dabrafenib in combination\r with trametinib; women of child-bearing potential must use at least two other accepted\r and effective methods of contraception and/or to abstain from sexual intercourse for\r at least 5 months after the last dose of nivolumab and/or ipilimumab and sexually\r active males must use at least two other accepted and effective methods of\r contraception and/or abstain from sexual intercourse for at least 7 months after the\r last dose of nivolumab and/or ipilimumab; should a woman become pregnant or suspect\r she is pregnant while she is participating in this study, she should inform her\r treating physician immediately\r\n\r - Patients must have unresectable stage III or stage IV disease\r\n\r - Patients must have measurable disease; all sites of disease must be evaluated within 4\r weeks prior to randomization\r\n\r - Patients must have histological or cytological confirmation of melanoma that is\r metastatic or unresectable and clearly progressive\r\n\r - NOTE: Any patient with BRAF V600 mutant melanoma (whether cutaneous, acral or\r mucosal primary) who meets the eligibility criteria is eligible for participation\r in this trial; patients with uveal melanoma are not eligible for this trial\r\n\r - Patients must have BRAF V600 mutation, identified by a Food and Drug Administration\r (FDA)-approved test at a Clinical Laboratory Improvement Act (CLIA)-certified lab; if\r test at CLIA-certified lab used a non-FDA approved method, information about the assay\r must be provided (FDA approved tests for BRAF V600 mutations in melanoma include:\r THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test, Foundation Medicine);\r prompt information on tumor BRAF mutation status can also be obtained via Novartis\r \"knowNow\" Program\r\n\r - Patients may have had prior systemic therapy in the adjuvant setting; however this\r adjuvant treatment must not have included a CTLA4 or PD1 pathway blocking antibody or\r a BRAF/MEK inhibitor; also, patients may not have had any prior systemic treatment for\r advanced (measurable metastatic) disease\r\n\r - Patients must have discontinued chemotherapy, immunotherapy or other investigational\r agents used in the adjuvant setting >= 4 weeks prior to entering the study and\r recovered from adverse events due to those agents; mitomycin and nitrosoureas must\r have been discontinued at least 6 weeks prior to entering the study; patients must\r have discontinued radiation therapy >= 1 week prior to entering the study and\r recovered from any adverse events associated with treatment; prior surgery must be >=\r 2 weeks from registration and patients must be fully recovered from post-surgical\r complications\r\n\r - White blood count >= 3,000/uL (obtained within 4 weeks prior to randomization)\r\n\r - Absolute neutrophil count (ANC) >= 1,500/uL (obtained within 4 weeks prior to\r randomization)\r\n\r - Platelet count >= 100,000/uL (obtained within 4 weeks prior to randomization)\r\n\r - Hemoglobin > 8 g/dL (obtained within 4 weeks prior to randomization)\r\n\r - Serum creatinine =< 1.5 x upper limit of normal (ULN) or serum creatinine clearance\r (CrCl) >= 40 ml/min (obtained within 4 weeks prior to randomization)\r\n\r - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x\r ULN for patients with documented liver metastases)\r\n\r - Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement\r and =< 7 x ULN for patients with known bone involvement) (obtained within 4 weeks\r prior to randomization)\r\n\r - Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those\r with known Gilbert's syndrome (obtained within 4 weeks prior to randomization)\r\n\r - STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE): The patient must have\r met all eligibility criteria (except as detailed below) at the time of crossover\r\n\r - RECIST defined measurable disease is not required\r\n\r - Only prior systemic therapy as part of step 1 is allowed; patients who received\r allowed systemic therapy in the adjuvant setting prior to Step 1 and were\r eligible for Step 1 are not excluded from proceeding to Step 2 if they meet other\r eligibility criteria\r\n\r - Malabsorption, swallowing difficulty, or other conditions that would interfere\r with the ingestion or absorption of dabrafenib or trametinib, or history of\r retinal vein occlusion are acceptable for patients crossing over to ipilimumab +\r nivolumab treatment\r\n\r - History of autoimmune disease, excluding interstitial lung disease or\r pneumonitis, is allowed in patients crossing over to dabrafenib/trametinib\r therapy\r\n\r - Patients crossing over from nivolumab/ipilimumab to dabrafenib/trametinib who\r underwent surgery or SRS to CNS metastases need not be off of steroids to start\r treatment\r\n\r - There is no restriction on serum lactate dehydrogenase (LDH) at crossover\r\n\r - Patients with a history of cardiovascular risks that developed during step 1 of\r therapy should be discussed with study principal investigator (PI) at time of\r crossover\r\n\r - STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE): Patients must have\r melanoma that is metastatic and clearly progressive on prior therapy\r\n\r - STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE): Patients must be at\r least 1 week from documented progressive disease (PD) on Step 1 of current study; all\r sites of disease must be evaluated within 4 weeks prior to registration\r\n\r - STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE): Patients must have\r recovered from adverse events (toxicities resolved to grade 1 or less) of prior\r therapy; patients with immune related toxicities from ipilimumab + nivolumab may\r continue onto Step 2 even if still on steroids to control side effects, so long as\r toxicity has resolved to grade 1 or less\r\n\r - STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE): Patients must have\r discontinued radiation therapy prior to registering to Step 2 of the study and\r recovered from any adverse events associated with treatment; prior surgery must be >=\r 2 weeks from registration to Step 2 and patients must be fully recovered from\r post-surgical complications\r\n\r - STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE): The effects of\r dabrafenib and trametinib or ipilimumab and nivolumab on the developing human fetus\r are unknown; furthermore, dabrafenib has been reported to interfere with the effect of\r hormone based oral contraceptives; for this reason and because other therapeutic\r agents used in this trial are known to be teratogenic, women of child-bearing\r potential and sexually active males must agree to continue to use the same\r contraception requirements as on Step 1 of this study (i.e.: use at least two other\r accepted and effective methods of contraception and/or to abstain from sexual\r intercourse for the duration of their participation in the study, and for at least 4\r weeks after treatment with dabrafenib or for 4 months after dabrafenib in combination\r with trametinib; women of child-bearing potential must use at least two other accepted\r and effective methods of contraception and/or to abstain from sexual intercourse for\r at least 5 months after the last dose of nivolumab and/or ipilimumab and sexually\r active males must use at least two other accepted and effective methods of\r contraception and/or to abstain from sexual intercourse for at least 7 months after\r the last dose of nivolumab and/or ipilimumab); should a woman become pregnant or\r suspect she is pregnant while she is participating in this study, she should inform\r her treating physician immediately\r\n\r Exclusion Criteria:\r\n\r - Women must not be pregnant or breast-feeding, as the effects of ipilimumab + nivolumab\r or dabrafenib + trametinib on the developing human fetus are unknown\r\n\r - All females of childbearing potential must have a blood test or urine study\r within 2 weeks prior to registration to rule out pregnancy\r\n\r - A female of childbearing potential is any woman, regardless of sexual orientation\r or whether they have undergone tubal ligation, who meets the following criteria:\r 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been\r naturally postmenopausal for at least 24 consecutive months (i.e., has had menses\r at any time in the preceding 24 consecutive months)\r\n\r - Patients must not receive any other investigational agents while on study or within\r four weeks prior to registration\r\n\r - Patients are ineligible if they have any currently active central nervous system (CNS)\r metastases; patients who have treated brain metastases (with either surgical resection\r or stereotactic radiosurgery [SRS]) could be eligible; patients must not have taken\r any steroids =< 10 days prior to randomization for the purpose of managing their brain\r metastases; repeat imaging after SRS or surgical resection is not required so long as\r baseline magnetic resonance imaging (MRI) is within 4 weeks of registration; patients\r with multiple brain metastases treated with SRS (with [w] or without [w/o] whole-brain\r radiotherapy [WBRT]), are not an exclusion; patients with definitive CNS metastases\r treated with only WBRT are ineligible; patients with potential CNS metastases that are\r too small for treatment with either SRS or surgery (e.g. 1-2 mm) and/or are of\r uncertain etiology are potentially eligible, but need to be discussed with and\r approved by the study principal investigator (PI)\r\n\r - Patients must not have other current malignancies, other than basal cell skin cancer,\r squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in\r situ of the breast; patients with other malignancies are eligible if they have been\r continuously disease-free for > 2 years prior to the time of registration\r\n\r - Patients must not have any serious or unstable pre-existing medical conditions (aside\r from malignancy exceptions specified above), including but not limited to, ongoing or\r active infection requiring parenteral antibiotics on day 1, or psychiatric\r illness/social situations that would limit compliance with study requirements,\r interfere with subject's safety, or obtaining informed consent; therapeutic level\r dosing of warfarin can be used with close monitoring of prothrombin time\r (PT)/international normalized ratio (INR) by the site; exposure may be decreased due\r to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted\r based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may\r be increased and thus close monitoring via PT/INR and warfarin dose adjustments must\r be made as clinically appropriate; prophylactic low dose warfarin may be given to\r maintain central catheter patency\r\n\r - Patients must not have a history of or evidence of cardiovascular risks including any\r of the following:\r\n\r - QT interval corrected for heart rate using the Bazett's formula (QTcB) >= 480\r msec. at baseline\r\n\r - History of acute coronary syndromes (including myocardial infarction or unstable\r angina), coronary angioplasty, or stenting within the past 24 weeks prior to\r registration\r\n\r - History prior to registration or evidence of current >= class II congestive heart\r failure as defined by the New York Heart Association (NYHA) functional\r classification system\r\n\r - Left ventricular ejection fraction (LVEF) =< 45% on cardiac echocardiogram (echo)\r or multi gated acquisition scan (MUGA)\r\n\r - Intra-cardiac defibrillator\r\n\r - Individuals who are known to be human immunodeficiency virus (HIV) infected are\r ineligible (note: HIV testing is not required for entry into the study)\r\n\r - Patients with active autoimmune disease or history of autoimmune disease that might\r recur, which may affect vital organ function or require immune suppressive treatment\r including systemic corticosteroids, should be excluded; these include but are not\r limited to patients with a history of immune related neurologic disease, multiple\r sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia\r gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE),\r connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's,\r ulcerative colitis, hepatitis; and patients with a history of toxic epidermal\r necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be\r excluded because of the risk of recurrence or exacerbation of disease; patients with\r vitiligo, endocrine deficiencies including thyroiditis managed with replacement\r hormones including physiologic corticosteroids are eligible; patients with rheumatoid\r arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with\r topical medication and patients with positive serology, such as antinuclear antibodies\r (ANA), should be evaluated for the presence of target organ involvement and potential\r need for systemic treatment; if no systemic immune suppression is deemed necessary\r they can be eligible\r\n\r - The following medications or non-drug therapies are also prohibited while on treatment\r in this study:\r\n\r - Other anti-cancer therapies\r\n\r - Other investigational drugs\r\n\r - Patients taking any medications or substances that are strong inhibitors or\r inducers of CYP3A or CYP2C8 are ineligible\r\n\r - Patients must not have history of retinal vein occlusion (RVO)\r\n\r - Patients must not have evidence of interstitial lung disease or pneumonitis\r\n\r - Patients must not have malabsorption, swallowing difficulty, or other conditions that\r would interfere with the ingestion or absorption of dabrafenib or trametinib\r\n\r - STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE): Patients are ineligible\r if they have any currently active CNS metastases; patients who have treated brain\r metastases (with either surgical resection or stereotactic radiosurgery [SRS]) could\r be eligible to proceed; patients crossing over from dabrafenib/trametinib to nivolumab\r (nivo)/ipilimumab (ipi) must not have taken any steroids =< 10 days prior to\r registration for the purpose of managing their brain metastases; patients with only\r whole brain irradiation for treatment of CNS metastases are ineligible; patients with\r definitive CNS metastases treated with only WBRT are ineligible; patients with\r potential CNS metastases that are too small for treatment with either SRS or surgery\r (e.g. 1-2 mm) and/or are of uncertain etiology are pote\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nPilot Study of Stem Cell Transplantation for Children and Young Adults With Refractory Crohn's Disease.\n\n**Clinical Trial Summary:**\n\nThis is a study for people with Crohn's Disease (CD) that are not responsive to standard\r treatment. CD is a chronic disease with an auto-immune component that goes away and relapses\r over the years and causes lifelong impairment of health and quality of life. Regardless of\r the therapy used some patients remain seriously ill with active disease after multiple\r therapeutic options have been exhausted. There is currently no drug that will cure CD. Drug\r treatment is focused on controlling symptoms. Another treatment is to perform surgery but\r again this does not lead to cure and is often linked to infection, short gut syndrome\r problems and psycho-social and cosmetic issues. Therefore, a treatment that does not involve\r surgery or long-term drug treatment may be beneficial especially to young adults.\r\n\r Hematopoietic stem cell transplantation (HSCT) has been of value in other auto-immune\r diseases and it is possible that it could be of value in CD. This is a pilot study to\r determine if HSCT is safe and effective for children and young adults with severe CD. For\r this study the stem cells will come from the patient. This is called an autologous\r transplant. The patient will undergo collection and storage of his/her peripheral blood stem\r cells (PBSC). The patient will be given drugs to move (or mobilize) the stem cells from\r his/her bone marrow into his/her blood where they will be collected on a machine called\r apheresis (similar to dialysis.) The cells will be stored and given back to the patient about\r 1 month after collection.\n\n**Clinical Trial Detailed Description:**\n\nCrohn's Disease (CD) is an immunologically mediated chronic illness that has a relapsing and\r remitting course, most commonly presenting in the 2nd or 3rd decade and causing lifelong\r impairment of health and quality of life. Mainstay of clinical treatment for severe disease\r is combination of anti-inflammatory agents like 5-aminosalicyaltes and immunosuppressive\r medications like corticosteroids and newer anti-TNF antibodies like Infliximab. None of the\r drugs are, at present, curative and a relevant subset of patients are refractory to many of\r these pharmacologic approaches.\r\n\r Immunoablative treatment followed by autologous stem cell rescue (Autologous HSCT) has been\r tried in this refractory group of patients with successful results. Autologous HSCT is\r effective in this auto-immune setting through the eradication of effector/memory T-cell\r clones due to a direct immuno-ablative effect of drugs used in the preparative regimen; by\r leading to an immune-reset- recovering clones of T- cells from the infused stem cells do not\r mount an auto- immune response and are tolerant to 'self' antigens and, by upregulation of T\r regulatory cells (Treg, CD4+CD25+FOXP3+ or CD8+ FOXP3+) via change in cytokine mileu during\r transplant. Increased population of Tregs restricts the activity of self-reactive effector\r T-cells.\r\n\r This pilot study is designed to gain on the success of previously published adult studies of\r autologous HSCT in refractory CD, with the aim to confirm the feasibility, safety and\r efficacy of HSCT and post-transplant cyclophosphamide when given post-HSCT in pediatric\r patients and young adults.\r\n\r Since, this combination of immuno-ablative therapy with post-transplant cyclophosphamide has\r not been extensively studied in children with CD, therefore transplant related mortality\r (TRM) and severe toxicity (> grade 3 toxicity by NCI criteria) will be monitored for 100 days\r post-transplant in all the patients and stopping rules will be enforced in case of excessive\r toxicity or TRM (>10%). Clinical assessments will be done for 1 year post-HSCT for disease\r activity, steroid free remission period to evaluate the 'clinical efficacy' of this\r procedure.\r\n\r The major aim of this pilot is to generate the preliminary safety data to confirm the\r feasibility and benefit of autologous HSCT in children and young adults with refractory CD.\r\n\r Study Design:\r\n\r This is a single arm, pilot study designed to estimate the feasibility, safety and benefit of\r immunoablation with hematopoietic stem cell transplantation (HSCT) using autologous stem\r cells followed by administration of post-transplant cyclophosphamide for children and young\r adults with refractory Crohn's disease (CD). The study population is patients with severe and\r refractory Crohn's disease who are ≥10 and ≤ 30 years of age.\r\n\r Objectives:\r\n\r Primary Objective:\r\n\r To determine the feasibility and toxicity of immunoablation with HSCT and post-HSCT infusion\r of cyclophosphamide in children and young adults with refractory Crohn's disease (CD). Death\r (transplant related mortality, TRM) and severe non-hematologic toxicity (≥ grade 3 toxicity;\r NCI Toxicity Criteria version 4.0) within the first 100 days after HSCT will be monitored to\r meet this end-point.\r\n\r Secondary Objectives:\r\n\r Secondary objectives are evaluations of incidence of HSCT related complications and\r evaluations of response. These include:\r\n\r 1. Incidence of viral reactivations - CMV and EBV\r\n\r 2. Incidence of invasive fungal infections\r\n\r 3. Immune reconstitution after HSCT lymphocyte subpopulations (absolute number of CD3, CD4,\r CD8 and CD19 cells), immunoglobulin levels (IgG) and CD4+ CD25+ CD127+ regulatory T\r cells (Treg) populations on day +30 , +60 , +100, day +180 and yearly post-HSCT.\r\n\r 4. Evaluate the efficacy and benefit of HSCT in this population at 1 year post HSCT, by\r serial assessments of clinical activity of CD, assessment of disease severity- CDAI\r scores and length of steroid free remissions.\r\n\r Hypotheses:\r\n\r Primary: The HSCT and post-transplant cyclophosphamide regimen will be well tolerated with\r acceptable toxicity and will lead to <10% transplant related mortality (TRM).\r\n\r Background and Rationale:\r\n\r Crohn's disease (CD) is a chronic illness that is immunologically mediated, of unknown\r etiology, but probably induced by an exposure to intestinal bacteria or their component\r antigens leading to an excessive T helper type 1 (TH-1) mediated chronic inflammation of the\r gastrointestinal (GI) tract 1. Crohn's disease is a relapsing and remitting disorder most\r commonly presenting in the 2nd or 3rd decade and causing lifelong impairment of health and\r quality of life 2.\r\n\r Regardless of the therapy used some patients remain seriously ill with active disease after\r multiple therapeutic options have been exhausted. In addition, patients with refractory\r disease suffer from an inability to eat, frequent nausea, vomiting, diarrhea, malnutrition,\r growth retardation, fistulae formation, abdominal pain and psychological distress, ileostomy\r or colostomy, and multiple surgeries that may lead to short-gut syndrome, severely affecting\r quality of life. Though not well characterized, a distinct excessive mortality exists in this\r group of patients 3,4.\r\n\r Patients with refractory CD have a higher mortality rate compared to normal population\r (hazard ratio of 1.73); but deaths are usually related to surgical complications, liver\r disease, infections and intestinal cancer in long term survivors 5. Even though the overall\r mortality is low in this group of patients, they suffer from significant morbidity,\r cortico-steroid side effects and poor quality of life and 50% patients with refractory\r disease will need surgical interventions (ileostomy, colostomy) further affecting the\r complications rate 2,3.\r\n\r Many drugs have been used for controlling the symptoms of CD, but no drug is, at present,\r curative and a relevant subset of patients are refractory to many pharmacologic approaches 6.\r Almost all drugs employed in the advanced form of disease, such as immunosuppressives and\r immunomodulators, have potential risks. Mainstay of clinical treatment is combination of\r anti- inflammatory agents like 5-aminosalicyaltes and immunosuppressive medications like\r corticosteroids4. Majority of the patients with severe refractory disease are treated with\r anti- Tumor Necrosis Factor (TNF) antibodies like Infliximab (Remicade), but limited options\r exist for patients who have failed to respond to anti-TNF therapy7. Approximately 40% of\r patients with CD develop intolerable side effects or fail to respond to anti-TNF therapy,\r hence there is a significant population of this subset of patients where options are very\r limited 8.\r\n\r Some symptoms may be controlled by prolonged steroids, but there are many known long term\r effects of continued steroid use- muscle loss, osteopenia, cataracts and cushingoid habitus.\r Majority of these patients enroll on other experimental Phase I/II drug trials or resort to\r surgical intervention to control symptoms. Surgical approach (partial gut resection of the\r inflamed segment with ileo-colostomy) is an option, but is associated with infection risk,\r psycho-social and cosmetic issues and increased morbidity due to short gut syndrome,\r especially in young adults. Increased mortality is also associated with surgical\r interventions 2,3.\r\n\r Therefore, any intervention that avoids surgery or long term corticosteroids in young adults\r may be beneficial. Given that hematopoietic stem cell transplantation (HSCT) have been of\r some value in other auto-immune diseases characterized by loss of immune tolerance and or a\r TH-1 predominant immune response, it is possible that these procedures could be of value in\r CD 9,10. Autologous transplantation might also be of benefit because clearing the body of\r committed lymphocyte clones might restore the patient to the status quo ante of being\r predisposed to CD but not suffering from it 11.\r\n\r Rationale of HSCT for CD\r\n\r HSCT may provide benefit in auto-immune disease by:\r\n\r 1. Eradication of effector/memory T-cell clones due to a direct immuno-ablative effect of\r drugs used in the preparative regimen.\r\n\r 2. Immune-reset: recovering clones of T-cells from infused stem cells do not mount an\r auto-immune response and are tolerant to 'self' antigens.\r\n\r 3. Upregulation of T regulatory cells (Treg, CD4+CD25+FOXP3+ or CD8+ FOXP3+) - by change in\r cytokine mileu during transplant. Increased population of Tregs restricts the activity\r of self-reactive effector T-cells.\r\n\r 4. Engraftment of uncommitted stem cells in the gut mucosa may lead to direct healing of\r mucosa.\r\n\r Evidence for the effectiveness of HSCT in Crohn's disease Initial observations were made in\r patients with Crohn's disease and hematologic malignancies. For patients who underwent HSCT\r for their hematologic malignancy they had remission of their Crohn's disease 12.\r\n\r Several studies have reported the clinical course of patients with Crohn's disease receiving\r autologous transplantation for another condition. Perhaps the most interesting concerned a\r patient who developed symptoms at the age of 9, who was diagnosed with Crohn's disease 4\r years later and who required substantial treatment over the next 7 years 13. Following\r autologous stem cell transplantation for non-Hodgkin's lymphoma it was reported that there\r was no clinical or laboratory evidence of recurrence of his Crohn's disease in the next 7\r years. Another reported case of Crohn's disease had diffuse pan colitis before\r transplantation and was asymptomatic (but had inflammation) at endoscopy 3 years later 14.\r Another patient who had symptomatic Crohn's disease for 2 years and had undergone surgery was\r free of disease 5 years after transplantation. Systematic colonoscopic evaluation showed\r persisting subclinical inflammation initially with progressive clearance. At Vanderbilt we\r performed an unrelated donor transplant for a patient with AML and Crohn's disease. He is\r currently 10 years post-transplant with no symptoms of Crohn's disease.\r\n\r HSCT specifically for Crohn's disease:\r\n\r The first report of stem cell transplantation for Crohn's disease concerned 2 patients from\r the Chicago group 15. In both of the initial cases Crohn's disease activity index was more\r than 250 (normal range <150, pathological range 220 - 600) despite treatment with infliximab.\r In both patients, peripheral blood stem cells (PBSC) were mobilized using cyclophosphamide\r and granulocyte colony stimulating factor (G-CSF), enriched ex-vivo by CD 34+ selection.\r Cyclophosphamide and antithyomcyte globulin (ATG) were used for immune conditioning prior to\r transplantation. The first patient was a 22 year old woman with a past history of a right\r hemicolectomy with severe ileocolic Crohn's disease causing intractable diarrhea with 25\r bowel actions per day, fistula and peri-anal sepsis. The second was a 16 year old boy who had\r been unwell for 6 years requiring tube feeding and receiving methotrexate, 6-mercaptopurine\r and 5 amino acyclic acid with Crohn's colitis. In both of these cases, following\r transplantation, diarrhea resolved and the Crohn's disease activity index normalized. In the\r first patient the haemoglobin rose, whereas in the second it remained at a slightly\r sub-normal level. Post-transplantation CRP was within normal limits and the albumin remained\r or became normal. These cases were accompanied by extensive colonoscopic evidence of disease\r activity. Prior to transplantation both cases had areas of severely active Crohn's disease\r with cobble stoning, fissuring and deep ulceration. Following transplantation the bowel\r remained abnormal though changes were much more trivial with superficial erosions only.\r\n\r Oyama et al reported on autologous HSCT for 12 patients median age of 27 (15-38) with severe\r refractory Crohn's disease 16. The conditioning regimen consisted of cyclophosphamide (200\r mg/kg) and equine ATG (90 mg/kg). Eleven of 12 patients entered a sustained remission defined\r by a CDAI < 150. After a median follow-up of 18.5 months (range, 7-37 months), only one\r patient has developed a recurrence of active CD, which occurred 15 months after HSCT.\r\n\r Hasselbatt et al reported on autologous HSCT 12 patients (ages 24-50) with refractory Crohn's\r disease using high dose cyclophosphamide (200 mg/kg) without ATG 17. PBSC harvest following\r mobilization chemotherapy was successful in 11/12 patients and resulted in a clinical and\r endoscopic improvement in 7/12 patients. Subsequent conditioning and autoPBSCT were performed\r in nine patients and were relatively well tolerated. Among those, five patients achieved a\r clinical and endoscopic remission within 6 months after autoPBSCT. However, relapses occurred\r in 7/9 patients during follow-up, but disease activity could be controlled by low-dose\r corticosteroids and conventional immunosuppressive therapy.\r\n\r In 2010 Burt et al reports on autologous HSCT in 24 patients with mean age of 24 years (range\r 15-52) with anti-TNF refractory Crohn's disease 18. Stem cells were mobilized from the\r peripheral blood using cyclophosphamide (2.0 g/m2) and G-CSF (10 ug/kg/day), enriched ex vivo\r by CD34 selection, and reinfused after immune suppressive conditioning with cyclophosphamide\r (200 mg/kg) and either equine antithymocyte globulin (ATG, 90 mg/kg) or rabbit ATG (6 mg/kg).\r Eighteen of 24 patients are 5 or more years after transplantation. All patients went into\r remission with a CDAI less than 150. The percentage of clinical relapse-free survival defined\r as the percent free of restarting CD medical therapy after transplantation is 91% at 1 year,\r 63% at 2 years, 57% at 3 years, 39% at 4 years, and 19% at 5 years.\r\n\r The percentage of patients in remission (CDAI < 150), steroid-free, or medication-free at any\r posttransplantation evaluation interval more than 5 years after transplantation has remained\r at or greater than 70%, 80%, and 6% respectively.\r\n\r Regulatory T cells (Tregs) and Auto-immune disease:\r\n\r Regulatory T cells (Tregs) are implicated in the suppression of immune responses and in\r maintenance of tolerance 19,20. The percentage of CD4+CD25+FOXP3+ T cells (T regs) is\r significantly decreased in patients with auto-immune diseases like SLE and Type 1 diabetes\r 20. Also, transfer of Treg can prevent auto-immune phenotype that develops after Treg\r depletion in animal models.\r\n\r During HSCT for auto-immune diseases, an increase in Treg population correlates with\r remission induction. Zhang et.al has shown that HSCT leads to a newly generated population of\r Treg cells that maintain patients in true immunological remission 21.\r\n\r Burt et.al, also evaluated the role of Treg cells in some of their patients who underwent\r HSCT for CD. Before HSCT the mean % of Treg cells was significantly low in CD patients (2.62%\r ± 2.01%), compared to normal volunteers (3.86% ± 1.67%). A robust increase in the % of Treg\r was observed after HSCT, but this was not sustained over period of time and may have\r contributed to relapses 18. Hence, there is clinical evidence that a sustained increase in\r Treg population may maintain remission in patients with auto-immune disorder.\r\n\r Rationale of the proposed Study:\r\n\r This pilot study is designed to estimate the feasibility of HSCT and safety of post-HSCT\r cyclophosphamide infusions for patients with refractory disease who have failed to respond to\r Infliximab/and or other immunosuppressive agents. This is designed as a small pilot study\r with built in 'stopping rules' in case of excessive toxicity or death.\r\n\r Rationale for the immuno-ablative regimen:\r\n\r Rationale of CY for mobilization: Cyclophosphamide (CY) will be used for mobilization of\r peripheral stem cells and for immuno-ablation prior to HSCT. CY has been traditionally used\r for mobilization in all HSCT for refractory CD.\r\n\r Rationale for post-transplant Cyclophosphamide (CY)- Recently, use of post-transplant CY has\r been pioneered by John Hopkins and shown to be a very effective GVHD prophylaxis in patients\r undergoing HSCT for hematologic malignancies, even in the setting of HLA mismatched and\r haploidentical donors. Post-transplant delivery of CY allows for effective deletion of\r proliferating allo-reactive T- cells that cause GVHD without adding to the toxicity of the\r regimens 22. In a recent study by the Hopkins group post-transplant cyclophosphamide was\r successfully used in patients with sickle cell disease undergoing haploidentical bone marrow\r transplant with no toxicities.\r\n\r Some studies have performed CD34+ stem cell selections to get rid of all immune-reactive T-\r cells clones and use purified CD34+ infusions for regenerating the immune system 18. The\r problem with this approach is delayed immune-reconstitution post-transplant and a higher\r incidence of infections.\r\n\r European trials have used un-manipulated peripheral blood stem cells (PBSCs) as infusions\r (without any T cell depletion or CD34+ selections) for SCT in auto-immune diseases 23. Since,\r peripheral stem cells contain the same T cells clones that are immuno-reactive and are\r infused along with the donor stem cells in non-T cell depleted infusion, this may be one of\r the reasons for relapse in T cell replete HSCT done till date for CD.\r\n\r Therefore, to overcome the above-mentioned issues, we propose to use un-manipulated PBSCs,\r but give two doses of CY pre- and two doses post-stem cell infusion to effectively deplete\r the immuno-reactive T cell clones present in the autologous infusion and therefore, decrease\r the incidence of relapse. The total dose of CY remains the same (200 mg/kg), therefore, it\r will not add to the toxicity of the regimen, but may lead to more effective depletion of the\r immune- reactive clones, obviating the need for costly in-vitro T cell depletions/CD34+\r selections.\r\n\r Also, CY causes sustained depletion of all T cell subsets, but more profound depletion of\r CD4+ CD25- subsets, resulting in relative enrichment of CD4+CD25+ cells, which we hope to\r expand by using post-transplant cyclophosphamide.\r\n\r Rationale for Rabbit-ATG (Thymoglobulin, Genzyme Corp, Cambridge, MA): will also be used for\r effective immune-ablation and for in-vivo T cell depletion post- stem cell infusion. Rabbit\r ATG will be used as this has been shown to promote the expansion of functional Tregs in-vitro\r 24. Rabbit ATG was use in the largest study by Burt et al 18.\r\n\r (Please note reference numbers can be found on pages 25-26 of the protocol.)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r All the subjects considered eligible for the study will be screened and reviewed by the\r Gastroenterology (GI) physicians prior to enrollment (Dedrick Moulton, MD or his designee\r at Vanderbilt Children's Hospital) 2. Age ≥ 10 and < 30 years 3. Disease status:\r\n\r 1. Confirmed diagnosis of Crohn's Disease: Diagnosis of Crohn's disease that has been\r established based on typical endoscopic/histologic and/or radiological appearances.\r\n\r 2. Active disease, defined as: Pediatric Crohn's Disease Activity Index (PCDAI) >30 (see\r Appendix I) or Crohn's Disease Activity Index (CDAI) of >250 (see Appendix II) at any\r time within 3 months prior to enrollment and any one of the following- i. Endoscopic\r evidence of active disease confirmed on histology within 3 months prior to enrollment,\r or ii. Clear evidence of active small bowel Crohn's disease on small bowel imaging\r within 3 months prior to enrollment.\r\n\r 3. Refractory disease- Moderate to severe disease that has been unresponsive to current\r or prior therapy with mercaptopurine and/or azathioprine (thiopurines), methotrexate\r and anti-TNF therapy. Patients should have relapsing disease (i.e. ≥ 1\r exacerbation/year) or corticosteroid dependence despite current or prior thiopurines,\r methotrexate and anti-TNF maintenance therapy or clear demonstration of intolerance or\r toxicity to these drugs. Patients who fail induction therapy with corticosteroids and\r anti-TNF therapy, and are therefore not eligible to receive maintenance therapy with\r thiopurines or methotrexate will also be candidates for enrollment.\r\n\r 4. Negative stool culture, C. difficile, and negative CMV pcr (in stool or colonic\r biopsy). Patients with CMV colitis will receive a trial of anti-viral treatment and\r only responders will be considered eligible for inclusion.\r\n\r 5. Patients with a prior ileostomy or colostomy may enter the study. For this group of\r patients', physician's global assessment will be used to assess clinical activity of\r CD, as Pediatric CDAI and CDAI scoring method may not be representative of disease\r activity.\r\n\r 6. Patients with abscesses are eligible to enroll once the abscesses or any other\r significant infection has resolved.\r\n\r Exclusion Criteria:\r\n\r 1. Pregnancy or unwillingness to use adequate contraception during the study- if a woman\r is of childbearing age.\r\n\r 2. HIV infection.\r\n\r 3. Organ function criteria-\r\n\r 1. Renal: creatinine clearance < 50 ml/min/1.73m2 (measured or estimated).\r\n\r 2. Cardiac: left ventricular ejection fraction <30% by multigated radionuclide\r angiography (MUGA) or a shortening fraction of < 25% by cardiac echocardiogram.\r\n\r 3. Pulmonary Function tests: DLCO < 30% or patient on oxygen.\r\n\r 4. Hepatic: serum bilirubin > 3 mg%; AST and ALT > 3x ULN for the institutional lab.\r\n\r 4. Uncontrolled Hypertension (using age based criteria) despite at least 2 anti-\r hypertensive agents.\r\n\r 5. Active Infection or risk thereof-\r\n\r 1. Current abscess or significant active infection\r\n\r 2. Perianal infection is not an exclusion criterion, provided there is drainage with\r or without placement of drain.\r\n\r 3. Abnormal chest x- ray (CXR) consistent with active infection or neoplasm.\r\n\r 6. Severe diarrhea due to short small bowel; patients believed to have < 700 mm of small\r bowel and diarrhea attributable to this will be excluded.\r\n\r 7. Patients with toxic megacolon, active bowel obstruction or intestinal perforation.\r\n\r 8. Unable to collect minimum of 3 x106/kg CD34+ cell dose. These patients will be\r excluded from receiving the preparative regimen.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"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\nProstatic Cancer Versus Androgen Deficiency\n\n**Clinical Trial Summary:**\n\nOpen study to make a comparison between hypogonadism and euogonadism patients regarding the\r severity of prostate cancer. The purpose of this study is to determine the importance of the\r relationship between the hormonal status and the type of the tumor at the time of surgical\r intervention as well as follow up of the patients.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male patients over than 18 years of age, with localized, stage I or II prostate\r cancer, not receiving local treatment (radiation, phototherapy, thermotherapy,…) or\r hormonal therapy, showing indication of radical prostatectomy.\r\n\r Exclusion Criteria:\r\n\r - Absence of radical prostatectomy indication\r\n\r - Patient received local or hormonal therapy prior to surgery\r\n\r - Patients already enrolled in other clinical study incompatible with the study\r\n\r - Patients on a treatment which can affect hormonal level (Prednisone, Ketoconazole,\r Abiraterone, Finasteride, Dutasteride)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
35,527
|
[
{
"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\nDexmedetomidine vs Propofol on the Recordings of Deep Brain Activity Measured Through Implanted Stimulators\n\n**Clinical Trial Summary:**\n\nThis clinical trial has been designed to study and compare changes in deep brain activity\r (field potentials) in Parkinson's disease (PD) patients while awake, and during sedation with\r dexmedetomidine or propofol. The recording is made through a deep brain stimulation (DBS)\r electrode implanted for PD management.\r\n\r The investigators hypothesize that dexmedetomidine produces fewer changes as compared to\r propofol, and that those changes are consistent and recognizable when compared to activity in\r patients not exposed to any sedation. Typification of those changes would in the future allow\r for patients to undergo this surgery comfortably while not compromising the quality of the\r recording and of the final clinical outcome. The principal variable analyzed is the signal's\r power in each of the frequency bands, absolute and relative. The analysis will include usual\r clinical methods such as rapid Fourier transform (FFT) and window fast Fourier transform\r (WFFT), wavelet analysis, Gabor, and coherence.\n\n**Clinical Trial Detailed Description:**\n\nComparative clinical trial, non blinded, controlled and sequential, evaluating the effects of\r propofol and dexmedetomidine in the basal ganglia of PD patients through a DBS electrode.\r\n\r It is a phase IV clinical trial evaluating the effects of a drug outside the approved.\r\n\r The study takes part in three phases:\r\n\r 1. DBS placement under sedation with dexmedetomidine at 0.2 μg/kg/h. This will be called\r \"dexmedetomidine record\".\r\n\r 2. Four days later and with no sedation, a recording will be registered in one of the\r specialized electrically isolated rooms at the Neurophysiology Department. This will be\r dubbed \"basal recording\". The equipment used is also the standard one used for routine\r postoperative recordings.\r\n\r 3. 5 days after the initial surgery, and following the protocol in place for these\r procedures, the tunnelization and battery placement will take place. This is done under\r general anaesthesia. During anaesthetic induction, the patient is exposed to incremental\r doses of propofol. Different plasmatic concentrations will be targeted using the\r mathematical model in the target controlled infusion (TCI) pump. These recordings will\r be called \"propofol at a 0.5, 1, 1.5, 2, 2.5 μg/mL\".\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Capacity to understand, consent and commit for the three phases of the study.\r\n\r - Older than 18 years old.\r\n\r - The patient is scheduled for DBS electrode placement for PD treatment by his\r neurologist.\r\n\r Exclusion Criteria:\r\n\r - Allergy or hypersensibility to dexmedetomidine or propofol\r\n\r - Cardiac blockade (types 2 and 3) without an implanted pacemaker\r\n\r - Low blood pressure (mean < 60 mmHg) or symptoms of low cardiac output.\r\n\r - Severe cerebrovascular disease.\r\n\r - Pregnancy or nursing mothers.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
35,528
