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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 Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine if usage of early lumbar drainage leads to less\r shunt surgery and less catheter associated complications in patients with communicating\r hydrocephalus after intracerebral hemorrhage with severe ventricular involvement.\n\n**Clinical Trial Detailed Description:**\n\nAll patients requiring external ventricular drain (EVD) for treatment of acute obstructive\r hydrocephalus receive intraventricular fibrinolysis with rt-PA via the ventricular catheter.\r Lumbar drainage (LD) is inserted at a timepoint, when communication between the internal and\r the external CSF-spaces is recognizable on CT (\"opening\" of third and fourth ventricle and\r aqueduct).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - supratentorial intracerebral hemorrhage <60ml\r\n\r - intraventricular hemorrhage with casting of the third and fourth ventricles\r\n\r - obstructive hydrocephalus with need of external ventricular drainage\r\n\r - GCS <9 on admission or within 48h of symptom onset\r\n\r - admission within 48h of symptom onset\r\n\r - preceding modified Rankin scale ≤3\r\n\r - age 18-85 years\r\n\r Exclusion Criteria:\r\n\r - ICH related to oral anticoagulation, trauma, tumor, arteriovenous malformation,\r aneurysm, systemic thrombolysis or sinus thrombosis\r\n\r - infratentorial hemorrhage\r\n\r - pregnancy\r\n\r - admission 48h after symptom onset\r\n\r - preceding modified Rankin scale >3\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
901
|
[
{
"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\nDiaphragmatic Movement Before and After Stellate Ganglion Block : A Ultrasonographic Study\n\n**Clinical Trial Summary:**\n\nThe temporary diaphrgmatic dysfunction will occur after stellate ganglion block(SGB) and will\r be easily detected by M-mode ultrasonography\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - ASA class I-II patients who have head and neck pain or shoulder pain or sudden sensory\r neural hearing loss\r\n\r Exclusion Criteria:\r\n\r - coagulopathy, pulmonary disease, neuropathy\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
902
|
[
{
"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\nProspective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage\n\n**Clinical Trial Summary:**\n\nIntraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in\r the United States. In the emergent setting, patients with obstructive hydrocephalus are\r routinely treated with placement of an external ventricular drain. This study will compare\r the effect of external ventricular drainage plus intraventricular thrombolysis versus\r external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients\r with hydrocephalus from intraventricular hemorrhage.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age 18-75\r\n\r - Radiographic evidence of intraventricular hemorrhage with hydrocephalus\r\n\r - Admission Glasgow Coma Scale ≥ 5 (motor score ≥ 2)\r\n\r - Placement of an external ventricular drain with an opening pressure >20 mm Hg\r\n\r Exclusion Criteria:\r\n\r - Intraventricular hemorrhage secondary to cerebral aneurysm, arteriovenous\r malformation, or tumor\r\n\r - Coagulopathy (Platelet count <100,000, International normalized ratio >1.5. Reversal\r of warfarin is permitted.)\r\n\r - Age <18 or >75\r\n\r - Pregnancy (positive pregnancy test)\r\n\r - Clotting disorders\r\n\r - Medical contraindications to administration of general anesthesia as determined by the\r attending anesthesiologist\r\n\r - Medical contraindications to surgery as determined by the attending neurosurgeon\r\n\r - Contraindication to recombinant tissue plasminogen activator administration:\r\n\r - Evidence of enlargening intracranial hemorrhage as evidenced by an increase in\r intracranial hemorrhage volume (>5 ml) on CT obtained after EVD placement\r\n\r - Internal bleeding, involving retroperitoneal sites, or the gastrointestinal,\r genitourinary, or respiratory tracts\r\n\r - Superficial or surface bleeding, observed at vascular puncture and access sites\r (e.g. venous cutdowns, arterial punctures) or site of recent surgical\r intervention\r\n\r - Evidence of cerebrospinal infection by Gram stain or culture\r\n\r - Advanced directive indicating Do Not Resuscitate or Do Not Intubate status\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
903
|
[
{
"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\nProcedures of Locoregional Analgesia and Quality of Life in Palliative Care Units\n\n**Clinical Trial Summary:**\n\nNumber of patients in mobile palliative care units have pain of both nociceptive and\r neuropathic origin. In certain cases, procedures of locoregional analgesia can be helpful.\r\n\r The Purpose of this study is to evaluate the impact of techniques of locoregional analgesia\r in a palliative population\n\n**Clinical Trial Detailed Description:**\n\nCancer pain is a serious problem in the palliative population. In particular, pain due to\r compression or invasion of nerve tissue by metastasis is frequent and often unresponsive to\r oral drug therapy and even to epidural administration of opioids. In such refractory pain in\r a palliative setting, one modality that could be helpful is the use of technics of\r locoregional analgesia. Currently, they are routinely used for the management of acute\r postoperative pain and become to be more widely used for cancer surgery. For example,\r intrapleural intercostal nerve blocks after major lung resection or preincisional\r paravertebral blocks after breast surgery have been shown to improve pain control. However,\r locoregional analgesia is only occasionally used in chronic cancer pain.\r\n\r The procedures used are epidural analgesia, rachianesthesia, or continuous nerve blocks.\r L-bupivacaine will be used. The procedure will be performed only if the injection test is\r positive.\r\n\r The patients will be evaluated before and after the procedure, the patient being his/her own\r control. Evaluations will take place immediately before the procedure, then at 48 hours, 1\r week and 1 month after the procedure.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient ≥ 18 years-old, male or female, whatever his/her ethnic group\r\n\r - Patient with untreatable cancer\r\n\r - Patient hospitalized in a palliative care unit, with a life expectancy ≥ 1 week\r\n\r - Pain unresponsive to conventional treatments\r\n\r - Effectiveness of the injection test\r\n\r - Signed informed consent\r\n\r Exclusion Criteria:\r\n\r - Patients > 18 years-old\r\n\r - Patients with pain other than cancer pain\r\n\r - Patient's refusal\r\n\r - Coagulation disorders\r\n\r - Local infection\r\n\r - Known hypersensitivity to local analgesics\r\n\r - Inefficacy of the injection test.\r\n\r - Contraindication for analgesics\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
904
|
[
{
"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\nIntraventricular Tissue Plasminogen Activator (tPA) in the Management of Aneurysmal Subarachnoid Hemorrhage\n\n**Clinical Trial Summary:**\n\nThe proposed study is to evaluate the acceleration the clearance of intraventricular blood\r (IVH) and subarachnoid hemorrhage (SAH) following ruptured intracranial aneurysms, thereby\r ameliorating complications, such as cerebral vasospasm, hydrocephalus and intracranial\r hypertension.\r\n\r The primary objectives are:\r\n\r 1. Estimate the rate and variance of hematoma clearance following aneurysmal SAH, thereby\r facilitating sample size determination for a subsequent larger study;\r\n\r 2. Assess the feasibility of a randomized controlled trial of intraventricular tissue\r plasminogen activator (TPA) among patients with SAH (enrollment rate, ability to blind\r investigators, protocol compliance);\r\n\r 3. Confirm the safety of intraventricular TPA.\n\n**Clinical Trial Detailed Description:**\n\nOutcome Measures:\r\n\r Safety will be assessed through adverse events, hemorrhagic complications and the development\r of ventriculostomy-related infections.\r\n\r The volume and clearance of intracranial blood will be determined (in ml) using computerized\r software, as well as validated semi-quantitative ordinal scales (SAH Sum Score, Modified\r Graeb Score). The amount of IVH and SAH will be assessed at baseline (day 0), 72 hours after\r treatment onset, and on post-SAH day 8.\r\n\r Additional secondary outcomes will include:\r\n\r 1. The occurrence of vasospasm, as determined using transcranial Doppler ultrasonography\r\n\r 2. The occurrence of radiographic vasospasm, using CT angiography.\r\n\r 3. The occurrence of \"clinical\" (symptomatic) vasospasm\r\n\r 4. The rate of catheter-related central nervous system infections\r\n\r 5. Levels of cytokines, endothelin and matrix metalloproteases in cerebrospinal fluid (CSF)\r and plasma\r\n\r 6. Levels of fibrin-derived products (FDP), TPA and plasminogen-activator inhibitor in CSF\r\n\r 7. Levels of S100β and neuron-specific enolase (NSE) in CSF and serum\r\n\r 8. Intracranial pressure\r\n\r 9. Volume of CSF drainage\r\n\r 10. Extended Glasgow Outcome Scale, modified Rankin scale, EuroQOL at 6 months post-SAH\r\n\r 11. Duration that ventriculostomy is required; need for permanent shunt\r\n\r 12. Fever burden\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adult patients (> 18 years old) with a proven ruptured cerebral aneurysm\r\n\r - Aneurysm has been / will be treated with coil embolization\r\n\r - EVD has been / will be placed as part of routine care\r\n\r - Modified Fisher score is 4 (cisternal blood > 1 mm thick with concomitant IVH)\r\n\r - CT scan after EVD placement shows \"stability\" with no increase in the amount of\r intracranial blood (Note: there is sometimes layering of blood, especially in the\r occipital horns of the lateral ventricles, that develops during the first 24-48 hours\r after a ruptured aneurysm due to circulation of blood in the CSF - this does not\r necessarily constitute an exclusion criterion).\r\n\r - Study drug can be administered within 72 hours of the time of SAH.\r\n\r Exclusion Criteria:\r\n\r - Concern expressed by endovascular neurosurgeon / interventional radiologist that\r aneurysm has only been incompletely treated / isolated by coil embolization.\r\n\r - Patient requires craniotomy and clipping of the culprit aneurysm.\r\n\r - CT scan performed post-EVD insertion OR post-coiling shows increase in amount of\r intracranial blood.\r\n\r - Uncorrected coagulation disturbance (INR > 1.5, PTT > 45); correction is permitted (if\r coagulation disturbance develops during the study, subsequent doses of TPA should\r simply be withheld until coagulation can be corrected).\r\n\r - Uncorrected thrombocytopenia (platelets < 50,000); correction with platelet\r transfusions is permitted.\r\n\r - Involvement in another clinical trial\r\n\r - Uncontrolled active internal hemorrhage\r\n\r - Known allergy to study drug\r\n\r - Patient is pregnant\r\n\r - Any other condition the investigator believes would place the subject at risk if\r included in the study.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
905
|
[
{
"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\nNeurologic and Neurophysiologic Assessment of Clinical Course in Patients With Intraspinal Processes\n\n**Clinical Trial Summary:**\n\nPatients included in the study are treated at the Klinik für Neurochirurgie USZ. The clinical\r course is documented at Paraplegikerzentrum Balgrist using validated diagnostic procedures\r (e.g. SCIM, ASIA, neurophysiology).\r\n\r Study aims:\r\n\r Prognostic value of clinical diagnosis and additional diagnostic procedures? Which parameters\r exhibit optimal prognostic power? Differences between tumor/AVM associated lesions and\r traumatic lesions? What can we learn for pathophysiology and treatment?\r\n\r - Trial with surgical intervention\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - Benign intraspinal process (tumor or vascular malformation AVM)\r\n\r - Primary lesion caudal of the brainstem, affecting C1\r\n\r - Cognitive ability to give written informed consent\r\n\r Exclusion criteria:\r\n\r - Metastases, malign tumors\r\n\r - Traumatic lesions\r\n\r - Myelitis, polyneuropathy\r\n\r - Disc prolaps\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
906
|
[
{
"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\nVascular Malformations and Abnormalities of Growth\n\n**Clinical Trial Summary:**\n\nTo take part in this study you/your child have a vascular malformation, a type of blood\r vessel disorder whose cause is unknown.\r\n\r The investigators will do this by looking at changes in the genes and proteins in the cells\r of the malformation as well as normal cells.\r\n\r The investigators are doing this research because currently there is no known cause of\r vascular malformations and no way to know whether or not other health problems will occur in\r addition to the malformation. Through this research we hope to create standard methods for\r doctors to examine and treat people with vascular anomalies.\n\n**Clinical Trial Detailed Description:**\n\nIf you/your child agree to participate\r\n\r 1. Informed consent and permission to use or disclose you/your child's health information\r for reserve purposes will be obtained by the research team. You will receive a copy of\r the consent form.\r\n\r 2. You/your child will be examined by a physician from the research team and interviewed\r about your medical background and condition every year for five years.\r\n\r 3. You/your child will have photographs taken of the affected area at each visit.\r\n\r 4. You/your child will have two, one time biopsies or skin samples taken by a\r dermatologist. Skin areas will be numbed with lidocaine and a 4 or 5 millimeter (or\r approximately 0.15 to 0.19 inch) sample will be taken in two different locations. The\r dermatologist taking the skin sample will use every effort to choose an area that can be\r covered by clothing or kept out of sight to others. The doctor will either use gelfoam\r or one stitch/suture per biopsy to seal off the area, which helps with healing and\r preventing bleeding. If a stitch is placed in the biopsy site, another visit about 7-10\r days following the procedure will be necessary to remove the stitch.\r\n\r 5. You may still participate in the study if you consent to having only one biopsy taken of\r your affected (lesion) skin and not one of your unaffected (normal) skin.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Greater than 1 year of age\r\n\r - Diagnosis of vascular malformation\r\n\r - Each patient's authorized legal guardian must understand the nature of the study and\r must provide written informed consent. Each patient must also give assent to study\r participation given they have the cognitive capacity to do so.\r\n\r Exclusion Criteria:\r\n\r - Patients less than 1 year of age\r\n\r - Vascular malformations likely to result in poor wound healing or located in areas of\r the body prone to significant scarring\r\n\r - Individuals with vascular malformations and previous diagnosis of disseminated\r intravascular coagulopathy\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
907
|
[
{
"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-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise\n\n**Clinical Trial Summary:**\n\nThis non-interventional observational study is designed to gain data for Neupro® in restless\r legs syndrome (RLS) under real life conditions in line with the summary of product\r characteristics (SmPC) related to effectiveness, tolerability and switching practice from\r other dopaminergic drugs as well as titration schemes.\n\n**Clinical Trial Detailed Description:**\n\nThere is a total of 64 subjects recorded as having discontinued due to Adverse Events.\r Documentation of Visit 2 and Visit 3, where the reason for discontinuation was documented,\r was not available for all subjects. From the documentation on the Adverse Events page in the\r Case Report Form, it is known that 100 subjects discontinued due to Adverse Events.\r\n\r The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - It was recommended that the patient's treatment was in accordance with the local\r marketing authorization (MA) for Neupro®\r\n\r - The patient must have a diagnosis of moderate to severe idiopathic RLS\r\n\r - The patient is considered reliable and capable of adhering to the visit schedule or\r medication administration according to the judgment of the investigator\r\n\r - The decision to prescribe the drug has been made by the physician independently of\r his/her decision to include the patient in the study\r\n\r - Subject is informed and given ample time and opportunity to think about his/her\r participation in the study and has given written informed data consent\r\n\r Exclusion Criteria:\r\n\r - Hypersensitivity to the active substance or to any of the excipients\r\n\r - Magnetic resonance imaging or cardioversion (see SmPC)\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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908
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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\nEmergency Department Crowding in Relation to In-hospital Adverse Medical Events\n\n**Clinical Trial Summary:**\n\nSince the report \"To Err is Human\" by the Institute of Medicine (IOM) in 1999, attention was\r brought to the general public that adverse events in medicine are common and are one of the\r leading causes of morbidity and mortality within the United States. The report estimates that\r 44,000 - 98,000 patients hospitalized in the United States die each year as a result of\r medical errors.\r\n\r In spite of the growing patient safety movement worldwide, health care has not become\r measurably safer. Health care is one of the few risk-prone areas in which public demand\r limits the use of common-sense safety-enhancing solutions, such as limiting the flow and\r choosing the type of incoming patients. The latter is especially true for emergency\r departments (EDs) since they deliver an important public service by providing emergency care\r 24 hours a day, 365 days per year, without discrimination by social or economic status. One\r of the key expectations of EDs is the ability to provide immediate access and stabilization\r for those patients who have an emergency medical condition. However, emergency department\r (ED) crowding is recognized to be a major, international problem that affects patients and\r providers. A recent report from the IOM noted that the increasing strain caused by crowding\r is creating a deficit in quality of emergency care. Crowding has been associated with reduced\r access to emergency medical services, delays in care for cardiac patients, increased patient\r mortality, inadequate pain management, increased costs of patient care, and delays in\r administration of antibiotic therapy.\r\n\r Several issues remain concerning ED crowding and it's relation to adverse events. First, the\r existing evidence on adverse event occurrence during ED crowding is largely anecdotal and\r inconclusive. Secondly, although a few studies showed a relationship between ED crowding and\r mortality, neither of these examined the causes of excess mortality. Finally, although a\r significant increase in the average length of hospital stay was shown during ED crowding the\r reasons for this are open to speculation.\r\n\r The purpose of this study therefore is to identify six explicit adverse events and mortality\r for patients who were admitted through ED and to compare these results in relation to ED\r crowding. This will provide us novel insight into the reasons for the hypothesized increased\r mortality during ED crowding.\n\n**Clinical Trial Detailed Description:**\n\nSince \"ED crowding\" is an unplanned condition, a randomized controlled trial is not possible\r to assess its impact on adverse patients' outcome. Therefore, a large prospective cohort\r study, with careful matching and correcting for risk factors is the second best design.\r\n\r The ED occupancy rate, defined as the ratio of the total number of ED patients to the number\r of licensed treatment bays per hour, will be used as a measure of ED crowding. The numerator\r includes all patients in the ED at any point during each study hour, regardless of ED\r location (including in the waiting room, boarding, hallway location). The denominator,\r constant per study hour, includes the total number of licensed treatment bays as defined\r according to the ED's original blueprint but excludes hallway locations. For each hour of the\r day, the ED occupancy rate will be derived from the ED information system. 104 weeks are\r divided into 13-week seasonal blocks and nursing shifts starting 23:00, 07:00 and 15:00. The\r mean ED occupancy rate is calculated for each shift as the sum of the occupancy rates within\r that shift divided by 8. The top quartile of all mean ED occupancy rates during the cohort\r period is considered as crowded. In order to match both 'crowded 'and 'not crowded' cohorts,\r the following data elements are extracted from the hospital information system for each\r registered patient: demographic data (age, sex, co-morbidities); referral source, surgical or\r medical admission; time of arrival (including season, month of year, day of week, time of\r day); triage category; ED and total hospital length of stay; and final admission diagnosis.\r\n\r Medical records of patients who presented to the ED will be reviewed for the occurrence of\r six adverse events and mortality up to ten days of their ED stay. The six adverse events are\r searched through explicit clinical criteria. The reviewer first rates on a scale of 1 to 6\r the confidence that medical management caused an adverse event. If the rating is 5 or 6,\r indicating that the injury is probably or definitely caused by management, the event is\r considered an adverse event. The same rating score is used to assess the degree of\r preventability. Hospital mortality will be searched for all patients who presented to the ED\r at some point in time and died during that hospital stay.\r\n\r In order to identify an adverse event occurrence hazard ratio of 1.2 with a power of 0.9\r during ED crowding, a cohort of 104,000 patients is needed. Therefore, data will be retrieved\r during a 2 year period during which the reviewer is blinded to the degree of ED crowding in\r relation to the findings on adverse events. The occurrence of adverse events and mortality\r will be compared to not crowded shifts, corrected for baseline risk factors. A carefully\r standardized admission form for registration of relevant information as well as a\r computerized search tool for screening for adverse events will allow finalizing this study\r within the foreseen time frame.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All adult (18 years or older) patients presenting to the ED\r\n\r - All adult (18 years or older) patients transferred from the ward to ED for upgrading\r of care\r\n\r Exclusion Criteria:\r\n\r - All patients who died on arrival in the ED\r\n\r - Patients transferred from another acute care facility\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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909
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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\nNutrition and Physical Activity in Patients With Cerebrovascular Disease\n\n**Clinical Trial Summary:**\n\nThe study will provide evidence of eating habits and physical activity in cerebrovascular\r patients in Luxembourg and of the degree to which these habits may be changed acutely (after\r one month) and in the long run (after 4 months) by intensive counselling. Furthermore the\r influence of intensive counselling and of the consumption of red wine on cerebrovascular risk\r factors, cognition, and on surrogate parameters for stroke will be assessed.\n\n**Clinical Trial Detailed Description:**\n\nQuality of life in the elderly and their families is severely affected by stroke and\r cognitive dysfunction caused by atherosclerosis of the brain supplying arteries. Nutrition,\r namely a Mediterranean-style diet, nuts, soybean products, whole grain products, dark\r chocolate, fish oil and avoidance of salt, and regular physical activity play a major role in\r the prevention of these diseases. Data are available on cardiac patients, however little is\r known on cerebrovascular patients. The role of red wine in the protection of cerebrovascular\r disease is discussed; it may be simply an epiphenomenon of otherwise healthy lifestyle in the\r population with a regularly low alcohol consumption not properly corrected for in\r epidemiological studies. No prospective randomised data is available.\r\n\r We intend to perform a prospective randomised study on nutrition and physical activity in 100\r patients with chronic cerebrovascular disease (i.e. patients with atherosclerotic stenosis,\r at least 20% of a brain supplying artery as demonstrated by carotid ultrasound and without an\r acute stroke/TIA). The study consists of three parts:\r\n\r (1) Assessment of eating and physical activity habits in these patients and correlation with\r indicators of cerebrocardiovascular disease (cerebral perfusion as measured by transcranial\r Doppler sonography, pulsatility of the transcranial and extracranial Doppler signal,\r elasticity of the carotid artery, ankle-brachial index, cognitive functioning) and risk\r factors of cerebrovascular disease (blood pressure and blood pressure amplitude assessed by\r 24 h ambulatory blood pressure measurement; HDL, LDL, triglycerides, Lp(a), glucose, HbA1c,\r homocysteine, and fibrinogen; waist-hip ratio and BMI).\r\n\r 2) Half of these patients will be randomised to intensive counselling concerning healthy\r eating and physical activity habits during the first month once a week. All the 100 patients\r will be reassessed after one month and after 4 months with the above mentioned parameters.\r\n\r 3) In a double cross-over design half of the patients allocated to intensive counselling\r (i.e. n=25) and half of the patients without intensive counselling (n=25) will be allocated\r to 0,2 l of red wine daily (men) or 0,1l of red wine daily (women), respectively. The\r remaining 50 patients will be advised to avoid red wine for the time of the study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - In- and outpatients of the Neurology Department of the CHL and their family members\r\n\r - Carotid atherosclerosis assessed by B-mode ultrasound of at least 20% lumen reduction\r\n\r - No acute stroke/TIA/amaurosis fugax (at least 3 months ago)\r\n\r - Temporal ultrasound window suitable for recording of the middle cerebral artery\r\n\r - Ability to give informed consent\r\n\r Exclusion Criteria:\r\n\r - No signed informed consent\r\n\r - patient not able to give informed consent\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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910
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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\nRemote Ischemic Preconditioning in Subarachnoid Hemorrhage\n\n**Clinical Trial Summary:**\n\nRupture of brain aneurysms is a common cause of death and disability, accounting for as many\r as 10% of stroke cases in the United States. While much of the resulting injury to the\r nervous system is caused by the initial bleeding from the aneurysm, many of these patients\r develop cerebral vasospasm, pathological constriction of the blood vessels supplying the\r brain, several days following hemorrhage. As many as a third of patients can suffer a\r resulting neurological deficit and stroke, presumably caused by the decreased blood flow to\r the brain (ischemia). This delayed brain injury accounts for a significant percentage of poor\r outcomes following aneurysm rupture. Studies have shown that remote ischemia to many organs\r can precondition other tissues (including the brain) to be more tolerant to decreases in\r blood flow. This \"remote ischemic preconditioning\" has the promise of protecting the brain\r from ischemic injury. Whereas in other forms of stroke the onset of ischemia cannot be\r predicted in the general population, following aneurysm rupture the investigators know which\r patients are likely to develop vasospasm and when. Therefore, ischemic preconditioning\r following aneurysm rupture may help prevent some of the ischemic injury caused by vasospasm.\r Remote ischemic preconditioning by transient limb ischemia (produced by inflation of a blood\r pressure cuff on the arm or leg) has been shown to minimize injury to other organs, most\r notably the heart. Remote ischemic preconditioning of the brain following aneurysm rupture\r has not yet been investigated.\n\n**Clinical Trial Detailed Description:**\n\nPhase I prospective clinical study to evaluate: the tolerance of clinical subjects with\r Subarachnoid Hemorrhage (SAH) to the maneuvers involved in the generation of Remote Ischemic\r Preconditioning (RIPC), the immediate and delayed hemodynamic effects of the RIPC in the\r cerebral vasculature, in terms of Transcranial Doppler (TCD) velocities, pulsatility index\r variations, Cerebral Blood Flow (CBF) measures, and cerebral arterial flow measurements using\r Magnetic Resonance Imaging with flow measurement capabilities (MRI NOVA). As a secondary\r goal, we will be valuating the impact of RIPC in the incidence of vasospasm, delayed\r neurological deficits, development of ischemic lesions in MRI and clinical outcome.\r\n\r Patient Enrollment: Patients who are admitted to the University of California Los Angeles\r (UCLA) Ronald Reagan Medical Center with a diagnosis of aneurysmal subarachnoid hemorrhage\r will be considered for inclusion in this study. As is standard of care for this condition,\r following admission patients' aneurysms are generally treated by one of two methods, surgical\r clipping or endovascular coiling. Following this definitive treatment of the aneurysm,\r generally performed emergently in the first 24 to 48 hours following hemorrhage, patients\r will be consented and enrolled in the study. No patients with unprotected (untreated)\r aneurysms will be enrolled. Patients with a known history of lower limb vascular disease or\r lower limb vascular bypass surgery will be excluded.\r\n\r Remote Ischemic Preconditioning (RIPC) Procedure: Following enrollment, patients will receive\r four rounds of lower limb remote ischemic preconditioning, starting at the earliest\r post-hemorrhage day possible following definitive treatment of their aneurysm. The remote\r ischemic preconditioning will typically take place on post-hemorrhage day 2, 3, 6 and 9. Each\r cycle of RIPC will consist of four 5-minute cycles of lower limb ischemia following by\r 5-minute periods of reperfusion. A large blood pressure cuff will be wrapped around the upper\r thigh of one leg. The cuff will be inflated to a pressure 20 mm Hg greater than the systolic\r arterial blood pressure measured by the patient's arterial line or upper limb blood pressure\r cuff. The adequate level of inflation will be confirmed by the absence of pulse in the\r ipsilateral pedal artery as detected by Doppler. The cuff will remain inflated for 5 minutes.\r The cuff will then be deflated and the limb will be allowed to re-perfuse for at least 5\r minutes. After the cuff is deflated, the same procedure will then be repeated three times for\r a total of four cycles.\r\n\r Evaluation of Tolerance to the RIPC Maneuvers: The patient will be continuously monitored for\r pain and discomfort during the RIPC session. If the patient pain is more than 6 in the\r traditional 1-10 scale or if the patient expresses their desire to stop the maneuver, the\r procedure will be stopped, and the data regarding number and duration of the maneuvers will\r be recorded. A down-escalation of the treatment will be proposed, by reducing the number of\r cuff inflations to 3 or 2, as tolerated.\r\n\r Hemodynamic evaluation of the effect of RIPC Maneuvers: Transcranial Doppler (TCD)\r measurements will be performed during the RIPC session. TCD and Cerebral Blood Flow (CBF)\r measurements will be performed at 24 hours and 72 hours after treatment.\r\n\r Cerebral arterial flow magnetic resonance imaging (MRI NOVA) will be measured the first day\r after treatment and 72 hours after treatment in patients suitable for transport to the MRI\r scan per Intensive Care Unit (ICU) clinical team criteria.\r\n\r Clinical assessments of the patients will be performed daily and at discharge from the ICU\r\n\r Treatment of subarachnoid hemorrhage (SAH) and Vasospasm: Aside from the RIPC procedures, all\r other treatment and monitoring of the patients will be as is standard of care for the\r treatment of patients with subarachnoid hemorrhage in our hospital. Patients will undergo\r neurological monitoring in the intensive care unit. Monitoring for cerebral vasospasm,\r including transcranial Doppler studies, angiograms, cerebral blood flow studies, Computed\r Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans and regular neurological\r examination will be performed as standard. Likewise, prophylaxis and treatment for vasospasm\r or any other complications of subarachnoid hemorrhage will be performed as usual, as is the\r standard of care. Apart from the rounds of RIPC, in no way will the monitoring and treatment\r of these patients differ from patients not enrolled in this study.\r\n\r Data Collection: Patients' clinical data will be collected in a password-protected study\r computer database. General patient demographics, past medical history, history of present\r illness, Hunt & Hess grade, admission Glasgow coma score, modified Rankin score, size and\r location of aneurysm, dates of subarachnoid hemorrhage and aneurysm treatment, type of\r aneurysm treatment, transcranial Doppler study values, cerebral blood flow measurements, and\r results of clinical examinations will all be noted and recorded in the study database.\r Additionally, clinical imaging studies performed (including CT scans, MRI scans and cerebral\r angiograms) will be reviewed and their findings noted. Specifically, size and location of\r aneurysm, extent and location of subarachnoid hemorrhage, Fisher grade, and presence and size\r of ischemic brain lesions will be noted. Clinical complications and outcomes will be\r recorded, including occurrence of angiographic vasospasm and delayed neurological deficit and\r condition at discharge and follow-up (Glasgow outcome score and modified Rankin score). Any\r complications associated with the RIPC procedure will be noted and reported appropriately.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of recent aneurysmal subarachnoid hemorrhage.\r\n\r - Definitive treatment of the aneurysm by surgical clipping or endovascular coiling has\r been completed.\r\n\r Exclusion Criteria:\r\n\r - Patients with unprotected (untreated) cerebral aneurysms.\r\n\r - Patients with a known history of lower limb vascular disease, lower limb vascular\r bypass surgery and/or peripheral neuropathy.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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911
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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\nCerebral Hemorrhage Risk in Hereditary Hemorrhagic Telangiectasia\n\n**Clinical Trial Summary:**\n\nThis study is one of the three projects of an NIH Rare Disease Clinical Research Consortium.\r A \"consortium\" is a group of centres sharing information and resources to perform research.\r The consortium research focuses on brain blood vessel malformations in three different rare\r diseases.\r\n\r The focus of this specific study is on Hemorrhagic Telangiectasia (HHT).\r\n\r HHT is a condition characterized by blood vessel malformations, called telangiectasia and\r arteriovenous malformations (AVMs), occurring in the brain, nose, lungs, stomach, bowels and\r liver. Brain AVMs (BAVMs) in HHT are difficult to study because they are rare, affecting\r approximately 10% of people with HHT. While other types of BAVMs have been studied in depth,\r studies in the HHT population have been very small. Here, we propose the first large-scale\r collaboration by joining with 12 HHT Centers of Excellence in North America to perform a\r large study of risk factors for bleeding from BAVMs, called intracranial hemorrhage (ICH) in\r HHT patients.\r\n\r The current standard of clinical practice across North America, is to screen all HHT patients\r for BAVMs with magnetic resonance imaging (MRI). If BAVMs are detected, patients are referred\r to a multidisciplinary neurovascular team for consideration for treatment. Treatment\r decisions are made on a case by case basis, balancing risks of complications from the BAVM\r with risks of therapy, but are limited by the few studies available in HHT. We hope that the\r knowledge we obtain about the risk factors for intracranial bleeding in these patients from\r this larger study will help us to improve the care of HHT patients.\r\n\r We plan to study risk factors for rupture of BAVMs, including primarily genetics and imaging\r characteristics of the BAVMs. Knowledge about risk factors will help in the care and\r management of HHT patients. This will be achieved through the collection of health\r information to construct a HHT database, blood sampling and banking (through the National\r Institute of Neurological Disorders and Stroke [NINDS]), and through genetic analysis at the\r University of California San Francisco.\n\n**Clinical Trial Detailed Description:**\n\n4. Study Design and Methods In conjunction with the DMCC, we will construct a relational\r database and web-based data collection instrument; see Table 1 showing the sites that will\r contribute to this effort. Data will include demographics, symptomology, cerebral\r angioarchitecture, other organ involvement and HHT gene mutation results.\r\n\r The database will be used to serve Aim 2 and Aim 3 but will also serve as a platform to\r foster further HHT research. The recruitment of HHT BAVM cases will be emphasized by use of a\r 3:1 ratio for enrolling non-BAVM to BAVM HHT cases, i.e., for each brain AVM recruited, 3\r patients without a brain AVM will be recruited. This will provide the largest RDCRN 6203\r Cerebral Hemorrhage Risk in single sample available that will also have centralized expert\r neuroradiological adjudication of the brain phenotype.\r\n\r The study design is detailed, by aim, in Section 6. The data to be collected is detailed in\r Sections 4.5 and 4.5.1 and the study schedule is detailed in Section 4.6.\r\n\r 4.1. Study Population: The study population will include patients with HHT, with inclusion\r and exclusion criteria as detailed in section 4.3. Cases will be recruited from two sources:\r (a) the network of HHT Centers of Excellence (Table 1); and (b) patients who contact study\r personnel or the HHT Foundation International after learning about the study through the HHT\r Foundation International social networks, the RDCRN public website, friends, physicians,\r relatives, etc.\r\n\r Inclusion and exclusion criteria are detailed in section 4.3. 4.2. Case Ascertainment and\r Enrollment As shown in Table 2, we estimate conservatively that 875 cases will be available\r for recruitment over five years. Cases will be derived from two sources. First, we will\r recruit from the HHT Centers of Excellence cases that are currently being followed and new\r cases as they pass through the individual clinics. Ascertainment and enrollment will use IRB\r approved, HIPAA-compliant procedures. Each center will submit cases using web-based forms.\r Second, we will recruit new cases through the HHT Foundation. The HHT Foundation has a\r mailing list of 5646 families; there is approximately 1000 new families added per year. HHT\r Patients who contact the HHT Foundation with an interest in participating in the study will\r be directed to the closest participating HHT Center of Excellence. The HHT Foundation will\r recruit patients who contact the HHT Foundation who are interested in participating in the\r BAVM arm of the study but who are not affiliated with a participating center or do not wish\r to visit a center to participate in the study. We will also enroll non-BAVM HHT cases to\r facilitate long-term involvement of the HHT community in systematic, organized rare disease\r research. We have structured the database to be scalable to accommodate all types of HHT.\r Under the supervision of the site PI, each local PI and research staff will identify and\r obtain informed consent from patients and their clinical information is entered into a master\r registry. At enrollment, arrangements for a blood specimen will also be made. Approximately\r 20 ml (about 4 teaspoons) of blood will be drawn (two ACD tubes of 8.5 ml each). If a blood\r draw is not possible, the UCSF core will provide bar-coded saliva DNA collection kits.\r Representative standard clinical imaging studies (MR and angiography) of enrolled cases will\r be provided to Dr. Karel TerBrugge at Toronto Western Hospital for adjudication and coding of\r angioarchitecture. We have conservatively estimated that we will be able to collect DNA from\r 500 of the 875 project cases that will be enrolled over the course of the study.\r\n\r 4.3 Patient Selection\r\n\r Inclusion Criteria:\r\n\r 1. (a) Definite clinical HHT diagnosis (at least 3 Curacao criteria) or genetic diagnosis\r of HHT Curacao criteria: (a) spontaneous recurrent nosebleeds; (b) mucocutaneous\r telangiectasia at characteristic sites (lips, oral cavity, fingers or the nose); (c)\r visceral involvement such as pulmonary, hepatic or CNS BAVM; and (d) an affected first\r degree relative by same criteria.(65) OR (b) Definite clinical HHT diagnosis (at least 3\r Curacao criteria) or genetic diagnosis of HHT Curacao criteria: (a) spontaneous\r recurrent nosebleeds; (b) mucocutaneous telangiectasia at characteristic sites (lips,\r oral cavity, fingers or the nose); (c) visceral involvement such as pulmonary, hepatic\r or CNS BAVM; and (d) an affected first degree relative by same criteria.(65) AND\r Presence of BAVM For the purpose of the study, we will focus on BAVM that directly\r shunts blood from arterial to venous circulations without an intervening capillary bed,\r including Toronto classifications(23) of A-V fistulas, \"micro\" BAVMs (<1 cm) and 8\r \"small\" (1-3 cm) BAVMs, and if present, larger lesions. We will not include intracranial\r telangiectasias in isolation.\r\n\r 2. Able to provide informed consent Exclusion Criteria: None 4.4 Recruitment and Informed\r Consent The prospective HHT population will consist of patients seen for evaluation and\r treatment of HHT. Health status for all patients will encompass a spectrum of\r disabilities encountered with the disease processes being studied. The Human Subjects\r Committee/Institutional Review Board of each clinical center will approve the informed\r consent form. A copy of the letter of approval from the IRB/REB and a copy of the\r consent form will be filed with the DMCC before a clinical center will be allowed to\r initiate enrollment. The informed consent will include the objectives of the study, a\r description of the screening process, the potential risks and benefits, the cost to the\r patient, alternatives to participation and liabilities of the particular participating\r center. All patients who are diagnosed with HHT, regardless of gender, race or\r ethnicity, are potential candidates for the RDCRC. To the best of our knowledge, there\r is no race-ethnicity predilection for HHT or sporadic BAVMs.\r\n\r 4.5 Data and Sample Collection Development A detailed table of relevant fields and their data\r types and ranges were constructed by combining elements that are in use by the HHT community\r and those fields that are collected in our ongoing study of sporadic BAVM. We used these data\r tables as a departure point to work with the DMCC in constructing both the relational\r database for the project as well as the data web entry forms. Database issues are also\r addressed in the GSAC and AU sections.\r\n\r All recruited participants will be assigned a Database study ID. The link between patient\r identifying information and database study ID will only be maintained at the recruiting\r center. Data will be entered through a web-based system into a central Database developed at\r the DMCC. Only de-identified information will be entered in the central Database.\r\n\r 4.5.1 Detailed Clinical and Radiographic Information to be Collected Information collected\r will include both attributes of the systemic manifestations of HHT with a focus on the brain\r vascular phenotype. Detailed tables of data fields and data web entry forms are available\r from the Site PI, Project Leader, and DMCC. The Clinical data elements include demographic\r information as well as specific clinical information about clinical features and\r complications of BAVMs, as well as other organ AVMs and complications related to HHT. The\r Neuroradiological elements include information about angiographic features, clinical\r presentation, complications and treatment of BAVMs. This data will be collect at baseline.\r Every year after recruitment, , participants will be contacted by the recruiting Center to\r collect a limited follow-up data set, regarding treatment and complications of BAVMs and\r mortal status.\r\n\r The diagnosis of BAVM will be made by referring centers and adjudicated by Dr. TerBrugge\r based on the submitted imaging studies. All imaging studies will be abstracted under the\r supervision of the consultant neuroradiologist, Dr. TerBrugge. The imaging source and date of\r CT, MRI, MR angiography, and any diagnostic cerebral angiography furnish primary descriptors\r including side, nidus size, anatomic location, \"eloquence,\" feeding arteries, arterial\r aneurysms, number of lesions, and venous drainage pattern. Additional factors include\r location, the presence of intra- and extranidal aneurysms, and the presence of venous\r stenoses, as described in the Writing Group paper. New AVM hemorrhage is bleeding into the\r brain or its surrounding spaces likely to be associated with AVM (age and location of\r hemorrhage are also estimated). The time from diagnosis to any new hemorrhage will be used in\r the survival analyses. We will also record other potential sources of co-morbidity, including\r hypertension, diabetes mellitus, smoking history, hyperlipidemia, i.e., factors that may\r non-specifically increase the risk of hemorrhage. Although functional status is not part of\r the primary aims, we will record Modified Rankin Score (mRS)(66-68) (adapted from the ISAT\r trial patient questions(69)) coded as : 0 = no symptoms and cope well with life; 1 = few\r symptoms which do not interfere with everyday life; 2 = symptoms which have changed my life\r but I am still able to look after myself; 3 = symptoms which significantly changed my life,\r and I need some help looking after myself; 4 = quite severe symptoms, I need help from other\r people; 5 = major symptoms which severely handicap me and I need constant attention day and\r night; deaths are coded as 6.\r\n\r The mRS will be recorded at least for patient status at the time of BAVM discovery and the\r last available date. For retrospective cases, these will be estimated using available\r clinical records; for prospective cases, the last available status during the project period\r will be assessed. New ICH during follow-up will also be recorded. Working with the DMCC, we\r will institute a web-based system to facilitate data entry. The main follow-up will be\r targeted to be completed during the fifth year of the RDCRC project and will include: (a)\r date and nature of any treatment; (b) any new hemorrhagic events; and (c) modified Rankin\r score.\r\n\r 4.5.2 Sample Collection, Processing and Banking Each site will arrange to obtain a blood\r sample from BAVM cases, but we will accommodate banking of samples from HHT patients without\r BAVM for exploratory analyses. Blood samples will be collected and sent directly to the\r Coriell/NINDS Human Genetics DNA and Cell Line Repository using their published instructions\r (http://ccr.coriell.org). Coriell with retain DNA and also release a DNA sample to the study\r investigators UCSF, where it will be stored as well. The advantages of using Coriell/NINDS\r are (1) 20 μg of genomic DNA will be made available to the researchers at no additional\r charge, and (2) lymphocytes will be immortalized, ensuring a durable renewable supply of DNA\r for future studies. The PI has worked with NINDS/Coriell before; we have sent approximately\r 100 sporadic brain AVM cases to the NINDS DNA bank.\r\n\r For cases unable to have blood drawn, we will use commercially available saliva mailing kits\r (Oragene). The kit is sent by the Study Coordinator with instructions for use, consent form,\r and a return mailing box with pre-printed postage and shipping label. The specimen will be\r labeled with a study ID number, and sent directly to UCSF for processing and DNA extraction.\r We have used these with excellent DNA yields and genotyping results. Such samples would be\r handled directly by the UCSF Genetics and Statistical Analysis Core (GSAC). The Specimen\r study ID number will be assigned separately from the Database study ID number. Samples will\r be retained until all DNA has been used up. If there is sample remaining when the study is\r complete, the study investigators may use the sample for future research studies into genetic\r factors of and brain AVMs or other aspects of HHT.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - Definite clinical HHT diagnosis (at least 3 Curacao criteria)or genetic diagnosis of\r HHT or\r\n\r - Definite clinical HHT diagnosis (at least 3 Curacao criteria) or genetic diagnosis of\r HHT and Presence of Brain Arteriovenous Malformation\r\n\r - Able to provide informed consent\r\n\r Curacao criteria:\r\n\r 1. spontaneous recurrent nosebleeds;\r\n\r 2. mucocutaneous telangiectasia at characteristic sites (lips, oral cavity or the nose);\r\n\r 3. visceral involvement such as pulmonary, hepatic or CNS BAVM; and (d) an affected first\r degree relative by same criteria.\r\n\r Willingness\r\n\r - Willingness to participate in the study and ability to give informed consent\r\n\r Exclusion Criteria:\r\n\r - Patients not complying with Inclusion criteria\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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912
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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\nCopeptin for Risk Stratification in Non-traumatic Headache in the Emergency Setting - The CoHead Study\n\n**Clinical Trial Summary:**\n\nHeadache is a common symptom, and patients often seek medical attention at emergency\r departments due to headaches.\r\n\r The aim of the CoHead Study is to find out if it is possible by measuring copeptin, a marker\r of stress in the blood, to find out which patients have simple headaches and which patients\r have dangerous headaches that are the symptom of an underlying disease and need further\r investigation and treatment.\r\n\r Copeptin is a marker for physical stress and has been tested in patients with stroke, heart\r attack and pneumonia. In all these illnesses, the patients with the most serious forms had\r the highest levels of copeptin, while the ones with only mild presentation or no affection at\r all had the lowest levels of copeptin.\r\n\r The investigators expect to show the same in patients with headaches.\n\n**Clinical Trial Detailed Description:**\n\nBackground: In the emergency setting, non-traumatic headache (NTH) is in 80% a benign\r symptom, but serious causes have to be ruled out.\r\n\r Copeptin, as a surrogate marker for antidiuretic hormone (ADH), is a marker for the\r individual stress level, even more subtle than cortisol. As a prognostic stress hormone it\r holds promise as a prognostic point of care tool in the risk stratification of different\r acute illnesses such as acute myocardial infarction, respiratory tract infections and\r cerebrovascular events, among others.\r\n\r Objective: To evaluate copeptin as a marker for risk stratification in NTH. Design:\r Prospective multicenter observational cohort study with a derivation set and a validation\r set.\r\n\r Location Setting: Emergency Department (ED) and Medical Policlinic (MUP; walk-in clinic) and\r Neurologic Clinic (NC) of the University Hospital of Basel. ED and NC of the Cantonal\r Hospital of Aarau.\r\n\r Intervention: Patients presenting to the ED or the MUP or the NC with NTH are recruited\r during a 1-year-period. After informed consent is given by the patient, baseline data will be\r assessed including medical history, clinical items (i.e. neurological status, vital\r parameters, blood pressure, BMI) and routine laboratory items. Patients will be evaluated\r using a validated standardized diagnostic tool and questionnaire. CT scans and other\r diagnostics, such as lumbar puncture, MRI, etc., will be ordered upon request of the treating\r physician. All diagnostic procedures, results, diagnosis made by the treating physicians and\r initiated therapy will be recorded. Copeptin will be measured on admission by batch analysis\r by blinded laboratory staff upon completion of the study.\r\n\r After 3 months, all patients will be followed-up by a structured telephone interview to\r assess the final diagnosis and outcome (i.e. MIDAS-Questionnaire). The final diagnosis will\r be made by two independent physicians according to ICHDII-criteria and verified by a\r board-certified neurologist, all blinded to copeptin levels. Thereby, primary and secondary\r headache entities will be classified according to ICHD.\r\n\r Endpoints: The primary endpoint of this study is serious secondary NTH as opposed to benign,\r self-limiting NTH. Serious secondary NTH will be defined as a composite endpoint including\r different secondary NTH causes and entities as listed in the International Classification of\r Headache Disorders (ICHD)-II-Criteria.\r\n\r The secondary endpoint will be clinical outcome of patients; thereby we will look at\r all-cause mortality within the 3-month follow-up period and at morbidity measured by the\r MIDAS-questionnaire.\r\n\r Study hypothesis: We hypothesize that copeptin will serve as a point of care tool to\r discriminate benign headache from potentially serious secondary headaches (e.g.\r subarachnoidal hemorrhage (SAH) or cerebral aneurysm, intracranial bleeding (ICB), brain\r tumor, vasculitis, meningitis) which require prompt hospitalisation and intervention. Based\r on copeptin values measured in other acute diseases, we assume a critical range between 5 and\r 20 pmol/l. The lower copeptin cutoff point of ≤ 5 pmol/l will have a sensitivity of ≥ 97% for\r ruling out serious secondary headache, and the higher cutoff point of ≥ 20 pmol/l will have a\r specificity of 90% to confirm serious NTH.\r\n\r Analysis: Based on data of two previous years, we aim to recruit 600 - 800 patients within\r one year at the sites of Basel and Aarau, respectively, of which 10-20% will present with\r serious secondary NTH. We will calculate 95% confidence intervals of sensitivity of copeptin\r of <10% and perform multivariable logistic regression analysis to assess the independent and\r additive utility of copeptin compared with other risk scores and outcome predictors. The\r first 50% of patients will be used as derivation set and the second 50% as the validation\r set, based on the timely inclusion of patients.\r\n\r Significance: If copeptin as a biomarker safely rules out serious secondary causes of NTH, it\r will represent a tool for an optimized allocation of health care resources.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - headache at the time of screening\r\n\r - Patients must be able to give informed consent\r\n\r Exclusion Criteria:\r\n\r - less than 18 years of age\r\n\r - preceding (head) trauma\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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913
