Kornimate/medical-research-clean huggingface dataset:
evaluating perceived fitness to drive while intoxicated

Conditions: Alcohol Drinking; Alcohol Intoxication; Perception, Self; Drinking, Alcohol; Driving Under the Influence; Drinking Behavior

Summary: the goal of this study is to conduct a laboratory-based pilot randomized control trial of smartphone-enabled breath alcohol monitoring on perceived fitness to drive a vehicle among intoxicated adults. the study team will enroll up to 30 adults aged \> 21-44 who are frequent drinkers without dependence who drive more than four times per week to complete a standardized alcohol drinking protocol in a monitored setting collecting breathalyzer measurements. the protocol involves consuming three weight-based doses of alcohol with a target bac of 0.10 and completing breathalyzer measurements every 20 minutes until a bac of 0.03 is reached. the control group will complete a visual analog scale on their perceived fitness to drive and be blinded to their breath alcohol readings with the bactrack mobile pro breathalyzer device, while the intervention group would do the same, but be shown their breath alcohol readings on the paired bactrack smartphone application. the research team's previous research has validated the accuracy of the bactrack mobile pro device to measure bac within +/- 0.001 of police-grade breathalyzer and estimate bac within +/- 0.01 of a blood test.


Eligibility criteria:
inclusion criteria: * age 21-39 years old, * less than 4 drinking days and less than 12 drinks per week on average in the past 2 months, * have consumed at least 4 (women) or 5 (men) drinks on one occasion, in the past year without experiencing adverse effects * have a valid photo id * willing and able to use a rideshare credit or septa token as transportation home from the study visit * drives at least 2 days per week on average. exclusion criteria: * desire alcohol treatment now or received it in the past 6 months, * have alcohol use disorder per dsm-v criteria * meet or have met criteria for a substance use disorder within the past 12 months per dsm v criteria * have a prior psychiatric condition requiring hospitalization * are non-english-speaking * individuals who have a medical condition or who are taking medication which limits or prevents the consumption of alcohol * are experiencing suicidal ideation
postoperative hypofractionated intensity-modulated radiation therapy with concurrent chemotherapy in cervical cancer

Conditions: Cervix Cancer; Radiotherapy, Adjuvant; Radiotherapy, Intensity-Modulated; Hypofractionated Dose; Chemotherapy, Concurrent

Summary: to investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by concurrent chemotherapy with hypofractionated intensity-modulated radiotherapy (2.5 gy x 16 fractions, once a day) after radical hysterectomy.


Eligibility criteria:
inclusion criteria: * histologically confirmed cervical cancer * radical hysterectomy and pelvic lymph node dissection was done * histologically indicated adjuvant chemoradiotherapy (more than one as below) * positive pelvic lymph node metastasis * positive parametrial invasion * positive tumor involvement on surgical margin * ecog performance status 0 or 1 * bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl * kidney function: creatinine \<2.0 mg/dl, bilirubin 1.5 mg/dl exclusion criteria: * positive distant metastasis (including retroperitoneal lymph node metastasis) * previous history of pelvic radiotherapy * more than 3 months after radical surgery for cervical cancer * neoadjuvant chemotherapy was done * previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
adalimumab in rheumatoid arthritis. an investigation of wholebody mri, conventional mri, ct and circulating biomarkers

Conditions: Rheumatoid Arthritis

Summary: adalimumab in rheumatoid arthritis. an investigation of changes in disease activity and course of joint destruction by use of 3 tesla whole-body mri, dedicated 3 tesla mri and ct of the hand, and soluble biomarkers. furthermore to compare ultrasound examination with wholebody mri etc.


Eligibility criteria:
inclusion criteria: * age \> 18 years old and \< 85 years old * ra in accordance with american college of rheumatology 1987 criteria * moderate or highly active ra defined as das28 \> 3,2 (crp based) * clinical indication for tnf-α inhibitor treatment by the treating physician * no contraindications for tnf-α inhibitor treatment * no contraindications for mri * serum creatinine in normal range * sufficient contraception for fertile women * capable of giving informed consent * capable of complying with the examination program of the protocol exclusion criteria: * other dmards than mtx from less than 4 weeks before inclusion and throughout the study period * cyclophosphamide, chlorambucil or other alkylating agents from less than 4 weeks before inclusion and throughout the study period * intramuscular or intravenous injection of glucocorticoid from less than 4 weeks before inclusion and throughout the study period * pregnancy wish, pregnancy or breast-feeding * contraindications for tnf-α inhibitor treatment * contraindications for mri * known recent drug or alcohol abuse * failure to provide written consent * incapable of complying with the examination program for physical or mental reasons
safety and immunogenicity of a newly 23-valent pneumococcal polysaccharide vaccine in chinese adults and children