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets.\n\n**Clinical Trial Summary:**\n\nThe objective of this study is to determine the effect of two dose strengths of\r dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable\r walking deficits in subjects with post-ischemic stroke.\n\n**Clinical Trial Detailed Description:**\n\nThis was a randomized, placebo-controlled, three-arm, parallel-group study designed to\r evaluate the efficacy, safety, and tolerability of dalfampridine extended release (ER)\r tablets on chronic walking deficits in subjects with post-ischemic stroke.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Clinical evidence of a stable walking deficit due to an ischemic stroke, as judged by\r the Investigator, based on review of medical records and physical exam. Such deficit\r was not present prior to the stroke and cannot be attributed primarily to other\r conditions (e.g. chronic obstructive pulmonary disease, arthritis). Evidence of\r walking deficits is objectively supported by any one of the following findings on\r clinical examination:\r\n\r 1. obvious slowness of movement assigned primarily to the stroke\r\n\r 2. use of an assistive walking device such as a cane or walker\r\n\r 3. Presence of movement pattern deviations such as stiff-legged gait, foot drop, hip\r hiking and hip circumduction\r\n\r - Modified Rankin Scale score of 1 - 3, regardless of the cause(s) of the disability\r\n\r - Sufficient ambulatory ability to independently complete the 2MinWT and 10MWT\r\n\r - ≥ 6 months from occurrence of most recent stroke\r\n\r Exclusion Criteria:\r\n\r - Woman who is not surgically sterile or is less than 2 years postmenopausal, and does\r not agree to use a highly effective birth control method during the study and up to 3\r months after the last dose of investigational product.\r\n\r - Woman who is pregnant, breastfeeding, or planning to become pregnant\r\n\r - History of seizures, except simple febrile seizures\r\n\r - Moderate or severe renal impairment as defined by a calculated creatinine clearance of\r ≤ 50 mL/minute using the Cockcroft-Gault Equation\r\n\r - Suicide attempt within 1 year prior to the Screening Visit, or severe suicidal\r ideation within 6 months prior to the Screening Visit, or subject is at significant\r risk of suicidal behavior in the opinion of the Investigator\r\n\r - Previous use of AMPYRA, dalfampridine, fampridine or 4-aminopyridine (4-AP)\r\n\r - Initiation of a serotonin reuptake inhibitor (SSRI) within 3 months prior to the\r Screening Visit, or any change in dosing regimen within 3 months prior to the\r Screening Visit\r\n\r - Botulinum toxin use within 2 months prior to the Screening Visit\r\n\r - Orthopedic surgical procedures in any of the extremities within the past 6 months\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
35,529
|
[
{
"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\nConsolidation of Motor Learning of Writing Skills and Its Related Brain Activity Changes in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe basal ganglia play an important role in motor learning, especially during the\r consolidation phase of motor learning. This raises the question whether it is possible to\r sustain learning increments in a neurodegenerative condition such as Parkinson's disease\r (PD). The aim of this study is to gain knowledge on whether it is possible to relearn skills\r which are actually affected by PD, such as writing, and determine whether neuroplasticity is\r possible. In this randomized controlled study, PD patients will either follow intensive\r writing training or a placebo treatment (stretch and relaxation training) during 6 weeks. The\r writing training will focus on automatization (withstanding dual task interference), transfer\r to an untrained task and retention. The placebo program is aimed to reduce stiffness in the\r upper limbs and has been shown to be ineffective in PD. To date, it is unknown how neural\r networks change as a result of consolidation after a prolonged period of motor learning in\r PD. Therefore the second arm of this study will investigate, for the first time, changes in\r neural connectivity using brain imaging data to elucidate which neuroanatomical regions are\r involved in consolidation of learning in PD. Finally, DTI and resting state fMRI-analysis\r will complement insights into the neural changes as a result of learning.\n\n**Clinical Trial Detailed Description:**\n\nThis translational study is a monocentric Randomized Controlled Trial (RCT). The\r investigators will recruit 40 PD patients from the early Hoehn & Yahr stages. Patients will\r be randomly allocated to an experimental group (writing training) and a control group\r (stretch- and relaxation training). All patients will receive the same frequency and duration\r of intervention. After the training period, patients will be followed up for another 6 weeks.\r Patients will be tested in the ON-phase of the medication cycle at 3 occasions: before (T1)\r and after training (T2) and after a 6-week retention period (T3). At T1 & T2 participants\r will be tested at the behavioral & neural level. At T3 participants will only be tested at\r the behavioral level.\r\n\r Motor performance will be measured using MRI-compatible touch sensitive tablets and pencils.\r This system allows registration and translation of writing movements into online-cursor\r movements on screen in and outside a scanner environment. Both patient groups will be\r compared during a behavioral test battery consisting of (i) a trained sequence with and\r without visual cues; (ii) an untrained sequence with and without visual cues to test\r transfer; and (iii) a trained dual task to test automatization. Visual cues will consist of\r differently colored target zones of different band widths, indicating the scale and accuracy\r of writing.\r\n\r Functional MRI measurements will take place in a 3T MR Philips Intera scanner. Before\r scanning, subjects will undergo a training session in a dummy scanner to familiarize them\r with the scanner environment and task instructions. During the fMRI sessions, participants\r will perform a trained and untrained sequence, both with and without visual cues. To control\r for differences in movement speed, all participants will perform the tasks at the same\r frequency, defined by an auditory pace. In addition to the fMRI measurements, resting state\r fMRI and DTI will also be performed to reveal alterations of the structural and functional\r connectivity between critical regions.\r\n\r Behavioral data will be recorded as xy-coordinates and pressure values at a sampling rate of\r 200Hz and with a spatial resolution of 32.5µm. Statistical analysis of the behavioral data\r will have a between-subject factor of group (experimental and placebo group) and a\r within-subject factor of time (before training, after training and after the retention\r period).\r\n\r Image analysis will be performed with Statistical Parametric Mapping (SPM) software. The\r investigators will contrast for either decreased or increased activation, as different\r regions may show divergent changes related to learning and transfer, with group as a\r between-subject factor and time (before and after training) and task condition (trained with\r cues, trained without cues, untrained with cues and untrained without cues) as within-subject\r factors.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of PD based on the UK Brain Bank criteria\r\n\r - Hoehn & Yahr stage I (with impairments on the right side) and II in the on-phase\r\n\r - Without cognitive impairment (MMSE >24)\r\n\r - On stable medication\r\n\r - Right handed\r\n\r Exclusion Criteria:\r\n\r - Deep Brain Stimulator\r\n\r - Other contra-indications for MR scanning\r\n\r - Colorblind\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
35,530
|
[
{
"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 Positive Family Support Project - Partnering With Families for a Successful Transition to School\n\n**Clinical Trial Summary:**\n\nThe Positive Family Support Project seeks to understand some of the factors that increase\r success for children in early elementary school, such as positive family support at home.\r This study will inform us on ways to help children learn and succeed in school.\n\n**Clinical Trial Detailed Description:**\n\nThe transition to elementary school is a critical time for the development of key skills that\r are necessary for school success, including sustained attention, self-regulation, initiating\r and sustaining successful peer relationships, and academic competence. Parent support at\r home, such as positive parenting and support for learning, is associated with school\r readiness indicators that predict successful adaptation to the school context. For many\r children at risk for poor developmental outcomes this transition can be difficult and may\r lead to early academic problems, which in turn may define a trajectory that culminates in\r more severe forms of problem behavior and learning difficulties. The purpose of this study is\r to evaluate the efficacy of implementing the Family Check-Up (FCU), a school-based,\r ecological approach to family intervention, during the transition into elementary school.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria: 700 Kindergarten children and their families entering Kindergarten in\r the Clackamas School District in 2014 and 2015 -\r\n\r Exclusion Criteria:\r\n\r -\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
35,531
|
[
{
"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 Assessing Utility of a Clinical Questionnaire to Identify Subjects With Features of Both Asthma and Chronic Obstructive Pulmonary Disease (COPD)\n\n**Clinical Trial Summary:**\n\nThe primary objective of the study is to identify demographic and non-spirometric clinical\r features predictive of the asthma-COPD overlap population. The study aims to explore and\r identify characteristics of the Asthma-COPD Overlap Syndrome (ACOS) patient's clinical\r profile that enable clinical differentiation from subjects with a primary diagnosis of either\r asthma alone (without persistent obstruction) or COPD alone (without reversibility). The\r study is designed as a targeted medical history survey which consists of a 41-item\r questionnaire, which will be administered by a qualified health care practitioner at the time\r a subject's medical history is taken. The questionnaire has been developed to elicit specific\r details of the respiratory history, including the following: bronchodilator use, disease\r progression, variation in symptoms, atopic history, symptom triggers, vagal bias, burden of\r disease, symptom presentation, co morbidities and age of onset. In addition, demographic\r information, standard medical history, co morbidity and spirometric results will also be\r obtained and analyzed in conjunction with the questionnaire results. Approximately 1000\r subjects are required for the study.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject must be 18 years of age or older.\r\n\r - Subject has been diagnosed as having asthma and/or COPD.\r\n\r - Informed consent is required for independent sites initiating this protocol\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
35,532
|
[
{
"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 Deep Brain Stimulation (DBS) Frequency on Neural Synchrony\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the effects of low frequency deep brain stimulation\r on subthalamic nucleus neural synchrony. Low frequency stimulation does not improve the\r cardinal motor signs of Parkinson's disease, and may be beneficial only for gait and speech.\r This study will provide insight into what the effects of low frequency stimulation are on\r neural synchrony.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - A diagnosis of idiopathic Parkinson's disease, with bilateral symptoms at Hoehn and\r Yahr Stage greater than or equal to II.\r\n\r - Documented improvement in motor signs on versus off dopaminergic medication, with a\r change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >=\r 30% off to on medication.\r\n\r - The presence of complications of medication such as wearing off signs, fluctuating\r responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment\r in the quality of life on or off medication due to these factors.\r\n\r - Subjects should be on stable doses of medications, which should remain unchanged until\r the DBS system is activated. After the DBS system is optimized (during which time the\r overall medication dose may be reduced to avoid discomfort and complications such as\r dyskinesias) the medication dose should remain unchanged, if possible, for the\r duration of the study.\r\n\r - Treatment with carbidopa/levodopa, and with a dopamine agonist at the maximal\r tolerated doses as determined by a movement disorders neurologist.\r\n\r - Age > 18\r\n\r Exclusion Criteria:\r\n\r - Subjects with significant cognitive impairment and/or dementia as determined by a\r standardized neuropsychological battery.\r\n\r - Subjects with clinically active depression, defined according to the Diagnostic and\r Statistical manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and as scored\r on a validated depression assessment scale.\r\n\r - Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage 5 on medication\r (non-ambulatory).\r\n\r - Age > 80.\r\n\r - Subjects with an implanted electronic device such as a neurostimulator, cardiac\r pacemaker/defibrillator or medication pump.\r\n\r - Subjects, who are pregnant, are capable of becoming pregnant, or who are breast\r feeding.\r\n\r - Patients with cortical atrophy out of proportion to age or focal brain lesions that\r could indicate a non-idiopathic movement disorder as determined by MRI\r\n\r - Subjects having a major comorbidity increasing the risk of surgery (prior stroke,\r severe hypertension, severe diabetes, or need for chronic anticoagulation other than\r aspirin).\r\n\r - Subjects having any prior intracranial surgery.\r\n\r - Subjects with a history of seizures.\r\n\r - Subjects, who are immunocompromised.\r\n\r - Subjects with an active infection.\r\n\r - Subjects, who require diathermy, electroconvulsive therapy (ECT), or transcranial\r magnetic stimulation (TMS) to treat a chronic condition.\r\n\r - Subjects, who have an inability to comply with study follow-up visits.\r\n\r - Subjects, who are unable to understand or sign the informed consent\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
35,533
|
[
{
"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 Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine whether clonazepam is effective and safe in the\r treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease\r (PD).\n\n**Clinical Trial Detailed Description:**\n\nRBD is one of the representative non-motor symptoms of PD and other synucleinopathies.\r Patients with RBD show dream-enacting behaviors such as punching, kicking, singing,\r screaming, or somnambulism. These can interfere in sleep quality and increase the risk of\r falling down from the bed and physical injuries of both the patient and sleep partner.\r Therefore, qualities of life of the patient and sleep partner are negatively influenced by\r presence of RBD.\r\n\r Clonazepam has been used for treatment of choice of RBD. It decreased RBD symptoms completely\r in 55-79% and partially in 11-32% of patients. However, these results are based on open-label\r or descriptive studies. There has been no randomized placebo controlled study that evaluated\r the efficacy and safety of clonazepam for treating RBD.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject was enrolled voluntarily and understood the contents of this clinical trial\r\n\r - Subject was diagnosed as Parkinson disease (PD) or Parkinson's syndrome\r\n\r - Hoehn and Yahr (H&Y) stage 1, 2, or 3\r\n\r - Existence of caregivers who can provide a information about symptoms of rapid eye\r movement sleep disorder (RBD) of the participant\r\n\r - Existence of RBD by answering \"yes\" to the question (RBD-1Q): \"Have you ever been\r told, or suspected yourself, that you seem to 'act out your dreams' while asleep (for\r example, punching, flailing your arms in the air, making running movements, etc.)?\"\r\n\r Exclusion Criteria:\r\n\r - Existence of cognitive decline hard to participate in the clinical trial\r\n\r - Subject has confusion or visual hallucination in daytime\r\n\r - Diagnosed as obstructive sleep apnea or severe snoring\r\n\r - Previous clonazepam treatment within 4 weeks\r\n\r - Current treatment with benzodiazepines at bedtime\r\n\r - Alcoholics or drug abuser\r\n\r - Lactating, pregnant, or possible pregnant\r\n\r - Hypersensitivity to clonazepam or benzodiazepines\r\n\r - Prior participation to other clinical trials within 3 months\r\n\r - Presence of severe comorbidities or a cancer\r\n\r - Existence of illness or problems which makes difficult to be enrolled to this trial\r judged by clinicians\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\ntDCS in Parkinson's Disease With Depression\n\n**Clinical Trial Summary:**\n\nParkinson's disease (PD) is a progressive neurological disease that has effects on both\r movement and mental health. One of the most common mental health complications of PD is\r depression. Up to 30% of Parkinson's patients will experience depression at some point. We\r aim to investigate whether transcranial direct current stimulation (tDCS), a type of\r electrical stimulation for the brain, can improve depression in PD as well as improve motor\r function in PD.\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of this double-blind, randomized control design study is to investigate the\r efficacy of 15-sessions of tDCS (versus 15-sessions of sham tDCS) to treat depression in PD.\r We will also assess dopamine function in a smaller cohort of participants before and after\r their 15 sessions of tDCS by using PET scanning.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. are outpatients,\r\n\r 2. are voluntary and competent to consent to treatment,\r\n\r 3. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of\r major depressive disorder (MDD),\r\n\r 4. have a diagnosis of PD according to the UK PD brain bank criteria,\r\n\r 5. are 19 years of age or more,\r\n\r 6. have a score > 13 on the Beck Depression Inventory-II (BDI-II),\r\n\r 7. still have depressive symptoms after 6 weeks or more of antidepressant (SSRI)\r medication treatment (and on a stabilized dose of at least 4 weeks),\r\n\r 8. are able to adhere to the treatment schedule,\r\n\r 9. are proficient in written and verbal English.\r\n\r Exclusion Criteria:\r\n\r 1. have a history of substance dependence or abuse within the last 6 months,\r\n\r 2. have a concomitant significant unstable medical illness,\r\n\r 3. have active suicidal intent,\r\n\r 4. have any history of seizure or medication-resistant epilepsy in the family,\r\n\r 5. have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of\r bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform\r disorder, delusional disorder, or current psychotic symptoms\r\n\r 6. have a MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder\r (current or within the last year), anxiety disorder (generalized anxiety disorder,\r social anxiety disorder, panic disorder), or dysthymia, assessed by a study\r investigator to be primary and causing greater impairment than MDD,\r\n\r 7. have failed a course of ECT in the current episode or previous episode,\r\n\r 8. have received tDCS or other neurostimulation therapy for any previous indication due\r to the potential compromise of expectancy effects,\r\n\r 9. have any significant neurological disorder or insult including, but not limited to:\r any condition likely to be associated with increased intracranial pressure, space\r occupying brain lesion, any history of seizure except those therapeutically induced by\r ECT, cerebral aneurysm, Huntington's chorea, multiple sclerosis, significant head\r trauma with loss of consciousness for greater than or equal to 5 minutes, or\r developmental disorder,\r\n\r 10. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear\r implants, or electrodes) or any other metal object within or near the head, excluding\r the mouth, that cannot be safely removed,\r\n\r 11. are taking a non-SSRI antidepressant medication,\r\n\r 12. are pregnant (women of childbearing age only).\r\n\r Exclusion Criteria for PET:\r\n\r 1. unable to tolerate staying off anti-parkinsonian medication for 12-18 hours pre-PET\r scan,\r\n\r 2. have a history of radiation therapy treatment or other high amounts of radiation.\r\n\r Exclusion Criteria for MRI:\r\n\r - Artificial heart valve;\r\n\r - Brain aneurysm clip;\r\n\r - Electrical stimulator for nerves or bones;\r\n\r - Ear or eye implant;\r\n\r - Implanted drug infusion pump;\r\n\r - Coil, catheter, or filter in any blood vessel;\r\n\r - Orthopedic hardware (artificial joint, plate, screws);\r\n\r - Other metallic prostheses;\r\n\r - Shrapnel, bullets, or other metal fragments;\r\n\r - Surgery or tattoos (including tattooed eyeliner) in the last six weeks.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,535
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nBiomarkers to Measure Treatment Response for Alcohol Dependence\n\n**Clinical Trial Summary:**\n\nThe purpose of the research study of the K23 award is to develop a blood test that can check\r how much alcohol a person has consumed in the past few days. We will enroll heavy social\r drinkers who do not have alcohol-related problems but used to drinking 5 or more beers on a\r single occasion. Both men and women between ages 21 and 65 years can join the study. All\r participants must be of European decent.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Experienced binge drinking episode(s) (5 or more standard drinks for men and 4 or more\r standard drinks for women consumed in about 2 hours according to NIAAA definition) in\r the past 30 days\r\n\r Exclusion Criteria:\r\n\r - DSM-IV diagnosed alcohol dependence, other drug dependencies including nicotine\r dependence\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,536
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nDo Core Stability Exercise Classes Help Children With Cerebral Palsy Improve Their Balance\n\n**Clinical Trial Summary:**\n\nThis study aims to determine if participation in a core stability physiotherapy group\r programme can improve the balance of children with cerebral palsy. It is hypothesised that\r teaching the children how and when to activate their deep core stabilising muscles may help\r improve their body awareness and their ability to control their alignment and therefore\r positively affect their balance. Children with cerebral palsy from the ages of 7 to 17, who\r can walk independently, will be randomly selected to join either the control group or\r intervention group, after completion of their baseline balance assessments. Each group will\r be re-assessed after completion of their 4 week intervention or control period.\n\n**Clinical Trial Detailed Description:**\n\nIntroduction\r\n\r The 'Core Muscles' are defined as '29 pairs of muscles that support the lumbo-pelvic hip\r complex in order to stabilize the spine, pelvis and kinetic chain during functional\r movement'.\r\n\r Core stability refers to the control, co-ordination and synergism required by the core\r muscles for the maintenance of functional stability and balance. The role the core\r musculature plays in movement and postural control is long established. The understanding\r that our core muscles work in a feed-forward manner, laying the foundation of distal limb\r movement, formed the basis for studies into the use of core stability training programmes,\r such as pilates, core control training and spinal stability training, for improved postural\r control and balance.\r\n\r Literature is replete with studies investigating the use of core stability programmes for\r varied populations from the adult population for chronic back pain to elite athletes for\r injury prevention and performance.\r\n\r Studies investigating its use in adults with postural control impairment due to upper motor\r neuron lesions (UMN) from Multiple Sclerosis and Stroke showed positive effects on balance\r and mobility. The randomised controlled trial, by Chung et al, looked at the effects of a 4\r week core stability exercise class on Dynamic Balance and Gait Function of 16 stroke\r patients. It showed a significant improvement of Timed-Up-And-Go (TUG) scores from 33.06\r +-18.39sec to 27.64+- 13.73 sec (p=0.057) in the intervention group. Gait velocity (from\r 44.83+- 18.83 cm/s to 58.91 +- 18.21 ; p=0.024) and cadence ( from 74.55+- 13.85 steps/min to\r 84.07 +- 14.00 steps/min ; p=0.041) also showed significant improvement in the intervention\r group. To date there are no studies investigating the use or potential benefit of specific\r core stability intervention in the Cerebral Palsy (CP) population.\r\n\r CP describes a group of permanent disorders of the development of movement and posture,\r causing activity limitation, that are attributed to non- progressive disturbances that\r occurred in the developing fetal or infant brain. It has been suggested that poor postural\r control may underlie delays and deviations in motor skill acquisition and development\r observed in children with CP. Therefore, it is important that treatment of children with CP\r tries to improve postural control and the evidence suggesting postural control mechanisms in\r school-age children with CP are modifiable signifies that this goal is achievable.\r\n\r Young children with CP have been shown to use excessive, non-reciprocal trunk and hip muscle\r activation during walking. It has been hypothesized that one reason for this may be their\r need to compensate for poor control of their core deep stabilising muscles, thus limiting\r their ability to control changes in their body's centre of mass (COM) during dynamic\r movements. To understand this further we must look closer at the different functions of the\r core muscles.\r\n\r The core muscles can be separated into large-lever, superficial global muscles, including the\r rectus abdominis and psoas major, that function as primary movers and smaller, deep, local\r muscles, including the Transverse Abdominis and Internal oblique, that function as primary\r stabilisers. It is postulated that if the deep stabilisers are not adequately functioning,\r then postural control is assisted by secondary compensatory activation of other muscles that\r typically function as primary movers like the hip flexors, knee flexors and spinal extensors.\r When a primary mover is being used to compensate for deep stabilisers, it becomes less\r efficient in its role in mobilizing and posturally adjusting.\r\n\r An ineffective deep stabilizing system also limits the ability of the body to maintain the\r joints in a position where muscles are at a mechanical advantage. This can have an added\r 'weakening' effect on muscles that are essential for postural control, like the gluteus\r medius, as it reduces their force-generating capacity.\r\n\r The objectives of the study are:\r\n\r 1. To measure changes in performance on a series of static, anticipatory and reactive\r balance tasks using three dimensional motion analysis in children who participate in\r core stability (intervention group) compared to children who continue their usual care\r (control group).\r\n\r 2. To compare changes in functional balance tests of the intervention group to the control\r group\r\n\r 3. To analyse qualitative data from a post intervention questionnaire to determine the\r broader effects of the 'Core stability' group intervention on the child's real life\r function, participation and quality of life.\r\n\r Selection Criteria\r\n\r The study aims to investigate the effects of a treatment intervention on children with\r Cerebral Palsy (CP). It is best research practice to choose a homogenous group of\r participants for meaningful results. It has been shown that in relation to balance of\r ambulatory children with spastic CP, a functional classification system (Gross motor Function\r Classification System-GMFCS level) can be used to group children more homogenously than\r traditional classification by diagnosis. On this basis, it was decided to include children\r with GMFCS levels I and II. Ambulatory children with a GMFCS classification level III were\r excluded as most studies showed a large gap in balance abilities between levels II to III.\r This would lead to a much greater variance in the participant sample.The Central Remedial\r Clinic (CRC) database of clients attending Clondalkin or Clontarf physiotherapy services will\r be used to generate a list of clients aged 7 to 17, with spastic CP diplegia or hemiplegia\r GMFCs level I or II for each centre.\r\n\r The study inclusion/exclusion criteria will then be applied to this list. The clients not\r meeting the inclusion criteria or those meeting the exclusion criteria will be removed. The\r remaining clients will be invited to participate in the study and a list will be generated of\r participants who agree.\r\n\r The resulting list will be split into 2 separate age groups (Age 7-12 years and Age 13-17\r years) and unique identifying numbers will be assigned to each client on the day of their\r initial baseline assessment.\r\n\r The clients will be assessed in groups of a minimum of 6 and maximum of 12 and will be\r randomised according to the procedure detailed below.\r\n\r Sample Size\r\n\r The sample size was calculated in Stata IC 13 (StataCorp, Texas, USA) using step length as\r the primary outcome measure. A previous study comparing gait in CP and typically developing\r children over level and uneven ground found a mean difference of 9cm (standard deviation 9cm)\r in step length between groups (Malone et al 2014, submitted for publication). With a power of\r 0.9 and significance level of 0.05, a sample size of 22 in each group was derived, giving a\r total of 44. To allow for a 10% drop out, it was decided to enroll 48 participants to the\r study.\r\n\r Randomisation\r\n\r A randomisation procedure will be carried out by an individual blinded to both the treatment\r and assessment procedure. The unique identifying number of the individual and their group\r will be in-putted into an electronic randomisation tool. Group assignment will be known to\r the treating therapists but not to the assessing therapist to ensure a single-blind design.\r\n\r The participants will be allocated based on randomisation to either Intervention (I) or\r control (C).\r\n\r Statistical analysis\r\n\r The primary research question is whether core stability classes improve movement and function\r in the intervention group (I) compared to the control group (C). Data will be plotted\r graphically and described in the first instance using means, medians, standard deviations.\r Normality will be assessed using the Shapiro Wilk test. Groups will be inspected for baseline\r comparability. Quantitative parametric data from movement analysis assessment will be\r compared for (I) and (C) groups using analysis of co-variance including baseline levels of\r the outcome and adjusting for any baseline imbalances. Non-normally distributed data, e.g.\r Functional Walk Test, will be compared using Poisson regression.\r\n\r Statistical analysis will be performed with Stata IC 13. Statistical assistance will be\r available from the Department of Epidemiology in RCSI.\r\n\r Ethical Approval\r\n\r Ethical approval has been obtained from the CRC Ethics committee\r\n\r Informed Consent A written explanation of the study and core control group will be provided\r for the parent/guardian and participant. The information will be presented in a manner that\r is easy to understand and outline the risks and benefits of the study clearly. Each parent\r and participant will be given the opportunity to ask questions in writing or verbally and the\r parent/guardian will then sign a consent form. Refusal to participate in the study will not\r affect the client's general physiotherapy care from the CRC in any way.\r\n\r Participants The control group will not work on focused balance specific core stability work\r in physiotherapy over the four-week control period. They will receive all other usual\r physiotherapy care during this period. Participants who are initially assigned to the control\r group will then be offered to participate in a Core Stability group after the control period\r assessments are completed. Therefore, all study participants (intervention and Control\r groups) will be given the opportunity to avail of the 'Core Stability' physiotherapy group\r programme. Each group will have to attend the same number of assessments (1 pre assessment\r and 1 post assessment)\r\n\r Data Collection and Protection All data collected from the study will be restricted to the\r circumstances listed on the signed consent form. The procedures in place in relation to data\r storage and processing in the Gait Laboratory and the Physiotherapy Department in the CRC\r will be followed. Identifying information will only be stored in the CRC secure server.\r\n\r Potential Risks During the Balance assessment in the gait laboratory, markers will be placed\r on the skin with adhesive tape. Taking these off may cause very slight discomfort. To\r alleviate this adhesive removal spray can be used.\r\n\r The gait lab balance assessment is designed to be a measure of dynamic balance. Therefore,\r participants will be asked to do some tasks that may be challenging to them. They will be\r supervised at all times when carrying out the assessment by the independent assessor. Stand\r by assistance will be provided if required for safety.\r\n\r The 'Core Stability' physiotherapy group intervention programme may be both mentally and\r physically challenging for the participants. It will involve concentration and repetition of\r activities. The group will be carried out under the supervision of two paediatric senior\r physiotherapists who work regularly with this CP population. These physiotherapists will have\r a strong knowledge base of this population's physical limitations. They are also experienced\r in how to encourage and motivate paediatric clients to carry out challenging activities.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Children with spastic Cerebral Palsy (CP)\r\n\r - Ages 7 - 17 (inclusive)\r\n\r - GMFCS I-II (Gross Motor Function Classification System)\r\n\r - Diplegia, Hemiplegia\r\n\r - Balance problems identified (Determined by primary PT's treating problem list and/or\r score on balance assessments in use)\r\n\r - Parental Informed Consent\r\n\r - Can follow verbal instructions and willing to participate in a group intervention\r setting\r\n\r Exclusion Criteria:\r\n\r - Recent surgery to lower limbs (within past year)\r\n\r - Botulinum Toxin (BTX-A) or serial casting to lower limbs within the last 3 months (or\r planned for during intervention or control period)\r\n\r - Completed a core stability training group within the previous year\r\n\r - Neurological or orthopaedic conditions unrelated to CP\r\n\r - Behavioural difficulties limiting ability to participate in groups\r\n\r - Intellectual difficulty that would make it difficult to comprehend and cooperate with\r treatment and/or testing\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,537
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nBradyXplore Phase II: Bradykinesia Feature Extraction System\n\n**Clinical Trial Summary:**\n\nStudy objectives are to improve motion sensor algorithms for measuring bradykinesia in the\r clinic and the home, evaluate test-retest reliability of motion sensor algorithms for\r measuring bradykinesia compared to clinician raters, determine if participant-perceived\r symptom severities correlate with motion sensor measures, determine if speed, amplitude, and\r rhythm fluctuate differentially throughout the day in individuals with implanted deep brain\r stimulation systems, receive feedback on the usability of Kinesia One, and evaluate Kinesia\r One compliance in the home.\n\n**Clinical Trial Detailed Description:**\n\nIn Clinic:\r\n\r Participants will arrive at the clinic with deep brain stimulation (DBS) turned on and on any\r previously prescribed Parkinson's disease (PD) medication. Motion sensor units will be placed\r on the index finger, thumb, and wrist of the participant's more affected hand. The\r participant will then perform three repetitive motion tasks and two tremor evaluation tasks,\r each performed for 15 seconds. The tasks will include repetitive finger-tapping, hand\r opening-closing, and pronation-supination, as well as arms resting and arms extended. The\r sequence of five tasks will be repeated (10 task performances total) so that test-retest\r reliability can be examined.\r\n\r The participant's DBS system will then be turned off. The two repetitions of five motor tasks\r will then be repeated 10 minutes, 20 minutes, and 30 minutes after DBS is turned off to\r measure the after-effects of DBS washout. During all task performances, motion data will be\r streamed from the motion sensors to a nearby computer for storage. The participant's hand\r will be videoed for subsequent clinical scoring. After each set of assessments (on and three\r time points after turning DBS off), participants will be asked to rate his/her \"slowness of\r movement\" on a 0-4 scale. The participant's DBS system will then be turned back on before\r he/she leaves the clinic.\r\n\r To examine test-retest reliability, motion sensor-based scores will be compared to the\r clinician ratings. Videos from participants at both sites will be randomized, and presented\r to movement disorder neurologists for clinical rating. The clinician will be blinded to the\r participant's identity as much as possible by obscuring everything other than the\r participant's hand.\r\n\r At Home:\r\n\r Before data collection begins, a technician will give the participant a Kinesia One system\r (one motion sensor unit, inductive charge-pad, and tablet computer) to take home and train\r him/her on use. The movement tasks to be performed will be explained in detail to ensure the\r participant is familiar with them. The participant will be required to perform the tasks\r using the system twice independently before leaving the clinic to ensure he/she fully\r understands how to use the system. The time it takes the participant to independently set up\r the system will be recorded. The system will be used for two weeks, after which it will be\r returned to the clinic either in person or in a pre-paid shipping box.\r\n\r During the two-week data collection, participants will perform a motor assessment three days\r per week (six days total). On each assessment day, assessments will be performed six times\r per day, spaced approximately two hours apart. All assessments will be performed with DBS\r turned ON. To begin each assessment, the participant will sit in front of the tablet\r computer. The software will guide the participant through the data collection procedure. The\r participant will be instructed to remove the motion sensor unit from the charge pad and place\r it appropriately on the index finger of the more affected hand. Software will then guide the\r participant through the assessment, which will consist of the three repetitive motion tasks\r and two tremor evaluation tasks, each performed for 15 seconds. The sequence of five tasks\r will be repeated a second time (10 task performances total) so that test-retest reliability\r can be examined. All data will be uploaded to a secure server. After each assessment,\r participants will enter rating corresponding to their perceived slowness of movement and\r Parkinson's state. Each week of paper diaries will be mailed back within three days after\r being completed in provided, pre-addressed and stamped envelopes.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of idiopathic Parkinson's disease\r\n\r - Has Deep Brain Stimulation Implant for Parkinson's disease\r\n\r - Historical bradykinesia rating of 2 or greater on at least one of the Unified\r Parkinson's Disease Rating Scale (UPDRS) finger-tapping, hand-movements, and\r pronation-supination tasks with DBS off.\r\n\r Exclusion Criteria:\r\n\r - Dementia (MoCA < 25)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,538
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nDevelopment of Parkinson's Glove for Detection and Suppression of Hand Tremor\n\n**Clinical Trial Summary:**\n\nThis study is aimed to study the feasibility and safety of parkinson's glove that combined 2\r module of tremor detection and tremor suppression with electrical muscle stimulation for\r using as device for rest tremor suppression in parkinson's disease patients\n\n**Clinical Trial Detailed Description:**\n\nStudy Population\r\n\r 1. Target: Thai Parkinson's disease (PD) patients with predominant rest tremor : 50\r patients\r\n\r 2. Population sample: Patients who are getting their treatment at the Chulalongkorn\r Comprehensive Movement Disorder Clinic at King Chulalongkorn Memorial Hospital.\r\n\r Study methods as follows:\r\n\r - All PD subjects will be provided the information on this research study and informed\r consent will be sought for every subjects.\r\n\r - All PD subjects will be interviewed by a movememt disorders specialist or a trained\r interviewer for their demographic and clinical data.\r\n\r - All PD patients will be examined for the severity of Parkinson's disease by a movement\r disorders specialist according the Unified Parkinson's disease Rating Scale (UPDRS),\r Hoehn and Yahr score, and tremor rating scale during the 'on period' in order to\r determine the additional effect of parkinson's glove and sham glove for suppression of\r tremor\r\n\r - All PD patients will be randomly allocated into 2 groups (25 Parkinson's glove and 25\r sham glove) with block randomization method.\r\n\r - All patients will get Parkinson's glove for home-based usage for 14 days, the\r appointment for follow -up will be done for 4 times, with once daily phone call from\r investigators in order to check for improvement symptoms and all adverse events such as\r pain will be recorded and determined it severity by the visual analog scale.\r\n\r Data collection\r\n\r - Demographic and clinical data: age, gender, clinical diagnosis, tremor rating scale,\r pain score by visual analog scale , Parkinson's disease's severity score for each\r subject according to establishing standard rating scale.\r\n\r - Tremor parameters form Parkinson's glove will be collected in SD card as 5 parameters:\r Peak magnitude, RMS, Angle, Frequency, Q. Number of stimulation times will be recorded.\r\n\r Data analysis The statistical analysis in this study is based from SPSS program version 17.\r Categorical data will be analyzed for frequency and percentage. Continuous data will be\r analyzed by mean and standard deviation (SD). Non-parametric study would be preferred if the\r small sample size or in case of distribution of data do not present as normal distribution\r (determined by Kolmogorov-Smirnov test). The repeated ANOVA will be used for determined the\r efficacy of parkinson's glove in the difference times in follow up periods.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - • Adults ≥ 18 years old.\r\n\r - Patients with Parkinson's disease diagnosed according to the UKPDSBB criteria\r with predominantly feature of rest tremor that intractable to medically\r treatment.\r\n\r - Informed consent\r\n\r Exclusion Criteria:\r\n\r - Patients with a history of cardiac arrhythmia, renal failure, hepatic failure, and\r pregnancy as well as those who had history of seizure or had the risk for tended to\r become seizure such as those who had focal brain lesions, encephalitis, and stroke\r patients.\r\n\r - Patients with a history of hand surgery and implanted screws or wires in hand\r area that supposed to place a surface EMG or EMS, as well as those patients who\r were implanted for electrical devices such as cardiac pacemaker, pulse generator\r of deep brain stimulation,and intrathecal baclofen pump.\r\n\r - Patients who cannot avoid the medication that may potentiate or attenuate tremor\r such as antihistamines, benzodiazepine, illicit drugs, and thyroid hormone\r supplement.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,539