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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\nAntihypertensive Treatment of Acute Cerebral Hemorrhage-II\n\n**Clinical Trial Summary:**\n\nThe specific aims of this study are to:\r\n\r 1. Definitively determine the therapeutic benefit of the intensive treatment relative to\r the standard treatment in the proportion of patients with death and disability (mRS 4-6)\r at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.\r\n\r 2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard\r treatment in the subjects' quality of life as measured by EuroQol at 3 months.\r\n\r 3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard\r treatment in the proportion of hematoma expansion (defined as increase from baseline\r hematoma volume of at least 33%) and in the change from baseline peri-hematoma volume at\r 24 hours on the serial computed tomographic (CT) scans.\r\n\r 4. Assess the safety of the intensive treatment relative to the standard treatment in the\r proportion of subjects with treatment-related serious adverse events (SAEs) within 72\r hours.\n\n**Clinical Trial Detailed Description:**\n\nThe report from a National Institute of Neurological Disorders and Stroke Workshop on\r priorities for clinical research in intracerebral hemorrhage (ICH) in December 2003\r recommended clinical trials for evaluation of blood pressure (BP) management in acute ICH as\r a leading priority. The Special Writing Group of the Stroke Council of the American Heart\r Association in 1999 and 2007 emphasized the need for clinical trials to ensure evidence-based\r treatment of acute hypertension in ICH. Consequently, we propose to conduct a five-year\r international, multicenter, open-labeled, randomized, controlled, Phase III trial to\r determine the efficacy of early, intensive antihypertensive treatment using intravenous\r nicardipine for acute hypertension in subjects with co-morbid hypertension and spontaneous\r supratentorial ICH. The primary hypothesis of this large, streamlined, focused trial is that\r the group treated with intensive BP reduction (systolic BP [SBP] of 140 mmHg or less -\r hereafter referred to as the intensive treatment) using intravenous nicardipine infusion for\r 24 hours reduces the proportion of death and disability at 3 months by 10% or greater\r compared with the group treated with the standard BP reduction (SBP of 180 mmHg or less -\r hereafter referred to as the standard treatment) among patients with ICH treated within 4.5\r hours of symptom onset. The underlying mechanism for this expected beneficial effect of\r intensive treatment is mediated through reduction of the rate and magnitude of hematoma\r expansion observed in approximately 38% of patients with acute ICH. The trial will recruit a\r maximum of 1,280 subjects with ICH who meet the eligibility criteria. The primary outcome is\r the proportion of death and disability at 3 months defined by modified Rankin scale (mRS)\r score of 4 to 6. The proposed clinical trial is the natural extension of numerous case\r series, a subsequent pilot trial funded by the National Institutes of Health National\r Institute of Health (NIH), and a preliminary randomized controlled trial in this patient\r group funded by the Australian National Health and Medical Research Council, that have\r recently confirmed the safety and tolerability of both the regimen and goals of the\r antihypertensive treatment in acutely hypertensive patients with ICH proposed in the present\r trial. The proposed trial will have important public health implications by providing\r necessary information regarding the efficacy and safety of antihypertensive treatment of\r acute hypertension observed in up to 75% of the subjects with ICH. BP treatment represents a\r strategy that can be made widely available without the need of specialized equipment and\r personnel and therefore can make a major impact upon outcome in patients with ICH.\r Substantial reduction in morbidity and mortality appears possible if the estimates of\r treatment effect sizes from current pilot trials are accurate.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age 18 years or older\r\n\r - IV nicardipine can be initiated within 4.5 hours of symptom onset.\r\n\r - Clinical signs consistent with the diagnosis of stroke, including impairment of\r language, motor function, cognition, and/or gaze, vision, or neglect.\r\n\r - Total Glasgow Coma Scale (GCS) score (aggregate of verbal, eye, and motor response\r scores) of 5 or greater at time of emergency department (ED) arrival.\r\n\r - International normalized ratio (INR) value < 1.5\r\n\r - CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement\r <60 cc.\r\n\r - For subjects randomized prior to IV antihypertensive administration: SBP greater than\r 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital\r treatment) AND WITHOUT spontaneous SBP reduction to below 180 mmHg at the time of\r randomization OR\r\n\r - For subjects randomized after IV antihypertensive administration: SBP greater than 180\r mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment)\r AND WITHOUT SBP reduction to below 140 mmHg at the time of randomization.\r\n\r - Informed consent obtained by subject, legally authorized representative, or next of\r kin.\r\n\r - Notes: The unit \"mmHg\" stands for \"millimeters of mercury\", a standard way of\r measuring blood pressure. Patients with SBP < 180 mmHg should be monitored for\r 4.5 hours from symptom onset as their SBP may rise to eligible levels before the\r eligibility window closes.\r\n\r Exclusion Criteria:\r\n\r - ICH is due to previously known neoplasms, arteriovenous malformation (AVM), or\r aneurysms.\r\n\r - Intracerebral hematoma considered to be related to trauma.\r\n\r - ICH located in infratentorial regions such as pons or cerebellum.\r\n\r - Intraventricular hemorrhage (IVH) associated with intraparenchymal hemorrhage and\r blood completely fills one lateral ventricle or more than half of both ventricles.\r\n\r - Patient to receive immediate surgical evacuation.\r\n\r - Current pregnancy, or parturition within previous 30 days, or active lactation.\r\n\r - Use of dabigatran within the last 48 hours**.\r\n\r - A platelet count less than 50,000 per microliter (µL or mm3)\r\n\r - Known sensitivity to nicardipine.\r\n\r - Pre-morbid disability requiring assistance in ambulation or activities of daily\r living.\r\n\r - Subject's living will precludes aggressive ICU management.\r\n\r - Subject is currently participating in another interventional clinical trial\r\n\r - Use of dabigatran was clarified through investigator presentations, educational\r materials, and clinical tools to include newer similar class medications (such as\r rivaroxaban, apixaban, and edoxaban) that were being developed and in various\r stages of approval across enrolling countries through the course of this trial,\r in the event that patients using these medications may have been encountered\r during screening.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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914
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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 Family-based Cognitive-behavioral Therapy for Chronic Pediatric Headache and Anxiety\n\n**Clinical Trial Summary:**\n\nThe primary aim of this proposal is to refine the intervention under investigation (i.e.,\r family-based CBT) and evaluate the feasibility and acceptability of the intervention and\r methods (e.g., recruitment, assessments).\r\n\r The secondary aim of this proposal is to compare the relative efficacy of an 8 session\r family-based cognitive-behavioral therapy (CBT) to Relaxation Training (RT) for reducing\r anxiety and chronic headaches in youth (N = 30) ages 7-17 years. It is hypothesized that CBT\r will result in greater reductions in both anxiety and headache frequency and severity\r compared to RT.\n\n**Clinical Trial Detailed Description:**\n\nChronic daily headache in children, as well as periodic migraine, is a prevalent, persistent,\r and debilitating pain condition affecting nearly 1 in 10 children. Emerging evidence suggests\r that affected youth also experience excessive and impairing symptoms of anxiety which may\r play a role in the etiology and/or maintenance of headache pain. Current behavioral\r treatments are effective in reducing headache frequency and intensity, however, many youth\r remain symptomatic and the exacerbating role of anxiety has largely been ignored. Moreover,\r current psychosocial treatments fail to incorporate parents in the therapeutic process. The\r current proposal is a pilot study designed to address the shortcomings of current behavioral\r treatments by evaluating the initial efficacy of a family-based cognitive-behavioral therapy\r (CBT) for youth who present with chronic tension headaches and migraines, and excessive\r anxiety. Rigorous scientific methods will be employed, including a randomized design,\r multiple informants and measures to assess key constructs, independent evaluators (IEs) to\r assess outcomes, and intensive training for therapists and IEs to assure a high quality of\r implementation. Using a pre-post experimental design, 30 youth with chronic tension headaches\r and/or migraines and anxiety will be randomly assigned to receive 8 weeks of family-based CBT\r or relaxation training (RT). IEs will complete assessments of child symptoms and functioning\r at pre and post-treatment and at one month follow-up. Youth in the family-based CBT condition\r are expected to evince greater reductions in both headache and anxiety frequency, severity,\r and duration. Results from this study will be used to make empirically informed modifications\r to the CBT treatment manual in order to facilitate replication and dissemination of the\r interventions to clinicians and researchers.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - To determine eligibility, youth will complete an evaluation consisting of clinical\r interviews, self-, and parent-report measures.\r\n\r - To be included in the study, all children must:\r\n\r 1. have a current diagnosis of chronic daily headache, tension-type headache, and/or\r migraine headache\r\n\r 2. obtain a total score on the Screen for Child Anxiety Related Disorders (SCARED)\r in the clinical range (i.e., > 20)\r\n\r 3. be between 7 and 17 years old\r\n\r 4. have a parent/guardian who gives consent and agrees to participate\r\n\r 5. be English speaking\r\n\r 6. not currently participating in other psychosocial treatments specifically\r directed at reducing head pain or anxiety.\r\n\r - For youth receiving prophylactic medication, it is preferable that they remain on a\r stable dose and agree to avoid medication changes while enrolled in the study. Thus,\r all participants will be permitted to continue with their prescribed\r medical/neurological treatment, however the use of medications (both prophylactic and\r over-the-counter analgesics) will be closely monitored.\r\n\r Exclusion Criteria:\r\n\r - Youth will be excluded from the study if they have a medical or psychiatric condition\r contraindicating study treatment or warranting an alternative intervention (e.g.,\r suicidality, depression).\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
915
|
[
{
"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\nCT Coronary Angiography and Computational Fluid Dynamics\n\n**Clinical Trial Summary:**\n\nAngiographically obtained fractional flow reserve(FFR) could provide functional and clinical\r information about stenotic lesion, but the invasiveness and measuring difficulty of FFR make\r it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion\r severity and lately developing computational fluid dynamics could provide functional\r information. The investigators build a patient specific model of computational fluid dynamics\r by CT coronary angiography and evaluate the functional significance by measuring fractional\r flow reserve via CT coronary angiography and computational fluid dynamics, and investigate\r its long-term prognostic implications.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Significant stenosis at CT angiography\r\n\r - Normal ejection fraction on echocardiography\r\n\r - Informed consented patient\r\n\r Exclusion Criteria:\r\n\r - total occlusion and collateral flow to target vessel\r\n\r - AV conduction abnormality\r\n\r - Left ventricular hypertrophy\r\n\r - significant valvular heart or primary myocardial disease\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
916
|
[
{
"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\nEthnic/Racial Variations of Intracerebral Hemorrhage (ERICH)\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to find risk factors for hemorrhagic stroke, specifically\r intracerebral hemorrhage (ICH), among Caucasians, African Americans, and Hispanics.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r All cases must meet the following eligibility criteria:\r\n\r 1. Age 18 years or greater, fulfillment of the criteria for intracerebral hemorrhage\r\n\r 2. Resident for at least 6 months within 50 miles of the recruiting center\r\n\r 3. No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of\r the hemorrhage\r\n\r 4. Ability of the patient or legal representative to provide informed consent\r\n\r Exclusion Criteria:\r\n\r Exclusion Criteria:\r\n\r 1. Malignancies leading to coagulopathy\r\n\r 2. Hemorrhagic transformation of ischemic infarct\r\n\r 3. Hemorrhage secondary to dural venous sinus thrombosis\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
917
|
[
{
"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\nFolic Acid Dosage and Malformations Reduction\n\n**Clinical Trial Summary:**\n\nIn 1991 the Medical Research Council Vitamin Study Group and in 1992 the Hungarian randomised\r clinical trial have shown conclusively that the risk of neural tube defects can be reduced\r substantially by taking folic acid during the peri-conceptional period. At present there is\r enough evidence to support the hypothesis that folic acid supplementation can reduce the risk\r of all congenital malformations or of a specific and selected group of them, namely: neural\r tube defects, oral clefts, cardiac defects, urinary tract anomalies except hypospadias, limb\r reduction defects, omphalocele, anal atresia and trisomy 21.\r\n\r The hypothesis that a higher intake of folic acid is related to an higher risk reduction of\r neural tube defects and of other congenital malformations is the main rationale for the\r present study.\r\n\r The present study is a randomized, double-blind, controlled trial evaluating whether\r supplementation with folic acid at high dose (4 mg/day) reduces the overall risk of major\r congenital malformations in the population more than the standard recommended dose (0.4\r mg/day). At the enrolment visit all the eligible women will be interviewed to assess\r sociodemographic, life style and health status. After randomization, women will be\r interviewed every 4 months to evaluate pregnancy status. Women who have a pregnancy diagnosis\r during the study period will be interviewed by telephone at the expected 16, 24 and 40 weeks\r of gestation to evaluate the pregnancy outcome. The health status of live births will be\r evaluated at the child's age of 1 month, 3 months and 1 year.\r\n\r The primary aim of this project is conducting a study to assess the effect of folic acid\r periconceptional supplementation of 4 mg/day compared to the 0.4 mg/day standard dose on\r reducing the occurrence of all congenital malformations. Secondary aims of this study include\r comparing severity of CMs in offspring of trial mothers, rates of \"selected congenital\r malformations\", rates of twinning, miscarriages, recurrent abortions, small-for-gestational\r age, preeclampsia and abruptio placentae. The sample size is not easy to be computed because\r lacking robust estimate of the size effect of the treatment. Three hypotheses of a size\r effect of 45%, 26% and 13% were considered. A sample size of outcomes (and women)\r respectively of 2,006 (5,015), 8,510 (21,275) and 30,126 (75,315) is needed. Since the sample\r size needed to evaluate different scenarios is large, the present study is also the pilot\r study to promote an international prospective meta-analysis.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - age between 18 and 44 years\r\n\r - women who intend to become pregnant (not excluded women\r\n\r Exclusion Criteria:\r\n\r - pregnant women\r\n\r - women planning to move to an area where the study is not ongoing\r\n\r - women who do not understand and speak Italian\r\n\r - women who do not have a phone\r\n\r - women affected by epilepsy, even not assuming anticonvulsivant drugs\r\n\r - women affected by diabetes\r\n\r - women who previously had a tumour or a disease relevant for the study (Crohn disease,\r rheumatoid arthritis, ulcerative colitis)\r\n\r - women who recently assumed antifolates, like methotrexate\r\n\r - women who currently abuse or previously abused alcohol\r\n\r - obese women\r\n\r - vegetarian women\r\n\r - women who had a previous pregnancy with neural tube defect (NTD) or any other\r congenital structural defect\r\n\r - women or partners with NTD, or one of their relatives with an NTD\r\n\r - women with positive family history for breast or colorectal cancer\r\n\r - women with positive family or personal history of hereditary syndrome like adenomatous\r polyposis, or hereditary nonpolyposis colorectal cancer\r\n\r - women allergic to folic acid\r\n\r - women presenting contraindications to folic acid\r\n\r - women affected by megaloblastic anaemia\r\n\r - assuming folic acid at defined doses for conditions other than those already mentioned\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
918
|
[
{
"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\nGenomic Study of Congenital Malformation\n\n**Clinical Trial Summary:**\n\nGenomic aberrations in patients diagnosed as congenital malformation with unknown etiology\r will be identified using high-density oligonucleotide array.\n\n**Clinical Trial Detailed Description:**\n\nThe Affymetrix GeneChip® Human Mapping SNP 6.0 array, includes more than 900,000 SNP probes\r plus more than 900,000 CNV probes in a single chip, can provide high density makers\r information for the human genome. The median inter-marker distance is 670 bases and the\r average inter-marker distance is 1.67 kb, and the resolution can be as high as 200 kb. The\r Affymetrix® Cytogenetics Whole-Genome 2.7M Array gives the greatest power to detect known and\r novel chromosome aberrations across the entire genome. In addition, the whole-genome array\r includes 400,000 single nucleotide polymorphisms (SNPs) to enable the detection of loss of\r heterozygosity (LOH), uniparental disomy (UPD), and regions identical-by-descent.\r\n\r If we are able to identify the candidate genomic regions that are associated with the\r congenital malformation/syndrome, we may have a better chance to understand the pathogenesis\r of congenital malformation/syndrome as well as the mechanisms underlying the abnormal\r chromosome rare diseases. The results from this study can also facilitate the clinical\r diagnosis and provide genetic basis for consultation.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subject is diagnosed as congenital malformation/syndromes.\r\n\r 2. Participants can be any ages, and both males and females are eligible.\r\n\r 3. Subjects agree and are capable of giving informed consent. If participants are under\r 18 years old or incapable of giving consent, an informed consent must be approved by\r their legal guardians.\r\n\r 4. Availability and willingness of the proband and first-degree biological family\r (parents, full sibling, or adult-age offspring) who also meets the same congenital\r malformation syndrome.\r\n\r 5. Availability and willingness of the proband's biological parents whatever with or\r without the same congenital malformation syndrome.\r\n\r Exclusion Criteria:\r\n\r 1. Subject or legal guardian is unable to understand or give informed consent.\r\n\r 2. The molecular cause for congenital malformation/syndromes of subjects or their\r affected first-degree biological family (parents, full sibling, or adult-age\r offspring) can be revealed by karyotype assay or FISH.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
919
|
[
{
"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\nPost Operative Walking Enhancements for Recovery (POWER) Trial\n\n**Clinical Trial Summary:**\n\nThis study is a non-blinded randomized controlled trial. Consenting participants will be\r randomized to routine post-operative ambulation vs. goal-augmented post-operative care (they\r will be given a goal number of steps to take on each post-operative day) following in-patient\r gynecologic surgery.\n\n**Clinical Trial Detailed Description:**\n\nThis study is a non-blinded randomized controlled trial. Consenting participants will be\r randomized to routine post-operative ambulation vs. treadmill-augmented post-operative care\r (placement of non-motorized treadmill in their room) following in-patient gynecologic\r surgery.\r\n\r We will approach all women undergoing gynecologic procedures that are expected to ambulate\r within 12 hours of their operation and are anticipated to remain hospitalized at least 18\r hours. Following confirmation of eligibility, we will enroll subjects either in the clinic\r when they are being consented for their gynecologic procedure or upon presentation to the\r hospital the day of their procedure. Randomization will occur at the completion of the\r gynecologic procedure when it has been confirmed by the primary surgeon that the patient is\r able to ambulate independently within 12 hours after completion of the procedure. At that\r time, participants will be randomized using opaque envelopes prepared by the study\r statistician in a 1:1 ratio to receive usual post-operative care or treadmill-augmented care.\r\n\r All patients will have a pedometer placed on their person in the post-anesthesia recovery\r unit (PACU) which will be removed the day of their discharge. The primary outcome assessed\r will be number of steps taken in the 24 hour period prior to discharge as assessed by the\r electronic pedometer readings.\r\n\r Pedometer will be placed on patients using a lanyard and pedometer clip in the recovery room.\r No participant will start ambulation without physician's clinical order. When the patient is\r ready for the first ambulation she will be accompanied by a nurse to sit up in a chair. Once\r the patient is able to ambulate herself she may ambulate in her room or in the hallway or if\r randomized to treadmill group she will be able to ambulate on the treadmill. She will be\r wearing her pedometer at all times until discharge from Loyola.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Independent ambulation pre-operatively\r\n\r - Undergoing gynecologic procedure\r\n\r - Expected to ambulate within 12 hours of their procedure\r\n\r Exclusion Criteria:\r\n\r - Children under the age of 18\r\n\r - Inability to ambulate independently prior to their surgery\r\n\r - Primary surgeon does not want patient to ambulate within 12 hours of procedure\r\n\r - English is not the primary language spoken by the patient\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
920
|
[
{
"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\nEARLYdrain - Outcome After Early Lumbar CSF-drainage in Aneurysmal SAH\n\n**Clinical Trial Summary:**\n\nThe intention of the study is to investigate whether drainage of cerebral spinal fluid via a\r lumbar route (\"Tuohy-drain\") will improve outcome after intracranial aneurysmal subarachnoid\r hemorrhage (SAH).\n\n**Clinical Trial Detailed Description:**\n\n1. Introduction\r\n\r Patients suffering from aneurysmal subarachnoid hemorrhage (SAH) are predominantly\r threatened by two distinct medical problems. Firstly, they may experience a second - and\r often more severe - hemorrhage, and secondly, they may suffer a constringence reaction\r of the vessels supplying the brain with blood, called vasospasm.\r\n\r The first problem is resolved by rapid cerebrovascular imaging and subsequent treatment\r of the ruptured aneurysm, thus preventing recurrent hemorrhage. Aneurysm treatment may\r be performed either via craniotomy and surgical clipping of the aneurysm or with\r endovascular techniques by occluding the aneurysm with small platinum coils.\r\n\r The vasospasm - the second problem - is more difficult to handle. A hypothesis is that\r the development of vasospasm is related to the amount of blood in the basal cisterns.\r Therefore, a possible strategy tries to remove this blood as much as possible. Excess\r removal of cerebral spinal fluid (CSF) via an external ventricular drain fails in\r preventing vasospasm and may lead to a higher incidence of posthemorrhagic shunt\r dependency. Reason is that after aneurysmal SAH, the blood is packed more densely in the\r basal cisterns and therefore only CSF, being more lightweight, is drained from the\r ventricles. As an alternative approach, application of a lumbar drain is proposed to\r address clotting of the blood in the basal cisterns. Three retrospective studies in\r patients after aneurysmal SAH, the newest being available only as abstract, were able to\r establish the safety of this approach (Klimo et al, Kwon et al, Tizi et al (abstract\r DGNC 2009)). One of the fully published studies addressed vasospasm prophylaxis after\r surgical clipping, while the other was performed in patients after endovascular coiling.\r All studies led to a markedly diminished incidence of angiographic vasospasm. Therefore,\r a prospective study addressing the efficacy of this novel therapeutic approach is\r warranted.\r\n\r The focus of the EARLYDRAIN study is to examine the efficacy of application of lumbar\r drainage in patients with acute subarachnoidal hemorrhage from a cerebral aneurysm.\r Hypothesis is that early application of lumbar drainage after aneurysmal SAH leads to a\r diminished incidence of cerebral vasospasm, as assessed by digital subtraction\r angiography, and an improved outcome, measured by the modified Rankin score, at six\r months.\r\n\r 2. Study outline\r\n\r Patients suffering from aneurysmal SAH are treated according to international standards.\r Aneurysm treatment is at the discretion of the neurovascular team taking care for a\r patient and not specified by the study protocol. All medical treatment is performed\r according to local guidelines and standard operating procedures.\r\n\r Any patient meeting the inclusion criteria and not violating the exclusion criteria may\r participate in the EARLYDRAIN study and be randomized to either receive a lumbar drain\r or not, thus defining the two distinct groups LD and NoLD. To prevent premature rupture\r of the aneurysm due to accidental drainage, randomization to the study and eventual\r placement of a lumbar drain takes place after securing the aneurysm by the preferred\r method of choice. Any patient in the LD group receives a lumbar drain during anesthesia\r required for aneurysm treatment. This is to be performed before anticoagulation or\r anti-platelet therapy is initiated, which sometimes is warranted after endovascular\r coiling. A post-procedural CCT scan of the brain is performed within to 24 hours of\r aneurysm treatment. In case of any neurological worsening after the procedure it is\r strongly recommended to perform the follow-up CCT scan as soon as possible.\r\n\r In patients in the LD group, CSF drainage is started via LD slowly and steadily at a\r rate of approximately 5 ml per hour after the post-interventional CCT. This leads to a\r planned daily CSF drainage of about 120 ml per day via lumbar route. Patients in both\r groups may receive additional CSF drainage via a ventricular device as required. The\r amount of CSF drained via ventricular route is according to clinical requirement and not\r specified.\r\n\r To facilitate accuracy of drainage, regular drainage control every other hour and\r stopping in case of excess drainage is strongly recommended by the principal\r investigators. In case of neurological decline suspiciously related to the lumbar\r drainage, the drain is closed immediately and may be gradually restarted after 12 to 24\r hours, after performing a CCT scan.\r\n\r If the post-procedural CCT or any other follow-up CCT scan shows absent basal cisterns\r or any signs of threatening herniation, lumbar CSF diversion in the LD group shall not\r be performed. It may still be feasible to carefully drain CSF via the lumbar route may\r (Tuettenberg et al), but this is at the discretion of the local investigator and not\r recommended.\r\n\r In patients requiring sedation and mechanical ventilation, either due to neurological\r impairment or otherwise, intracranial pressure monitoring is mandatory. This may be\r performed according to local policy either with parenchymal or ventricular devices. If\r the intracranial pressure exceeds 20 mmHg, further CSF drainage via lumbar route shall\r be interrupted until the ICP is below 20 mmHg again. Careful CSF drainage via the lumbar\r route may be still feasible in case of high intracranial pressure (Tuettenberg et al),\r but is at the discretion of the local investigator.\r\n\r Further neuromonitoring with TCD, EEG, brain tissue oxygenation, jugular bulb oxymetry,\r regional cerebral blood flow, microdialysis or other devices is at the discretion of the\r center and according to its local guidelines. As far as possible, this data should be\r saved electronically for post-hoc analysis.\r\n\r A CCT scan as well as conventional digital subtraction angiography, CT angiography or MR\r angiography for assessment of vasospasm in the larger vessels is routinely performed on\r day 7 to 10 after the initial hemorrhage, regardless of the patient condition. In case\r of clinical suspicion of vasospasm, angiography may be performed at any time. If it is\r performed earlier and the patient shows no clinical deterioration thereafter, the\r angiography on day 7 to 10 is omitted.\r\n\r After cerebrovascular imaging on day 7 to 10, or day 8 in case of an earlier\r angiography, the lumbar drainage of CSF is stopped in the LD group. It may be pursued on\r a clinical base, as required.\r\n\r Amount and duration of CSF drainage Patients randomized to the lumbar drainage group\r shall receive a daily drainage of 120 ml CSF, or 5 ml per hour for seven days. If higher\r amounts of CSF need to be drained on clinical grounds as in patients with hydrocephalus,\r this is preferably performed via external ventricular drain.\r\n\r The drain is planned to remain in place until the control angiography on day 7 to 10\r after the initial hemorrhage. The local investigator may decide to remove the drain\r earlier in patients fully mobilized without clinical necessity of CSF drainage. However,\r consecutive drainage should not be less than four days to achieve a valid study result.\r Lumbar CSF drainage may be prolonged beyond the control angiography on clinical\r requirement. The amount of CSF drainage may then be adjusted to clinical needs and bears\r no further restriction.\r\n\r Patients randomized to the control group should not receive a lumbar drain before the\r planned control angiography to be performed on day 7 to 10 after SAH. If the patient\r develops hydrocephalus, and no EVD was placed initially for CSF drainage, a lumbar drain\r may be installed at the discretion of the local investigator. These patients are\r analyzed in the intention-to-treat analysis, but are not suitable for per-protocol\r analysis.\r\n\r 3. Consent to the study\r\n\r Consent for study inclusion is sought after explanation and agreement to a specific\r aneurysm treatment. Thus, patients capable of consenting to the aneurysm treatment get\r the study details explained themselves and may or may not agree to participate. If a\r patient is incapable for consenting to the proposed treatment, the legal representative\r should be informed on the conditions of treatment choices and afterwards, on the details\r of the EARLYDRAIN study. A patient may be randomized if the legal representative gives\r informed consent to the study, based on the presumed will of the patient. If neither the\r patient is capable of giving informed consent nor a legal representative is available in\r due time, an independent physician not involved in the patient's treatment nor in the\r trial may be asked for study approval. In these cases of deferred consent, a legal\r representative needs to be established as soon as possible, according to German law. As\r soon as a legal representative is available and/or the patient is capable again to\r consent to the study, he or she must be asked to give informed consent. If the patient\r or his/her legal representative refuses consent after inclusion by advice of an\r independent physician, no further study participation of the patient is possible. In\r this case, however, the patient or his/her legal representative are asked to give\r consent for evaluation of already acquired data.\r\n\r 4. Safety of lumbar drains after aneurysmal SAH\r\n\r In all three retrospective studies, mortality was lower in the lumbar drainage group.\r None of the retrospective studies mentions procedural related complications for the\r lumbar drains (Klimo et al, Kwon et al, Tizi et al (abstract at the DGNC 2009)). In\r patients with increased intracranial pressure, careful lumbar drainage of CSF may be a\r possible treatment even in case of compressed basal cisterns (Tuettenberg et al). To\r date, there is no data available indicating an increased risk of lumbar drainage in a\r controlled neurointensive care environment.\r\n\r 5. Insurance coverage\r\n\r As the EARLYDRAIN study compares two standard procedures of CSF drainage after subarachnoid\r hemorrhage used in clinical routine, no additional patient insurance is necessary to perform\r the study. German laws §§ 40 to 42 Arzneimittelgesetz or §§ 20 to 23 Medizinproduktegesetz\r are not applicable. Any hypothetical adverse events of either treatment are covered by the\r regular treatment contracts which do include clinical research.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age of 18 years or older\r\n\r - First aneurysmal SAH\r\n\r - Pre-morbid modified Rankin Scale score 0 or 1\r\n\r - Aneurysm treatment performed in the first 48 hours after the initial hemorrhage.\r\n\r - Informed consent by the patient or his/her legal representative. In case neither the\r patient is capable of giving informed consent nor a legal representative is available,\r informed consent can be given by an independent physician neither involved in the\r patient´s treatment nor the trial (for specification see below)\r\n\r Exclusion Criteria:\r\n\r - Subarachnoid hemorrhage of other than aneurysmal origin\r\n\r - No hemorrhage visible on initial CCT scan (Fisher Grade I)\r\n\r - Pregnancy\r\n\r - Concurrent participation in another interventional trial (participation in an\r observational trial is allowed)\r\n\r - Life expectancy less than 1 year for other reasons than the actual SAH\r\n\r - Other concomitant severe disease that would confound with treatment\r\n\r - Other clear contraindication for treatment\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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921
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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\nInvestigating the Acute Effects of Flavonoids in Blueberries on Cognitive Function.\n\n**Clinical Trial Summary:**\n\nThis study was a controlled, cross-over, acute flavonoid intervention trial with younger and\r older adults. Subjects consumed a blueberry beverage during one visit and a control beverage\r on another. Cognitive function pre drink was assessed, blood and urine samples were taken as\r well as blood pressure and a measure of vascular reactivity. These outcome measures were\r taken at 2 and 5 hours post drink.\r\n\r It was predicted that the flavonoids in the blueberry drink would lead to improved\r performance on the cognitive tests and vascular reactivity measure compared to following the\r control drink. It was thought this could be due to increased vaso-dilation and improving\r blood flow to the brain which was investigated in an extension to the project where a sample\r of individuals underwent brain imaging in an MRI scanner pre and post a blueberry and a\r control drink.\n\n**Clinical Trial Detailed Description:**\n\nThe control drink was matched to the blueberry drink for other bioactive compounds which may\r have affected cognition, specifically sugars and vitamin C. Volunteers were healthy, not on\r any medication, without high blood pressure, high cholesterol, high BMI, diabetes or other\r medical conditions. Older adults were aged 61-75 years and younger adults 18-26 years.\r\n\r Blood and urine samples will be analysed for flavonoid levels and Brain Derived Neurotrophic\r Factor, a biomarker of memory and learning, flavonoids may lead to increased BDNF production\r through the ERK-CREB-BDNF pathway.\r\n\r Flavonoids may also increase nitric oxide production and improve the flexibility of the blood\r vessels hence the measure of vascular reactivity using the Digital Volume Pulse machine. This\r can lead to increased vaso-dilation and blood flow to the brain, therefore an fMRI study was\r carried out the investigate this using arterial spin labeling following acute blueberry\r supplementation compared to a control drink.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - No medical conditions\r\n\r - Not taking any medication or supplements (or willing to stop taking supplements for\r duration of study)\r\n\r - Not lactose intolerant\r\n\r - Willing to give blood and urine samples\r\n\r - Not partaking in frequent vigorous exercise\r\n\r - Not suffering from or history of depression\r\n\r Exclusion Criteria:\r\n\r - On blood pressure medication, taking Aspirin or other blood thinning medication\r\n\r - BMI > 30\r\n\r - Cholesterol > 6\r\n\r - Diabetes or other serious medical condition\r\n\r - Lactose intolerant\r\n\r - Any learning difficulty e.g. dyslexia\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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922
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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\nElectrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches\n\n**Clinical Trial Summary:**\n\nThis investigation will gather information about a procedure called sphenopalatine ganglion\r (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those who\r suffer migraine headaches which may result in chronic severe disability. The SPG is a small\r collection of nerve cells in the head, and is located near the base of the nose on either\r side. Participation involves the surgical implantation of an electrode (small electrical\r conductor) over the sphenopalatine ganglion. The electrode is connected to a stimulator which\r will enable treatment for migraine headaches. Tiny electrical current is delivered to the\r stimulator device by an internal pulse generator implanted in the area at the top of the\r chest, to stop the migraine headaches. The implant system will be controlled with a wireless\r remote provided after the implant procedure.\r\n\r Participation will record headache diaries throughout the study, which will last\r approximately 8½ months, and a yearly visit annually for five years.\n\n**Clinical Trial Detailed Description:**\n\nThis application proposes a clinical study of electrical stimulation of the sphenopalatine\r ganglia (SPG) as a treatment for up to three individuals with episodic migraine headache. The\r present study is aimed at obtaining pilot data to guide a future controlled trial of this\r treatment modality. The study population will include individuals suffering from episodic\r migraine headaches with chronic severe disability, as demonstrated by the Migraine Disability\r Assessment Questionnaire (Lipton, 2000) and Headache Impact Test short form (HIT-6™)\r (Kosinski, 2003).\r\n\r The treatment involves implantation of an electrode into the SPG. The electrode is connected\r subcutaneously to an infraclavicular stimulator (PrimeAdvanced™ 37702 Multi-program\r Neurostimulator System, Medtronic Inc., Minneapolis MN). Proper electrode placement will be\r verified using anatomic and physiologic techniques. Participants will receive the Medtronic\r Model 3389 or 3387 lead, or Medtronic subcompact lead Model 3776-45, 3776-60, or 3776-75.\r Stimulation will be delivered in a range of frequencies from 20 to 130 Hz, and pulse width\r from 60 to 450 μsec, and a titrated voltage. The voltages used for chronic stimulation may\r range up to the pulse generator maximum of 10.5 volts but are anticipated to generally be\r below 3 volts, keeping below the 30 µcoulomb/cm² charge density safety limit, and below the\r threshold for adverse stimulation-related effects. The minimum number of contacts on the\r quadripolar leads will be activated as necessary to produce a response.\r\n\r The Prime Advanced neurostimulator to be used in this study allows the clinician to set all\r stimulation parameters including the maximum allowable amplitude. It is our responsibility to\r assure that appropriate stimulation parameters are used to result in appropriate electrical\r exposure charge density) below a 30 µC/cm2/phase limit. As is done with commercially\r available neurostimulators, during this study, we will utilize the charts presented in\r Figures 1 and 2 below to assist in selection of programming parameters, and this programming\r will be maintained by software controls within the neurostimulator.\r\n\r For this exploratory study of 3 patients, the maximum electrical stimulating parameters,\r resulting electrical exposure (e.g., charge density), will be determined using the methods\r described above. It is our responsibility to assure that safe stimulation parameters are used\r at all times and that the maximum settings do not exceed the safety limits. Our plan is to\r begin with lead 3776 if possible, because it does not require an extra extension, but we\r would use 3387 or 3389 if clinically indicated.\r\n\r The proposed study is a physician-sponsored research investigation of three patients, and the\r attention to stimulation parameters will be much greater than can be expected for a\r commercially released product. It is our responsibility within this investigational study to\r insure the selected stimulation parameters do not exceed the safety limit of 30μC/cm2/phase.\r Patients participating in the study will only be able to lower stimulation amplitudes,\r thereby keeping stimulation parameters BELOW any clinician set maximum. The only programs\r available to or accessible by the patients will maintain the previously described parameter\r set limitations. Thus, the programming of the Implantable Programmable Generator (IPG) will\r keep the three patients from stimulating outside or above the set and safe parameters.\r\n\r The primary outcome measures for assessing the efficacy of migraine treatment will be a\r subject reported daily diary noting frequency and intensity of headaches. During this\r investigation we will obtain preliminary controlled data on the safety and efficacy of SPG\r stimulation for migraine treatment.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age ≥18 years.\r\n\r 2. Subject has onset of migraine headache occurring before age 60.\r\n\r 3. Subject has been diagnosed with migraine headache with or without aura, according to\r the 2004 IHS criteria 1.1 and 1.2.\r\n\r 4. Subject reports a HIT-6 score of >56, a MIDAS score of >20 and/or a failure of\r adequate and appropriate previous migraine treatment.\r\n\r 5. Subject has carried the diagnosis of migraine for at least 6 months prior to\r enrollment.\r\n\r 6. Subject has had at least three migraine headache attacks per month.\r\n\r 7. Subject has had at least three headache days (migraine or non-migraine) per month and\r maintains this requirement during the baseline period on diary.\r\n\r 8. Subject is able to distinguish migraine headache attacks as discrete from other\r headaches (i.e., tension-type headaches).\r\n\r 9. Subject has the ability to read, comprehend and legibly and reliably record\r information as required by the protocol.\r\n\r 10. Subject is able to provide written informed consent prior to participation in the\r study.\r\n\r 11. Subject agrees to not participate in supplemental or alternative therapy during the\r baseline or treatment phases of the clinical study. This includes: acupuncture, spinal\r manipulation, TENS, and magnetic field treatments.\r\n\r 12. Subject agrees to maintain current preventative headache medication regimens (no\r change in type, frequency, or dose) from baseline screening visit to the end of the\r Phase 2 treatment phase.\r\n\r Exclusion Criteria:\r\n\r 1. Subject currently has Medication Overuse Headache (MOH) in the judgment of the\r investigator or by ICHD-II criteria.\r\n\r 2. Subject has a history of headaches days ≥ 15 per month.\r\n\r 3. Subject has a history of trigeminal autonomic cephalalgias.\r\n\r 4. Subject has any medical condition or disorder that:\r\n\r 1. Is considered to be clinically significant and may pose a safety concern\r\n\r 2. Could interfere with the accurate assessment of safety or efficacy\r\n\r 3. Could potentially affect a subject's safety or study outcome.\r\n\r 5. Subject has had a major infection or surgery in the past month.\r\n\r 6. Subject has undergone facial surgery in the area of sphenopalatine ganglia for\r cosmetic, corrective, therapeutic, or traumatic reasons.\r\n\r 7. Subject has been treated with radiation to the face.\r\n\r 8. Subject was diagnosed with any major infectious processes, primary or secondary\r malignancies involving the face that have been active or required treatment in the\r past six (6) months.\r\n\r 9. Subject currently meets criteria as defined by the Diagnostic and Statistical Manual\r of Mental Disorders (DSM-IV-TR) for an active major depressive episode or for active\r significant psychiatric disorders, including dementia, uncontrolled general anxiety\r disorder, psychotic disorders or uncontrolled bipolar disorder. Exclusion criteria\r include: suicidality, active psychosis, untreated severe depression and/ or anxiety\r disorder, litigation, addiction, homicidal ideation, significant Axis II disorders and\r untreated sleep disorder.\r\n\r 10. Subject currently has clinically significant drug or alcohol abuse as defined by\r DSM-IV-TR or is unable to refrain from substance abuse throughout the study.\r\n\r 11. Subject is currently participating or has participated in the last month in another\r clinical study in which the subject has, is, or will be exposed to an investigational\r or non-investigational drug or device.\r\n\r 12. Subject is felt to be at risk of non-compliance (e.g. for completing the diary or\r maintaining a stable headache medicine regimen) in the investigator's opinion.\r\n\r 13. Subject is woman of childbearing age who is pregnant, nursing, or not using\r contraception.\r\n\r 14. Subject has had previous radio-frequency ablation of the SPG.\r\n\r 15. Subject has had blocks of the SPG in last 3 months.\r\n\r 16. Subject has undergone botulinum toxin injections of the head and/or neck in the last 3\r months.\r\n\r 17. Subject has an implantable stimulator or any implanted devices in the head and/or\r neck.\r\n\r 18. Subject has H/O bleeding disorders or coagulopathy, or is on anticoagulation,\r antiplatelet, or GP IIb IIIa inhibitor medication.\r\n\r 19. Subject has H/O malignancy or any other condition that requires MRI monitoring.\r\n\r 20. Subject has or requires pacemaker/defibrillator.\r\n\r 21. Subject is not suitable for the study, in the judgment of the Investigators, due to\r social, co-morbid psychological, and/or medical considerations.\r\n\r 22. Subject has H/O stroke, cardiovascular disease, and/or epilepsy.\r\n\r 23. Subject was on antipsychotic or antidepressant medications (except for migraine\r prevention) in the past 3 months prior to the study.\r\n\r 24. Subject is allergic or has shown hypersensitivity to materials of the Medtronic\r components which come in contact with the body.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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923
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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 Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache\n\n**Clinical Trial Summary:**\n\nCluster headache is a disorder marked by frequent attacks of short-lasting, severe,\r unilateral head pain with associated autonomic symptoms. It is the most severe head pain\r syndrome known. Currently, the two most common treatments for cluster headaches are inhaled\r oxygen and injectable sumatriptan. These treatments do not work for all cluster headache\r patients, and patients who smoke may eventually develop contraindication to triptans. New\r treatment options are needed.\r\n\r An alternative method of oxygen delivery (as opposed to continuous flow) uses a demand valve\r that is controlled by respiration rate, allowing increased oxygen flow in response to\r increased demand. This system may be more efficacious at stopping a cluster headache attack\r than the currently prescribed oxygen delivery system.\r\n\r This study will compare the effectiveness of oxygen delivered via demand valve versus\r continuous high flow oxygen via non-rebreather face mask in the acute treatment of a cluster\r headache attack. All patients will treat one cluster headache with each of the 2 treatment\r methods.\n\n**Clinical Trial Detailed Description:**\n\nCluster headache is a primary headache disorder marked by frequent attacks of short-lasting,\r severe, unilateral head pain with associated autonomic symptoms. The goal of acute therapy\r for cluster headache is fast, effective and consistent relief.\r\n\r In the currently recommended dosing strategy of continuous flow 100% oxygen given via a\r non-rebreather face mask at 7-15L/min, the time to improvement can sometimes take upwards of\r 20-30 minutes and is not effective for all cluster headache sufferers.\r\n\r An alternative method of oxygen delivery (versus continuous flow) uses a demand valve which\r is controlled by the respiration rate, allowing increased oxygen flow in response to\r increased demand. This delivery system may be better at stopping a cluster headache attack\r than the continuous flow model as it can support hyperventilation which can enhance cerebral\r arterial vasoconstriction via a state of hyperoxia and hypocapnia. Arterial vasoconstriction\r is one hypothesized method by which oxygen can abort a cluster headache attack.\r\n\r This proof of concept trial will evaluate if oxygen delivered via demand valve with a\r specific breathing technique is effective as a cluster headache acute treatment and is more\r effective than the traditional continuous high flow oxygen treatment with a non-rebreather\r face mask.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Men or women 18 to 65 with history of moderate severe or very severe cluster headaches\r and currently in a cluster headache period or cycle are included.\r\n\r Exclusion Criteria:\r\n\r - Subjects who have a history of chronic obstructive lung disease, those who have major\r neurologic disorders other than cluster headaches, those with a history of syncope, or\r lightheadedness with hyperventilation and pregnant women are excluded.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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924