Conditions: Pneumococcal Infectious Diseases

Summary: a newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase iii trial in china. a large scale, double blind, randomized, pneumovax 23 (merck \& co., inc.) controlled phase 3 clinical trial was conducted.

the world health organization (who) estimated that more than 800 000 children younger than 5 years died from pneumococcal disease in 2000, making it the leading vaccine-preventable cause of death. pneumococcal polysaccharide vaccines have progressed from 2-valent vaccines to the current 23-valent vaccine, which has been available since the early 1980s. the 23-valent vaccine includes serotypes accounting for 72% to 95% of invasive pneumococcal disease, depending on the geographic area. many countries have added pneumococcal polysaccharide vaccine to their existing national immunization programs or recommended it for people aged 65 years and older and for individuals aged 2-64 who are at increased risk of pneumococcal disease. a newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase iii trial in china. a large scale, double blind, randomized, pneumovax 23 (merck \& co., inc.) controlled phase 3 clinical trial was conducted.

Eligibility criteria:
inclusion criteria: * healthy participants older than 2 years were recruited and enrolled in september or october 2012. * participants with axillary temperature less than celsius 37 degrees * not yet having received pneumococcal vaccine and other prevention products within 7 days. exclusion criteria: * exclusion criteria were any known primary or secondary immunodeficiency * allergy * severe cardiovascular disease bleeding disorders * receipt of immunoglobulin or blood products within one month and so on.-
immunological markers predictive of response and toxicity to checkpoint inhibitors in non-small cell lung cancer

Conditions: Lung Cancer

Summary: a prospective, observational, single-center study to determine the proportion of patients who have or will develop changes in biological markers of immunity during immunotherapy treatment.

the study will run for 12 months with a 6-month follow-up at the inclusion of the last patient. patients will be included from the initiation of immunotherapy treatment regardless of the line.the routine immunological workup will be performed before the first immunotherapy infusion in order to analyze a certain number of immunological markers (autoantibodies, rf, ldh, complement (c3 c4), anti-tissue antibodies, lymphocyte immunophenotyping). this assessment will then be performed at progression, at the appearance of side effects requiring the immunotherapy to be stopped, or at 6 months of follow-up in case of continuation of the immunotherapy. the investigators will evaluate the response to the treatment, the progression via re-evaluation assessments performed in standard practice (every 3 to 4 courses depending on the type of immunotherapy) as well as the appearance of side effects throughout the follow-up will be evaluate.

Eligibility criteria:
inclusion criteria: * major patient * metastatic non-small cell lung cancer * initiation of anti pdl1 therapy (nivolumab, pembrolizumab or atezolizuamb) in daily practice * no objection made exclusion criteria: * autoimmune disease diagnosed prior to initiation of immune checkpoint inhibitor therapy. * previous immune-modulating therapy (including corticosteroid therapy greater than 10 mg/day) * patient with prior checkpoint inhibitor therapy * patient with a contraindication to immunotherapy * patient under legal protection * refusal to participate
attention bias modification treatment (abmt) for anxiety disorders in youth

Conditions: Anxiety Disorders

Summary: attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. attention bias modification treatment (abmt) utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. this is a double-blind randomized controlled trial of abmt for clinically anxious 10-18 year-olds. participants will be assessed using clinical interviews and parent- and self-rated questionnaires before, in the middle and after twelve sessions of abmt or control groups, and again at ten-week follow-up. outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with youth and their parents. attentional threat bias, attentional control and interpretation of ambiguous information will also be measured to explore potential mediators of abmt's effect on anxiety. the investigators expect the findings to inform pathways to treatments for anxious children and to provide initial information on mechanisms of abmt efficacy.


Eligibility criteria:
inclusion criteria: * primary diagnosis of gad, sop, or sad. * co-morbid attention deficit hyperactivity disorder (adhd) or depressive disorders must be treated with medication and stable. * tics or impulse control problems must be treated with medication, stable and cause minimal or no impairment. exclusion criteria: to be excluded youth must: * meet diagnostic criteria for organic mental disorders, psychotic disorders, pervasive developmental disorders, or mental retardation. * show high likelihood of hurting themselves or others. * have not been living with a primary caregiver who is legally able to give consent for the child's participation. * be a victim of previously undisclosed abuse requiring investigation or ongoing supervision. * be involved currently in another psycho-social treatment. * have a serious vision problem that is not corrected with prescription lenses. * have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.