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThis is a study with two sequential cohorts, each with three treatment periods. Single doses\r of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose\r projected to be under the current limits for drug concentration. Each cohort will aim to\r achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary\r endpoint is MDS-UPDRS part III.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - L-DOPA-responsiveness\r\n\r - Hoehn & Yahr Stage II-III inclusive\r\n\r - Experiencing motor fluctuations\r\n\r - Stable daily dose of L-DOPA of at least 300 mg\r\n\r - Females on non-childbearing potential and male subjects\r\n\r Exclusion Criteria:\r\n\r - History of troublesome dyskinesias\r\n\r - History of surgical intervention for Parkinson's disease\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,540
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Retrospective, Open-label, Uncontrolled Cohort Study to Assess the Effectiveness and Safety of Lactulose Retention Enema in the Treatment of Cirrhotic Patients With Grade 3 or 4 (West Haven Criteria) Hepatic Encephalopathy (HE) [The RETRO Study]\n\n**Clinical Trial Summary:**\n\nThis is a retrospective study in adult patients with cirrhosis and grade 3 or 4 HE (West\r Haven Criteria) to evaluate the effectiveness and safety of lactulose retention enema in the\r treatment of deep grade HE (West Haven Criteria). The study will be conducted retrospectively\r in a multi center of a multispecialty tertiary care hospital in India, in which lactulose\r retention enema is the mainstay of management of cirrhotic patients with grade 3 or 4 HE\r (West Haven criteria). Dosing of lactulose retention enema in this study will be done\r according to the dosing described for rectal administration of lactulose (India): 300ml of\r lactulose mixed with 700ml of potable water to be used as a retention enema; the enema is to\r be retained for 30-60 minutes and repeated every 4-6 hours until the patient is able to take\r oral medication. This treatment regime is also the standard protocol of management of deep\r grade HE (West Haven criteria) in the study centers. The standard treatment protocol of deep\r grade HE (West Haven criteria) of the study centers will also ensure that all known\r contraindications of lactulose will be respected before administration of lactulose retention\r enema to the study patients. The retrospective hospital records of the patient population of\r interest within the past 6 months will be identified, and these records will be used to\r collect data required for analysis.\n\n**Clinical Trial Detailed Description:**\n\nData to be collected:\r\n\r Data that would be collected for the study as part of retrospective chart review:\r\n\r 1. Patient demographics: age, gender, weight\r\n\r 2. Medical history\r\n\r 3. Etiology of cirrhosis (alcohol abuse, hepatitis, autoimmune, cryptogenic, other)\r\n\r 4. Diagnosis of cirrhosis\r\n\r 5. History of previous HE (if yes, the number of episodes in the past)\r\n\r 6. Grade of HE (as per the West-Haven criteria) at admission, 24 hrs and 48 hours post\r treatment with lactulose\r\n\r 7. Precipitating factor(s) of HE (Dehydration, GI bleeding, protein overload, constipation,\r infection, others)\r\n\r 8. Dose and duration of lactulose enema\r\n\r 9. Treatment given for precipitating factors\r\n\r 10. Laboratory data on haemoglobin, platelet, bilirubin, albumin, aspartate aminotransferase\r (AST), alanine aminotransferase (ALT), urea, creatinine, sodium, potassium, and blood\r ammonia\r\n\r 11. Complete reversal of deep-grade HE (< Grade 2 as per West-Haven criteria) (yes/no)\r\n\r 12. Time to complete reversal of deep-grade HE\r\n\r 13. Number of days in hospital\r\n\r 14. Adverse drug reaction experienced by the patient\r\n\r 15. Complications experienced by the patient\r\n\r 16. Other pharmacovigilance relevant information (OPRI)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients aged between 18 and 65 years of either gender.\r\n\r - Patients admitted to the hospital with liver cirrhosis and grade 3 or grade 4 (West\r Haven Criteria) HE\r\n\r - Patients treated with lactulose retention enema within 48 hours of onset of grade 3 or\r 4 (West Haven Criteria) HE\r\n\r Exclusion Criteria:\r\n\r - Patients treated with agents other than lactulose retention enema for grade 3 or 4\r (West Haven Criteria) HE.\r\n\r - Patients who had significant concomitant diseases that could impair or contribute to\r the impairment of consciousness\r\n\r - Patients who had a major neuropsychiatric illness\r\n\r - Patients who had a contraindication to lactulose, including Hypersensitivity to the\r active substance or to any of the ingredients; Galactosaemia; Gastrointestinal\r obstruction, digestive perforation or risk of digestive perforation\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,541
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAdaptive Closed Loop Neuromodulation and Neural Signatures of Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nContinuous deep brain stimulation (cDBS) is an established therapy for the major motor signs\r in Parkinson's disease. Currently, cDBS is limited to \"open-loop\" stimulation, without\r real-time adjustment to the patient's state of activity, fluctuations and types of motor\r symptoms, medication dosages, or neural markers of the disease. The purpose of this study is\r to determine if an adaptive DBS system,responding to patient specific, clinically relevant\r neural or kinematic feedback, is more effective than continuous DBS on the motor Unified\r Parkinson's Disease Rating Scale (UPDRS III) and specific phenotypic measures in Parkinson's\r Disease.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. A diagnosis of idiopathic Parkinson's disease, with bilateral symptoms at Hoehn and\r Yahr Stage greater than or equal to II.\r\n\r 2. Documented improvement in motor signs on versus off dopaminergic medication, with a\r change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >=\r 30% off to on medication.\r\n\r 3. The presence of complications of medication such as wearing off signs, fluctuating\r responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment\r in the quality of life on or off medication due to these factors.\r\n\r 4. Subjects should be on stable doses of medications, which should remain unchanged until\r the DBS system is activated. After the DBS system is optimized (during which time the\r overall medication dose may be reduced to avoid discomfort and complications such as\r dyskinesias) the medication dose should remain unchanged, if possible, for the\r duration of the study.\r\n\r 5. Treatment with carbidopa/levodopa, and with a dopamine agonist at the maximal\r tolerated doses as determined by a movement disorders neurologist.\r\n\r 6. Ability and willingness to return for study visits, at the initial programming and\r after three, six and twelve months of DBS.\r\n\r 7. Age > 18\r\n\r Exclusion Criteria:\r\n\r 1. Subjects with significant cognitive impairment and/or dementia as determined by a\r standardized neuropsychological battery.\r\n\r 2. Subjects with clinically active depression, defined according to the Diagnostic and\r Statistical manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and as scored\r on a validated depression assessment scale.\r\n\r 3. Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage 5 on medication\r (non-ambulatory).\r\n\r 4. Age > 80.\r\n\r 5. Subjects with an implanted electronic device such as a neurostimulator, cardiac\r pacemaker/defibrillator or medication pump.\r\n\r 6. Subjects, who are pregnant, are capable of becoming pregnant, or who are breast\r feeding.\r\n\r 7. Patients with cortical atrophy out of proportion to age or focal brain lesions that\r could indicate a non-idiopathic movement disorder as determined by MRI\r\n\r 8. Subjects having a major comorbidity increasing the risk of surgery (prior stroke,\r severe hypertension, severe diabetes, or need for chronic anticoagulation other than\r aspirin).\r\n\r 9. Subjects having any prior intracranial surgery.\r\n\r 10. Subjects with a history of seizures.\r\n\r 11. Subjects, who are immunocompromised.\r\n\r 12. Subjects with an active infection.\r\n\r 13. Subjects, who require diathermy, electroconvulsive therapy (ECT), or transcranial\r magnetic stimulation (TMS) to treat a chronic condition.\r\n\r 14. Subjects, who have an inability to comply with study follow-up visits.\r\n\r 15. Subjects, who are unable to understand or sign the informed consent\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,542
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nFreezing of Gait: Clinical, Cognitive, and Imaging Features\n\n**Clinical Trial Summary:**\n\nFreezing of gait (FOG) is among the most disabling motor features of Parkinson disease (PD)\r and is present in other forms of parkinsonism as well. FOG is a brief (usually lasting <30\r seconds) episode of absence or a greatly reduced forward movement of the feet despite\r intention to walk. It typically occurs when patients initiate gait (so-called \"start\r hesitation\") and when attempting to turn. It is a leading cause of falls and often results in\r a wheelchair-dependent state. FOG greatly interferes with activities of daily living, causes\r social isolation and poor quality of life.\r\n\r FOG is one of the least understood features of PD. It possibly may develop independent of the\r other motor features of the disease, and be caused by specific pathological changes in the\r brain. Previous studies on FOG have shown conflicting information and have not lead to clear\r understanding of the pathophysiology. One key reason for this is that there appears to be\r multiple subtypes which have rarely been taken into account.\r\n\r The purpose of this study is to show that different types of FOG exist and to see if there is\r a connection to cognitive differences or gait patterns.\n\n**Clinical Trial Detailed Description:**\n\nThis study is an observational study to assess FOG via using multiple methods such as:\r clinical features, imaging, cognition and dopamine blood levels. The study consists of four\r parts (plus an optional fifth part) that will be completed over two-three separate days\r within a 30 day span. The four parts will not necessarily be performed in this order. Part\r one will be clinical and written questionnaire assessments of PD and FOG followed by 3D\r motion capture evaluations. Part two are cognitive or neuropsychiatric assessments. Part\r three is a magnetic resonance image (MRI) to examine the brain structure. Part four is\r Positron Emission Tomography (PET) imaging scan that measures norepinephrine transporter\r levels. The optional part 5 is a lumbar puncture that will measure cerebrospinal fluid\r catecholamines and proteomics.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria for Parkinson disease (PD) subjects with freezing of gait (FOG):\r\n\r - Diagnosis of PD by United Kingdom Brain bank criteria\r\n\r - Hoehn & Yahr stage I-IV\r\n\r - Levodopa treated and responsive\r\n\r - Able to manage 12 hours off dopaminergic medication\r\n\r - Age 18-85 years\r\n\r - Presence of FOG by history and seen by examiner at their clinical office visit or in a\r video taken at home\r\n\r - Able sign a consent document and willing to participate in all aspects of the study\r\n\r - Able to have an MRI scan (no pacemakers or history of claustrophobia)\r\n\r Exclusion Criteria for Parkinson disease (PD) subjects with freezing of gait (FOG):\r\n\r - Dementia that precludes completing study protocol\r\n\r - Stage V PD - unable to walk independently when \"off\"\r\n\r - History of FOG without ever being seen to have it\r\n\r - Atypical parkinsonism: Progressive Supranuclear Palsy (PSP), Multiple System Atrophy\r (MSA), Corticobasal Degeneration (CBD), Vascular Parkinsonism\r\n\r - Treatment with medications that cause parkinsonism: drug-induced parkinsonism\r\n\r - Any neurological or orthopedic disorders that interfere with gait\r\n\r - Treatment with medications that will interfere with NET-PET (norepinephrine\r transporter-positron emission tomography) ligand binding\r\n\r a. Noradrenergic drugs: methylphenidate, atomoxetine, serotonin-norepinephrine\r reuptake inhibitors (e.g., venlafaxine)\r\n\r - Absence or loss of levodopa response\r\n\r - Any contraindications for MRI scan including pacemaker, deep brain stimulator, bladder\r stimulator, etc.\r\n\r Inclusion Criteria for Parkinson disease (PD) subjects but no freezing of gait (FOG):\r\n\r - Diagnosis of PD by United Kingdom Brain bank criteria\r\n\r - Hoehn & Yahr stage I-IV\r\n\r - Levodopa treated and responsive\r\n\r - Able to manage 12 hours off dopaminergic medication\r\n\r - Age 18-85 years, age, gender and duration matched to the PD with FOG recruits\r\n\r - Absence of FOG by history and by exam, confirmed by caregiver and FOG-Q item 3 score\r of 0.\r\n\r - Able sign a consent document and willing to participate in all aspects of the study\r\n\r - Able to have an MRI scan (no pacemakers or history of claustrophobia)\r\n\r Exclusion Criteria for Parkinson disease (PD) subjects but no freezing of gait (FOG):\r\n\r - Dementia that precludes completing study protocol\r\n\r - Stage V PD - unable to walk independently when off.\r\n\r - History of FOG at any time\r\n\r - Atypical parkinsonism: Progressive Supranuclear Palsy (PSP), Multiple System Atrophy\r (MSA), Corticobasal Degeneration (CBD), Vascular Parkinsonism\r\n\r - Treatment with medications that cause parkinsonism: drug-induced parkinsonism\r\n\r - Any neurological or orthopedic disorders that interfere with gait\r\n\r - Treatment with medications that will interfere with NET-PET ligand binding\r\n\r - Absence or loss of levodopa response\r\n\r - Any contraindications for MRI scan including pacemaker, deep brain stimulator, bladder\r stimulator, etc.\r\n\r Inclusion Criteria for subjects with freezing of gait (FOG) but not Parkinson disease (PD):\r\n\r - Diagnosis of Primary Progressive Freezing gait by accepted Criteria 71\r\n\r - Diagnosis of atypical parkinsonism; Progressive Supranuclear Palsy (PSP) or Multiple\r System Atrophy (MSA) with predominant and early onset FOG.\r\n\r - Hoehn & Yahr Stage I-IV parkinsonism\r\n\r - Limited response to Levodopa but FOG unresponsive, but may be on levodopa or other\r dopaminergic medications\r\n\r - Age 18-85 years\r\n\r - Presence of FOG by history and seen by examiner at their clinical office visit or in a\r video taken at home\r\n\r - MRI scan demonstrating no structural lesions: stroke, tumor or hydrocephalous\r\n\r - Able sign a consent document and willing to participate in all aspects of the study\r\n\r - Able to have an MRI scan (no pacemakers or history of claustrophobia).\r\n\r Exclusion Criteria for subjects with freezing of gait (FOG) but not Parkinson disease (PD):\r\n\r - Dementia that precludes completing study protocol\r\n\r - Stage V Parkinsonism - unable to walk independently.\r\n\r - Treatment with medications that cause parkinsonism: drug-induced parkinsonism\r\n\r - MRI scan demonstrating structural lesions or hydrocephalous\r\n\r - Notable levodopa response suggesting a diagnosis of PD including motor fluctuations or\r dyskinesia.\r\n\r - Any neurological or orthopedic disorders that interfere with gait.\r\n\r - Treatment with medications that will interfere with NET-PET ligand binding.\r\n\r - Any contraindications for MRI scan including pacemaker, deep brain stimulator, bladder\r stimulator, etc.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"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\nSpinal Cord Stimulation for the Treatment of Motor and Nonmotor Symptoms of Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nAlthough DBS improves patient's quality of life advanced Parkinson's patients (PD) by\r addressing the cardinal symptoms and reducing levodopa motor complications, symptoms still\r worsen over time. Postural problems, frequent falls, freezing of gait impairment and other\r locomotion difficulties still remain as important causes of disability and incapacity. Novel\r therapeutics approaches are needed to restore quality of life (QoL).\r\n\r This study aims to explore the effects of spinal cord stimulation in locomotion, falls and\r freezing of gait in advanced PD patients.\r\n\r Twenty PD patients will undergo thoracic spinal cord stimulation at high frequencies in a\r prospective study for six months.\r\n\r Changes in locomotion capacity and freezing of gait rating will be the primary out come.\r Secondary outcomes will be: QoL and common motor outcome measures in PD patients. Always\r comparing the status before, one, three and six months after stimulation was initiated. A\r double blind trial will be performed within three months of follow up (high X low frequency\r stimulation).\n\n**Clinical Trial Detailed Description:**\n\nBackground: Currently there are no available Parkinson's disease (PD) therapy can really stop\r disease progression. Although Deep Brain Stimulation (DBS) improves patient's quality of life\r by addressing the cardinal symptoms and reducing Levodopa motor complications, non motor\r symptoms still increasing over time. Gait problems as falls and freezing are important cause\r of disability and incapacity. Novel therapeutics approaches are needed to restore quality of\r life. Data from animal PD model suggest that spinal cord stimulation (SCS) can enhance\r locomotion in mice. Although clinical results, mostly from case reports, in PD patients are\r still conflicting, a few patients benefited from SCS in thoracic levels.\r\n\r Aim: Evaluated Spinal cord stimulation effects in locomotion, gait, freezing and falls in PD\r patient's.\r\n\r Method: 20 PD patients will undergo thoracic spinal cord stimulation with high frequency in a\r prospective study for six months. Gait and freezing evaluation will consists in: timed up and\r go test, timed up and go test with dual task, 20 m walk test, 20 m walk test with obstacle,\r freezing of gait scale and falls scale. PDQ 39 and Schwab and England scales will be used to\r measure quality of life. Unified Parkinson's Disease Rating Scale for motor symptoms and\r general evaluation. All tests will be done before surgery, after one week, one, three, six\r months. All patients will be stimulated with the same parameters: High frequencies and 90 mcs\r pulse width and the sensory threshold will be measured. At the third month the parameters of\r SCS will be changed and comparative tested for low frequency in a double blind trail.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Idiopathic PD\r\n\r 2. Gait and locomotion problems as the main complain/symptom\r\n\r 3. PD patients with or without DBS\r\n\r 4. Hoehn and Yahr scale equal or more than 2.0\r\n\r Exclusion Criteria:\r\n\r 1. Dementia\r\n\r 2. Hoehn and Yahr scale more than 4\r\n\r 3. Less than 5 years of Parkinson's disease symptoms\r\n\r 4. General contraindications of surgery\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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35,544
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic Disorder\n\n**Clinical Trial Summary:**\n\nThe primary aim of this study is to evaluate the efficacy of Vortioxetine in an adult\r population with a diagnosis of PD. PD is generally treated with benzodiazepines which are\r very effective but have a high risk for addiction, fall, and cognitive impairment. There is\r still a need for better treatment for PD for longer term use. There are other drugs within\r the SSRI/SNRI class which have proven to be effective in treating patients with this\r diagnosis.\n\n**Clinical Trial Detailed Description:**\n\nThe primary objective of the study is to evaluate the efficacy of Vortioxetine (5, 10, or\r 20mg) over a period of 10 weeks in subjects with PD, with or without Agoraphobia. The\r efficacy of Vortioxetine will be evaluated using the Mean Change from Baseline in the Panic\r Disorder Severity Scale (PDSS) score and the reduction in occurrence of panic attacks as\r measured by item 1 in the PDSS Scale after 10 weeks of treatment with Vortioxetine. This\r study is an open-label, adaptive study with flexible dose strategies lasting 10 weeks.\r Approximately 20 male and female subjects over the age of 18aged 18-60 years who currently\r meet DSM-IV criteria for PD with or without Agoraphobia or who have a PDSS score > 8 at\r Baseline will be enrolled in this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. The subject voluntarily agrees to participate in the study under their own free will.\r\n\r 2. The subject meets the DSM-V criteria for PD with or without Agoraphobia or has a PDSS\r score > 8 at the Baseline visit.\r\n\r 3. The subject is between the ages of 18-60 years old inclusive at the time of consent.\r\n\r 4. The subject is capable of understanding and complying with protocol requirements.\r\n\r 5. The subject has signed the Informed Consent Form. No study-related procedures may be\r performed before the subject has signed the form.\r\n\r Exclusion Criteria:\r\n\r 1. Female subjects who are pregnant or nursing, or may become pregnant during the course\r of the study. In addition, all subjects of childbearing potential who are sexually\r active most use adequate contraception from signing of informed consent and throughout\r the duration of the study. Male subjects who have been surgically sterilized, are at\r least one year post-vasectomy, are not required to use contraceptives. Females not of\r childbearing potential are defined as those who have been surgically sterilized\r (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal\r (defined as one year since last regular menses).\r\n\r 2. Subjects who have a past or present primary diagnosis with a psychotic disorder other\r than PD with or without Agoraphobia.\r\n\r 3. Subjects who have a current uncontrolled co-morbid psychiatric disorder other than PD\r with or without agoraphobia.\r\n\r 4. Subject who have a history of alcohol abuse or dependence within the 12 months prior\r to screening, as defined by the DSM-V criteria.\r\n\r 5. Subjects who have a comorbid severe medical diagnosis such as Cancer, adults with\r chronic heart failure, uncontrolled, long-term type 2 Diabetes, etc.\r\n\r 6. Subjects with a history of liver disease such as cirrhosis of liver, neoplasm of the\r liver, or active Hepatitis C.\r\n\r 7. Subjects weighing less than 100lbs at the Baseline visit.\r\n\r 8. Subjects with a history of cardiac abnormalities including but not limited to, acute\r cardiovascular events, serious cardiovascular risk, myocardial infarction (MI),\r unstable angina (UA), percutaneous coronary intervention, coronary artery bypass\r graft, stroke, or deep vein thrombosis/pulmonary embolism within 1 year of screening,\r or have planned cardiovascular surgery or percutaneous coronary angioplasty.\r\n\r 9. Subjects who are reasonably judged by the Investigator based on interview or\r information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS) at the\r Baseline visit to present a significant suicide risk, or who are likely to require\r psychiatric hospitalization during the course of the study.\r\n\r 10. Subjects who are unable to fully understand the potential risks and benefits of the\r study and unable to give informed consent.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,545
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\ntDCS Immediate Effect on Cardiorespiratory Parameters in Hemiparetics Adults Patients Due to Stroke.\n\n**Clinical Trial Summary:**\n\nPrevious studies found important function of brain in exercises regulation on healthy and\r athlete patients and this studies showed not invasive stimulation on temporal cortex brain,\r induces electrics field to insula cortex, in addition modulate autonomic nervous system\r cognition efforts during submaximal (maximal hight frequency) and maximal exercises. Measure\r immediate effects of transcranial stimulation in bloodstream (tDCS) anodic on right and left\r temporal cortex in the cardiorespiratory parameters (functional capacity, perception of\r efforts and modulation of autonomic nervous system) in patients with hemiparesis due stroke.\r Methods and Material: It Is a clinical trial, controlled and Double blind, using 30 adult\r patients with stroke sequel, like roam. Evaluation will be hemodynamic measure data such as:\r Heart Rate, Respiratory Rate, Blood Pressure, Lung Capacity Vital and assessment of the\r Autonomic Nervous System, before and after anodic electro stimulation from bloodstream on\r right and left temporal cortex region (T3 area) and cathodic position in contralateral\r supraorbital region to anode (Fp2). On temporal cortex will be applied of 2mA during\r stimulation of 20 minutes. Sham stimulation all electrodes Will be used. The stimulator turns\r on for 30 seconds. Results: The primary results will analyze cardiac frequency before and\r after tDCS and second step will assess the travelled distance on walking test for 6 minutes\r with and without tDCS and compare these respiratory reviews results with stroke gravity.\n\n**Clinical Trial Detailed Description:**\n\nThis is a clinical protocol, randomized, crossover, double-blind (patient and data analyst)\r will be held. The study protocol is registered in clinicalTrials.gov - NCT02398344.\r\n\r Methods\r\n\r Individuals with AVE will be recruited from the physical therapy clinics of the Universidade\r Nove de Julho - Sao Paulo, Brazil. The participants will be recruited and selected based on\r the following eligibility criteria:\r\n\r Sample size Sample of 20 the participants (05 participants in each level of motor impairment\r - mild, moderate, marked and severe) will taken. This value will assumed, based on studies of\r Okano et al.²⁰ evaluating HRV after tDCS in 10 athletes and Vandermeeren et al.²⁶ that\r evaluated the effect of tDCS over the cardiorespiratory system in 30 healthy individuals.\r\n\r As the primary outcome will considered the heart rate variability, validated for the\r population of adults with hemiparesis after a stroke and a variable considered secondary\r outcome, by correlating the functional capacity with the severity of the stroke, the 6-minute\r walk test, considering the cardiorespiratory fitness and the patient's mobility before and\r after the application of tDCS and correlate whether there are differences on the immediate\r effect of tDCS applied in both cerebral hemispheres (right and left).\r\n\r Procedures Initially, participants will be screened at University Nine July physical therapy\r clinics at São Paulo. Individuals who meet the eligibility criteria will be invited to\r participate in the study, being included after agreement by signing the Instrument of\r Consent.\r\n\r The following description of the evaluation procedures:\r\n\r Identification form: After screening, an identification sheet of the selected volunteers will\r be filled in, containing the following information: name, date of birth, age (years and\r months), topographic diagnosis of stroke, classification of the type of stroke (hemorrhagic\r or ischemic), weight (kg), height (cm), blood pressure (BP), classification of functional\r severity according to Fulg Meyer ²⁷ (Mild, Moderate, marked and severe) time since injury,\r area of committed member, carried out therapies and how long, muscle strength of the paretic\r body side according to Kendall et al. ²⁸ and Ashworth ²⁹.\r\n\r Functional Mobility Scale: This scale will be used for screening, in order to assess how the\r individual moves in the environment to achieve their interaction in everyday life with family\r and the social environment. The FMS provides scores in three different lengths (5m, 50m and\r 500m), relating to mobility at home, school and community. The classification is performed\r according to the patients needs in assistance to movement and according to the distance ²⁵.\r The included patient should wander at least 50 m.\r\n\r All data will be recorded on a card and then the patients will informed about the\r experimental procedures, including previous recommendations to each test: have a light meal\r in the days of the tests; abstain from caffeine and alcohol intake and / or smoking, avoid\r moderate or excessive effort the day before and on test day, have a good night's sleep and\r present ourself in comfortable clothes and shoes that allow good mobility.\r\n\r Pulmonary function tests: spirometry evaluation EasyOne Plus Diagnostic Sprometry System® in\r order to identify the presence of lung function changes measured by forced expiratory volume\r in the first second (FEV1), forced vital capacity (FVC), peak flow expiratory (PEF) and FEV1\r / FVC ratio, according to the criteria of the American Thoracic Society ³⁰. Spirometric\r indices will be presented in absolute terms and as a percentage of the reference values.\r Volunteers must complete at least three acceptable and reproducible forced expiratory\r maneuvers.\r\n\r Respiratory muscle strength: Respiratory muscle strength will be obtained through maximal\r inspiratory pressure (MIP) and maximal expiratory pressure (MEP), which measures the\r inspiratory and expiratory muscle strength, respectively, and will be obtained by the method\r of Black & Hyatt³¹. In order to accomplish these steps, it uses a scaled manometer in cm H2O,\r with an operating range of ± 300 cmH2O adapter equipped with nozzles and containing a safety\r valve through a bore, 2mm in diameter, in order to prevent increased pressure in the oral\r cavity generated exclusively by facial²⁴ muscle contraction. The MIP is obtained by a maximal\r inhalation maneuver starting from a maximum expiration and MEP obtained by a maximum\r exhalation maneuver starting from maximum inspiration. Each maneuver will be maintained for a\r minimum of two to three seconds. The MIP and MEP performed three times for each patient, and,\r for analysis, will count the highest value obtained ³².\r\n\r FulgMeyer scale (EFM) - The motor impairment assessment instruments measure the level of\r motor recovery of hemiplegic patients, highlighting the motor test procedure in Hemiplegia.\r The proposed measures in the FSM are based on neurological examination and sensory-motor\r activity of upper and lower limbs in order to identify selective and synergistic activity\r patterns of patients who suffered strokes. This scale was constructed following the\r hypothesis that restoration of motor function in hemiplegic patients follow a defined course.\r It is represented by a three-point ordinal scale that is applied in every item: 0- can not be\r performed, partially performed 1- and 2 - fully realized. The total of this scale is 100\r points for normal motor function, where the maximum score for the upper end is 66 and the\r lower 34. The motor evaluation includes measurement of motion, coordination and reflex\r activity of shoulder, elbow, wrist, hand, hip, knee and ankle determining a score according\r to the motor impairment level, where less than 50 points indicates a severe motor impairment;\r 85-95 moderate; 50-84 remarkable and 96-99 light ²⁷.\r\n\r Analysis of heart rate variability (HRV):\r\n\r The Heart rate variability will be analyzed in four stages:\r\n\r 1. Resting 01: The heart rate (HR) is captured by means of a heart rate monitor (RS800 CX)\r with online data transmitted to a computer, over a period of 10 minutes of rest.\r Individuals will be instructed to remain recumbent for 10 minutes, avoiding any activity\r and without sleep, after this examination the patient will remain in the sitting\r position posture for over 10 minutes following the same guidelines given above.\r\n\r 2. In exercise: After the initial 20 minutes of rest, the patient will start the six-minute\r walk test. The FC will be collected through the same heart rate monitor throughout the\r walk test, as well as in post exercise recovery (for 2minutes). In this recovery the\r patient will remain in the sitting position, and will be instructed to not verbalize and\r not move during the evaluation.\r\n\r 3. Electrical stimulation by direct current (Home): After the walk (6MWT) and the recovery\r of hemodynamic parameters to baseline parameters, stimulation with tDCS in sitting\r position posture starts, and during stimulation HR will be collected.\r\n\r 4. 6 minute walk test 02: After finishing the tDCS, the patient should again perform the\r 6MWT through the same guidelines of the American Thoracic Society ³⁰, assessing the FC.\r\n\r After the test there will be given a continuity of HRV analysis for 2 minutes with the\r patient in the sitting position, without verbalizing and without moving , in order to analyze\r the behavior of the autonomic nervous system.\r\n\r 6-minute walk test - a reliable measure for assessing physical fitness and functional\r mobility ³⁰. The test quantifies in meters the distance traveled by the individual in six\r minutes. It is performed in accordance with the guidelines established by the American\r Thoracic Society ³⁰.\r\n\r During the walk test the patient will be told to stop if he feels bad, there will always be a\r researcher on the side to avoid possible falls during the test run and will be monitored by\r the oximeter (More Fitness MF-417®).\r\n\r 2.5.1. Stimulation procedures transcranial direct current The transcranial electrical\r stimulation DC (tDCS) will be performed with a tag device 1 CH Tct Research tDCS Simulator\r model 101® by means of two surface sponge electrodes , (non-metallic) 5-7 cm2 in humidified\r saline, with a 2mA current.\r\n\r Individuals will be submitted to four experimental conditions, and the order distributed by\r randomization through manila envelopes.\r\n\r 1. tDCS anode on the left temporal cortex (T3) and cathode on the contralateral\r supraorbital region;\r\n\r 2. tDCS sham on left temporal cortex (T3) and cathode on the above-orbitalcontralateral\r region;\r\n\r 3. tDCS anode on the right temporal cortex (T4) and cathode on the contralateral\r supraorbital region;\r\n\r 4. tDCS sham on right temporal cortex (T4) and cathode on the contralateral supra orbital\r region.\r\n\r Protocol 1 and 2: The anode electrode will be positioned on the left temporal cortex (T3),\r located 40% of the distance from the left side of Cz point following the international 10-20\r system electroencephalogram and the cathode electrode on the region supra orbital\r contralateral to the anode.\r\n\r Protocol 3 and 4: The anode electrode will be positioned on the right temporal cortex (T4)\r and cathode positioned on the left supraorbital region.\r\n\r Active stimulation application time or placebo 20 minutes. In all sham stimulation, electrode\r placement procedures will also be performed like the procedures with anodic tDCS, the left\r and right temporal cortex, however, the stimulator is turned on for 30 seconds only, and the\r patient will be told that he will feel a slight initial tingling, but it will reduce,\r disappear or remain during the 20 minutes of application. Thus, individuals will feel it\r initially, but receive no stimulation in the remaining time. This procedure is a valid form\r of control in challenge studies transcranial direct current ³³. The equipment itself has a\r sham configuration.\r\n\r According to Okano et al. ²⁰, before receiving any of the experimental conditions\r (transcranial direct-current stimulation (anodic or sham), individuals must rest for a period\r of 10 minutes (sitting comfortably), so that the cardio respiratory variables return to\r baseline measurements.\r\n\r The two study conditions (anodic stimulation and sham) will be performed with an interval of\r 48 hours ³⁴ and always in the same period of the day.\r\n\r Protective measures to subjects Patients will be exposed to minimal risk during the search,\r trying to be controlled at all times by the researcher, who will accompany and monitor all\r cardiorespiratory changes, giving support if the patient has imbalance or discomfort, and\r interrupting the action immediately if necessary.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - 30 individuals wich hemiparesis stemming from a stroke;\r\n\r - Rating of Functional Mobility Scale levels (FMS- functional mobility scale)\r\n\r - Walking at least 50 meters (GRAHAN et al. 2004); Science signature in consent term\r exempt and enlightened (TCLE) .\r\n\r Exclusion Criteria:\r\n\r - Positive Cutoff to cognitive wastage screening (mental mini) - Visual commitment may\r intervene in tests achievement;\r\n\r - Cardiac vast problems and use of pacemaker;\r\n\r - Contraindication of tDCS application (history of recurrent seizures, recurrent\r epilepsy and brain tumor in stimulation site);\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,546
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nImmune Modulation From Trichuris Trichiura\n\n**Clinical Trial Summary:**\n\nMucosal immunology during helminth infection\n\n**Clinical Trial Detailed Description:**\n\nThe present study investigates the effects of Trichuris trichiura on human mucosal and\r systemic immunity in a single self-infected individual.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - The included volunteer is a researcher within parasitology with main focus on\r Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our\r department with the purpose of being monitored during this infection for safety\r (medical supervision) and research reasons. The only clinical criterion for his\r inclusion in the study was that he was healthy.\r\n\r Exclusion Criteria:\r\n\r - N/A\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,547
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMulti-electrodes Set for Deep Brain Stimulation in Parkinson Disease\n\n**Clinical Trial Summary:**\n\nThis study aims to demonstrate innocuity and feasibility of deep brain stimulation with a\r multi-electrodes set.\n\n**Clinical Trial Detailed Description:**\n\nBilateral stimulation in subthalamic nucleus with the multi-electrodes set will be compared\r with single electrode.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - more or equal than 18 years old and less than 70 years\r\n\r - patient affiliated to social security or similarly regime\r\n\r - informed consent form signed\r\n\r - parkinson disease (UPDRS III20 score up than 30/108 except for severe tremors)\r\n\r - motor and non motor dysfunctions\r\n\r - pre-operative cerebral MRI without lesion\r\n\r - without chirurgical contraindications\r\n\r - without psychiatric disease\r\n\r Exclusion Criteria:\r\n\r - Pregnant women and lactating mothers\r\n\r - Ward of court or under guardianship\r\n\r - Adult unable to express their consent\r\n\r - Person deprived of freedom by judicial or administrative decision\r\n\r - Person hospitalized without their consent\r\n\r - Person under legal protection\r\n\r - Person with carcinological antecedent during precedent 5 years\r\n\r - Chirurgical or MRI contraindications\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
35,548
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia\n\n**Clinical Trial Summary:**\n\nThe purpose of this study to evaluate the safety and efficacy of high-dose donepezil (23mg)\r in Parkinson's disease with dementia compared to standard dose donepezil.\n\n**Clinical Trial Detailed Description:**\n\nThis study is open-label, prospective, randomized paralleled study. The investigators\r evaluate the efficacy of high-dose donepezil in patients with Parkinson's disease with\r dementia (PDD) who have taken standard donepezil (10mg) for 12 weeks. The participants, who\r sign the informed consent, are assigned into two groups randomly (high-dose donepezil group\r and standard donepezil group). All participants will be maintained the medication for 24\r weeks and assessed cognitive function at 24 weeks. They will visit to clinic for 3 times (4,\r 12, 24 weeks) to assess cognitive function and adverse event. After the end of study, all\r participants were administrated by standard dose donepezil again.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria :\r\n\r - Patients diagnosed as Parkinson's disease according to Queen Brain Bank criteria\r\n\r - Patients who have been diagnosed as dementia after diagnosing Parkinson's disease at\r least 1 year.\r\n\r - Patients with Hoehn and Yahr staging from 2 to 4\r\n\r - Patients with MMSE score from 10 to 24\r\n\r - Patients who have taken donepezil for at least 12 weeks before screening period\r\n\r - Patients whose medications for Parkinson's disease have not change for 1 month\r\n\r - Patients who give informed consent\r\n\r Exclusion criteria :\r\n\r - Patients who cannot be performed neuropsychiatric test because of hearing and visual\r difficulty\r\n\r - Patients who have taken medicine affecting cognitive function such as anticholinergic\r drug and memantine -Patients diagnosed as dementia with Lewy body and vascular\r dementia-\r\n\r - Patients who have history of neurosyphilis, head trauma, encephalitis or other\r movement disorders\r\n\r - Patients who have psychiatric disease\r\n\r - Except patients who are stable state under antidepressant or atypical neuroleptics\r\n\r - Patients with child-bearing periods\r\n\r - Patients who have severe liver or kidney disease necessary for aggressive treatment\r\n\r - Patients who have gastrointestinal disease needed for treatment\r\n\r - Patients who cannot taken tablet per oral\r\n\r - Patients who are participated in other clinical trial except observational study\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,549
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nApplicability Clinic of Cement Portland Structural White in Endodontic Surgery\n\n**Clinical Trial Summary:**\n\nThirty teeth twelve patients, two female and a male, who had persistent periradicular lesions\r were selected to participate in this study. The lesions were diagnosed with cone-beam\r computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging Sciences International LLC).In\r patients with two teeth to be treated, a tooth was retroobturado with PBEA cement,\r (experiment) and another tooth was retroobturado with MTA cement (control).\r\n\r There was significance for the two cements on the repair of wounds. Key words: Apicoectomy;\r Oral Surgery; Biocompatible Materials; Dental Cements; Translational Medical Research\n\n**Clinical Trial Detailed Description:**\n\nObjective: to evaluate the clinical applicability of structural Portland white cement\r additive in retrofilling surgeries. Method: persistent apical periodontitis 30 teeth of 12\r patients were diagnosed by computed tomography CT, cone beam. Each of them had from two to\r four compromised teeth. The endodontic surgery were performed and the teeth were retrofilling\r Each patient had a retrofilling tooth with cement mineral trioxide aggregate (MTA) control\r and other tooth with white Portland cement structural additive (PBEA) experiment. When the\r patient presented four teeth with injury, two were retrofilling with MTA and two Portland\r cement with structural white cement additive. Six months after surgery, there were new scans\r to evaluate the repair or not the wounds.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - patients were diagnosed by computed tomography CT, cone beam\r\n\r - each of them had from two to four compromised teeth\r\n\r Exclusion Criteria:\r\n\r - patients who did not return for review after six months\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,550
