bioihbjkbjnl/mcl2 huggingface dataset:
Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors
Condition: End Stage Renal Disease; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Kidney Failure, Chronic
Intervention: Glecaprevir/pibrentasvir
Intervention description: Glecaprevir/pibrentasvir 300mg/120mg once daily by mouth for 2 weeks post-transplant.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In this study, individuals without hepatitis C infection who are on the kidney transplant
      waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be
      treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg /
      pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant
      procedure and continued for 2 weeks post-renal transplant.
    

Eligibility criteria:

        Recipient Inclusion Criteria:

          -  Participants ≥ 18 years old

          -  On the deceased donor kidney waitlist at Johns Hopkins Hospital

          -  Awaiting a first or second kidney transplant

          -  No available living kidney donors

          -  On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined
             as a glomerular filtration rate <15 ml/min for ≥ past 90 days

          -  HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors
             for contracting HCV other than being on hemodialysis

          -  Calculated panel reactive anti-human leukocyte antigens (anti-HLA) antibody (flow
             cPRA) below 80%

        Recipient Exclusion Criteria:

          -  Plan to receive a multi-organ transplant

          -  Plan to receive a dual kidney transplant (including en bloc)

          -  History of prior solid organ transplant other than first kidney transplant

          -  Participating in another study that involves an intervention or investigational
             product

          -  Plan to receive a blood type incompatible kidney

          -  History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B
             (HBV) infection, defined as being on active antiviral treatment for HBV, detectable
             hepatitis B surface Ag or detectable hepatitis B DNA

          -  Unable to safely substitute or discontinue a medication that is contraindicated with
             the study medication

          -  Psychiatric or physical illness that in the opinion of the investigator would make it
             unsafe to proceed with transplantation or interfere with the ability of the subject to
             participate in the study
Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children
Condition: Pneumonia; Diarrhea; Malaria; Co-infection; Death; Malnutrition
MeSH terms: Coinfection; Malnutrition; Diarrhea
Intervention: Azithromycin; Placebo
Intervention description: oral administration of Azithromycin; 5 days of taste/appearance/bottle-matched inactive substance
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1400.0
Sex: All
Minimum age: 1 Month
Maximum age: 59 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: post-discharge mortality; morbidity and mortality prevention; azithromycin; linear growth

Summary:

      Children hospitalized with severe illness in sub-Saharan Africa are at high risk of morbidity
      and mortality following discharge from hospital. These children represent an accessible
      high-risk population in which targeted interventions to prevent morbidity and mortality could
      have dramatic impact. A large cluster randomized trial of azithromycin delivered in a mass
      drug administration program within trachoma endemic areas in sub-Saharan Africa demonstrated
      an almost 50% mortality benefit in children 1-9 years of age in treated communities. However,
      mass drug administration of azithromycin leads to the rapid emergence of macrolide resistance
      within treated communities and is expensive. The targeted delivery of azithromycin to
      children at hospital discharge may be a novel and practical intervention to maximize benefit
      while minimizing risk of antibiotic resistance. This is a randomized, double-blind,
      placebo-controlled trial to determine the efficacy of azithromycin provided at discharge,
      compared to placebo, in reducing mortality and re-hospitalization rates in children age 1-59
      months in Kenya. The study will also investigate potential mechanisms by which azithromycin
      may reduce morbidity and mortality in this population and will assess the emergence of
      antibiotic resistance among treated individuals and their primary caregivers. A
      cost-effectiveness analysis of the intervention will also be conducted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 1-59 months,

          -  Plan to remain in study area greater than 6 months

          -  Discharged from hospital following non-trauma related admission

        Exclusion Criteria:

          -  Contraindication to azithromycin use and other prophylactic antibiotic use
Concomitant Administration of FSH With HCG Improves Oocyte Maturation and Quality Double -Blinded Randomized Trial
Condition: Infertility
MeSH terms: Infertility
Intervention: Bravelle(follicle stimulating hormone); Saline ( placebo)
Intervention description: One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.; 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 232.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Infertility; Pregnancy; in vitro fertilization

Summary:

      Marcelle Cedars, M.D., Victor Fujimoto, M.D., Mitch Rosen, M.D., Heather Huddleston, M.D.,
      Paolo Rinaudo, M.D., Anthony Dobson, M.D., and Shehua Shen, M.D. from the UCSF Department of
      Obstetrics and Gynecology and Reproductive Sciences are conducting a study to learn about
      ovarian stimulation and oocyte maturation to improve fertilization, embryo quality,
      implantation and clinical pregnancy rates in patients undergoing in vitro fertilization
      (IVF). Two hormones, follicle stimulating hormone and human chorionic gonadotropin (FSH/hCG)
      will be compared to the standard one hormone, hCG, for the ovulation trigger.