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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 Prospective Study of Postpartum Depression in Women With Major Depression\n\n**Clinical Trial Summary:**\n\nBackground:\r\n\r - Postpartum depression (PPD) is a serious syndrome that resembles a major depressive episode\r and occurs in 10% to 20% of all mothers in the year following delivery. Women with histories\r of major depressive disorder (MDD) are at an increased risk for PPD and recurrent PPD with\r subsequent pregnancies. One possible genetic vulnerability to depression and PPD in\r particular is the BDNF gene. BDNF is a protein that affects the growth and development of\r brain cells, including those that help to regulate mood. BDNF levels have been shown to be\r significantly lower in individuals with depression, including women. Researchers are\r interested in studying BDNF levels and hormones such as estrogen in pregnant women who have\r MDD and are at risk for developing PPD.\r\n\r Objectives:\r\n\r - To study connections between the BDNF protein and hormonal levels in pregnant women who are\r at risk for developing postpartum depression.\r\n\r Eligibility:\r\n\r - Women who are currently pregnant and have a history of major depressive disorder, and\r either are taking a selective serotonin reuptake inhibitor (SSRI) or are not taking an\r antidepressant.\r\n\r Design:\r\n\r - This study involves six visits over the course of 12 months, during the first, second,\r and third trimesters (if possible) as well as 1 week, 1 month, and 3 months postpartum.\r Women will be allowed to participate at any point during pregnancy, but researchers are\r most interested in recruiting women who are in the first trimester.\r\n\r - Participants will be screened with a physical examination and medical history, blood\r samples, and questionnaires about their history of depressive episodes.\r\n\r - At each visit, participants will complete a number of questionnaires on depression\r symptoms, such as sleep disturbance and stress levels. Participants will also provide\r blood samples for hormone and other testing.\r\n\r - Participants who become depressed during the study will be referred to a treating\r psychiatrist or other professional for appropriate care and treatment.\n\n**Clinical Trial Detailed Description:**\n\nPostpartum depression (PPD) is a serious syndrome which resembles a major depressive episode\r and occurs in 10-20% of all mothers in the year following delivery. The etiology of PPD\r involves psychological factors, environmental factors such as stress and sleep deprivation,\r biological factors including hormonal changes, and social factors. Women with histories of\r major depression (MDD) are at an increased risk for PPD and recurrent PPD with subsequent\r pregnancies. No consistent hormonal abnormalities have been found in women with PPD and,\r instead, they may be sensitive to the normal changes in hormone levels during the postpartum\r time. One possible genetic vulnerability to depression, and in particular PPD, is the\r brain-derived neurotrophic factor (BDNF) gene. BDNF is an important member of the\r neurotrophin family and is known to affect neuronal outgrowth, differentiation, synaptic\r connectivity and neuronal repair for a broad range of neuronal cell types including\r serotonergic neurons. In humans, serum BDNF levels have been shown to be significantly lower\r in patients with depression, including women . Interestingly, estrogen has been shown to\r upregulate the expression of the BDNF gene in animals, suggesting that BDNF could be a\r critical link for women who have hormonally related depressive symptoms. In addition,\r serotonin-selective reuptake inhibitors (SSRI) used to treat depression are known to\r upregulate the expression of BDNF in the brain. Interestingly, links between depression,\r perturbed energy metabolism and BDNF signaling have recently been elucidated. In the present\r study, NIA investigators will measure levels of BDNF and reproductive and energy-regulating\r hormones in serum samples from subjects enrolled in Dr. Jennifer Payne s study of PPD.\r\n\r All subjects in this study will be enrolled, evaluated and serum samples collected by Dr.\r Payne and her staff at Johns Hopkins University School of Medicine under Dr. Payne s already\r Johns Hopkins approved IRB protocol NA_0008149.\r\n\r NIA Role:\r\n\r Coded serum samples will then be sent to Dr. Mattson at the NIA facility. Data obtained in\r the analysis of serum samples will be sent to Dr. Payne and maintained in her database, and\r analyzed to elucidate relations between levels of serum markers and clinical and genetic data\r acquired by Dr. Payne.\n\n**Clinical Trial Eligibility Criteria:**\n\n- INCLUSION CRITERIA:\r\n\r Women who are currently pregnant and who have a history of MDD.\r\n\r In order to minimize heterogeneity in the sample, all women must be currently taking a\r serotonin reuptake inhibitor (SSRI) antidepressant medication or not taking\r antidepressants.\r\n\r We will attempt to recruit approximately 50% in each category (SSRI versus no medications).\r If a woman becomes depressed during the study she will be referred to her treating\r psychiatrist or given appropriate clinical care. We will continue to follow women for the\r specified time course even if she placed on an (any) antidepressant medication during the\r course of the study.\r\n\r EXCLUSION CRITERIA:\r\n\r Diagnosis of bipolar disorder\r\n\r Current active suicidal ideation or medical instability\r\n\r Active substance abuse or dependence during the last 90 days.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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925
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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\nEffect of Osteopathic Manipulative Treatment for Patients With Chronic Headache\n\n**Clinical Trial Summary:**\n\nParticipants with chronic or recurrent headache, unrelated to any known pathology or disease,\r will be randomly assigned to one of four interventions: Osteopathic manipulation of the body\r other than the head, osteopathic manipulation of the head, osteopathic manipulation of the\r head and rest of the body, or light touch on the head only but no manipulation. Measurements\r of heart rate and blood pressure variability, peripheral blood flow, and behavioral changes,\r such as mood, pain duration, intensity and frequency will be assessed.\n\n**Clinical Trial Detailed Description:**\n\nSixty subjects will be recruited to participate in the study via word of mouth and mass email\r notification of employees and students at Western University of Health Sciences in Pomona,\r CA.\r\n\r Patients will be randomly assigned to 1 of 4 groups for a specific Osteopathic Manipulative\r Treatment (OMT): Compression of Fourth Ventricle (CV4) only, CV4 and subject appropriate OMT,\r subject appropriate OMT only (no CV4), and sham (touch only). There will be 8 subjects per\r OMT group, making it 24 subjects altogether assigned to one of the three OMT groups, and 24\r sham subjects.\r\n\r Power analysis for determination of sample sizes: The investigators have no data on\r preliminary studies of the effect of OMT on chronic headaches, and there is only one study of\r the immediate effect on tension type headache patients after CV4, so power analysis is a\r rough estimate at this point for the one week headache symptom evaluation post OMT. From\r preliminary studies in this lab, the investigators can expect for 'CV4 only' 80% of\r participants to have significant still point objective response vs sham treatment which the\r investigators expect will significantly effect about 10% of the participants. There needs to\r be at least 16 subjects in each of two groups assessing this outcome measure, so 16 receiving\r CV4 and 16 sham to detect the 70% difference in still point measure. To detect differences\r between any OMT and sham, since there are three groups receiving OMT of some type, when the\r investigators consider how many in each of these three groups vs the sham group, the\r investigators figured 8 per each OMT group, of which 2 are CV4 (thus 16 get CV4), making it\r 24 subjects in the combined OMT groups. Therefore, the investigators need 24 sham subjects to\r make it equal numbers for balanced analysis (OMT vs sham), and to detect differences in the\r OMT interventions and sham interventions. Considering a possibility of 25%, or 12 subjects,\r not responding to the follow up survey at one week, the investigators figured recruitment of\r 60 subjects would ensure the investigators would have enough to make our calculations and be\r able to determine if there are significant differences between groups.\r\n\r The investigators have no preliminary studies on the effect of OMT or sham on mood in patient\r with headaches, so this part of the study is an exploratory assessment and sample size\r calculations will be able to be performed with the data gathered from this study for\r subsequent studies.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - chronic or recurrent headaches at least as often as one time per week\r\n\r Exclusion Criteria:\r\n\r - recent head trauma\r\n\r - brain disease or pathology\r\n\r - seizure disorder\r\n\r - using beta or alpha blocker medications\r\n\r - allergy to sticky tape used to affix leads to skin\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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926
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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\nIntervening to Improve Infant Health in Ghana\n\n**Clinical Trial Summary:**\n\nThe purpose of the study is to understand how cooking might affect the health of pregnant\r women and their babies.\r\n\r The goal of the research is to determine whether, interventions in decreasing exposure to\r smoke from cook stoves can bring about a significant change in the indoor air pollution\r levels and health of communities in Ghana.\r\n\r Hypothesis 1. Use of improved cook stoves starting by the third trimester pregnancy will lead\r to a significant increase in average birth weight in newborns.\r\n\r Hypothesis 2. Use of improved cook stoves will lead to a significant reduction in the rate of\r severe acute lower respiratory disease during the first 12 months of life.\n\n**Clinical Trial Detailed Description:**\n\n2. Overview of design and analysis [per CONSORT 2010] 2.1 Trial design [CONSORT 3a] The study\r is a three-arm cluster randomized trial, with two intervention arms and a control arm. The\r primary justification for intervening at the village level is that an individual level\r randomization, which would entail treatments and controls living side-by-side in a village,\r could lead to conflict within villages.\r\n\r 2.2 Study Participants [CONSORT 4a, 4b] The study will take place in the catchment area of\r Kintampo Health Research Centre. This comprises a population of 146,000. The study population\r is primarily rural and agricultural, and cooks primarily with biomass fuels. The study area\r is well described in Owusu-Agyei et al. 2012 (38).\r\n\r A cluster was eligible to participate if it:\r\n\r - Is located in Kintampo North or South Districts (this is the core study area for KHRC)\r\n\r - Is primarily rural (in practice, this excludes Kintampo, which is a small city of\r approximately 40,000 people);\r\n\r - Is operationally feasible (in practice, this excluded a handful very small, isolated\r clusters that would have presented extraordinary logistical challenges);\r\n\r - Is home to women who primarily deliver at one of our four staffed birth facilities (in\r practice this excluded one village on the edge of the study area, in which women travel\r to another district for deliveries).\r\n\r A woman will be eligible to participate in the study if she:\r\n\r - Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation;\r this is to ensure that the intervention is actually delivered prior to 27 weeks)\r\n\r - Is carrying a live singleton fetus (twins will be excluded)\r\n\r - Is the primary cook in her household or compound; and\r\n\r - Is a non-smoker. 2.3 Interventions [CONSORT 5]\r\n\r The study has three arms:\r\n\r 1. LPG intervention arm, in which households receive a two burner LPG cookstove and monthly\r gas deliveries;\r\n\r 2. An efficient biomass arm, in which households receive two BioLite cookstoves; and\r\n\r 3. A control arm 2.4 Outcomes [CONSORT 6a]\r\n\r The primary health outcome measures for the study are:\r\n\r 1. Infant weight at birth, and\r\n\r 2. Physician assessed pneumonia. Baseline assessments of outcomes No baseline data for ALRI\r prevalence from Ghana is available. Our study will thus provide very valuable baseline\r data regarding this important disease.\r\n\r KHRC has, in the course of conducting other research projects, captured some information\r regarding birth weight; statistics calculated from these data were used as inputs into power\r calculations. These data are described in (39).\r\n\r 2.5 Sample size [CONSORT 7a, 7b] For the three-arm design, we calculate that we need to\r enroll households to achieve our target of 1225 births (assuming that 85% of the pregnancies\r will result in a recorded birth after, accounting for move out, drop out, and still birth\r rates). These will be spread across 35 or more clusters, as outlined in the following table.\r\n\r Clusters Births Enrollment BioLite 13 455 525 Control 13 455 525 LPG 9 315 365 total 35 1225\r 1415\n\n**Clinical Trial Eligibility Criteria:**\n\nA cluster was eligible to participate if it:\r\n\r - Is located in Kintampo North or South Districts (this is the core study area for KHRC)\r\n\r - Is primarily rural (in practice, this excludes Kintampo, which is a small city of\r approximately 40,000 people);\r\n\r - Is operationally feasible (in practice, this excluded a handful very small, isolated\r clusters that would have presented extraordinary logistical challenges);\r\n\r - Is home to women who primarily deliver at one of our four staffed birth facilities (in\r practice this excluded one village on the edge of the study area, in which women\r travel to another district for deliveries).\r\n\r A woman will be eligible to participate in the study if she:\r\n\r - Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks\r gestation; this is to ensure that the intervention is actually delivered prior to 27\r weeks)\r\n\r - Is carrying a live singleton fetus (twins will be excluded)\r\n\r - Is the primary cook in her household or compound; and\r\n\r - Is a non-smoker.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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927
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Effect of Stimulating Substances on Brain Activity of Preterm Infants\n\n**Clinical Trial Summary:**\n\nIntroduction: Methylxanthines and doxapram have been widely used for the treatment of apneas\r of prematurity. Both substances have effects on the central nervous system. While there are\r data available concerning the use of caffeine (the methylxanthine used at our NICU) even\r proposing a positive effect on neurodevelopmental outcome of very preterm infants, there are\r data which suggest a negative effect of the central stimulants doxapram on longterm outcome\r in this group of infants. Nevertheless concerning both medications only few studies have been\r published and only scarce data are available concerning the effect of these medications on\r brain activity of very preterm infants until now.\r\n\r The aim of this study: is the assessment of the effect of stimulating substances on brain\r activity of preterm infants born below 30 weeks of gestation and their longterm\r neurodevelopmental follow-up.\r\n\r Methods: This study is a prospective study including preterm infants born below 30 weeks of\r gestational age. Brain activity is measured by one-channel amplitude-integrated EEG (aEEG).\r The first aEEG measurement is performed without caffeine and/or doxapram medication. At least\r one hour of brain activity is registrated. The second measurement is done at least 24 hours\r after the start of caffeine and/ or doxapram treatment.\r\n\r The percentage of different background patterns, the occurrence and duration of\r sleep-wake-cycling, and the occurrence and duration of seizures is assessed and analysed.\r Neurodevelopmental outcome is assessed at one and two years of corrected age by assessment of\r the Bayley Scales of Infant Development II and standardized clinical neurological\r examination.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r see above\r\n\r Exclusion Criteria:\r\n\r - intraventricular hemorrhage\r\n\r - posthaemorrhagic hydrocephalus\r\n\r - cerebral infection\r\n\r - cerebral malformation\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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928
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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\nStereotactic Body Radiotherapy for Spine Tumors\n\n**Clinical Trial Summary:**\n\nThis study will evaluate the local control rate as well as acute and late toxicity rates of\r stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine\r tumors.\n\n**Clinical Trial Detailed Description:**\n\nThis study is a single site, non-randomized, prospective, phase IV trial. Patients are\r composed of 2 groups:Spine Metastases OR Benign Spine Tumors. Data collected will include\r patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose\r received by adjacent critical normal tissues, tumor recurrence data, and acute and late\r toxicities.\r\n\r Follow up data will be collected during the patient's standard office visits. The anticipated\r duration of this study is 5 years\n\n**Clinical Trial Eligibility Criteria:**\n\nEligibility Criteria:\r\n\r - Patient age >= 18 years\r\n\r - performance status of 0-3\r\n\r - Vertebral and/or paraspinal metastases, with or without prior surgery and/or\r fractionated radiotherapy\r\n\r - Benign extradural spine tumors such as chordomas, meningiomas, schwannomas,\r neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).\r\n\r - Established histologic diagnosis of a benign or malignant tumor of the spine.\r\n\r - Arteriovenous malformation of the spine identified radiographically (no biopsy)\r\n\r - Well-defined lesion involving no more than 2 adjacent vertebral levels or spinal\r segment\r\n\r - Minimal spinal canal compromise that is not rapidly progressive. Ideally, the tumor\r should not be within 5 mm of the spinal cord.\r\n\r - If chemotherapy is planned, ideally it should not have been given within 30 days of\r starting radiation and should not resume until at least 2 weeks after completing\r radiation. In addition, it is not recommended to perform SBRT when targeted\r anti-angiogenesis therapy is planned within 2 months of the procedure.\r\n\r - Signed study-specific consent form\r\n\r Exclusion Criteria:\r\n\r - Lesion involving > 3 adjacent vertebral levels\r\n\r - Overt spinal instability\r\n\r - Neurologic deficit due to bony fragments/bony compression of neural structures\r\n\r - Prior radiotherapy at the involved level(s) within 3 months of radiosurgery, more than\r one prior course of radiotherapy at the involved level(s), or more than 45 Gy previous\r radiation exposure at the involved level(s)\r\n\r - Rapidly progressive spinal cord compromise or neurological deficit\r\n\r - Paralysis, or otherwise compromised motor function due to radiographically confirmed\r cord compression\r\n\r - Patient unable to undergo an MRI\r\n\r - Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown\r effects of RT on lactating females\r\n\r - Patients with psychiatric or addictive disorder that would preclude obtaining informed\r consent\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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929
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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\nHepatitis A Vaccine in Patients With Immunomodulating Drugs\n\n**Clinical Trial Summary:**\n\nHepatitis A vaccine is the most frequently used traveller's vaccine, yet data on its ability\r to induce protective immunity in immunosuppressed travellers are scarce. The investigators\r assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis\r (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).\n\n**Clinical Trial Detailed Description:**\n\nMethods: Parameters registered at baseline were: age, sex, duration of disease, medications,\r activity of disease (Visual Analogue Scale=VAS, Health Assessment Questionnaire Disability\r Index = HAQ, Disease Activity Score =DAS-28, CRP and total IgG in plasma). Hepatitis A\r vaccine (Epaxal or Havrix) were given at 0 and 6 months. Hepatitis A virus (HAV) antibodies\r is measured before vaccination and at month 1, 6 (before dose 2), 7 and 12 with quantitative\r HAV IgG, using the HAVAb-IgG Architect System, and by the HAVAB 2.0 assay on the AxSYM\r machine from Abbott. The level of protective immunity to HAV is defined as HAV IgG >\r 10mIU/mL.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of rheumatoid arthritis\r\n\r - TNF-alfa blocker and / or methotraxate in use as a medication against RA\r\n\r - A desire to get protected against hepatitis A\r\n\r - Men and women age 18-65 years\r\n\r - Written informed consent\r\n\r - Women of childbearing potential must use effective contraception -\r\n\r Exclusion Criteria:\r\n\r - Treatment with rituximab within 9 months before study start\r\n\r - Known previous hepatitis A infection\r\n\r - Previous vaccination against hepatitis A\r\n\r - Allergy to eggs or formaldehyde\r\n\r - Pregnancy or lactation\r\n\r - Excessive use of alcohol\r\n\r - Mental retardation\r\n\r - Acute disease at the time of examination (fever > 38 degrees)\r\n\r - Volunteer works as an employee of the researchers\r\n\r - Previous vaccination against hepatitis A\r\n\r - Egg-, henprotein- or formaldehyde allergy\r\n\r - Pregnancy or lactation\r\n\r - Excessive use of alcohol\r\n\r - Another vaccine given within a month\r\n\r - Acute disease at the time of examination (fever > 38 degrees)\r\n\r - Not suitable for other reason in the investigator's opinion (other serious disease,\r i.e. AIDS/HIV-positive, cancer with ongoing cytostatic treatment)\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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930
|
[
{
"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\nTrial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery\n\n**Clinical Trial Summary:**\n\nTo determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable\r Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native\r common iliac artery and/or native external iliac artery.\n\n**Clinical Trial Detailed Description:**\n\nThe MOBILITY study was a prospective, non-randomized, two-arm, multi-center study. The 2 arms\r (Omnilink Elite arm and Absolute Pro arm) were designed to independently assess the safety\r and effectiveness of the 2 devices used in this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nClinical Inclusion Criteria:\r\n\r 1. Subject must be at least 18 and < 90 years of age.\r\n\r 2. Subject has been informed of the nature of the trial, agrees to its provisions, and\r has signed the informed consent form.\r\n\r 3. Subject must agree to undergo all protocol-required follow-up examinations and\r requirements at the investigational site.\r\n\r 4. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or\r ischemic rest pain (Rutherford Becker Clinical Category 4).\r\n\r 5. Female subjects of childbearing potential must have had a negative pregnancy test\r before treatment, and must not be nursing at the time of treatment, and agree at time\r of consent to use birth control during participation in this trial up to and including\r the follow-up at 9 months.\r\n\r Angiographic Inclusion Criteria\r\n\r 1. Up to two bilateral de novo or restenotic lesions of the native common iliac artery\r and/or native external iliac artery may be treated(one per side).\r\n\r 2. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis\r (total occlusion)\r\n\r 3. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis\r\n\r 4. Lesion length for stenosis of the common or external iliac artery visually estimated\r to be ≥ 10 mm and ≤ 110 mm (Absolute Pro)\r\n\r 5. Lesion length for total occlusion of the common iliac artery visually estimated to be\r ≤40 mm\r\n\r 6. Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm\r (Absolute Pro)\r\n\r 7. On the treatment side(s), patent superficial femoral and popliteal arteries and at\r least one patent distal outflow artery with in-line distal vessel flow to the foot as\r confirmed by arteriography. Patent is defined as < 50% stenosis.\r\n\r 8. Lesion length for stenosis of the common or external iliac artery visually estimated\r to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite).\r\n\r 9. Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm\r (Omnilink Elite).\r\n\r Clinical Exclusion Criteria\r\n\r 1. Subject is unable to walk.\r\n\r 2. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary\r artery bypass graft surgery, thoracic surgery.\r\n\r 3. Subject has received, or is on the waiting list for a major organ transplant (heart,\r lung, kidney, liver).\r\n\r 4. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6.\r\n\r 5. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion\r side(s).\r\n\r 6. Subject has elevated serum creatinine > 2.0 mg/dl.\r\n\r 7. Subject has uncontrolled diabetes mellitus (DM) (serum glucose > 400 mg/dl).\r\n\r 8. Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30\r days.\r\n\r 9. Subject has had a stroke within the previous 30 days and/or has deficits from a prior\r stroke that limits the subjects ability to walk.\r\n\r 10. Subject has unstable angina defined as rest angina with ECG changes.\r\n\r 11. Subject has a groin infection, or an acute systemic infection that is currently under\r treatment.\r\n\r 12. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.\r\n\r 13. Subject requires any planned procedure within 30 days after the index procedure that\r would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following\r the procedure.\r\n\r 14. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that\r may cause the subject to be non-compliant with protocol requirements, confound the\r data interpretation, or is associated with limited life-expectancy (i.e., less than 2\r years).\r\n\r 15. Subject is currently participating in an investigational drug or device trial that has\r not completed the primary endpoint follow-up or that clinically interferes with the\r current trial endpoints.\r\n\r 16. Subject is unable to understand or unwilling to cooperate with trial procedures or is\r unwilling or unable to return to the treatment center for follow-up visits.\r\n\r 17. If intended stent is Absolute Pro, subject has known hypersensitivity or\r contraindication to nickel, titanium or platinum; subject has known hypersensitivity\r or contraindication to standard intraprocedure anticoagulant(s); subject has\r sensitivity to contrast which cannot be adequately pre-treated with medication.\r\n\r 18. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if\r allergy or contraindication is to clopidogrel, subject is unable to tolerate\r ticlopidine (Ticlid®).\r\n\r 19. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood\r transfusions.\r\n\r 20. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index\r procedure that would interfere with antiplatelet therapy.\r\n\r 21. If intended stent is Omnilink Elite, subject has known hypersensitivity or\r contraindication to cobalt chromium; subject has known hypersensitivity or\r contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity\r to contrast which cannot be adequately pre-treated with medication.\r\n\r 22. Requirement of general anesthesia or spinal block for the procedure.\r\n\r 23. Presence of contralateral limb amputation that was performed to treat any\r non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic.\r\n\r 24. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior\r tibial, posterior tibial, peroneal, ipsilateral to the target lesion.\r\n\r 25. Subject requires a concomitant percutaneous endovascular procedure in another vessel,\r e.g. coronary.\r\n\r 26. Target lesion is in an iliac artery that has been previously stented.\r\n\r Angiographic Exclusion Criteria\r\n\r 1. Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to\r the target lesion.\r\n\r 2. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the\r target lesion\r\n\r 3. Target lesion is within or adjacent to an aneurysm.\r\n\r 4. Lesion is located within or beyond a vessel that contains a bypass graft.\r\n\r 5. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery.\r\n\r 6. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm\r > 3cm.\r\n\r 7. Lesion extends beyond the inguinal ligament.\r\n\r 8. Subject has angiographic evidence of thrombus in the target disease segment or vessel\r that is unresponsive to anti-thrombotic therapies.\r\n\r 9. Subject has multilevel disease in the target extremity that requires other staged\r procedures within 30 days before or after the procedure.\r\n\r 10. On the treatment side(s), subject is without patent superficial femoral and popliteal\r arteries and at least one patent distal outflow artery with in-line distal vessel flow\r to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis.\r\n\r 11. Requirement for > 1 stent to treat full length of lesion.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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931
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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\nObservational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury\n\n**Clinical Trial Summary:**\n\nThe purpose of the current study is proposed to prospectively assess how accurately the\r BrainScope® Ahead™ M-100 can distinguish risk categories for acute head injury.\n\n**Clinical Trial Detailed Description:**\n\nOne million patients attend Emergency Departments (ED) with head injuries each year in the\r United Kingdom (UK) and Ireland. 150,000 of these patients will need hospital admission and\r one study estimates an incidence of 45-48% moderate or severe disability in those surviving\r admission. Although the incidence of head injury is high, the incidence of death from head\r injury is low. Therefore ED's are required to see a large number of patients with a\r minor/mild head injury, and identify the very small number of these that will go on to have\r serious complications. The challenge to the emergency medicine clinician is identifying which\r patients with a head injury have an important brain injury that requires further attention\r and which patients can be safely sent home. The standard for determining an important brain\r injury is the result on the Computerised Tomography (CT) scan of the head. CT scanning is\r nonportable and exposes individuals to high radiation levels.\r\n\r The study medical device is a portable, point of care, noninvasive and non radiation-emitting\r medical device designed to assist clinicians in early identification, staging, and\r optimisation of treatment for patients who are head injured.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Males and females ages 18 to 80 (the entire age range), who are admitted to the\r Emergency Department (ED), who are suspected of a traumatically induced structural\r brain injury and/or clinical manifestations of functional brain injury, as a result of\r insult to the head from an external force, e.g., the head being struck by an object,\r the head striking an object, the head being exposed to forces generated from a blast\r or explosion, and/or the brain undergoing an acceleration/deceleration movement\r without direct external trauma to the head with a Glasgow Coma Scale of >8. The acute,\r suspected traumatically induced structural brain injury and/or clinical manifestations\r of functional brain injury will have occurred within the past 24 hours upon admission\r to the ED.\r\n\r - The 'head injured' control group will be males and females ages 18 to 80 (the entire\r age range), who are admitted to the ED and are suspected or who have sustained a head\r injury but do not report or manifest symptoms, e.g. facial lacerations and/or\r whiplash.\r\n\r - The ED normal control group will be males and females ages 18 to 80 (the entire age\r range), who are admitted to the ED for presenting complaints that do not involve the\r head or neck (no trauma above the clavicles) and no history of Road Traffic Accident\r requiring an ED visit or TBI within the last one (1) year and no primary complaint of\r syncope.\r\n\r Exclusion Criteria:\r\n\r - Subjects will be excluded who have forehead, scalp, or skull abnormalities or other\r conditions that would prevent correct application of the electrode headset on the\r skin. In addition, subjects with dementia, Parkinson's Disease, multiple sclerosis,\r seizure disorder, brain tumours, history of brain surgery, psychiatric disorder for\r which there is a prescribed psychiatric medication taken on a daily basis, substance\r dependence, history of TIA or stroke within the last year, currently receiving\r dialysis or in end-stage renal disease, active fever defined as greater than 100\r degrees F or 37.7 degrees C, current condition is listed as \"critical\", subject is\r suffering from an open head injury, subject requires advanced airway management (i.e.\r mechanical ventilation), currently receiving procedural sedation medications (e.g.\r benzodiazepine, anaesthetic, NMDA receptor antagonist, or opioid agonist), subjects\r below the age of 18 years, pregnant women, and prisoners will not be eligible for\r study. ED normal control subjects will be excluded if there is a suspected neck injury\r or trauma above the clavicles, a primary complaint of generalized weakness, or a\r primary complaint of headache or migraine.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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932
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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-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine\n\n**Clinical Trial Summary:**\n\nChronic Migraine (CM), or 15 or more migraine headaches per month, is common in tertiary\r headache care and is associated with a number of deleterious outcomes, especially higher\r disability and poorer quality of life, relative to those with Episodic Migraine (EM) defined\r as 14 or fewer migraine headaches per month. Limited work has begun to examine factors that\r increase or decrease the risk of developing CM. One factor that appears especially relevant\r is symptomatic medication use. The current study builds upon and expands previous work\r considering the influence non-steroidal anti-inflammatory drug (NSAID) and/or triptan use has\r on the likelihood of developing CM.\r\n\r This study is a retrospective observational cohort study of data collected via mail survey\r and collated in the American Migraine Prevalence and Prevention (AMPP) database.\r\n\r Survey results from the AMPP study will be analyzed retrospectively. The AMPP is a\r longitudinal, population-based, mailed-questionnaire survey. In 2004, 120,000 United States\r (US) households were screened and 24,000 individuals who reported severe headaches were\r identified and additional questionnaires have been administered annually. This analysis uses\r data from respondents who meet second edition of the International Headache Classification-2\r (IHCD-2) criteria for EM in 2005 with follow up results in 2006, 2007, 2008, and 2009. EM is\r defined as 1 to 14 headaches per month and CM is defined as 15 or more headaches per month.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Respondents age 18 or older at the time of survey completion\r\n\r - Respondents completed the questionnaires in 2004 and at least one other year (2005,\r 2006, 2007, 2008, 2009)\r\n\r - Based on the respondents answers to the 2004 survey, their symptoms meet the criteria\r for EM which is characterized by headaches meeting International Classification of\r Headache Disorders - 2 (ICHD-2) criteria for migraine 1-14 days a month\r\n\r Exclusion Criteria:\r\n\r - Responses to questions suggest that the respondent's diagnosis is not migraine or CM\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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933
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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 Comparison of Narrow Band Imaging (NBI) and Standard White Light Laparoscopy to Detect Endometriosis\n\n**Clinical Trial Summary:**\n\nEndometriosis is a relatively common chronic gynecological condition that affects\r approximately 10% of all women of reproductive age. It is a pelvic inflammatory disease that\r is characterized by the presence of endometrial glands and stroma outside of the uterine\r cavity. Typical symptoms of endometriosis include dysmenorrhea, pelvic pain, and infertility;\r the severity of pain associated with this disease often leads to a considerable decrease in\r quality of life.\r\n\r The standard treatment for severe pelvic pain and infertility is to surgically remove\r endometriotic areas. Identifying all endometriotic lesions is paramount to \"optimal\r endometriosis debulking.\" The inability to see all endometriosis lesions has been thought to\r be a factor for patients with little or no relief following surgery. Using the Narrow Band\r Imaging (NBI) method has the potential to improve visualization of endometriosis lesions,\r assist in debulking and thus, result in improved clinical outcomes.\r\n\r NBI is a technique that uses a specific narrow wavelength of light to change the normal color\r contrasts of the endoscopic image and improve detection of neovascularization, which is the\r pathological feature of endometriosis for both superficial and deeper vascularization. This\r type of imaging has the potential to offer improved discrimination of lesions, increasing\r diagnostic yield as well as resulting in more complete debulking.\r\n\r This study is designed to determine the degree to which NBI improves the detection and\r diagnosis of endometriosis lesions. Data collected during the study will be used to test the\r hypothesis that the use of NBI will improve the detection and diagnosis of endometriotic\r lesions at the time of laparoscopy compared to standard visible white light examination.\r Furthermore, this study will also determine the impact of the use of NBI compared to use of\r white light examination on reported severity of pain at 6-weeks, 3-months, and 6 months\r following surgery.\r\n\r Hypotheses:\r\n\r The use of NBI in addition to white light examination will improve the diagnostic yield of\r endometriotic lesions at the time of laparoscopy compared to only using white light\r examination.\r\n\r The use of NBI in addition to white light examination will improve the sensitivity of\r detecting endometriotic lesions and reduce false positives at laparoscopy compared to only\r using white light examination.\r\n\r Secondarily, the use of NBI will be associated with a greater reduction in pain at the\r 6-week, 3-month, and 6-month follow-up compared to the use of white light examination alone\r because of improved lesion identification and debulking.\n\n**Clinical Trial Detailed Description:**\n\nIntroduction:\r\n\r Endometriosis is a relatively common chronic gynecological condition that affects\r approximately 10% of all women of reproductive age. It is a pelvic inflammatory disease that\r is characterized by the presence of endometrial glands and stroma outside of the uterine\r cavity. Typical symptoms of endometriosis include dysmenorrhea, pelvic pain, and infertility;\r the severity of pain associated with this disease often leads to a considerable decrease in\r quality of life.\r\n\r The standard treatment for severe pelvic pain and infertility is to surgically remove\r endometriotic areas. Identifying all endometriotic lesions is paramount to \"optimal\r endometriosis debulking.\" The inability to see all endometriosis lesions has been thought to\r be a factor for patients with little or no relief following surgery. Using the Narrow Band\r Imaging (NBI) method has the potential to improve visualization of endometriosis lesions,\r assist in debulking and thus, result in improved clinical outcomes.\r\n\r NBI is a technique that uses a specific narrow wavelength of light to change the normal color\r contrasts of the endoscopic image and improve detection of neovascularization, which is the\r pathological feature of endometriosis for both superficial and deeper vascularization. This\r type of imaging has the potential to offer improved discrimination of lesions, increasing\r diagnostic yield as well as resulting in more complete debulking.\r\n\r The results of a pilot study of 21 patients conducted at Mercy Medical Center demonstrated\r that use of NBI resulted in the diagnosis of pathologically-proven endometriosis among 4\r patients whose lesions were missed with visible white light only examination. In addition,\r the number of confirmed endometriosis lesions increased with the use of NBI in addition to\r white light. The study also suggested that NBI may assist in discriminating endometriosis\r from other lesions, thus reducing false positives: one patient had no lesions detected with\r NBI and the lesions biopsied based on visible white light examination were not endometriosis\r at pathologic examination.\r\n\r Lesion discrimination under white light examination based on lesion color has been previously\r described in the literature. Red (also known as clear and/or pink) lesions are considered to\r be active and early lesions on endometriosis. White lesions may indicate areas of fibrosis\r and may be latent or dormant lesion of endometriosis. The red and white lesions are also\r known as the \"subtle\" lesions of endometriosis. Black (also known as brown, chocolate green,\r purple or blue) represent a more severe stage of the disease. Black lesions are also known as\r \"gunshot\" or \"powder-burn\" lesions and are considered the \"typical\" lesions of endometriosis.\r Mixed color lesions can include a mixture of any color. It has been speculated that the\r subtle lesions of endometriosis are more likely to be positive lesions and to be missed under\r white light examination. The red lesions are also considered to have more vessels of smaller\r diameter and may also include peritoneal microlesions and therefore may be more easily\r detected under NBI.\r\n\r The investigators will conduct a multi-center study with the following primary aims to\r determine the degree to which NBI improves the detection and diagnosis of endometriosis\r lesions.\r\n\r 1. Determine the degree to which NBI improves the diagnosis of endometriosis (diagnostic\r yield) of laparoscopic examinations compared to use of visible white light-only\r laparoscopy.\r\n\r 2. Determine if NBI improves sensitivity in the detection of potential endometriosis\r lesions and reduces false positives compared to visible white light.\r\n\r Secondary aim:\r\n\r Determine the impact of the use of NBI, and presumed more complete removal of endometriotic\r lesions, compared to use of white light examination on reported severity of pain at 6-weeks,\r 3-months, and 6 months following surgery.\r\n\r The results of this study would significantly advance the state of art for the diagnosis and\r treatment of endometriosis. Improved detection and treatment of endometrial lesions should\r translate to a significant health benefit to women suffering from endometriosis. Potential\r health benefits include improved diagnosis of the etiology of pelvic pain, therefore guiding\r appropriate treatment management for women with pelvic pain due to endometriosis and improved\r debulking of lesions.\r\n\r The proposed study design is a multisite randomized controlled device trial conducted in two\r clinical centers. Women will be randomized to have laparoscopic examination with white light\r followed by NBI (white light/NBI) examination or white light followed by repeat white light\r examination (white light/white light). Women of reproductive age (<50 years of age)\r undergoing diagnostic laparoscopy for pelvic pain, suspected endometriosis, or infertility\r will be eligible. A systematic examination covering the four quadrants of the pelvis will be\r conducted using white light followed by either NBI or white light to identify and document\r endometriotic lesions.\r\n\r Study Aims\r\n\r Hypotheses:\r\n\r The use of NBI in addition to white light examination will improve the diagnostic yield of\r endometriotic lesions at the time of laparoscopy compared to only using white light\r examination.\r\n\r The use of NBI in addition to white light examination will improve the sensitivity of\r detecting endometriotic lesions and reduce false positives at laparoscopy compared to only\r using white light examination.\r\n\r Secondarily, the use of NBI will be associated with a greater reduction in pain at the\r 6-week, 3-month, and 6-month follow-up compared to the use of white light examination alone\r because of improved lesion identification and debulking.\r\n\r Pass/Fail Criteria for Primary Aims. In this randomized clinical trial, failure is defined as\r no statistically significant difference in the primary outcomes of diagnostic yield or\r sensitivity between the white only examination arm and the white light followed by NBI\r examination arm.\r\n\r Study Design and Methods The investigators will test the hypotheses by conducting a\r multicenter device trial. Participants will be randomized to either white light/NBI or white\r light/white light at a 3:1 ratio. In both study groups, each of the quadrants of the pelvis\r will first be examined by white light.\r\n\r Once a full exam is performed using the white light with lesion location documented with\r photographs, a randomization envelope will be opened to reveal the patient's second modality\r (NBI or white light). Each area will then be inspected by this second modality with\r photographs taken for each quadrant, documenting lesion location. All identified lesions in\r areas amenable to resection will then be resected, labeled by method of detection, and sent\r for pathologic examination.\r\n\r Study Outcomes:\r\n\r The primary outcomes are the comparison of the diagnostic yield, sensitivity, and false\r positive rate of visible white light (white light/white light) versus NBI (white light/NBI)\r based on pathology gold standard.\r\n\r Methods:\r\n\r Investigator Training:\r\n\r The investigators will be trained on the visualization of endometriosis under NBI\r\n\r - Viewing WL and NBI images of potential endometrial lesions of various types\r\n\r - The procedural use of NBI\r\n\r - Completion of study forms to ensure data integrity\r\n\r The participating surgeons and assistants from each site will be trained on the procedural\r use of NBI by Olympus and the coordinating center. A minimum of three cases of patients\r suspected to be positive for endometriosis will be watched by surgeons and coordinators from\r remaining sites. The training surgeon will perform the sweep through the quadrants of the\r pelvis. Each area will be viewed under white light. The training surgeon will ask the\r surgeons to identify suspicious areas that they would biopsy. Then the training surgeon will\r switch to NBI and once again ask the training surgeons to identify suspicious areas that they\r would biopsy. This will be done to ensure that all participating surgeons are able to\r identify suspicious areas under both imaging modalities to learn what potential endometrial\r lesions look like under NBI.\r\n\r Olympus will visit each site prior to the first procedure and train the assistant(s) on the\r completion of the study case report forms. Olympus will also monitor adherence to the\r protocol and the completion of the first study case report forms during the time of study\r start (first patient enrollment) to ensure the surgeon is performing the procedure according\r to the protocol and that the assistant is accurately capturing all of the required\r information.\r\n\r Study Population:\r\n\r The population will include women of reproductive age undergoing diagnostic laparoscopy for\r suspected endometriosis. The study population may include:\r\n\r - Patients undergoing initial diagnostic laparoscopy for pelvic pain, suspected\r endometriosis or infertility\r\n\r - Patients previously evaluated with laparoscopy undergoing repeat laparoscopy for\r suspected recurrence or onset of endometriosis\r\n\r Recruitment:\r\n\r Women will be recruited through the gynecologic practices of the participating physicians. At\r the pre-surgery visit, patients will be informed of the purpose of the study as well as the\r risks and benefits of the procedure and will be asked to sign an informed consent.\r\n\r After signing the informed consent, women will be asked to complete a baseline questionnaire\r to obtain information on demographic characteristics, medication history, and symptoms. A\r 10-centimeter (cm) visual analog scale and a validated endometriosis symptom questionnaire\r [the Endometriosis Health Profile-30 (EHP-30)] will also be administered to assess pain. The\r EHP-30 is an instrument specifically designed to measure pain and quality of life among women\r diagnosed with endometriosis. The EHP-30 consists of a core questionnaire with 30 items and\r five scales and six modular parts consisting of 23 questions. The EHP-30 has demonstrated\r both high reliability and validity.\r\n\r Equipment:\r\n\r - OLYMPUS HD EndoEYE Video Telescope (Models WA50011A, WA50013A, WA50013L, WA50013T,\r WA50015L) or OLYMPUS HD EndoEYE Laparo-Thoraco Videoscope LTF-VHOLYMPUS CLV-180 EVIS\r EXERA II Xenon Light Source OLYMPUS CV-180 EVIS EXERA II Video System Center OLYMPUS HD\r LCD Surgical Monitor\r\n\r - SONY HD recorder PDW-70MD\r\n\r - Printers OEP-4\r\n\r Examination Procedures:\r\n\r The laparoscopic examination will be conducted in a standardized fashion with visible white\r light (standard), followed by an additional sweep with either white light (control) or NBI.\r The second look examination will be determined by random assignment after completion of the\r first examination with white light.\r\n\r The examination will include visualizing each quadrant of the pelvis (Right Anterior, Right\r Posterior, Left Posterior, Left Anterior).\r\n\r Each area will first be viewed and photographed under white light. The absence or presence of\r suspected endometrial lesions will be noted. If suspected lesions are seen, the number of\r lesions, the extent of the lesions and the surgeon's confidence in the lesion being\r endometriosis will be recorded. Photographs will be labeled by quadrant and all lesions will\r be circled and numbered. Clinicians will record their degree of confidence on a 5 point\r likert scale that the lesion to be excised is a lesion of endometriosis.\r\n\r Following visualization, photographic identification and documentation of the quadrants under\r white light has been completed, the study coordinator will open the randomization envelope\r and reveal the second modality to be used. The physician will then repeat the exam and\r photographs with either white light (control) or under NBI (switching on NBI).\r\n\r Again, under the second modality, the absence or presence of suspected endometrial lesions\r will be noted. If suspected lesions are seen, the number of lesions, the extent of the\r lesions, the lesion color and the surgeon's confidence in the lesion being endometriosis will\r be recorded. A photograph will be taken, labeled and all lesions will be circled and\r numbered. Clinicians will record their degree of confidence on a 5 point likert scale that\r the lesion to be excised is a lesion of endometriosis. The surgeon will record if the lesion\r was also visualized under the 1st imaging modality or under only one of the modalities.\r\n\r The order at which the areas are examined through the sweep will be at the surgeon's\r discretion. Examination by both sweeps will be photographed. Photos of all areas and detected\r lesions will be printed, labeled and lesions will be circled and numbered.\r\n\r All suspected endometrial lesions will be included in the analysis, even lesions that may be\r latent or healed (otherwise known as white lesions).\r\n\r Once both exams are complete, additional areas of the abdomen can be evaluated at the\r surgeon's discretion; those randomized to white light only will continue with only white\r light examination.\r\n\r All lesions detected by either method that are amenable to resection will be numbered and\r biopsied. Data collected will include location, method of detection and clinical diagnosis\r confidence score. Pathologists will be masked to method of detection (NBI versus white\r light).\r\n\r Lesions will be recorded according as falling within three categories: visible white\r light-detected only; NBI-detected only; or both NBI- and visible white light-detected.\r Pathology will be performed at each center following a standardized protocol for the\r diagnosis of endometriosis. Pathologists at each institution will be masked to the method of\r examination used to identify the specimen. All discordant lesions (visualized under only one\r imaging modality), a random 10% sample of specimens and a random 10% of images from each\r center will be re-reviewed by a central independent reviewer at the coordinating center.\r\n\r Lesions that are not amendable to resection will be photographed only and will not be\r included in the data analysis.\r\n\r Data Collection:\r\n\r 1. Patient baseline questionnaire: symptoms, medication history, demographic information,\r pain measurement (including 10-cm visual analog scale and EHP-30)\r\n\r 2. Photo documentation of each light examination\r\n\r 3. Case report forms:\r\n\r - Recording of location of lesion by method of examination\r\n\r - Notation of lesion color\r\n\r - Clinical impression of detected lesions - degree of confidence on a scale of 1 to 5\r that the lesions observed are endometriosis\r\n\r - Notation of lesions excised\r\n\r - Photographic documentation of lesions\r\n\r - Change in surgical treatment (larger excision/smaller excision/organ removal) based\r on results of visualization under the different imaging modalities.\r\n\r 4. Pathology reports\r\n\r 5. Medical record review\r\n\r 6. Provider questionnaire: planned follow-up treatment after surgery\r\n\r 7. Follow-up questionnaires for pain at 6-weeks, 3-months and 6-months; follow-up surveys\r will include both the 10-cm visual analog scale and the EHP-30\r\n\r Quality Control:\r\n\r Quality control will be maintained by standardizing the protocols across the centers. As\r stated above, in each patient, the locations of all lesions suspected to be endometriosis\r detected with each modality will be documented with photographs. All discordant lesions (seen\r under only one imaging modality) and a random 10% sample of the images and specimen samples\r from each center will be re-reviewed by a central independent reviewer at the coordinating\r center. The results between the site physician and the central reviewer will be compared. If\r the site and central reviewer have disagreement on the photographed lesion or pathology,\r adjudication will be performed between the site and the central reviewer. If a consensus\r still cannot be reached, a third party (surgeon and/or pathologist (from the remaining site)\r will be used as the tie breaker.\r\n\r Randomization Procedure Subjects will be assigned to one of two groups in a stratified\r randomized design. All subjects will undergo a white light examination followed by either a\r second examination with white light or an examination using NBI. Investigators will be\r blinded to second look imaging method until after the initial white light examination is\r complete. Randomization to either white light/NBI or white light/white light will occur at a\r 3:1 ratio. Each site is treated as independent and subjects will be combined across sites for\r analyses.\r\n\r A randomization table will be generated using Microsoft Excel at the beginning of study\r recruitment. The randomization number will be a three digit number and will form the last 3\r digits of the study ID. Sealed envelopes will be provided to each site by the coordinating\r center to be opened after the initial white light examination.\r\n\r Sample size\r\n\r Sample size in the original protocol for this study was calculated as described in section\r 12.1 below. Because data from a third site of this multicenter trial (Atlanta Northside) will\r not be used, the total sample size goal (N = 170) in the original protocol will not be\r reached. Mercy was approved by the IRB in September 2012 to enroll 100 patients total; the\r Chicago site is approved to enroll 57 patients. Thus, the total sample size goal has been\r revised to 157; minimal detectable differences under the conditions of 90% power are\r described in section 12.2 below.\r\n\r Sample size calculations from original protocol, dated 5/14/2010\r\n\r Sample size calculations were based on the primary outcomes of diagnostic yield and\r sensitivity as well as the secondary outcome of impact on pain symptoms. The sample size is\r largely driven by the primary outcome of diagnostic yield. A sample size of 170 will provide\r 90% power to detect an improvement in diagnostic yield of 20% (95% CIs 72%-85% white light\r and 95%-100% NBI), based on a randomization scheme of 3:1 for white light/NBI versus white\r light/white light examination. This sample size takes into consideration a 25% drop out/not\r evaluable rate for the following reasons: incomplete visualization of the pelvis, loss to\r follow-up for pain assessment or patients not evaluable for pain assessment (a subset of\r infertility patient who may not have pain as a presenting symptom).