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEvaluating the Influence of Externally vs. Internally Focused Exercise on Rehabilitation in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the underlying mechanism and influence of externally\r vs. internally focused exercise on rehabilitation in Parkinson's disease. The upcoming\r exercise intervention methodology will aim to meet the requirements of a 1A silver ranking\r level, single blind, randomized control trial according to the criterion of the Cochrane\r Musculoskeletal Review Group\n\n**Clinical Trial Detailed Description:**\n\nParkinson's disease is a slow progressing neurodegenerative movement disorder with both motor\r and non-motor symptoms. The gold standard medical pharmacotherapy (levodopa) lends relief\r from symptoms. However, some of the non-motor symptoms are not responsive to this therapy or\r eventually become non-responsive, such as impaired proprioception (sensory feedback from the\r limbs providing awareness of one's body in physical space). Although it is unclear as to why\r levodopa is unable to relieve proprioception impairments, a key underlying mechanism that may\r be responsible is an impaired sensorimotor integration (the combination of sensory and motor\r information in the brain utilized to guide movements). This is not the result of corrupted\r input information from proprioceptors into the brain (such as muscle spindles and golgi\r tendon organs), but rather the downstream integration of this information in the brain. With\r faulty signalling through the area of the brain damaged in Parkinson's disease (the basal\r ganglia), deficient sensorimotor integration impairs patients' ability to rely on sensory\r feedback during movement. This subsequently impairs ability to automatize learned movements\r in Parkinson's disease and causes previously automatic movements (such as walking) to require\r conscious control (lose automaticity). This is problematic in instances where attention is\r diverted from a movement that is no longer automatically controlled, such as engaging in a\r conversation while walking. Without attention on the movement, motor control breaks down,\r leading to heightened chance of falls and injury. However, Wulf and Colleagues (2009)\r demonstrated that when individuals with Parkinson's disease focused externally, and greater\r reliance on sensorimotor integration was fostered, balance control was improved compared to\r when these individuals focused attention internally. This suggests that individuals with\r Parkinson's disease may retain ability to rely on sensorimotor integration. Therefore, by\r fostering neuroplasticity through the basal ganglia with the utilization of exercise, and\r improving ability to rely on sensorimotor integration in individuals with Parkinson's disease\r (by using dual task training), automaticity of movements may be improved, subsequently\r decreasing the risk of falling and injury. Furthermore, by improving sensorimotor\r integration, symptom severity might improve and disease progression may slow.\r\n\r In addition to providing improvements to symptoms of Parkinson's disease, this will provide a\r greater understanding into the pathophysiological mechanisms underlying improvements\r associated with exercise rehabilitations employed for Parkinson's disease. To date,\r goal-directed exercises have yet to investigate the rudimentary aspects of the exercise,\r since no studies have directly compared identical exercise regimens while participants focus\r \"internally\" on the movements of their limbs compared to focusing \"externally\" on the\r movement of an object that is being manipulated. For this reason, this study will investigate\r large magnitude gait and balance training in two groups, one focusing internally on limb\r movements throughout the exercise program, and the other focusing externally on the movement\r of coloured labels attached to their limbs. The gait, balance, stretching and coordination\r exercises that will be provided in the proposed intervention to the two exercise groups will\r follow the exact Parkinson's disease Sensory Attention Focused Exercise (PD-SAFEx™) protocol\r designed by Sage and Almeida (2009). PD-SAFEx™ is a group setting intervention, which will be\r led by the primary investigator who is trained in conducting the exercise protocol. The first\r half of the exercise class will include walking exercises that include large magnitude and\r coordinated movements. All walking will be performed slowly. Walking exercises will be\r followed by balance, stretching, and coordination exercises while sitting in, or standing\r near, standard office chairs, utilizing latex Thera-bands®. To ensure that balance and\r coordination are constantly challenged throughout the intervention, the exercise program\r progresses each week, increasing in difficulty.\r\n\r Sixty-five participants diagnosed with idiopathic Parkinson's disease will be recruited. This\r present intervention study will span over a 20- week period. Pre-assessments to measure\r baseline symptoms and functionality will be conducted over the initial 2-week period prior to\r the start of the intervention. After pre-assessments have been conducted, participants will\r be randomized to one of three groups:\r\n\r Group 1: Internal Focus of attention Exercise (Original PD-SAFEx™) While performing the\r exercises in PD-SAFEx™, participants will be instructed to focus their attention on sensory\r feedback. This will include focusing participants' attention on the stretch in their limbs\r while walking, on the straightness of their backs while sitting, on limb and body orientation\r in space while coordinating their movements, and on chest movements during breathing\r exercises. Throughout each exercise session, the instructor and volunteers will constantly\r provide attention-directing instructions.\r\n\r Group 2: External Focus of attention Exercise (Modified PD-SAFEx™) While performing the\r exercises from the PD-SAFEx™ program, participants will be instructed to focus their\r attention towards the movement of coloured labels attached to their hands, elbows, knees and\r feet.\r\n\r Group 3: Control Group This group will be asked to refrain from changing activities of their\r daily lives throughout the 20-week duration of the experiment (from pre-assessment to\r washout).\r\n\r The exercise program will follow the pre-assessment baseline measures, and will last 12\r weeks. Each exercise session will last 60 minutes, and will be provided three times per week.\r Post-assessment of all outcome measures tested prior to the intervention will be assessed in\r a 2-week period immediately after the cessation of the exercise program. The washout period\r will last 6 weeks; thereafter assessments will be completed again. Since the present research\r study aims to understand the mechanism underlying these rehabilitations, as well as ensure\r ecological validity, symptom severity (UPDRS-III) will be assessed in all individuals in both\r the \"ON\" and \"OFF\" state of dopaminergic medication. Since the individuals are in the \"ON\"\r state during all daily activities, exercise classes will be performed in the \"ON\"\r dopaminergic medication state. If there are individuals who are naïve to dopaminergic\r medication (De novo), they will only be assessed once (in the \"OFF\" dopaminergic state). All\r individuals included in the rehabilitation program will be required to complete a Physical\r Activity Readiness Medical Examination (ParMed X), signed by a physician prior to joining the\r rehabilitation program.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Either gender, no age or location restriction\r\n\r - Diagnosed with idiopathic Parkinson's disease by a Neurologist\r\n\r - Able to stand 2 minutes, unassisted\r\n\r - Able to walk 10 meters, unassisted\r\n\r - Able to understand English instructions\r\n\r Exclusion Criteria:\r\n\r - A neurological disease other than Parkinson's disease\r\n\r - Peripheral neuropathy\r\n\r - Clinically diagnosed with dementia\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
35,551
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment\n\n**Clinical Trial Summary:**\n\nProstate cancer is the most common cancer in men in the United Kingdom (UK) with over 40,000\r men diagnosed each year. Prostate cancer (PrCa) can run in some families and research studies\r have identified several genetic changes that are thought to increase the risk of developing\r prostate cancer. This study aims to look at the potential risk of these changes in targeted\r screening. Some of these changes may cause a very slight increase in prostate cancer risk\r while others may cause a much larger increase in risk of developing prostate cancer. The\r investigators will invite men with a family history of prostate cancer for targeted prostate\r screening (Prostate Specific Antigen (PSA) testing and a biopsy of the prostate gland) and\r genetic profiling. This research will help us to determine what the risk of cancer is for men\r who have inherited these genetic changes and also increase our knowledge about the role of\r genetics in developing prostate cancer targeted screening. Some of these changes may cause a\r very slight increase in prostate cancer risk while others may cause a much larger increase in\r risk of developing prostate cancer.\r\n\r The investigators will invite men with a family history of prostate cancer for targeted\r prostate screening (PSA testing and a biopsy of the prostate gland) and genetic profiling.\r This research will help us to determine what the risk of cancer is for men who have inherited\r these genetic changes and also increase our knowledge about the role of genetics in\r developing prostate cancer.\n\n**Clinical Trial Detailed Description:**\n\nPurpose and Design\r\n\r The aim of the PROFILE study is to investigate the role of targeted prostate cancer screening\r in men with a family history of the disease and with the role of specific genetic profiles\r and biomarkers (both biological samples and DWMRI). This study has been designed using an\r observational approach to look at the correlation of cancer incidence (on biopsy) with\r genetic profile. The aim is to evaluate targeted screening for prostate cancer in men with a\r family history of the disease, to estimate the incidence of prostate cancer and the\r sensitivity and specificity of PSA screening in these populations and correlate this with\r single nucleotide polymorphism (SNP) profiles and biological endpoints.\r\n\r Two cohorts will be recruited:\r\n\r 1. Men with family history of prostate cancer.\r\n\r 2. Men of AfroCaribbean descent.\r\n\r Men with no prior screening will be offered immediate biopsy and genetic profiling. This will\r provide data on genetic profiling and correlation with biopsy irrespective of PSA in men who\r have not had any previous screening.\r\n\r A PSA screening algorithm was considered as an alternative to biopsy but there is great\r controversy over the PSA threshold that should be used as a cut-off. Recent data have shown\r that a considerable percentage of men with a PSA within normal range have cancer at biopsy.\r Therefore it has been decided by the Steering Committee that all participants should be\r offered a biopsy within this study. This will tell us the acceptability of this approach.\r\n\r Some men may opt not to have biopsy. These men will be followed up six monthly PSA and biopsy\r performed if PSA is above or equal to 1.0ng/ml if the man is aged under 50 years, or where\r PSA is above or equal to 2.0ng/ml if the man is aged fifty years or over.\r\n\r Eligibility and Recruitment\r\n\r Men with either:\r\n\r 1. A positive family history of PrCa defined as:\r\n\r - Men with a first degree relative (or second degree if through female line) with\r histologically or death certificate proven PrCa diagnosed at <70 years\r\n\r - Men with two relatives on the same side of the family with histologically or death\r certificate proven PrCa where at least one is diagnosed at <70 years\r\n\r - Men with three relatives on the same side of the family with histologically or\r death certificate proven PrCa diagnosed at any age\r\n\r 2. Of African or Caribbean ancestry defined as:\r\n\r Both parents and all 4 grandparents from that origin\r\n\r - Age 40- 69 years\r\n\r - WHO performance status 02 (see Appendix A)\r\n\r - Absence of any psychological, familial, sociological or geographical situation\r potentially hampering compliance with the study protocol and follow up schedule.\r\n\r Exclusion criteria\r\n\r - Previous cancer with a life expectancy of less than five years.\r\n\r - Previous PrCa\r\n\r - Negative biopsy within one year before recruitment\r\n\r - Comorbidities making prostate biopsy risk unacceptable (Warfarin or Clopidogrel).\r\n\r - Contraindications to having an MRI (pacemakers, aneurysm clips, claustrophobia)\r\n\r Subject Withdrawal\r\n\r o Subjects may withdraw from the study at any time if they so wish without giving a reason.\r No further data will be collected about that individual, and any unused samples will be\r destroyed. Data collected up to that point will be retained for audit purposes.\r\n\r Cancer cases Men who are found to have prostate cancer at biopsy will be referred to their\r local urologist for treatment according to local policy. Men will be followed up for 10 years\r in order to evaluate the different treatment regimens.\r\n\r Genetic Profiling All men will have genetic profiling to correlate with disease status and\r men will be given the results of this test. It will be emphasised that these are research\r results and written information will be provided as a reference guide.\r\n\r Informed Consent All subjects will be informed of the aims of the study, the possible adverse\r events, the procedures and possible hazards to which he will be exposed, and the mechanism of\r treatment allocation if prostate cancer was to be diagnosed. He will be informed as to the\r strict confidentiality of his patient data, but that his medical records may be reviewed for\r trial purposes by authorised individuals other than their treating physician.\r\n\r It will be emphasised that the participation is voluntary and that the subject is allowed to\r refuse further participation in the protocol whenever he wants. This will not prejudice the\r subject's subsequent care. Documented informed consent will be obtained, according to the\r principals of good clinical practice (GCP), for all subjects included in the study before\r they are registered onto the study.\r\n\r Risks, burdens, benefits There is a risk of complications from having a prostate biopsy, and\r these complications are detailed in the patient information sheet, together with likelihood\r of incidence. Complications are rare and standard procedures will be followed at all sites to\r minimise their occurrence. The benefit of taking part may be that prostate cancer may be\r diagnosed in men previously unaware that they had the disease. While there is the potential\r for overdiagnosis of indolent disease, there is also the potential for detecting and treating\r clinically significant disease.\r\n\r Provision of results from the genetic profiling One further consideration is the occurrence\r of anxiety as a result of taking part in the study, particularly in receiving research\r genetic test results. There is considerable uncertainty about how genetic profile relates to\r predicted risk of prostate cancer. For this reason individualised written information will be\r provided to each participant putting the research results in the context of the current\r population risks. It will be stressed that these are research results only and that the\r investigators do not fully understand the meaning of the results.\r\n\r A psychosocial study is being run concurrently and will explore these issues in more depth\r and the participant's experience of receiving these results will be an important component of\r the evaluation of this study.\r\n\r Confidentiality All information which is collected will be accessible only to the immediate\r study team. Any data that is shared will be de-identified and any published data will be\r anonymised so that no participant is recognisable from the results.\r\n\r Medical records and the data collected for the study may be looked at by authorised persons\r from the Institute of Cancer Research, by regulatory authorities and by authorised people to\r check that the study is being carried out correctly. All will have a duty of confidentiality\r to participants.\r\n\r End of Study Follow-up After the participant has completed the study they will be advised\r about any ongoing screening or follow-up that is required. This will be organised through the\r participants general practitioner (GP).\r\n\r Use of samples in future research The informed consent process will explain that samples are\r donated as a \"gift\". If any of the samples collected are to be considered for use in future\r research projects this would have to be approved by the Ethics Committee first.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Men with either:\r\n\r 1. A positive family history of PrCa defined as:\r\n\r - Men with a first degree relative (or second degree if through female line) with\r histologically or death certificate proven PrCa diagnosed at <70 years\r\n\r - Men with two relatives on the same side of the family with histologically or\r death certificate proven PrCa where at least one is diagnosed at <70 years\r\n\r - Men with three relatives on the same side of the family with histologically or\r death certificate proven PrCa diagnosed at any age\r\n\r 2. Of African or Caribbean ancestry defined as:\r\n\r Both parents and all 4 grandparents from that origin\r\n\r - Age 40- 69 years\r\n\r - WHO performance status 02 (see Appendix A)\r\n\r - Absence of any psychological, familial, sociological or geographical situation\r potentially hampering compliance with the study protocol and follow up schedule.\r\n\r Exclusion Criteria:\r\n\r - Previous cancer with a life expectancy of less than five years.\r\n\r - Previous PrCa\r\n\r - Negative biopsy within one year before recruitment\r\n\r - Comorbidities making prostate biopsy risk unacceptable (Warfarin or Clopidogrel).\r\n\r - Contraindications to having an MRI (pacemakers, aneurysm clips, claustrophobia)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,552
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nImpact of Community Health Workers on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico\n\n**Clinical Trial Summary:**\n\nThis study evaluates the effectiveness of community health workers when added to routine care\r for patients with diabetes and high blood pressure in rural clinics in Chiapas, Mexico. It\r does so by recording information on adherence to therapy, blood pressure and hemoglobin A1c\r while a non-governmental organization working in Mexico trains and introduces a community\r health worker program.\n\n**Clinical Trial Detailed Description:**\n\nCompañeros en Salud (CES), an affiliate project of Partners in Health, has been working in\r the rural Sierra of Chiapas, Mexico since February 2012. CES works in partnership with the\r local Ministry of Health to rehabilitate and staff existing government primary care clinics.\r Each community's clinic is staffed by one CES project physician year-round. CES activities\r span the range of allopathic medicine, but the focus of the project is in the prevention,\r detection, diagnosis and management of non-communicable diseases (NCDs) such as diabetes and\r hypertension. CES currently operates in several rural communities with catchment areas of\r approximately 1,500 - 2,500 people. Routine care for NCDs is based on national guidelines and\r consists of monthly in-clinic visits by primary care physicians.\r\n\r Over 9 months in 2014 and again over 6 months in 2016, CES will introduce a community health\r worker program called \"Acompañantes\" to its project communities to augment care of patients\r with NCDs. Acompañantes are lay health workers and members of the community who bridge the\r gap between project clinics and patients, improving understanding of NCDs, their treatments,\r and adherence to therapy. The introduction of Acompañantes to communities is planned in a\r once-every-three-months fashion, the most rapid roll-out logistically feasible for CES. The\r investigators' project will document their experience over this time, and for one year after\r introduction of the Acompañantes program to all seven study communities, by documenting\r adherence to therapy, hemoglobin a1c, and blood pressure at every-three month intervals over\r this time frame.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Formal diagnosis of Type II Diabetes Mellitus, Stage I or II Hypertension or both\r\n\r - Daily medications required for patient's condition\r\n\r - Residence and receipt of therapy within the study catchment area\r\n\r - Age greater than or equal to 18 years.\r\n\r Exclusion Criteria:\r\n\r - Known or suspected secondary hypertension\r\n\r - Known or suspected Type 1 diabetes\r\n\r - Pregnancy\r\n\r - Chronic use of glucocorticoids.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,553
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nLong-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS\n\n**Clinical Trial Summary:**\n\nOur recent study (Xie et al, Neurology 2015; 84: 415-420) found that bilateral STN DBS of\r 60Hz, compared to the traditional 130Hz, decreased the aspiration frequency and swallowing\r difficulty, freezing of gait (FOG), and other axial symptoms and parkinsonism in Parkinson\r patients with FOG refractory to 130Hz and medications. The benefit of 60Hz stimulation\r persisted during the 6-week study period, but with worsening tremor in one patient. However,\r it remains unknown whether the benefit of 60Hz would persist on prolonged stimulation period,\r and whether there is carry-over effect across different conditions. Hence, the investigators\r would like to test the hypothesis that the 60Hz stimulation, compared to 130Hz might have\r persistent benefit over an extended period in reducing the swallowing dysfunction, FOG, and\r other axial symptoms in these PD patients even after correcting the potential carry-over\r effect.\n\n**Clinical Trial Detailed Description:**\n\nThe investigators will enroll 14 Parkinson patients with bilateral STN DBS and refractory FOG\r to 130Hz stimulation and dopaminergic medications for two visits of at least 6-month apart.\r The 6 patients remaining on 60Hz stimulation after our previous study consisting of 7\r patients will be assessed once again as visit-2 after previous visit-1 of their last study.\r We anticipate to have 20 patents complete for visit-1 and at least 18 patients complete for\r visit-2 in this randomized double-blind prospective crossover study with their usual\r medication \"on\" state, with 6-7 patients on each starting condition (60Hz vs 130Hz vs DBS\r off). Swallowing function on modified barium swallowing test and swallowing questionnaire,\r FOG in stand-walk-sit test and questionnaire, and other axial and motor function on UPDRS-III\r will be assessed under each DBS condition. Changes in measurements between 60Hz and 130Hz at\r each visit and under 60Hz between two visits will be analyzed, with swallowing function and\r FOG as primary, and the rest as secondary outcomes, correcting for potential carryover\r effect. Changes between other DBS conditions might also be explored in this 2-year study.\r\n\r This would be the first study on the long-term effect of 60Hz stimulation on dysphagia, FOG\r and other axial and motor symptoms in Parkinson patients with bilateral STN DBS and FOG\r refractory to 130Hz stimulation and dopaminergic medications, which will have significant\r impact on the treatment of difficult axial symptoms of high morbidity and mortality.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - PD patients with bilateral STN DBS placement and FOG at 130Hz even at usual medication\r \"on\" state.\r\n\r Exclusion Criteria:\r\n\r - Known history of recent aspiration pneumonia\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,554
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPF-06669571 In Subjects With Idiopathic Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThis study is designed to assess safety, tolerability and pharmacokinetic data for multiple\r doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study\r will assess whether PF-06669571 is able to demonstrate superior efficacy compared with\r placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence\r of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or\r bradykinesia).\r\n\r - Must be Hoehn & Yahr Stage II-III inclusive and experiencing motor fluctuations in the\r form of end-of-dose wearing off during the morning hours or early morning akinesia.\r\n\r - Subjects should be able to recognize their \"wearing off\" symptoms and verify that they\r usually improve after their next dose of Parkinson's disease medication. Subjects\r should be able to recognize drug-induced dyskinesias and verify whether or not they\r are troublesome.\r\n\r Exclusion Criteria:\r\n\r - History or clinical features consistent with an atypical parkinsonian syndrome, (for\r example: ataxia, dystonia, clinically significant orthostatic hypotension.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,555
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSystemic Synuclein Sampling Study (S4)\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to measure alpha-synuclein in peripheral body tissues and fluids\r in Parkinson's disease (PD). This may help in developing better treatments for PD patients in\r the future.\n\n**Clinical Trial Detailed Description:**\n\nThis is a multi-center, cross-sectional, observational study to evaluate α-syn pathology in\r multiple tissues and biofluids in individual subjects with PD and HC at a single time point.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria (PD subjects):\r\n\r - Male or female age 40 or older at the time of PD diagnosis.\r\n\r - Clinical diagnosis of PD based on bradykinesia plus one of the following: rest tremor\r or rigidity.\r\n\r - DAT deficit at screening based on visual interpretation of DaTSCAN™ imaging.\r\n\r - PD subjects will need to fall into one of the following stages:\r\n\r - Early untreated PD not requiring dopamine replacement medication\r (anticholinergics, MAO-B inhibitors and amantadine permitted), Hoehn and Yahr\r 1-2, < 2 years from diagnosis.\r\n\r - Moderate PD responsive and currently treated with dopamine replacement therapy\r without evidence of motor fluctuations or dyskinesias.\r\n\r - Advanced PD with motor fluctuations or dyskinesias, > 5 years from diagnosis.\r\n\r - Ability to provide written informed consent in accordance with Good Clinical Practice\r (GCP), International Conference on Harmonization (ICH), and local regulations.\r\n\r - Willing and able to comply with scheduled visits, required study procedures and\r laboratory tests.\r\n\r Inclusion Criteria (HC subjects):\r\n\r - Male or female age 50 or older at the time of the screening visit\r\n\r - Ability to provide written informed consent in accordance with Good Clinical Practice\r (GCP), International Conference on Harmonization (ICH), and local regulations.\r\n\r - Willing and able to comply with scheduled visits, required study procedures and\r laboratory tests.\r\n\r Exclusion Criteria (all subjects):\r\n\r - Has a history of cancer (other than basal and squamous cell skin cancers), autoimmune\r disorder, liver disease, or other hematological disorder within the past 5 years.\r\n\r - Current treatment with anticoagulants (e.g., Coumadin, heparin) that would preclude\r safe completion of the lumbar puncture (LP) and tissue biopsy procedures.\r\n\r - Current treatment with an antiplatelet agent (Plavix or aspirin >325 mg/day).\r\n\r - Has a diagnosis of diabetes mellitus requiring either an oral agent or insulin\r therapy.\r\n\r - A bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\r\n\r - Has received botulinum toxin injections to the submandibular gland within the past\r year.\r\n\r - Has a condition that precludes safe performance of routine LP, such as prohibitive\r lumbar spinal disease.\r\n\r - Has a condition that precludes the safe performance of the flexible sigmoidoscopy\r procedure or may interfere with obtaining evaluable colonic tissue biopsies, including\r a prior colonoscopy with significant findings (e.g. polyp with a positive finding,\r ulcerative colitis, Crohn's disease, inflammatory disease).\r\n\r - Has a condition that precludes the safe performance of the submandibular gland\r procedure or may interfere with obtaining evaluable submandibular tissue biopsies,\r including any previous or active significant disease affecting the submandibular gland\r (e.g. inflammatory disease, infection, tumor).\r\n\r - Has a condition that precludes the safe performance of the skin punch biopsy procedure\r or may interfere with obtaining evaluable skin tissue biopsies, including any previous\r or active significant dermatological disease (e.g. previous biopsy with any of the\r following findings: inflammatory disease, scar tissue, psoriasis, keloid formation,\r skin cancer).\r\n\r - Any other medical or psychiatric condition or laboratory abnormality, which in the\r opinion of the Site Investigator would preclude participation.\r\n\r - Use of investigational drugs or devices within 30 days prior to the screening visit.\r\n\r Exclusion criteria (PD subjects):\r\n\r - Has other significant neurological disorders (clinically significant stroke, brain\r tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis,\r repeated head trauma, polyneuropathy).\r\n\r - Has significant autonomic dysfunction (symptomatic orthostasis, hypotension or urinary\r incontinence) suggestive of an atypical parkinsonism.\r\n\r - Has atypical features of parkinsonism including but not limited to supranuclear gaze\r palsy, early recurrent falls, corticospinal track abnormalities, cerebellar\r abnormalities, significant cognitive dysfunction.\r\n\r Exclusion criteria (HC subjects):\r\n\r - Has a family history of PD in any first-degree relative.\r\n\r - Has a significant neurological disorder (a neurodegenerative condition, clinically\r significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative\r disorders, encephalitis, repeated head trauma, polyneuropathy).\r\n\r - Has a Montreal Cognitive Assessment (MoCA) score of less than 26.\r\n\r - Has a diagnosis of REM sleep behavior disorder.\r\n\r - Has a primary dystonia, restless legs syndrome, essential tremor, or other movement\r disorder.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,556
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nVariable Frequency Stimulation of Subthalamic Nucleus for Freezing of Gait in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThis is the first study on the effect of the variable frequency stimulation (VFS) on Freezing\r of gait (FOG) in Parkinson's disease (PD) patients with STN DBS. FOG has responded poorly to\r High frequency stimulation (HFS) but can be alleviated by relatively VFS. This study would\r have significant clinical implications in the management of Freezing of gait (FOG) in these\r PD patients with subthalamic nucleus (STN) DBS. The investigators hypothesize that VFS could\r have better effect on FOG than HFS and low frequency stimulation (LFS).\n\n**Clinical Trial Detailed Description:**\n\nHFS of STN provides consistent, long-term improvement of the cardinal motor signs of PD, such\r as bradykinesia, tremor and rigidity. FOG has responded poorly to HFS and tends to continue\r to deteriorate over time, but this can be alleviated by relatively LFS. Evidence has\r indicated that LFS-STN can improve axial signs in some but not all PD patients, but most of\r them experienced loss of efficacy in the short term. Then comes to the little improvement or\r even worse of tremor, rigidity and bradykinesia, which consists of the three main symptoms of\r Parkinson's disease. Thus even if axial problems could be solved by LFS in a long way, it\r could also be hard to tolerate by those patients. The effect of VFS on FOG will be studied.\r The investigators hypothesize that VFS could have better effect on Freezing of gait than HFS\r and LFS.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients were receiving bilateral STN stimulation for more than six months.\r\n\r 2. They were optimized on conventional HFS for control of tremors, rigidity and\r bradykinesia yet complained of freezing of gait.\r\n\r 3. Subjects had an ability to walk at least 10 meters independently during ON DBS\r condition.\r\n\r Exclusion criteria:\r\n\r 1. gait disorders perceived by patients as a direct consequence of STN stimulation and\r not the primary disease.\r\n\r 2. any change in the HFS DBS settings, three months prior to participation in the study.\r\n\r 3. complete inability to walk despite assistance while DBS ON.\r\n\r 4. Subjects responding to reprogramming of chronic DBS settings (report improvement of\r freezing).\r\n\r 5. Subjects could not tolerate prolonged OFF medication condition.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
35,557
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAllogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to assess the safety, feasibility, and efficacy of intravenous\r allogeneic bone marrow-derived mesenchymal stem cell (MSC) therapy for idiopathic Parkinson's\r disease (iPD).\n\n**Clinical Trial Detailed Description:**\n\nAllogeneic bone marrow-derived mesenchymal stem cells (MSCs) will be delivered intravenously\r at one of four doses: 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg\r of body weight to a population of patients with idiopathic Parkinson's disease (iPD). The\r infusion will be at 1 week after the baseline visit, following two screening visits. Patients\r will be followed until 52 weeks after the infusion visit. The safety of the therapy, as well\r as the impact of the therapy on the rate of Parkinson's disease (PD) progression, will be\r assessed.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Men and women between the ages of 45 and 70. The 45-year-old age cutoff ensures that\r we do not enroll juvenile PD patients.\r\n\r - Diagnosis of Parkinson disease by the United Kingdom (UK) brain bank criteria\r including the presence of 2 cardinal signs of PD plus bradykinesia. Diagnosis will be\r confirmed by the PI or other specialists in Movement Disorders and based on medical\r history, physical and neurological exams. Patients should have an asymmetric onset,\r unilateral symptoms and a negative pull test. (See Appendix A)\r\n\r - Moderate to severe microsmia (UPSIT <29).\r\n\r - A modified Hoehn and Yahr stage of 3 or less in the levodopa OFF state. (See Appendix\r B)\r\n\r - Diagnosis of PD between 4 to 7 years.\r\n\r - Robust response to dopaminergic therapy (defined as greater than 33% reduction in\r symptoms (on the Unified Parkinson's Disease Rating Scale; UPDRS) when measured in the\r ON medicine state compared to OFF state.\r\n\r - If subject is taking any central nervous system acting medications (e.g.,\r benzodiazepines, antidepressants, hypnotics) regimen must be optimized and stable for\r 90 days prior to the screening visit.\r\n\r - A stable Parkinson's disease symptomatic therapy for at least 90 days prior to\r screening and not projected to require additional Parkinson's disease symptomatic\r therapy for at least one year from the baseline visit.\r\n\r - Women of childbearing potential will be required to use a reliable form of\r contraception from 30 days prior to baseline visit until 6 months after the final dose\r of the study drug.\r\n\r Exclusion Criteria:\r\n\r - Atypical or drug-induced Parkinsonism.\r\n\r - A UPDRS rest tremor score of 3 or greater for any limb.\r\n\r - A Montreal Cognitive Assessment (MoCA) score of less than 25. (See Appendix C)\r\n\r - Clinical features of psychosis or refractory hallucinations.\r\n\r - Uncontrolled seizure disorder, defined as a seizure within the last 6 months.\r\n\r - Developmental delay.\r\n\r - Chronic kidney disease defined as glomerular filtration rate (GFR) < 50 mL/min/m2.\r\n\r - Hepatic disease or altered liver function as defined by alanine transaminase (ALT)\r >150 U/L and or T. Bilirubin >1.6 mg/dl at admission.\r\n\r - Presence of clinically refractory orthostatic hypotension at the screening or baseline\r visit defined as greater than or equal to 20 mmHg change in systolic BP and greater\r than or equal to 10 mmHg change in diastolic BP from sitting position to standing\r after 2 minutes that does not respond to medical treatment or baseline sitting BP less\r than 90/60.\r\n\r - History of congestive heart failure, clinically significant bradycardia, presence of\r 2nd or 3rd degree atrioventricular block.\r\n\r - Pulmonary disease: chronic obstructive pulmonary disease (COPD) with\r oxygen-requirement at rest or with ambulation; or moderate to severe asthma.\r\n\r - Active malignancy or diagnosis of malignancy within 5 years prior to the start of\r screening (Cancer free for at least 5 years is permitted; skin cancers, except for\r melanoma, are permitted).\r\n\r - Any diagnosis of autoimmune disease or immunocompromised state, including chemotherapy\r administration within last 3 years or current immunosuppression as defined by white\r blood cell (WBC) <3 x 103 cells/ml.\r\n\r - History of strokes or traumatic brain injury.\r\n\r - Major surgery within the previous 3 months or planned in the ensuing 6 months.\r\n\r - Clinically significant abnormalities in the Screening Visit laboratory studies.\r\n\r - History of use of an investigational drug within 30 days prior to the screening visit.\r\n\r - History of brain surgery for PD.\r\n\r - Unable to return for follow-up visits for clinical evaluation, laboratory studies, or\r imaging evaluation.\r\n\r - Substance abuse disorder.\r\n\r - Active anticoagulation treatment.\r\n\r - Any other condition that the investigator feels would pose a significant hazard to the\r patient if enrolled or complicate the study assessments.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"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\nSubthalamic Stimulation in Tourette's Syndrome\n\n**Clinical Trial Summary:**\n\nThe main objective of this project is to evaluate the efficacy of subthalamic nucleus deep\r brain stimulation (STN DBS) in treating motor and phonic tics in medically refractory\r Tourette's syndrome (TS).\r\n\r Secondary objectives are to individuate and standardize the best electrical parameters for\r STN stimulation in TS, to evaluate the efficacy and safety on non-motor TS features, such as\r behavioral abnormalities and psychiatric disorders, during chronic STN stimulation, to\r correlate the improvement of TS motor and non-motor symptoms to the modification in brain\r activity recorded by PET study and to explore the pathophysiology of TS, and to evaluate the\r safety of STN DBS in TS patients.\n\n**Clinical Trial Detailed Description:**\n\nBackground Tourette's syndrome (TS) is characterized by the occurrence, before 18 years of\r age, of multiple motor and vocal tics, which do not necessarily occur concomitantly. Tics\r constitute the clinical hallmark of TS; they are sudden, brief, intermittent involuntary (or\r semi-involuntary) movements (motor tics) or noises (sound tics). Tic severity is variable:\r some patients have mild or bearable tics, whereas in others tics are so severe to cause bone\r fractures or cervical myelopathy. Diagnostic criteria set by the Tourette Syndrome\r Classification Study Group and the American Psychiatric Association are commonly used. It is\r currently recognized that TS is far more common than previously thought, with a prevalence of\r 1 to 10 children of adolescents per 1000.\r\n\r Tics are usually treated in cases where disability at school, in the social environment or at\r home is severe enough to warrant medical intervention. TS commonly presents with co-morbid\r features, mainly consisting in obsessive-compulsive traits, attention deficit with\r hyperactivity disorder and depression. Psychopathologic features are partly an aftermath of\r tics, particularly in those patients who display severe tics affecting their social and work\r activities. Therefore, amelioration of tics may substantially improve daily life and\r adaptation to social and work environments.\r\n\r Medication is the first choice treatment, with the aim to reduce the intensity of tics and\r the associated clinical features. Different drugs, belonging to several pharmacologic\r classes, such as α-adrenergic drugs, typical and atypical neuroleptics, and tetrabenazine are\r used. In some cases drug treatment provides satisfactory symptomatic benefit. Overall, it is\r reckoned that a meaningful proportion of TS patients do not have adequate benefit with drug\r treatment and the majority of patients have side effects of variable severity.\r\n\r Ablative psychosurgery has been historically used to treat more severe cases of TS, but the\r results have been disappointing and burdened by irreversible side effects. The recently\r developed technique of deep brain stimulation (DBS) allows to selectively modulate the\r activity of brain structures that control movements and behaviors in patients with different\r neurological disorders. This approach is warranted in those patients who respond poorly to\r available medical therapy.\r\n\r Recently, therapeutic DBS trials have been performed in patients with severe TS, who were not\r satisfactorily controlled by medication. At first, the same thalamic nuclei targeted by\r ablative surgery, particularly the centromedian-parafascicular (CM-pf) nuclear complex, have\r been implanted with some success.\r\n\r Another anatomical target has been the anterior capsule in proximity of the nucleus accumbens\r or the nucleus accumbens itself, aiming at interfering with tics and obsessive-compulsive\r features at the same time. More recently, the globus pallidus internum (GPi) has been\r implanted. This constitutes the main output station of the basal ganglia towards the thalamus\r and the cerebral cortex.\r\n\r Hypothesis driven rationales\r\n\r 1. There is preliminary evidence that the subthalamic nucleus can be another promising\r target in treating motor and non-motor feature of TS. A clinical observation has\r recently shown that STN DBS improved motor and vocal tics in a patient with consistence\r of Parkinson's disease and TS\r\n\r 2. Literature evidences have showed that stereotyped behaviors in nonhuman primates,\r resembling tics and compulsive disorders, were related to dysfunction of the limbic\r parts of the globus pallidus externum, the STN, and the SN reticulata, rather than to\r dysfunction of the GPi\r\n\r 3. From a physiologic perspective, STN occupies a privileged position influencing both\r output nuclei of the basal ganglia, GPi and substantia nigra (SN) reticulata. Several\r findings have highlighted the putative role of the STN in integrating emotional,\r cognitive and motor functions and this nucleus would thus be an effective target for the\r treatment of conditions that combine motor symptoms, behavioral disorders,\r obsessive-compulsive disorders\r\n\r 4. Involvement of the SN in TS was also found in a functional MRI study. Furthermore,\r stimulation of the anterior STN was effective in reducing stereotypes in a primate model\r of behavioral disorder and STN DBS in PD can also result in behavioral changes. Indeed,\r the small size of this nucleus may allow modulation of abnormal neuronal activity of\r both limbic and sensorimotor territories, more easily than GPi or thalamic DBS\r\n\r 5. The small and well-defined volume of the STN combined with well standardized implant\r techniques, would lead to a reduced inter-patient variability in targeting\r\n\r The novelty of the project The STN may be a potential target for DBS in TS. The choice of STN\r as a target for this project is the current model of basal ganglia functioning: this\r anatomical location aims at modulating the sensory-motor, associative and limbic subdivisions\r of cortico-subcortical-cortical loops that are thought to be dysfunctional in TS. STN DBS may\r provide a quicker relief of symptoms than medial thalamic nuclei or GPi stimulation.\r\n\r The main objective of this project is to evaluate the efficacy of subthalamic nucleus deep\r brain stimulation (STN DBS) in treating motor and phonic tics in medically refractory\r Tourette's syndrome (TS).\r\n\r Secondary objectives are to individuate and standardize the best electrical parameters for\r STN stimulation in TS, to evaluate the efficacy and safety on non-motor TS features, such as\r behavioral abnormalities and psychiatric disorders, during chronic STN stimulation, to\r correlate the improvement of TS motor and non-motor symptoms to the modification in brain\r activity recorded by PET study and to explore the pathophysiology of TS, and to evaluate the\r safety of STN DBS in TS patients.\r\n\r Clinical evaluation will include a complete neurological examination (videotaped tic scales\r throughout), a structured psychological interview and a psychiatric evaluation. Quantitative\r evaluations will be performed using appropriate validated neurological (including the Yale\r Tic Global Severity Scale (YTGSS) and neuropsychological rating scales, including the\r Yale-Brown Obsessive Compulsive scale (Y-BOCS), as detailed hereafter.\r\n\r Neurological evaluations\r\n\r - Tourette's motor and phonic tics checklist\r\n\r - YTGSS\r\n\r - Global assessment scale (GAS)\r\n\r - Global Clinical Impression Scale (GCI-S)\r\n\r - Sickness Impact Profile (SIP)\r\n\r - Gilles de la Tourette syndrome-quality of life scale (GTS-QOL)\r\n\r Behavioral evaluations\r\n\r - Y-BOCS\r\n\r - Depression (MADRS, HAM-D)\r\n\r - ADHD and Anxiety (ADHD-RS, HAM-A)\r\n\r Neuropsychological evaluations\r\n\r - Global deterioration\r\n\r - Executive functions\r\n\r - Working memory\r\n\r - Fluency\r\n\r Power calculation. A retrospective analysis of published data on DBS-treated TS patients\r reports an average YGTSS at inclusion of 50 ±15 points. This is in keeping with our inclusion\r criteria of YGTSS >35. Considering a 50% improvement as meaningful, a 25-point variation is\r expected from baseline to post-implant in the active stimulation group and a 10% 5-point\r variation in the sham stimulation group. The investigators assume a comparable standard\r deviation at baseline and at end of the observational periods and a good correlation of YGTSS\r measures (correlation coefficient: 0.8). An actual number of at least 5 patients per group\r should allow to demonstrate a 25-point YGTSS difference between the two active stimulation\r and the sham stimulation groups, with a statistical potency of 85% (bilateral\r Mann-Whitney-Wilcoxon test, alpha = 5 %).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age at least of 18 years (with potential exceptions)\r\n\r - Diagnosis of TS based on the diagnostic criteria of the Tourette Syndrome\r Classification Study Group\r\n\r - A Yale Tic Global Severity Scale (YTGSS) > 35/50 for at least 12 months, with tic\r severity documented by a standardized videotape assessment\r\n\r - Inadequate response to standard drug treatment or botulinum toxin\r\n\r Exclusion Criteria:\r\n\r - Diagnosis of secondary tic disorder, of heredodegenerative or neurometabolic diseases\r or history of toxic exposures or encephalitis\r\n\r - Previous surgery for TS (with potential exceptions)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,559