Keywords: attention bias modification treatment attention training anxiety disorders clinical trials
the role of quadriceps contraction in patellar repositioning - a computed tomography study

Conditions: Patellofemoral Pain Syndrome

Summary: background previous studies have a great discrepancy concerning the effects of quadriceps contraction on patellar lateral displacement and tilt in patients with patellofemoral pain syndrome. this discrepancy may be caused by lack of information regarding to classifications of patellofemoral alignment under quadriceps relaxed. we hypothesized quadriceps contraction has different effects on each type of patellofemoral malalignment. methods the investigators expect to recruit 150 subjects with patellofemoral pain syndrome to participate in this study. all patients underwent computed tomography imaging of symptomatic knees, with and without quadriceps muscle contraction in 0°, 15° and 30° of knee flexion. patellar lateral condyle index and patellar tilt angles of sasaki and modified fulkerson were measured to investigate the effect of quadriceps contraction on patellar repositioning.

background previous studies have a great discrepancy concerning the effects of quadriceps contraction on patellar lateral displacement and tilt in patients with patellofemoral pain syndrome. this discrepancy may be caused by lack of information regarding to classifications of patellofemoral alignment under quadriceps relaxed. we hypothesized quadriceps contraction has different effects on each type of patellofemoral malalignment. we expect to recruit 150 subjects with patellofemoral pain syndrome to participate in this study. all patients underwent computed tomography imaging of symptomatic knees, with and without quadriceps muscle contraction in 0°, 15° and 30° of knee flexion. patellar lateral condyle index and patellar tilt angles of sasaki and modified fulkerson were measured to investigate the effect of quadriceps contraction on patellar repositioning.

Eligibility criteria:
inclusion criteria: * the inclusion criteria for patients with pfps were suffering from pain with at least two kinds of knee-flexing activities such as: * sitting * getting up from sitting * walking upstairs or downstairs * squatting * getting up from squatting * running * kneeling * jumping exclusion criteria: the exclusion criteria included: * the presence of any major medical disease * rheumatoid arthritis, gouty arthritis * recent history (within 3 months) of knee surgery * image findings of osteoarthritis * any deformity of lower limbs

Keywords: patellofemoral pain quadriceps contraction
study of focal cryoablation in low-risk prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to find out if men, with low-risk prostate, can have the small amount of cancer within their prostate removed by freezing, called focal cryoablation or cryotherapy.


Eligibility criteria:
a two-step consenting process will be in place for all patients being enrolled to this study. the two-step method is necessary because all patients being enrolled will need to have a repeat transrectal biopsy after meeting the initial study requirements. the two step consent process would enroll patients considering focal cryotherapy into the initial part of the study (qol assessment at baseline, pca3 test, and repeat biopsy); those deemed eligible after the re-staging biopsy would be consented to participate in the remainder of the study (focal cryotherapy, qol studies, repeat biopsy at 6 months for efficacy, pca3 test). first step enrollment inclusion criteria: * men ≥ 21 years of age with a life expectancy estimated to be \> 10-years. * diagnosis of adenocarcinoma of the prostate and confirmed by mskcc review * no prior treatment for prostate cancer * ecog performance status of 0 or 1 * prostate cancer clinical stage t1c-t2a * psa \< 10ng/ml (this will be the psa level prompting the prostate biopsy) * prostate size \<60 cc on transrectal ultrasound * exclusion criteria: * medically unfit for anesthesia * histology other than adenocarcinoma * men who have received any hormonal manipulation (antiandrogens; lhrh agonists) within the previous 6 months * men who are currently receiving anticoagulant drugs (e.g.: coumadin, warfarin) second step enrollment inclusion criteria: * repeat transrectal prostate biopsy that must meet the following parameters: * minimum of 12 biopsy cores * no biopsy gleason grade 4 or 5 * unilateral cancer (only right-sided or left-sided, not bilateral) * no more than 50% cancer in any one biopsy core * no more than 25% of cores containing cancer exclusion criteria: * medically unfit for anesthesia * histology other than adenocarcinoma * men who have received any hormonal manipulation (antiandrogens; lhrh agonists) within the previous 6 months * men who are currently receiving anticoagulant drugs (e.g.: coumadin, warfarin)

Keywords: focal cryotherapy low-risk prostate cancer
evaluation of outcomes of restoring pelvic floor support with topas in women with moderate fecal incontinence symptoms

Conditions: Fecal Incontinence

Summary: the study purpose is to gain experience with the topas system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence

this is a multi-center study under a common protocol. approximately 20-30 patients will be enrolled across 5 sites in the u.s. the study population is females at least 21 years of age who have attempted but have not been satisfied with conservative therapy for their fecal incontinence symptoms. the study follow-up is two years.