      Over the past two decades, the success rate of assisted reproductive technology (ART) has
      dramatically increased. This increase has largely been attributed to improvements in the
      laboratory conditions and improvements in ovarian stimulation protocols (those medications
      used to increase the number of eggs maturing each cycle). Less work has been done on
      different ways to cause the final maturation of the eggs and the release of the egg from the
      ovary. The investigators propose to change the final injection prior to the egg retrieval
      (the ovulation trigger) so that it looks more like what happens in a normal menstrual cycle,
      where two hormones (both luteinizing hormone (LH) and FSH) increase. The investigators want
      to find out if this will improve egg quality and increase chances for pregnancy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients undergoing in vitro fertilization

        Exclusion Criteria:

          -  risk of ovarian hyperstimulation syndrome
Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Buprenorphine; Codeine paracetamol
Intervention description: buprenorphine transdermal system 5, 10 and 20 mg; combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Intervention MeSH terms: Acetaminophen; Buprenorphine; Codeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 219.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: OA; Elderly; Pain; OA of the hips and/or knees

Summary:

      The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with
      standard- treatment in subjects with osteoarthritis (OA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Either sex aged 65 or above

          -  Diagnosis of OA of the hip and/or knee

          -  Severe pain requiring step two medication

          -  Taking maximum dose of paracetamol

        Exclusion Criteria:

          -  Painful disease of the joints other than OA

          -  Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal
             anti-inflammatory agents (NSAIDS)

          -  Subjects taking cyclooxygenase (COX) II selective inhibitors
Effect of Oral Choline Supplementation on Postoperative Pain
Condition: Postoperative Pain; Inflammation
MeSH terms: Inflammation; Pain, Postoperative
Intervention: Choline; Placebo
Intervention description: Oral Choline 20 grams before surgery; Gelatin Capsule
Intervention MeSH terms: Choline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This research will test whether consuming additional choline before gynecological surgery
      decreases postoperative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  open pelvic surgery

          -  able to swallow pills

        Exclusion Criteria:

          -  chronic pain

          -  opioid use

          -  pregnancy

          -  lactation
Mexiletine for the Treatment of Muscle Cramps in ALS
Condition: Muscle Cramps in Amyotrophic Lateral Sclerosis
MeSH terms: Muscle Cramp; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Spasm; Sclerosis
Intervention: Mexiletine; Placebo
Intervention description: Sodium channel blocker; Placebo
Intervention MeSH terms: Mexiletine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 21 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Muscle cramps; Cramp; ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig's disease; Motor Neuron Disease; MND

Summary:

      The purpose of this study is to determine if mexiletine is effective for the treatment of
      muscle cramps in Amyotrophic Lateral Sclerosis (ALS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ALS diagnosed according to El Escorial criteria (Awaji version) as: Possible,
             Probable, or Definite.

          -  Experiencing cramps as a moderate or severe symptom as defined by willingness to take
             a medication for the symptom

          -  ≥2 cramps per week during run in week

          -  Life expectancy > 6 months, estimated by clinician

          -  Able to take drug capsule by mouth

          -  No significant EKG abnormality on screening

          -  aspartate aminotransferase / alanine aminotransferase <2x upper limit of normal
             measured at screening

          -  Having successfully filled out the cramp diary and cramp and fasciculation scales on
             six out of the last seven days of run in period

        Exclusion Criteria:

          -  Inability to communicate by telephone or email

          -  Allergy/ known sensitivity to mexiletine

          -  Prior use of mexiletine

          -  AV block unless subject has pacemaker

          -  Cardiac arrhythmia

          -  Prior myocardial infarction

          -  Other significant EKG abnormality

          -  Liver disease

          -  History of leucopenia (WBC <3,500/mm3)