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nNon-motor Symptoms and Brain Dopamine Transporter Binding\n\n**Clinical Trial Summary:**\n\nThis project aims to clarify the role non-motor symptoms in the development of Parkinson's\r disease (PD) and to improve diagnostics at very early stages of PD. The project involves\r multidimensional measures of disease biomarkers together with brain dopamine transporter\r (DAT) imaging with [123I]FP-CIT single photon emission computed tomography (SPECT).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or Female\r\n\r - Age 18-100 years\r\n\r - Referred for clinical DAT SPECT in Turku or Helsinki\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,560
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPrevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)\n\n**Clinical Trial Summary:**\n\nThis is a randomized sham-controlled double-blind study to test the hypothesis that\r transcranial static magnetic field stimulation (tSMS) of the motor cortex improves\r levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will\r receive real tSMS treatment, the other half will receive sham treatment (placebo).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - advanced idiopathic Parkinson's disease (Brain Bank criteria)\r\n\r - optimal clinical response to dopaminergic medication (>30% UPDRS-III improvement)\r\n\r - presence of clinically relevant levodopa-induced peak-dose dyskinesias in at least one\r upper limb\r\n\r Exclusion Criteria:\r\n\r - MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)\r\n\r - other main neuropsychiatric co-morbidity\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,561
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPreventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate\n\n**Clinical Trial Summary:**\n\nChlorthalidone (CTD) may produce various metabolic disturbances, including hypokalemia,\r activation of Renin-Angiotensin- Aldosterone (RAA) system, oxidative stress, dyslipidemia,\r Fibroblast growth factor 23 (FGF23) synthesis, and magnesium depletion. These factors may\r interact with each other to contribute to the development of insulin resistances and\r metabolic syndrome. Smaller studies have suggested that Potassium magnesium Citrate (KMgCit)\r can ameliorate CTD- induced metabolic side effects independent of correction of hypokalemia.\r This study will tests if KMgCit ameliorates CTD induced metabolic effects independent of\r correction of hypokalemia.\n\n**Clinical Trial Detailed Description:**\n\nCTD- induced metabolic side effects were though to be dependent on hypokalemia, but\r subsequent studies suggested that CTD - induced side effects were independent from\r hypokalemia. On the other hand, magnesium depletion has been linked to increased\r Renin-Angiotensin- Aldosterone (RAA) system, the development of metabolic syndrome and\r insulin resistance with magnesium supplementation ameliorating these effects.\r\n\r Participants will participate in a double-blinded, parallel design study. After baseline\r evaluation participants will take Chlorthalidone (CTD) alone for 2-3 weeks. They will then be\r randomized to two equal groups to take KMgCit powder or Potassium Chloride (KCl) powder along\r with CTD for 4 months.\r\n\r We speculate that Mg depletion is responsible for hepatic fat deposition, which then produces\r insulin resistance. Co-administration of KMgCit powder would avert magnesium (Mg) depletion,\r block hepatic fat deposition by restoring normal Mg status and direct intestinal binding of\r fat, thereby ameliorating insulin resistance. To test this hypothesis, we shall quantitate\r muscle Mg status and hepatic fat content by magnetic resonance spectroscopy (MRS) before and\r after KMgCit. Change in fasting glucose, insulin resistance, serum potassium, FGF23, and\r aldosterone will be compared between KCL and KMgCit groups after 4 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r • Treated or untreated stage I hypertension\r\n\r Exclusion Criteria:\r\n\r - Diabetes mellitus,\r\n\r - Renal impairment (serum creatinine > 1.4 mg/dL),\r\n\r - Any heart diseases such as congestive heart failure, sustained arrhythmia, or coronary\r heart disease,\r\n\r - Chronic regular NSAID use,\r\n\r - Allergy to thiazide diuretics,\r\n\r - Gastro-esophageal reflux disease (GERD) requiring treatment with acid reducing agents\r or antacid more than once a week,\r\n\r - Esophageal-gastric ulcer or history of gastrointestinal bleeding,\r\n\r - Chronic diarrhea, vomiting,\r\n\r - Excessive sweating,\r\n\r - Unprovoked hypokalemia (serum K < 3.5 mmol/L) or hyperkalemia (serum K > 5.3 mmol/L),\r\n\r - Abnormal liver function test (Aspartate transaminase (AST) or Alanine transaminase\r (ALT) above upper limit of normal range),\r\n\r - Subjects on any potassium supplement on a regular basis for any reason, such as\r patients with primary aldosteronism,\r\n\r - Pregnancy,\r\n\r - History of major depression, bipolar disorder, or schizophrenia,\r\n\r - History of substance abuse,\r\n\r - Gout,\r\n\r - Metabolic alkalosis, with serum bicarbonate > 32 meq/L,\r\n\r - Severe dietary salt restriction, less than1/2 spoonful or 50 meq sodium/day.\r\n\r - Patient with Claustrophobia will not have MRI but can still participate in the study\r without MRI\r\n\r - Metal implants will not have MRI but can still participate in the study without MRI\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,562
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nGADGET-PD Genetic and Digital Diagnosis of Essential Tremor and Parkinson's Disease Trial\n\n**Clinical Trial Summary:**\n\nThe proposed study will capitalize on the early predictive information stored in an\r individual's genetic risk for Parkinson Disease (PD) in combination with the subtle features\r of tremors that can be extracted from movement data gathered by modern compact accelerometers\r in order to determine if accurate discrimination of essential tremor (ET) from PD can be\r achieved. Both of these technologies have a proven but somewhat limited ability to inform\r diagnosis of PD or differentiation of PD from ET - especially at early stages of the disease.\r The investigators hypothesize that a combination of prior genetic risk and current disease\r symptomology can synergize for accurate and early discrimination of PD from ET and ultimately\r inform a cost effective approach to movement disorder diagnosis.\r\n\r In this study, the investigators will collect blood from individuals with confirmed\r late-onset diagnosis of PD and ET. Gold standard diagnosis status will be determined via the\r Unified Parkinson's Disease Rating Scale (UPDRS) - the accepted clinical gold standard for\r Parkinson's Disease diagnosis. DNA will be extracted from blood samples to characterize the\r genetic risk of individuals for PD via proven genetic risk models. In addition, participants\r will wear a wristwatch-like accelerometer device that will track their movements (tremors) at\r high temporal resolution and transmit movement data via a smartphone. Cognitive distraction\r tasks will be administered via mobile phones while simultaneously collecting movement data.\r Predictive tremor features will be extracted from movement data via signal processing\r approaches - e.g. discrete wavelet transformation. A final predictive model combining\r movement tracking information and genetic information will be designed in attempt to\r distinguish PD from ET individuals.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Idiopathic Parkinson's Disease as defined by the UK brain bank criteria and history of\r resting tremor, or:\r\n\r - Essential Tremor with history of resting tremor. Diagnosis made by a movement disorder\r specialist.\r\n\r - Midstage in disease process for Parkinson's disease with history of resting tremor\r\n\r Exclusion Criteria:\r\n\r - Dementia as defined by a mini-mental state examination cutoff score of 27\r\n\r - Atypical Parkinsonism\r\n\r - Akinesia/ rigidity Parkinson's Disease\r\n\r - Movement Disorders - Stiff-Person syndrome, choreatic disease, dystonia, progressive\r supranuclear palsy\r\n\r - Motor neuron disease - Multiple sclerosis, amyotrophic lateral sclerosis, motor\r neuritis, progressive bulbar palsy, progressive muscular atrophy, spinal muscular\r atrophy\r\n\r - Significant neurological comorbidities:\r\n\r - Stroke\r\n\r - Brain cancer or brain metastases\r\n\r - History of bone marrow transplant\r\n\r - Cerebral palsy and spastic paraplegia\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,563
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nInitiating and Maintaining Physical Activity in Depressed Individuals\n\n**Clinical Trial Summary:**\n\nThe investigators propose a randomized clinical trial in which 240 depressed individuals are\r assigned to one of three arms, with each successive arm having an added component that may\r serve to increase and maintain physical activity:\r\n\r 1. brief advice (BA) to exercise (control condition);\r\n\r 2. BA + supervised & home-based exercise (SHE) + health education (HE) contact control; and\r\n\r 3. BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise\r (CBEX).\r\n\r The primary aim is to assess and optimize the safety, feasibility, acceptability of each\r intervention component, as well as barriers limiting their effectiveness in order to prepare\r for a larger scale randomized clinical trial.\n\n**Clinical Trial Detailed Description:**\n\nThe investigators propose a randomized clinical trial in which 240 depressed individuals are\r assigned to one of three arms, with each successive arm having an added component that may\r serve to increase and maintain physical activity:\r\n\r 1. brief advice (BA) to exercise (control condition);\r\n\r 2. BA + supervised & home-based exercise (SHE)+health education (HE) contact control; and\r\n\r 3. BA+SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise\r (CBEX).\r\n\r There are two phases for participants: intervention phase (3 months), which consists of\r intensive contact, and the follow-up phase (6 months). BA will consist of one, 45-minute\r session about public health recommendations, and strategies for getting started. SHE will be\r a 12-week intervention consisting of 1x/week supervised exercise plus exercise prescriptions\r for home-based exercise with the goal of gradually achieving the public health recommendation\r of 150 minutes/week of moderate-to-vigorous physical activity (MVPA), CBEX and HE sessions\r will be individual, 30-minute, weekly sessions during the intervention phase. CBEX will\r address barriers to physical activity that are particularly pronounced in depression -i.e.,\r anhedonia, decreased motivation, and decreased energy, as well as poor problem-solving\r skills. During the follow-up phase, groups who received SHE during the intervention phase\r will receive brief, monthly phone check-ins from an exercise specialist.\r\n\r Primary Aims:\r\n\r 1. To compare the efficacy of the 3 arms for increasing physical activity during the\r 12-week intervention phase. We hypothesize that BA + SHE + CBEX will be superior to BA +\r SHE + HE, and that BA + SHE + HE will be superior to BA alone in terms of objectively\r measured MVPA levels.\r\n\r 2. To compare the longer-term impact of the three arms on objectively-measured minutes of\r MVPA at 6- and 9-month follow-ups (i.e., follow-up phase). Hypotheses are the same as\r for the intervention phase (aim #1).\r\n\r Secondary Aims:\r\n\r 3. To assess the impact of proposed intervention combinations on depression, physical\r health outcomes including cardiorespiratory fitness and body composition, and\r self-reported MVPA in all phases. Hypotheses mirror those described in our primary aims\r above.\r\n\r 4. To determine whether amount of MVPA mediates the association between group assignment\r and change in depressive symptoms. We hypothesize that amount of MVPA will serve as a\r mediator.\r\n\r 5. To examine behavior change theory-based mediators of the association between group\r assignment and MVPA. Hypothesized mediators include: perceived benefits of exercise,\r perceived barriers to exercise, exercise self-efficacy, intrinsic motivation to\r exercise, and identified motivation to exercise.\r\n\r 6. To examine whether social and environmental barriers to exercise predict exercise\r maintenance.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Sedentary, i.e., have not participated regularly in moderate-to-vigorous physical\r activity (MVPA) for 90 minutes per week or more for the past 12 weeks.\r\n\r 2. Medically cleared for MVPA, documented by a note from their primary care provider.\r\n\r 3. No significant medical condition or physical disability that would interfere with\r physical activity or study participation. The investigators will exclude individuals\r with significant cardiovascular disease, hematologic disorders, and autoimmune\r disorders. The investigators will also exclude individuals who are planning a surgery\r in the next 9 months and those with dementia.\r\n\r 4. Elevated depression symptoms. To meet criteria for elevated symptoms, participants\r must have a QIDS score of 10 or greater (i.e., at least moderate depression levels),\r and must have a score of \"1\" or greater on at least one of the two core DSM-V\r depressive symptoms, i.e., sad mood or anhedonia. -\r\n\r 5. No current bulimia or anorexia (past 3 months); no history of bipolar disorder,\r schizophrenia, or a chronic psychotic condition (assessed using the SCID).\r\n\r 6. No hazardous drug or alcohol use in the past 6 months, as assessed by: a. no substance\r abuse treatment in the past 6 months; and b. does not meet criteria for a substance\r use disorder in the past 6 months.\r\n\r 7. Depression is not very severe, i.e., QIDS score is < 20.\r\n\r 8. No suicidality requiring immediate treatment.\r\n\r 9. Not pregnant or planning on becoming pregnant in the next year.\r\n\r 10. Understands English sufficiently well to consent and complete study assessments.\r\n\r 11. Aged 18-65.\r\n\r 12. Able to make one of the 2 available exercise class times.\r\n\r 13. Able to walk 1 mile\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,564
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMapping Functional Networks of Brain Activity Using EEG in Patients With Essential Tremor or Parkinson Disease Before and After MR-guided Focused Ultrasound Thalamotomy for Tremor\n\n**Clinical Trial Summary:**\n\nA cornerstone in PD and ET research is the investigation of neurophysiological changes as\r potential bio-markers that could help in tracking disease progression and response to\r therapy. Electroencephalography (EEG) could provide a non-invasive and relatively inexpensive\r tool for identification of such bio-markers. In this study the investigators will use\r high-density electroencephalographic (EEG) recordings, in order to develop a platform of\r sensitive and reliable bio-markers for disease progression and response to MR-guided Focused\r ultrasound thalamotomy (FUS-T) intervention for tremor.\n\n**Clinical Trial Detailed Description:**\n\nParkinson's disease (PD) is a common neurodegenerative disease the neurochemical hallmark of\r which is dopamine deficiency in nigrostriatal pathways, and characterized clinically by a\r movement disorder consisting of rest tremor, bradykinesia, rigidity, impairment of postural\r reflexes and gait difficulties. The disease may leads to severe neurological dysfunction\r within several years.\r\n\r Essential tremor (ET) is a neurological disorder characterized by the presence of action\r tremor in different body parts mainly in the hands, head, larynx (voice box), tongue, and\r chin. The lower body is rarely affected.\r\n\r INSIGHTEC uses MR guided Focused Ultrasound to perform a \"non-invasive\" thalamotomy to\r relieve medication refractory tremor in patients with ET or tremor-dominant PD. The effect of\r MRgFUS is based on tissue destruction targeted to the Vim nucleus of the thalamus which\r enables a highly accurate and controlled thermal effect.\r\n\r Ultrasound energy is delivered across the skull, without an incision or craniotomy, heating\r the targeted tissue above the protein denaturation threshold at temperatures near 60°C. Prior\r to the delivery of high temperatures, destructive sonication delivery of lower energy focused\r ultrasound allows for proper anatomic localization, as well as physiologic evaluation of\r symptom relief and/or any unwanted side effects. This process allows for adjustments before\r making a permanent lesion. Treatment effects are immediate and the several hour treatment is\r generally well tolerated with mild sedatives.\r\n\r The FUS-T procedure was shown as an efficacious procedure for tremor in both ET patients and\r PD patients; Elminda developed an algorithm of Brain network activation (BNA) Mapping\r Functional Networks of Brain Activity Using EEG.\r\n\r Studying brain morphology and function with Neuroimaging and electrophysiological measures is\r critical for our understanding of the pathology and pathophysiology of PD and ET.\r\n\r The BNA network can shed a lite on the brain connectivity changes that occur as a result\r treatment in neurological patients, in this case patients with either PD or ET tremor going\r through FUS-T.\r\n\r BNA can help understanding the effects of FUS-T on the brain physiology and perhaps to\r identify biomarkers that may serve as tools for chosing the best candidates for this\r treatemnt and optimal treatment parameters.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with essential Tremor and unilateral tremor-dominant Idiopathic Parkinson's\r Disease -undergoing ExAblate 4000 Transcranial MR guided focused ultrasound (TcMRgFUS)\r thalamotomy).\r\n\r Exclusion Criteria:\r\n\r - In the investigator's opinion, any unstable or clinically significant condition that\r would impair the participants' ability to comply with study requirements.\r\n\r - Patients with significant psychiatric symptoms or history\r\n\r - Treatment with neuroleptics.\r\n\r - Currently with lice or open wounds on scalp.\r\n\r - Significant sensory deficits, e.g., deafness or blindness\r\n\r - Current drug abuse or alcoholism.\r\n\r - Pregnancy or not using a reliable method of birth control\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,565
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTreatment of OSA Associated Hypertension With Alpha 2 Agonist or Diuretic\n\n**Clinical Trial Summary:**\n\nPatients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep.\r They often develop high blood pressure. We are not sure what drug is best to treat the high\r blood pressure. This study will give the patients guanfacine or hydrochlorothiazide (HCTZ)\r for 6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24\r hour monitoring.\n\n**Clinical Trial Detailed Description:**\n\nThis is a blinded crossover study measuring the antihypertensive efficacy of guanfacine vs\r HCTZ in up to 34 subjects. Subjects with an apnea-hypopnea index (AHI) > 10 and hypertension\r can enter the study. Hypertension is defined as a systolic blood pressure (SBP) > 140 or a\r diastolic blood pressure (DBP) > 90 on the average of three seated blood pressure\r measurements or a history of medical therapy for hypertension. Subjects who have tried and\r abandoned continuous positive airway pressure (CPAP) therapy for sleep apnea are eligible for\r this study. All others will be advised that CPAP is preferred treatment for sleep apnea and\r are eligible only if they decline CPAP or use it for too short a time at night to be\r effective.\r\n\r Then patients will have their antihypertensive drugs tapered off and receive single blind\r placebo for two weeks. After that, all subjects receive guanfacine or HCTZ for six weeks with\r a full evaluation at that time. Subjects are crossed over to HCTZ 12.5 mg for 2 weeks\r followed by HCTZ 25 mg for 4 more weeks Guanfacine 1mg will be taken daily at bedtime for 2\r weeks and then as a dose of 2 mg for the remaining 4 weeks. Subjects will receive a telephone\r call at the time of increased dosage as a reminder. Blood, urine and 24-hour blood pressure\r measurements, hemodynamic measurements, questionnaires and drug accountability are measured\r in the same manner toward at the the end of placebo and each drug treatment. The entire study\r will take 14 weeks, although each study period may be lengthened by one week if necessary for\r the convenience of the subject's personal schedule.\r\n\r Patients will provide blood pressure readings from their home monitor or in clinic and will\r not have the dose increased if they have systolic blood pressure below 105 mm Hg or side\r effects, such as excessive somnolence, drowsiness, or depression, suggesting that an\r increased dose might worsen side effects\r\n\r At the end of each treatment period, subjects will undergo noninvasive hemodynamic testing.\r Ultrasound will be used to measure aortic diameter and blood velocity in the ascending aorta\r in order to better estimate cardiac output. Then, finger plethysmography will be used to\r acquire beat-to-beat finger blood pressure and pulse rate. Beat-to-beat derived hemodynamic\r variables will be calculated by a model flow algorithm (e.g. brachial artery flow, stroke\r volume, cardiac output, ejection time, blood pressure rate of change, peripheral resistance).\r Applanation tonometry will be used to obtain pulse wave velocity and central arterial\r pressure. ECG will be recorded with standard ECG leads to determine heart rate variability in\r both time and frequency domains. Spontaneous baroreflex will be determined from beat-to-beat\r changes in blood pressure and pulse pressure interval. Forearm reactive hyperemia will be\r used to quantify endothelial dysfunction during 4 minutes of post-ischemic change. Subjects\r will then complete an Epworth Sleepiness Scale questionnaire (ESS) and a Functional Outcomes\r of Sleep Questionnaire (FOSQ) to find whether they are drowsy in the daytime and if they feel\r that they are compromised by not having adequate rest. Any adverse event will be recorded.\r They are asked about any concurrent medication over the prior period, including prescription\r medication, over the counter medication, and caffeine intake. Medication compliance is\r evaluated by pill count. Those who fail to return their pill bottle are requested to bring it\r in. Finally, a 24-hour ambulatory blood pressure monitor (ABPM) will be attached to\r automatically collect blood pressure and heart rate values every 15 minutes during the wake\r period and every 30 minutes during the sleep period.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients ranging from 20 - 80 years\r\n\r 2. Body mass index (BMI) of 20-38 to include the typical obese OSA patients and avoid the\r practical difficulties in blood drawing from the massively obese\r\n\r 3. Hypertension with blood pressures > 140/90 but less than 180/105 mmHg.\r\n\r 4. Apnea-hypopnea index above 10\r\n\r Exclusion Criteria:\r\n\r 1. Receiving medications other than anti-hypertensives known to influence the sympathetic\r nervous system, sleep medicines (including heavy alcohol use) or drugs with adverse\r interactions with study medication.\r\n\r 2. Women who have premenstrual syndrome, or those who are pregnant or capable of\r pregnancy and unwilling to use effective non-hormonal contraception\r\n\r 3. Shift workers or have symptoms of narcolepsy, restless legs syndrome or insomnia, in\r order to minimize confounding effects of other sleep disorders\r\n\r 4. Have apneas which are primarily central\r\n\r 5. Have sleep fragmentation caused by syndromes such as chronic pain or movement\r disorders\r\n\r 6. Have diseases such as asthma or chronic obstructive pulmonary disease that compromises\r respiration.\r\n\r 7. Have known coronary or cerebral vascular disease, history of arrhythmias,\r cardiomyopathy, history of psychosis, current alcohol or drug abuse.\r\n\r 8. Have any contraindications to any study materials, such as heart block.\r\n\r 9. Have secondary hypertension\r\n\r 10. Have creatinine levels above 2.5 mg %, more than 1+ proteinuria by dipstick, hematuria\r or electrolyte disorders.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,566
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nParkinson's KinetiGraph, PKG in Patients With Deep Brain Stimulation and Continuous Levodopa Infusion Therapy\n\n**Clinical Trial Summary:**\n\nIn this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and\r continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by\r using Parkinson's KinetiGraph™ device which is a movement and acceleration measuring device.\r In this study we also evaluate the usability of Parkinson's KinetiGraph™ device by comparing\r it with written patient diaries.\n\n**Clinical Trial Detailed Description:**\n\nIn this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and\r continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by\r using Parkinson's KinetiGraph™ logger (PKG) device which is a movement and acceleration\r measuring device.\r\n\r A measurement is done before and after the implantation of selected therapy. PKG will measure\r automatically in every two minutes the movement of selected limb (usually the more affected\r upper extremity) for six days. At the same time a patient will keep a written diary of\r his/her Parkinsonian symptoms. Diary and collected PKG data will be compared. PKG will also\r remind with vibration the patient of the time drug administration and the patient can confirm\r this with pressing a button on PKG. The collected data will be transmitted to a computer and\r analyzed mathematically to produce a visual graph of daily movements. The aim is to evaluate\r PKG's usability in measuring Parkinsonian symptoms and in evaluation the outcome of DBS and\r levodopa therapy. Main parameters in evaluation are bradykinesia score and dyskinesia score.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient with diagnosed Parkinson's disease\r\n\r - Parkinson's disease is in advanced state (defined by the treating physician)\r\n\r - A good response with over 30 % improvement of scores in Unified Parkinson's disease\r rating scale part III in pre-DBS evaluation\r\n\r Exclusion Criteria:\r\n\r - Age older than 70 years (this is a clinical exclusion criteria for DBS treatment)\r\n\r - No history of psychosis or depression (this is a clinical exclusion criteria for DBS\r and intraduodenal levodopa therapy)\r\n\r - No diagnosed dementia (this is a clinical exclusion criteria for DBS and intraduodenal\r levodopa therapy)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,567
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nShoulder Disorders in Patients With Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nParkinson's disease (PD) is a multisystem neurodegenerative disorder that is increasingly\r recognized in our ageing population. It is characterized by cardinal clinical features\r including bradykinesia, tremor, rigidity, and postural instability. For most people with PD,\r the most serious concern is with the motor system: stiffness, slowness of movement, impaired\r handwriting and coordination, poor mobility and balance. However, more than half of all\r people with PD have experienced painful symptoms. Most people experience aching, stiffness,\r numbness and tingling at some point in the course of the illness. Defazio et al reported that\r pain may begin at clinical onset of PD or thereafter as a non-motor feature of PD.5 Aching\r muscles and joints are especially common in PD. Rigidity, lack of spontaneous movement,\r abnormalities of posture and awkward mechanical stresses all contribute to musculoskeletal\r pain in PD.\n\n**Clinical Trial Detailed Description:**\n\nOne of the most common musculoskeletal complaints is shoulder pain or shoulder disorders,\r including frozen shoulder, bursitis, and rotator cuff lesions. Actually, shoulder pain or\r shoulder disorder can be the first sign of PD. The prevalence and severity of shoulder\r disorders in Parkinson's disease are not totally clear. In a retrospective study, Stamey\r found shoulder pain was present in 11% of patients with PD.\r\n\r Over the past ten years ultrasound (US) has become popular in the evaluation of shoulder\r disorders. It allows for the detailed assessment of a wide range of changes involving\r different anatomic structures of the shoulder joint, including rotator cuffs, biceps tendon,\r and subdeltoid bursa. Koh et al found among 33 PD patients, 22 patients had abnormal US\r findings on the dominant side, and all 22 patients with abnormal US finding had a tendon tear\r and 9 patients had frozen shoulder. However, there were no control group in Koh' s study, and\r diagnosis of frozen shoulder with US findings is still controversial.\r\n\r The purposes of this study are to evaluate patients with PD with a combination of physical\r examination and US study of the shoulder, and to compare the frequency and type of shoulder\r lesion in US between patients with PD and normal subjects. The investigators also plan to\r test the correlation between shoulder disorders or US abnormality and the severity of PD.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients fulfilled the diagnosis of PD, as described by the United Kingdom Parkinson's\r Disease Society Brain Bank,\r\n\r - Aged 50 to 80 years old.\r\n\r Exclusion Criteria:\r\n\r - Fracture or dislocation of the shoulder,\r\n\r - Previous shoulder joint surgery,\r\n\r - Severe medical comorbidities,\r\n\r - Cognitive impairment (Mini-Mental Status Examination < 24).\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,568
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nVestibular Stimulation in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine whether caloric vestibular stimulation improves\r symptoms of Parkinson's Disease.\n\n**Clinical Trial Detailed Description:**\n\nParkinson's Disease (PD) is a nationwide public health problem, inflicting a complex\r constellation of physical and neuropsychiatric symptoms which are shown to progress with\r time. This research will investigate the potential of caloric vestibular stimulation (CVS), a\r non-invasive form of brain stimulation, as a treatment for individuals who suffer from\r Parkinson's Disease. Investigators will investigate whether core cognitive and physiological\r deficits are responsive to stimulation by comparing participants' performance on behavioral\r and physiological measures after baseline and either active or placebo stimulation phases\r with the aim of drawing initial insights into the application of CVS within this population.\r The study design is based on a single-case study that recently demonstrated durable,\r clinically meaningful gains in the motor and cognitive symptoms of PD.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - diagnosis of Parkinson's Disease (as defined by the UK PDS Brain Bank Criteria) or\r atypical Parkinson's disease (aka Parkinsonism), comprising progressive supranuclear\r palsy, multiple system atropy and cortico-basal degeneration).\r\n\r - limitations to Activities of Daily Life (ADL, UPDRS subscale 2)\r\n\r - Capacity to consent to the study\r\n\r - good level of spoken English\r\n\r Exclusion Criteria:\r\n\r - Diagnosis of induced Parkinson's or essential/dystonic tremor\r\n\r - Premorbid psychiatric history (including affective disorder, psychosis or deliberate\r self- harm)\r\n\r - Previous exposure to neurostimulation\r\n\r - Inner ear pathology\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,569
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCirculating Tumor DNA in Patients at High Risk for Lung Cancer\n\n**Clinical Trial Summary:**\n\nPatients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic\r surgery without a distant history of cancer will have their blood drawn for measurement of\r circulating tumor DNA (ctDNA) to validate the utility of molecular diagnostic assays for the\r early detection of lung cancer.\n\n**Clinical Trial Detailed Description:**\n\nSpecific somatic (i.e. acquired and not inherited) mutations have been found in many cancers.\r Some of these cancers shed this DNA into the patient's blood stream and is called circulating\r tumor DNA (ctDNA). Pathway Genomics has developed a new molecular assay that uses blood\r plasma as the source of DNA fragments. The ctDNA is isolated, amplified and analyzed for the\r presence of one or more of 96 known mutations that are found in 9 cancer driver genes. This\r technique of using a \"liquid biopsy\" to screen for and monitor cancer has been documented in\r a number of recent medical publications. However, the majority of published studies are on\r subjects who have already been diagnosed with cancer. Therefore, the investigators wish to\r look at a population of patients who are scheduled to undergo a diagnostic or therapeutic\r bronchoscopy or thoracotomy without a know history of cancer (other than basal cell\r carcinomas of the skin). The blood will be drawn at the time of or a few weeks before the\r procedure. The analysis of the blood sample will take placed in the Pathway Genomics clinical\r laboratory which is Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified.\r\n\r Following an informed consent process, the patients will fill out a health questionnaire and\r will have the blood drawn prior to the surgical procedure. Up to 30 ml of blood\r (approximately 2 tablespoons) will be drawn at any one time. The patient will be asked to\r agree to being contacted by the investigators yearly for up to 5 years to provide follow-up\r medical information. No patient will be identified in presentations or publications resulting\r from this work and all data will be reported from analysis of combined information from\r participants in this study.\r\n\r Individuals may participate in this study if they are 18 years of age or older, have not had\r a prior diagnosis of cancer (other than a skin cancer or if they are undergoing the thoracic\r surgical procedure for a cancer that was diagnosed within the prior month), and are\r undergoing a diagnostic or therapeutic bronchoscopy or thoracotomy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - 18 years of age or older, not previously diagnosed with cancer (except for basal cell\r carcinomas of the skin or a diagnosis of cancer within a month of surgery and for\r which the surgical procedure is being performed).\r\n\r Exclusion Criteria:\r\n\r - Prior history of cancer.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,570
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nHandwriting Rehabilitation in Parkinson Disease\n\n**Clinical Trial Summary:**\n\nThe aim of the study is to evaluate the efficacy of an intensive handwriting treatment in\r Parkinson's Disease.\n\n**Clinical Trial Detailed Description:**\n\nThe investigators aimed to understand whether an intensive handwriting treatment with\r cognitive engagement is more effective than a treatment exploiting only the passive wrist\r joint mobilization in Parkinson's Disease.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Parkinson's Disease patients\r\n\r Exclusion Criteria:\r\n\r - Mini Mental State Examination (MMSE) score < 24\r\n\r - Left handed subjects\r\n\r - Subjects with dyskinesias\r\n\r - Subjects with Deep Brain Stimulation\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,571
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMental Practice in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nIntroduction Although drug therapy is the mainstay of treatment for Parkinson's disease, the\r therapy also has its importance by means of exercises which maintains the muscular activity\r and preserve mobility. One of the techniques that has been used for physical therapy is the\r mental practice of the mental simulation of movement, aiming at learning or improvement of\r motor skills through the cortex areas of activation responsible for the movement of\r preparation before it is executed. In patients with Parkinson's disease motor anticipation\r this system is compromised, culminating in the march changes and increased risk of falls.\r Objective: To evaluate the effects of mental practice on physical therapy on the march and\r the risk of falls in people with Parkinson's disease. Method: The study is defined as a\r randomized clinical trial with systematic recruitment. Recruitment will be conducted at the\r Clinic of Neurology, Hospital das clinics Federal University of Pernambuco (Pro-Parkinson\r Project: Neurology) and the intervention will be held at the same hospital physiotherapy\r clinic. Both the control group and the trial will be subjected to 15 therapy sessions twice a\r week, lasting 40 minutes for physical therapy and 15 for mental practice.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with clinical diagnosis of idiopathic Parkinson's disease\r\n\r - Male and female\r\n\r - Stage 1-3 of the Hoehn and Yahr scale.\r\n\r Exclusion Criteria:\r\n\r - Have other neurological diseases\r\n\r - They have decompensated systemic diseases\r\n\r - Musculoskeletal changes that prevent the achievement of movements\r\n\r - With lowering of the cognitive level assessed using the Mini-Mental State Examination\r with cutoff point according to education\r\n\r - With respiratory impairment\r\n\r - With medical restrictions for performing exercises\r\n\r - Do not get hold motor imagination during the application of Visual and Kinesthetic\r Imagery Questionnaire-10\r\n\r - In physical therapy, occupational therapy service for 3 months or more;\r\n\r - Patients with moderate to severe depression assessed by inventory Beck Depression\r Inventory\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,572