Eligibility criteria:
inclusion criteria: * females at least 21 years of age who have evidence of pelvic floor weakness * females who attempted but not been satisfied with conservative therapies such as dietary changes, dietary bulking agents, biofeedback, etc. * subjects, who have an external anal injury, must have some voluntary sphincter control exclusion criteria: * subjects who are unwilling or unable to sign an informed consent form * subjects who are currently pregnant or considering future child-bearing * subjects who are contraindicated for surgery * subjects who are allergic to polypropylene mesh * subjects who are enrolled in a concurrent clinical trial * subjects with previous implantation of mesh or trauma to the pelvic area * subjects who engage in anal receptive intercourse * subjects with a significant evacuation disorder such as chronic constipation * subjects with crohn's disease, ulcerative colitis or chronic diarrhea as the primary cause for fecal incontinence * subjects who had a hysterectomy within 6 months prior to enrollment * subjects with vaginal prolapse that passes the hymen * subjects with complete rectal prolapse * subjects with a history of pelvic radiation that compromises the anal canal * subjects who have psychiatric disturbance or debilitation as a possible cause for fecal incontinence * subjects with a neurological disorder such as amyotrophic lateral sclerosis, multiple sclerosis, or brain tumor as a possible cause for fecal incontinence symptoms * subjects with an active pelvic infection or a recto-vaginal fistula * subjects who have not had a negative screening exam for colon cancer within 10 years of enrollment * subjects who have other inappropriate conditions as determined by the physician

Keywords: device study pelvic floor weakness fecal incontinence
urdu version of arthritis impact measurement scales 2 short form:reliability and validity study

Conditions: Quality of Life

Summary: in this study ,investigators will observe the reliability and validity of arthritis impact measurement scale 2 short form translated in urdu language in pakistani population to check quality of life in patients suffering from osteoarthritis.

the main aim of this study is to translate and culturally adapt aims2 sf into urdu language and to investigate the reliability and validity of aims2 sf in osteoarthritis patients among urdu speaking pakistani population. the study will be completed in 5 steps such as translation ,synthesis ,back translation ,expert committee review and pre testing. the study will be a cross sectional survey .the result of the study helps to know the validity and reliability of aims2 sf in urdu version to check the quality of life .the reliability of the scale will be checked through internal consistency and test retest method .internal consistency will be analyzed through cronbach's alpha value to estimate whether each item of a scale is appropriate for assessing the underlying concept of its scale with 165 patients will be used.

Eligibility criteria:
inclusion criteria: 1. male and female patient age 18 years or older. 2. diagnosed with oa of the knee , hip and hand . 3. patients diagnosed according to acr criteria. 4 - x-ray scored according to kellgren and lawrence classification. exclusion criteria: 1 - radiograph not older than 6 months . 2- age less than 18 are excluded from this study.

Keywords: aims2 sf urdu oa acr
a pilot study of transcoronary myocardial cooling

Conditions: Acute Myocardial Infarction

Summary: patients with heart attacks caused by blocked coronary arteries are usually treated with a technique called primary angioplasty. although this treatment is very successful it can result in damage to the heart muscle when the artery is opened due to reperfusion injury. cooling the entire body has been shown to reduce heart muscle damage during heart attacks in some patients but not in others, however it is uncomfortable due to the shivering, expensive and can result in delays in opening the blocked artery. we are investigating a simpler way to cool the heart muscle directly using cooled fluid passed through the catheter without the shortcomings of entire body cooling. this pilot will address safety and feasibility considerations.

the precise mechanisms involved in ischaemia/reperfusion injury is not fully understood but a number of factors are thought to contribute to cardiac dysfunction14, 15. these include : 1. reperfusion arrhythmias; 2. microvascular obstruction or no-reflow phenomenon; 3. myocardial stunning and 4. cardiomyocyte apoptosis. it is estimated that ischaemia/reperfusion injury occurs in \> 30% of patients and is associated with reduced myocardial salvage and poor prognosis16-18. ischaemia/reperfusion injury may account for up to 50% of the final infarct size9. deep hypothermia (\< 30 °c) has long been used in protecting the heart during coronary artery bypass grafting and heart transplantation. intermittent antegrade or retrograde infusion of cold cardioplegia appears to reduce myocardial ischaemia and improves outcome19, 20. deep hypothermia however can cause spontaneous ventricular fibrillation and impaired cardiac function and its application is limited to the unconscious patient.

Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 80 years presenting with ischaemic chest pain of \ 0.2 mv in 2 contiguous leads. exclusion criteria: * patients with cardiac arrest, previous ami or cabg, known congestive heart failure, endstage kidney disease or hepatic failure, recent stroke, coagulopathy, pregnancy, or cardiogenic shock. * patients who are unable or unwilling to provide assent and informed consent.

Keywords: st elevation myocardial infarction transcoronary cooling