\r\n\r This sample size provides 90% power to detect an average increase of one additional\r endometriosis lesion with the NBI examination (white light/NBI group) compared to white light\r only examination (white light/white light group). To note, this power calculation was based\r on data from the pilot study that showed an average of 2 lesions (per patient) found using\r white light and 3 lesions (per patient) detected using NBI; the calculation assumes a common\r standard deviation of 1.\r\n\r Data used for sample size calculations:\r\n\r Diagnostic yield: The calculations for sample size were based on information obtained from a\r pilot study that examined patients using white light followed by NBI during diagnostic\r laparoscopy. In that study, 4 additional patients were diagnosed with endometriosis with the\r addition of NBI to white light examination for an absolute improvement of 27% (4/15 patients\r with endometriosis were found with NBI examination only) (Barrueto and Audlin, 2008). Using\r these data, sample size calculations were conducted using nQuery 6.01 (Elashoff, 2005) for a\r two group chi-square test with unequal Ns (3:1 ratio). A two group chi-square test with a\r 0.05 two-sided significance level will have 90% power to detect the difference between a\r Group 1 (white light/white light) diagnostic yield of 0.79 and a Group 2 (white light/NBI)\r diagnostic yield of 0.99 when the sample sizes in each group are 34 and 101, respectively (a\r total sample size of 135).\r\n\r Sensitivity and false positive rate:\r\n\r In the pilot study, 15 of 20 patients examined were diagnosed with endometriosis on\r histology. All 15 patients were detected with NBI and white light. Four patients were\r diagnosed by lesions that were detected only with NBI. Based on these data, the estimated\r sensitivities of white light and NBI are 73% and 100% respectively. Given these sensitivities\r and the small total sample size, 95% confidence intervals are wide (48%-90% white light and\r 80%-100% NBI). At the lesion level, pilot data have shown an average of 2 lesions seen under\r white light compared to an average of 3 lesions using NBI. Using a common standard deviation\r of 1, the current sample size has at least 90% power to detect an average difference of at\r least one additional lesion.\r\n\r Pain difference:\r\n\r The study will also consider pain reduction as a clinically relevant outcome. A recently\r published study by Abbott et al (2003) reported that participants undergoing laparoscopy for\r potential endometriosis on average rated non-menstrual pelvic pain prior to surgery as 6 on a\r 10-point visual analogue scale, with 10 being the worst pain. In the Abbott et al (2003) and\r other similar studies, laparoscopic surgery using white light was shown to be associated with\r a 30% reduction in pain at 6 month follow up and 50%-75% at 12 month follow up with\r increasing variance (Abbott et al., 2004, Jarrell et al., 2005). An RCT from Jarrell et al.\r (2005) showed a reduction in pain score of 1.9 (SD 0.5) at 6 month follow up and 2.6 (SD 0.5)\r at 12 month follow up, although the sample size of this study was small (N=16 overall, N=7\r for laparoscopy arm). This study will test the hypothesis that NBI will result in an\r additional 20% decrease in pain compared to what has been observed in these previously\r published studies examining the reduction in pain using white light laparoscopy.\r\n\r Using the unbalanced randomization design with 1 patient randomized to white light/white\r light for every 3 patients randomized to white light/NBI , a two group t-test with a 0.050\r two-sided significance level will have 90% power to detect the difference in pain change with\r a Group 1 (white light/white light) mean change of 1.9 and a Group 2 (white light/NBI) mean\r of 2.28, a difference in means of 0.38 with a common SD of 0.5, when the sample sizes in the\r two groups are 25 and 75, respectively (a total sample size of 100). We project that the\r majority of patients enrolled (over 70%) will be symptomatic with pelvic pain despite the\r indication for surgery (i.e. pelvic pain or infertility). Only 1 of the 2 study center sites\r has a significant population of women undergoing laparoscopy for evaluation and treatment of\r infertility.\r\n\r Amended sample size The sample size of the study has been adjusted downward to 157 due to the\r loss of one of the study centers for accrual. The revised sample size considers the outcomes\r of diagnostic yield and sensitivity of clinical determination of identified lesions at the\r time of surgery, by modality. A review of the first 69 patients enrolled and assigned to the\r combined white light/NBI arm shows an average detection rate for any lesion to be 4.2 per\r patient using NBI versus 2.9 per patient with white light. The minimal detectable difference\r in diagnostic yield and sensitivity was determined using nQuery 6.01 (Elashoff, 2005). With\r the current projected sample size of 157 patients, the minimal detectable difference between\r the two modalities, with 90% power, in diagnostic yield proportions and sensitivity estimates\r is 12.2%. Thus, the power of the study remains sufficient to detect a clinically meaningful\r difference in detection of endometriosis by white light and NBI.\r\n\r Data Analysis The investigators hypothesize that NBI will improve detection of endometriosis\r lesions thus improving the diagnosis of endometriosis. For the primary outcome of diagnostic\r yield, the reference standard will be the pathologic confirmation of excised lesions where\r any one lesion within an individual detected by either method will confirm the diagnosis of\r endometriosis. The investigators will address the detection of endometriosis by comparing the\r diagnostic yield of the white light/white light group versus the white light/NBI group. The\r investigators will use a McNemar's test for the proportion comparison, which accounts for the\r pairing of assessment within a participant and makes no assumptions about the distribution of\r samples. At the lesion level, the investigators will assess the average change in the number\r of lesions detected between the white light/white light group to the white light/NBI group\r using independent samples t-test. The investigators will also calculate and compare the\r sensitivities and false positive rates for the white light/white light group and the white\r light/NBI group. Pain across the study period will be assessed by comparing average change in\r pain score (using both the VAS and the EHP-30 scores) between the two groups. The difference\r in average pain change scores will be assessed using an independent samples t-test.\r Differences in average pain between baseline and follow-up will be assessed using paired\r t-tests.\r\n\r Data Management A copy of the consent form will be sent to the Data Coordinating Center\r (DCC). Report forms will be sent by fax or electronically (secured/encrypted) to the DCC data\r entry. The data will be checked for consistency by using selected double entry where 1/10th\r of the entered data will be re-entered and checked for errors. Data cleaning procedures will\r be done using SAS with extensive program files to ensure the correctness of skip patterns and\r responses. After baseline information is collected and entered, an analysis will be done to\r confirm comparable baseline characteristics across the two groups.\r\n\r Confidentiality:\r\n\r Hard copies of questionnaires and interview records will be locked in file cabinet with\r limited keyed access to research personnel. Computer data files are also kept on the Mercy\r Medical Center Intranet in a password protected file that is accessible only by research\r staff.\r\n\r Any results from this study will be published using data from the group as a whole. No\r individual will be identified in any reports.\r\n\r Risks/Benefits Assessment\r\n\r Risks/Discomforts:\r\n\r White light examination is the current standard of care. NBI itself does not incur any\r additional risk. However, the use of NBI may result in the identification of additional\r lesions and thus incur the risk of additional resection at the time of laparoscopy.\r Additional sites identified for biopsy using NBI have no additional risks for removal as\r compared to white light. Lesions identified which are associated with higher risk structures\r such as the bowel and the diaphragm will not be removed.\r\n\r Benefits:\r\n\r It is uncertain to what extent participants may benefit clinically and this will be clearly\r stated in the consent form. If diagnosis of endometriosis is improved, then patients may\r benefit from improved medical management. If additional lesions are identified and resected,\r patients may benefit from an improved clinical outcome.\r\n\r Withdrawal from protocol All participants are informed that taking part in this study is\r completely voluntary and they have the right to not participate. If they do not want to join\r the study, or if they wish to withdraw from the study, they will still receive the same\r quality of medical care.\r\n\r Modifications to the Protocol Any modifications to the protocol will be sent to the IRB for\r approval.\r\n\r Protocol Deviations The IRB (and other review boards as required for this study) will be\r notified of any protocol deviations.\r\n\r Reporting of Serious Adverse Events and Unanticipated Problems The protocol has minimal\r additional risks beyond the usual risks associated with diagnostic laparoscopy. Should any\r unanticipated problems develop, the investigators will attend to/address the problem and\r notify institutional IRBs and the sponsor.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Women 18 years of age or older\r\n\r - Women of reproductive age (less than 50 years) undergoing diagnostic laparoscopy for\r suspected endometriosis.\r\n\r - Willingness to provide informed consent\r\n\r Exclusion Criteria:\r\n\r - Pregnancy\r\n\r - General health issues that the physician determines would make laparoscopy unsafe.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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934
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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 the Penumbra Coil 400 System to Treat Aneurysm\n\n**Clinical Trial Summary:**\n\nThis is a prospective, multi-center study of patients with intracranial or peripheral\r aneurysms who are treated by the PC 400 System. The primary objective is to gather post\r market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial\r and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral\r aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each\r patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long\r term follow-up to one year will be conducted in accordance to the standard of care at each\r participating hospital.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Patients enrolled in this study must be those treated according to the cleared indication\r for the PC 400 System which is for the endovascular embolization of:\r\n\r - Intracranial aneurysms\r\n\r - Other neurovascular abnormalities such as arteriovenous malformations and\r arteriovenous fistulae\r\n\r - Arterial and venous embolizations in the peripheral vasculature\r\n\r Exclusion Criteria:\r\n\r - Patients in whom endovascular embolization therapies other than Penumbra Coils are\r used will be excluded from this study. However, adjunctive use of balloon and stent\r are acceptable.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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935
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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\nRelation of Glucose and Acute Pancreatitis\n\n**Clinical Trial Summary:**\n\nAcute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a\r systemic inflammatory response syndrome with significant morbidity and mortality in 20% of\r patients. Part of endocrine function of pancreas would be affected in AP. Stress\r hyperglycemia would explode at acute phase. So the investigators decide to follow up and\r observe 200 cases of patients with acute pancreatitis, determining of blood sugar, blood\r amylase, hemoglobin and glycosylated hemoglobin level. At last, using ROC curve method to\r identify the die cutting between blood glucose level and acute pancreatitis, and makes\r analysis of the diagnostic value.\n\n**Clinical Trial Detailed Description:**\n\nAcute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a\r systemic inflammatory response syndrome with significant morbidity and mortality in 20% of\r patients. Part of endocrine function of pancreas would be affected in AP. Stress\r hyperglycemia would explode at acute phase. There are two reasons. One is because that\r sympathetic hyperactivity makes glucagon elevated. Secondary, microcirculation disorder makes\r pancreas edema, ischemia and necrosis, affecting secretion and excretion of insulin. In\r severe acute pancreatitis, there may be ketoacidosis. Many scoring systems for predicting\r prognosis of severe acute pancreatitis also contains glucose values, such as the Ranson\r scoring system and the Glascow scoring system. On the other hand, Type 2 diabetes has become\r a global pandemic disease. Most of patients of type 2 diabetes are obese, who easily\r complicated gallstone disease and hypertriglyceridemia. All of above could be the risk\r factors for acute pancreatitis. Our initial small sample research also suggests undiagnosed\r diabetes patients whose glucose value elevated is significantly worse than the known diabetic\r patients. Therefore, the investigators believe that glucose directly affects the prognosis of\r AP. So the investigators decide to follow up and observe 1000 cases of patients with acute\r pancreatitis, determining of blood sugar, blood amylase, hemoglobin and glycosylated\r hemoglobin level. At last, using ROC curve method to identify the die cutting between blood\r glucose level and acute pancreatitis, and makes analysis of the diagnostic value.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r patients that newly diagnosed as acute pancreatitis.\r\n\r Exclusion Criteria:\r\n\r exclude other acute abdomen, such as peptic ulcer with perforation, mesenteric arterial\r embolism or ruptured ectopic pregnancy.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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936
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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\nMRA/fMRI Study of Spontaneous Migraine\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to examine migraineurs during spontaneous migraine attacks\r without aura, using high resolution magnetic resonance imaging (MRI), to study following:\r\n\r - Changes in resting state blood-oxygenation-level-dependent-signal (BOLD-signal) using\r functional MRI (fMRI).\r\n\r - Changes in circumferences of intra- and extracranial arteries using MR-angiography\r (MRA).\r\n\r - Changes in regional and global cerebral blood flow (CBF) using the arterial spin\r labeling (ASL) method.\r\n\r Moreover to perform diffusion tensor imaging (DTI) scans during spontaneous migraine attacks.\r\n\r The migraine specific drug sumatriptan will be given to relieve pain and the effect will be\r registered using MRA and fMRI if possible.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Migraine without aura according to IHS criteria.\r\n\r Exclusion Criteria:\r\n\r - Other primary headaches.\r\n\r - Tension-type headache more than 5 days/month.\r\n\r - Use of anti-pain medication before the scanning on the examination day.\r\n\r - Pregnant or nursing women.\r\n\r - Contraindication for MR scan.\r\n\r - Anamnestic or clinical signs of cardiovascular or cerebrovascular disease, unregulated\r psychiatric disease or drug misuse.\r\n\r - Other clinical conditions assessed by the examining doctor.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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937
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Natural History of Procalcitonin in Hemorrhagic Stroke\n\n**Clinical Trial Summary:**\n\nApproximately 12% of strokes in the United States are hemorrhagic.1 Hemorrhagic stroke can\r lead to multiple complications including fever that is not infectious. Identifying the cause\r of fever can help physicians choose the best care for the patient to try and prevent further\r damage to the already injured brain. Bacterial infection is one possible cause of fever in\r the stroke patient; however an incorrect diagnosis of infection can lead to unnecessary\r antibiotic use. Better screening tools for infection are being developed to help fight the\r problem of antibiotic resistance and unnecessary antibiotic use. Unnecessary use of\r antibiotics in patients increases the risk of adverse events and overall healthcare costs.\r Procalcitonin (PCT) is one such screening tool which has been used previously to help tell\r apart bacterial and nonbacterial causes of infection in other disease states; however, PCT\r has not been studied in hemorrhagic stroke patients. The purpose of this study is to\r understand the progress of PCT in hemorrhagic stroke patients in order to see whether PCT can\r be a useful marker for infection in these patients.\n\n**Clinical Trial Detailed Description:**\n\nStroke is the second leading killer worldwide and the third leading cause of death in the\r United States. The two major mechanisms causing brain damage in stroke are, ischemia and\r hemorrhage. Several complications can arise from these cerebral insults ranging from minor\r neurologic dysfunction, complete immobility, or death. In the intensive care setting,\r clinicians combat the pathophysiologic processes that lead to the aforementioned sequelae of\r stroke and contest other acute issues which may or may not be secondary to the stroke itself,\r with one such issue being hyperthermia. Hyperthermia is defined by the Society of Critical\r Care Medicine as a temperature greater than 38.3°C. In one prospective study, hyperthermia\r was reported to occur in 43% of patients during the first week of hospitalization following\r an ischemic or hemorrhagic (excluding subarachnoid hemorrhage) stroke. Hyperthermia in the\r stroke patient can be detrimental leading to increased infarct size and worsened neurological\r outcomes. The etiology of the hyperthermia may not be clear upon initial evaluation but\r cessation of fever is essential to prevent further damage.\r\n\r One possible cause of hyperthermia in the stroke patient is bacterial infection. Infection\r complicating cerebral insult can lead to poor functional outcome and increased mortality.\r Kilpatrick and colleagues found that fever occurred in 47% of patients who were admitted with\r either a traumatic or ischemic brain injury and 70% of these patients received at least one\r antibiotic within 24 hours of their febrile episode, however the antibiotics had no effect on\r controlling the fevers. With bacterial resistance ever increasing, it is vital that\r clinicians reserve antibiotics for patients in whom the source of fever is believed to be\r secondary to an infectious process. It has been estimated that the United States health care\r system spends more than $20 billion annually on antibiotic-resistant infections and these\r infections result in more than eight million additional hospital days. Antibiotic use across\r health care disciplines has been estimated to be administered either inappropriately or\r unnecessarily 50% of the time. Considering clinical symptoms of infection can mirror other\r disease processes, reliable diagnostic biomarkers would be useful in helping determine the\r appropriate diagnosis.\r\n\r PCT is a 116 amino acid peptide with a sequence identical to calcitonin but lacking hormonal\r activity. PCT was first utilized by Assicot et al in the setting of sepsis to help determine\r whether the inflammatory response from the patient was secondary to bacterial infection.\r Since this finding, PCT has been shown in several studies to have a high sensitivity and\r specificity for indicating systemic bacterial infections. During infection PCT is secreted\r into the bloodstream without increasing calcitonin. PCT has been shown prospectively to only\r be elevated in patients with bacterial infections while remaining consistently low in\r patients infected with viruses or other inflammatory processes. Often when insulted, the body\r utilizes proteins and metabolic products, and the changes noted in these substances are often\r used as markers of inflammation. Unlike erythryocyte sedimentation rate (ESR) and C-reactive\r protein (CRP), PCT remains low during these inflammatory states. Furthermore, it has been\r shown that PCT levels increase earlier after stimulation (3-6hrs) compared to C-reactive\r protein (12-24hrs), indicating PCT can be utilized to rapidly detect bacterial infections.\r Normal PCT levels in adults are less than 0.1 ng/mL while PCT values greater than 0.5ng/mL\r have been determined to be predictive of bacterial infection. PCT has been evaluated in\r several clinical scenarios to help determine a bacterial versus a non-bacterial source of\r infection, however, to our knowledge, the effects of hemorrhagic stroke on PCT are not yet\r known. Determining the natural history of PCT in a hemorrhagic stroke patient would provide\r beneficial information as to whether PCT can be used as a biomarker in this population to\r help differentiate a bacterial from a non-bacterial cause of hyperthermia.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Hospitalization for an admitting diagnosis of hemorrhagic stroke admitted to the\r neurosurgical intensive care unit\r\n\r - Age greater than 18 years\r\n\r - No evidence of ischemic cerebrovascular injury\r\n\r Exclusion Criteria:\r\n\r - Concomitant traumatic brain injury\r\n\r - Antibiotics on admission to the NICU\r\n\r - Immunocompromised by chemotherapy or HIV positive or patient with neutropenia (ANC\r <1000)\r\n\r - Women who are pregnant and/or of childbearing age where a pregnancy test has not\r already occurred\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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938
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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\nMagnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE)\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the effectiveness of magnesium oxide supplements on\r the reversal of calcium deposits in the skin, and the yellow bumps and folds of skin in\r subjects with pseudoxanthoma elasticum (PXE). Magnesium oxide is a dietary supplement that\r has been shown in some research to reduce these calcium deposits. This study consists of two\r parts. The first part is a year-long, double-blind, placebo-controlled study. Part two is an\r open-label, year-long study. In Part 1, qualified subjects will be randomized to receive\r either magnesium oxide supplements or placebo, in a 1:1 ratio for the first 12 months. The\r starting dose will be 1000 mg daily, and depending on tolerability, doses may be decreased.\r Baseline evaluations will be comprised of: blood tests; clinical evaluations; skin biopsy;\r eye examination; bone density test; and photography of skin lesions. Subjects will be\r evaluated at week 2, week 6, month 3, and then every 3 months during the first year. Upon\r completion of the first year, barring any safety concerns, all subjects will be administered\r magnesium oxide supplements for up to one additional year. Subjects will undergo the same\r evaluations/ procedures every 3 months. We hypothesize that the magnesium oxide will cause a\r reduction in calcifications in the subject's soft tissue/skin. Funding Source - FDA OOPD.\n\n**Clinical Trial Detailed Description:**\n\nPseudoxanthoma elasticum (PXE) is a systemic connective tissue disorder involving elastic\r fiber calcification and fragmentation with major clinical manifestations occurring in the\r cutaneous, ocular and cardiovascular systems.\r\n\r Calcification of the elastic fibers leads to cracks in Bruch's membrane, an elastic\r tissue-containing membrane that separates the vascular choroid from the retinal pigment\r epithelium. These are known as angioid streaks and may be the only sign of the disease for\r years. Retinal hemorrhage and loss of vision are common. Calcification of the internal\r elastic lamina of arteries results in gastrointestinal bleeding, sometimes fatal in nature.\r Accelerated heart disease is an additional complication.\r\n\r Cutaneous manifestations are characterized by the presence of yellow papules in a cobblestone\r pattern or plaques resembling \"plucked chicken-skin\" in flexural regions. Redundant folds of\r skin may develop in more advanced cases. The most frequent sites of cutaneous involvement\r include the neck, axillae, inguinal region, antecubital and popliteal fossae and the\r periumbilical area. Skin lesions provide an easy way of grading degree of calcification of\r elastic tissue.\r\n\r A clinical study of 80 subjects with a variety of cutaneous soft tissue mineralization\r disorders had the affected areas injected locally with magnesium sulfate while also receiving\r oral magnesium lactate for 4 to 6 months. About 75% of these subjects showed a significant\r decrease or complete disappearance of calcification.\r\n\r More recently, a knockout mouse model for PXE has linked a reversal in calcification to a\r diet high in magnesium. Mice were placed on diets that were either high or low in phosphate,\r high or low in magnesium, or on a controlled diet. The mice placed on the high magnesium diet\r did not show any evidence of connective tissue mineralization, while those on the other diets\r did show mineralization as characterized by calcification of the connective tissue capsule\r surrounding the vibrissae.\r\n\r Based on this information and the research linking increased magnesium levels to decreased\r calcification, we plan to supplement the diets of PXE patients with magnesium oxide in order\r to show a reduction in elastic fiber calcification in the skin and to slow the progression of\r the disease.\r\n\r Randomized subjects will be instructed to take study drug (active or placebo) for 12 months,\r then all subjects will receive active study drug for the following 12 months.\r\n\r When ingested through foods, magnesium has not demonstrated any adverse effects. When\r obtained through supplements, however, excessive magnesium intake has been known to result in\r diarrhea as well as other gastrointestinal effects such as nausea, and abdominal cramping.\r Large pharmacological doses of magnesium have been associated with more serious side effects,\r such as metabolic alkalosis and hypokalemia with the repeated daily ingestion of 30g of\r magnesium oxide. Hypermagnesemia may result with excessive magnesium supplement ingestion,\r however, it has rarely been reported in individuals with normal renal function.\r\n\r Study data will be analyzed using the Wilcoxon Rank Sum Test to compare changes in physician\r global assessment of skin lesions, evaluation of target lesions and assessment of biopsies\r between treatment and placebo groups. Assuming a negligible placebo response, we believe\r power analyses can be performed on our primary measure in 40 completed subjects as proposed\r in this study. Analyses will be based on intent-to-treat, with the last observation carried\r forward. Patients who withdraw for safety, lack of efficacy, and generally those without\r other documentation will in the absence of the requested 'final-visit evaluation' be assigned\r the highest (worst) score. A finding of significance based on the intent-to-treat analysis\r would be supplemented with an analysis of patients completing the trial without any protocol\r deviations.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or female subject at least 18 years of age\r\n\r - If female, the subject is not pregnant or nursing\r\n\r - If female of child bearing potential, the subject has a negative urine pregnancy test\r at the first visit, and agrees to use an approved method of contraception (hormonal\r contraceptives [birth control pills, implants [Norplant] or injections [DepoProvera]);\r intrauterine device (IUD); two forms of barrier methods [condoms and diaphragm]; or\r abstinence (no sexual activity) throughout the entire study\r\n\r - Biopsy confirmed diagnosis of pseudoxanthoma elasticum (documenting some calcification\r of elastic fibers)\r\n\r - Subject has a clinical disease severity grade of at least \"1\" (Poorly defined, barely\r visible macules) at screening.\r\n\r - Normal kidney function tests\r\n\r Exclusion Criteria:\r\n\r - Any subject who is pregnant or becomes pregnant during the study\r\n\r - Subjects with a serum creatinine greater than 1.6 mg/dL\r\n\r - Subjects with hypermagnesemia, hypokalemia, or idiopathic hypercalciuria\r\n\r - Subjects with kidney disease or renal tubular defects (eg. Fanconi's syndrome), or on\r dialysis\r\n\r - Subjects with hypothyroidism or hypoparathyroidism or primary hyperparathyroidism\r\n\r - Subjects with acute gout\r\n\r - Subjects with malabsorption, or osteomalacia\r\n\r - Subjects on diuretics, magnesium containing antacids, or anabolic steroids\r\n\r - Subjects with Cushing's syndrome\r\n\r - Subjects receiving lithium and those with significant psychiatric disorders that would\r likely interfere with participation in this study\r\n\r - Subjects taking anti-seizures medications and anti-arrhythmics medications\r\n\r - Subjects on tetracycline or metronidazole and ace inhibitors\r\n\r - Subjects taking cyclosporine or calcineurin inhibitors\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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939
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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-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine\n\n**Clinical Trial Summary:**\n\nThe purpose of this pilot study is to assess feasibility and clarify the design of future\r study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or\r prevention of migraine symptoms.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Is between the ages of 18 and 55 years.\r\n\r - Has been previously diagnosed as suffering from migraine, in accordance with the\r ICHD-2 Classification criteria (2nd), with or without aura.\r\n\r - Experiences at least 2 migraines per month, but less than 15 headache days per month\r (over the last 3 months).\r\n\r - Has age of onset of migraine less than 50 years old.\r\n\r - Is able to give written Informed Consent\r\n\r Exclusion Criteria:\r\n\r - Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head\r trauma.\r\n\r - Has a lesion (including lymphadenopathy) at the GammaCore™ treatment site.\r\n\r - Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid\r artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF),\r coronary artery disease or recent myocardial infarction.\r\n\r - Has a history or baseline ECG that identifies the presence of a clinically significant\r unstable cardiac arrhythmia, second degree heart block type II, history of ventricular\r tachycardia or ventricular fibrillation, or known cardiac syndromes that may be\r associated with increased risk of sudden death in otherwise healthy people.\r\n\r - Has had a previous bilateral or right cervical vagotomy.\r\n\r - Has a clinically significant irregular heart rate or rhythm.\r\n\r - Has uncontrolled high blood pressure.\r\n\r - Is currently implanted with an electrical and/or neurostimulator device, including but\r not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal\r stimulator, bone growth stimulator, or cochlear implant.\r\n\r - Has a history of carotid endarterectomy or vascular neck surgery on the right side.\r\n\r - Has been implanted with metal cervical spine hardware or has a metallic implant near\r the GammaCore™ stimulation site.\r\n\r - Has a recent or repeated history of syncope.\r\n\r - Has a recent or repeated history of seizure.\r\n\r - Has a history or suspicion of narcotic abuse.\r\n\r - Takes medication for acute headaches more than 10 days per month.\r\n\r - Is pregnant, nursing, thinking of becoming pregnant in the next 3 months, or of\r childbearing years and is unwilling to use an accepted form of birth control.\r\n\r - Is participating in any other therapeutic clinical investigation or has participated\r in a clinical trial in the preceding 30 days.\r\n\r - Belongs to a vulnerable population or has any condition such that his or her ability\r to provide informed consent, comply with follow-up requirements, or provide\r self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner).\r\n\r - Is a relative of or an employee of the investigator or the clinical study site.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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940
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAssessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology\n\n**Clinical Trial Summary:**\n\nThe objectives of the study are to document device performance with respect to the primary\r and secondary endpoints.\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of the current study is proposed to prospectively validate the BrainScope Ahead®\r M-100 device design, performance, and labeling with respect to the device's target intended\r use and indications for use:\r\n\r - Primary Endpoint:\r\n\r - Structural Injury Assessment\r\n\r - There are four co-primary endpoints in this study: two sets of sensitivity and\r specificity to divide the data into three classes.\r\n\r - Using a BrainScope classification algorithm, the Ahead® M100 will identify subjects\r showing sensitivities among 3 classes: Green-normal, nonhead injured\r controls,Yellow-head injured subjects who do not exhibit brain electrical activity\r that is consistent with a structural brain injury observable on CT or for whom CT\r was not deemed necessary,Red-head injured subjects who exhibit brain electrical\r activity consistent with a structural brain injury observable by CT.\r\n\r - Secondary Endpoint:\r\n\r - Functional Injury Assessment\r\n\r - There are two co-secondary endpoints for the secondary objective, the sensitivity\r and specificity to split Yellow from the primary endpoint into two sub groups\r depending on degree of brain functional impairment observable by an evaluation of\r the clinical findings on a clinical charter used as the assessment of truth.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Males and females ages 18 to 80 (the entire age range), who are admitted to the\r Emergency Department (ED), who are suspected of a traumatically induced structural\r brain injury and/or clinical manifestations of functional brain injury, as a result of\r insult to the head from an external force, e.g., the head being struck by an object,\r the head striking an object, the head being exposed to forces generated from a blast\r or explosion, and/or the brain undergoing an acceleration/deceleration movement\r without direct external trauma to the head with a Glasgow Coma Scale of > 8.\r\n\r - The acute, suspected traumatically induced structural brain injury and/or\r clinical manifestations of functional brain injury will have occurred within the\r past 24 hours upon admission to the ED.\r\n\r - The ED normal control group will be males and females ages 18 to 80 (the entire age\r range), who are admitted to the ED for presenting complaints that do not involve the\r head or neck (no trauma above the clavicles) and no history of MVA requiring an ED\r visit or TBI within the past one (1) year, and no primary complaint of syncope\r\n\r Exclusion Criteria:\r\n\r - Subjects will be excluded who have forehead, scalp, or skull abnormalities or other\r conditions that would prevent correct application of the electrode headset on the\r skin.\r\n\r - In addition, subjects with dementia, Parkinson's Disease, multiple sclerosis, seizure\r disorder, brain tumors, history of brain surgery, mentally retarded, psychiatric\r disorder for which there is a prescribed psychiatric medication taken on a daily\r basis, substance dependence, history of TIA or stroke within the last year, currently\r receiving dialysis or in end-stage renal disease, active fever defined as greater than\r 100oF or 37.7oC, current condition is listed as \"critical\" in the opinion of the\r investigator, subject is suffering from an open head injury, subject requires advanced\r airway management (i.e. mechanical ventilation), currently receiving procedural\r sedation medications (e.g. benzodiazepine, anesthetic, NMDA receptor antagonist, or\r opioid agonist), subjects below the age of 18 years, pregnant women, and prisoners\r will not be eligible for study.\r\n\r - ED normal control subjects will be excluded if there is a suspected neck injury or\r trauma above the clavicles, a primary complaint of generalized weakness, or a primary\r complaint of headache or migraine\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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941
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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\nNeurovascular Non Contrast-Enhanced MR Angiography at 3T\n\n**Clinical Trial Summary:**\n\nMR angiography (MRA) has become essential in the treatment of neurovascular diseases,\r including ischemic stroke - the first cause of disability in occidental countries, vascular\r malformations such as aneurysms, arteriovenous fistulas and malformations, whose treatments\r are improving year after year.\r\n\r MRA is an alternative to digital substracted angiography (DSA), circumventing th use of\r endovascular catheterism, irradiation and injection of iodinated contrast agent.\r Contrast-Enhanced MRA (CE-MRA) with gadolinium injection is currently the reference standard\r for vascular MR exploration but still presents many limitations inherent to the injection of\r contrast medium. Hence, the synchronization of the acquisition with bolus contrast injection\r limits the improvement of spatial and temporal resolutions and requires an accurate\r synchronization of the acquisition with the arrival of the bolus.\r\n\r Moreover, the acquisition can be repeated as required as it does not require any contrast\r injection.\r\n\r Besides, the increase in nephrogenic systematic fibrosis clinical cases, which would be\r secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has\r restricted the use of CE-MRA. More than 500 cases were described to date in the world.\r\n\r Its occurrence is currently estimated around 4 % for patients in terminal chronic renal\r insufficiency and its mortality around 30 %.\r\n\r According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast agent\r (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate Dimeglumine-MAGNEVIST\r *, Bayer HealthCare) are contraindicated if the glomerular filtration rate is lower than 30\r ml/mn.\r\n\r Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide\r complete and non-invasive investigation of the vasculature, thus offering patients with\r chronic renal insufficiency, as well as pregnant or nursing women a surrogate with no side\r effects.\r\n\r Moreover, the use of high field (3T) MR imaging offers improved signal to noise ratio.\r Combined with the use of phased array coils and parallel imaging, new NCE MRA sequences can\r achieve juxta-millimeter isotropic spatial resolution and temporal resolution of about 50 ms\r close to those of cerebral DSA.\r\n\r These sequences allow a joint hemodynamical and morphological assessment of lesions, both at\r the cervical and cerebral levels, whether at diagnosis or during patient follow-up\n\n**Clinical Trial Detailed Description:**\n\nThe main objective is to evaluate the quality of the NCE images obtained in the exploration\r of neurovascular diseases, at the cervical and cerebral levels.\r\n\r Secondary objectives are:\r\n\r - to compare the NCE MRA sequences with the CE MRA sequences used in the clinical routine.\r\n\r - to evaluate the anatomic and hemodynamic changes observable with sequences in the\r follow-up of patients, particularly those treated with partial embolization or\r radiosurgery.\r\n\r By circumventing the limitation to short bolus duration synchronization, the new dynamic\r sequences have the potential to achieve higher temporal resolution without compromising\r spatial resolution. Arteries and arteriovenous shunts may be more precisely identified and,\r due to a better visibility of small vessels allow a more accurate dynamic analysis.\r\n\r Finally, the sequence being derived from arterial spin labeling, and differing from time of\r flight or phase contrast sequences, should allow for an exploration less dependent on the\r vascular geometry with better anatomical analysis. For example, the tendency to overestimate\r arterial stenoses could be reduced.\r\n\r The robustness of sequences allow the non-invasive monitoring of patients including it\r possible to monitor the hemodynamic changes after radiosurgery or embolization.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Men and women over 18 years\r\n\r - Any adult patient known or clinically suspect to present a neurovascular disease\r (arterial stenosis ou arteriovenous malformations), the assessment of which requires\r an MRA or patient having an arteriovenous malformation for which treatment by\r embolization or radiosurgery is indicated multidisciplinary meeting and followed in\r the ordinary course of this treatment\r\n\r - Patient able of accepting protocol information\r\n\r - Patient who received information about the protocol and had not expressed its\r opposition to participate\r\n\r Exclusion Criteria:\r\n\r - A contraindication to MRI, in particular pacemakers or implantable defibrillators,\r cochlear implants, neurosurgical clips, intra-orbital or brain metallic foreign\r bodies, endo prothesis since less than 4 weeks or osteosynthesis material since less\r than 6 weeks\r\n\r - Contraindication to the injection of contrast agent: pregnancy, lactation, history of\r allergic reaction to contrast agent injection\r\n\r - Hemodynamically unstability, acute respiratory failure, a precarious condition or a\r need for continuous monitoring incompatible with the constraints of MR imaging\r\n\r - Patient with severe kidney with Glomerular Filtration rate < 30 ml/min\r\n\r - Persons subject to major legal protection (safeguarding justice, guardianship,\r trusteeship), persons deprived of liberty\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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942
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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 VENous Thromboembolism In Hemorrhagic Stroke Patients\n\n**Clinical Trial Summary:**\n\nPatients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism.\r Intermittent pneumatic compression combined with elastic stockings have been shown to be\r superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis\r after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings alone are\r ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic\r stroke. Less clear is the role of anticoagulation in the prevention of venous thromboembolism\r in patients with ICH because the use of anticoagulants may cause an enlargement of the\r hematoma. In a multicenter, randomized trial, the investigators will assess the efficacy and\r safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous\r intracerebral hemorrhage. Enoxaparin (40 mg once daily) or standard therapy (graduated\r compression stockings and/or intermittent pneumatic compression and/or early mobilization)\r will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke\r onset.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Intracranial spontaneous hemorrhage on brain CT scan\r\n\r - Intracranial hemorrhage during treatment with oral anticoagulants\r\n\r - Bedridden patients (item 6 of NIHSS: motor leg points 3 or 4 or severe ataxia for\r cerebellar hemorrhage).\r\n\r Exclusion Criteria:\r\n\r - cerebral hemorrhage due to intracranial vascular malformation\r\n\r - rebleeding on CT scan after 72 hours from stroke (before randomization)\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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943
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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\nCharacterization of Proteoglycan Depletion in Femoroacetabular Impingement With T1ρ Magnetic Resonance Imaging (MRI)\n\n**Clinical Trial Summary:**\n\nMagnetic resonance imaging (MRI) has proven to be one of the best ways to image articular\r cartilage. A tremendous amount of research has focused on cartilage imaging with an emphasis\r of early-osteoarthritis (OA) characterization. One of the techniques which has shown great\r promise is the imaging technique called T1ρ . The advantage of this pulse sequence is that it\r is sensitive to proteoglycans (PG), a major macromolecule degraded in OA. The study objective\r is to determine if T1ρ can acutely assess PG content in femoroacetabular impingement (FAI)\r which may allow physicians to differentiate between normal and early-OA cartilage states in\r FAI patients.\n\n**Clinical Trial Detailed Description:**\n\nMagnetic resonance imaging (MRI) is one of the best ways to image articular cartilage. One of\r the techniques which has shown great promise is the imaging technique called T1ρ (T1-rho).\r T1ρ is a modified pulse sequence from the standard T1 sequence used in the clinical MRI.\r Because the initial phases of arthritis occur at the molecular level, the main advantage of\r the T1ρ pulse sequence is that it is sensitive to proteoglycan. Proteoglycan is a molecule\r that is important to cartilage structure, and is lost as osteoarthritis develops. If we can\r show that this non-invasive tool can accurately assess cartilage damage and levels of\r proteoglycan, the clinical applications are numerous. The results can potentially help\r determine optimal surgical techniques and timing of surgical intervention to halt or slow the\r progression of arthritis, and will assist in the study of the effects of FAI and the success\r of the surgery performed to correct FAI.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Group 1: Patient has been diagnosed by the surgeon as having femoro-acetabular\r impingement (FAI) of the hip)\r\n\r - Group 1: Must meet all the following criteria: A) History and Physical Exam 1)\r Intermittent pain worse with activity 2) Positive impingement test (pain with flexion,\r adduction, and internal rotation of affected hip) B) X-ray 1) No signs of OA on plain\r radiological films (i.e. no osteophytes, no loss of joint space) 2) Non-spherical\r femoral head\r\n\r - Group 2: Patient has not been diagnosed by the surgeon as having any hip problems.\r\n\r Exclusion Criteria:\r\n\r - Previous Hip Surgeries (Pelvic Osteotomies)\r\n\r - Previous Hip Trauma\r\n\r - History of Pediatric Hip Pathology: Slipped Capital Femoral Epiphysis or Hip Dysplasia\r\n\r - Over the age of 40 years\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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944
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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\nCombination of the Hedgehog Inhibitor, LDE225, With Etoposide and Cisplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to test the safety of study drug LDE225 at different dose\r levels. The investigators will be testing three different dose levels and the dose will\r depend on when the patients enters the study and which dose is being tested at that time. At\r the same time, the investigators will also be testing the safety of LDE225 in combination\r with etoposide and cisplatin.\r\n\r The investigators also want to learn more about how to manage side effects the patient may\r develop during chemotherapy. Cancer patients may develop side effects during treatment, such\r as nausea, pain, fatigue, diarrhea, constipation, or shortness of breath. These symptoms may\r be due to the cancer itself, or due to treatments. Doctors and nurses often ask patients\r about their symptoms, because an important part of cancer treatment is to make patients feel\r as well as possible. If patients do not feel well, the investigators may need to change the\r way they are treating the patients or prescribe therapies that will decrease their symptoms.\r\n\r The best way to find out how the patient is feeling is to ask them directly. The\r investigators are interested in developing new ways to ask patients about how they are\r feeling, using the Internet. A special new website called STAR (\"Symptom Tracking and\r Reporting for Patients\") has been developed to help patients record this information, so that\r their doctors and nurses can review it during clinic appointments. This study is designed to\r help us see if STAR is a helpful way for us to keep track of information about patients'\r symptoms and quality of life. The information from STAR is going to be placed on a very\r secure Internet site. This will provide your doctor with all of the information needed to\r determine if this drug combination is safe enough for you and whether to continue it.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Patients eligible for inclusion in this study must meet all of the following criteria:\r\n\r - SCLC pathologically confirmed at MSKCC.\r\n\r - Untreated ES- SCLC, defined as those patients with extrathoracic metastatic disease,\r malignant pleural effusion, bilateral or contralateral supraclavicular\r lymphadenopathy, or contralateral hilar adenopathy.\r\n\r - Age 18 years or older.\r\n\r - Karnofsky Performance Status ≥ 70.\r\n\r - Presence of at least one measurable site of disease as defined by Response Evaluation\r Criteria in Solid Tumors 1.1 (RECIST 1.1).\r\n\r - Adequate bone marrow, liver and renal function, as specified below:\r\n\r - Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L\r\n\r - Hemoglobin (Hgb) ≥ 9 g/dL\r\n\r - Platelets ≥ 100 x 109/L\r\n\r - Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN )\r\n\r - AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present\r\n\r - Plasma creatine phosphokinase (CK) < 1.5 x ULN\r\n\r - Serum creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 60ml/min for patients with\r creatinine levels above institutional normal.\r\n\r - Patients with asymptomatic CNS metastases will be eligible. For patients that have\r undergone radiation therapy for their CNS metastases, a minimum of 14 days must elapse\r prior to study registration, and patients must have recovered from any adverse events\r related to radiotherapy with the exception of alopecia and grade 1 neuropathy.\r\n\r Exclusion Criteria:\r\n\r Patients eligible for this study must not meet any of the following criteria:\r\n\r - Patients who have had major surgery within 4 weeks of initiation of study medication.\r\n\r - Patients who are unable to take oral drugs.\r\n\r - Patients who have previously been treated with systemic LDE225 or with other Hh\r pathway inhibitors.\r\n\r - Patients who have taken part in an experimental drug study within 4 weeks of\r initiating treatment with LDE225.\r\n\r Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted\r therapy, or radiotherapy) concurrently or within 2 weeks of starting treatment.\r\n\r - Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular\r dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy).\r\n\r - Patients who are on concomitant treatment with drugs that are contraindicated in this\r study and that cannot be discontinued within the time frames as listed.\r\n\r - Patients who are planning on embarking on a new strenuous exercise regimen that can\r result in significant increases in plasma CK levels.\r\n\r - Patients who are receiving treatment with medications known to be moderate and strong\r inhibitors or inducers of CYP3A4/5 or with drugs metabolized by CYP2B6 or CYP2C9 that\r have narrow therapeutic index that cannot be discontinued before starting treatment\r with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued at\r least 7 days and strong CYP3A/5 inducers should be discontinued for at least 14 days\r prior to starting treatment with LDE225 Some of these medications are recognized to\r cause rhabdomyolysis.)\r\n\r - Patients who are receiving treatment with statins that are known to cause\r rhabdomyolysis and that cannot be discontinued at least 2 days prior to starting\r LDE225 treatment.\r\n\r - Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r infection, or psychiatric illness/social situations that would limit compliance with\r study requirements.\r\n\r Impaired cardiac function or clinically significant heart disease, including any one of the\r following: congestive heart failure, angina pectoris within 3 months, acute myocardial\r infarction within 3 months, QTcF > 450 msec for males and > 470 msec for females on the\r screening ECG, history of clinically significant ECG abnormalities, family history of\r prolonged QT-interval syndrome, or other clinically significant heart disease (e.g.\r congestive heart failure, uncontrolled hypertension, history of labile hypertension, or\r history of poor compliance with an antihypertensive regimen).\r\n\r - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a\r female after conception and until the termination of gestation, confirmed by a\r positive hCG laboratory test (> 5 mIU/mL).\r\n\r - Women of child-bearing potential, defined as all women physiologically capable of\r becoming pregnant, unless they are using highly effective methods of contraception\r during dosing and 4 months after the last study treatment. Highly effective\r contraception methods include the following:\r\n\r Total abstinence or\r\n\r - Male or female sterilization or\r\n\r - Combination of any two of the following (a+b or a+c, or b+c):\r\n\r - Use of oral, injected, or implanted hormonal methods of contraception\r\n\r - Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n\r - Barrier methods of contraception: condom or occlusive cap (diaphragm or\r cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n\r - Women are considered post-menopausal and not of child bearing potential if\r they have had 12 months of natural (spontaneous) amenorrhea with an\r appropriate clinical profile (e.g. age appropriate, history of vasomotor\r symptoms) or have had surgical bilateral oophorectomy (with or without\r hysterectomy) or tubal ligation at least six weeks prior to initiation of\r the study. In the case of oophorectomy alone, only when the reproductive\r status of the woman has been confirmed by follow up hormone level assessment\r is she considered not of child bearing potential.\r\n\r - Sexually active males must use a condom during intercourse while taking the\r drug and for 6 months after stopping treatment and should not father a child\r in this period. A condom is required to be used also by vasectomized men in\r order to prevent delivery of the drug via seminal fluid.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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945