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAerobic Dance Training in Small Vessel Disease\n\n**Clinical Trial Summary:**\n\nIntroduction: Cerebral small vessel disease (SVD) is associated with age-related disabilities\r including dementia, depression, physical and functional impairment. Chinese are more prone to\r developing SVD than Caucasians. Physical exercise may improve multiple negative consequences\r associated with SVD.\r\n\r Objective and hypothesis to be tested: To examine the effects of a 24-week structured aerobic\r dance training on cognition, mood, physical and daily functions in stroke and dementia free\r older adults with SVD, and whether such effects are mediated through improved cerebral\r vasomotor reactivity (CVR), a marker of cerebral autoregulation which is impaired in SVD.\r\n\r Design and subjects: Rater-blind RCT comparing the effects of 24-week of structured aerobic\r dance training upon cognition, mood, physical and daily functions on 110 community dwelling,\r stroke- and dementia-free persons aged ≥65 with MRI evidence of significant SVD, defined as\r the presence of multiple (≥2) lacunes and/or early confluent or confluent WML.\r\n\r Interventions: Participants are randomized in a 1:1 ratio into a 24-week of structured\r therapist-led group aerobic dance training with home practice or simple stretching plus\r health education control group.\r\n\r Main outcome measures: Cognition, mood, physical and daily functions and CVR measured using\r Transcranial Doppler at baseline, weeks 12, 24 and 36.\r\n\r Data analysis: Intent-to-treat with multiple imputations with treatment efficacy analyzed\r using mixed effects models. Mediation effects of CVR between aerobic dance training and\r treatment outcomes tested using mediation models.\r\n\r Expected results: In persons with significant SVD, aerobic dance training improves cognitive,\r mood, physical and daily functions and such effects are mediated by changes in CVR.\n\n**Clinical Trial Detailed Description:**\n\nCerebral small vessel disease (SVD) is manifested as age-related white matter lesions (WML)\r and lacunar infarcts and on brain imaging. SVD is prevalent in the elderly population. In\r community dwelling persons ≥ 60 years of age, up to a quarter had lacunar infarcts and 96%\r had varying degree of WML. Significant SVD, namely early confluent or confluent WML and\r multiple lacunar infarcts, are found in up to 1 in every 5 elderly persons. In a previous\r study we found that Chinese are more prone to develop significant SVD than Caucasians. SVD is\r associated with a plethora of age-related disabilities such as dementia, falls, depression,\r impaired daily functioning and death Cognition - SVD is the most common cause of vascular\r cognitive impairment (VCI) and vascular dementia, which is the second most prevalent type of\r dementia. Community elderly persons with SVD had two-fold increased risk of developing\r dementia when compared to those without. SVD may direct damage neural structures, disrupt\r connectivity or cause atrophy in brain regions important for cognitive functioning.\r Depression - Disconnection of frontosubcortical pathways by SVD contributes to late-life\r depression, and increased comorbidity of depression and SVD has been observed in the older\r populations. Depression contributes to poor quality of life and death in older persons.\r\n\r Physical impairment - increased severity of SVD is associated with poor physical functions\r including poor gait and balance. SVD is a strong risk factor for falls, a major contributing\r factor for disability and death in older persons. In summary, non-disabled older adults with\r SVD are at high risk of multiple disabilities.\r\n\r As the elderly population in Hong Kong is projected to triple over the next 30 years, means\r to prevent age-related disabilities such as cognitive decline, depression and physical\r impairments in vulnerable individuals are of enormous importance to the patient, family and\r healthcare system. Existing preventive therapies mainly involve medications to control\r vascular risk factors associated with SVD. Primary prevention by means of lifestyle\r intervention is therefore of utmost importance.\r\n\r Evidence on effects of physical activities upon cognition, mood and physical functions The\r health values of physical activities are well recognized. Physical activities can be\r performed by anybody at any time and place at minimal cost. Physical activities are shown to\r improve the clinical conditions associated with SVD. For cognition, physical activities are\r associated with reduced risk of cognitive decline in normal and cognitively impaired elderly\r persons. Aerobic and strength training improved executive functions, memory and general\r cognitive functions in community-dwelling adults with mild cognitive impairment. The\r investigators showed that in a large cohort (n=1,013) of stroke patients free of dementia\r before the stroke, participation in regular physical activities reduced 79% of risk of\r incident dementia after stroke. With regard to the mechanism, physical activities may improve\r endothelial functions and blood perfusion and neuroplasticity in brain regions mediating\r cognitive functions. Moreover, physical exercise may protect cognition by reducing incident\r strokes, which is particular relevant to people with SVD due to their increased risk of\r strokes. A randomized controlled trial (RCT) showed that a 24-week, 3 x 50-minute per week of\r moderate intensity exercise intervention significantly improved cognitive functions in\r patients at risk of AD, with outcome effect size superior to that reported for drug treatment\r in another study. Moreover, treatment benefits persisted at least one year after active\r intervention, suggesting that physical exercise is associated with enduring changes in the\r neurological substrate underpinning cognitive functioning. However, this study only recruited\r patients likely to have degenerative (Alzheimer's) pathology. For mood, physical activities\r may protect against depression in older adults. For physical functions, the investigators\r previously showed that physical exercise training improved balance, gait performance,\r exercise endurance and quality of life in local patients with Parkinson's Disease (PD). Taken\r together, there is good evidence that physical activities can improve many of the negative\r consequences of cerebral SVD.\r\n\r Possible biological mechanism underlying physical exercise in SVD The development of SVD is\r hypothesized to be related to endothelial dysfunction that results from chronic hypertension\r impairs cerebral vasomotor reactivity (CVR), a marker of cerebral autoregulation. Changes in\r CVR may reflect impairment in the homeostasis of blood pressure in the brain, hence cerebral\r perfusion becomes more dependent on the systemic blood pressure. Ischemia occurs in response\r to drop of systemic blood pressure and lead to hypoperfusion and subsequently the development\r of SVD. Using Transcranial Doppler (TCD) ultrasonography, our group previously showed that\r decreased CVR is associated with SVD. Reduced CVR is linked to cognitive decline, depression\r and poor physical functions in elderly persons. Physical exercise may lead to significant\r improvement in CVR. These data suggest that physical exercise is likely to benefit cognition,\r mood and physical functions in persons with SVD due to its positive effects on CVR.\r\n\r Dancing as a mean of physical activity intervention Dance is a rhythmic movement usually\r performed with music. To many, it is a pleasurable activity that can be taken up as a hobby\r and social activity and therefore engagement can be self-sustaining. It is of minimal-cost\r and can be performed even in older persons with physical and cognitive impairment. Dancing\r involves movement of the body and limbs and is in itself a physical training. It also\r involves memory, attention, sensory stimulation, social interaction, emotional perception and\r expression that presumably could protect against cognitive decline and depression. Dance\r training may improve verbal fluency, word list delayed recall and word list recognition in\r older adults with metabolic syndrome, suggesting that dance may be effective in preventing\r cognitive decline. Aerobic dance also has been shown to enhance exercise endurance strength,\r balance, agility and gait performance in older adults. Our team had previously designed and\r implemented a balance dance to a group of patients with PD for 8 weeks. Together with other\r training, balance ability and walking speed increased and the effects lasted for 12 months\r after treatment completion. Given the likely positive effects of aerobic dance, it appears to\r be a good exercise candidate for enhancing cognitive, mood and physical functions in patients\r with cerebral SVD.\r\n\r Data Collection Assessment of cognitive functions The 30-minute protocol of the National\r Institute of Neurological Diseases and Stroke - Canadian Stroke Network VCI protocols will be\r used. The 30-minute protocol provides a comprehensive assessment of cognitive functions with\r emphasis on executive functions, psychomotor speed and memory, which are the cognitive\r domains predominately impaired in VCI. With support from Health and Health Service Research\r fund (PI: Vincent CT MOK; Reference Number 06070231), the investigators adapted and validated\r the 30-minute protocol in a group of Chinese stroke patients and controls and demonstrated\r good external validity (area under ROC=0.79 [95%CI 0.69-0.89], p<0.001) in differentiating\r stroke patients from non-stroke controls and concurrent validity with functional measures. In\r addition to the 30-minute protocol, the digit span tests from the Wechsler Memory Scale will\r be administered because of the involvement of immediate attention and working memory in VCI.\r\n\r Measure of depressive symptoms The 15-item Geriatric Depression Scale (GDS), which is a\r self-reported questionnaire to rate depressive symptoms in elderly persons, will be used. It\r has been used in local study on SVD patients and demonstrated excellent classification power\r >90% in detecting depression in the local elderly population.\r\n\r Measures of physical functions The Mini-Balance Evaluation Systems Test (Mini-BESTest) will\r be used to assess dynamic balance performance of individuals. The 14-item Mini-BESTest\r represents 4 dynamic balance domains: anticipatory postural adjustments, postural responses,\r sensory orientation and stability in gait. Each item is rated from 0 to 2, and the total\r score ranges from 0-28 with a higher score indicating better balance.\r\n\r The Timed-up-and-go test (TUG) will be used to examine functional mobility of subjects. This\r test measures the time which participants takes to rise from the chair, walk 3 meters, turn\r around, walk back to the chair and sit down.\r\n\r The 6-minute walk test will be used to determine the walking capacity. This test measures the\r distance (in metres) participants walk in 6 minutes. Participants will walk at their own\r speed, and stops and resting are allowed if necessary.\r\n\r Measure of daily functions The Lawton's Instrumental Activities of Daily Living (IADL) will\r be used to assess complex activities of daily functions that are impaired early in patients\r with SVD. It take about 10 minutes to administer and contains 8 items including ability to\r use telephone, shopping, food preparation, housekeeping, laundry, taking transportation,\r handling medications and finances. It is has been used as a primary outcome instrument in the\r Pan-European Leukoaraiosis and Disability in the Elderly Study in SVD.\r\n\r Measure of overall physical activities Physical activities performed outside of training\r session will be recorded using the long form of the International Physical Activity\r Questionnaire (IPAQ). The IPAQ has been very widely used in studies of physical activity\r across different ages and medical conditions (http://www.ipaq.ki.se/publications.htm). The\r IPAQ records the types, frequency and duration of physical activities across 4 activity\r domains including leisure time physical activity, domestic related physical activities,\r work-related and transportation related physical activities. The IPAQ yields scores for\r walking, moderate-intensity and vigorous-intensity activities with each of these activity\r domains. A total score is calculated by summing the duration and frequency for all types of\r activities across all domains. This score will be used to account for the potential\r confounding effects of physical activities performed outside of training session in both\r groups.\r\n\r It is estimated that it takes approximately 2 hours to complete the assessment and TCD\r examination. To avoid rater bias, the research assistant (RA) who performs the study\r assessment will be blind to treatment allocation and encouraged not to discuss with the\r participants about the interventions. Clinical assessments will be performed by a trained RA\r under the supervision of a qualified clinical psychologist (PI of this application).\r\n\r TCD Examination TCD examination will be performed at baseline, weeks 12, 24 and 36. A 2-MHz\r pulsed Doppler hand-held probe is used to insonate the middle cerebral artery (MCA) through\r temporal window above the zygomatic arch at a depth of 52-56mm, and the vertebral artery (VA)\r through occipital window at a depth of 64mm. The Pulsatility Index (PI) and Breath Holding\r Index (BHI) will be calculated. The PI is a measure of vascular resistance of cerebral\r vessels. The mean PI of the middle MCA and vertebral VA will be obtained. A previous study by\r the investigators showed that these measures highly differentiated stroke patients with and\r without WML on MRI (AUC = 0.85 [MCA] and 0.81 [VA], sensitivity and specificity between 70\r and 82%]). According to the standard protocol, the simple breath holding procedure will be\r performed during the same TCD session to obtain the BHI, which will serve as a marker of CVR.\r A trained postgraduate research student under the supervision of a broad certified\r neurologist (Co-A Vincent MOK) will perform the TCD blind to participant's treatment\r allocation.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age ≥65\r\n\r 2. Community dwelling\r\n\r 3. Presence of significant SVD, defined by the presence of multiple (≥2) lacunar infarcts\r and/or a rating of ≥2 (i.e. beginning confluence of lesions to diffuse involvement of\r lesions in periventricular and/or deep white matter) of WML using the Age-related\r White Matter Changes (ARWMC) Scale on MRI\r\n\r 4. Presence of good temporal window on at least one side for TCD evaluation\r\n\r 5. Written informed consent given\r\n\r Exclusion Criteria:\r\n\r 1. History of stroke\r\n\r 2. Dementia, determined by a score on Cantonese MMSE less than education adjusted cutoff\r score for dementia or history of dementia diagnosis\r\n\r 3. Comorbidity with medical conditions affecting the central nervous system or cerebral\r white matter\r\n\r 4. Inadequately controlled psychiatric disorders affecting cognition and mood\r\n\r 5. Physical or sensory impediments hindering participation in cognitive assessment or\r exercise training.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,573
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCompRest - a Comparison Between Sleep Compression and Sleep Restriction for Treating Insomnia\n\n**Clinical Trial Summary:**\n\nThis study includes two consecutive sub-trials.\r\n\r Cognitive Behavioral Therapy (CBT) is treatment of choice for Insomnia. One of the most\r important treatment Components in CBT for insomnia (CBT-i) is Sleep Restriction (SR), but\r lately, adverse effects related to SR have been reported. A treatment method with\r similarities to SR is Sleep Compression (SC). SC is not as well studied as SR, but appears to\r have similar effects to SR but without the adverse effects. The first sub-trial thus aims at\r directly comparing SR and SC. The second sub-trial aims at evaluating any additional effects\r of CBT-i components given as an add-on treatment to a randomized selection of half\r participants in each original treatment arm.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Clinical level of Insomnia (more than 10 on ISI)\r\n\r - Meets criteria for Insomnia Disorder according to DSM-V\r\n\r - Sufficient language skills\r\n\r - Having access to Internet to fill out forms and participating in treatment\r\n\r - Not foresee obstacles to participating in treatment during the coming 20 weeks, or\r participating in measurements during the coming year.\r\n\r Exclusion Criteria:\r\n\r - Sleep disorders requiring other treatment\r\n\r - High consumption of alcohol/drugs that affect sleep\r\n\r - Somatic or psychiatric conditions counter-indicative of treatments given in the study,\r requiring acute care, or with symptoms and level of functioning affecting the ability\r to participate in the treatment programs.\r\n\r - Working (night) shifts\r\n\r - Ongoing psychological treatment for Insomnia with sleep restriction or sleep\r compression as a treatment component - also previous such treatment can be excluding\r\n\r - Use of sleep medication in such a way that may hinder the implementation of the\r methods in this treatment\r\n\r - Pre-treatment measurements not finished within the given time-frame.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,574
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nComparison of Palonosetron Versus Combination of Palonosetron and Dexamethasone for Preventing Postoperative Vomiting in Patients Receiving Fentanyl by Patient-controlled Analgesia After Minor Orthopedic Surgery\n\n**Clinical Trial Summary:**\n\nPostoperative nausea and vomiting (PONV) is related with extended hospital day and risk\r factor of aspiration pneumonia. Postoperative patient controlled intravenous analgesia is\r related with postoperative nausea and vomiting. Selective 5-HT3 antagonist, Palonosetron, is\r the most recent medication for prevention of PONV. Purpose of our study is comparison of PONV\r preventive effect of palonosetron and combination of palonosetron and dexamethasone.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - patients who are undergoing minor orthopedic surgery.\r\n\r - IV patient controlled analgesia\r\n\r Exclusion Criteria:\r\n\r - 1. minority (0~19 year)\r\n\r - patients who are belongs to ASA class 3 or more, and have underlying complicated\r cardiovascular or psychological disease.\r\n\r - Steroid medication\r\n\r - Diabetes Mellitus medication\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,575
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nContinuous Behavior Assessment of the Effects of a Physical Therapy Program for Patients With Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nIntroduction: Parkinson's disease (PD) results from dysfunction of the dopaminergic system of\r degenerative and progressive, with changes in the nigrostriatal pathway, and decreased\r concentration of dopamine. Has as clinical signs, symptoms called cardinal engines: resting\r tremor, bradykinesia, rigidity and postural instability. In addition to drug therapy,\r physical therapy is also considered a useful tool for the treatment of motor disorders of the\r disease. The role of physiotherapy aims to stimulate the security and independence of\r patients with PD in carrying out activities and to preserve and improve physical function.\r Some studies have shown the negative effect of the disease on quality of life and functional\r mobility. Few studies have been conducted to evaluate the effects of long-term therapy in PD,\r but many report the beneficial effects of a rehabilitation program in a short period of time.\r\n\r Objective: To continually assess the effects after the completion of a physical therapy\r program in patients with Parkinson's disease.\r\n\r Methods: Type study randomized double blind clinical trial in Parkinson Pro Program Hospital\r of the Federal University of Pernambuco. Will be recruited subjects with PD, both sexes, in\r stages 1 to 3 on the scale of Hoehn Yahr and score greater than 18 on the Mini-Mental.\r Patients who are recruited will undergo an assessment using the scales of assessment of\r functional mobility, quality of life and motor examination before starting physical therapy\r at the end of treatment and two months after completion of treatment, and the intervals\r assessments of a month.\n\n**Clinical Trial Detailed Description:**\n\nThe Parkinson's disease results from dysfunction of the dopaminergic systems, cholinergic,\r serotonergic and noradrenergic, though the neuropathological basic pattern is the change of\r the nigrostriatal pathway, with decreased concentration of dopamine at the level of dopamine\r receptors in the body striatum.\r\n\r With still little known etiology in most instances, the Parkinson's disease has as clinical\r signs, symptoms called cardinal engines: resting tremor, bradykinesia, rigidity and postural\r instability. Additionally, patients may exhibit cognitive deficits and emotional changes with\r the progression of the disease.\r\n\r The clinical diagnosis is primarily based on the identification of the cardinal motor\r symptoms plus the initial response to levodopa therapy . The literature is unanimous in\r admitting that the use of Levodopa (L-dopa) is the most effective drug for the treatment, and\r its administration the most recommended in satisfactory symptom control.\r\n\r In addition to drug therapy, physical therapy is also considered a useful tool for the\r treatment of motor disorders associated disease. Although the speed of the motor of the\r patient learningParkinson's disease is lower than their control group of the same age,\r rehabilitation, these individuals may also acquire motor skills as well as improve their\r performance through practice repetition.\r\n\r Although a physical rehabilitation program to be beneficial to improve the activities of\r daily living (ADL) and mobility in patients with Parkinson's disease , it is not yet clear\r how long its effect is sustained. Most clinical trials of physiotherapy in PD were based on\r short-term rehabilitation programs.\r\n\r Few studies have been conducted to evaluate the effects of long-term physical therapy in\r Parkinson's disease, but many report the beneficial effects of a short-term rehabilitation\r program, without having to concern monitoring after the physical therapy.\r\n\r Thus this study aims to continuously evaluate the behavior of the effects of a physical\r therapy program in patients with Parkinson's disease.\r\n\r Knowledge of the time interval which is the decline of the gains from physiotherapy is a\r guiding point to guide the patient regarding their return to service for revaluation, also\r considering the fact that the disease have progressive.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients diagnosed with Idiopathic Parkinson's disease according to the Bank of London\r Brain (Hughes et al, 1992);\r\n\r 2. Both sexes;\r\n\r 3. Patients in stages 1 through 3 for this modified version of the Hoehn & Yahr scale\r (HY);\r\n\r 4. the patient Agreement to participate in the research after explanation and\r understanding of it and signing the Consent and Informed.\r\n\r Exclusion Criteria:\r\n\r 1. cognitive disorder identified by the Mini-Mental State Examination as schooling ;\r\n\r 2. Patients with other neurological diseases;\r\n\r 3. initiate other rehabilitative treatment throughout and after the physical therapy\r program.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
35,576
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nDefining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine the potential for a Parkinson's Disease (PD)\r -specific breath signature as a non-invasive screening tool for identifying PD patients with\r inflammation, tracking the progression of disease, and responsiveness to various therapeutic\r interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological\r disorders include any disorder involving the brain or the nervous system, for example memory\r disorders, stroke, movement disorders and many other conditions.\r\n\r The study will lay the foundation for future studies in which breath fingerprinting could be\r used as a screening technique. Investigators will also be looking at how the breath\r fingerprint correlates with inflammatory proteins in the blood.\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of this study is to determine the potential for a Parkinson's Disease (PD)\r -specific breath signature as a non-invasive screening tool for identifying PD patients with\r inflammation, tracking the progression of disease, and responsiveness to various therapeutic\r interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological\r disorders include any disorder involving the brain or the nervous system, for example memory\r disorders, stroke, movement disorders and many other conditions.\r\n\r The study will lay the foundation for future studies in which breath fingerprinting could be\r used as a screening technique. Investigators will also be looking at how the breath\r fingerprint correlates with inflammatory proteins in the blood.\r\n\r Investigators will determine how molecules in human breath can define a \"breath signature\"\r that can be associated with neurological disorders like Parkinson's disease. The long-term\r goal of this study is to use blood inflammatory marker relationships and Breath Analytical\r Approach to identify individuals at risk for development of neurologic disorders and to\r monitor the effects of immune interventions on the rate of disease progression.\r\n\r The study team will recruit a total of 100 participants: 50 early stage (defined by a Hohn &\r Yahr Stages 1-2), non-smoking Parkinson's Disease patients from among the Emory Movement\r Disorders Clinic and 50 age and sex-matched healthy controls (HC). Investigators will recruit\r six to eight participants per month over an 18-month time period.\n\n**Clinical Trial Eligibility Criteria:**\n\nParticipants with Parkinson's Disease (PD)\r\n\r Inclusion Criteria:\r\n\r - Must be capable of providing written informed consent\r\n\r - Non-smoking\r\n\r - Clinical diagnosis of PD Hohn & Yahr Stages 1 and 2\r\n\r Exclusion Criteria:\r\n\r - Cognitively impaired to the degree that they are not able to provide consent\r\n\r Healthy Controls\r\n\r Inclusion Criteria:\r\n\r - Must be capable of providing written informed consent\r\n\r - Age matched and a family member or healthy community control\r\n\r Exclusion Criteria:\r\n\r - Diagnosed with cancer and/or undergoing cancer treatment.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
35,577
|
[
{
"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 Endothelium A and EGFR Receptor in Fibrocytes From Asthma With Obstructive Sleep Apnea\n\n**Clinical Trial Summary:**\n\nThe investigators will compare the circulating fibrocyte proportion in asthmatic patients\r with obstructive sleep apnea (OSA) and not with OSA In addition, the investigators will\r compare the expression of epidermal growth factor receptor (EGFR), endothelin A receptor\r (ETAR) and connective tissue growth factor (CTGF) The association of those factors and annual\r decline of forced expiratory volume in 1 second (FEV1) will be performed\n\n**Clinical Trial Detailed Description:**\n\nAsthma is characterized by airflow obstruction, chronic airway inflammation and remodeling.\r The investigators' report has shown directly the relationship between fibrocytes, and chronic\r airflow obstruction with rapid decline in FEV1 in asthma. Asthma concomitant of obstructive\r sleep apnea (OSA) may appear intermittent hypoxia and result in the frequent attack of asthma\r symptoms. In animal model, hypoxia may increase the circulating fibrocytes, thus play a role\r in pulmonary hypertension. The investigators' published paper also showed that an increased\r expression of EGFR, ETAR and Vascular endothelial growth factor receptor (VEGFR) in\r circulating fibrocytes in chronic obstructive asthmatics. It is unknown whether circulating\r fibrocytes from asthma with OSA have the higher expression of EGFR, connective tissue growth\r factor receptor, VEGFR and ETAR compared to asthma without OSA. The investigators are also\r interested in whether proliferation and differentiation of fibrocytes are different between\r asthmatics with or without concomitant of OSA. The investigators will study the correlation\r between the percentage of circulating fibrocytes and the oxygen desaturation index (ODI) and\r severity of sleep apnea to clarify the role of hypoxia, which contributing to chronic asthma.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - clinical diagnosis of asthma\r\n\r Exclusion Criteria:\r\n\r - chronic obstructive pulmonary disease (COPD)\r\n\r - bronchiectasis\r\n\r - cystic fibrosis\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
35,578
|
[
{
"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\nParkinsonics: A Controlled Study of Group Singing in Parkinson Disease\n\n**Clinical Trial Summary:**\n\nThe overall objective of this study is to observe the effect of group Vocal performance\r training and performance experience on patients' reported symptoms and quality of life. The\r effectiveness of PD medications varies significantly in different patients depending on their\r symptoms. By using music-based interventions to improve symptoms that may be inadequately\r treated by medications, the investigators hope to improve quality of life in PD patients.\r \"Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in\r Parkinson disease\" (PD) is a controlled crossover behavioral intervention study of once\r weekly choral classes for patients with idiopathic PD (progressing toward a group\r performance) and once weekly discussion/support group meetings.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of idiopathic PD based on UK Parkinson's Disease Society Brain Bank Clinical\r Diagnostic Criteria for PD (Hughes et al. 1992).\r\n\r Exclusion Criteria:\r\n\r - Patients unable to consent to the study.\r\n\r - Patients unable or unwilling to participate in weekly singing classes for 12 weeks, or\r unwilling to perform in a concert setting.\r\n\r - Patients with active psychiatric disturbances (agitation, active hallucinations).\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
35,579
|
[
{
"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 Families Project\n\n**Clinical Trial Summary:**\n\nOne person in every 500 has Parkinson's and around 127,000 people are living with the\r condition in the UK. The aim of the study is to identify new genes that predispose or cause\r Parkinson's Disease or Parkinsonism. There is a pressing need to study the genetic makeup of\r family members both with and without Parkinson's. As families share a common genetic\r background, it is easier to find new Parkinson's genes by studying the genetic makeup of\r people with Parkinson's alongside other members of their families. We are particularly\r interested in studying the genetic makeup of two groups of people:\r\n\r 1. those who developed Parkinson's before the age of 45; and\r\n\r 2. those who have a family history of other relatives affected by Parkinson's.\r\n\r By identifying genetic factors that cause Parkinson's, we hope to understand more about the\r condition. Doing so will lead to the development of better diagnosis, improved disease\r models, and we hope in time, to the development of better treatment.\n\n**Clinical Trial Detailed Description:**\n\nOne person in every 500 has Parkinson's and around 127,000 people are living with the\r condition in the UK. Unfortunately, it is a progressive disease that has no cure. Many\r treatments are available that can improve or maintain someone's quality of life, but the\r investigators would like to develop treatments that can be used much earlier in the disease\r process. These could slow down the disease or prevent it from progressing further.\r\n\r For most people who develop Parkinson's there is no clear underlying cause. However, the\r investigators are particularly interested in the minority of people diagnosed with\r Parkinson's who have either early onset disease and/or other relatives affected with\r Parkinson's. The investigators believe that variations in inherited material (genes) can\r sometimes cause the disease, and this may run in families. This opens the door to a range of\r studies on the effects of gene variation at a nerve cell and brain level, which the\r investigators hope will lead to new targeted treatments.\r\n\r It is already known that some rare gene variants can cause Parkinson's. Some of these are\r inherited in what is called an 'autosomal dominant' way i.e. each child of a person with this\r type of gene change has a 50% chance of inheriting it. However, it is also known that not\r everyone who carries the change will go on to develop the disease. Some people appear to be\r protected against developing the disease and the investigators would like to understand this\r better. Other variants, particularly important in early onset Parkinson's are \"recessive\",\r and in this form of inheritance there is a very low risk to parents and children.\r\n\r The investigators are looking closely at the genetic makeup of people with Parkinson's in\r comparison with unaffected people and in comparison to unaffected and affected family members\r in order to find out more about which gene changes can cause Parkinson's.\r\n\r Following the identification of genetic variation that causes Parkinson's, in collaboration\r with the NHS and other researchers, the investigators plan to: 1) develop new NHS tests of\r Parkinson's and 2) develop new disease model which can act as a testbed for new treatments\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Clinical diagnosis of Parkinson's disease or parkinsonism, and either family history of\r Parkinson's/parkinsonism (first or second degree family member affected by Parkinson's or\r parkinsonism) AND/OR Early onset Parkinson's/parkinsonism (symptom onset before the age of\r 45 years) First or second degree family member of an Index Case, affected or unaffected by\r Parkinson's/parkinsonism.\r\n\r Aged over 16 years\r\n\r Exclusion Criteria:\r\n\r Lack of capacity to consent to participate in the project.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,580
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nBiomarkers in Neural Disorders\n\n**Clinical Trial Summary:**\n\nThis study seeks to establish the sensitivity and specificity of what appears to be a unique\r brainstem biomarker of Parkinson's Disease (PD) - an electrically induced olygosynaptic\r nasotrigeminal reflex response - in differentiating early stage PD from normal controls and\r from patients with various other neurodegenerative diseases. This study will additionally\r compare the biomarker to olfactory testing.\n\n**Clinical Trial Detailed Description:**\n\nParkinson's disease (PD), a devastating age-related disease that is clinically defined by its\r effects on the motor system, afflicts more than six million people worldwide, imposing\r enormous burdens on patients, relatives, caretakers, and society in general. Diagnostic\r errors are common, particularly as symptoms first arise. The most common misdiagnoses are\r Alzheimer's disease (AD), essential tremor, and vascular pseudo-Parkinson's Disease. An\r accurate diagnosis is typically made at a later stage of the disease when marked and\r irreversible damage has occurred within the motor control system of the brain. Sensitive and\r specific biomarkers of the early stages of PD are urgently needed. Identification of such\r markers is critical for the development and assessment of medications and other interventions\r designed to eliminate or reduce the gradual and irreversible decline of neurons involved in\r the disorder. This study seeks to establish the sensitivity and specificity of what appears\r to be a unique brainstem biomarker of PD - an electrically induced trigeminal nerve blink\r reflex response - in differentiation of early stage PD from normal controls and such\r neurodegenerative diseases as early stage AD, progressive supranuclear palsy (PSP), and\r diffuse Lewy Body disease (DLBD). This study will additionally compare the biomarker to\r olfactory test results.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - The Parkinson's disease (PD) patients will be Hoehn and Yahr stage 2 or less with a\r history of motor symptoms less than two years.\r\n\r - The Alzheimer's disease (AD) patients will meet the 2011 National Institute on\r Aging-Alzheimer's Association and the 1984 National Institute for Neurological and\r Communicative Disorders and Stroke-Alzheimer's disease and Related Disorders\r Association criteria for probable AD.\r\n\r - The progressive supranuclear palsy (PSP) patients will have met the NINDS-SPSP\r criteria for probable PSP, which requires vertical supranuclear gaze palsy, prominent\r postural instability, and falls in the first year of onset, as well as a number of\r other clinical features.\r\n\r - The DLBD patients will meet the Consensus Criteria for the clinical diagnosis of DLBD.\r\n\r - The healthy controls will be matched to the PD patients on such variables as sex, age,\r education level, and ethnicity.\r\n\r - The essential tremor (ET), multiple system atrophy (MSA), myasthenia gravis (MG),\r multiple system atrophy (MSA), Parkinson's disease dementia (D-PD), and Spinal Cord\r Injury (SCI) patients will meet the generally-accepted diagnostic criteria for these\r disorders.\r\n\r Exclusion Criteria:\r\n\r - Drug abuse.\r\n\r - Any other known and potentially confounding condition that could reasonably be\r expected to interfere with the study assessments.\r\n\r - Under age 18.\r\n\r - Over age 80.\r\n\r - Smoker.\r\n\r - Pregnant or nursing.\r\n\r - Healthy control with a first degree relative who has a neurodegenerative disease.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,581
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMonitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients\n\n**Clinical Trial Summary:**\n\nVoltage fluctuation as a result of brain activity will be recorded into the computer using an\r EEG device.\n\n**Clinical Trial Detailed Description:**\n\nPatients with Parkinson's disease may have gait disturbances including freezing of gait.\r Visual and auditory stimuli may improve gait. Investigators will analyze brain wave during\r walking while giving the subject different stimuli.\r\n\r The voltage fluctuation (in hundreds of microvolts) will be recorded using the EEG cap and\r amplifier into a computer.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r • Patients with Parkinson's disease that are ambulatory and can sign a written informed\r consent\r\n\r Exclusion Criteria:\r\n\r - Patients with Parkinson's disease who are not ambulatory\r\n\r - Patients with dementia\r\n\r - Patients that are blind\r\n\r - Patients that have severe hearing impairment\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,582
