Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of combination grazoprevir (mk-5172) + elbasvir (mk-8742) + ribavirin (rbv) in genotype 2 hepatitis c infection (mk-5172-047)

Conditions: Hepatitis C

Summary: this is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of grazoprevir (mk-5172) used in combination with or without 50 mg of elbasvir (mk-8742) and/or ribavirin (rbv) in treating non-cirrhotic treatment-naïve participants with chronic genotype (gt) 2, 4, 5, and 6 hepatitis c infection. in part a there is no randomization or stratification; all gt2 participants will be assigned to arm a1. in part b, all gt2 participants will be assigned to arm b1 and all participants with gt4, gt5 and gt6 will be randomized in a 1:1 ratio to either arm 3 or arm 4 with stratification by genotype.


Eligibility criteria:
inclusion criteria: parts a and b: -body weight ≥50 kg (111 lbs) and ≤ 125 kg (275 lbs) -has absence of cirrhosis -agrees to use two acceptable methods of birth control from at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential). part a only: -has chronic hcv gt2 infection part b only: -has chronic hcv gt2, gt4, gt5, or gt6 infection exclusion criteria: parts a and b: -is not treatment naïve (participant has had previous treatment with any interferon, rbv, approved or experimental direct acting antiviral(s), or other investigational therapies for hcv) -is determined to be coinfected with hepatitis b virus (hbsag positive) or hiv -has evidence of, or is under evaluation for, hepatocellular carcinoma (hcc) -has a clinical diagnosis of substance abuse including the following specified drugs within specified timeframes: alcohol, intravenous drugs, inhalational, psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs (within 1 year of the screening visit), is receiving opiate agonist substitution therapy (within 1 year of screening visit), or excessive historic marijuana use -has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years -female participant who is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment, or male participant who is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using a two methods of birth control throughout treatment and after the completion of all treatment -has evidence or history of chronic hepatitis not caused by hcv, including but not limited to nonalcoholic steatohepatitis (nash), drug-induced hepatitis, and autoimmune hepatitis. -has uncontrolled diabetes (documented hba1c \>8.5%) part a only: -has non gt2 hcv infection part b only: -has hcv infection with a genotype other than gt2, gt4, gt5 or gt6
understanding rural patient and provide preferences for mobile lung cancer screening clinics

Conditions: Lung Cancer

Summary: the purpose of this study is to research patient preferences for lung cancer screening and pilot mobile units to address the barrier of access that decreases participation in lung cancer screening.

the overarching goal of this study is to research patient preferences for lung cancer screening and pilot mobile units to address the barrier of access that decreases participation in lung cancer screening. to facilitate this, the investigators will evaluate the feasibility of mobile lung cancer screening clinics to improve access through focus group study in designated rural areas of new hampshire and vermont, canvas and survey these areas to confirm need, and pilot the mobile lung cancer screening clinic to establish practicability. findings from the proposed project will be used as preliminary data to apply for further funding and to implement the mobile unit in these identified rural communities on a consistent basis.

Eligibility criteria:
inclusion criteria: * adults age 50 to 80 years old * 20 pack-year smoking history who are currently smoking or have quit smoking within the last 15 years exclusion criteria: -
mindfulness intervention for people with psychosis

Conditions: Recent-onset Psychosis

Summary: people with psychosis demonstrated a tendency to use maladaptive cognitive emotion regulation strategies as compared with healthy control groups. the present study is the first randomized controlled trial of group mindfulness-based intervention for psychosis. half group will join the mindfulness-based cognitive intervention while another half will participate in psychoeducation to examine whether mindfulness will have a positive impact on emotion regulation and distress.

concurrently with positive and negative symptoms, affective symptoms and full affective disorder episodes are common in psychotic disorders particularly in the acute phase of illness. affective symptoms are a significant risk factor accounting for approximately 5-6% of suicide rates which remain or becomes higher shortly after a psychotic episode or hospital discharge (american psychiatric association, 2013). it has been proved that the emotion management and cognitive reappraisal were negatively associated with schizophrenia. in the study, it is hypothesized that the intervention will have a positive impact on psychotic symptoms, general symptoms such as affective symptoms, psychological flexibility, mindfulness skills, quality of life and re-hospitalization by facilitating strategies on emotion regulation.