|
[
{
"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\nPregnancy Environment and Newborn Malformations\n\n**Clinical Trial Summary:**\n\nCongenital malformations rate is about 3% in France. There are already 5 registries in\r France, covering about 16% of French births: Paris Registry, (about 38 000 births /year),\r Alsace Registry, (about 23 000 births/year), Rhône-Alpes Registry, (about 56 000\r births/year), Auvergne Registry, (about 14 000 births/year), and la Réunion Registry. The aim\r of malformation registries is to carry out epidemiologic surveillance of congenital\r anomalies. The objectives are mainly to provide essential epidemiologic information on\r congenital anomalies, to facilitate the early warning of teratogenic exposures, to act as an\r information and resource centre regarding clusters, to provide data for research related to\r the causes and prevention of congenital anomalies.\r\n\r A previous study was carried out in Brittany in 2008-2009, by the perinatal network of Ille\r et Vilaine, in collaboration with two research teams (Inserm U1085 and Inserm U 936), to\r record all cases of 4 types of congenital anomalies: congenital heart disease, spina bifida,\r diaphragmatic hernia and hypospadia. The results showed prevalence rates similar to those\r observed by Eurocat for spina bifida and diaphragmatic hernia, but a higher prevalence\r regarding congenital heart diseases and hypospadia. In this study the investigators could not\r determine whether this was due to a real higher frequency or to a particular exhaustiveness\r in the recording methodology.\r\n\r There are hypothesis about the role of intrauterine exposure to pesticides, known as\r endocrine disruptors, and the risk of congenital genital anomalies. Brittany is an intensive\r agricultural area, and it is thus worth studying the impact of pesticides exposure on\r congenital anomalies.\r\n\r There are also hypothesis on the impact of occupational exposure to solvents on congenital\r anomalies (Garlantezec 2009), and on the role of alcohol exposure (which concerns about 8%\r pregnant women in France) on oro-facial clefts and congenital heart diseases.\r\n\r The Registry of congenital anomalies in Brittany was set up in 2010. The main aim is to study\r the impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of\r congenital malformations diagnosed at births, by measuring the exposure both directly in\r meconium, and indirectly by questionnaires.\r\n\r Secondary objectives are to study other risk factors such as medicine intake, pregnancy\r illness…\n\n**Clinical Trial Detailed Description:**\n\nPopulation based case-control study:\r\n\r 2 controls per case will be included, corresponding to the first 2 births without congenital\r anomalies, with same sex and same birth place, following the case.\r\n\r INVESTIGATION METHODOLOGY :\r\n\r All maternity in Brittany were proposed to participate. In each maternity, the referent\r practitioner informs the parents and includes the cases.\r\n\r For each case and control, meconium samples and a mother's lock are collected by nurses or\r midwives, medical data are collected from medical reports by the registry investigator, and a\r self-questionnaire is filled by the mother.\r\n\r Meconium samples are immediately stored in a freezer (-20°C), secondarily transported to a\r biological storage centre at the university hospital and then dispatched to specialised\r laboratories for toxicological analyses: INERIS (for solvents and pesticides) and Toxicology\r Unit, University hospital Rennes (for Alcohol).\r\n\r For dead fetuses (stillbirths or termination of pregnancy), meconium will be collected by the\r pathologist in charge of the autopsy, after parents' consent.\r\n\r Evaluation of exposure:\r\n\r - direct evaluation: by toxicological analyses in meconium samples: Alcohol, Solvents and\r pesticides\r\n\r - indirect evaluation: by maternal self-questionnaire including data on occupational and\r domestic exposures, hobbies, life habits…, precise address (for spatial location)\r\n\r Particular cases: mild congenital heart defects, genital anomalies and hip dislocation\r diagnosed later after birth (after the period oh meconium and before the age of one): these\r cases will be spotted through the Registry, there won't be any biological sample for them,\r but mothers will be contacted by main investigator and medical data and mother questionnaires\r will be collected. There won't be any control included for those cases included after birth.\r\n\r Associations between exposure risk factors (alcohol, solvents and pesticides) and the risk of\r congenital malformations will be estimated by a multivariate analysis.\r\n\r - Exposure to solvents will be estimated by assay in meconium and by occupational\r questionnaire\r\n\r - Exposure to alcohol will be estimated by assay of Ethylglucuronide et de Ethylsulfate in\r meconium.\r\n\r - Exposure to pesticides will be estimated by assay in meconium, by questionnaire and by\r spatial location.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r All live births, fetal deaths with gestational age (GA) ≥22 weeks and terminations of\r pregnancy (at any gestational age) after prenatal diagnosis of malformation.\r\n\r - born from mothers living in Brittany at delivery\r\n\r - with a congenital anomaly according to Eurocat criteria, diagnosed or suspected (and\r then confirmed) at birth\r\n\r - or with mild congenital heart defects, genital anomalies or hip dislocation diagnosed\r after birth (and before the age of one)\r\n\r Non inclusion criteria :\r\n\r - Spontaneous abortion before 22 weeks gestational age.\r\n\r - Mother with legal protection (guardianship)\r\n\r Exclusion Criteria:\r\n\r - Prenatally suspected malformations, which are not confirmed by postnatal screening or\r clinical evolution\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
946
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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 Neuromarker S-100B in Patients With Different Types of Intracranial Injury\n\n**Clinical Trial Summary:**\n\nAbstract:\r\n\r The most widely studied neuro-markers in traumatic brain injury (TBI) are S100B and neurone\r specific enolase (NSE). S-100B is localized in astroglia. This marker is used to predict\r neuronal damage caused by traumatic brain injury. The investigators conduct a study to derive\r and validate the measurement of S-100B in serum of patients with different types traumatic\r brain injuries.\n\n**Clinical Trial Detailed Description:**\n\nThe neuromarker S-100B is a well established tool for decision making in patients traumatic\r brain injury (TBI)in Europe. In many hospitals S-100B is used routinely as a part of a set of\r high- and medium risk factors aiding the decision to perform a cranial computed tomography\r (CCT) in patients with minor head injury (MHI). In patients with severe head injury Raabe et\r al. found a significant correlation between the S-100B levels and unfavourable outcome in\r patients with severe brain injury with serum levels higher than 0.50 μg/l measured 24h after\r injury. The average level of the neuromarker, compared with other studies. The study of\r Biberthaler et al. showed highest levels in patients with epidural hematomas, followed by\r subdural, subarachnoidal and intracerebral hematomas. On the contrary the average S-100B\r levels of patients with epidural hematomas featured in a study by Unden et al. published in\r 2005 displayed normal levels (<0.2 μg/L). They concluded that S-100B was unreliable as a\r marker for epidural hematomas.\r\n\r Aim of the study Validation of S-100B in patients with intracerebral, epidural, subdural, and\r subarachnoidal hematoma, brain edema and concussion (Group 1-6), to find evidence which kind\r of injury leads to which level of elevation of the neuromarker measured in peripheral blood.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - all patients with traumatic brain injury\r\n\r Exclusion Criteria:\r\n\r - patients without traumatic brain injury\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
947
|
[
{
"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 Value of the Canadian CT Head Rule and the New Orleans Criteria in Minor Head Trauma\n\n**Clinical Trial Summary:**\n\nThe New Orleans Criteria (NOC) and the Canadian CT Head Rules (CCHR) have been developed to\r decrease the number of normal computed tomography (CT) in mild head injury (MHI). The aim is\r to compare the clinical performance of these 2 decision rules for indentifying patients with\r intracranial traumatic lesions and those who required an emergent neurosurgical intervention\r following MHI.\n\n**Clinical Trial Detailed Description:**\n\nA multicenter external validation study in 7 Tunisian teaching and non teaching hospitals\r including patients with MHI defined as a blunt trauma to the head within 24 hours with a\r Glasgow Coma Scale (GCS) score of 13 to 15 and at least one of the following: history of loss\r of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic\r seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and\r neurologic deficit. Primary outcome was need for neurosurgical intervention defined as either\r death or craniotomy, or the need of endotracheal intubation within 30 days of the traumatic\r event. Secondary outcome was the presence of traumatic lesions on head CT scan. Comparaision\r of both decision rules using sensitivity specifications, positive and negative predictive\r value.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient with acute MHI was defined as a patient having a blunt trauma to the head\r within 24 hours with a Glasgow Coma Scale (GCS) of 13 to 15 and at least 1 of the\r following risk factors: history of loss of consciousness, short-term memory deficit,\r amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external\r evidence of injury above the clavicles, confusion, and neurologic deficit.\r\n\r Exclusion Criteria:\r\n\r - Patients are excluded from the study if they are younger than 10 years, had GCS score\r of less than 13 or instable vital signs, came to the ED more than 24 hours after head\r trauma, were pregnant, were taking warfarin or had bleeding disorder, had an obvious\r penetrating skull injury or had contraindications for CT.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
948
|
[
{
"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, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine whether ancrod is effective and safe in the\r treatment of sudden sensorineural hearing loss (SSHL).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB\r\n\r - Symmetric hearing prior to onset of SSHL\r\n\r - Enrollment has to be accomplished within 7 days after SSHL onset\r\n\r Exclusion Criteria:\r\n\r - Bilateral SSHL\r\n\r - Incomplete recovery after previous SSHL\r\n\r - Previously existing, known retrocochlear hearing loss\r\n\r - Any history of any ear operation or local inflammatory disease in the past one year\r\n\r - History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic\r trauma immediately preceding SSHL\r\n\r - History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss,\r endolymphatic hydrops.\r\n\r - Treatment with steroids for any reason within the preceding 30 days.\r\n\r - Body weight > 140 kg\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
949
|
[
{
"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\nUtility of a Survey Instrument to Predict Benefit From a Novel Treatment for Vertical Heterophoria\n\n**Clinical Trial Summary:**\n\nPatients with acute exacerbation of chronic headache disorder present frequently to the\r Emergency Department (ED) for pain management. A novel etiology of headaches is Vertical\r Heterophoria (VH), a poorly understood and little recognized binocular vision malady that\r when treated with realigning prismatic spectacle lenses results in marked reduction in\r headache and other associated VH symptoms.\r\n\r This study aims to determine the accuracy of the Vertical Heterophoria Symptom Questionnaire\r (VHSQ) in identifying a ED headache patients who will experience significant reduction in VH\r symptoms with use of realigning prismatic spectacle lenses. This study's secondary purpose is\r to determine if VH is a common cause of chronic headache disorders in ED headache patients.\r\n\r To achieve these goals, a prospective observational study will be performed on ED headache\r patients > 18 years old. All will be given the VHSQ, and all will be assessed for a diagnosis\r of VH by an optometrist who will utilize a novel VH testing method. High and low score groups\r on the VHSQ will then be compared to each other to determine the prevalence of VH in each.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInitially include all patients presenting to Emergency Department with chief complaints of\r Headache, Head Pain, Face Pain and/or Migraine.\r\n\r Inclusion Criteria:\r\n\r - Greater than or equal to 18 years old\r\n\r - Ability to speak and read English\r\n\r - Chronic headache disorder as defined by physician diagnosis, or greater than three\r months of headaches requiring symptom relief with medication more than once every two\r weeks, or having headaches so severe that previous Emergency Department evaluation or\r treatment was necessary\r\n\r Exclusion Criteria:\r\n\r - Symptoms directly caused by trauma within the last three months\r\n\r - Known TMJ disorder and presenting with TMJ pain\r\n\r - Suspected infectious sinusitis or meningitis\r\n\r - Pain originating from ear\r\n\r - Pain originating from dental source\r\n\r - Patient not willing or able to travel to study optometrist for follow-up\r\n\r - Known history of cerebral aneurysm\r\n\r - Known history of brain tumor\r\n\r - Without previous CT, MRI, or other imaging to assess patient's headache disorder\r\n\r - Patient a prisoner\r\n\r - Patient under temporary or permanent custodianship\r\n\r - Patient currently with questionable state of mental competence\r\n\r - Treating physician or study investigator believes patient to be inappropriate for\r study participation\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
950
|
[
{
"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 Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells\n\n**Clinical Trial Summary:**\n\nThe study is to investigate the efficacy and safety of autologous transplantation of\r adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain\r injury.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject has a confirmed diagnosis of a brain AVM (arteriovenous malformation).\r\n\r - Stroke-like symptoms, including paralysis, caused by brain AVM hemorrhage.\r\n\r - Subject's modified Rankin scale (mRS) grades IV~V.\r\n\r - Ages between 20~40 years.\r\n\r - Estimated life expectancy must be greater than 2 months.\r\n\r - Signed informed consent from the subject.\r\n\r Exclusion Criteria:\r\n\r - Pregnancy test positive.\r\n\r - Subject infected with hepatitis C, HIV or syphilis.\r\n\r - Subject not suitable for liposuction surgery.\r\n\r - Subject not eligible for PET or MRI.\r\n\r - Subject enrolled in any other cell therapy studies within the past 30 days.\r\n\r - Subject deemed to be not suitable for the study by the investigator.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
951
|
[
{
"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\nRenal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension\n\n**Clinical Trial Summary:**\n\nThe purpose of this trial is to test how well the iCAST™ RX Stent works in patients diagnosed\r with atherosclerotic renal artery stenosis and whether or not increased blood flow by the\r stent will help to control blood pressure.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective, single-arm, multicenter clinical trial that will take place at up to\r 25 US/ Outside US (OUS) sites. Primary endpoints have been determined to show the safety,\r effectiveness, and clinical outcomes of the iCAST™ RX Stent System. Safety and effectiveness\r will be evaluated based on the primary patency rate at 9-months on a per lesion basis\r evaluated against a performance goal of published studies with bare-metal stents. The primary\r clinical endpoint will assess the improvement in Systolic Blood Pressure (SBP) at 9-months as\r compared to baseline Systolic Blood Pressure.\r\n\r Eligible subjects will undergo a two-week Medical Documentation Screening period to confirm\r resistant hypertension (SBP ≥ 155mmHg) while on maximum tolerable doses of ≥ three\r anti-hypertensive medications from at least three distinct classes of drugs, one of which\r must be a diuretic.\r\n\r There must be documented clinical evidence to support likelihood of angiographic findings >\r 80% whether it is Duplex Ultrasound (DUS), Computed Tomography angiogram (CTa), Magnetic\r Resonance angiogram (MRa) or other medical evidence. After meeting screening and clinical\r eligibility criteria, subjects will undergo a baseline assessment for angiographic\r eligibility. After angiographic documentation of a ≥ 80% renal artery stenosis or Fraction\r Flow Reserve (FFR) < 0.8 is confirmed, the subject may be enrolled in the trial by placement\r of the investigational device.\r\n\r The 9-month visit will include a follow-up DUS of the target renal artery. If the DUS is\r non-diagnostic due to an imaging problem, such as overlying bowel gas or body habitus, a\r second DUS may be attempted. If the DUS is indicative of ≥ 60% stenosis as determined by the\r core laboratory, or the second DUS remains non-diagnostic, a contrast angiogram will be used\r to assess the degree of restenosis of the covered stent(s).\r\n\r Clinical follow-up visits will be required for all enrolled subjects at 30-days, 9-months,\r 12-months, 24-months, and 36-months. A 6-month and 18-month visit will occur via telephone to\r collect medication usage and Adverse Events (AEs) only. The 36-month clinic office visit will\r be required as the final safety visit.\n\n**Clinical Trial Eligibility Criteria:**\n\nGeneral Inclusion Criteria:\r\n\r 1. Age ≥ 18 at the time of informed consent.\r\n\r 2. Subject or subject's legal representative have been informed of the nature of the\r trial, agrees to participate, and has signed an Institutional Review Board\r (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF).\r\n\r 3. Subjects that have bilateral kidneys or a solitary functioning kidney with Renal\r Artery Stenosis in at least one kidney and an average Systolic Blood Pressure (SBP) ≥\r 155mmHg.\r\n\r 4. Subject has a history of maximum tolerable dose of ≥ 3 anti-hypertensive medications\r of different classes, one of which must be a diuretic (for at least two weeks prior to\r Medical Documentation Screening period).\r\n\r a. A documented history for a minimum of 3 months showing reasonable and aggressive\r efforts to manage hypertension prior to consent. This must include the use of a broad\r variety of medications that have been used and failed or not tolerated.\r\n\r 5. Subject must have documented clinical evidence to support likelihood of angiographic\r findings > 80% whether it is DUS, CTa, MRa or other medical evidence.\r\n\r 6. New York Heart Association (NYHA) class I, II, or III the time of trial enrollment.\r\n\r Note: When a subject has bilateral Renal Artery Stenosis both of which require stenting, it\r is recommended to treat both kidneys with an iCAST™ RX Stent System during the index\r procedure. In the event that a subject needs a renal stenting procedure staged for renal\r protection, it is important that the Investigator treats the second renal artery with an\r iCAST™ RX Stent System after 30 days of the index procedure. If subjects with bilateral\r stenosis have only one lesion that meets protocol inclusion criteria that lesion should be\r treated per protocol. The recommendation is to NOT treat the second non-qualifying lesion,\r however if the operator feels strongly it is indicated, then they should treat per standard\r of care after 30-days post index procedure in order to comply with exclusion criteria #10.\r\n\r Subjects with flash pulmonary edema are allowed into the trial should they meet all other\r Inclusion and Exclusion criteria.\r\n\r Angiographic Anatomic Inclusion Criteria:\r\n\r 1. Angiographic diameter renal artery stenosis ≥ 80% involving unilateral or bilateral\r renal arteries.\r\n\r a. The degree of percent diameter stenosis for all lesions intended to be treated,\r must be confirmed via one of the following methods: i. Manual or automated measurement\r with calipers ii. Measured Flow Fraction Reserve (FFR) < 0.8 using a pressure wire\r iii. Measured translesional peak pressure gradient of > 21 mmHg after induced\r hyperemia via dopamine or papaverine using a 4 Fr or less catheter or pressure wire.\r\n\r b. Subjects with 60-79% angiographic stenosis who have confirmed FFR < 0.8 may be\r enrolled.\r\n\r 2. Renal pole-to-pole length > 8cm (per visual estimate).\r\n\r 3. Target lesion length ≤ 16mm per vessel (per visual estimate).\r\n\r 4. Renal artery vessel diameter ≥ 5.0mm and ≤ 7.0mm (per visual estimate).\r\n\r 5. Lesion originating ≤ 15mm of the renal ostium.\r\n\r General Exclusion Criteria:\r\n\r 1. Subject's estimated life expectancy is < 12 months.\r\n\r 2. Subject has a history of transplanted kidney(s), has had another recent organ\r transplant or polycystic kidney disease.\r\n\r 3. Subject with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2\r\n\r 4. Subject has a history of bleeding diathesis or coagulopathy or refuses blood\r transfusions.\r\n\r 5. Subject has a known contraindication to heparin, aspirin, thienopyridine, other\r anti-coagulant/antithrombotic therapies, contrast media, stainless steel, and/or\r polytetrafluoroethylene (PTFE).\r\n\r 6. Subject has had a previous renal bypass operation, a bypass is planned, or the target\r lesion is located within or beyond a bypass graft.\r\n\r 7. Subject has received a thrombolytic agent within the past 30 days.\r\n\r 8. Subject has documented acute pulmonary edema or systolic heart failure with ejection\r fraction < 30% and/or hospitalization requiring intubation and ventilation support for\r this diagnosis within the previous 90 days or hypertensive emergencies defined as\r resulting in organ damage.\r\n\r 9. Concurrent enrollment in any investigational trial wherein subject's participation has\r not been completed.\r\n\r 10. Subject has had a planned or anticipated cardiovascular surgical or interventional\r procedure outside of the affected renal artery (including, but not limited to, aortic,\r renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30 days prior to\r the index procedure and prior to completion of the 30 day follow-up.\r\n\r 11. Subject has suffered a stroke or Transient Ischemic Attack (TIA) in the past 3 months.\r\n\r 12. Subject is pregnant, lactating, or is of child-bearing potential and plans to become\r pregnant during the follow-up trial period.\r\n\r 13. Subject with significant valvular disease.\r\n\r 14. Subject with known significant proteinuria > 2+ or > 2.0gm/d.\r\n\r 15. Subject with known bilateral upper-extremity arterial stenosis that result in\r spuriously low arm pressures or without the ability to gain reliable blood pressure\r measurements in at least one upper extremity.\r\n\r 16. Subject with active sepsis.\r\n\r 17. Subject with serum creatinine ≥ 3.0mg/dL.\r\n\r 18. Subject with NYHA Class IV at the time of enrollment.\r\n\r 19. Subject is on hemodialysis.\r\n\r 20. Subject has a history of renal aneurysm.\r\n\r 21. Subject with cardiogenic shock.\r\n\r 22. Subject with cardiomyopathy.\r\n\r 23. Subject has an uncontrolled concurrent illness, including but not limited to ongoing\r or active infection or active autoimmune disease requiring immunosuppressive therapy.\r\n\r 24. Any subject with clinically significant cardiovascular, respiratory, neurologic,\r hepatic, endocrine, major systematic disease, making implementation or interpretation\r of the protocol or protocol results difficult or who in the opinion of the\r investigator would not be a good candidate for enrollment.\r\n\r Angiographic Anatomic Exclusion Criteria:\r\n\r 1. The planned site of intervention is totally occluded or has an anatomic configuration\r likely to prohibit adequate dilatation, and/or passage or implantation of the\r investigational device.\r\n\r 2. Subject has multiple ipsilateral lesions of the target renal artery that cannot be\r covered by a single stent.\r\n\r 3. There is a previously implanted stent in the target vessel or there is a previously\r implanted stent in the contralateral vessel < one year.\r\n\r 4. Subject has fibromuscular dysplasia, in renal artery and/or other vascular bed.\r\n\r 5. The target lesion site is associated with a thrombus.\r\n\r 6. Target lesion treated with laser atherectomy, directional atherectomy or other\r adjuncts to percutaneous balloon angioplasty (PTA).\r\n\r 7. Subject has a critical stenotic (> 70%) small accessory renal artery.\r\n\r 8. Subject has an abdominal aortic aneurysm > 4.0cm in diameter or a severe\r atherosclerotic aorta.\r\n\r 9. Main renal artery length ≤ 15mm precluding the safe deployment of a covered renal\r stent.\r\n\r 10. Any lesion that would include blocking of renal artery side branch.\r\n\r 11. Renal artery stenosis due to dissection of renal artery: spontaneous or traumatic.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
952
|
[
{
"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 Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation\n\n**Clinical Trial Summary:**\n\nTo evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in\r Japanese subjects with hypervascular tumor or arteriovenous malformation\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r 1. Subjects who are subject to any of the following vascular embolization therapies\r\n\r 1. Subjects with hepatocellular carcinoma (HCC) who have deep stained early stage tumor\r confirmed by dynamic computerized tomography (CT) after bolus intravenous infusion of\r contrast media and have a typical finding of hypervascular tumor, and are not amenable\r to resection and local therapy, and meet any of the following (a) to (c).\r\n\r 1. 1 lesion of >50 mm in diameter\r\n\r 2. 2 or 3 lesions of >30 mm in at least one diameter\r\n\r 3. 4 or more lesions\r\n\r 2. Metastatic hepatic cancer Subjects with metastatic hepatic cancer who have deep\r stained early stage tumor confirmed by dynamic CT after bolus intravenous infusion of\r contrast media and have a typical finding of hypervascular tumor but not amenable to\r resection, and whose primary lesion and extrahepatic lesion are controlled.\r\n\r 3. Hypervascular tumor other than metastatic hepatic cancer Subjects with deep stained\r early stage tumor confirmed by dynamic CT after bolus injection of contrast media and\r who have a typical finding of hypervascular tumor other than the liver (e.g., renal\r cell carcinoma, bone soft tissue sarcoma) and meets any of the following (a) to (b).\r\n\r 1. Subjects applicable to pre-operative arterial embolization therapy to reduce\r tumor size or volume of bleeding for safer conduct of surgical resection or local\r therapy (e.g., radiofrequency ablation (RFA))\r\n\r 2. Subjects in stable general condition and are applicable to pain control treatment\r\n\r 4. Arteriovenous malformation:\r\n\r Subjects with arteriovenous malformation (except for central nervous system, heart, and\r lung) confirmed by dynamic CT but at a low risk of undesirable reflux into systemic\r circulation and with vessel malformation suitable for particle embolization in size\r\n\r 2. Subjects with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 (PS\r 0-1 for metastatic hepatic cancer)\r\n\r 3. No carry-over effect of prior therapy or adverse drug reactions which may influence the\r embolic effect of E7040, if having a history of prior therapy time elapsed from the end of\r prior therapy to the start of E7040 embolization therapy should be: Surgery: greater than\r or equal to 6 weeks Local therapy: greater than or equal to 4 weeks Embolization for\r non-target vessel: greater than or equal to 4 weeks\r\n\r 4. With a survival of greater than or equal to 12 months after the prior arterial\r embolization therapy using E7040\r\n\r Exclusion criteria:\r\n\r 1. Subjects with clinical symptom or brain metastasis or cerebral encephalopathy\r requiring medical treatment\r\n\r 2. Suspected to have hepatocellular carcinoma (HCC) judging from clinical findings in\r patients with any disease other than HCC\r\n\r 3. Previously treated with arterial embolization therapy in target vessel\r\n\r 4. Previously treated with arterial embolization therapy in non-target vessel, resection\r in target organ, or local therapy (e.g., RFA) (except for HCC patient)\r\n\r 5. Subjects expected to have artery-pulmonary vein shunt or right-to-left shunt, or those\r with a possible risk of influx of embolized particles into the central nervous system.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
953
|
[
{
"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\nINSORB Versus Subcuticular Sutures at Cesarean Section\n\n**Clinical Trial Summary:**\n\nThe proposed study is a randomized controlled trial with two arms. All patients admitted to\r Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered\r entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section,\r the patient will be randomized at time of cesarean section to receive skin closure by either\r the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the\r standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment\r score (PSAS) will be obtained during this visit. The patient will then be contacted by\r telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey)\r assessing her satisfaction with the resulting scar.\n\n**Clinical Trial Detailed Description:**\n\nThe proposed study is a randomized controlled trial with two arms. All patients admitted to\r Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered\r entry into our study during the routine consent process which includes consent for cesarean\r section that occurs with each patient. Once the patient is enrolled, and if she undergoes a\r cesarean section, the patient will be randomized at time of cesarean section to receive skin\r closure by either the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture\r as is the standard practice. The size of the suture (3-0 vs. 4-0) and type of needle used to\r sew is at the discretion of the surgeon. The indications for and performance of the cesarean\r section will remain standard care by the Obstetrical team and the patient's participation in\r this study will have no impact whatsoever on the obstetrical course of the patient. The only\r additional procedure that will be asked of the obstetrical team performing the cesarean\r section is to measure and close the subcutaneous tissue if the depth from the skin edge to\r the transversalis fascia is greater than 2cm as this has been shown to decrease subsequent\r seroma formation and wound disruption. The dressing will be standardized as follows: a folded\r abdominal (ABD) pad will be placed in a sterile fashion directly over the incision and foam\r tape will be applied to provide a \"pressure dressing.\" The dressing will be removed on\r post-operative day #2.\r\n\r The patient's postoperative course will remain unchanged and her discharge will be at the\r discretion of her obstetrical providers. On post-operative day #3, a picture of the incision\r will be taken with the patient's identifying number adjacent to the picture and the patient\r will be asked to complete a brief survey asking about post-operative pain and scars (see\r included PSAS survey). The patients will follow-up with her Obstetrician for her normal\r post-partum visit where another picture of the incision will be taken. Both an observer scar\r assessment score (OSAS) and patient scar assessment score (PSAS) will be obtained during this\r visit. The patient will then be contacted by telephone by a study member 3 months after her\r surgery for a brief survey (same PSAS survey) assessing her satisfaction with the resulting\r scar. At this point, the patient's participation in the study will end.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - cesarean section via transverse skin incision informed consent\r\n\r Exclusion Criteria:\r\n\r - vertical skin incision\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
954
|
[
{
"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\nMRI for the Early Evaluation of Acute Intracerebral Hemorrhage\n\n**Clinical Trial Summary:**\n\nWhat happens in the borderzone of a cerebral hemorrhage remains widely onknown and furhter\r the best timing for doing MR to look for vascular pathology in cerebral hemorrhage has not\r yet been determined. In this study we do acute MRS, a non-invasive imaging mathod to detemine\r the biochemsty in the border zone and structural MRI for vascular malformation. We repeat\r structural MRI after 8 weeks.\n\n**Clinical Trial Detailed Description:**\n\nIn this study we want to investigate the ability of MRI to identify underlying pathology\r (tumor or vascular malformations) in acute patients admitted with intracerebral hemorrhage\r (ICH). Today MRI-scan is normally done 3-4 weeks after symptom onset but very little is known\r about the early use of MRI to detect underlying pathology. This would allow an early\r intervension and less uncertainty for the patients.\r\n\r We further want to investigate the metabolic penumbra-zone surrounding the hematoma. It is\r the current perception in the litterature that this zone represent a metabolic zone marked by\r apoptosis and inflammation rather than ischemia.\r\n\r We are planning to:\r\n\r When patients arrive in our stroke department they will within 7 hours be subject to MRI scan\r with the protocoled sequences. Standard sequences: Axial T2, axial DWI, Sagittal T1, T2 flair\r og axial GRE-sequence.\r\n\r Susceptibility weighted imaging (SWI)\r\n\r Chemical Shift Imaging (CSI) multivoxel spectroscopi\r\n\r Post contrast 3D box reconstruction\r\n\r After 8 weeks the patients are subject to another MRI-Scan in accordance with the standard\r clinical guideline to rule out underlying pathology.\r\n\r After 3 month the patients are seen in the outpatient-clinic to follow-up evaluation.\r\n\r To sum up the purpose of this present study is to conduct a pilot investigation of MRI in the\r early evaluation of ICH-patients. Second it is our intension to use multivoxel magnetic\r resonance spectroscopy to study the metabolic penumbra-zone surrounding the ICH.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - CT demonstrated ICH\r\n\r - Cardiopulmonary stable\r\n\r - Informed consent from patient or proxy\r\n\r - No General contraindication of MRI\r\n\r - Age above 18\r\n\r Exclusion Criteria:\r\n\r - Lack of informed consent\r\n\r - lack of cooperability\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
955
|
[
{
"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 and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care\n\n**Clinical Trial Summary:**\n\nSubjects enrolled into this 10 week study will for the first two weeks document the number of\r cluster headaches and the means of treating (medication) of these attacks. Subjects will then\r be randomized to into either two groups. The first group is continuing with standard of care\r and the second group is treatment with the investigational device (GammaCore) for a period of\r 4 weeks. After this 4 week period, all subjects will treat with the GammaCore for another 4\r week period. It is hypothesized the the treatment group will have a reduction in mean cluster\r headaches per week by 50% compared to the standard of care group.\n\n**Clinical Trial Detailed Description:**\n\nThe study is a prospective randomized controlled multi-center investigation designed for\r comparison of two parallel groups, GammaCore® (active treatment) and Standard of Care, SoC,\r (control). The study period begins with a 2 week run-in period, followed by a 4 week\r comparative period when the subjects are randomized to either active treatment or control\r 1:1. The comparative period will be followed by a period where all subject will receive\r GammaCore® for 4 weeks.After the subject signed the Consent Form for participation the\r baseline (visit1) data will be collected. Subject will be informed how to complete the 2 week\r diary during the run-in period During the run-in period, all subjects will use stable SoC\r according to their individual prescriptions. The subject will record as CH attack regarding\r duration and frequency and the use of medication and oxygen.\r\n\r Once subjects have finalized the run-in period, they are randomized to continue in 4 weeks\r comparative period. During this period, the control group continues with stable SoC and the\r active group is provided with a GammaCore® device for prophylactic and acute treatment in\r addition to the stable SoC Subjects stimulate 3 x 2 times daily as part of the prophylactic\r treatment regimen (cervical vagal nerve). Three 90 second stimulations are self-administered\r by the subject with 5 minutes between each stimulation on the right side of the neck.\r\n\r This preventive stimulation regimen is performed:\r\n\r - First Daily Treatment - within 1 hour of waking\r\n\r - Second Daily Treatment - 7-10 hours following the first daily treatment\r\n\r Acute CH attack:\r\n\r - 3 x 90 second treatments consecutively at the onset of pain or symptoms. If the attack\r is not aborted within 15 minutes the subject should be informed to take SOC abortive\r medication.\r\n\r - If an acute cluster headache attack is treated with the GammaCore® device, the subject\r will try to work within the preventive treatment window to avoid a preventive treatment\r in the 2-hour refractory period following the acute treatment.\r\n\r A total of minimally 6 stimulations for the preventive part and as needed for the acute\r attacks. The active group also continues with the stable SoC during the entire 4 weeks\r period. Both groups record all CH attacks in the diary together with medication and oxygen\r use. All adverse events shall also be recorded in the diary.\r\n\r The end of the 4 week comparative period marks the completion of the randomized part of the\r study, however all subjects are provided the option to continue to a 4 week GammaCore®\r treatment with the same stimulation parameter as during the 4 week randomization period. All\r subjects randomized to the SoC group will receive training.\r\n\r During the entire study period, subjects are allowed to take rescue medication including\r oxygen inhalation for abortion of CH attacks. The amount and doses of the medication and\r oxygen are recorded in the diary.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Signed Informed Consent Form 2. Subjects between the age of 18-70, both genders 3.\r Subjects diagnosed with chronic cluster headache for at least 1 year, without remission\r periods or with remission periods lasting <1 month, in accordance with the ICHD-II\r classification criteria (2ndEd):\r\n\r a. At least 5 attacks fulfilling the following criteria: i. Severe or very severe\r unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated\r ii. Headache is accompanied by at least 1 of the following:\r\n\r 1. Ipsilateral conjunctival injection and/or lacrimation\r\n\r 2. Ipsilateral nasal congestion and/or rhinorrhea\r\n\r 3. Ipsilateral eyelid oedema\r\n\r 4. Ipsilateral forehead and facial sweating\r\n\r 5. Ipsilateral miosis and/or ptosis\r\n\r 6. A sense of restlessness or agitation iii. Attacks have a frequency from 1 every other\r day to 8 per day and are not attributed to another disorder iv. Attacks recur over > 1\r year without remission periods or with remission periods lasting < 1 month.\r\n\r 4. Has minimum mean attack frequency of 4 CH attacks per week. 5. Is able to distinguish CH\r from other headaches (i.e. tension-type headaches).\r\n\r 6. Is capable of completing headache pain self-assessments. 7. Agrees to use the GammaCore®\r device as intended and follow all of the requirements of the study, including follow-up\r visit requirements.\r\n\r 8. Is willing to keep all concomitant medication stable during the entire study period.\r\n\r 9. Women of child-bearing potential must use 2 methods of contraceptive i.e. hormones and\r condom.\r\n\r Exclusion Criteria:\r\n\r 1. Is currently taking CH prophylactic medication for indications other than CH which in\r the opinion of the clinician may interfere with the study\r\n\r 2. Has had a change in type or dosage of prophylactic headache medications < 1 month\r prior to enrollment\r\n\r 3. Has a history of intracranial or carotid aneurysm, intracranial hemorrhage, brain\r tumors or significant head trauma.\r\n\r 4. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal\r anatomy at the GammaCore® treatment site.\r\n\r 5. Has other significant pain problem that might confound the study assessments in the\r opinion of the investigator.\r\n\r 6. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid\r artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF),\r known severe coronary artery disease or recent myocardial infarction (within 5years).\r\n\r 7. Has had a previous unilateral or bilateral vagotomy.\r\n\r 8. Has uncontrolled high blood pressure.\r\n\r 9. Is currently implanted with an electrical and/or neurostimulator device, including but\r not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain\r stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.\r\n\r 10. Has a history of carotid endarterectomy or vascular neck surgery on the right side.\r\n\r 11. Has been implanted with metal cervical spine hardware or has a metallic implant near\r the GammaCore® stimulation site.\r\n\r 12. Has a history, the last 12 month, of syncope.\r\n\r 13. Has a history, the last 12 month of seizures.\r\n\r 14. Has a known history or suspicion of substance abuse or addiction, or overuse of acute\r headache medication for headaches other than CH.\r\n\r 15. Has psychiatric or cognitive disorder and/or behavioral problems which in the opinion\r of the investigator may interfere with the study\r\n\r 16. In the opinion of the investigator the subject is incapable of operating the\r GammaCore® device as intended and performing the data collection procedures.\r\n\r 17. Is participating in any other therapeutic clinical investigation or has participated\r in a clinical trial in the preceding 30 days.\r\n\r 18. Woman who are pregnant or lactating.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
956
|
[
{
"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\nSTOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial\n\n**Clinical Trial Summary:**\n\nThe aim of the study is to test if intracerebral haemorrhage (ICH) patients who have contrast\r extravasation on computed tomography angiography, the \"spot sign\", have lower rates of\r haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset, compared\r to placebo.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients presenting with an acute ICH\r\n\r - Contrast extravasation within the haemorrhage, \"spot sign\", evaluated from the CTA\r according to three criteria, all of which must be present:\r\n\r 1. Serpiginous or spot-like appearance within the margin of a parenchymal haematoma\r without connection to an outside vessel;\r\n\r 2. The density (in Hounsfield units) should be greater than that of the background\r haematoma (site investigators are not required to document the density); and\r\n\r 3. No hyperdensity at the corresponding location on non-contrast CT.\r\n\r - Age ≥18 years\r\n\r - Treatment can commence within 1 hour of initial CT and within 4.5 hours of symptom\r onset (or in patients with unknown time of symptom onset, the time patient was last\r known to be well)\r\n\r - Informed consent has been received in accordance to local ethics committee\r requirements\r\n\r Exclusion Criteria:\r\n\r - Glasgow coma scale (GCS) total score of <8\r\n\r - Brainstem ICH\r\n\r - ICH volume >70 ml as measured by the ABC/2 method\r\n\r - ICH known or suspected by study investigator to be secondary to trauma, aneurysm,\r vascular malformation, haemorrhagic transformation of ischaemic stroke, cerebral\r venous thrombosis, thrombolytic therapy, tumor, or infection\r\n\r - Contrast already administered within 24 hours prior to initial CT or contraindication\r to imaging with CT contrast agents (e.g. known or suspected iodine allergy or\r significant renal failure)\r\n\r - Any history or current evidence suggestive of venous or arterial thrombotic events\r within the previous 12 months, including clinical, ECG, laboratory, or imaging\r findings. Clinically silent chance findings of old ischemia are not considered\r exclusion.\r\n\r - Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency.\r\n\r - Use of heparin, low-molecular weight heparin, GPIIb/IIIa antagonist, or oral\r anticoagulation (e.g. warfarin, factor Xa inhibitor, thrombin inhibitor) within the\r previous 14 days, irrespective of laboratory values\r\n\r - Pregnancy (women of childbearing potential must be tested)\r\n\r - Planned surgery for ICH within 24 hours\r\n\r - Concurrent or planned treatment with haemostatic agents (e.g. prothrombin complex\r concentrate, vitamin K, fresh frozen plasma, or platelet transfusion)\r\n\r - Participation in any investigational study in the last 30 days\r\n\r - Known terminal illness or planned withdrawal of care or comfort care measures.\r\n\r - Any condition that, in the judgment of the investigator could impose hazards to the\r patient if study therapy is initiated or affect the participation of the patient in\r the study.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
957
|
[
{
"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\nVenous Thromboembolic Prophylaxis After Trauma: Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin\n\n**Clinical Trial Summary:**\n\nThe rate of venous thromboembolic events in trauma patients at high risk for deep vein\r thrombosis and pulmonary embolism receiving low dose unfractionated heparin every 8 hours\r will be equivalent or less than a similar group of patients given a standard every 12 hour\r dose of low molecular weight heparin.\n\n**Clinical Trial Detailed Description:**\n\nVenous thromboembolism (VTE) is a common and potentially life threatening complication of\r major trauma. The risk of developing deep vein thrombosis (DVT) following major trauma\r exceeds 50% unless adequate chemoprophylaxis is used. Recent national quality improvement\r initiatives, such as the Surgical Care Improvement Project (SCIP), mandate the risk\r stratification of hospitalized patients and the use of VTE prophylaxis based on the risk\r assessment. Low Molecular Weight Heparin (LMWH, enoxaparin) and Low Dose Unfractionated\r Heparin (LDUH) are commonly used alternatives for VTE chemoprophylaxis following major\r trauma. LMWH became favored in most trauma centers following a prospective randomized\r controlled trial comparing the two agents that demonstrated superior efficacy and equivalent\r safety of LMWH over a twice per day dosing of LDUH. The results of this study were largely\r responsible for practice guideline recommendation changes favoring the use of LMWH in trauma\r patients by both the American College of Chest Physicians (ACCP) and the Eastern Association\r for the Surgery of Trauma (EAST). , This landmark paper did not, however, utilize a three\r times a day (every 8 hours) dosing of LDUH for prophylaxis, which is the dosing schedule\r recommended by earlier trials. LDUH administered every 8 hours was demonstrated to have\r similar efficacy to LMWH in trauma patients in a recent retrospective study. These results\r call into question the validity of the conclusions of the 1996 study. Because LDUH is less\r expensive ($0.50/dose) than LMWH (Enoxaparin, $28/dose), similar effectiveness would imply a\r significant reduction in the cost of prophylaxis and increased value to patients, providers\r and accountable care organizations and tax-payers.\r\n\r To validate this hypothesis the investigators propose to achieve the following study\r objectives:\r\n\r 1. Assess the degree of risk for VTE in each patient admitted to the trauma service\r\n\r 2. Determine the rate of VTE events in high risk trauma patients receiving either:\r\n\r - LMWH (30mg enoxaparin) given every twelve hours\r\n\r - LDUH (5000 Units unfractionated Heparin) given every eight hours.\r\n\r 3. Identify and quantify any adverse events associated with either treatment arm.\r\n\r 4. Compare the value of LMWH versus LDUH in the prophylactic treatment of VTE disease in\r trauma patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Admitted to Scripps Mercy Trauma Service\r\n\r - ≥18 Years old\r\n\r - Stratified to either Significant or Highest risk of VTE by ACCP guidelines\r\n\r Exclusion Criteria:\r\n\r - Estimated Injury Severity Score (ISS) ≤9\r\n\r - Likely to be discharged before hospital day 7\r\n\r - Systemic coagulopathy defined with an International Normalized Ratio (INR) of ≥1.2\r\n\r - Body Mass Index (BMI) >40\r\n\r - Likely to Survive for <7 Days\r\n\r - Pregnancy\r\n\r - Evidence of renal insufficiency (Cr ≥1.3)\r\n\r - Delayed transfer to this facility (>24 hrs)\r\n\r - Prisoners\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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958
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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\nFunctional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery\n\n**Clinical Trial Summary:**\n\nLittle is known about the effect of fMRI navigation in the intracranial arteriovenous\r malformation surgery. The investigators aim to perform a multicenter prospective randomized\r single -blind clinical trial to assess the effect and safety of fMRI navigation in the brain\r arteriovenous malformation surgery.\n\n**Clinical Trial Detailed Description:**\n\nIntracranial arteriovenous malformations (AVMs) are congenital lesions that consist of\r multiple arteries and veins, connecting as a fistula without an intervening normal capillary\r bed. Surgical removal is thought as a major treatment option for AVMs. However, compared with\r stereotaxic radiosurgery and endovascular embolization, microsurgery of AVMs is regarded with\r high mortality and morbidity, particular for high level classification AVMs .\r\n\r Blood oxygen level dependent fMRI can be used to mapping the motor and language regions of\r the brain noninvasively. It has been one of the most advanced functional imaging techniques\r and it has quickly grown to be a vital tool for clinical and cognitive neuroscience research.\r Many clinical researches have been reported about the utility of fMRI in brain tumor surgery.\r However, the effect of fMRI navigation for neurofunction protection in the intracranial\r arteriovenous malformation surgery was unclear.\r\n\r We aim to perform a multicenter prospective randomized single -blind clinical trial to assess\r the safety and effect of fMRI navigation in the intracranial AVMs surgery. We hypothesize\r that application of blood oxygen level dependent fMRI is able to improve long term prognosis\r of patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Diagnosis of intracranial AVM by DSA/CT/MRI\r\n\r 2. Age from 12-60 years\r\n\r 3. Be suitable for microsurgery treatment\r\n\r 4. All patients are able to cooperate with the fMRI examination\r\n\r 5. All patients gave written informed consent\r\n\r Exclusion Criteria:\r\n\r 1. Patients with age < 12 years or > 60 years\r\n\r 2. Various conditions unable to meet the indications for microsurgery treatment\r\n\r 3. Intracranial hemorrhage need emergency surgery\r\n\r 4. Patients can not cooperate with fMRI examination\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
959
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIdentification of Genetic and Cellular Markers Associated With Vascular Endothelial Modifications in Cutaneous Arteriovenous Malformations\n\n**Clinical Trial Summary:**\n\nCutaneous Arteriovenous malformations (AVM's) rare congenital high-flow vascular\r malformations in which arteries and veins are directly connected through a complex web of\r abnormal arteries and veins instead of a normal capillary network. Arterial feeders and\r enlarged draining veins directly connect through arteriovenous fistulas that create the\r \"nidus\". The natural history of AVMs is organized into a clinical staging system: during the\r first phase of quiescence, the arteriovenous malformation mimics a capillary malformation.\r After many years, the AVM may enlarge with loco-regional expansion and tissular destruction.\r At the ultimate stage, AVM may impact the heart function. They are considered non malignant\r but can expand and become a significant clinical risk when extensive. The management of these\r high flow AVM remains often problematic. Complete and large surgical excision of the nidus\r after hyperselective embolization is the only potential therapeutic solution but this, is\r often difficult if not impossible. There is no pathogenetic hypothesis for the development of\r these malformations. Histopathological examination (performed only on surgical resection\r specimen) is poor and does not provide sufficient evidence to assess the evolutivity or the\r severity of the MAV. Recent data hypothesize that these vascular malformations are associated\r with alterations of the vascular endothelium caused by genetic abnormalities involved in the\r control of angiogenesis and vascular homeostasis. The detection of these anomalies allows the\r search for cellular and genetic markers that might be useful to optimize the clinical\r classification, staging, predicting the evolution of these defects and some understanding of\r its pathophysiological mechanisms. To our knowledge, no studies to identify cellular markers\r / genetic and endothelial associated with the development of cutaneous AVMs have been\r published to date.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or feminine Subject\r\n\r - Subject of 10 and more years old,\r\n\r - Subject weighing more than 55 kg. patients:\r\n\r - Subject presenting a cutaneous artério-venous deformation there outside of any other\r deformation or known vascular tumor.\r\n\r - Subject presenting no other susceptible pathology to influence endothéliaux markers\r (Renal insufficiency, inflammatory pathology chronicles, infections, pathologies\r cardiovascular, diabetes, evolutionary tumoral pathology).\r\n\r volunteers:\r\n\r - Unhurt Subject of deformation or vascular tumor.\r\n\r - Subject presenting no other susceptible pathology to influence endothéliaux\r markers(scorers) (Renal insufficiency, inflammatory pathology chronicles, infections,\r pathologies cardiovascular).\r\n\r Exclusion Criteria:\r\n\r - Subject of less than 10 years old\r\n\r - Subject weighing less than 55 kg\r\n\r - Subject presenting another type(chap) of vascular vascular deformation or tumor\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