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nParkinsonian Brain Repair Using Human Stem Cells\n\n**Clinical Trial Summary:**\n\nImplantation of Celavie human stem cells (OK99) is intended to address the underlying\r pathology of the disease by replacing damaged/destroyed cells of the brain, and/or\r stimulating the patient's brain to repair itself.\n\n**Clinical Trial Detailed Description:**\n\nThis trial is a longitudinal, prospective, interventional, uncontrolled study designed to\r test, firstly, the safety and secondly, the potential efficacy of intraputaminal grafting of\r undifferentiated hfSC for the treatment of PD. Patients were monitored carefully for any\r adverse effects. All patients underwent baseline and 6- and 12-month post-surgery\r neurological, neuropsychological, MRI, and PET evaluations.\r\n\r Procurement, isolation, expansion, and characterization of hfSC, as well as assessment of\r patients' immune response to hfSC grafting, were performed at Celavie Biosciences, LLC\r (Oxnard, CA USA). Patient selection, pre- and post-surgery neurological, neuropsychological,\r and MRI evaluations, as well as stereotactic surgery and post-surgery care, were performed at\r Hospital Angeles del Pedregal (Mexico City, Mexico). Synthesis of radiopharmaceuticals and\r PET imaging were carried out at the Radiopharmacy-Cyclotron Unit of the Faculty of Medicine,\r Universidad Nacional Autonoma de Mexico (Mexico City, Mexico). Eight patients with moderate\r to advanced PD were selected for this trial. One of the patients was lost to follow up due to\r reasons unrelated to this study. Subjects that completed follow up were 2 females and 5\r males, with ages ranging between 43-74 years (mean age 56 years).\r\n\r Procurement and expansion of hfSC\r\n\r Human fetal brain tissue was procured via routine sterile manual aspiration methods with\r informed consent from the donor in accordance with NIH guidelines for use of fetal tissue as\r well as federal, and state laws. Tissue donor and hfSC recipients remained unknown to each\r other.\r\n\r Maternal blood samples (sera) were tested for: HIV (Abbott Laboratories, Abbott Park IL, USA)\r hepatitis A, B and C (Abbott); HTLVI (Abbott); VDRL (Baxter Agglutination Slide Test and\r reflex FTA), and cytomegalovirus (Quest, Oxnard CA). Women with a history of genital herpes,\r cancer, asthma, lupus, rheumatoid arthritis, allergies, vasculitis of autoimmune origin, and\r drug abuse were excluded. Gestation was determined according to Carnegie stages. Fetal tissue\r was harvested at the sixth week of gestation after elective abortion. Fetal brain was\r dissected, minced and triturated to a single cell suspension. Cells were cultured in flasks\r incubated at 37°C under hypoxic conditions (5% O2 and 5% CO2) through 4 doublings. At the\r second doubling (D2) cell culture was tested for sterility (USP <71>) and at D4 culture was\r karyotyped and PCR tested for presence of adventitious agents: HTLV-1, HTLV-2, HIV-1 (A, B,\r D, F, H, N), hepatitis A, B and C, T. p. pallidum, CMV, HSV-1, HSV-2, HPV. Cells were then\r transferred to a closed bioreactor system (GE WAVE Bioreactor 2/10 System, Uppsala SWE),\r operating under the same physical and chemical conditions. The bioreactor was used to create\r the Master Cell Bank (MCB), which was harvested, tested, characterized and rate-control\r cryopreserved after a total of seven doublings (D7).\r\n\r After the MCB was safety tested and characterized, a portion of the batch was thawed and used\r to seed the bioreactor for the Working Cell Bank (WCB) production. Cells were cultured in the\r bioreactor until they reached D13. They were harvested (Centritech LAB-III, Carr Centritech\r Separation System, Rancho Cucamonga, CA, USA), aliquoted (Fill-It; TAP Biosystems,\r Wilmington, DE, USA), and cryopreserved to create a WCB. The WCB was subjected to release\r testing for safety and characterization assays. Safety testing included sterility (USP <71>),\r mycoplasma (USP <63), endotoxin (USP <85>), and karyotyping (Cell Line Genetics, Madison WI,\r USA). Characterization included flow cytometry testing for: Oct-4 >90% (10H11.2, EMD\r Millipore, Billerica, MA, USA; AF488 conjugated), Sox-2 >90% (Btjce, eBioscience, San Diego\r CA, USA; AF488 conjugated), MHC-I <10% (A4, eBioscience; APC conjugated), MHC-II <10% (CVS20,\r Novus Biologicals, Littleton CO, USA; AF488 conjugated), CD105 <10% (SN6, eBioscience; PE-Cy7\r conjugated), and tyrosine hydroxylase <10% (EP1532Y, Abcam, Cambridge, UK; FITC conjugated\r goat anti-rabbit IgG; Abcam; polyclonal). Both MCB and WCB were stored in gas phase LN2 at\r -196°C.\r\n\r All procedures were performed under aseptic conditions in an ISO 8 clean room, utilizing ISO\r 5 bio-safety cabinets and laminar airflow hoods, according to validated protocols. Cells were\r shown to have a normal karyotype and did not produce teratomas in immunocompromised rodents\r (unpublished data).\r\n\r Pharmacotherapy\r\n\r Immunosuppression via cyclosporine A at a dose of 15 mg/kg/day was started 10 days prior to\r surgery and continued for one month thereafter. Patients also received Indomethacin\r 225mg/day, starting at 10 days prior to implantation and for six months postoperatively\r thereafter. Wide spectrum antibiotic (Zannat 700mg) was given preoperatively and 48 hours\r post-operatively. Antiparkinsonian medications were adjusted to patient's requirements.\r\n\r Stereotactic surgery\r\n\r MRI-guided stereotactic intraputaminal cell implantation into PD patients was performed using\r a Leksell Stereotactic System and Stealth Station Surgical Navigation System (Fridley,\r Minnesota, USA). Ropivacaine was used as a local anesthetic for frame placement. For target\r locations, measurements were made using CT-scan images fused with previous MR images (both in\r DICOM format, in axial sections 1.0 mm thick). With the patient under general anesthesia, the\r stereotactic frame was fixed to the operating table with a Mayfield head holder. Bilateral\r parasagittal incisions and corresponding 14 mm burr holes (one for each hemisphere) were made\r in preparation for cell suspension injections. Two different needle tracks through the same\r burr hole were selected for each side. Target locations were determined by height and length\r of putaminal nuclei. The lowest Z-coordinates of each track were located in the dorsal\r putamen and spaced 4mm apart in the X-direction. Each needle track received 1X106 cells in 1\r cc of culture medium. To ensure complete cell suspension delivery, injections were carried\r out slowly for 2 min with reciprocal withdrawal of the delivery needle to avoid both damage\r to stem cells and brain tissue, as well as to avert reflux or bubble formation. After\r surgery, patients were kept in a conventional post-operative care unit for 1 h. The day\r following surgery, MR images were obtained to confirm correct placement of cell suspensions.\r All patients were discharged 24 h after surgery.\r\n\r Neurological evaluations\r\n\r Neurological endpoints of this study included evaluation of the number and severity of\r adverse events after cell grafting, and the efficacy in the improvement of motor responses,\r as assessed on the UPDRS part I (mentation, behavior and mood), part II (motor activities of\r the daily living), part III (motor performance), and part IV (complications of therapy), as\r well as the modified Höehn and Yahr Scale, and the modified Schwab and England Activities of\r the Daily Living Scale. Patients were clinically evaluated with these scales at screening (as\r baseline, before surgery), and then after the procedure at six and 12 months. At every visit,\r patients were asked to discontinue antiparkinsonian medications at least 12 hours before the\r UPDRS assessment (for practical purposes, \"OFF\" state was defined as overnight drug\r withdrawal) in order to be rated in their \"OFF\" state and then, UPDRS \"ON\" medication\r evaluations were performed 1 hour after receiving their usual dose of levodopa. Each patient\r received the same preoperative levodopa dose for each assessment. Adverse events, including\r those reported by the patients spontaneously and those observed during the evaluations were\r recorded. After obtaining signed informed consent from all patients that completed the study,\r all \"OFF\" and \"ON\" UPDRS evaluations, were videotaped.\r\n\r Neuropsychological evaluations\r\n\r Cognitive performance was evaluated using the following instruments: Mexican adaptations of\r Beck and Steer's anxiety [25] and depression [26] inventories; our brief neuropsychological\r (NEUROPSI)[27,28] and computerized neuropsychological test batteries, and the Mini-mental\r Parkinson State Examination (MMPSE)[29]. Patients reported on their quality of life as\r related to their daily living activities; physical and mental well-being (health status);\r cognition and communication, and one summary index.\r\n\r Immunogenicity testing\r\n\r Patient's blood was evaluated for increase in titers of hfSC specific antibodies and for\r increase in antibody-dependent cell-mediated cytotoxicity after implantation as compared to\r baseline values. Samples were drawn one month prior to cell implantation, and then one month\r and six months after surgery. Whole blood specimens were collected from each patient and\r processed as serum one and six months post-grafting using the lipophilic membrane dye PKH67\r (Sigma-Aldrich) as described by the manufacturer for cell tracking in immune response and\r cytotoxicity assays by flow cytometry [30,31]. Cytotoxicity assay was performed with 100:1,\r 50:1, and 25:1 effector to target ratios.\r\n\r MRI\r\n\r MR images were obtained before surgery (baseline) and three times after cell implantation at\r 24 h, and six and 12 months post-surgery. They were acquired with a 3 Tesla magnet, MR\r Systems Achieva release 2.6.3.8 Philips (Best, The Netherlands).\r\n\r PET molecular imaging\r\n\r Patients underwent PET molecular imaging at baseline, at six months (data not presented), and\r at one year after hfSC implantation. Radiopharmaceuticals utilized were\r (+)-alpha-[11C]Dihidrotetrabenazine (DTBZ), 6-[18F]Fluoro-L-DOPA (FDOPA), and [11C]Raclopride\r (RAC). All patients underwent DTBZ-PET scans and one additional study with either FDOPA or\r RAC, at least one week apart. Patients were asked to discontinue antiparkinsonian medications\r at least 12h before each study. Scans were acquired on a Siemens Biograph 64 PET/CT.\r Thirty-minute brain emission scans were acquired 20 minutes post-injection of DTBZ or RAC,\r while 15 min scans were acquired for FDOPA 75 min post-injection. All patients studied with\r FDOPA were pre-medicated with 150 mg of carbidopa to prevent peripheral decarboxylation.\r Images were reconstructed using an OSEM-2D algorithm and analyzed with the software\r Statistical Parametric Mapping (SPM v.12). Each individual PET brain image was normalized on\r an anatomical MRI atlas to be evaluated within a standard space. Following normalization, FSL\r structural atlases were used for definition of the regions of interest. To facilitate the\r quantitative analysis, specific uptake ratios (SUR) in the caudate and putamen were\r calculated by subtracting the background signal of a reference region with nonspecific uptake\r from striatal activity and dividing by reference region activity [(target uptake - reference\r uptake)/reference uptake], using occipital cortex (DTBZ and FDOPA) and cerebellum (RAC), as\r reference regions.\r\n\r Statistical analysis\r\n\r Comparisons between baseline and 12-month follow-up measurements for anxiety, depression,\r NEUROPSI, MMPSE examinations, right and left finger tapping in \"ON\" and \"OFF\" medication\r states were performed using the Wilcoxon test. All other end measures were reported as\r individual results for each patient.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of idiopathic PD with tremor, rigidity or hypokinesia as major symptoms.\r\n\r - A two to twenty-five-year history of PD with significant medical management or\r difficulty in medical management.\r\n\r - A definite response to levodopa compounds with inadequately relieved of symptoms, or\r severe secondary effects of the drug.\r\n\r - Good general health.\r\n\r - A strong will or desire to have the procedure after being fully informed of its\r experimental nature.\r\n\r Exclusion Criteria:\r\n\r - History of repeated strokes with stepwise progression of parkinsonian features\r\n\r - History of repeated head injury\r\n\r - History of definite encephalitis\r\n\r - Oculogyric crises (unless drug-induced)\r\n\r - Neuroleptic treatment at onset of symptoms\r\n\r - Supranuclear gaze palsy\r\n\r - Cerebellar signs\r\n\r - Babinski sign\r\n\r - Presence of cerebral tumor or communicating hydrocephalus on CT scan\r\n\r - Sustained remission or negative response to an adequate dose of levodopa\r\n\r - Patients with parkinsonism other than Idiopathic PD\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,583
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nDetermining Clinical Profile of Parkinson's Disease Among Egyptian Population\n\n**Clinical Trial Summary:**\n\nParkinson's disease is the second most common neurodegenerative disease affecting about 1-3%\r of population above 60 years. Recently, non-motor symptoms are getting more attention in PD\r management. The pattern of PD onset and clinical course differ from one population to\r another. Many studies have been conducted to determine the clinical profile of PD in\r populations worldwide. However, no similar studies have been conducted in Egypt. Therefore,\r the investigators will conduct a nation-wide, collaborative, cross sectional study to\r determine the pattern of Parkinson's disease onset, clinical course, and non-motor symptoms\r among Egyptian population.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients who meet the Parkinson's disease criteria of United Kingdom Brain Bank within\r the study centres.\r\n\r Exclusion Criteria:\r\n\r - Patients with vascular Parkinsonism (history of stroke)\r\n\r - Patients with treatment induced Parkinsonism\r\n\r - Patients with history of dopaminergic neurotoxin\r (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,584
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nVirtual Reality Effects on Functional Capacity and Quality of Life of People With Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nIntroduction: Parkinson's disease (PD) is a progressive neurodegenerative disorder of\r dopaminergic neurons that can cause some mobility limitations and it has association with\r quality of life (QOL) in patients with PD. Virtual reality (VR) has been used to treat of\r these patients Objective: Evaluate the functional capacity and QOL of individuals with PD\r using VR with X-Box Kinect®. Methods: Were selected 20 individuals classified as stages 1-3,\r aged 50-75 years. They were divided by lot into two groups (control and experimental) with\r ten patients in each. The group (CG) treated with exercises (conventional therapy) during\r five-week, with two sessions per week lasting 60 minutes, while the experimental group (EG)\r spent half the time with conventional physical therapy and other half of time in virtual\r rehabilitation (VR). Subjects were evaluated before and after treatment using the following\r scales: Unified Parkinson's Disease Rating Scale and Parkinson's Disease Questionnaire .\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with clinical diagnosis of idiopathic Parkinson's disease\r\n\r - Male and female\r\n\r - Stage 1-3 of the Hoehn and Yahr scale.\r\n\r Exclusion Criteria:\r\n\r - Have other neurological diseases\r\n\r - They have decompensated systemic diseases\r\n\r - Musculoskeletal changes that prevent the achievement of movements\r\n\r - With lowering of the cognitive level assessed using the MiniMental State examination\r with cutoff point according to education\r\n\r - With respiratory impairment\r\n\r - With medical restrictions for performing exercises\r\n\r - In physical therapy, occupational therapy service for 3 months or more;\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,585
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nVirtual Reality in Parkinson Disease\n\n**Clinical Trial Summary:**\n\nPatients affected by Parkinson disease (PD) can benefit from rehabilitation although the\r evidences are scattered. In the last years there are increased evidences that virtual reality\r can improve functional outcome in Parkinson's disease. No evidences are known concerning the\r cardiological safety and effect on balance of Virtual Reality. The aim of this study is to\r compare a virtual reality rehabilitation program versus a conventional one in a sample of\r patients affected by mild to moderate Parkinson and to collect data on cardiological effects.\n\n**Clinical Trial Detailed Description:**\n\nThis study will be a prospective, single-blinded, randomized controlled trial aimed to\r compare two different rehabilitation programs in PD disease and to evaluate the effect of\r Virtual Reality on cardiocirculatory system.\r\n\r Patients will undergo Conventional or Virtual Reality Rehabilitation Program for 6\r consecutive weeks, 3-times in a week for a 40 minute session. Moreover, in order to acquire\r data on cardiocirculatory system during the first and the last sessions an Holter-\r electrocardiography will be used. Data will be compared with healthy subjects (matched for\r age and gender).\r\n\r The used protocols are reported below.\r\n\r Conventional (C) Rehabilitation Program The Conventional rehabilitation program will be\r performed according to the \" Royal Dutch Society for Physical Therapy Guidelines for physical\r therapy in patients with Parkinson's disease\". In each C rehabilitation session, patients\r will undergo 3 phases: 1) Warm-up phase: passive mobilization of main joints and muscular\r strengthen of lower limbs; 2) Active phase (both standing than seated): exercises of motor\r coordination with upper and lower limbs, balance training, start and stop exercises,\r deambulation training; 3) cool-down phase (with seated patient): manipulation exercises,\r mobilization exercises, respiratory exercises.\r\n\r Virtual Reality (VR) Rehabilitation Program Each session will consist of multiple exercises.\r These ones are described below, each exercise will be performed by the patient for 4 minutes\r followed by a 1 minute of rest.\r\n\r Exercise 1 (named Trumpet H2D1): patients placed in the center of the room and asked to\r randomly touch a moving trumpet displayed on the wall screen. When the trumpet will be\r reached by patient's arm, it will disappear giving out a sound.\r\n\r Exercise 2 (named Pink rose hemiarch left and right H1D2): patients placed in the center of\r the room and asked to touch the rose projected on the wall screen as a hemiarch, in this\r exercise the sequence of rose to touch and therefore the distance between the target and the\r patient will be decided by the physical therapist.\r\n\r Exercise 3 (named Doggy): patients placed in the center of the room and asked to lead a dog\r in the four corner of the wall screen. Patients will be free to move in the room.\r\n\r Exercise 4 (named Eggs): patients placed in the center of the room and asked to touch as fast\r as possible eggs projected in the wall screen in a random order. When the egg will be reached\r by patient's arm, it will disappear giving out a sound.\r\n\r Exercise 5 (named Mole): patients placed in the center of the room and asked to reach a mole\r that will go out from a hole. The patients will know where the mole will be and they will\r move in the room. When the mole will be reached by patient's arm, it will disappear giving\r out a sound.\r\n\r Exercise 6 (named Stay Or Move In Between): patients placed in the center of the room and wre\r asked to perform the motor task as indicated by physical therapist while maintaining balance\r between two lateral bars in order not to touch them and not make them sound.\r\n\r Exercise 7 (named Leaves): patients placed in the center of the room and asked to clean from\r wall screen as fast as possible all the leaves projected in the wall.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients affected by mild to moderate PD, according to motor examination section (Part\r III) of the Unified Parkinson's Disease Rating Scale (UPDRS III)\r\n\r - ability to independently perform motor rehabilitation\r\n\r - absence of cognitive impairment (MMSE >25)\r\n\r Exclusion Criteria:\r\n\r - severe hearing loss and/or visual deficit\r\n\r - serious comorbidity making impossible to perform rehabilitation (postural hypotension,\r heart disease, stroke, severe shoulder-hip disease)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,586
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nStudy of Motor Slowing in Parkinson's Disease by a Computerized Mental Chronometry Paradigm\n\n**Clinical Trial Summary:**\n\nAction slowing has been demonstrated in many diseases. Parkinson's disease (PD) and\r Huntington's disease (HD) are two neurodegenerative diseases affecting the basal ganglia,\r particularly the medial globus pallidus, and the clinical expression of these two diseases is\r characterized by a combination of motor and cognitive disorders, but with two opposing\r patterns of dysfunction. Action slowing has been demonstrated in both of these diseases and\r has been extensively studied in Parkinson's disease, suggesting a perceptive-cognitive\r origin. Far fewer studies have been conducted in Huntington's disease. However, all of these\r studies were performed with different methodologies in small cohorts and the value of the\r proposed study is to use a validated and standardized computerized mental chronometry\r paradigm, providing a better understanding of the mechanisms of action slowing in these two\r diseases and to more clearly define a disease-specific profile.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Agreeing to participate in the study\r\n\r - French mother tongue\r\n\r - MMSE > 20/30\r\n\r - Specific to the MP and MH:\r\n\r - Parkinson's disease:\r\n\r - defined by the criteria of the UKPDSBB\r\n\r - stage 1 , 2 or 3 Hoehn and Yahr (ON)\r\n\r - age of onset of the disease known\r\n\r - brain MRI performed during follow-up\r\n\r - Huntington disease :\r\n\r - genetically defined (CAG > 35)\r\n\r - weaning neuroleptic ( Tercian® and Solian® : 2 days; Haldol® : 5 days ;\r Tiapridal® and Xenazine : 1 day ; Zyprexa® : 4 days)\r\n\r - Early stage : Fahn and Shoulson I and II is a CFT score between 7 and 13\r\n\r Exclusion Criteria:\r\n\r - Illiteracy, writing or reading difficulties\r\n\r - Visual perceptual auditory deficit or preventing reading, drawing, writing or\r understanding instructions\r\n\r - Visual hallucinations\r\n\r - Significant history may sound on cognition (unbalanced thyroid dysfunction, ischemic\r heart disease or embolic unstabilized or symptomatic, progressive neoplasia, chronic\r alcoholism weaned or not)\r\n\r - Current or previous neurological diseases other than MH or MP: ischemic cerebral\r vascular accident or bleeding, head injuries (loss of higher knowledge in 15 minutes),\r epilepsy requiring treatment.\r\n\r - Psychiatric disorders depression unless treated (stable treatment for 1 month)\r\n\r - Psychotropic treatment (except anxiolytic, antidepressant steady since 1 month)\r\n\r - Inability to achieve an autonomous operation without technical assistance over a\r distance of 20 meters.\r\n\r - Inability to stand without technical assistance for 30 seconds.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,587
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nOne-year Follow-up of Iron in Basal Ganglia - R2*: a Biomarker of Parkinson's Disease Progression?\n\n**Clinical Trial Summary:**\n\nThe study of non-invasive and reliable biomarkers to track progression of Parkinson's disease\r (PD) is essential while disease-modifying treatments are being developed. Many clinical\r biological or imaging biomarkers have been tested but no \"gold standard\" has been found as of\r yet. Among these, Magnetic Resonance Imaging (MRI) relaxometry using R2* measurement (R2* =\r 1/T2*), which is a validated marker for estimating brain iron concentration, appears to be an\r attractive technique because its safety, rapidly measured in clinical conditions and its ease\r to ensure individual longitudinal follow-up. Current data of cross sectional studies of R2*,\r which have shown an iron increase in Substantia Nigra (SN), led to suppose that it could be a\r biomarker of disease vulnerability. Recently, the investigators have conducted the first\r longitudinal follow-up of R2* (1.5 T MRI), which showed a rapid R2* increase in both parts of\r the SN and in the caudal putamen. We propose, here, a multicenter prospective study of\r one-year cohort follow-up of R2* variations (ΔR2*) in three regions of interest (ROIs) (the\r SN, the Ventral Tegmental Area (VTA) and the Putamen) of 160 patients with PD, using a 3\r Tesla MRI, to evaluate the potential interest of R2* as a biomarker of disease progression.\r The variation of R2* (ΔR2*) will be correlated with clinical markers of disease progress,\r non-motor symptoms. 80 healthy controls subjects will also be included to assess the effect\r of aging on cerebral physiological iron levels.\n\n**Clinical Trial Detailed Description:**\n\nUse lay language.\r\n\r The study of non-invasive and reliable biomarkers to track progression of Parkinson's disease\r is essential while disease-modifying treatments are being developed. Many clinical biological\r or imaging biomarkers have been tested but no \"gold standard\" has been found as of yet. Among\r these, Magnetic Resonance Imaging (MRI) relaxometry using R2* measurement (R2* = 1/T2*),\r which is a validated marker for estimating brain iron concentration, appears to be an\r attractive technique because its safety, rapidly measured in clinical conditions and its ease\r to ensure individual longitudinal follow-up. Current data of cross sectional studies of R2*,\r which have shown an iron increase in substantia nigra, led to suppose that it could be a\r biomarker of disease vulnerability. Recently, we have conducted the first longitudinal\r follow-up of R2* (1.5 T MRI), which showed a rapid R2* increase in both parts of the SN and\r in the caudal putamen. We propose, here, a multicenter prospective study of one-year cohort\r follow-up of R2* variations (ΔR2*) in three regions of interest (the substantia nigra, the\r ventral tegmental area and the putamen) of 160 patients with Parkinson's disease, using a 3\r Tesla MRI, to evaluate the potential interest of R2* as a biomarker of disease progression.\r The variation of R2* (ΔR2*) will be correlated with clinical markers of disease progress,\r non-motor symptoms. 80 healthy controls subjects will also be included to assess the effect\r of aging on cerebral physiological iron levels.\r\n\r Type of study : Interventional multicenter prospective study of cohort follow-up.\r\n\r Number of centers : 6 (Clermont-Ferrand, Lyon, Grenoble, Paris, Limoges, Lille)\r\n\r Study population :\r\n\r Recruitment\r\n\r 160 patients with Parkinson's disease divided into four subgroups of 40 patients according to\r disease duration:\r\n\r - < 5 years\r\n\r - Between 5 and 10 years\r\n\r - Between 10 and 15 years\r\n\r - > 15 years\r\n\r In parallel, 80 sex-age matched healthy controls subjects matched equally distributed in the\r 4 groups (n = 20/group) based on a stratified plan by gender and age (ratio 1:2).\r\n\r Subjects will be assessed twice, one year apart by the procedures detailed below. The two\r neurological assessments should be made by the same certified neurologist.\r\n\r Patients' procedure:\r\n\r Visit 1 (Day 0) (duration: 1 day or 2 half days)\r\n\r - Signature of an informed consent form (only at Day 0).\r\n\r - Demographic and clinical characteristics (sex, age, disease duration, treatments).\r\n\r - Neurological evaluation.\r\n\r - Neuropsychological evaluation.\r\n\r - Self-administered questionnaires.\r\n\r - 1st MRI acquisition.\r\n\r Visit 2 (Day 0 + 1 year) (duration: 1 day or 2 half days)\r\n\r - Current treatment(s), adverse event(s), serious adverse event(s).\r\n\r - Neurological evaluation.\r\n\r - Neuropsychological evaluation.\r\n\r - Self-administered questionnaires.\r\n\r - 2d MRI acquisition.\r\n\r Matched healthy controls subjects' procedure:\r\n\r Visit 1 (Day 0) (duration: 1 half day)\r\n\r - Signature of an informed consent form (only at Day 0).\r\n\r - Demographic and clinical characteristics (sex, age, disease duration, treatments).\r\n\r - Brief neuropsychological evaluation.\r\n\r - 1st MRI acquisition.\r\n\r Visit 2 (Day 0 + 1 year) (duration: 1 half day)\r\n\r - Current treatment(s), adverse event(s), serious adverse event(s).\r\n\r - Brief neuropsychological evaluation.\r\n\r - 2d MRI acquisition.\r\n\r MRI acquisition (duration: 45 to 60 min)\r\n\r The procedure will be performed on a 3 Tesla MRI, allowing a substantial gain in\r signal-to-noise ratio compared with the one obtained at 1.5 Tesla.\r\n\r Different sequences will be planned:\r\n\r - T2-weighted sequence * 3D GRE multi-echo. This sequence will generate a R2* maps of the\r whole brain.\r\n\r - T1-weighted sequence in high resolution 3D. This sequence will allow the anatomical\r characterization of different brain structures and will help the normalization of T2* in\r pictures an anatomical reference space.\r\n\r - T2* sequence 3D multiple gradient echo (Spoiled Gradient Recalled echo sequence). This\r sequence will measure the decay rate of NMR signal according to the echo time.\r\n\r - 2D spin echo sequence T1-weighted for neuromelanin. This sequence view the substantia\r nigra and locus coeruleus (optional sequence).\r\n\r - Optional Diffusion-weighted sequence. This sequence determines the movements of water\r molecule in the brain and to infer the main lines of connections between neurons\r (optional sequence).\r\n\r The R2* (1/T2*) will be measured in three different regions of interest (substantia nigra,\r ventral tegmental area and the putamen) for the 2 MRI's in order to calculate ΔR2.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria for PATIENTS :\r\n\r - Parkinson's Disease (UK Parkinson's Disease Society Brain Bank Criteria).\r\n\r - No Deep Brain Stimulation (DBS).\r\n\r - From 40 to 80 years old.\r\n\r Inclusion criteria for HEALTHY CONTROL SUBJECTS :\r\n\r - From 40 to 80 years old.\r\n\r Exclusion criteria for PATIENTS :\r\n\r - Dementia (MoCA < 24).\r\n\r - Atypical parkinsonism (MSA, PSP, …).\r\n\r - Severe current psychiatric or somatic disease.\r\n\r - Iron treatments (Desferal® (deferoxamine), Ferriprox® (deferiprone) et Exjade®\r (deferasirox), Fumafer® (ferrous fumarate), Tardyferon® (ferrous sulfate (II)),…),\r Ferinject® (ferric carboxymaltose), Venofer® (iron sucrose),…).\r\n\r - Contra-indication to MRI (claustrophobia, pace maker,…).\r\n\r Exclusion criteria for HEALTHY CONTROL SUBJECTS :\r\n\r - Neurological disease.\r\n\r - Psychiatric or somatic disease.\r\n\r - Dementia (MoCA < 24).\r\n\r - Iron treatments (Desferal® (deferoxamine), Ferriprox® (deferiprone) et Exjade®\r (deferasirox), Fumafer® (ferrous fumarate), Tardyferon® (ferrous sulfate (II)),…),\r Ferinject® (ferric carboxymaltose), Venofer® (iron sucrose),…).\r\n\r - Contra-indication to MRI (claustrophobia, pace maker,…).\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,588
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nInternational Registry for Patients With Castleman Disease\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to collect clinical, laboratory, and patient survey data from\r patients with Castleman disease to improve understanding, diagnosis, and treatment of the\r disease.\n\n**Clinical Trial Detailed Description:**\n\nThis project is supported by the Castleman Disease Collaborative Network.\r\n\r Visit the CDCN website at http://www.cdcn.org/accelerate to sign up for the ACCELERATE\r registry!\r\n\r The ACCELERATE patient registry will give patients and families the opportunity to contribute\r their medical data to improve understanding of Castleman Disease. The patient registry will\r obtain real-world demographic, clinical, laboratory, and patient reported outcomes, and\r treatment data from 500 patients worldwide with Castleman Disease.\r\n\r This registry will help to provide important data for future Castleman Disease research\r studies. The patient registry helps centralize information on this rare disease, and provides\r researchers a way to obtain data on Castleman Disease patients. The major objectives for the\r registry include:\r\n\r 1. Improve our understanding of the natural history (signs, symptoms, laboratory values,\r survival data, outcome predictors), pathogenesis, and treatment of Castleman disease by\r collecting a standardized set of demographic and longitudinal data from CD patients,\r\n\r 2. Build capacity for collaboration between patients, providers, researchers, and industry\r by collecting clinical data and tracking the location of all available tissue samples\r for future studies (\"virtual biorepository\"), and\r\n\r 3. Assemble \"real-world\" data related to burden of disease, treatments used, tolerability,\r and safety data.\r\n\r Individuals affected by Castleman Disease and families of deceased patients are invited to\r join the registry. The patient registry will have two methods of entry. Patients located in\r the following countries (Germany, France, Italy, UK, or Spain) are recommended to contact the\r specific investigators at the sites listed below via the \"physician-directed arm.\"\r Participating physicians will consent and enroll patients, enter their medical record data\r into the registry, and update medical records periodically.\r\n\r Patients located anywhere in the United States of America (USA), Canada, or rest of world\r (except for patients in select countries in the EU listed below) will be able to enroll\r themselves directly into the registry via the \"patient-powered arm.\" Participants in the\r patient-powered arm will enroll online and be asked to provide their electronic medical\r records to University of Pennsylvania researchers for data extraction. All patients in both\r groups will also be asked to complete questionnaires every three months about their symptoms,\r treatments, and experiences with Castleman Disease. Complete participant information will be\r stored in a secure database.\r\n\r Researchers who are interested in studying Castleman Disease can also request access to\r registry datasets.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Person of any age\r\n\r - Have a reference pathology report suggesting \"Castleman disease\" not limited to\r cutaneous involvement only that can be uploaded\r\n\r - Be able to provide electronic informed consent, as per local regulations\r\n\r - Deceased patients may also be enrolled when a reference pathology report suggesting\r \"Castleman disease\" can be supplied or when the ART is able to locate and upload such\r a pathology report.\r\n\r Exclusion Criteria:\r\n\r - Because this registry is designed to provide as wide a picture of routine clinical\r practice as possible, inclusion criteria are set deliberately wide and there are no\r exclusion criteria.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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35,589
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThe major purpose of the Stage 1 is to study the safety and tolerability of the proposed\r dosage regimen of the study drug. The form of cannabidiol (CBD) used in this study is\r GWP42003, supplied by GW Pharmaceuticals. The dosage regime is based on their experience.\r This is an open label study in 10 subjects, during which the dose is gradually increased to\r the manufacturers recommended target dose, with tolerability being evaluated at each dose\r level. Based on the response of subjects in the Stage 1, a target dose is determined for the\r next stage. Standardized tools will be administered to study both tolerability and efficacy.\r Efficacy assessments are simply explorative, and are done to look for an effect that warrants\r specific or different evaluation in the next stage.\n\n**Clinical Trial Detailed Description:**\n\nPersons with Parkinson's disease (PD) have progressive disabling tremor, slowness, stiffness,\r balance impairment, cognitive deficits, psychiatric symptoms, autonomic dysfunction, fatigue\r and insomnia. Tremor may interfere with necessary daily and work functions. The disorder\r affects approximately seven million people globally. The total economic cost in the US is\r around 23 billion dollars. In addition to economic costs, PD reduces quality of life of those\r affected and their caregivers.\r\n\r Cognitive impairment is a common feature and ranges from delayed recall in early stages to\r global dementia in up to 80% at end stage. PD with dementia has been associated with reduced\r quality of life, shortened survival, and increased caregiver distress.\r\n\r Depression, anxiety and psychosis are also common and are particularly disabling in PD, even\r at the earliest stages. These symptoms have important consequences for quality of life and\r daily functioning, are associated with increased carer burden and risk for nursing home\r admission. Anxiety affects up to 40% of patients with PD, and may predate motor symptoms by\r several years. The most common anxiety disorders in PD are panic attacks (often during\r off-periods), generalized anxiety disorder, and simple and social phobias. Psychotic symptoms\r vary in frequency according to the definition used. If mild forms are included, these affect\r up to 50% of patients. Visual hallucinations are the most common type. However,\r hallucinations occur in all sensory domains and delusions of various types are also\r relatively common. The impact of psychosis is substantial in that it is associated with\r dementia, depression, earlier mortality, greater caregiver strain, and nursing home\r placement.\r\n\r Current therapies are inadequate. Medications have improved the prognosis of PD, but also\r have problematic adverse effects. Since treatment of PD is often unsatisfactory and since\r marijuana has recently become legal and readily available in Colorado, persons with PD have\r been trying it. Patients have heard from the internet, support groups and other sources that\r marijuana is helpful. Most are doing so on their own, without the supervision or even\r knowledge of their neurologist. In a survey conducted in the spring of 2014 in University of\r Colorado Movement Disorders Center (UCMDC) clinic about 5% of 207 PD patients, average age\r 69, reported using marijuana. In the same clinic, about 30% of the PD patients have asked\r doctors during their visits over the past 6 months about marijuana. In another study Katerina\r Venderova and colleagues reported that 25% of PD patients had taken cannabis in the General\r University Hospital in Prague.\r\n\r PD mostly affects the elderly, and with the cognitive, psychiatric and motor problems,\r subjects are prone to falls. Cannabis is well documented to cause psychosis, slowness, and\r incoordination. Studies have also shown that chronic users have structural and functional CNS\r alterations. Thus cannabis is expected to be risky in persons with PD. Further, there are\r many components of cannabis, and the cannabis preparations being sold in Colorado vary widely\r in composition. There are no definitive data regarding the benefits and risks of these\r various preparations in PD. Studies on safety and efficacy are greatly needed to protect this\r fragile Colorado population.\r\n\r Cannabidiol (CBD) is a cannabinoid that is present to a lesser extent in street marijuana,\r and limits delta-9-tetrahydrocannabinol (THC)'s psychoactive effect. CBD acts in some\r experimental models as an anti-inflammatory, anticonvulsant, anti-oxidant, anti-emetic,\r anxiolytic and antipsychotic agent, and therefore has potential beneficial medical uses.\r Further, animal studies suggest that CBD is neuroprotective, perhaps due to reported\r anti-oxidative and anti-inflammatory actions.\r\n\r Human trials report that CBD decreases anxiety and causes sedation in healthy individuals,\r decreases psychotic symptoms in schizophrenia and PD, and improves motor and non-motor\r symptoms and alleviates levodopa-induced dyskinesia in PD. The ratio of THC to CBD plays a\r role in the preparation's therapeutic outcome: strains of cannabis with higher concentrations\r of CBD did not produce short-term memory impairment vs. strains with higher concentrations of\r THC and lower concentrations of CBD.\r\n\r Many clinicians who suspect cannabis may have a positive effective upon a particular patient\r group have no idea of the cannabinoid profile that is being used. Without knowing the\r composition, it is impossible to draw any conclusions simply because of the huge variety of\r strains utilised.\r\n\r Given the current literature regarding CBD: possible neuroprotective effect, good\r tolerability, anxiolytic and antipsychotic effects and general lack of be well tolerated in\r PD, including its effect on tremor, the investigators hypothesize that CBD would be well\r tolerated and would reduce tremor, anxiety and psychosis, and would stabilize cognitive\r decline in PD. First the investigators will perform an open label study to determine a\r reasonable dose, and then a randomized, double-blind, placebo-controlled crossover study to\r evaluate the efficacy and tolerability of oral CBD on tremor and other important aspects of\r PD. A strength of the study is that it uses well defined form or CBD.\r\n\r Stage 1: Open Label Dose Escalation Tolerability Study\r\n\r Primary Specific Aim: To confirm that the dosage regimen of CBD, in the form of GWP42003-P\r recommended by the study drug manufacturer is safe and tolerated in 10 subjects with PD.\r GWP42003-P is started at 5 mg/kg/day and is increased by 5 mg/kg at 3 day intervals to a\r target dose of 25 mg/kg/day.\r\n\r Secondary Specific Aim: To examine the effect of CBD on severity & duration of tremor and\r other conditions that are problematic in PD.\r\n\r The dose escalation tolerability study will be conducted in 10 subjects (the investigators\r will be recruiting up to 15 subjects to end up with 10) as an open label study lasting\r approximately 3 weeks followed by a 2-week safety follow up. Subjects are closely monitored\r as the dose is titrated. Subjects will have a screening visit, a baseline visit within the\r next three weeks, a visit when subjects are on 20 mg/kg/day, a final assessment visit when\r subjects have been on the maximal tolerated or the targeted dose for 10-15 days, and a safety\r visit 2 weeks later. The subject is to be on the maximal tolerated or targeted dose for 10-15\r days. Subjects will be called on the 3rd day of each dose. During phone calls subjects are\r monitored for adverse events, especially excessive daytime sleepiness, symptoms of\r hepatotoxicity, as well as changes in medical history and concomitant medications. Subjects\r are also called 3 days after stopping the study drug to check for signs of withdrawal.\n\n**Clinical Trial Eligibility Criteria:**\n\nStage 1:\r\n\r Inclusion criteria:\r\n\r - Male or female subjects between 45 and 78 years of age inclusive.\r\n\r - Willing and able to give informed consent.\r\n\r - Idiopathic PD, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical\r Diagnostic Criteria\r\n\r - Rest tremor amplitude score of ≥2 in any limb on question 3.17 of the MDS-UPDRS (ON\r state).\r\n\r - Anti-parkinsonian medication is fixed for at least 1 month prior to study entry\r\n\r - If MoCA<22 subject must have a legally authorized representative (LAR) sign the\r consent, and must have a designated caregiver that agrees to ensure study protocols\r followed. This includes accompanying patient to study visits and being available for\r study phone calls.\r\n\r - Must have a driver to drive them to and from study visits\r\n\r - Has a significant other (someone who knows the subject well) that is appropriate for\r doing the NPI assessment, can accompany patient to study visits, and agrees to do so\r\n\r - Agrees to not take more than 1 gram per day of acetaminophen, due to a possible\r interaction with study drug that could increase risk of hepatotoxicity.\r\n\r Exclusion criteria:\r\n\r - Known or suspected allergy to cannabinoids or excipients used in the study drug\r formulation.\r\n\r - Cannabinoids taken currently or in the previous 30 days.\r\n\r - History of drug or alcohol dependence; defined by prior inpatient stay(s) for this or\r that patient stats s/he has a history of this.\r\n\r - Use of dopamine blockers within 180 days and amphetamine, cocaine, and MAO-A\r inhibitors within 90 days of baseline.\r\n\r - Currently taking tolcapone, valproic acid, felbamate, niacin, isoniazid and\r ketoconazole due to risk of liver injury and clobazam and ketoconazole because of risk\r of toxic interactions with the study drug. These medications need to be stopped 90\r days before the baseline visit.\r\n\r - Unstable medical condition.\r\n\r - Any of the following laboratory test results at screening:\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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35,590