Eligibility criteria:
inclusion criteria: * must be chinese residents and aged above 18 * have a primary diagnosis of psychosis (non-affective) and/or other psychotic disorders met the diagnostic and statistical manual dsm-5 * have been diagnosed equivalent to or less than 5 years * mentally stable as assessed by the researcher and a psychiatrist to comprehend the education and training provided (a pre-recruitment briefing session for potential participants will be conducted to verify their ability to follow instructions and understanding in participation, and case files will be reviewed to ensure a stable medication regime for at least 6 months) in order to ensure their ability to make a valid consent * able to read and understand chinese exclusion criteria: * have recently participated in (less than 3 months) or are receiving other structured psycho-education and/or psychotherapies * have comorbidities (a) developmental impairment (b) learning disability, (c) personality disorders, and/or (d) any clinically significant medical diseases (by case-file review). * have organic psychosis or a primary drug or alcohol addiction

Keywords: mindfulness cognitive therapy
prospective registry for assessment of acute ischemic stroke patients treated with neurothrombectomy devices in india

Conditions: Acute Ischemic Stroke

Summary: praan is a post-market registry designed to collect real-world data associated with the use of medtronic market release neurothrombectomy devices in acute ischemic stroke (ais) patients from india.

the objective of this registry is to access clinical outcomes associated with the use of these device in patients experiencing the ais due to large intracranial vessel occlusion within 8 hours of last known well. real-world evidence per standard-of-care (soc) will be generated using medtronic neurothrombectomy devices approved in india, using on-label indications for use in this post-market clinical follow-up registry.

Eligibility criteria:
inclusion criteria: 1. subject/subject's legally authorized representative has given informed consent according to country regulations, and/or ec requirements 2. subject is 18 years of age or older 3. subject has experienced an acute ischemic stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ica), m1 and m2 segments of the middle cerebral artery (mca), basilar, and vertebral arteries 4. subject has been or will be treated with a medtronic market-released neuro thrombectomy device as the initial device used to remove the thrombus 5. subject is willing to participate in a 90-day follow-up visit 6. treatment within 24 hours of last known well. for subjects with stroke onset \>6 hours: * aspects score \>5 (per dw-mri) or \>6 (per ncct) * ncct core infarct \< 70 ml or mri dwi with \< 70 ml core volume or ctp ratio of volume of ischemic tissue (penumbra) to infarction of ≥1.8 and an absolute volume of potentially reversible ischemia of ≥15ml 7. pre-stroke modified rankin scale (mrs) score ≤1 (immediately) prior to stroke onset 8. pre-treatment national institutes of health stroke scale (nihss) * ≥6 and ≤30 for patients with ≤6 hours of stroke onset. * ≥10 and ≤30 for patients with \>6 hours of stroke onset. exclusion criteria: 1. concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis 2. patients meeting the contraindication as mentioned in the ifu of devices. 3. significant mass effect with midline shift

Keywords: acute ischemic stroke neurothrombectomy revascularization
a long-term follow-up study to evaluate the predictive value of bms747158 in patients suspected of coronary artery disease (cad)

Conditions: Coronary Artery Disease (CAD)

Summary: this long-term study will follow patients with known or suspected of having coronary artery disease (cad) and have participated in present and future bms747158 clinical studies. the purpose of this study is to evaluate the long-term predictive value associated with bms747158 positron emission tomography (pet) myocardial perfusion imaging (mpi).


Eligibility criteria:
inclusion criteria: * have known or suspected cad * have participated in a bms747158 clinical study * have received at least 1 dose of bms747158 * provide signed informed consent for this study prior to any follow-up contact * be capable of communicating effectively with study personnel exclusion criteria: * if determined by the investigator that participation in the study is not in the best interest of the patient or for any sound medical, psychiatric, and/or social reason.