960
|
[
{
"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\nTrigger Point Therapy in Cervicogenic Headache\n\n**Clinical Trial Summary:**\n\nIt is a pilot randomized controlled trial comparing real and simulated manual treatment of\r trigger points (TrPs) in patients with cervicogenic headache (CeH). The purpose of the\r current randomized clinical pilot trial was to determine the preliminary effects of TrP\r manual therapy in individuals with CeH with sternocleidomastoid muscle active TrPs as\r compared to manual contact over the muscle tissues.\n\n**Clinical Trial Detailed Description:**\n\nCeH pain has been mostly related to joint, disk and ligament pain from the upper cervical\r spine; however, clinicians should consider that the upper cervical spine also receives\r afferent inputs from muscles. In fact, the role of referred pain to the head elicited by\r muscle TrPs has received particular interest in recent years. No study has investigated the\r effectiveness of TrP manual therapy in patients with CeH exhibiting active TrPs.\r Investigators hypothesized that patients receiving a real TrP treatment will exhibit a\r greater reduction in pain, sensitivity, cervical range of motion and neck endurance than\r those receiving a manual control non-therapeutic intervention.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - unilateral pain starting in the neck and radiating to the frontal-temporal region\r\n\r - pain aggravated by neck movement\r\n\r - restricted cervical range of motion\r\n\r - joint tenderness in at least one of the joints of the upper cervical spine (C1-C3)\r\n\r - headache frequency of at least one per week over a period greater than 3 months\r\n\r - active TrPs in the sternocleidomastoid muscle\r\n\r Exclusion Criteria:\r\n\r - other primary headaches (i.e., migraine, tension type-headache)\r\n\r - bilateral headaches\r\n\r - had received treatment for neck or head pain in the previous year\r\n\r - presented any contraindications to manual therapy\r\n\r - had pending legal action regarding their neck and head pain.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
961
|
[
{
"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-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache\n\n**Clinical Trial Summary:**\n\nMulti-center, prospective, double-blind, randomized, sham-controlled pivotal study of\r non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of\r cluster headache. The study compares the safety and effectiveness of an active treatment\r (GammaCore) against a sham treatment.\n\n**Clinical Trial Detailed Description:**\n\nPhase 1: Prospective, randomized (1:1 active treatment:sham control allocation), double\r blinded, sham controlled treatment (active or sham) phase\r\n\r Phase 2: Prospective, non-randomized, active treatment phase.\r\n\r Phase 1 - Two Arms:\r\n\r 1. Active Treatment with the GammaCore Device\r\n\r 2. Sham Treatment with a placebo device\r\n\r Phase 2 - One Arm:\r\n\r Active Treatment with the GammaCore Device\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Is between the ages of 18 and 75 years.\r\n\r 2. Has been diagnosed with cluster headache, in accordance with the ICHD-2\r\n\r Classification criteria (2ndEd):\r\n\r o At least 5 attacks fulfilling the following criteria:\r\n\r - Severe or very severe unilateral orbital, supraorbital and/or temporal pain\r lasting 15-180 minutes if untreated\r\n\r - Headache is accompanied by at least 1 of the following:\r\n\r - Ipsilateral conjunctival injection and/or lacrimation\r\n\r - Ipsilateral nasal congestion and/or rhinorrhea\r\n\r - Ipsilateral eyelid edema\r\n\r - Ipsilateral forehead and facial sweating\r\n\r - Ipsilateral miosis and/or ptosis\r\n\r - A sense of restlessness or agitation\r\n\r 3. currently experiencing cluster headaches, and from clinical history is expected to\r continue experiencing cluster headaches for a period of at least 4 weeks.\r\n\r 4. able to distinguish CH from other headaches (i.e. migraine, tension-type headaches).\r\n\r 5. capable of completing headache pain self-assessments.\r\n\r 6. [Intentionally left blank].\r\n\r 7. Agrees to use the GammaCore device as intended and follow all of the requirements of\r the study, including follow-up visit requirements.\r\n\r 8. Agrees to record usage of the GammaCore device, all required study data, and report\r any adverse device effects to the study center within 24 hours of any such adverse\r device effects.\r\n\r 9. able to provide written Informed Consent\r\n\r Exclusion Criteria:\r\n\r 1. had surgery to treat cluster headache.\r\n\r 2. currently taking prophylactic medication (including chronic opioids and non-prescribed\r street drugs) for indications other than CH that in the opinion of the clinician may\r interfere with the study.\r\n\r 3. [Intentionally left blank].\r\n\r 4. undergone botulinum toxin injections in the head and/or neck in the last 3 months or\r nerve blocks (occipital or other) in the head or neck in the last month.\r\n\r 5. history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.\r\n\r 6. lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy\r at the treatment site.\r\n\r 7. structural intracranial, or cervical vascular lesions that may potentially cause\r headache attacks.\r\n\r 8. other significant pain problem (including cancer pain, fibromyalgia, and trigeminal\r neuralgia/TAC-cluster) that might confound the study assessments.\r\n\r 9. known or suspected severe atherosclerotic cardiovascular disease, severe carotid\r artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF),\r known severe coronary artery disease or recent myocardial infarction.\r\n\r 10. history of prolonged QT interval or a history of clinically significant arrhythmia.\r\n\r 11. abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation,\r atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation,\r or clinically significant premature ventricular contraction).\r\n\r 12. previous bilateral or right cervical vagotomy.\r\n\r 13. uncontrolled high blood pressure.\r\n\r 14. currently implanted with an electrical and/or neurostimulator device, including but\r not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain\r stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.\r\n\r 15. history of carotid endarterectomy or vascular neck surgery on the right side.\r\n\r 16. implanted with metal cervical spine hardware or has a metallic implant near the\r GammaCore stimulation site.\r\n\r 17. recent or repeated history of syncope.\r\n\r 18. recent or repeated history of seizure.\r\n\r 19. known history or suspicion of substance abuse or addiction, or overuse of acute\r headache medication for headaches other than CH.\r\n\r 20. psychiatric or cognitive disorder and/or behavioral problems which in the opinion of\r the clinician may interfere with the study.\r\n\r 21. pregnant, nursing, thinking of becoming pregnant in the next 4 months, or of\r childbearing years and is unwilling to use an accepted form of birth control.\r\n\r 22. participating in any other therapeutic clinical investigation or has participated in a\r clinical trial in the preceding 30 days.\r\n\r 23. Belongs to a vulnerable population or has any condition such that his or her ability\r to provide informed consent, comply with follow-up requirements, or provide\r self-assessments is compromised\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
962
|
[
{
"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 [11C]DPA-713 for Temporal Lobe Epilepsy\n\n**Clinical Trial Summary:**\n\nBackground:\r\n\r - Some people with epilepsy have an epileptic focus, a small part of the brain that is the\r starting point of the seizure. This focus is like an irritant or an inflammation, and helps\r cause the seizure. People with epilepsy that affects the temporal lobe of the brain often\r have an epileptic focus. Researchers want to look at the epileptic focus by using a drug that\r attaches to a protein associated with inflammation. An imaging study with the drug will show\r how much inflammation is in the area of the brain where the seizures start. The drug, called\r [11C]DPA-713, will be tested for its effectiveness in people with temporal lobe epilepsy. Its\r effects will be compared with imaging studies given to healthy volunteers.\r\n\r Objectives:\r\n\r - To see if [11C]DPA-713 can show the inflammation in the epileptic focus of seizures.\r\n\r Eligibility:\r\n\r - Individuals at least 18 years of age who have temporal lobe epilepsy.\r\n\r - Healthy volunteers at least 18 years of age.\r\n\r Design:\r\n\r - Participants will have three outpatient visits to the National Institutes of Health\r Clinical Center. The visits will last from 2 to 5 hours.\r\n\r - Participants will be screened with a physical exam, neurological exam, and medical\r history. Blood samples will be collected before the start of the study.\r\n\r - Participants will have a positron emission tomography (PET) scan. This scan will be used\r to look at brain chemistry and function. The study drug will be given during the scan to\r see how well it shows points of inflammation in the brain. Some participants will\r provide additional blood samples during the PET scan.\r\n\r - Participants will also have a magnetic resonance imaging (MRI) scan. This scan will look\r at the structure of the brain.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVE:\r\n\r Translocator protein 18 kDa (TSPO) is highly expressed in activated microglia and reactive\r astrocytes in brain, and it may, thereby, be a useful biomarker of neuroinflammation. We\r developed [11C]PBR28 as a positron emission tomographic (PET) radioligand to bind to TSPO and\r measure its density. The purpose of this study is to assess a new TSPO radioligand,\r [11C]DPA-713, and to compare it with [11C]PBR28.\r\n\r Although [11C]PBR28 has high in vivo specific signal, it is very sensitive to the high and\r low affinity states of TSPO, which are caused by a single nucleotide polymorphism (SNP) in\r the fourth exon of the TSPO gene. This co-dominant mutation yields three genetic groups: HH,\r HL, and LL, where H is the high-affinity form and L is the low affinity form. The frequency\r of the L allele is approximately 30%; thus, the frequency of the LL homozygote is\r approximately 9%. The affinity of PBR28 to H and L forms differs about 50 fold; thus, LL\r carriers provide no measureable signal in brain from [11C]PBR28. In contrast, the affinity of\r DPA-713 differs by only four-fold and LL carriers provide measureable brain uptake, although\r diminished in comparison to HH and HL carriers.\r\n\r We recently reported that [11C]PBR28 binding is increased in epileptogenic mesial temporal\r lobe in HH and HL carriers, using the ratio of brain uptake in ipsilateral and contralateral\r regions. This study will compare [11C]DPA-713 and [11C]PBR28 in two ways. First, what is the\r relative robustness of absolute quantitation of TSPO in healthy subjects and patients with\r epilepsy, using an arterial input function and pharmacokinetic modeling? Second, what is the\r relative sensitivity of [11C]DPA-713 and [11C]PBR28 to detect the seizure focus in patients\r with epilepsy and measured as the ratio of brain uptake ipsilateral and contralateral to the\r seizure focus.\r\n\r STUDY POPULATION\r\n\r This protocol will study a total of 30 patients with epilepsy and 30 healthy human volunteers\r using [11C]DPA-713. Studies with [11C]PBR28 in the same subjects will be performed under\r other protocols, including 12-N-0182 ( Positron emission tomography measurement of\r neuroinflammation and P-glycoprotein in localization-related epilepsy, PI: W. Theodore).\r\n\r DESIGN\r\n\r For absolute quantification of TSPO, 10 patients with epilepsy and 25 healthy controls will\r have arterial blood sampling concurrent with PET imaging using [11C]DPA- 713. Scans of\r healthy subjects will also be used to study effect of the polymorphism to the binding of\r [11C]DPA- 713. The subjects will choose to undergo the PET scan with or without the arterial\r line. Most, but not all, subjects will also have a scan with [11C]PBR28 under another\r protocol. LL homozygotes would be excluded from [11C]PBR28 but would be included with\r [11C]DPA- 713.\r\n\r For detection of increased TSPO receptor binding in epileptogenic foci as a ratio of\r ipsilateral to contralateral regions, about 20 patients with epilepsy will be studied with\r [11C]DPA-713. Since the ratio of brain uptake will also be obtained as part of absolute\r quantitation in ten patients, this ratio of brain uptake will require an additional ten\r subjects, who would not require an arterial catheter.\r\n\r To account for dropouts and data variability, we request a ceiling of 30 epilepsy patients\r (about 10 of whom will have an arterial line) and 30 controls. All subjects will have blood\r drawn to genotype the TSPO SNP and to perform in vitro radioligand binding to TSPO on\r lymphocytes.\r\n\r OUTCOME MEASURES\r\n\r To assess absolute quantitation of TSPO with [11C]DPA-713, we will primarily use two outcome\r measures: the identifiability and time stability of distribution volume calculated with\r compartmental modeling. By comparing data of HH, HL, and LL, we will also estimate\r nondisplaceable distribution volume. To assess the sensitivity of [11C]DPA-713 to localize\r the epileptogenic focus, we will compare ratio of brain uptake in medial temporal lobe,\r ipsilateral and contralateral to the seizure focus.\n\n**Clinical Trial Eligibility Criteria:**\n\n- INCLUSION CRITERIA:\r\n\r For healthy volunteers\r\n\r - Age 18 or older.\r\n\r - Able to give written informed consent.\r\n\r - No prior diagnosis of drug or alcohol abuse or dependence.\r\n\r For patients\r\n\r - Age 18 or older.\r\n\r - Able to give written informed consent.\r\n\r - Having clinically documented partial seizures with consistent EEG evidence as defined\r by the 1981 International Classification of Epileptic Seizures, which may be\r refractory or responsive to standard antiepileptic treatment. This criterion will be\r established by preliminary screening in the NINDS Clinical Epilepsy Section outpatient\r clinic under protocol 01-N-0139, and if necessary, inpatient video-EEG monitoring.\r Seizure focus localization will be determined by standard clinical, neurophysiologic,\r and imaging studies.\r\n\r - Negative toxicology testing at the time of screening.\r\n\r - No prior diagnosis of drug or alcohol abuse or dependence.\r\n\r EXCLUSION CRITERIA:\r\n\r For healthy volunteers\r\n\r - Any current Axis I diagnosis.\r\n\r - Clinically significant laboratory abnormalities.\r\n\r - Positive test for HIV.\r\n\r - Unable to have a MRI scan.\r\n\r - History of neurologic illness or injury with the potential to affect study data\r interpretation.\r\n\r - History of seizures, other than in childhood and related to fever.\r\n\r - Recent exposure to radiation (i.e., PET from other research) which when combined with\r this study would be above the allowable limits.\r\n\r - Inability to lie flat on camera bed for at least two hours.\r\n\r - Pregnancy or breast feeding.\r\n\r - Able to get pregnant but does not use birth control.\r\n\r - Drug/alcohol abuse or dependence\r\n\r For patients\r\n\r - Previous radiation exposure (X-rays, PET scans etc.) that, together with study\r procedures, would exceed NIH RSC research limits.\r\n\r - Claustrophobia to a degree that the subject would feel uncomfortable in the MRI\r machine.\r\n\r - History of brain disease other than epilepsy.\r\n\r - Cannot lie on their back for at least two hours.\r\n\r - Known cause for seizures, other than mesial temporal sclerosis, such as tumor or\r infection.\r\n\r - Serious medical illness, other than epilepsy.\r\n\r - Clinically significant laboratory abnormalities.\r\n\r - Positive test for HIV.\r\n\r - Brain abnormality such as a brain tumor, stroke, brain damage from head trauma or\r blood vessel abnormalities, on an MRI scan.\r\n\r - Pregnancy or breast feeding.\r\n\r - Able to get pregnant but does not use birth control.\r\n\r - Risk for MRI scan, such as a pacemaker or other implanted electrical devices, brain\r stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of\r a large artery), metallic prostheses (including metal pins and rods, heart valves, and\r cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel\r fragments. Welders and metal workers are also at risk for injury because of possible\r small metal fragments in the eye of which they may be unaware.\r\n\r - For drug-responsive subjects: occurrence of a seizure within the last three months.\r\n\r - Drug/alcohol abuse or dependence\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
963
|
[
{
"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 (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the effectivenes of a home-based physical therapy\r program designed to improve balance following traumatic brain injury by incorporating the use\r of a virtual reality system.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Has sustained a documented TBI that required an inpatient rehabilitation program;\r\n\r - is at least one year post TBI;\r\n\r - is at least 18 and no more than 64 years of age at the time of enrollment;\r\n\r - is English or Spanish speaking\r\n\r - is at least three months beyond completion of formal PT, including acute inpatient\r rehabilitation, outpatient and home-based therapy;\r\n\r - provides written medical clearance for participation in an in-home balance exercise\r program;\r\n\r - ambulates independently within the home (with assistive devices and/or orthotics as\r needed);\r\n\r - has active range of motion of bilateral upper extremities of at least 90 degrees of\r abduction to allow for control of the VR system;\r\n\r - completes a 15 minute trial using a VR system in the absence of a negative physical or\r behavioral reaction;\r\n\r - self-reports ongoing balance deficits and demonstrate such deficits by scoring at or\r below one standard deviation above the mean (75 or below) on the CB&M; and\r\n\r - provides informed consent, or has a guardian available to provide consent.\r\n\r Exclusion Criteria:\r\n\r - has a history of another medical illness or neurological disorder which may affect\r balance;\r\n\r - has experienced a seizure within the last year;\r\n\r - has a history of psychiatric disorder requiring hospitalization;\r\n\r - is currently participating in another RCT;\r\n\r - is currently using VR technology to address specific balance goals;\r\n\r - is unable to travel to Craig for assessments throughout the study period;\r\n\r - is unable to communicate effectively to complete standardized assessments;\r\n\r - has cognitive impairment that precludes completion of baseline testing;\r\n\r - is unavailable to participate in 12 continuous weeks of therapy;\r\n\r - has no access to television able to connect to VR-gaming system; and\r\n\r - reports inadequate space required for VR-gaming system sensors.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
964
|
[
{
"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\nRole of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine the role of Proteomics and Metallomics in Cerebral\r Vasospasm following Subarachnoid Hemorrhage\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Non traumatic SAH documented by CT scan\r\n\r - Patient with SAH who would need external ventricular drain (EVD) for the management of\r hydrocephalus\r\n\r - Patients with normal pressure Hydrocephalus that require an external drain\r\n\r - Control (non - hemorrhagic) group - CSF collected from patients with posterior fossa\r tumor or stroke with EVD in place for the management of hydrocephalus.\r\n\r Exclusion Criteria:\r\n\r - Recent infection within last 1 month of presentation- can increase inflammatory\r markers\r\n\r - Recent surgery or acute myocardial infarction within last 1 month of presentation\r\n\r - Age > 89 years or < 18 years\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
965
|
[
{
"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\nNationwide Treatment Survey of Intracranial Arteriovenous Malformation in China\n\n**Clinical Trial Summary:**\n\nThis register study will collect the treatment information of the intracranial arteriovenous\r malformation patients in China. We aim to understand the current treatment situation of the\r disease in China.\n\n**Clinical Trial Detailed Description:**\n\nIntracranial arteriovenous malformations are congenital lesions that consist of multiple\r arteries and veins, connecting as a fistula without intervening normal capillary bed. The\r treatment strategy including surgical removal, endovascular embolism and stereotaxic\r radiosurgery and comprehensive treatment. China is a united multi-ethnic nation of 56 ethnic\r groups, and has the largest population in the world. We have most extensive and valuable\r clinical resources of intracranial arteriovenous malformation in the world. But we know\r little about the current treatment situation of the disease in China.\r\n\r In order to realize the treatment situation of intracranial arteriovenous malformation in\r China, we designed a retrospective and prospective register study to collect the treatment\r and outcome information all over China.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All the patients that diagnosed of intracranial AVM by DSA/CT/MRI\r\n\r - All patients gave written informed consent\r\n\r Exclusion Criteria:\r\n\r - patients refuse to attend the survey\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
966
|
[
{
"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 a Nurse for Migraine Management: the IMPACT Project\n\n**Clinical Trial Summary:**\n\nHeadache disorders are prevalent, disabling, under recognized, under diagnosed and under\r treated. Migraine has a prevalence of 10% in men and 25% in women in Canada. The treatment of\r migraine is based on patient education (lifestyle habit modification, trigger avoidance), and\r pharmacological acute treatment and prophylaxis. A multidisciplinary approach allows a\r repartition of tasks between different health professionals.\r\n\r In a 2010 meeting, the Canadian Headache Society members supported the concept of Headache\r Centers, and a headache nurse was judged as an essential component of such centers.\r\n\r Gaul has reviewed the structured multidisciplinary approach that could be used in a headache\r centre and the existing studies using such structures. Five studies did include a headache\r nurse. No study did observe the impact of a nurse only. Resources in medical care are\r limited. One study did use a program of 96 hours, which does not seem realistic on the\r long-term and for a large pool of patients in a public hospital. Patients are not always able\r to pay for paramedical help such as physiotherapy and psychotherapy. Even if they do, finding\r a specialized therapist for chronic headache is difficult. Defining the role of a nurse and\r demonstrating the impact on patient care is therefore a first step in the concept of a\r headache center. Possible roles of a headache nurse according to Gaul are patient education,\r follow-up of the treatment plan, addressing patient queries, and monitoring of patient\r progress. The headache nurse may also participate in research projects. In a hospital\r Headache Clinic, the nurse may be involved in intra-venous treatments and blood sampling for\r research.\r\n\r In summary, evidence to demonstrate the impact of a nurse in a headache clinic is lacking. We\r propose to study this aspect prospectively. A study with positive findings would encourage\r health ministers to fund and support headache nurses for headache centers across Canada for\r headache management. Chronic headache and therefore chronic migraine would be a focus of such\r centers, since most patients seen in specialized centers are chronic.\r\n\r HYPOTHESIS: The addition of a headache nurse to the headache team will help the CHUM Migraine\r Clinic to improve treatment outcome, and reduce the burden of headache. This\r multidisciplinary approach will also allow a higher efficiency of the team.\n\n**Clinical Trial Detailed Description:**\n\nSTUDY DESIGN:\r\n\r The goal of this study is to compare two treatment approaches for migraineurs. The first\r approach will be based on the physician only and is limited to fixed appointments (control\r group). The second approach will be based on a team involving a headache nurse (active group)\r who will participate in patient education and follow-up. The goal is to improve patient\r outcome but also physician productivity.\r\n\r First 100 patients (control group, phase 1): patients with episodic and chronic migraine will\r be screened, sign consent and be enrolled. They will be seen by the physician only, without\r the nurse's support. This situation will reproduce the actual conditions at the clinic.\r During this phase, the nurse will be involved in the follow-up of known patients (who will\r not be included in the protocol) and data collection. She will develop her headache\r management abilities and help the physicians to develop some educational tools for patients.\r\n\r Following 100 patients (active group, phase 2) : patients with episodic and chronic migraine\r will be screened and enroled. They will be seen by the physician and nurse team, with a\r treatment plan tailored to specific needs including regular scheduled visits, follow-up of\r chronification factors and educational sessions. Phone call follow-ups will be planned.\r Patients will have an easier and quicker contact with the team in an emergency situation.\n\n**Clinical Trial Eligibility Criteria:**\n\nINCLUSION CRITERIA:\r\n\r - Age 18 or more\r\n\r - Diagnosis of migraine, chronic or episodic, at the first visit. We expect the majority\r of patients to suffer form frequent or chronic migraine.\r\n\r - Consent to participate in the CHUM Migraine Clinic IMPACT project.\r\n\r - For future post-hoc analysis, groups will be stratified according to baseline headache\r frequency (all severity included), assessed retrospectively at the first visit:\r\n\r - <6 headache days per month,\r\n\r - 6 to 14 headache days per month\r\n\r - 15 or more headache days per month\r\n\r EXCLUSION CRITERIA:\r\n\r - Patients whom first headache diagnosis is not migraine (for example post-traumatic\r headache, cluster headache, trigeminal neuralgia, facial pain).\r\n\r - Women with ongoing or planned pregnancy.\r\n\r - Patient with an active psychiatric condition (needing hospitalisation or psychosis).\r\n\r - Patient with mental retardation impairing assessment or follow-up.\r\n\r - Patient with an active medical condition which may lead to frequent hospitalisations\r (eg active cancer, organ graft, hemodialysis etc). This will be determined and\r detailed by the evaluating physician.\r\n\r - Active drug addiction or alcoholism.\r\n\r - Active follow-up at a pain clinic.\r\n\r - Patient speaking a language other than french and incapable to communicate in a\r reliable way.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
967
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSafety Study of Nicardipine to Treat Cerebral Vasospasm\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine if intrathecal nicardipine is safe for the\r treatment of cerebral vasospasm.\n\n**Clinical Trial Detailed Description:**\n\nSubarachnoid hemorrhage accounts for approximately 5% of all strokes and affects 30,000\r Americans per year. Poor outcome from aneurysmal subarachnoid hemorrhage (SAH) occurs in 50\r to 75% of patients, and this is attributed to secondary ischemia in approximately 30% of\r patients. This delayed cerebral ischemia has been attributed to the anatomic narrowing of\r arteries in the cerebral vasculature which occurs following SAH.\r\n\r Because of this relationship between cerebral vasospasm, cerebral ischemia, and poor outcome,\r there has been significant effort to establish treatments that decrease the incidence of\r vasospasm after SAH. Currently, medications and hemodynamic maneuvers are used as standard of\r care for the treatment of vasospasm and to improve outcome after SAH.\r\n\r The calcium channel blocker, nimodipine, is one of the few treatments for vasospasm that has\r been shown to be of proven benefit. Nicardipine is another calcium channel blocker that has\r been evaluated in several studies via an intravenous administration route. These studies did\r show significant improvements in symptomatic and angiographic vasospasm, although a benefit\r in outcome was not seen. However, the intravenous administration of nicardipine was\r associated with significant systemic side effects that may have affected outcome including\r hypotension, pulmonary edema, and azotemia.\r\n\r The administration of nicardipine via an intrathecal route avoids the systemic complications\r associated with intravenous dosing since the direct cerebrospinal fluid dosing is much lower.\r The result is that the systemic concentration will remain low avoiding systemic side effects,\r and central nervous system concentration will remain high. We propose that this difference\r may improve outcomes while minimizing complication related effects on patient outcomes.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or female 18 years of age and older\r\n\r - Subarachnoid hemorrhage documented on head CT\r\n\r - Fisher Grade 3 or 4\r\n\r - Hunt Hess Grade 1-5\r\n\r - Cerebral aneurysm as definitive source of subarachnoid hemorrhage\r\n\r - Cerebral aneurysm must be treated via open or endovascular techniques\r\n\r - Presence of external ventricular drain\r\n\r - Written informed consent obtained from subject or subject's legally authorized\r representative\r\n\r Exclusion Criteria:\r\n\r - Absence or inability to have an external ventricular drain (coagulopathy)\r\n\r - Non-aneurysmal subarachnoid hemorrhage (perimesencephalic)\r\n\r - Untreated cerebral aneurysm\r\n\r - Inability to be randomized prior to post-hemorrhage day 4\r\n\r - Elevated intra-cranial pressures that would preclude external ventricular drain\r clamping for 30-60 minutes\r\n\r - Inability to administer study medication (severe intra-ventricular hemorrhage,\r occluded external ventricular drain)\r\n\r - Inability to obtain angiography (coagulopathy, renal failure)\r\n\r - Pregnant\r\n\r - Presence of a condition or abnormality that in the opinion of the Investigator would\r compromise the safety of the patient or the quality of the data\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
968
|
[
{
"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\nAn Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of JNJ-17299425 in Participants With Traumatic Brain Injury\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate safety, tolerability, pharmacokinetics (explores\r what the body does to the drug) and pharmacodynamics (the study of the action or effects a\r drug has on the body) of JNJ-17299425 in participants with traumatic brain injury (acute and\r chronic injuries to the brain, including the cerebral hemispheres, cerebellum, and brain\r stem).\n\n**Clinical Trial Detailed Description:**\n\nThis is an open-label (all people know the identity of the intervention), multi-center\r (conducted in more than one center), and exploratory study of single and repeat, escalating,\r intravenous (injection of a substance into a vein) doses of JNJ-17299425 in participants with\r traumatic brain injury. The study consists of 2 parts (Part 1 and Part 2), and each part will\r have 2 stages (Stage 1 and Stage 2). In Stage 1 of each part only standard care will be\r given, through sedation, analgesia and ventilation. If Intra cranial pressure (ICP) rises to\r greater than 20 millimeter of mercury (mmHG) after ventricular drainage, participants will\r enter Stage 2 of each part and will receive JNJ-17299425 (single dose in Part 1 and repeated\r dose in Part 2). During Part 1, safety and efficacy of JNJ-17299425 will be evaluated and\r during Part 2, safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses\r will be evaluated. Efficacy will primarily be evaluated by reduction in ICP. Blood samples\r will be collected for pharmacokinetic evaluation at pre and post administration of study\r treatment. Participants' safety will be monitored throughout the study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Participants with traumatic head injury and requiring intracranial pressure (ICP)\r monitoring\r\n\r - Post menopausal females, (or when known not to have menstruated for at least 12\r months), or previously documented sterilization\r\n\r - Body Mass Index (BMI=weight per square height): 18 to 35 kilogram per square meter\r inclusive\r\n\r - Legally acceptable representatives (relatives or guardians) must have signed an\r informed consent document indicating that they understand the purpose of and\r procedures required for the study and are allowing the participant to participate in\r the study\r\n\r - To participate in the optional pharmacogenomic component of this study, legally\r acceptable representatives (relatives or guardians) must have signed the informed\r consent form for pharmacogenomic research indicating willingness to participate in the\r pharmacogenomic component of the study (where local regulations permit). Refusal to\r consent for this component does not exclude a participant from participation in the\r clinical study\r\n\r Exclusion Criteria:\r\n\r - Major injury (multi-trauma) or disease outside the central nervous system causing\r significant vital organ or blood counts dysfunction (for example, disseminated\r intravascular coagulation, serious hepatic or kidney failure, acute respiratory\r distress syndrome, etc)\r\n\r - Participants who already received specific ICP lowering therapy, other than\r ventricular drainage, before being dosed with JNJ-17299425\r\n\r - Rapid increase of ICP expected to result in death of the participant\r\n\r - Relevant abnormal values for hematology, clinical chemistry or urinalysis at admission\r\n\r - Any known significant history or family history of anemia, hemolytic or autoimmune\r disease or thrombocytopenia\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
969
|
[
{
"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\nMinimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III\n\n**Clinical Trial Summary:**\n\nA phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally\r invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).\n\n**Clinical Trial Detailed Description:**\n\nPrimary Objectives:\r\n\r Efficacy: Demonstrate that minimally invasive surgery (MIS) plus recombinant tissue\r plasminogen activator (rt-PA) for three days improves functional outcome by a 12% increase in\r the modified Rankin Scale (mRS) score 0-3 compared to medically treated subjects assessed at\r 365 days.\r\n\r Secondary Objective:\r\n\r Demonstrate that the end of treatment volume and percent of ICH reduction from MIS+rt-PA is\r related to improved functional outcome, as compared to medically treated subjects.\r\n\r Safety:\r\n\r Demonstrate that early use of MIS+rt-PA for three days is safe for the treatment of ICH\r relative to rates of mortality, rebleeding, and infection in the medically treated subject at\r 30 days.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging\r (computerized tomography (CT), computerized tomography angiography (CTA), etc.), with\r a Glasgow Coma Scale (GCS) ≤ 14 or a NIHSS ≥ 6.\r\n\r - Stability CT scan done at least 6 hours after diagnostic CT showing clot stability\r (growth < 5 mL as measured by ABC/2 method).\r\n\r - Symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of\r onset is exclusionary).\r\n\r - Ability to randomize between 12 and 72 hours after dCT.\r\n\r - Systolic Blood Pressure (SBP) < 180 mmHg sustained for six hours recorded closest to\r the time of randomization.\r\n\r - Historical Rankin score of 0 or 1.\r\n\r - Age ≥ 18 and older.\r\n\r Exclusion Criteria:\r\n\r - Infratentorial hemorrhage.\r\n\r - Intraventricular hemorrhage (IVH) requiring treatment for IVH-related (casting) mass\r effect or shift due to trapped ventricle. External ventricular drain (EVD) to treat\r intracranial pressure (ICP) is allowed.\r\n\r - Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and\r non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions. Note:\r Patients with a posterior fossa ICH or cerebellar hematomas are ineligible.\r\n\r - Irreversible impaired brain stem function (bilateral fixed, dilated pupils and\r extensor motor posturing), GCS ≤ 4.\r\n\r - Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya\r disease, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (< 1\r year) hemorrhage diagnosed with radiographic imaging.\r\n\r - Patients with unstable mass or evolving intracranial compartment syndrome.\r\n\r - Platelet count < 100,000; international normalized ratio (INR) > 1.4.\r\n\r - Any irreversible coagulopathy or known clotting disorder.\r\n\r - Inability to sustain INR ≤ 1.4 using short- and long-active procoagulants (such as but\r not limited to NovoSeven, Fresh Frozen Plasma (FFP), and/or vitamin K).\r\n\r - Subjects requiring long-term anti-coagulation are excluded. Reversal of\r anti-coagulation is permitted for medically stable patients who can realistically\r tolerate the short term risk of reversal. Patient must not require Coumadin\r (anticoagulation) during the first 30 days, and normalized coagulation parameters must\r be demonstrated, monitored closely and maintained during the period of brain\r instrumentation.\r\n\r - Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the\r similar medication class) prior to symptom onset.\r\n\r - Internal bleeding, involving retroperitoneal sites, or the gastrointestinal,\r genitourinary, or respiratory tracts.\r\n\r - Superficial or surface bleeding, observed mainly at vascular puncture and access sites\r (e.g., venous cutdowns, arterial punctures, etc.) or site of recent surgical\r intervention.\r\n\r - Positive urine or serum pregnancy test in pre-menopausal female subjects without a\r documented history of surgical sterilization.\r\n\r - Allergy/sensitivity to rt-PA.\r\n\r - Prior enrollment in the study.\r\n\r - Participation in a concurrent interventional medical investigation or clinical trial.\r Patients in observational, natural history, and/or epidemiological studies not\r involving an intervention are eligible.\r\n\r - Not expected to survive to the day 365 visit due to co-morbidities and/or are do not\r resuscitate (DNR)/ do not intubate (DNI) status prior to randomization.\r\n\r - Any concurrent serious illness that would interfere with the safety assessments\r including hepatic, renal, gastroenterologic, respiratory, cardiovascular,\r endocrinologic, immunologic, and hematologic disease.\r\n\r - Patients with a mechanical heart valve. Presence of bio-prosthetic valve(s) is\r permitted.\r\n\r - Known risk for embolization, including history of left heart thrombus, mitral stenosis\r with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis.\r\n\r - Any other condition that the investigator believes would pose a significant hazard to\r the subject if the investigational therapy were initiated.\r\n\r - Active drug or alcohol use or dependence that, in the opinion of the site\r investigator, would interfere with adherence to study requirements.\r\n\r - In the investigator's opinion, the patient is unstable and would benefit from a\r specific intervention rather than supportive care plus or minus MIS+rt-PA removal of\r the ICH.\r\n\r - Inability or unwillingness of subject or legal guardian/representative to give written\r informed consent.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
970
|
[
{
"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-Heme Iron Load Quantification in the Brain - MRI of Patients With Stroke\n\n**Clinical Trial Summary:**\n\nThis study will determine if MRI imaging can be used to estimate the amount of iron in areas\r of the brain affected by a stroke. This may help future patients if the scan can be used to\r predict the amount of brain damage and therefore the effects on the patient.\r\n\r New research treatments are being used to reduce the amount of iron build-up in the brain.\r The effects of that treatment may also be estimated using new MRI techniques.\n\n**Clinical Trial Detailed Description:**\n\nHemorrhagic stroke has devastating consequences. The mechanisms resulting in early and\r delayed brain injury following a hemorrhagic stroke is poorly understood. One of the\r mechanisms demonstrated in\r\n\r animal studies points towards deposition of iron in the brain tissue following hemorrhage.\r Preliminary data in animal studies also support a favorable effect of iron chelate agents.\r Iron chelate agents are compounds that bind iron to them and may show the extent of neural\r tissue damage.\r\n\r Initial results of human trials based on this hypothesis demonstrated the safety of\r increasing amounts of desferroxamine given to human patients. The evaluation of iron chelate\r agents for hemorrhagic stroke is entering into phase II/III trials.\r\n\r There is no modality at this date that can quantify the iron in tissue non invasively. Some\r preliminary studies have demonstrated the role of MRI in identifying parenchymal iron\r deposition in traumatic brain injury.\r\n\r We propose to validate an MRI based method to not only identify but also quantify the non\r heme iron levels deposited in brain tissue following hemorrhagic stroke. Once validated this\r method will be a robust mechanism to reliably quantify tissue iron in the brain which then\r can be closely followed through iron chelate therapy in a trial setting.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a\r CT of the head.\r\n\r Exclusion Criteria:\r\n\r 1. You cannot take part in this study unless you have evidence of having a stroke\r (hemorrhage in your brain).\r\n\r 2. You cannot take part in this study if you are not able to safely have an MRI exam.\r\n\r 3. Women cannot take part in this study if they are pregnant.\r\n\r 4. Women may not participate in this study if they are attempting to become pregnant or\r think they might be pregnant. We will provide a one-time pregnancy test for anyone who\r is uncertain about being pregnant.\r\n\r 5. You cannot take part in this study if you have evidence of a large amount of\r calcifications found on CT exams that have been performed as part of the clinical\r evaluation for your current condition.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
971
|
[
{
"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\nFeasibility Study of New MRI Protocol in Assessing Early Blood Brain Barrier Disruption (BBBD)in Related to Delay Brain Edema\n\n**Clinical Trial Summary:**\n\nMRI research Group in the Advanced Technology Center of the Sheba Medical Center has\r developed an innovative methodology based on leakage (extravasation) contrast agent that\r allows to map the entire brain with high resolution and high sensitivity to check and\r describe disorders BBB (blood brain barrier).\r\n\r The aim of the current study is to evaluate the feasibility of the BBB disruption detection\r method to predict delayed peri - hemorrhage edema.\n\n**Clinical Trial Detailed Description:**\n\nResearch's Protocol:\r\n\r Evaluation and Correlation between the disruption in blood-brain-barrier and the development\r of secondary brain edema associated with brain damage by using MRI in patients with various\r types of intra-cranial bleeding .\r\n\r Research team:\r\n\r Main (Primary researcher):\r\n\r Sagi Harnof MD , Neurosurgery department, Sheba medical center, Tel Hashomer\r\n\r Secondary researchers:\r\n\r Prof. David Tanne (M.D), Neurology department .\r\n\r Dr. Yael Mardor (PhD), Advanced technology department.\r\n\r Dr. Oded Goren (M.D), Neurosurgery department.\r\n\r Dr. Masswadeh Ahmad (M.D), Neurosurgery Department.\r\n\r Background :\r\n\r Spontaneous brain hemorrhage is one of the most difficult issues in strokes concept regarding\r underlying pathology, reasons and treatment.\r\n\r Etiology:\r\n\r - General prevalence of about approximately 10-15% in all strokes.\r\n\r - Mortality and morbidity associated with it are the most severe with mortality rates of\r up to 50-60%.\r\n\r There are various pathologies thought to be responsible for bleeding, most commonly known to\r be :\r\n\r hypertension, Angiopathies, amyloidotic or vascular problems and space occupying lesions.\r\n\r Treatment process that takes place is very limited and most patients are treated only\r conservatively.\r\n\r Cytotoxic brain edema that develops around the bleeding results usually from local cell\r damage and local pressure. It usually increases in the first days after bleeding and is\r considered to be one of the main causes of deterioration after cerebral hemorrhage .\r\n\r Sub-dural cerebral hemorrhage is a common disease due to traumatic injury, often with serious\r consequences.\r\n\r Regarding the natural history of subdural bleeding, not only It's believed to be difficult\r predicting the bleeding's course, but the risk to induce cerebral edema and later on to\r develop into chronic sub Dural bleeding is unpredictable as well .\r\n\r Nevertheless chronic sub-dural bleeding is one of the most common cases seen in neurosurgery\r practice, But worthy to notify that only little is known about the pathogenesis of the\r disease, appearance of symptoms , preferable time for drainage and its complications .\r\n\r Although hasn't been contributing much in clinical evaluation of stoke, MRI has a growing\r importance in the field of stroke lately .\r\n\r In a previous neuro-imaging research that included patients after ischemic stroke it was\r shown that with an innovative methodology based on leakage extravasation) contrast agent in\r MRI which allows to map the entire brain with high resolution, we can easily evaluate the\r sensitivity disorder in BBB .\r\n\r In 27% of patients who showed no anomalies at BBB in normal MRI, calculated maps with late\r leakage showed significant volumes of BBB opening ischemic areas.\r\n\r MRI research Group in the Advanced Technology Center of the Sheba Medical Center has\r developed an innovative methodology based on leakage (extravasation) contrast agent that\r allows to map the entire brain with high resolution and high sensitivity to check and\r describe disorders BBB.\r\n\r Data Acquisition:\r\n\r MRI will be performed using the General Electric (GE) T3.0/1.5 with a standard head coil of 8\r channels.\r\n\r MRI scans will include high-resolution spin-echo T1-weighted MRI , acquired before and at\r several time points after injection (1, 12, 20, 23, 30, 70 minutes after injection).\r\n\r T1-MRI may be done with Echo Time (TE) / Repetition Time (TR) = 22/240 ms, field of view 26 x\r 19.5 inch, 5/0.5 mm slice thickness and 512x512 - pixels.\r\n\r To notify : T1-MRI data is acquired simultaneously with any conventional imaging protocol\r accepted at Sheba Medical center by routine practice. (Sheba's routine).\r\n\r Type of study:\r\n\r A prospective feasibility study performed on a group of patients with cerebral hemorrhage.\r\n\r The purpose of the study:\r\n\r 1. Assess the ability to characterize quantitatively the BBB disruption around cerebral\r hemorrhage.\r\n\r 2. Find a correlation between the degree of BBBD immediately after bleeding and cerebral\r edema 3-5 days after bleeding.\r\n\r 3. Search for clinical correlation between the degree of BBBD immediately after the\r bleeding and the clinical course that follows it later on.\r\n\r Methods:\r\n\r This is a prospective study aimed to test the feasibility of using BBBD protocol in MRI in\r order to predict the development of edema and clinical deterioration.\r\n\r Course of the experiment:\r\n\r Once the -on call- neurosurgery resident is notified about a patient with spontaneous ICH he\r would contact any of the researchers to begin the screening process for participation in the\r study. Patients who had undergone intracranial hemorrhage (ICH) that was discovered in the\r past twelve hours will undergo a screening process performed by any of the researchers in\r order to determine whether or not they meet the inclusion criteria. Such patients may arrive\r from the emergency room, intensive care unit or any of the other wards in the hospital.\r\n\r 3. An initial Baseline MRI is to be done:\r\n\r 1. for spontaneous ICH bleeding - within 6-24 hours from the bleeding.\r\n\r 2. for chronic sub dural bleeding - at the time of diagnosis .\r\n\r 3. for acute sub-dural bleeding - within 6-24 hours from the bleeding.\r\n\r It should be emphasized that the purpose of the MRI is to assess the extent of BBBD and is\r intended for research purposes only. This MRI protocol does not allow complete diagnostic\r assessment. .\r\n\r Whether the patient needs an accompanying doctor while in MRI or not, is solely determined by\r a researcher, depending on the patient's clinical situation.\r\n\r 4. Clinical follow-up : neurological status, registration of National Institutes of Health\r Stroke Scale (NIHSS questionnaire).\r\n\r a- for spontaneous bleeding - Daily monitoring & registering National Institutes of Health\r Stroke Scale (NIHSS) for five consequent days. Additional clinical follow-up will be\r performed two weeks later.\r\n\r b- for chronic or acute sub-dural bleeding follow up visit after 14 days.\r\n\r 5. second MRI which serves as review :\r\n\r 1. for spontaneous intra-cranial bleeding: on the 3rd -5th day after bleeding.\r\n\r 2. For chronic sub Dural bleeding : within two weeks.\r\n\r 3. For acute sub Dural bleeding: within two weeks.\r\n\r 6. Two months later, third MRI will be reviewed for all types of bleeding.\r\n\r 7. Result - Analysis of the outcomes as follows:\r\n\r Search correlation between BBBD and clinical status. Search BBBD correlation with\r hematoma growth.\r\n\r Search correlation between BBBD and the development of cerebral edema.\r\n\r Search correlation between BBBD and growth process of Chronic Subdural Hematoma (CSDH)\r\n\r Search correlation between BBBD and the drainage of CSDH.\r\n\r Search correlation between BBBD while Acute Subdural Hematoma (ASDH) is converted to\r CSDH.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age between 18-80 years.\r\n\r - patient is able to sign the informed consent form.\r\n\r - Spontaneous brain hemorrhage ICH in the last12 hours ( pre- admission,or sub- dural\r bleeding (whether acute or chronic ).\r\n\r Exclusion Criteria:\r\n\r - The patient meets a contraindication to undergo MRI.\r\n\r - The patient is too unstable to undergo MRI\r\n\r - The patient is a candidate for surgery within 24 hours.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
972
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nClinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache\n\n**Clinical Trial Summary:**\n\nThe purpose of this multi-center study is to assess the efficacy of headache relief of new\r paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type\r headache (ETTH).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Participants in good general health, and with diagnosis of ETTH with following\r conditions:\r\n\r 1. number of days with the condition is historically greater than or equal to two\r per month;\r\n\r 2. severity of headaches is historically at least moderate;\r\n\r 3. duration of headaches is historically more than or equal to 4 hours, if\r untreated.\r\n\r Exclusion Criteria:\r\n\r - Participant with known or suspected hypersensitivity, allergy, intolerance or\r contraindication to the use of any of the study medications\r\n\r - Participant has chronic tension type headache, psychiatric disease or a significant\r cognitive disorder, or any chronic pain disorder.\r\n\r - Participant currently taking or has taken medications or herbal supplements within the\r three months that are likely to interfere with the validity of subject-rated\r assessments.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
973