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRegistry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now\n\n**Clinical Trial Summary:**\n\nREVOLUTION will be a US multicenter observational registry in scope and governed by a\r steering committee of approximately 8 experts in NSCLC and outcomes research. The primary\r goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be\r a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to\r those with EGFR mutations may be enrolled following the initial study period as needed to\r ensure adequate sample sizes needed to examine primary questions of interest in the EGFR\r mutant population. Patients will be enrolled over a three year period across approximately 25\r geographically diverse academic as well as community based sites within the US. The five year\r follow-up period will ensure robust survival data for correlations with clinical, tumor, and\r treatment variables.\r\n\r The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with\r particular characteristics of interest including patients with adenocarcinoma, and EGFR\r mutations and effectively evaluate these patients with respect to key outcomes of interest\r including overall survival, time to progression, stage at progression, secondary metastases\r including brain metastases (at diagnosis and progression), comorbidity burden, and\r performance status at index date.\r\n\r The study design allows a cross-sectional perspective with collection of detailed patient and\r clinical characteristics at enrollment followed by longitudinal assessment of clinician and\r patient-reported endpoints every three months. Centralized follow-up will be conducted by\r having sites upload patient data following each visit via the web-based data system, with\r patients who do not show up for site visits being contacted via telephone by the Duke\r Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will\r be weighted based upon provider specialty and ability to enroll patients with NSCLC with the\r specified inclusion criteria.\n\n**Clinical Trial Detailed Description:**\n\nREVOLUTION will be a US multicenter observational registry in scope and governed by a\r steering committee of approximately 8 experts in NSCLC and outcomes research. The primary\r goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be\r a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to\r those with EGFR mutations may be enrolled following the initial study period as needed to\r ensure adequate sample sizes needed to examine primary questions of interest in the EGFR\r mutant population. Patients will be enrolled over a three year period across approximately 25\r geographically diverse academic as well as community based sites within the US. The five year\r follow-up period will ensure robust survival data for correlations with clinical, tumor, and\r treatment variables.\r\n\r The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with\r particular characteristics of interest including patients with adenocarcinoma, and EGFR\r mutations and effectively evaluate these patients with respect to key outcomes of interest\r including overall survival, time to progression, stage at progression, secondary metastases\r including brain metastases (at diagnosis and progression), comorbidity burden, and\r performance status at index date.\r\n\r The study design allows a cross-sectional perspective with collection of detailed patient and\r clinical characteristics at enrollment followed by longitudinal assessment of clinician and\r patient-reported endpoints every three months. Centralized follow-up will be conducted by\r having sites upload patient data following each visit via the web-based data system, with\r patients who do not show up for site visits being contacted via telephone by the Duke\r Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will\r be weighted based upon provider specialty and ability to enroll patients with NSCLC with the\r specified inclusion criteria.\r\n\r Study Patient Selection Criteria\r\n\r Patients are eligible to be included in the study if they meet all of the following criteria:\r\n\r 1. ≥19 years of age\r\n\r 2. Patients with a primary diagnosis of NSCLC within the past 5 years who are eligible for\r their first systemic therapy based on disease characteristics. Systemic therapy may\r include any cytotoxic, targeted, immune-based, or otherwise non-local treatment\r modality. Specific allowed settings include the following:\r\n\r - Incident metastatic disease (stage IV) undergoing palliative therapy\r\n\r - Non-metastatic disease undergoing adjuvant, neoadjuvant, or concurrent\r chemoradiation with either curative or palliative intent\r\n\r - Recurrent or subsequently metastatic disease (any stage)\r\n\r 3. Pathologic confirmation of malignancy prior to initiation of first systemic therapy\r\n\r 4. Patient agrees to the submission of archival biospecimen sample(s) (collected up to two\r years prior) for analysis\r\n\r 5. Availability of key variables at the time of screening (e.g. stage, demographics)\r\n\r 6. Have been fully informed and are able to provide written consent for longitudinal\r follow-up and agree to be accessible by phone\r\n\r 7. Patients may be concurrently enrolled in unblinded clinical trials, but not blinded\r clinical trials in which the treatment being administered is unknown\r\n\r Patients are excluded if they meet any of the following criteria:\r\n\r 1. Pre-specified enrollment caps have been met (Figure 1)\r\n\r 2. Suspected recurrent or subsequently metastatic disease that is not biopsy confirmed\r prior to receipt of initial systemic therapy\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. ≥19 years of age\r\n\r 2. Patients with a primary diagnosis of NSCLC within the past 5 years who are eligible\r for their first systemic therapy based on disease characteristics. Systemic therapy\r may include any cytotoxic, targeted, immune-based, or otherwise non-local treatment\r modality. Specific allowed settings include the following:\r\n\r 1. Incident metastatic disease (stage IV) undergoing palliative therapy\r\n\r 2. Non-metastatic disease undergoing adjuvant, neoadjuvant, or concurrent\r chemoradiation with either curative or palliative intent\r\n\r 3. Recurrent or subsequently metastatic disease (any stage)\r\n\r 3. Pathologic confirmation of malignancy prior to initiation of first systemic therapy\r\n\r 4. Submission of archival biospecimen sample(s) (collected up to two years prior) for\r analysis\r\n\r 5. Availability of key variables at the time of screening (e.g. stage, demographics)\r\n\r 6. Have been fully informed and are able to provide written consent for longitudinal\r follow-up and agree to be accessible by phone\r\n\r 7. Patients may be concurrently enrolled in unblinded clinical trials, but not blinded\r clinical trials in which the treatment being administered is unknown\r\n\r Exclusion Criteria:\r\n\r 1. Pre-specified enrollment caps have been met (Figure 1)\r\n\r 2. Suspected recurrent or subsequently metastatic disease that is not biopsy confirmed\r prior to receipt of initial systemic therapy\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,591
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nApplication of Telemedicine for Dermatological Emergency Patients\n\n**Clinical Trial Summary:**\n\nAfter admission to the emergency room each dermatological patient is routinely assessed to\r Manchester Triage System (MTS) by the nursing staff. Thereby data are collected for anamnesis\r followed by randomization in two equal study groups.\r\n\r Patients of group A (control group) wait routinely until the dermatological investigator in\r charge arrives at the emergency room. Once the dermatological investigator is on site, he\r gives a diagnosis and proposes a therapy.\r\n\r For Patients of group B (teledermatology) study-related photographs of the skin lesion and\r anamnesis data are uploaded to the hospital information system \"medico\". Those data can\r directly be processed by the dermatological investigator in charge who enters his diagnosis\r and his therapy proposal.\r\n\r Subsequently an internal control is carried out as the same investigator comes personally to\r the emergency room to check its telemedical diagnosis and therapy proposal.\r\n\r Finally both time periods patients have to wait in the emergency room for their diagnosis and\r therapy are compared with each other.\n\n**Clinical Trial Detailed Description:**\n\nAfter admission to the emergency room each dermatological patient is routinely assessed to\r Manchester Triage System (MTS) by the nursing staff. Thereby data are collected for anamnesis\r (duration of symptoms, allergies, self-medication, medical history) followed by randomization\r in two equal study groups.\r\n\r Patients of group A (control group) wait routinely until the dermatological investigator in\r charge arrives at the emergency room. Once the dermatological investigator is on site, he\r gives a diagnosis and proposes a therapy.\r\n\r Time is measured from the patients admission to the emergency room up to the personnel\r diagnosis and therapy by the dermatological investigator in charge.\r\n\r For Patients of group B (teledermatology) first of all study-related photographs of the skin\r lesions are taken with a tablet. After that the registration of the consult \"teledermatology\"\r is carried out by the emergency investigator in charge, who uploads the photographs as well\r as the data for anamnesis to the hospital information system \"medico\". The consult\r \"teledermatology\" can directly be processed by the dermatological investigator in charge who\r enters his diagnosis and his therapy proposal.\r\n\r Time is measured from admission to the emergency room up to the telemedical diagnosis and\r therapy by the dermatological investigator in charge.\r\n\r Subsequently an internal control is carried out as the same investigator comes personally to\r the emergency room to check its telemedical diagnosis and therapy proposal.\r\n\r Finally both time measurements are compared with each other.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or female aged ≥ 18 years\r\n\r - Written informed consent prior to study participation\r\n\r - Adults who are contractually capable and mentally able to understand and follow the\r instructions of the study personnel.\r\n\r - Dermatological emergency patient\r\n\r Exclusion Criteria:\r\n\r - Male or female aged < 18 years\r\n\r - Missing informed consent prior to study participation\r\n\r - Patient has been committed to an institution by legal or regulatory order\r\n\r - Persons in dependence from the sponsor or working with the sponsor\r\n\r - Participation in another clinical trial within the previous 2 months\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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35,592
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nDiagnosis of PD and PD Progression Using DWI\n\n**Clinical Trial Summary:**\n\nThis project will evaluate the utility of diffusion tensor imaging (DTI) as an adjunctive\r method to improve early diagnosis of Parkinson's disease (PD). Two populations will be\r evaluated in this study: 1) Individuals with uncertain PD diagnosis who receive a DaTscan,\r and 2) individuals with well characterized PD and healthy controls, drawn from the fully\r enrolled Parkinson's Progression Markers Initiative (PPMI) PD and control cohorts.\n\n**Clinical Trial Detailed Description:**\n\nSpecific Aim 1a: Compare the outcome of a DTI based prediction with a contemporaneous\r clinical DAT scan in 100 subjects with suspected parkinsonism, and determine rate of\r concordance between the two diagnostic techniques.\r\n\r Specific Aim 1b: Compare predictive accuracy of a baseline DTI with a \"gold standard\" expert\r diagnosis after 36 months of follow up in 100 subjects receiving DaTscan for suspected\r parkinsonism.\r\n\r Specific Aim 2a: Use TBM to evaluate volume and cross-sectional caliber (based on point-wise\r fiber track direction) of the fimbria, pallidonigral tracts, and subthalamic-nigral tracts in\r PD and healthy controls. Ascertain if changes in white matter volume and caliber can be used\r to predict presence of PD from the PPMI study. Secondarily, using a model free approach,\r determine what white matter features based on TBM predict presence of disease.\r\n\r Specific Aim 2b: Use TBM to determine if an increased rate of change in volume and\r cross-sectional caliber of the fimbria, and hypertrophic pallidonigral, and\r subthalamic-nigral tracts identified in aim 2a, are associated with a more rapid rate of\r disease progression in PD. Secondarily, using a model free approach, determine what white\r matter features based on TBM predict a faster rate of disease progression over the 5 year\r course of the PPMI study.\r\n\r Specific Aim 3a: Compare DTI FA in TD-PD and PIGD-PD in the thalamus and lobule IX of the\r cerebellum , studying subjects from the PPMI study. Predict signal in these regions will\r predict phenotypic expression of disease. Using TBM and bootstrapping, determine the\r relationship between phenotypic expression of disease and white matter input/output pathways\r from the thalamus, and from lobule IX of the cerebellum.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients 19 and older\r\n\r - Referred for clinical DaTscan for possible PD\r\n\r - Controls from the PPMI dataset.\r\n\r Exclusion Criteria:\r\n\r - Pregnant women\r\n\r - Participants that cannot participate in MRI (metallic artifact or other\r contraindication(s) to MRI at 3T)\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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35,593
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCompensation Mechanisms in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nParkinson's disease onset is clinically defined as the appearance of motor symptoms including\r akinesia, tremor and hypertonia. Several studies have shown that motor symptoms occur when at\r least 50 % of dopaminergic neurons are lost. However, there are evidence suggesting that the\r level of dopaminergic denervation is not homogenous at the time of diagnosis.\r\n\r Some patients have a higher level of dopaminergic loss at disease onset indicating the\r existence of compensation mechanisms. The aim of this study is to decipher how the metabolism\r of dopamine is involved in this compensation with a focus on the polymorphism of the COMT\r gene. This gene is expressed according to two variant: (i) COMT H that encodes a form of the\r enzyme with a high level of activity and (ii) COMT L that encode a form of the enzyme with a\r low level of activity. Thus, there are 3 possible genotypes in the population: (i) COMT HH\r associated with an increased degradation of dopamine, (ii) COMT LL associated with a\r decreased degradation of dopamine and (iii) COMT HH (intermediary between COMT HH and COMT\r LL).\r\n\r The hypothesis is that this polymorphism of the COMT gene may participate to compensation\r mechanisms in early PD. Patients with COMT HH genotype may have an earlier motor symptoms\r onset than patients with COMT LL genotype.\r\n\r To test this hypothesis, we will recruit 51 patients with de novo PD will be recruited (17\r patients for each genotype). Given the distribution of COMT polymorphism in the population, a\r maximum sample of 76 patients will be screened to recruit 17 patients for each genotype.\r\n\r Clinical evaluation will include MDS-UPDRS, Non Motor Symptoms Scale, segmental symptoms\r scale, Montreal Cognitive assessment, MMSE, Frontal assessment battery and Parkinson's\r disease behavioral assessment scale (ECMP). All the patients will have a monophotonic\r emission tomography with I-123-Ioflupane in order to assess the level of dopaminergic\r denervation and an MRI scan with resting state study. Cerebrospinal fluid sampling will be\r optional and will allow direct measurements of dopamine metabolites.\r\n\r The main outcome measure will be the level of dopaminergic denervation on I-123-Ioflupane\r scans according to COMT genotype, age, gender and severity of motor symptoms on the MDS-UPDRS\r part 3.\r\n\r If this hypothesis is confirmed, this will allow to test the efficacy of COMT inhibitors in\r order to delay dopaminergic drugs initiation for PD patients.\n\n**Clinical Trial Detailed Description:**\n\nParkinson's disease onset is clinically defined as the appearance of motor symptoms including\r akinesia, tremor and hypertonia. Several studies have shown that motor symptoms occur when at\r least 50 % of dopaminergic neurons are lost. However, there are evidence suggesting that the\r level of dopaminergic denervation is not homogenous at the time of diagnosis. Some patients\r have a higher level of dopaminergic loss at disease onset indicating the existence of\r compensation mechanisms.\r\n\r The aim of this study is to decipher how the metabolism of dopamine is involved in this\r compensation with a focus on the polymorphism of the COMT gene. This gene is expressed\r according to two variants: (i) COMT H that encodes a form of the enzyme with a high level of\r aactivity and (ii) COMT L that encode a form of the enzyme with a low level of activity.\r Thus, there are 3 possible genotypes in the population: (i) COMT HH associated with an\r increased degradation of dopamine, (ii) COMT LL associated with a decreased degradation of\r dopamine and (iii) COMT HH (intermediary between COMT HH and COMT LL).\r\n\r The hypothesis is that this polymorphism of the COMT gene may participate to compensation\r mechanisms in early PD. Patients with COMT HH genotype may have an earlier motor symptoms\r onset than patients with COMT LL genotype.\r\n\r To test this hypothesis, 51 patients with de novo PD will be included (17 patients for each\r genotype). Given the distribution of COMT polymorphism in the population, a maximum sample of\r 76 patients will be screened for inclusion of 17 patients for each genotype.\r\n\r Only untreated patients will be included in the study in order to have a reliable assessment\r of motor severity without interference of dopaminergic drugs.\r\n\r The study will be scheduled as follow:\r\n\r - At the first visit (V1), inclusion criteria will be checked and patients will sign the\r informed consent. COMT genotype of selected patients will be analyzed.\r\n\r - Result of COMT genotype will be obtained within 4 weeks. Only the 17 first patients with\r each genotype will continue the study\r\n\r - For these patients, an evaluation visit with clinical assessment including MDS-UPDRS,\r Non Motor Symptoms Scale, segmental symptoms scale, Montreal Cognitive assessment, MMSE,\r Frontal assessment battery and Parkinson's disease behavioral assessment scale (ECMP)\r will be performed..\r\n\r All the patients will have a monophotonic emission tomography with I-123-Ioflupane in order\r to assess the level of dopaminergic denervation. An MRI scan with resting state study will\r also be performed to assess the compensation mechanisms at the networks level. Cerebrospinal\r fluid sampling will be optional and will allow direct measurements of dopamine metabolites.\r\n\r The main outcome measure will be the level of dopaminergic denervation on I-123-Ioflupane\r scans according to COMT genotype with and without adjustment for age, gender and severity of\r motor symptoms on the MDS-UPDRS part 3.\r\n\r Secondary outcome measures will include:\r\n\r - level of dopaminergic denervation compared across the 3 genotypes (COMT HH, COMT HL and\r COMT HH) with and without adjustment for age, gender and motor scores\r\n\r - determination of functional compensation at the networks scale assessed on fMRI resting\r state scan according to dopaminergic denervation\r\n\r - determination of CSF dopamine metabolite profile at the time of diagnosis (CSF sampling\r will be optional).\r\n\r If this hypothesis is confirmed, this will allow to test the efficacy of COMT inhibitors in\r order to delay dopaminergic drugs initiation for PD patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Man or woman ≥ 18 years old,\r\n\r - Caucasian origin\r\n\r - Parkinson's disease considered to be probable as defined by the criteria of UK\r Parkinson's disease Brain Bank (Hugues and coll 2002)\r\n\r - Absence of anti-parkinsonian medication\r\n\r - Patient affilied to a social security system\r\n\r - Signed information consent form\r\n\r Exclusion Criteria:\r\n\r - Parkinsonian syndrome secondary to neuroleptics\r\n\r - Atypical parkinsonian syndrome such a multisystem atrophy, progressive supranuclear\r paralysis, dementia with levy bodies.\r\n\r - MRI contraindication (claustrophobia, not compatible mechanical heart valve MRI,\r pacemaker, cochlear implant, other body ferromagnetic objects, pregnancy) - MPET\r contraindication (pregnancy, feeding, hypersensitivity to ioflupane [123]\r\n\r - Patient under guardianship or trusteeship\r\n\r - Any other significant pathology that could prevent patient participation and\r achievement of planned examinations (except for lumbar puncture)\r\n\r - Patient participating or having participated in other biomedical research involving a\r drug in the three months prior to inclusion\r\n\r - Specific exclusion criteria if lumbar puncture is accepted by the patient:\r Anticoagulation or antiplatelet treatment; history of hemostasis disorders; platelets\r <150,000 mm3; TP <80%; TCA (patient / control)> 1.2.\r\n\r - Hypersensitivity to local anesthetics with amide link or to any of the excipients\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nParkinson's Repository of Biosamples and Network Datasets (Tracking Parkinson's)\n\n**Clinical Trial Summary:**\n\nProspective observational study of Parkinson's disease with repeat clinical assessment and\r biobanking of blood samples.\n\n**Clinical Trial Detailed Description:**\n\nTo identify genetic and biomarker factors which affect the expression of Parkinson's Disease.\r\n\r Primary objective: To define the severity and rates of progression of clinical features of\r Parkinson's Disease.\r\n\r Secondary objective: To relate clinical phenomenology of Parkinson's disease to genetic and\r biomarker changes.\n\n**Clinical Trial Eligibility Criteria:**\n\nA. Parkinson's Disease patients\r\n\r Inclusion criteria\r\n\r 1. Diagnosis of Parkinson's disease, based on UK Brain Bank criteria and made within the\r preceding 3 years ('recent onset cases') or diagnosed at under 50 years ('under 50\r years cases')\r\n\r 2. Age ≥18 to <90years\r\n\r 3. Subject is able and willing to provided informed consent.\r\n\r Exclusion criteria\r\n\r 1. Patient has severe comorbid illness that would prevent full study participation\r\n\r 2. Patient has features indicating another type of degenerative parkinsonism, e.g.\r progressive supranuclear palsy\r\n\r 3. Drug-induced parkinsonism (Drug-unmasked PD is allowed)\r\n\r 4. Symmetrical lower body parkinsonism attributable to significant cortical and/or\r subcortical cerebrovascular disease (patients with 'incidental' small vessel disease\r on brain imaging are allowed).\r\n\r 5. Negative or normal functional imaging of the presynaptic dopamine system\r\n\r 6. The presence of UK Brain Bank exclusion criteria will be recorded at baseline,\r allowing for the presence of 1 or 2 exclusion criteria (e.g. dopamine antagonist Drug\r used; more than one affected relative) (if justified e.g. by abnormal SPECT).\r\n\r B. First degree relatives Inclusion criteria\r\n\r 1. Age ≥18 to < 90years\r\n\r 2. Resident in the United Kingdom and able to access one of the PRoBaND study centres.\r\n\r 3. Subject is able and willing to provided informed consent.\r\n\r Exclusion criteria\r\n\r 1. Subject has severe comorbid illness that would prevent study participation\r\n\r 2. Subject already has a diagnosis of Parkinson's disease\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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35,595
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEvaluation of Directional Recording and Stimulation Using spiderSTN\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to provide proof-of-concept that directional stimulation and\r directional recording, in an intraoperative setting, is perceivable in a subject. The tests\r will be performed using a dedicated intraoperative lead connected to an external\r neuro-recorder/stimulator, during a deep brain stimulation implantation surgery.\n\n**Clinical Trial Detailed Description:**\n\nDeep brain stimulation (DBS) technique involves implanting electrodes using a stereotactic\r method and connecting them to a pulse generator to deliver a current in localized areas in\r the brain.\r\n\r The optimum location for DBS electrodes is determined by pre-operative brain imaging, often\r combined with an intraoperative microelectrode recording/stimulating (MER) sequence. Current\r MER practice involves inserting micro-recording/stimulating electrodes into guide tubes in\r the brain and lowering them towards the target, performing recordings at selected steps. The\r recordings differ based on the types of neuronal structures they are passing through.Based on\r the recordings, some promising locations are further discriminated by stimulation using\r macro-electrodes, and the target for final lead placement is chosen.\r\n\r The spiderSTN lead (Aleva Neurotherapeutics SA, Switzerland) is capable of recording and\r stimulating from both its inner and outer surface, allowing the user to steer the direction\r of stimulation during the target location phase. This will allow the neurosurgeon greater\r flexibility in investigating the balance between therapeutic benefits and stimulation-induced\r side effects at a given location.\r\n\r This feasibility study is designed to explore the effect of directional stimulation and the\r ability to differentiate between stimulation induced side effects at a given location, during\r the DBS surgery. It will be proposed to patients who suffer from Parkinson disease (PD) or\r essential tremor (ET) and for whom DBS is indicated according to standard criteria at the\r hospital. It will be restricted to a limited number of patients (10), sufficient to assess\r the recording and stimulating capacity of the spiderSTN device. The patient undergoes the\r normal DBS surgery until the position for the final lead has been chosen. Then the spiderSTN\r test phase takes place. Once test phase is completed, the conventional DBS surgery resumes.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Patient foreseen to undergo DBS for Parkinson's disease or Essential Tremor according to\r routine criteria of the center.\r\n\r For Parkinson Disease:\r\n\r - Person is between 18 and 75 years of age\r\n\r - Established diagnosis of idiopathic Parkinson's disease with progression of symptoms\r for a minimum of 2 years.\r\n\r - Person has a history of at least 30% improvement on the UPDRS therapy in L-dopa\r (levodopa), except in the case of tremor dominant patient\r\n\r - Weak control of symptoms by dopaminergic therapy (off phenomenon, fluctuations on /\r off, dyskinesia on)\r\n\r For Essential Tremor:\r\n\r - Person is between 18 and 80 years of age\r\n\r - Established diagnosis of Essential Tremor for a minimum of 2 years\r\n\r - Functional disability due to tremor was not adequately controlled by medication for at\r least 3 months prior to implant.\r\n\r Person has given his/her written consent\r\n\r Exclusion Criteria:\r\n\r - Person suffering from an active major psychiatric disorder\r\n\r - Mattis Dementia Rating Scale score <130 or otherwise not capable of discernment\r\n\r - Presence of major co-morbidity or medical condition that may affect participation to\r the study\r\n\r - Presence of an electrical or electromagnetic implant (e.g., cochlear implant,\r pacemaker)\r\n\r - Person with a previous surgery for the treatment of Parkinson's disease or Essential\r Tremor\r\n\r - Person with a previous brain ablation procedure\r\n\r - Person who suffers from epilepsy\r\n\r - Person who is pregnant: a pregnancy test will be performed in patients of childbearing\r age\r\n\r - Person with coagulopathies\r\n\r - Abuse of drugs or alcohol\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,596
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSerotonin and Amyloidopathy\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine if changes in brain serotonin affects the\r accumulation of amyloid in the brain. The investigators will use brain imaging methods to\r measure the amount of serotonin and amyloid in the brain of individuals with Parkinson's\r Disease (PD) and otherwise healthy older people. PD participants will undergo repeat brain\r imaging to assess amyloid accumulation two years after their first brain imaging session. All\r participants will undergo examinations to assess their motor function, and asked questions to\r assess their mood and thinking.\n\n**Clinical Trial Detailed Description:**\n\nParkinson's disease (PD) is a common problem of older people often causing significant\r problems with thinking and memory. Abnormal accumulation within in the brain of a protein\r called amyloid is felt to contribute to impaired thinking and memory in PD. Excessive\r accumulation of this protein is also involved in Alzheimer disease (AD) and may influence\r thinking and memory in otherwise healthy older people. Recent evidence suggests that changes\r in the amount of another brain chemical, serotonin, influences the amount of amyloid\r accumulating in the brains of people with PD and otherwise healthy older people. The purpose\r of this study is to determine if changes in brain serotonin affects the accumulation of\r amyloid in the brain. The investigators use brain imaging methods to measure the amount of\r serotonin and amyloid in the brain of individuals with PD and otherwise healthy older people.\r PD participants will undergo repeat brain imaging to assess amyloid accumulation 2 years\r after their first brain imaging session. All participants will undergo examinations to assess\r their motor function, and asked questions to assess their mood and thinking.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Persons who have been diagnosed with Parkinson disease age 45 years and older are\r eligible to participate in this study.\r\n\r - Healthy older individuals (ages 60-80) without neurologic problems are eligible to\r participate.\r\n\r Exclusion Criteria:\r\n\r - Individuals using some drugs cannot participate. These include anti-depressant\r medications, buproprion, or St. John's Wort, as well as dopamine antagonist\r medications.\r\n\r - Women of childbearing age may not participate.\r\n\r - Individuals unable to have MRI scans because of a pacemaker or metal fragments may not\r participate.\r\n\r - Individuals with a history of stroke may not participate. People with any\r contraindication of PET imaging such as previous participation in research procedures\r involving ionizing radiation may not be eligible to participate in this study.\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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35,597
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTherapeutic Yoga to Improve Function in Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nThis is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.\n\n**Clinical Trial Detailed Description:**\n\nThis is a single blind, randomized, wait-list controlled, phase II exploratory pilot study\r utilizing an after-trial embedded mixed methods approach that will examine the efficacy of\r therapeutic yoga as a rehabilitation strategy for individuals with PD to improve balance and\r reduce fear of falling (FoF). Potential participants will have a FoF in order to enter the\r study. An after-trial embedded mixed methods design will be employed in this study and will\r include the collection of qualitative data to assist in the overall interpretation of the\r more heavily weighted quantitative trial data. Adding qualitative methods will serve as a\r post-hoc analysis capturing participant perceptions of the relationships between the yoga\r intervention and various outcomes. More specifically, the qualitative data will aide in\r explaining the link between the various yoga techniques and mechanisms that participants\r attribute to improved balance, reduced FoF, and other bio-psychosocial outcomes and\r experiences. Qualitative data will be collected using focus group interviews with\r participants in the yoga group at the end of the class in week 8.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of Parkinson's Disease with a rating of 1.5-4 on the Modified Hoehn and Yahr\r Scale of Parkinson's Disease Progression\r\n\r - Endorsement of FoF,44 able to stand and walk 10 meters with or without an assistive\r device\r\n\r - >18 years old; able to speak English\r\n\r - Score >4 out of 6 on the short Mini Mental Status Exam\r\n\r - Able and willing to attend twice weekly sessions for 8 weeks\r\n\r Exclusion Criteria:\r\n\r - People with self-reported life expectancy <12 months\r\n\r - Inability to attend sessions due to transportation issues\r\n\r - Current involvement with other physical activity (including yoga), rehabilitation, or\r other intervention studies\r\n\r - Inability or refusal to provide informed consent\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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35,598
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIntervention to Increase Treatment Engagement Among Individuals Referred for Post-Crisis Mental Health Services\n\n**Clinical Trial Summary:**\n\nThis study will evaluate the preliminary effectiveness of Make It!, a single 15-minute\r intervention aimed at increasing attendance to a follow-up appointment for psychological\r services (i.e., an information class) among clients accessing walk-in services at a mental\r health crisis response centre. As a secondary aim, we will examine the demographic\r correlates, presenting problems, and symptom correlates of clients who do and do not attend\r follow-up services.\n\n**Clinical Trial Detailed Description:**\n\nThe current study will employ a quasi-experimental design whereby several frontline\r clinicians at a mental health crisis response will be trained to deliver the Make It!\r intervention and the others will not. An attempt will be made to train staff who commonly\r share work days or shifts in order to avoid details of the active intervention reaching\r clinicians who continue to deliver treatment as usual. For the duration of the study period,\r clinicians trained in Make It! will be instructed to use the intervention as their standard\r of care with all of the clients they assess whom are subsequently referred to the Information\r Class. The remaining clinicians will continue to use treatment as usual.\r\n\r During a 90 minute workshop, Make It! will be introduced and modeled by the Principal\r Investigator (PI). Make It! consists of a 10-15 minute intervention with 5 components: 1)\r Acknowledgement that the client has experienced distressing events and/or very stressful\r situations, and that this exposure can lead to a range of reactions, 2) Client-generated,\r clinician-assisted, pros and cons of attending the Information Class, 3) Detailed\r visualization of the First Information in order to reduce anxiety about what to expect, 4)\r Expression of confidence that the client can begin progress towards the changes they want to\r make, 5) Reiteration of main information and appointment card given. Each clinician trained\r will be observed administering the intervention to a co-worker, with fidelity checks being\r implemented throughout the study period. These fidelity checks will be implemented by the PI,\r who will occasionally and sporadically observe the clinicians administer the intervention\r through a one-way mirror, with the verbal consent of the participant and the clinician.\r\n\r All clients accessing the walk-in service at the crisis response centre currently receive a\r mental health assessment by a staff clinician. Throughout the course of the assessment, if\r the clinician perceives that the client may benefit from follow-up psychological services, he\r or she provides the client with an appointment date and time for the next available\r Information Class. The Information Class is a group appointment, and its purpose is to\r provide information about the services offered at the centre. It serves as the entryway into\r follow-up services such as cognitive behavioral therapy classes for mood and anxiety symptoms\r or dialectical behavioral therapy-informed classes. Walk-in clients who receive an\r appointment for this Information Class typically are given an appointment date that is within\r 1-2 weeks of their walk-in visit.\r\n\r Once the clinician makes a decision to refer a client to an Information Class, the clinician\r will contact the study coordinator. The study coordinator or research volunteer will come\r into the interview room while the clinician steps out, will explain the study to the\r participant, and will obtain informed consent. In the event that a potential participant\r requires more time to consider whether he or she wants to consent to study participation, the\r individual will be provided with the contact information of the study coordinator in order to\r be able to consent at a later date. The study coordinator or research volunteer will also ask\r the participant to complete some brief questionnaires at this time assessing barriers to\r seeking mental health care and stages of change.\r\n\r The study coordinator or research volunteer will then leave and the clinician will return to\r the interview room. If the clinician has not been trained in Make It!, he/she will proceed\r with care as usual. This condition involves providing the client with detailed information\r about the upcoming Information Class. If the clinician has been trained in Make It!, then the\r intervention will proceed at this time.\r\n\r A few days before the client's Information Class, a reminder call is made by an\r administrative assistant at the centre. When the administrative assistant is unable to reach\r the client, she leaves a brief message, if possible to do so.\r\n\r On the day of the Information Class, attendance will be taken. Clients sit in a classroom\r setting and complete a package of questionnaires. Those participants enrolled in the study\r will complete the Life Events Checklist-5, the University of Rhode Island Change Assessment,\r and an open-ended question assessing barriers to care, in addition to 5 questionnaires\r assessing a range of mental health symptoms that are already administered at the Information\r Class for clinical purposes. After the Information Class, clients have the opportunity to\r meet individually for 5-10 minutes with a staff member in order to discuss their treatment\r needs and preferences, and to connect them with subsequent services. If the client is a\r participant in the study, the staff member will provide them with a debriefing document that\r also contains the PI's contact information should they have any additional questions,\r comments, or concerns. This concludes the client's participation in the study.\r\n\r For study participants who do not attend the Information Class, the questionnaires\r administered at the Information Class will be mailed to the participant along with a standard\r Information Class \"no show\" letter and the study's debriefing document. Participants will be\r encouraged to complete the questionnaires and return them in the self-addressed stamped\r envelope to the PI. This will represent the end of the participant's role in the study.\r\n\r If a participant calls in advance of the Information Class to reschedule their Class date, or\r if they inform the administrative assistant that they wish to reschedule when she makes the\r reminder call, the participant will continued to be considered a participant until their\r rescheduled appointment.\n\n**Clinical Trial Eligibility Criteria:**\n\nCriteria for being referred to the crisis centre's Information Class and thus, for\r participation in the study are:\r\n\r - presenting to the walk-in service with a mental health-related crisis (e.g.,\r difficulty coping with acute stressors, suicidality),\r\n\r - a willingness by the client to participate in class-based or group interventions,\r\n\r - the ability to attend and have transportation to services during daytime hours,\r\n\r - the client is not better served by another service for their presenting problem (e.g.,\r Addictions Foundation of Manitoba when alcohol or substance is primary),\r\n\r - the client is literate and will be able to understand and benefit from attending\r class-based or group psychotherapy interventions, and\r\n\r - the client is not being admitted to the Crisis Stabilization Unit or hospital (i.e.,\r is not at imminent risk of harming themselves or others).\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
35,599
|
[
{
"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\nMental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease\n\n**Clinical Trial Summary:**\n\nAmong the impairments associated to Parkinson's disease, gait disturbance is one of which\r that has the most negative impact on the independence in daily living activities and quality\r of life of people living with Parkinson's disease. Despite the considerable amount of\r research, we have no consensus about the most efficient physiotherapeutic approach to improve\r the gait disturbance. Mental practice is considered an efficient strategy to improve the\r motor performance in healthy individuals and people with stroke. However, there is scarce\r evidence about its therapeutic results to improve the gait performance in people living with\r Parkinson's disease. Thus, the aim of this study is to investigate the effects of gait mental\r practice associated to physical practice to improve the gait performance in people living\r with Parkinson's disease.\n\n**Clinical Trial Detailed Description:**\n\nBackground: Among the impairments associated to Parkinson's disease, the gait disturbance is\r one of which that has the most negative impact on the independence in daily living activities\r and quality of life of people living with Parkinson's disease. Despite the considerable\r amount of research, we have no consensus about the most efficient physiotherapeutic approach\r to improve the gait disturbance. Mental practice is considered an efficient strategy to\r improve the motor performance in healthy individuals and people with stroke. However, there\r is scarce evidence about its therapeutic results to improve the gait performance in people\r living with Parkinson's disease.\r\n\r Objectives: To investigate the effects of mental gait practice associated with physical\r practice to improve the gait performance of people living with Parkinson's disease.\r\n\r Design: Parallel, prospective, double-blind, multicentre randomized clinical trial.\r\n\r Setting: Brazilian Parkinson Association.\r\n\r Participants: Twenty-two people living with Parkinson's disease in stages 2-3 of disease\r evolution according to Hoehn and Yahr Classification.\r\n\r Interventions: The participants will be randomly allocated in an experimental group and a\r control group. Both groups will perform 10 individual training sessions, two times per week,\r for five weeks. The training sessions consist of four blocks of mental practice intercalated\r with four blocks of physical practice of gait under different conditions. The only difference\r between the groups will be the content of mental practice blocks: the experimental group will\r perform mental practice of gait while the control group performs non-gait mental practice.\r\n\r Randomization: Participants will be randomized by ClinStat software into one of two groups:\r Experimental Group (EG), which will perform gait mental practice; and Control Group (CG),\r which will perform the non-gait mental practice.\r\n\r Statistical analysis: The training effects for each primary and secondary outcome measure\r will be analyzed for the two training conditions (i.e., control and experimental) at the four\r assessment time points (i.e., pre-intervention, 7 days post-completion and at 30 and 60-day\r follow-up) using a mixed-design ANOVA with training as the between-group factor and the\r assessment time point as the within-group factor. The effect sizes (ES) will be calculated\r for all comparisons at alpha = 0.05. A Tukey HSD post-hoc test will be used for multiple\r comparisons and p-values below 5 % will be considered as statistically significant.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria;\r\n\r - in stage 2-3 of the disease evolution according to the Hoehn and Yahr;\r\n\r - treated with levodopa or its synergists;\r\n\r - capable to walk independently indoors without aid;\r\n\r - referring 5 years of education or more.\r\n\r Exclusion Criteria:\r\n\r - presence of other neurological (excluding PD), orthopedic or cardiopulmonary problems;\r\n\r - visual and auditory deficiency uncorrected;\r\n\r - dementia [assessed by Montreal Cognitive Assessment (MoCA), cut-off 26];\r\n\r - depression [according to the Geriatric Depression Scale (GDS-15), cut-off 6];\r\n\r - declined imagery capacity [according to the Revised Movement Imagery Questionnaire\r (MIQ-R) cut-off 10].\n\n**Patient Description:** \n\nThe patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.\n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
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