Keywords: coronary artery disease pet imaging spect imaging
productive value of sonographic measurement of optic nerve in transitional multiple

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: 1.to evaluate the potential role of the optic nerve diameter ( ond determined by ultrasonography and and visual nerve function by visual evoked potential as a biomarker of early axonal loss and disability in patients with relapsing remitting multiple sclerosis (rrms).

multiple sclerosis (ms) is one of the leading disabling neurological diseases in young adults. characteristically reliable biomarkers for every independent ms pathogenic factor are extremely important. 1 increasing evidence has demonstrated that neuronal and axonal damage within the central nervous system (cns) contributes substantially to the development of permanent disability in patients with ms * 2 thus, reliable, economic and easily assessable complementary surrogate biomarkers for axonal degeneration and consequently disability remain to be identified * 3 the optic nerve can serve as a useful clinical tool for studying these characteristics and can be used to measure and monitor the pathological process of the disease. the optic nerve is most commonly assessed by ophthalmoscopy and magnetic resonance imaging (mri), but measurement of the optic nerve diameter (ond) by a simple ultrasound examination and measurement of optic nerve function by visual evoked potential might permit a rough estimation of the extent of brain parenchymal involvement and the consequent global cerebral atrophy and disability in relapsing-remitting ms (rrms) patients. the analysis of the diameter of the optic nerve showed that it is possible to detect its atrophy in the affected eyes (with optic neuritis ) and, to a lesser extent, in un affected eye also the visual evoked potential study has the ability to quantify the unsuspected clinically silent lesions, hence, allows confirming the vague deterioration of visual functions.

Eligibility criteria:
1. inclusion criteria 1. both sex 2. age group from 15 to 50 yrs 3. patient with rrms without history of optic neuritis 2. exclusion criteria : 1. history of previous optic neuritis 2. medical illness of eye(e.g. diabetes and hypertension) 3. ms patient on fingolimod for 6 months or more 4. relapsing or use of steroid in the past 3 months 5. proved alternative diagnosis (neuromyelitis optica ) 6. local eye disease or surgery
stability of driving pressure changes during "best positive end expiratory pressure (peep)" trial

Conditions: Acute Respiratory Failure; Acute Respiratory Distress Syndrome

Summary: the goal of this study is to better understand in changes in lung compliance as indicated by driving pressure (a non-invasive marker) following changes in positive end expiratory pressure (peep; a standard of care ventilator parameter). the main question it aims to answer is: the time to stability of driving pressure after a change in peep is made type of study: observational study participant population/health conditions participants will undergo a "best peep trial" which is a standard intensive care intervention for patients undergoing invasive mechanical ventilation. this involves changing the patient's peep and looking for response in driving pressure. this will be done in a more protocolized format and data will be collected.


Eligibility criteria:
inclusion criteria: * adult patients \>18 years of age * undergoing intubation and mechanical ventilation in medical intensive care unit (micu) or medical critical care unit (mccu) at the university of alabama birmingham. exclusion criteria: * prisoner * pregnant * age \<18 years of age * intensive care unit (icu) team declines participation * unstable oxygenation (requiring 100% fio2 to maintain saturations greater than 90% oxygen saturation following initial peep titration by primary team) * hemodynamic instability: vasopressor requirement of \>0.3 mcg/kg/min of norepinephrine or equivalent * pneumomediastinum * pneumothorax without chest tube * previous enrolled in trial * need for immediate travel out of icu following intubation for procedures, tests
prevalence of glucose intolerance and risk factors in ethiopian immigrants in israel; follow-up study.

Conditions: Diabetes Mellitus; Glucose Intolerance

Summary: high risk population: screening for impaired glucose tolerance.


Eligibility criteria:
inclusion criteria: * participation in the year 2000 study * signature of informed consent form exclusion criteria: pregnancy -

Keywords: ethiopians diabetes mellitus glucose tolerance israel included in the year 2000 study
postoperative pain control after hip hemiarthroplasty: intrathecal morphine vs periarticular infiltration of bupivacaine

Conditions: Femoral Neck Fracture

Summary: falls are a common problem in elderly people which they have to receive the operation. hemiarthroplasty is one of the common orthopedics operations. the prompt operation and good pain control will provide the good recovery and outcome. the investigators compare the efficacy of postoperative pain control between intrathecal morphine 0.1 milligrams (mg.) with the local infiltration of 0.25% bupivacaine for 20 milliliters (ml.) in patients received hip hemiarthroplasty under spinal anesthesia.