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nImproving Patient-centered Care Using an Inventory\n\n**Clinical Trial Summary:**\n\nThis study will use a multi-phase mixed-methods approach to develop and test a patient\r inventory to facilitate patient-centered care delivery. In Phase I the investigators will\r identify which factors should be considered for inclusion in the patient inventory. This will\r involve qualitative data collection with providers and patients using interviews and focus\r groups, respectively; and developing a question repository. The interviews and focus groups\r will take place at the six study sites: Hines VA Hospital and two Community Based Outpatient\r Clinics(CBOCs) in LaSalle, Illinois (IL) and Kankakee, IL; Jesse Brown VA Medical Center; and\r two CBOCs in Crown Point, IN; and Chicago Heights, IL. The question repository will involve a\r research assistant (RA) performing a literature review to gather items related to areas of\r patient context.\r\n\r Phase II will develop and test an item inventory using a Delphi panel - a panel of\r stakeholders including Veteran representatives, VA providers, researchers and representatives\r from the investigators' operations partners. The panel of at least 14 respondents will\r develop a questionnaire through three rounds of email exchanges ranking the list of items to\r be included in the patient inventory. Once the patient inventory is finalized, it will be\r integrated into an iPad application for patient use.\r\n\r In Phase III the investigators will test the patient inventory in a randomized trial.\r\n\r The investigators will conduct a randomized trial of the patient inventory to a control\r condition (e.g., healthy living video) to assess whether use of the inventory results in care\r that is more patient-centered and decisions that are more collaborative. Eligible\r participants will be identified and recruited from the Patient Aligned Care Team (PACT)\r clinics at Hines and Jess Brown VA facilities. Patients will be randomly assigned to either\r complete the patient inventory on the iPad or watch a health video on the iPad. Patients in\r the Intervention group will give a copy of the summary of the inventory to their provider.\r Both groups will be asked to carry a concealed tape recorder during their visit. Following\r the visit, patients in both groups will complete a set of questionnaires about the encounter\r including the CARE and CCM. The recordings will be analyzed by the team using a coding system\r developed in a previous Health Services Research and Development (HSR&D) study to see if the\r use of the patient inventory facilitated patient-centered care during the encounter. A second\r coding scheme, the Informed Decision Making (IDM) will also be applied to examine\r collaborative decision making.\n\n**Clinical Trial Detailed Description:**\n\nResearch Design and Methods: This study will utilize a multi-phase mixed-methods approach to\r develop and test a patient inventory to facilitate patient-centered care delivery. In Phase I\r the investigators will identify which factors should be considered for inclusion in the\r patient inventory. This will involve interviews and focus groups with providers and patients,\r respectively; and a review of the relevant literature. In Phase II the investigators will\r develop and test an inventory using a Delphi panel and assembling a questionnaire repository.\r In Phase III the investigators will conduct a randomized trial comparing the patient\r inventory to a control condition (e.g., healthy living video) to assess whether use of the\r inventory results in care that is more patient-centered and decisions that are more\r collaborative.\r\n\r Phase I: To identify patient contextual factors and preferences, and patients' experiences,\r awareness, resources, and willingness to use technology for care delivery, the investigators\r will conduct focus groups with patients at 2 facilities and 4 CBOCs in Veterans Integrated\r Service Network 12 (VISN 12) representing urban and rural settings and a mix of\r sociodemographic characteristics.\r\n\r In order to capture the perspective of Veterans who live in more rural areas and who may\r represent a broader range of socio-demographic characteristics, the investigators will\r conduct focus groups at four CBOCs associated with the medical facilities that represent\r urban/rural and ethnic diversity.\r\n\r The investigators plan to recruit both patients who have received care through technology\r (e.g., home telehealth (HT), CVT) and those who have had little or no experience with care\r delivered through technology. The investigators will conduct separate focus groups with\r patients who have received care through technology and those who have not used technology for\r health care. Focus group discussions will be transcribed verbatim and analyzed using constant\r comparative techniques to code the data thematically. This information will serve as the\r foundation for developing the inventory.\r\n\r A total of 8-12 focus groups will be conducted with 5-8 Veteran participants per group (n=40\r to 96 patients). The investigators will conduct 2 focus groups at each VA facility, and 1-2\r focus groups at each CBOC. Based on prior experience conducting focus groups with Veterans,\r the investigators believe that this number of focus groups will provide sufficient data to\r reach saturation, the point at which no new information is uncovered during group discussion.\r Two members of the research team will manage each focus group.\r\n\r Patient Focus Group Questions. A discussion guide that includes open-ended items with probes\r and follow-up questions will be used to conduct focus groups with patients. The guide\r consists of questions designed to generate discussion among participants concerning\r contextual factors, patient-centered care, and technology use for health care delivery. The\r first set of questions will assist in identifying contextual factors that affect patients'\r abilities to manage their care. The second set of questions will explore patients'\r understanding of and preferences for patient-centered care. The final set of questions will\r describe patients' awareness of, available resources, and willingness to use health\r technology.\r\n\r Data will be analyzed using constant comparative techniques consistent with a grounded-theory\r approach\r\n\r Provider Interviews. Semi-structured interviews will be conducted with healthcare providers\r at each of the sites. Providers will consist of PACT and/or primary care team members\r including nurse care managers and physicians. The investigators will use semi-structured\r interviews for providers because of the added flexibility afforded by this method with\r respect to time and scheduling. The investigators developed a semi-structured interview guide\r to address the research objectives. The first set of questions is designed to identify\r contextual factors and understand how providers attempt to address them. Data will be\r analyzed using the same process detailed for analysis of focus group data (i.e., constant\r comparative techniques consistent with grounded theory).\r\n\r Question Repository. In parallel with focus groups and interviews, the investigators'\r research assistant will review the available literature through PubMed, psycINFO and other\r reference search engines for surveys/questionnaires that include items related to areas of\r patient context. Initial search terms include: assessment tool, assessment scale, risk\r assessment, contextual factors, patient questionnaires and context specific terms such as\r technology resources, social support and patient-centered care. The investigators will\r assemble a repository of questions that could be used for the investigators' inventory. If\r there are contextual areas in which the investigators are unable to find adequate questions,\r the investigators will generate items for consideration by the Delphi panel.\r\n\r Phase II: Creating the Patient Inventory. Using findings from focus groups, information from\r the literature, and input from an expert panel the investigators will draft a patient\r inventory that can serve as a collaborative decision tool for patients and providers. The\r investigators will work with the expert panel to identify and refine the content areas for\r the inventory using a modified Delphi panel approach. The goal of the project is to develop\r an instrument that would take no more than 10-15 minutes for a patient to complete.\r\n\r Participants/procedures. A heterogeneous panel will be chosen based on participants'\r willingness to participate and knowledge of the relevant topic. Because patients are the key\r stakeholder for patient-centered care, the investigators will assemble a panel that includes\r Veteran representatives, VA providers, researchers and representatives from the\r investigators' operations partners. To maintain at least 14 respondents (70%), the\r investigators will initially recruit 20 panelists (5 in each stakeholder group).\r\n\r The investigators will conduct the Delphi process through a series of email exchanges. In the\r first email round, a list of possible items for each of the context areas will be\r distributed. Panelists will be asked to rank the importance of the areas of context\r identified, comment on whether they feel that there is redundancy in categories, and provide\r input on the relevance of items within each content area to patient context, patient-centered\r care and/or collaborative decision-making. The investigators will also ask an open-ended\r question allowing panel members to identify areas that they feel should be included.\r Responses will be entered without identification of the panelists. Each participant will be\r assigned an ID code. Categories and items for which the panelists agree do not fit or are\r redundant with other items that are better worded, and those items that are ranked very low\r will be dropped.\r\n\r A revised set of categories and items will be sent to the panelists for a second round of\r review. At that time, the panelists will repeat the process used for the first round review.\r A final draft will be sent to the panel for one more review. The investigators will also\r include feedback about qualitative comments made by panelists in each round and data about\r specific item ratings (e.g., median, lowest and highest ratings per item, etc.) The responses\r to this last review will be used to finalize the patient inventory. The investigators\r anticipate that this process will take approximately 4-5 months to complete the Inventory\r Template. Once the patient inventory is finalized, the investigators will integrate them into\r an iPad application for patient use. The iPad provides multiple advantages for collecting\r patient information, providing a portable, touch-driven multimedia experience popular across\r different demographic strata. The iPad inventory will include skip patterns for respondents\r to jump over non-relevant items, out-of-range checking and validation so that respondents do\r not enter erroneous information, drop-down boxes, and utilize examples and explanations for\r clarity. Patients will have the opportunity to \"not answer\" any items, based on personal\r comfort of what information should be shared.\r\n\r The investigators will perform iterative testing of the iPad version of the inventory to\r ensure acceptability by patients. All information entered in the iPad will be kept private\r and secure, such that other patients cannot access any stored data. As an additional\r safeguard, the iPad will \"time out\" if not used for some duration of time to prevent\r extraneous viewing by others. The iPad will be used in waiting areas by patients prior to\r encounters with health care providers. Research staff will maintain the iPad, including\r charging, storing securely when not in use to prevent theft, applying anti-bacterial cleaner,\r and monitoring device use.\r\n\r When patients use the iPad inventory, the application will create a brief report summarizing\r patient preferences and contextual factors. This report will be available to the PACT at the\r point of care to facilitate patient/provider communication and collaborative decision-making.\r For the initial study, research staff will facilitate communication of the report to health\r care providers by generating a paper summary that patients will hand to providers. However,\r design and testing will consider future implementation strategies, including incorporation\r into clinical workflow patterns and adoption by clinical staff.\r\n\r Phase III: Testing the Patient Inventory. The investigators plan to pilot the patient\r inventory in a sample of Veterans in two sets of PACT clinics; one at Hines and the other at\r JBVA. The study design is a randomized controlled trial. The investigators will randomize\r half the patients to complete the patient inventory and the other half to a control condition\r (i.e., health video). The investigators will stratify by Veterans Affairs Medical Center\r (VAMC) to ensure that there are equal samples. The randomization scheme will be developed\r using computer generated random assignment.\r\n\r Eligible patients will be identified and recruited from the PACT clinics at Hines and Jesse\r Brown VAMCs. No subjects will be excluded based on gender, race, or ethnicity. Eligibility\r criteria include: (1) adult, age 18 or over; (2) assigned primary care provider in PACT\r clinic; (3) no history of dementia; (4) no blindness (unable to view iPad app). Only patients\r of participating providers will be eligible for the study, to ensure both patient and\r provider consent to audio-recordings and study procedures.\r\n\r It is possible that providers will discern that their visits with patients that involve the\r use of 'summary' forms are the same visits that will be audio-recorded. To address the\r likelihood of a Hawthorne effect the following strategies will been undertaken. First,\r providers will be informed that some of the visits that are recorded will include patients\r providing additional written information for providers while other visits will not include\r this information. Second, the investigators will undertake sensitivity analyses comparing\r data from the first 10% of audio-recorded encounters to the 2nd and 5th 10% of encounters.\r The investigators will assess whether provider behavior is significantly different at these\r points in time. If the first several visits result in different behavior then later visits,\r the investigators can eliminate the first recordings from their analyses. Thus, the\r investigators will over-recruit patients by 10%, with patients evenly distributed between\r intervention and control arms.\r\n\r Intervention: The patient inventory developed through focus groups and Delphi panel will\r serve as the intervention. The inventory will be deployed using an iPad. Patients will\r provide a copy of the summary to their provider at the beginning of their visit.\r\n\r Control Condition. To address concerns about a Hawthorne effect, the investigators will\r implement an attention control. The control group will use the iPad to will view a brief\r health video (e.g., 8-10 minutes) containing general health information. The VA National\r Center for Health Promotion and Disease Prevention (NCP) is currently developing a set of\r video-based health living messages. The investigators will utilize one of these videos in for\r their control group. Alternatively, Agency for Healthcare Research and Quality (AHRQ) has\r developed several videos that are available at no cost and are 508 compliant. The 'Be\r involved in your health care - Questions are the answer' is a 7 minute video that is focused\r on talking to your provider and asking questions\r (http://www.ahr.gov/questions/video/waitroom/). Control patients will also be asked to\r audio-record their encounter with their provider, but not to reveal that they are doing so.\r\n\r Patients will complete the informed consent process, agreeing to use of the iPad to either\r complete an inventory or view a video about their health, willingness to have their encounter\r with the provider audio recorded, and completion of a set of questionnaires following the\r clinic visit. Consenting patients will complete the patient inventory or view the video on an\r iPad prior to their clinic visit. A research assistant will instruct the patient on how to\r use the iPad and what the patient needs to do to complete the questionnaire (in the\r intervention condition). The RA will be available to answer questions or provide additional\r instruction, as needed. After intervention patients complete the questionnaire, the RA will\r hook the iPad up to a portable printer so that a hard copy of the inventory can be generated\r for patients to immediately give their provider. The patient will proceed to his/her visit\r with the provider. To ensure adequate use of the iPad and the patient inventory, the RA will\r be available to assist subjects in use as necessary. The research team will collect\r information on how frequently assistance is needed, and form of support provided. The\r investigators estimate the inventory will take approximately 10-15 minutes to complete.\r Patients will have the opportunity to complete the inventory in a designated, private area to\r reduce interruptions and distractions.\r\n\r In both the intervention and control arms, patients will be asked to conceal a small\r recording device in their pocket and/or bag in order to record their conversation with the\r provider. The patient will be told that the provider has agreed to be recorded during some of\r their patient visits but that the provider will not know which visits will be recorded. The\r RA will turn the device on before handing it to the patient and the patient will return the\r recorder after the visit. Weiner has successfully utilized this strategy in two HSR&D funded\r studies.\r\n\r Following the clinic visit, the patient will be asked to complete a set of questionnaires.\r These items will be completed using paper and pencil. The investigators will also ask\r patients to indicate whether they have used any technology for their health care using a\r checklist (use of home telehealth, CVT, secure messaging, prescription refills through\r HealtheVet [MHV], use of mobile apps like PTSD coach, accessing VA Facebook or twitter sites)\r and whether any future care plans include use of technology.\r\n\r Providers. PACT providers will also serve as research subjects for the study. The\r investigators will ask providers to consent to having some of their encounters recorded over\r a one year period. The investigators will explain to providers that they are interested in\r examining the effects of providing or not providing additional patient-generated information\r to providers at the time of their visit on patient/provider interactions. Providers will be\r assured that no identifiable information will be recorded on the transcriptions (e.g.,\r providers will be referred to by a unique study ID number). The investigators will also ask\r providers to participate in a debriefing interview at the end of the study to ask them about\r the value and use of the pre-visit patient inventory in their encounters with patients. Only\r patients of providers who consent to participate will be approached about study\r participation.\r\n\r Study Measures: To determine patient-centeredness the investigators will ask patients to tell\r them about their experiences with care and the extent to which care they received met their\r preferences and addressed their contextual factors. The investigators will utilize measures\r of patient-centeredness including the Consultation and Relational Empathy (CARE) measure and\r the Consultation Care Measure (CCM).\r\n\r To objectively evaluate the extent to which care being provided is patient-centered, the\r investigators will obtain audiotapes of patient/provider encounters and code them using\r Weiner's 4C analysis measure and the Informed Decision Making (IDM) tool to evaluate\r collaborative decision making during patient/provider encounters. These measures are\r described below:\r\n\r CARE. The Consultation and Relational Empathy (CARE) Measure is a process measure of empathy\r and holistic care in the context of a therapeutic relationship. Mercer defines empathy in the\r medical encounter as the ability of the provider to understand the patient's situation,\r perspective and feelings; to communicate to the patient what their understanding is and check\r whether s/he is correct in this interpretation, and then to act in a way that is helpful and\r therapeutic .This description fits into many definitions of patient-centered care. The CARE\r measure has 10 items and it specifically asks about today's consultation. To better fit the\r definition of care in the US, the investigators will change the word consultation to 'visit.'\r For each item, the respondent rates their response as poor, fair, good, very good, excellent,\r or does not apply. Questions include: How was the provider at 'making you feel at ease',\r 'letting you tell your \"story\"', 'being positive.' The score for each item is added for a\r maximum score of 50 and minimum of 10; a higher score reflects greater\r 'patient-centeredness'.\r\n\r CCM. The Consultation Care Measure (CCM) measures a patient's perceptions of patient-centered\r care during their last visit with their provider. There are 5 subscales in this 21-item\r scale. CCM assesses communication and partnership (11 items), personal relationship (3\r items), health promotion (2 items), positive and clear approach to the problem (3 items),\r interest in effect on life (2 items). The items use a 4-point Likert scale for scoring from\r 1= very strongly agree to 2= strongly agree to 3=agree to 4=neutral/disagree. Cronbach's\r reliabilities range from 0.84 to 0.96 for the subscales. A higher level of\r patient-centeredness based on the CCM (lower score) was associated with short-term better\r health outcomes.\r\n\r Informed Decision Making (IDM) measures the extent to which decision making involving the\r patient and provider includes 7 elements of a complete decision. The 7 elements include:\r discussion of patient's role in decision making, clinic issue or nature of the decision,\r alternatives, pro and cons (benefits and risks), uncertainties, patient understanding, and\r patient preference. For each decision, a score between 0-7 is assigned based on review of the\r audio-recorded encounter. A higher score is expected if the decision is more complex\r (decisions can be categorized as basic, intermediate or complex). For basic decisions (e.g.,\r refilling a medication), a score of 2-3 would indicate a good IDM event, while a more\r intermediate decision (e.g., prescribing use of a new piece of equipment - such as CPAP)\r should result in a score of 5-6 reflecting an informed decision; and a complex decision\r (e.g., lifestyle counseling) would receive a score of 7 if all the elements of the IDM were\r noted during the decision.\r\n\r Content Coding for Contextualizing Care (4C). The 4C analysis is methodology for assessing\r patient centered clinical decision making. Specifically, 4C rates encounters based on whether\r the provider (a) probes for clinically relevant context and (b) plans the care accordingly.\r The analysis is generated from both the patient's medical record and from an audio recording\r of the provider-patient visit. 4C may be conducted by as few as two individuals or as many as\r five, with the additional personnel required to verify inter-rater reliability and other\r sources of evidence for validity. Coding will be done by an experienced coder who has worked\r with Dr. Weiner on two prior studies utilizing the 4C analysis. Using this coding we will\r determine how often providers probe for contextual factors during patient encounters, and how\r often they incorporate this information into their care planning for that encounter.\r\n\r Sample size/power: The primary measure of patient-centered care is the CARE measure.\r Normative data on the CARE indicates a mean score of 40.8 (range 10-50) with a\r between-physician variance of patients receiving care from the same physician, = 9.0247, and\r within-patient variance = 69.2149, for a total variance = 78.2396 (SD=8.85) (Mercer 2005).\r Without taking into account related patient CARE scores of patients being treated by the same\r physician, 64 patients in both control and intervention groups (total n=128) will be adequate\r to detect a moderate effect size (Cohen's d=0.5) at the 0.05 level with 0.8 power. Of course,\r patients receiving care from the same physician might respond similarly to questions\r regarding empathy and holistic care pertaining to their physician, as recorded by the CARE\r measure. The multiplicative effect on the standard error due to clustering is 1 + (m-1)*ICC,\r where m represents the size of each cluster (patients per physician) and ICC the intraclass\r correlation of same-physician patient CARE outcomes. 25 doctors with 11 patients each, or 24\r doctors with 12 patients each will be sufficient in detecting a moderate effect size (Cohen's\r d=0.5) at the 0.05 level with 0.8 power. Accounting for the possibility that patients may\r change their mind, be too fatigued, and/or have not enough time to complete the post-visit\r questions, or deficiencies in physician attrition, the investigators have added an additional\r 10% (28 more patients/25-26 physicians) to the total.\r\n\r The total study sample size is 25-26 providers and 300-308; 150-154 patients per group.\r\n\r Patients enrolled in the PACT clinics at Hines and Jesse Brown will serve as the patient\r subject pool and the providers in these PACT teams will serve as the provider subjects. Only\r patients who are in the panels of providers who consent to participate will be recruited for\r the study.\r\n\r Analysis: Descriptive statistics including frequencies and means will be calculated to\r characterize the investigators' patient sample, including demographics (e.g., mean age,\r gender, ethnicity/race). The investigators will utilize t-tests to make comparisons of\r intervention and comparison groups on the patient measures. The overall scores and the\r subscale scores for the CARE and the CCM will be compared using t-tests. They will then\r examine the extent to which other characteristics including study site (Hines, JBVA) and\r patient characteristics (age, race) account for differences in ratings of patient-centered\r care using linear regression models. The investigators will use the standard formula Y = a +\r b1X + b2X +. biX, with no more than 15 covariates (using 1 covariate for every 10\r observations) in addition to the intervention effect (b1). As many patients may have the same\r provider, there could be an effect for provider. They will explore use of multi-level\r modeling to account for provider effects.\r\n\r 4C Coding and Analysis. 4C analysis rates encounters based on whether the provider probes for\r clinically relevant context and plans care accordingly. The analysis uses both the patient's\r medical record and an audio- recording of the provider-patient visit. 4C coding includes the\r following:\r\n\r 1. Contextual red flag identification: Following an encounter, the first step for coders is\r to determine if there were any contextual red flags that the provider would need to have\r explored to provide appropriate care. Red flags include things like missed appointments,\r non-adherence of medications or receipt of laboratory tests or deterioration of chronic\r illness (e.g., uncontrolled blood pressure). A contextual red flag is defined as\r anything a patient says or that was observed about his situation or behavior that\r suggests that contextual factors were not addressed and may be contributing to problems\r with their care. The search for contextual red flags begins with a structured medical\r record review by a contextual red flag \"screener\". If no flags are found in the medical\r record the coder listens to the audio-recording to determine if the patient made\r statements suggesting underlying contextual issues essential to their care. For example:\r a. Contextual red flag identified from chart review: Rising systolic blood pressure in\r patient with hypertension who has been previously well controlled. b. Contextual red\r flag identified from audio-recording: Visually impaired Veteran with hypertension\r mentions that his daughter, who sets up his medications in a daily pill box, has\r relocated to another city for her job.\r\n\r 2. Coder(s) formulate an unambiguous direct probe of red flag: The coder(s) compose an\r unambiguous provider probe to the identified contextual red flag, e.g. \"I notice that\r your hypertension used to be well controlled but your blood pressure has been very high\r over the last couple of months. What do you think is going on in your life that might be\r a factor in this problem?\" The probe is always in the form of a question by the provider\r in response to a red flag. The purpose of this exercise is to help the coder identify\r what s/he should be listening for to indicate that the provider has noticed and is\r pursuing the contextual red flag.\r\n\r 3. Coder listens for clinician probe: The coder then listens for whether the provider\r pursued the contextual red flag in a manner that substantively approximates their direct\r probe.\r\n\r 4. Coder listens for a 'patient reveal' in response to a probe: If the provider probed, the\r coder determines whether the patient revealed contextual information that is relevant to\r care, such as \"It's a lot more difficult for me to remember to take my medication when\r I'm supposed to since my daughter left.\"\r\n\r 5. Coder formulates an unambiguous direct response to the patient reveal: If the patient\r reveals contextual issues in response to the probe, the coder formulates an unambiguous\r response to the reveal that indicates the provider recognized the need to contextualize\r the care plan, e.g. \"Let's talk about how you could change your medication schedule to\r help you remember.\"\r\n\r 6. Coder listens for contextualization of care plan: The coder then listens for whether the\r provider recommends a plan of care that substantively approximates their direct probe.\r (e.g., switches all medications to morning)\r\n\r Because coding can be quite nuanced, Weiner et al. has developed a comprehensive training\r manual, similar to those developed for other coding systems, such as Debra Roter's \"Roter\r Interaction Analysis System\" (RIAS), utilized for coding physician patient communication.\r RIAS codes interactional process behaviors (e.g. when clinician or patient asks open vs\r closed ended questions, gives instructions, asks for understanding, paraphrases, etc.) but\r not content. The 4C coding manual is available from Dr. Weiner, co-inv on the study.\r (http://dvn.iq.harvard.edu/dvn/dv/4C)\r\n\r IDM Analysis. Reliability of coding between three coders will be established with at least\r 85% concurrence before the coders will individually code encounters. The investigators will\r recheck reliability after every 25 encounters by having all coders code the same encounter to\r ensure that they are all coding in a similar manner. If concurrence is below 75%, the\r investigators will review coding criteria and re-establish concurrence using the next 2-3\r audiotaped encounters. Coders will listen to the audiotapes and identify the number and types\r of decisions that occurred during each encounter. Then they will select the decision of more\r interest/concern of the patient and code that decision using the IDM criteria. The\r investigators will compare the mean IDM scores by decision type by intervention vs. control\r groups to determine whether use of the inventory facilitates more informed decision making\r\n\r Cost impact: In this study, the investigators will conduct a cost-identification analysis to\r assess the cost of providing the intervention in this study. Additionally, they will conduct\r a budget impact analysis to assess the impact on costs to a VA medical center of implementing\r the patient inventory. The cost of the intervention includes the cost of the equipment needed\r for the intervention (i.e., the iPad and printer) and the cost of any change in clinic\r personnel time that results from the intervention. The patient inventories may impact clinic\r personnel's time due to the need to train and assist the patient in entering the inventory as\r well as potentially changing the duration of the clinic visit due to discussions facilitated\r by the patient inventory. The RA will record 1) the time it takes to train each patient to\r use the iPad, 2) the time it takes for each patient to complete the patient inventory and the\r proportion of this time the RA spent assisting the patient, and 3) the time it takes to print\r the inventory for the patient to give to the provider. Additionally, the RA will record\r whether it interferes with being on time for the clinic visit. The RA will also record the\r length of the provider/patient encounter by recording the time the provider entered the\r clinic room to see the patient and then when he leaves the room/completes the visit. In order\r to make comparisons to usual care, the RA also will record the length of time of usual\r encounters by timing the encounters of the control patients in the randomized.\r\n\r The investigators will also conduct a budget impact analysis to evaluate the cost of\r implementing the intervention at a VA medical center. The estimated budget impact on the\r medical center will be sum of the purchase price of the equipment, the cost of the clerical\r personnel's time, and the cost of physicians' time (which will be estimated as an average\r physician's wage multiplied by the difference in the average time of clinic visits between\r intervention and control patients). The investigators will estimate the total cost of\r providing the intervention to patients under the alternative scenarios regarding the number\r of patients who would complete the inventory and the amount of equipment that would need to\r be purchased.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Phase I:\r\n\r - VA patients who have had some experience with care receipt through technology (e.g.,\r home telehealth, CVT, secure messaging with providers).\r\n\r - A second group will be conducted with patients who have not had experience receiving\r care through technology.\r\n\r - There are no other specific inclusion criteria and the investigators plan to recruit\r both male and female Veterans, as well as minorities.\r\n\r Phase II:\r\n\r - Veterans who receive care from VA and are comfortable using the Internet.\r\n\r - There are no other specific inclusion criteria and the investigators plan to recruit\r both male and female Veterans, as well as minorities.\r\n\r Phase III:\r\n\r - Veterans who receive care from Hines VA or Jesse Brown VA in a primary care/PACT\r clinic.\r\n\r - No subjects will be excluded based on gender, race, or ethnicity. Eligibility criteria\r include:\r\n\r - (1) adult, age 18 or over\r\n\r - (2) assigned primary care provider in PACT clinic\r\n\r - (3) no history of dementia\r\n\r - (4) no blindness (unable to view iPad app).\r\n\r - Only patients of participating providers will be eligible for the study, to ensure\r both patient and provider consent to audio-recordings and study procedures.\r\n\r - There are no other specific inclusion criteria and the investigators plan to recruit\r both male and female Veterans, as well as minorities.\r\n\r Exclusion Criteria:\r\n\r - A history of dementia\r\n\r - Blindness\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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974
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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\nCryoablation of Venous Vascular Malformations\n\n**Clinical Trial Summary:**\n\nTo now, two alternatives for the management of venous vascular malformations are recognized,\r appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is\r effective on symptoms in 80% of cases and excision removes the malformation completely or\r partially, but it is aggressive and recurrences are common.\n\n**Clinical Trial Detailed Description:**\n\nIn order to propose an additional alternative option, cryoablation has been recently tested\r with promising results. Therefore, the purpose of this study is to evaluate the safety and\r efficacy of cryotherapy on venous vascular malformations.\r\n\r Fourteen patients will be included after discussion in multidisciplinary meeting. Patients\r will be follow until 6 months to evaluate the safety and the 6 months efficacy on symptoms. A\r MRI will be perform at 6 months to evaluate the size of ablated zone following RECIST\r criteria.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient over 18 years,\r\n\r - Initial radiological diagnosis of venous or glomovenous vascular malformation proved\r by Doppler ultrasound and MRI,\r\n\r - Recurrence of symptoms after initial treatment,\r\n\r - Symptomatic deformation :pain, tangible mass,functional discomfort\r\n\r - Recurrence after treatment by surgery or sclerosis\r\n\r - Cryotherapy considered technically feasible after discussion in multidisciplinary\r committee,\r\n\r - Localization at distance from the skin and major neurovascular structures,\r\n\r - Absence of contra-indication of anaesthesia,\r\n\r - Signed informed consent,\r\n\r - Coverage by French social security\r\n\r Exclusion Criteria:\r\n\r - Localization of the lesion does not allow the implementation of cryotherapy in\r adequate conditions: ablation zone too close to the major anatomic structures (nerve),\r\n\r - TP <50% TCA> 1.5 x control, anticoagulation\r\n\r - Platelets <90000/mm3,\r\n\r - Progressive infection\r\n\r - Patient included in another clinical study,\r\n\r - Unable to undergo medical tests for geographical, social or psychological,\r\n\r - Adult under a legal guardianship or unable to consent,\r\n\r - Pregnancy and breastfeeding.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
975
|
[
{
"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\nCONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)\n\n**Clinical Trial Summary:**\n\nThe primary objectives of this study are to compare the difference in glycosylated hemoglobin\r (HbA1c) from baseline to Month 6 using Hylenex recombinant preadministration in continuous\r subcutaneous insulin infusion (CSII) versus standard CSII and to evaluate the safety of\r Hylenex recombinant preadministration, including local tolerability, adverse events, and\r hypo- and hyperglycemia rates.\n\n**Clinical Trial Detailed Description:**\n\nThis Phase 4 study is designed to demonstrate noninferiority of pretreatment with Hylenex\r recombinant in the CSII setting to rapid-acting analog insulin alone with respect to glycemic\r control as assessed by changes in HbA1c in participants with Type 1 diabetes mellitus.\r\n\r Total duration of study treatment is 24 months. However, according to the study design, the\r primary outcome measure is to be assessed at 6 months and an interim analysis is to be\r completed at 6 months for the secondary outcome measures and adverse events. Therefore, data\r reported in this clinical trials record is for the 6-month interim analysis.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Male or female of age 18 years or older with a history of T1DM for at least 12 months\r\n\r 2. Glycosylated hemoglobin (HbA1c) 6.5% to 9.5% (inclusive) based on central laboratory\r results\r\n\r 3. Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)\r\n\r 4. Current use of an insulin pump compatible with available tubing for Hylenex\r recombinant infusion and use of an infusion set compatible with the tubing available\r or willingness to switch to an infusion set compatible with tubing available for\r infusion of Hylenex recombinant\r\n\r 5. Current treatment at the time of screening with insulin <300 units per day (U/day)\r\n\r 6. Participants who routinely use continuous glucose monitoring (CGM) (defined as average\r CGM use 5 or more days per week over the preceding 3 months) and those who do not\r routinely used CGM are both eligible for inclusion in the study. Intermittent use of\r CGM is also acceptable but will not be a criterion use for stratified randomization.\r\n\r 7. Participants should be in good general health based on medical history and physical\r examination, without medical conditions that might prevent the completion of study\r drug infusions and assessments required in this protocol.\r\n\r Exclusion Criteria:\r\n\r 1. Type 2 diabetes\r\n\r 2. Known or suspected allergy to any component of any of the study drugs in this study\r\n\r 3. Severe proliferative retinopathy or maculopathy, and/or gastroparesis, and/or severe\r neuropathy, in particular autonomic neuropathy, of such severity as to impede the\r participant's ability to comply with protocol procedures, as judged by the\r Investigator\r\n\r 4. History of transmural myocardial infarction, congestive heart failure and uncontrolled\r hypertension (diastolic blood pressure [BP] consistently >100 millimeters of mercury\r [mmHg]) are exclusionary\r\n\r 5. As judged by the Investigator, clinically significant active disease of the\r gastrointestinal, cardiovascular (including history of stroke, history of arrhythmia,\r or conduction delays on electrocardiogram [ECG]), hepatic, neurological, renal,\r genitourinary, pulmonary, or hematological systems of such severity as to impede the\r participant's ability to comply with protocol procedures\r\n\r 6. History of any illness or disease that in the opinion of the Investigator might\r confound the results of the study or pose additional risk in administering the study\r drugs to the participant\r\n\r 7. As judged by the Investigator, clinically significant findings in routine laboratory\r data at screening\r\n\r 8. Use of drugs that may interfere with the interpretation of study results or are known\r to cause clinically relevant interference with hyaluronidase action, insulin action,\r glucose utilization, or recovery from hypoglycemia (including systemic pharmacologic\r corticosteroid). Use of pramlintide or a glucagon-like peptide [GLP]-1 receptor\r agonist is not exclusionary but participants using these agents will be subjected to\r stratified randomization. Use of aspirin (acetylsalicylic acid [ASA]) up to 325\r milligrams (mg)/day is not exclusionary but should be noted for analysis.\r\n\r 9. Hypoglycemic unawareness of such severity as to impede the participant's ability to\r comply with protocol procedures, as judged by the Investigator.\r\n\r 10. Current addiction to alcohol or substance abuse as determined by the Investigator.\r\n\r 11. Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate\r contraceptive measures (adequate contraceptive measures consist of sterilization,\r intra-uterine device [IUD], oral or injectable contraceptives, and/or barrier\r methods). Abstinence alone is not considered an adequate contraceptive measure for the\r purposes of this study.\r\n\r 12. Mental incapacity, unwillingness, or language barriers precluding adequate\r understanding or cooperation in this study\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
976
|
[
{
"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 Study of Insulin Glargine and NPH Insulin\n\n**Clinical Trial Summary:**\n\nThis study will compare the safety, effectiveness, and cost of two different types of\r long-acting insulin.\n\n**Clinical Trial Detailed Description:**\n\nIn this study the investigators will be comparing two long-acting insulins, insulin glargine\r and NPH insulin. The trial will be evaluating differences in effectiveness, safety and cost\r between the two agents when used in patients on more than 80 units or 1unit/kg long-acting\r insulin. The investigators hypothesis is that patients switched from lantus to NPH will have\r improved blood glucose control.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adult patients at 22 Providence Medical Group primary care clinics\r\n\r - Diagnosis of type 2 diabetes mellitus\r\n\r - Currently using greater than 80 units/day of insulin glargine or greater than 1\r unit/kg/day of insulin glargine\r\n\r - Current A1C > 8.5% (within 3 months of randomization)\r\n\r Exclusion Criteria:\r\n\r - Diagnosis of type 1 diabetes mellitus\r\n\r - Age > 85 years\r\n\r - Self-reported history of severe hypoglycemia or hypoglycemia unawareness\r\n\r - Hospice/limited life expectancy\r\n\r - Current enrollment in Providence Medical Group Medication Assistance Program\r\n\r - Current use of a GLP1 agonist (i.e., liraglutide, exenatide, exenatide\r extended-release)\r\n\r - End stage renal disease (i.e., dialysis or estimated glomerular filtration rate <15\r ml/min/1.73m2)\r\n\r - Cirrhosis\r\n\r - Unstable coronary artery disease or chronic heart failure (i.e. an exacerbation or\r hospitalization within 6 months pre-randomization)\r\n\r - Psychiatric condition that prevents adequate follow-up (i.e., > 3 missed follow-up\r visits within a 3 month period or persistent non-adherence to dosing or monitoring\r recommendations)\r\n\r - Active alcohol or drug abuse\r\n\r - Inability to provide informed consent\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
977
|
[
{
"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\nOccipital Nerve Stimulation in the Treatment of Migraine\n\n**Clinical Trial Summary:**\n\nThe objective of this proof-of-concept study is to generate initial safety and effectiveness\r data for the neuro-modulation stimulation (NMS) E-Box in patients with chronic migraine in an\r acute setting. The results of this study will determine if further development of this device\r in a larger study is warranted.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Adult ≥ 18 and ≤ 65 years of age females or males;\r\n\r 2. Willing to participate in the study and to complete all study-related procedures,\r evaluations, and headache diaries;\r\n\r 3. Able to understand, agree to, and sign the study's IRB-approved informed consent form;\r\n\r 4. Has a physician-made diagnosis of Chronic Migraine as defined by the following (a, b,\r and c):\r\n\r 1. Headache (tension-type and/or migraine) lasting a minimum of 4 hours on ≥15 days\r per month for at least 3 months and on ≥XX (redacted by sponsor to preserve\r integrity of study) days in the 30 days prior to the Screening Visit;\r\n\r 2. Headaches on ≥8 days per month for at least 3 months that have fulfilled the\r following:\r\n\r i. Headaches with at least two of the following:\r\n\r - unilateral location;\r\n\r - pulsating quality;\r\n\r - moderate or severe pain intensity;\r\n\r - aggravation by or causing avoidance of routine physical activity (e.g. walking or\r climbing stairs);\r\n\r ii. AND at least one of the following:\r\n\r - nausea and/or vomiting;\r\n\r - photophobia and phonophobia;\r\n\r iii. OR headaches that have been treated and relieved by triptan(s) or ergot before\r the expected development of the symptoms listed in 4.b.i and 4.b.ii above;\r\n\r c. Headaches are not attributed to a substance or substance withdrawal, infection,\r cranial neuralgias, cluster headaches, autonomic cephalalgias, or cranial, cervical\r vascular, non-vascular, intracranial homeostasis and psychiatric disorders;\r\n\r 5. If taking medication (prescribed or over-the-counter) for migraine prophylaxis, the\r medication must have been taken for at least 2 months and the dosage(s) must have been\r stable for at least 1 month prior to the Screening Visit. There must be no plan to add\r to, discontinue, or change the dose of these medications throughout the subject's\r participation in the study;\r\n\r 6. To be eligible for the inpatient Treatment Period: the subject must have recorded in\r the Headache Diary ≥XX (redacted by sponsor to preserve integrity of study) headaches\r days (at least 4 hours of continuous head pain per headache day) in the 30 days\r immediately prior to the Inpatient Treatment Eligibility Visit (Visit 2);\r\n\r 7. To be eligible for the inpatient Treatment Period: mean head pain severity of ≥XX\r (redacted by sponsor to preserve integrity of study) and ≤XX (redacted by sponsor to\r preserve integrity of study) based on the 11-point Numerical Rating Scale (NRS) in the\r 30 days immediately prior to the Inpatient Treatment Eligibility Visit (Visit 2) [only\r data from headache days will be used to calculate the mean head pain severity; missing\r data on a headache day will be considered to be zero (0) for this calculation]; and\r\n\r 8. To be eligible for the inpatient Treatment Period: The subject must be experiencing\r head pain on the day of the inpatient Treatment Eligibility Visit (Visit 2). Subjects\r may continue the Screening Period for another week if head pain is not present at\r Visit 2.\r\n\r Exclusion Criteria:\r\n\r 1. Any head pain, including coexisting head pain, not attributable to Chronic Migraine as\r defined in this study's Inclusion Criterion #4;\r\n\r 2. Any condition that could affect the subject's ability to assess the effect of\r neurostimulation or in which neurostimulation may be a safety concern, including but\r not limited to:\r\n\r 1. Known history of epilepsy or recurrent seizures;\r\n\r 2. Known neurogenic and neuromuscular disorders (i.e. myasthenia gravis, multiple\r sclerosis, autonomic disorders);\r\n\r 3. Uncontrolled diabetes mellitus;\r\n\r 4. Known peripheral neuropathy;\r\n\r 3. History of taking the following medications in the 30 days prior to the Screening\r Visit:\r\n\r 1. Opioid and opioid-containing medications;\r\n\r 2. Butalbital, butalbital-containing, and barbiturate medications;\r\n\r 3. Systemic corticosteroids (exceptions: acute corticosteroid medication including\r inhaled therapy (pulmonary), ocular therapy, or non-spinal intra-articular\r therapy);\r\n\r 4. Urine drug screen that is positive for any of the tested drugs (i.e., cannabis,\r opiates, barbiturates, amphetamines , benzodiazepines and cocaine) at the Screening\r Visit (Visit 1) and the Inpatient Treatment Eligibility Visit (Visit 2);\r\n\r 5. Positive pregnancy test at the Screening Visit (Visit 1) or at the Inpatient Treatment\r Eligibility Visit (Visit 2);\r\n\r 6. Known history of cardiac conduction or heart rate abnormalities associated with\r symptoms;\r\n\r 7. Uncontrolled hypertension;\r\n\r 8. Any tattoos or extensive tissue scarring in the cervical/occipital area;\r\n\r 9. Any active skin lesions, skin damage, broken skin, history of easy bruising or\r bleeding disorders, or history of surgery and/or trauma in the cervical/occipital area\r at the time of the Screening Visit;\r\n\r 10. History of occipital nerve (ON) block, peripheral ON stimulation, or botulinum toxin\r (e.g., Botox) for treatment of headaches within the 90 days prior to the Screening\r Visit;\r\n\r 11. Radiofrequency rhizolysis involving the occipital nerve or cervical nerves;\r\n\r 12. Surgery involving the occipital nerve or cervical nerves (e.g. neurectomy or\r rhizotomy), or cervical ganglionectomy;\r\n\r 13. History of craniotomy or intracranial surgery;\r\n\r 14. Presence of metallic implant (e.g., metal pin, staple, clip) in the skull or neck\r area;\r\n\r 15. Presence of any implanted neuromodulation or cardiac device;\r\n\r 16. Severe or uncontrolled psychiatric disorders (i.e. schizophrenia, depression, anxiety,\r or at investigator discretion);\r\n\r 17. Any other medical condition, concomitant medication or finding for which, at the\r discretion of the investigator, the subject should be excluded for reasons of safety\r or capacity for study compliance; or\r\n\r 18. Participation in any other clinical study (not to include registries or survey-only\r studies) within 30 days or 5 half lives of an investigational drug, whichever is\r longer, of Visit 1 (Screening Visit) and for the duration of the study.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
978
|
[
{
"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\nSuperficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy\n\n**Clinical Trial Summary:**\n\nAim of the SuSPect-CAA study is to prospectively evaluate the prognostic significance of\r cortical superficial siderosis in patients with suspected cerebral amyloid angiopathy with a\r primary focus on future stroke and mortality.\n\n**Clinical Trial Detailed Description:**\n\nNon-traumatic cortical superficial siderosis (cSS) is a common finding in patients with\r cerebral amyloid angiopathy (CAA) and can be its sole imaging sign. The clinical features and\r course as well as the prognostic significance of cSS in CAA patients remain unclear. In a\r retrospective study we have previously shown that cSS might be an important predictor or\r warning sign for future intracranial hemorrhage. However, prospective data are missing.\r\n\r The Superficial Siderosis in Patients with suspected Cerebral Amyloid Angiopathy\r (SuSPect-CAA) study is designed as a prospective observational multi-centre cohort study.\r Primary objective of the study is to evaluate if cSS is a predictor for future stroke and\r mortality (primary endpoint: combined rate of stroke and death after 36 months). Secondary\r objectives of the study include 1) to evaluate if cSS represents a marker of future\r intracranial haemorrhage, especially at the site of initial siderosis, 2) to describe the\r clinical presentation and course of cSS, 3) to assess to associated imaging findings, 4) to\r determine the differential diagnoses of cSS.\r\n\r All subjects presenting to the respective neurological centers (out- or inpatient treatment\r with neuroimaging) will be screened. The study population will consist of two patient groups:\r 1) Patients meeting the modified Boston criteria for probable or possible CAA, i. e. patients\r with SS +/- lobar intracerebral hemorrhage or microbleeds in cortico-subcortical localization\r and absence of other cause of hemorrhage than CAA will be assigned to the study group. 2)\r Patients meeting the classic Boston criteria for possible or probable CAA but without any SS\r will be assigned to the control group. A total of 100 patients per group will be enrolled.\r Baseline and follow-up assessment at 6, 12, 24, and 36 months will be performed by visits in\r the respective neurological outpatient clinic including a structured interview and\r neurological exam, neuropsychological tests, EEG and MRI.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria (study group):\r\n\r - Fulfillment of the modified Boston criteria for CAA-related hemorrhage with evidence\r of supratentorial superficial siderosis on MRI\r\n\r - MR-/CT-/digital subtraction (DS) -angiography without evidence of cerebral aneurysm,\r arterio-venous malformation (AVM) , AV-fistula or other pathology of relevance (e.g.\r tumor, hemorrhagic infarction)\r\n\r - A maximum of two lobar or cerebellar intracranial hemorrhages (ICH) (old or acute)\r\n\r - Written informed consent by patient or guardian prior to study participation\r\n\r - Willingness to participate in follow-up\r\n\r Inclusion Criteria (control group):\r\n\r - Fulfillment of the classic Boston criteria for CAA-related hemorrhage\r\n\r - Absence of superficial siderosis on MRI\r\n\r - A maximum of two lobar or cerebellar ICHs (old or acute)\r\n\r - MR-/CT-/DS -angiography without evidence of cerebral aneurysm, AVM, AV-fistula or\r other pathology of relevance (e.g. tumor, hemorrhagic infarction)\r\n\r - Written informed consent by patient or guardian prior to study participation\r\n\r - Willingness to participate in follow-up\r\n\r Exclusion Criteria (both groups):\r\n\r - Severe medical condition with expected life expectancy <3 years\r\n\r - More than two lobar or cerebellar ICH (old or acute)\r\n\r - any intracerebral hemorrhage in the deep grey matter (basal ganglia or thalami) or in\r the brain stem\r\n\r - History of head trauma resulting in loss of consciousness or radiologically visible\r traumatic brain injury (contusions, diffuse axonal damage) in the last 5 years prior\r to inclusion\r\n\r - Cerebral aneurysm or history of aneurysmal subarachnoid hemorrhage\r\n\r - Infratentorial siderosis\r\n\r - Infratentorial subarachnoid hemorrhage\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
979
|
[
{
"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\nInjection of Botox in the Perineal Muscles in Resistant Cases of Vaginal Spasm\n\n**Clinical Trial Summary:**\n\nDuring the first visit, the couple will be acquainted with their condition. This will include\r the epidemiology of their condition, some sex education tips, as well as the therapeutic\r modalities available. This is followed by short description of the protocol. In the procedure\r room, each patient will be examined to determine the degree of vaginismus and classify her\r condition according to Lemont's classification as modified by Pacik, from 1 to 5. In the same\r or subsequent sessions, surface anesthesia of the area of injection followed by ice packs is\r used before the BOTOX is injected into the muscle.\n\n**Clinical Trial Detailed Description:**\n\nIn the first session, proper history taking includes the difficulties they are facing, and\r the measures taken to solve it whether medical or folk treatment. Proper counseling of the\r couple to describe the new modality including the BOTOX injection and subsequent dilatation\r sessions. Proper informed consent forms will be signed. Therapy sessions will starts with the\r gentle informed approach to the genital area to gain trust of the patient. This is followed\r by the digital vaginal examination of the patient to determine the degree of spasm and the\r muscle(s) involved.\r\n\r The patient will be asked to lie down comfortably on the examination table in the lithotomy\r position. Her husband is allowed to stand on her left shoulder side and may be allowed to\r hold her hand. We started by sterilizing the perineal area and injection site in the vaginal\r introitus using povidone iodine solution. The patient is warned effectively before each step\r of the procedure and what to expect as regards pain. We used surface (Xylocaine gel)\r anesthesia half an hour before the injection.We did not use local anesthetic infiltration\r injections at the site of BOTOX injection. In addition we used ice packs, pre-prepared in a\r surgical latex glove finger, on the perineum and introitus before the injection of BOTOX to\r act as a counter irritant. However in advanced cases of Vaginismus (V4-5), we used general\r intravenous anesthesia\r\n\r We made sure to check that the tip of the needle is not in a vessel by aspirating before\r proceeding with the injection of each bolus of BOTOX. We only did one skin puncture, and used\r that to radially injecting the intended area by changing the direction of the tip of the\r needle. We found this much less painful to the patient. The injection site will be monitored\r by the other free hand index and thumb. Following the withdrawal of the needle from the\r muscle, we distributed the bolus of BOTOX uniformly within the muscle digitally using an arc\r fashion massage of the introitus. We applied pressure, whenever needed to stop the bleeding\r from the injection site.\r\n\r Following the procedure, we instruct the patient to do Kegel exercises as much as 100\r contractions or more over 48 hours. This will help in distributing the BOTOX within the\r muscles as well as recognition of the patient of the whereabouts of the muscles involved in\r vaginismus. We followed up on our patients daily by phone calls for 4 days following the\r procedure for possible adverse effects.\r\n\r Thereafter, the patient will be instructed to attend dilatation sessions twice weekly in the\r clinic, in the presence of the husband, for 3-4 weeks. We use silicone dilators covered by\r lubricated condoms. We prepared the vaginal introitus by the use K-Y jelly for lubrication of\r the dilators. The patient is introduced to the dilator and allowed to hold it in her hand,\r for size and feel, prior to its introduction into her vagina. During each session the patient\r will be asked to lie down on the examination table in the lithotomy position, relax and feel\r comfortable. The husband may stand beside her and may hold her hand. In the initial phase of\r the dilatation procedure we start with the appropriate size of the dilator according to the\r capacity of the introitus and the degree of vaginismus, in each session, and increase the\r size gradually. We always start by the smaller size and move up size wise. At later sessions\r we allow the patient herself with its introduction into the vagina using only her tactile\r sense, with no visual aid or doctor instructions, covering her thighs with sheets to feel\r more private. She is asked to report the termination of the introduction or difficulties she\r is facing. Verbal support is always and repeatedly used. In case of difficulty, the doctor\r does not offer to help and ask the patient to try on her own once more. This helps her to be\r proactive and gain control of the procedure. They usually succeed to carry on the procedure\r on their own. The couple will be instructed not to have trials of intercourse before the\r patient uses dilator number 4 comfortably.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - cases with resistant vaginismus\r\n\r Exclusion Criteria:\r\n\r - cases with congenital anomalies in the lower female genital tract\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
980
|
[
{
"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 Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage\n\n**Clinical Trial Summary:**\n\nThis study will evaluate the hypothesis that the administration of intraventricular tPA\r reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent\r hydrocephalus in patients with aneurysmal subarachnoid hemorrhage.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age greater than 18 years old.\r\n\r - SAH due to aneurysm, as determined by CT angiogram or cerebral angiogram.\r\n\r - Modified Fisher (mF) grade 3 or 4 SAH, defined as thick cisternal blood without (grade\r 3) or with (grade 4) intraventrciular blood.\r\n\r - Exclusion of the aneurysm from the parent circulation by endovascular embolization\r (Raymond class I or II) within 48 hours of ictus.\r\n\r - Ventriculostomy placement must occur prior to randomization.\r\n\r - Informed consent obtained from the patient or patient's decision maker\r\n\r Exclusion Criteria:\r\n\r - Determination by treating physician(s) that no ventriculostomy is needed.\r\n\r - Presence of intrinsic clotting disorders (e.g. due to hepatic failure, nephrotic\r syndrome, etc). Subjects whose pharmacologic anticoagulation is reversed, as\r determined by PT/INR, PTT within our institution's normal range, will be permitted to\r participate in this study.\r\n\r - Presence of significant anemia, defined as hemoglobin < 8 gm/dL.\r\n\r - Patients who undergo endovascular techniques requiring post-operative dual\r anti-platelet therapy.\r\n\r - Residual aneurysm sac filling (Raymond class III occlusion).\r\n\r - Aneurysm or vessel perforation during the endovascular procedure.\r\n\r - Presence of craniectomy.\r\n\r - Significant neurologic disability prior to the onset of SAH.\r\n\r - Determination that administration of tPA/placebo cannot be initiated within 72 hours\r of symptom onset.\r\n\r - Presence of untreated intracranial aneurysms larger than 3mm on CT angiography or\r cerebral angiogram.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
981
|
[
{
"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\nRandomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury\n\n**Clinical Trial Summary:**\n\nThis study is a prospective multi-centre randomized trial to compare the effect of long-term\r mild hypothermia versus routine normothermic intensive management in patients with severe\r traumatic brain injury.\r\n\r The primary hypothesis is that the induction of mild hypothermia (maintained at 34-35℃) for 5\r days will improve the outcome of patients at six months post injury compared with\r normothermia.\n\n**Clinical Trial Detailed Description:**\n\nTraumatic brain injury (TBI) remains a leading cause of death and disability in people with\r injuries and constitutes a major public health concern both in developed and developing\r countries. There are multiple clinical trials of hypothermia therapy for TBI conducted,\r however, with conflicting results. Subgroup analysis of most meta-analysis showed that\r therapeutic effect was significant when hypothermia was maintained more than 48 hours. We\r have previously reported a multicenter trial of mild hypothermia (33-35℃) for severe\r traumatic brain injury, in which 215 patients was randomized to long-term mild hypothermia\r group (n = 108) for 5 ±1.3 days mild hypothermia therapy and short-term mild hypothermia\r group ( n = 107) for 2±0.6 days mild hypothermia therapy. The results shown improved outcomes\r in patients with long-term mild hypothermia and similar frequency of complications. Therefore\r we concluded that long-term hypothermia, which maintains at 33-35℃ for 5 days, could be\r considered in the management of severe traumatic brain injury.\r\n\r Hypothermia therapy was recommend as the level III evidence by the 2007 Brain Trauma\r Foundation's guideline and this treatment is currently used in our department and other large\r neurosurgical centers across China, with the aim to decrease the high intracranial pressure\r (ICP) and improve the functional outcome of TBI patients. When the decision was made, the\r injured patients would be placed on cooling blankets, tracheotomized and ventilated. The\r patients would receive continuous infusions of a paralytic drug (Tracrium 10-40 mg/hour) and\r chlorpromazine (5-10 mg/hour) administered using an infusion pump to prevent shivering. The\r dosage was given according to each patient's temperature, blood pressure, heart rate, and\r muscular tone. Once the patient's rectal temperature reached 33˚C, it was kept at\r approximately that temperature (33-35˚C) 5 to 7 days. Then the patients were passively\r rewarmed to a temperature of 37 to 38˚C at a rate no greater than 1˚C/hour, by gradual\r adjustment of the blanket thermostat.\r\n\r The present multi-center, randomized controlled trials is designed to investigate the\r efficacy and safety of long-term (5 days) mild hypothermia versus normothermia on the outcome\r of patients following severe traumatic brain injury. The primary outcome is the neurological\r function assessed at 1, 6 months post injury with the Glasgow Outcome Score (GOS).\r Additionally, the following data will also be recorded and compared: the baseline data,\r Glasgow Coma Score,imaging examination (e.g. CT scan), need of surgery, intracranial\r pressure, laboratory tests (e.g. blood routine test, liver and kidney function, blood gas\r analysis, etc), the complications (e.g. pneumonia, significant bleeding) and so on.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age 18 - 65 years within 6 hours post injury;\r\n\r - Closed head injury;\r\n\r - Glasgow Coma Scale(GCS) score 4 to 8 after resuscitation;\r\n\r - The intracranial pressure is more than 25 mmHg;\r\n\r - Cerebral contusion on computed tomographic scan.\r\n\r Exclusion Criteria:\r\n\r - GCS of 3 with bilateral fixed and dilated pupils;\r\n\r - A life-threatening injury to an organ other than the brain;\r\n\r - No spontaneous breathing or cardiac arrest at the scene of the injury;\r\n\r - No consent;\r\n\r - Pregnancy.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
982
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nUse of Lumbar Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage.\n\n**Clinical Trial Summary:**\n\nRecently, a clinical trial showed that the use of lumbar drains compared to ventricular drain\r in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic\r neurological deficits but failed to show a clinical benefit after 6 months. The underlying\r assumption was, that the cerebrospinal fluid (CSF) obtained from lumbar drains has a higher\r concentration of blood than CSF from lumbar drains. The investigators decided to test this\r assumption. In this study, the investigators will randomize patients to either placement of a\r ventricular or a lumbar drain and analyze the CSF drainage on a daily basis.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients admitted to the neuro-ICU with aneurysmal subarachnoid hemorrhage\r\n\r - In need for CSF drainage based on clinical judgment\r\n\r Exclusion Criteria:\r\n\r - intraventricular clots\r\n\r - intraparenchymal clots causing midline shift\r\n\r - pregnancy\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
983
|
[
{
"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\nCorrelation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin\n\n**Clinical Trial Summary:**\n\nThe proposed project is a prospective observational, single-center cohort study aimed to\r examine the progression of atherosclerotic alterations of the carotid arteries (IMT, plaque\r volume) during a follow-up of up to four years and to correlate the observed changes with\r traditional and novel biomarkers of atherosclerosis. A total of 600 subsequent patients with\r or established cardiovascular disease or at least one cardiovascular risk will be tested with\r a high-frequency ultrasound probe equipped with automated IMT measurements and 3D\r quantitative plaque volumetry. Plasma samples will be collected and tested for traditional\r and novel cardiovascular risk factors. Both ultrasound examinations and blood sampling will\r be repeated once per year to assess changes in these parameters over time depending on\r treatment modalities, which are left to the discretion of the treating physicians. The\r primary endpoint of the planned study will be the correlation between P-selectin and the\r progression of atherosclerosis as measured by plaque volume and IMT in the carotid and\r femoral arteries, respectively. Secondary endpoints will include the correlation of\r established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP,\r P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1\r (ICAM-1), CETP TaqIb polymorphism) with the progression of atherosclerosis, the correlation\r of cardiovascular events with the progression of atherosclerosis and the additional\r predictive value of plaque volume and IMT compared to an established risk score (SCORE card).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients (male and female) aged 30 to 85 years\r\n\r - with at least one traditional cardiovascular risk factor (hypertension, smoking,\r diabetes, dyslipidemia, family history) or established coronary artery disease,\r cerebrovascular disease, or peripheral artery disease diagnosed by objective testing\r\n\r Exclusion Criteria:\r\n\r - lack of informed consent\r\n\r - the impossibility of follow-up testing once per year for the following four years\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
984
|
[
{
"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 Study Looking at the Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis\n\n**Clinical Trial Summary:**\n\nPatients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an\r improved right ventricular function 72 hours post treatment.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of\r the thorax with embolus involving at least one main or lower lobe pulmonary artery and\r RV:LV ratio > 0.9\r\n\r Exclusion Criteria:\r\n\r - age > 80\r\n\r - Recent thrombolytic therapy (with in 4 days)\r\n\r - Active bleeding or know bleeding diathesis\r\n\r - Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT\r > 50\r\n\r - Thrombocytopenia (PLT cound < 100,000)\r\n\r - History of any intracranial or intraspinal surgery, trauma or bleed\r\n\r - Intracranial neoplasms, AVM, or aneurysm\r\n\r - Recent (< 1 month) GI bleed\r\n\r - Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy\r\n\r - Recent (< 7 days) major surgery, trauma, or obstetrical delivery\r\n\r - Renal insufficiency with eGFR < 45 ml/min\r\n\r - Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA\r\n\r - Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP\r > 90 mm Hg for > 15 min or need for pressor agents to maintain BP > 90.\r\n\r - Severe Hypertension (sustained systolic > 180 mm Hg or diastolic > 90 mm Hg.\r\n\r - Pregnant patients\r\n\r - known right to left shunt\r\n\r - Large (>10 mm)intracardiac thrombus\r\n\r - Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of inclusion.\r\n\r - Life expectancy < 30 days\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
985
|
[
{
"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 Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601\n\n**Clinical Trial Summary:**\n\nThis is a phase IV clinical study to evaluate the preventive effectiveness of\r NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind,\r active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug\r of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for\r four weeks.\n\n**Clinical Trial Detailed Description:**\n\nAfter filling an Informed consent form, subjects are joined the clinical trials. First of\r all, Screening test including the endoscopy test is performed.\r\n\r Subjects, which fit the inclusion/Exclusion criteria, are assigned randomly. Subjects takes\r investigation products as randomized.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Need to take NSAID pills for longer than four weeks\r\n\r - should be normal diagnosed by the endoscopy test\r\n\r Exclusion Criteria:\r\n\r - The patients have gastric ulcer or duodenal ulcer within 30 days\r\n\r - The patients have a gastro-intestinal surgery within a year\r\n\r - The patients are taking the following drugs within seven days: H2 receptor antagonist,\r PPI, sucralfate, misoprostol, Stillen etc)\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
986
|
[
{
"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 Treatment on Decision-making in Major Depression\n\n**Clinical Trial Summary:**\n\nIn this trial, fifty participants with current major depressive disorder who are not\r receiving an antidepressant medication and fifty healthy controls will complete\r questionnaires and computerized tasks to assess their decision-making styles. There will be\r three visits for depressed patients and two for healthy controls (the first and third\r visits). The first visit will involve interviews and questionnaires to assess the\r participant's level of depression, medical history and quality of life. Participants will\r then complete the decision-making tasks, and will earn between $5-40 based on their choices,\r in order to make the decisions on the computer tasks financially meaningful. At the\r completion of this visit, depressed patients will be prescribed an FDA-approved\r antidepressant, chosen in consultation with the treating psychiatrist. Patients will be\r responsible for paying for the prescription themselves. After two weeks on the medication,\r the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After\r six weeks on the medicine, patients and healthy controls will return to repeat the\r questionnaires and the computer based decision-making tasks, and will again earn between\r $5-40 based on their performance.\n\n**Clinical Trial Detailed Description:**\n\nDuring episodes of depression patients with major depressive disorder (MDD) may make\r sub-optimal decisions based on exaggerated negative beliefs about themselves, the future, or\r the world around them. These disruptions in decision-making contribute adversely to quality\r of life, in both work and personal realms. Although effective treatments for depression are\r available, very little work has explored the effects of treatment on how people make\r decisions. The specific aspects of decision-making that differ between depressed and health\r control individuals are unknown, and whether any changes in these decision-making features\r occur as a result of improvement from depression, or whether medication treatment itself can\r lead to changes in decision-making, even in the absence of clinical improvement.\r\n\r In this trial, fifty participants with current major depressive disorder who are not\r receiving an antidepressant medication and fifty healthy controls will complete\r questionnaires and computerized tasks to assess their decision-making styles. There will be\r three visits for depressed patients and two for healthy controls (the first and third\r visits). The first visit will involve interviews and questionnaires to assess the\r participant's level of depression, medical history and quality of life. Participants will\r then complete the decision-making tasks, and will earn between $5-40 based on their choices,\r in order to make the decisions on the computer tasks financially meaningful. At the\r completion of this visit, depressed patients will be prescribed an FDA-approved\r antidepressant, chosen in consultation with the treating psychiatrist. Patients will be\r responsible for paying for the prescription themselves. After two weeks on the medication,\r the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After\r six weeks on the medicine, patients and healthy controls will return to repeat the\r questionnaires and the computer based decision-making tasks, and will again earn between\r $5-40 based on their performance.\r\n\r The overall goal of this study will be to identify whether decision-making characteristics in\r people with major depression is affected by treatment, and whether depressed patients make\r decisions differently from healthy controls. A total of 4 decision-making tasks and one\r control task will be administered via computer to eligible subjects. The specific tasks are:\r\n\r 1. Risk Task - This task assesses tolerance of risk by having participants decide whether\r they wish to accept a specific dollar payout, or to play a lottery with an uncertain\r payout.\r\n\r 2. Balloon Analogue Risk Task - The participant is presented with a balloon and offered the\r chance to earn money by pumping the balloon up by clicking a button. Each click causes\r the balloon to incrementally inflate and money to be added to a counter up until some\r threshold, at which point the balloon is over inflated and explodes. Thus, each pump\r confers greater risk but also greater potential reward. If the participant chooses to\r cash-out prior to the balloon exploding then they collect the money earned for that\r trial, but if balloon explodes earnings for that trial are lost. Participants are not\r informed about the balloons breakpoints; the absence of this information allows for\r testing both participants' initial responses to the task and changes in responding as\r they gain experience with the task contingencies.\r\n\r 3. Temporal Discounting Task - Participants are initially asked to choose between taking an\r immediate reward now or a larger reward at some time in the future. Decisions for seven\r time points over a 10-year time frame are proposed. The task is then repeated using\r choices between immediate and delayed losses, based on the same seven time points. This\r task assesses the manner in which subjects value immediate outcomes compared to\r long-term consequences.\r\n\r 4. Ultimatum Game - The ultimatum game (UG) is a well-established game-theoretical paradigm\r commonly employed in behavioral economics to measure emotional reactions to unfair\r offers. In the UG, two subjects sequentially exchange real monetary amounts.\r Specifically, a proposer is provided with a sum of money by the experimenter ($10), and\r asked to share this amount of money with another player, the responder. The responder\r then decides whether to accept or reject the offer made by the proposer. If the\r responder accepts the offer, both players receive the respective amounts from the\r proposer's offer. If she rejects the offer made by the proposer, both players receive\r nothing ($0). This is best illustrated via the following two potential scenarios: 1. the\r proposer offers a fair split of $5 for himself and $5 for the responder. This is an\r offer that is typically accepted by a great majority of responders. 2. The proposer\r offers a split of $9 for himself and $1 for the responder. Such offers are commonly\r rejected by the majority of responders, despite incurring a financial loss of $1.\r\n\r 5. Continuous Performance Task - This task involves identifying patterns of numbers briefly\r displayed on a computer screen. This task will serve as a control variable for attention\r in analyzing the results of the decision-making tasks.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria for MDD Subjects:\r\n\r 1. Male or female, age 18-65\r\n\r 2. Primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text\r Revision (DSM-IV TR) Diagnosis of Major Depressive Disorder.\r\n\r 3. Has a 17-item Hamilton depression rating scale (HDRS-17) score >=16.\r\n\r 4. Ability to visually read and understand English language\r\n\r 5. Not currently taking an antidepressant.\r\n\r 6. Women of reproductive potential must be willing to take a medically approved form of\r birth control throughout the duration of the study.\r\n\r Inclusion Criteria for Healthy Control Subjects:\r\n\r 1. Male or female, age 18-65\r\n\r 2. No current DSM-IV TR diagnosis of a mental illness.\r\n\r 3. No lifetime history of Major Depressive Disorder or Dysthymia.\r\n\r 4. Has a 17-item Hamilton depression rating scale (HDRS-17) score ≤7.\r\n\r 5. Ability to visually read and understand English language\r\n\r 6. Not currently taking any psychoactive medication\r\n\r Exclusion Criteria for all subjects:\r\n\r 1. Has met criteria at any time during their life for bipolar disorder, a primary\r psychotic disorder (e.g. schizophrenia), or dementia.\r\n\r 2. Meet criteria for substance abuse or dependence within three months of the screening\r visit.\r\n\r 3. Presents with a clinically significant suicide risk, as assessed by a study physician.\r\n\r 4. Presence of any unstable or central nervous system-related medical illness that would\r interfere with cognition or participation.\r\n\r 5. Women who are currently pregnant or lactating, or plan to become pregnant during the\r study.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
987
|
[
{
"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 Pepper Gas Exposure in Non-combatant Bystanders.\n\n**Clinical Trial Summary:**\n\nPepper sprays and pepper gas grenades are used by riot police at various places in the world\r for crowd control. Data about the acute effects based on human studies is extremely scarce.\r Kashmir valley in the northern Indian state of Jammu & Kashmir has witnessed political\r turmoil for the past 22 years and incidents of stone pelting are common wherein groups of\r youth indulge in stone pelting at the security personnel. While there have been previous\r episodes of fatalities associated with incidents of firing by the security personnel; non\r lethal methods are adopted routinely now. These include lathis, water cannons, tear gas and\r more recently the pepper gas grenades. The pepper grenades explode in the area and the\r adverse effects are perceived by the population in the area too who are even sitting in their\r homes. The study proposes to observe the health effects of the pepper gas exposure in\r non-combatant civilians.\n\n**Clinical Trial Detailed Description:**\n\nEligibility:\r\n\r History of exposure to a pepper grenade explosion.\r\n\r Exclusion:\r\n\r Participation in combat operation/ stone pelting/ demonstration.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r All participants with a history of exposure to pepper gas grenade explosion\r\n\r Exclusion Criteria:\r\n\r Combatant role while exposure\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
988
|
[
{
"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\nOptimal Regimen in Endovascular Therapy in Ischemic Cerebrovascular Disease Based on Clopidogrel Resistance\n\n**Clinical Trial Summary:**\n\n1. Clopidogrel resistance is common in patients of ischemic cerebrovascular disease.\r\n\r 2. Genetic polymorphisms are the most important factors to clopidogrel resistance.\r\n\r 3. The purpose of this study is to find the genes which are the related to clopidogrel\r resistance.\r\n\r 4. Through gene sequencing, we can filter patient of clopidogrel resistance, so another\r drug maybe used to avoid the undesired efficacy.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic\r atherosclerosis research database.\r\n\r - 90 days had a stroke or transient ischemic attack is defined as symptomatic\r Intracranial atherosclerotic atherosclerosis\r\n\r - stenosis ≥ 50% (MRI or CT angiography).\r\n\r - Intracranial vascular stenosis measured according to the method reported Warfarin\r aspirin symptomatic intracranial disease research.\r\n\r Exclusion Criteria:\r\n\r - diffuse intracranial arterial stenosis.\r\n\r - cranial magnetic resonance imaging shows lesions as the branch artery blockage caused.\r\n\r - non-atherosclerotic lesions.\r\n\r - occurred within 6 weeks of vascular lesions in the region of intracranial hemorrhage.\r\n\r - potential cardiac thrombus source.\r\n\r - has concurrent intracranial tumors, intracranial aneurysm or arteriovenous\r malformation.\r\n\r - ipsilateral extracranial carotid or vertebral artery stenosis ≥ 50%;\r\n\r - known to heparin, aspirin, clopidogrel, anesthetics and contrast agents\r contraindications;\r\n\r - hemoglobin less than 10g/dL, platelet count <100000/dL;\r\n\r - responsibility left after cerebral vascular-related serious neurological dysfunction\r (mRS ≥ 3);\r\n\r - international normalized ratio> 1.5\r\n\r - there are factors that can not be corrected by bleeding;\r\n\r - life expectancy <1 year;\r\n\r - pregnant or lactating women;\r\n\r - indications Commission determines that the patient is not suitable for the study\r treatment.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
989
|
[
{
"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 Chart Review to Evaluate Diagnosis and Treatment of Chronic Migraine and Headache\n\n**Clinical Trial Summary:**\n\nThis study is a retrospective chart review in patients diagnosed with headache or migraine to\r evaluate treatment patterns and diagnosis.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of chronic migraine or other diagnosis of migraine or headache for a minimum\r of 15 months\r\n\r - Eight (8) headache days per month for at least 1 of the preceding 15 months\r\n\r Exclusion Criteria:\r\n\r - Not currently diagnosed with chronic migraine, headache or migraine\r\n\r - History of receiving botulinum toxin injections for the treatment of chronic migraine.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
990
|
[
{
"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\nWaterless Hand Cleansing With Chlorhexidine During the Perinatal Period\n\n**Clinical Trial Summary:**\n\nBackground (brief):\r\n\r 1. Burden:\r\n\r Neonatal death still unacceptably high in low income countries. The common causes of\r neonatal death are pneumonia, sepsis and omphalitis. Many neonatal infections occur\r because the mother's hands or the hands of the person who attended the birth are\r unclean. Our previous study found that there was substantial concern about excessive\r exposure of the mother or the neonate to water during handwashing because of the\r perception that frequent contact with water could lead to respiratory illness.\r\n\r 2. Knowledge gap:\r\n\r Chlorhexidine has been evaluated for use in hand hygiene applications in high-income\r countries, particularly in healthcare, but it has not been evaluated or promoted for\r hand cleansing at the household level in low- and middle-income countries.\r\n\r 3. Relevance:\r\n\r A waterless hand cleanser employing chlorhexidine would overcome important barriers to\r handwashing with soap, perceptions of cold resulting from exposure to water, and the time\r limitations perceived by mothers.\r\n\r Hypothesis: Mothers who are exposed to a chlorhexidine-based hand cleansing intervention will\r clean their hands (with chlorhexidine or soap and water) more frequently than mothers who are\r not exposed to the chlorhexidine-based hand cleansing program.\r\n\r Objectives:\r\n\r The primary objective\r\n\r 1. To demonstrate the behavioural impact of chlorhexidine-based hand hygiene intervention\r on hand cleansing of mothers during the neonatal period The secondary objectives\r\n\r 2. To demonstrate the impact of chlorhexidine-based hand hygiene intervention on hand\r cleansing of other family members, visitors to the neonate, and birth attendants during\r the neonatal period\r\n\r 3. To evaluate the acceptability of chlorhexidine for hand cleansing in the neonatal period\r among mothers, other family members, and birth attendants\r\n\r Methods:\r\n\r We propose a randomized controlled trial in a rural area of Bangladesh, with an active\r control. Randomization will be at the level of the participating pregnant woman. Each arm\r will include 150 participants. All intervention visits will follow baseline data collection.\r A trained health and hygiene promoter will carry out two visits in the antenatal period and\r one postnatal visit to deliver intervention messages.\r\n\r Outcome measures:\r\n\r 1. Observed hand cleansing behavior of mother with chlorhexidine or soap and water at\r critical times.\r\n\r 2. Observed hand cleansing behavior of other household members and visitors to home with\r chlorhexidine or soap and water at critical times.\n\n**Clinical Trial Detailed Description:**\n\nNeonates (babies < 28 days old) die at unacceptably high rates (26deaths per 1000 live\r births) in many resource-limited countries, accounting for about 40% of deaths among all\r children under 5 years old. Infections such as pneumonia, sepsis, and omphalitis are common\r causes of neonatal death. Many neonatal infections occur because the mother's hands or the\r hands of the person who attended the birth are unclean. In Nepal, newborns who survived were\r significantly more likely than newborns who died to have mothers reporting handwashing, and\r birth attendants who were reported to wash hands before the delivery. But, mothers and birth\r attendants often do not wash their hands, despite the vulnerability of the neonatal period.\r\n\r The traditional approach to improving handwashing among caregivers of young children is to\r teach about critical times to wash hands and how to wash hands. This narrow, prescriptive\r approach ignores the barriers to hand hygiene unique to the Perinatal and neonatal periods.\r Moreover, our qualitative findings suggest that frequent handwashing with water may not be\r acceptable. That is, both mothers and birth attendants reported that, when mothers come into\r contact with water frequently (e.g. by washing hands often), the newborn child is at risk of\r developing upper and lower respiratory infection. A novel technological solution - one that\r provides efficiency and portability and obviates the need for washing with water - may\r overcome important obstacles to improving hand cleansing behavior in the neonatal period.\r\n\r During the discrete time frame of the neonatal period, chlorhexidine for hand cleansing\r represents a focused intervention with substantial potential for scalability. The shelf-life\r of chlorhexidine is long (2-3 years), facilitating its scaling up and efficient distribution,\r for example, in clean delivery kits that are provided to low-income mothers throughout\r resource-limited countries.\r\n\r Given the potential for this low-technology solution to break through critical barriers to\r handwashing with water and soap, and markedly reduce neonatal mortality, we propose to\r conduct a randomized controlled trial to evaluate the impact of a chlorhexidine-based hand\r cleansing intervention on maternal, familial, and birth attendant hand cleansing behavior in\r the peripartum and neonatal periods.\r\n\r Methods Study design\r\n\r We propose a randomized controlled trial in a rural area of Bangladesh, with an active\r control. The two treatment arms are:\r\n\r - Active control arm Maternal and neonatal health counseling (described in \"Intervention\"\r section)\r\n\r - Intervention arm\r\n\r - Maternal and neonatal health counseling\r\n\r - Hand hygiene promotion (described in \"Intervention\" section) Randomization will be\r at the level of the participating pregnant woman (i.e. individual-level\r randomization). We will use a block randomization strategy to randomize\r participants to either the intervention or active control arm.\r\n\r The intervention:\r\n\r All intervention visits will follow baseline data collection. A trained health and hygiene\r promoter will carry out two visits in the antenatal period (at 34-35 weeks and at 36-38\r weeks) and one postnatal visit (1-3 days after delivery) to deliver intervention messages.\r\n\r Maternal and neonatal health counseling:\r\n\r Study participants in both intervention and control arms will receive maternal and neonatal\r health counseling. The objectives of the maternal and neonatal health counseling are to:\r\n\r - Highlight the vulnerability of the neonatal period\r\n\r - Inform participant and her family of the schedule recommended by the Government of\r Bangladesh for prenatal care and strongly encourage participants to seek appropriate\r prenatal care, including Tetanus Toxoid vaccination. Tetanus toxoid is provided free of\r cost as part of antenatal care at all Government of Bangladesh health facilities.\r\n\r - Discuss birth plans and encourage participants to develop a birth plan, including\r location of the birth, materials, persons needed and an emergency plan.\r\n\r - Introduce and discuss the use of a clean delivery kit for hygienic delivery to reduce\r infections. This will include instructions on cutting the umbilical cord. Provide a\r clean delivery kit to the participant, which will include a clean blade, clean string\r for tying the cord, clean mat for the mother to lie on, among other items.\r\n\r - Encourage close family members to motivate or demand hand washing with soap by birth\r attendants before and during labor and delivery.\r\n\r - Discuss maternal danger signs with participant and her family and encourage care seeking\r when recognized\r\n\r - Discuss neonatal danger signs with participant and her family and encourage care seeking\r when recognized\r\n\r - Discuss neonatal hypothermia prevention with participant and her family and work with\r the family to build acceptance of the message\r\n\r - Discuss the benefit of immediate and exclusive breastfeeding with participant and her\r family and work with the family to build acceptance of the message\r\n\r - Provide chlorhexidine and gauze, and explain chlorhexidine cord care to the participant\r and work with her and her family.\r\n\r Materials: Each participant will be given a clean delivery kit and a culturally appropriate\r pictorial card depicting each of the danger signs for the mother pre-, during, and\r post-labor, and for the neonate.\r\n\r Description of behavioral communication approach: Interactions with the health and hygiene\r promoter will be in the form of a discussion where the health/hygiene promoter will\r facilitate discussions and provide explanation and guidance as needed.\r\n\r Hand hygiene counseling:\r\n\r Objectives of hand hygiene counseling:\r\n\r - Present hand cleansing as an opportunity for the mother to protect the health of her\r child, and to improve perception of herself as a good mother\r\n\r - Remind of the vulnerability of the newborn period, and suggest that the use of\r chlorhexidine for hand cleansing makes loving hands to be protective hands\r\n\r - Encourage maternal self-efficacy for protecting the health of the baby\r\n\r - Identify motivators and barriers to hand cleansing among mothers and other people that\r care for the baby\r\n\r - Identify critical times for hand cleansing with chlorhexidine\r\n\r - Increase individual and social (family/compound) expectations for hand cleansing among\r mothers and other caregivers\r\n\r - Guide family to create solution for barriers to hand cleansing\r\n\r - Introduce chlorhexidine as a product to help protect the baby's health, demonstrate use\r and discuss who, when and how to use it.\r\n\r - Discuss demanding or motivating use of chlorhexidine by other family members, visitors\r and the birth attendant\r\n\r - Set up a visual cue card, and a calendar with visual reminders in the home as references\r and cues for hand cleansing at specific critical times\r\n\r - Discuss creating a habit of hand cleansing, what that concretely means and how to do so\r\n\r Critical times for hand cleansing:\r\n\r - For mothers and secondary caregivers:\r\n\r - Before umbilical cord care\r\n\r - After contact with respiratory secretions\r\n\r - At three fixed times of day: morning, after lunch, and evening: given the residual\r antimicrobial effect of chlorhexidine, hand cleansing at these fixed times will result\r in hands being protected from contamination for much of the day.\r\n\r - For visitors to the household and for children:\r\n\r - Before touching the neonate\r\n\r - After contact with respiratory secretions or contact with nasal or oral mucosa\r\n\r Timing of intervention visits:\r\n\r Respondents randomized to the intervention arm will receive one hand hygiene promotion during\r the second visit (at 36-38 weeks of gestation) prior to the review of the maternal and\r neonatal health counseling.\r\n\r Chlorhexidine for hand cleansing: We are positioning chlorhexidine as a product that is of\r unique importance in the neonatal period, and may have substantive bactericidal and\r bacteriostatic effects, making it superior to soap for hand cleansing, particularly in the\r vulnerable newborn period.\r\n\r Data collection Identification of pregnant women and selection criteria: The proposed study\r will be conducted in 4 unions in Mirzapur that are already under demographic surveillance.\r Pregnant women are routinely identified as part of the demographic surveillance.\r\n\r Obtaining informed consent and baseline data collection: A data collector will describe the\r study to the pregnant woman at 32-34 weeks gestation and seek informed consent from her for\r participation. The data collector will also request informed consent from the head of\r household for interview of secondary caregivers regarding practices during the labor and\r delivery process, and two structured observations of hand cleansing behavior among all\r household members.\r\n\r Randomization and initiation of intervention: We will use a block randomization strategy,\r using blocks of 4, to randomize participants to either the intervention or active control\r arm. Block randomization is also referred to as \"restricted randomization\" and allows for the\r numbers in the intervention arm to be roughly similar to those in the control arm throughout\r the enrolment period.\r\n\r Objectives 1 and 2: Hand cleansing behavior measurement\r\n\r To compare treatment arms with respect to mothers' hand cleansing behavior in the neonatal\r period (Objective 1), we will do the following:\r\n\r 1. Observe hand cleansing, either by use of chlorhexidine or by handwashing with water +\r soap, during 3-hour structured observations\r\n\r 2. Measure residual sanitizer weight and volume as markers of chlorhexidine consumption\r Structured observations involve the placement of a study staff member in the\r participant's home / household compound for an extended period of time in order to\r observe typical behaviors. In this study the observations will be conducted in both\r intervention and treatment arms by female field staff who will sit in a suitable place\r to observe the mothers without getting in the way of their normal care giving activities\r of the neonates. We are interested in observing the following behaviors during\r structured observations (Appendix 6).\r\n\r Hand cleansing at critical times (either by chlorhexidine use or by washing hands with soap\r and water; handwashing with soap will be considered the corollary to chlorhexidine use since\r the control arm does not have access to chlorhexidine) Objective 3: Acceptability of\r chlorhexidine In both groups, we will record participant- or household member-initiated\r reporting of any skin reactions, other possible adverse events, and acceptability of the\r chlorhexidine with respect to ease of use, scent, skin comfort and the occurrence of skin\r reactions (Objective 3).\r\n\r At approximately day 28 of the neonate's life, we will conduct an end line survey (Appendix\r 7) with the mother, during which we will assess the following in a quantitative manner in the\r intervention group:\r\n\r - Acceptability of chlorhexidine\r\n\r - Reported use of chlorhexidine versus handwashing hardware\r\n\r - Behavioral determinants of hand hygiene We will collect qualitative data from a subset\r of mothers in the intervention arm to understand in-depth about barriers and motivators\r to chlorhexidine use for hand cleansing at the conclusion of all quantitative data\r collection.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Pregnant women older than 18 years that are at 32-36 weeks gestation and intend to reside\r in the location which they are residing at the time of recruitment into the study through\r the remainder of the antenatal period and the first 4 weeks after birth.\r\n\r Exclusion Criteria:\r\n\r - Plans to move out of study area between enrollment and 1 month after birth.\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
991
|
[
{
"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\nPREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma\n\n**Clinical Trial Summary:**\n\nThe occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist\r treatment leads to a high risk of bleeding.\r\n\r Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to\r reverse anticoagulation with concomitant administration of prothrombin complex concentrates\r (PCCs) and vitamin K.\r\n\r However, even if a reversion is performed, the prognostic of post-traumatic intracranial\r bleeding remain bad.\r\n\r The investigators hypothesize that, for patients admitted in an emergency department after a\r minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion\r with PCCs can lead to a significant reduction of intracranial haemorrhage and can also\r improve the neurological prognostic of patients versus the current strategy.\r\n\r PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial\r involving 400 patients.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Admission in an emergency departement for a recent and isolated minor head trauma with\r at least one of the following characteristic : a period of alteration in the level of\r consciousness, a period of loss of consciousness (< 30 min), a posttraumatic amnesia,\r persistant posttraumatic headache, repeated vomitting (at least 2 episodes) or any\r other neurological sign such a convulsion or a localised neurological sign, wound of\r the scalp or the face testifying of the importance of the cranial trauma...\r\n\r - Subject receiving anticoagulant treatment with anti-vitamin K for the treatment of\r atrial fibrillation (AF)\r\n\r - Initial ED Glasgow Coma Scale (GCS) score of ≥13\r\n\r - Achievable follow up\r\n\r - Informed consent form signed by the patient or if he/she isn't able an emergency\r inclusion can be realised.\r\n\r Exclusion Criteria:\r\n\r - Delay between the minor head trauma and the possible preventive PCC's administration >\r 6h\r\n\r - Subject receiving anticoagulant treatment other than anti vitamin K (heparin,\r fondaparinux, dabigatran, rivaroxaban, apixaban...)\r\n\r - Subject receiving anticoagulant treatment for other reason than a AF\r\n\r - Subject on antiplatelet treatment (except the use of low dose of aspirin (≤ 100\r mg/day)\r\n\r - Delocalised biology INR in capillary blood < 1.5 if it's available (only in\r departement where this analyse is a usual practice)\r\n\r - Haemorrhage or suspected haemorrhage other than intracranial which could led to a\r reversion of the anticoagulation\r\n\r - Head trauma associated with one or further potential haemorrhagic traumatic lesions\r\n\r - Subject who reject the use of products derived from human blood\r\n\r - Women who are pregnant\r\n\r - Subject with any condition that, as judged by the investigator, would place the\r subject at increased risk of harm if he/she participated in the study\r\n\r - Subject without social security registered\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
992
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nUse of MigraineBoxTM Head and Neck Cooling Bath for Treatment of Primary Headache in the Emergency Department\n\n**Clinical Trial Summary:**\n\nMigraineBoxTM is a simple, contoured cooling bath for the head and neck. Effectiveness of\r MigraineBoxTM will be studied in primary headaches in the emergency department. The user\r simply reclines his/her head and neck into this device that has contours that support the\r head and neck. Luke warm water is filled into the MigraineBoxTM before use and then a frozen\r insert is placed inside. This will gradually cool the water surrounding the patient's head\r and theoretically provide headache relief.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - 18-85 years old\r\n\r - Benign headache\r\n\r - Physician intends to treat headache pain in the ED with either droperidol,\r prochlorperazine, or a parenteral narcotic\r\n\r Exclusion Criteria:\r\n\r - Unable to provide informed consent\r\n\r - Headache due to trauma, subarachnoid hemorrhage, meningitis, intracerebral bleed,\r cranial tumor, sinusitis, dental pathology, temporomandibular joint dysfunction,\r glaucoma, or systemic infection\r\n\r - Known renal impairment\r\n\r - Known hepatic impairment\r\n\r - A history of coronary artery disease, peripheral vascular disease, or cerebrovascular\r disease\r\n\r - Perforated ear drum\r\n\r - Pregnant\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
993
|
[
{
"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\nIncidence of Headache Following an Unintentional Dural Puncture\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the use of intrathecal morphine administration\r following an unintentional dural puncture, to decrease the incidence of post dural puncture\r headaches (PDPH) in obstetric patients.\n\n**Clinical Trial Detailed Description:**\n\nUnintentional dural puncture is a known risk of neuraxial techniques, occurring in roughly 1%\r of all epidural catheter placements. The incidence of post dural puncture headaches(PDPH)\r after unintentional dural puncture (UDP) is 50-80%. A PDPH is defined as a headache that\r occurs following a dural puncture, worsens within 15 minutes after sitting or standing and\r improves within 15 minutes after lying, with at least one of the following: neck stiffness,\r tinnitus, hypacusia, photophobia, or nausea. The headache develops within 5 days after dural\r puncture and resolves either spontaneously within 1 week or within 48 hours after effective\r treatment of the spinal fluid leak.\r\n\r The rates of PDPH following unintentional dural puncture with placement of an intrathecal\r catheter will be compared in two groups: intrathecal morphine (treatment) versus intrathecal\r saline (control) administered 1-2 hours after delivery, followed by immediate catheter\r removal. Patients randomized to the treatment group (morphine) will receive preservative-free\r morphine 0.3 mL (150 mcg) intrathecally. Those randomized to the control group will receive\r normal saline 0.3 mL intrathecally. After administration of intrathecal morphine, all\r patients will have their respirations monitored every hour for a period of 12 hours and then\r every two hours for a period of 12 hours. On postpartum days 1-5, all patients will be\r visited daily while inpatient and/or contacted by phone after discharge from the hospital.\r\n\r PDPH can lead to significant morbidity and negatively impact patient satisfaction with\r postpartum recovery. Along with headache, patients may develop cranial nerve palsy during the\r postpartum period leading to permanent disability. In addition, new mothers are unable to\r bond with their babies due to headache and associated symptoms of nausea, vomiting and\r limited mobility secondary to pain. Therefore, an effective intervention to decrease the risk\r of PDPH after UDP would be useful.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Postpartum patients following vaginal delivery\r\n\r - Unintentional dural puncture\r\n\r - Functioning intrathecal catheter\r\n\r - Patients must be 18 years of age or older\r\n\r - English speaking.\r\n\r Exclusion Criteria:\r\n\r - History of previous PDPH\r\n\r - Body mass index BMI > 40 kg/m2\r\n\r - History of obstructive sleep apnea (OSA)\r\n\r - Morphine allergy\r\n\r - Patients who receive Cesarean delivery\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
994
|
[
{
"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\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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
|
995
|
[
{
"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\nUser Evaluation of the MiniMed 640G Insulin Pump\n\n**Clinical Trial Summary:**\n\nThis four center international study will include two United Kingdom National Health Service\r centers, and two centers in Melbourne, Australia. The objective of the study is to evaluate\r subject acceptance of a new insulin pump and transmitter together with the accompanying\r training materials. Descriptive data from participant questionnaires and device uploads will\r be evaluated.\r\n\r Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of\r age upwards, who currently use an insulin pump in the management of their type 1 or type 2\r diabetes, will be invited to participate. Each subject will be trained on the study device\r and then use it for approximately four weeks. During this time there will be three in-clinic\r visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of\r this period, they will revert back to their original insulin pump and complete a\r questionnaire on the study pump training materials, features and usability.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nCriteria for Inclusion: A subject is eligible for the user evaluation study if all of the\r following criteria are met:\r\n\r 1. Subject is 7 years or older at time of screening\r\n\r 2. Subject is current insulin pump user for at least 3 months\r\n\r 3. Subject has the following CGM experience as determined by the Investigator:\r\n\r - Has experience and is able to insert/change sensor by herself/himself and\r\n\r - Has experience and can recharge the transmitter and\r\n\r - Has experience and can read sensor data in real-time on her/his pump screen\r\n\r 4. Subject/legal representative has signed a Patient Informed Consent and is willing to\r comply with the study procedures;\r\n\r 5. Subject is willing to complete study questionnaires throughout the study\r\n\r 6. Must have the following clinical diagnosis:\r\n\r 1. Type 1 diabetes, for a minimum of 6 months prior to enrollment\r\n\r Criteria for Exclusion: A subject is excluded from the user evaluation if any of the\r following criteria are met:\r\n\r 1. Female subject has a positive urine pregnancy screening test.\r\n\r 2. Female subject who plans to become pregnant during the course of study. If a woman\r becomes pregnant during participation, she will be withdrawn\r\n\r 3. Subject has any condition that, in the opinion of the Investigator or qualified\r Investigational Centre staff, may preclude him/her from participating in the study and\r completing study related procedures.\r\n\r 4. Subject has impaired vision or hearing problems that could compromise the handling of\r the device as determined by Investigator or qualified Investigational Centre staff\r\n\r 5. Subject is unable to tolerate tape adhesive in the area of sensor placement\r\n\r 6. Subject has any unresolved adverse skin condition in the area of sensor placement\r (e.g. psoriasis, rash, Staphylococcus infection)\r\n\r 7. Subject has travel plans which would make it difficult for the subject to attend\r on-site study visits as scheduled\r\n\r 8. Subject is actively participating in an investigational study (drug or device) wherein\r he/she has received treatment from an investigational study drug or investigational\r study device in the last 2 weeks (CEP267 User Evaluation is not included in this\r exclusion criteria).\n\n**Patient Description:** \n\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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996
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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\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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997
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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\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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998
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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\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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999
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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\nA 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**].\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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