study process all the patients who assigned the hip hemiarthroplasty without any exclusion criteria will be enrolled in the study and be divided into 3 groups randomly 1. control group : the patients will be received spinal anesthesia with 0.5% isobaric bupivacaine and postoperative pain control by intravenous (iv) patient - control analgesia (pca) 2. morphine group : the patients will be received 0.1 mg. of morphine added in isobaric bupivacaine for spinal anesthesia and postoperative pain control by iv pca 3. local group : the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% bupivacaine and postoperative pain control by iv pca data collection 1. demographic data : age, sex, body weight, body mass index (bmi), ... 2. pain score every 3 hours postoperatively in the first 6 hours and at the 12th hours by visual analogue scoring system 3. patient global assessment and patient satisfactory visual analogue scoring system at 24th and 48th hour 4. the amount of morphine during 24 and 48 hours postoperative and the time of first dose they received

Eligibility criteria:
inclusion criteria: * age between 18-90 years * co-operative, able to use pca * asa classification 1-3 * no contraindication for spinal anesthesia * patient acceptance for spinal anesthesia * body weight \> 30 kg. * bmi between 20-35 * no history of drug allergy, e.g. local anesthetics, paracetamol, etc. exclusion criteria: * age \> 90 years * previous hemiarthroplasty (the same site) * pathological fracture such as severe infection, bone cancer
efficacy of pain neurophysiology education in combination with motor control training for unspecific low back pain

Conditions: Low Back Pain

Summary: the purpose of the present study is to evaluate whether the addition of two pain neurophysiology education sessions to motor control training may result in an improvement of the outcome measures of pain and disability, compared to motor control training alone.

sixty-two subjects with unspecific low-back pain were randomly recruited for the present study. the subjects were randomly allocated to a control group (which received only motor control training) and an intervention group (which underwent two pain neurophysiology education sessions prior to motor control training). primary outcome measures were pain (measured with the visual analogical scale) and disability (measured with the oswestry disability index). secondary outcome measures are kinesiophobia (tampa scale for kinesiophobia), the global perceived effect (global perceived effect scale) and quality of life (sf-12). these will be measured before the intervention, at the end of the intervention, and 3 and 6 months after ending the intervention.

Eligibility criteria:
inclusion criteria: * unspecific low back pain for at least 3 months * patients must be knowledgeable in the language in which the educational sessions will be provided (spanish) exclusion criteria: * specific low back pain (e.g. infection, tumor, fracture, radiculopathy). * signs and symptoms of neuropathic pain or generalized chronic pain. * history of lumbar or cervical spine surgery. * pregnancy. * concomitant pathologies that impede the performance of exercises. * psychiatric treatment.

Keywords: low back pain pain neurophysiology education motor control
a study of quantitative assessments of angle width in chinese patients with open-angle glaucoma and/or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: this study will assess angle width in chinese patients with open-angle glaucoma and/or ocular hypertension.


Eligibility criteria:
inclusion criteria: * of chinese descent * open-angle glaucoma or ocular hypertension in each eye exclusion criteria: * history of a narrow-angle or angle closure glaucoma * angle abnormalities in either eye
prospective randomized endovascular therapy in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: 1. to assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses in ms patients with ccsvi as documented by sonographic (extracranial echocolor-doppler (ecd) and transcranial color doppler (tcd) 2. to study the morphology of the venous anomalies by using intraluminal ultrasound (ivus). 3. to evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (edss)), sonographic (ecd/tcd) and mri/mrv parameters. 4. to evaluate change in patients self-reported qol following the therapeutic angioplasty 5. to evaluate whether changes in qol, fatigue, msfc or attention following therapeutic angioplasty are associated with brain changes as measured by functional mri (fmri).


Eligibility criteria:
inclusion criteria: * age 18-65 years * edss 0-6.5 * diagnosis of relapsing ms according to the mcdonald criteria (polman et al., 2005) * be on treatment with currently fda approved disease-modifying treatments * evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see table 1 background and 1.5 section) * demonstration of venous occlusive disease on cervical mrv * normal renal function: creatinine clearance level of \>60: constant= 1.23 for men; 1.04 for women exclusion criteria: * • relapse, disease progression and steroid treatment in the 30 days preceding study entry * pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.) * severe peripheral chronic venous insufficiency * abnormal renal function * contrast allergy (anaphylaxis) * not accepting to undergo the endovascular treatment * peripheral vascular disease

Keywords: multiple sclerosis