          -  Epilepsy

          -  Other serious and unstable medical condition

          -  Pregnant woman

          -  Breastfeeding woman

          -  Active drug or alcohol use or dependence that, in the opinion of the site
             investigator, would interfere with adherence to study requirements

          -  Use of quinidine (alone or as a component of Nuedexta®) during the study

          -  Inability or unwillingness of subject to give written informed consent

          -  Woman of childbearing potential, not willing to use at least two approved methods of
             contraception

          -  Use of a prohibited medication during study
Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
Condition: Obesity; Binge Eating
MeSH terms: Obesity; Weight Loss; Bulimia; Binge-Eating Disorder
Intervention: Xenical + behavioral intervention; Behavioral intervention + placebo
Intervention description: 120 mg TID; Behavioral weight loss in Spanish; Behavioral weight loss treatment in Spanish Placebo TID
Intervention MeSH terms: Orlistat
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Binge Eating; Monolingual Hispanic Persons; Orlistat; Behavioral Weight Loss Treatment

Summary:

      This is a research study designed to examine the effectiveness of an obesity medication
      (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese
      monolingual (Spanish-speaking only) men and women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Monolingual Spanish Speaking

          -  Obese (BMI >= 30)

        Exclusion Criteria:

          -  Pregnancy

          -  Current cardiac disease

          -  Serious neurologic illnesses
Misoprostol for Reduction of Blood Loss During Fibroid Surgery
Condition: Fibroids
MeSH terms: Leiomyoma; Myofibroma; Hemorrhage
Intervention: Misoprostol; Placebo
Intervention description: 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.; 25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
Intervention MeSH terms: Pyridoxine; Vitamin B 6; Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: fibroids, leiomyomata, blood loss, misoprostol

Summary:

      The aim of this research work is to assess the impact of a single preoperative dose of buccal
      misoprostol in reducing blood loss during abdominal fibroid surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting for abdominal myomectomy with documented uterine fibroids on
             pelvic imaging (pelvic ultrasound or MRI) within in last 12 months

          -  Age ≥ 18 years and ≤ 50 years

          -  Pre-operative hemoglobin >8 g/dl

          -  Willing to have buccal administration of misoprostol or a placebo at least one hour
             pre-procedure.

          -  Ability to understand and the willingness to sign a written informed consent.

          -  Admissible medical/surgical history

          -  Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills

          -  Intraoperative use of vasopressin and uterine tourniquet is permissible

          -  Can have had prior Cesarean delivery

        Exclusion Criteria:

          -  Patients who have had a prior abdominal myomectomy

          -  Post-menopausal women

          -  Patients with known bleeding/clotting disorders

          -  Patients with a history of gynecologic malignancy

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to misoprostol

          -  Any cases converted to abdominal hysterectomy or other additional elective surgical
             procedures performed at time of abdominal myomectomy will be excluded from data
             analysis

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.
Effects of Metformin on Hepatic FFA Metabolism
Condition: Type 2 Diabetes; Dyslipidemia
MeSH terms: Diabetes Mellitus, Type 2; Dyslipidemias
Intervention: Metformin; Placebo
Intervention description: 1000 mg metformin twice daily in 3 months; 2 tablets twice daily in 3 months
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 50 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Type 2 diabetes; Hepatic fatty acid oxidation; Dyslipidemia; Metformin

Summary:

      Background: Metformin treatment has beneficial effects on both glucose and lipid metabolism.
      Whereas there is general agreement that the blood glucose lowering effect of metformin
      results from inhibition of hepatic gluconeogenesis, it is less clear exactly how the drug
      lowers blood triglyceride concentration. There are indications that it enhances hepatic free
      fatty acid (FFA) oxidation thus diminishing substrate for reesterification and resecretion as
      very-low-density-lipoprotein (VLDL) triglycerides (TG). However, the liver is not easily
      accessible for sampling in humans and data on the clinical effects of metformin in the liver
      are therefore lacking. This may change due to the increasing use of the positron emission
      tomography (PET) technique. Using PET isotopes (11C or 18F) coupled to either palmitate or a
      fatty acid analogue, it is possible to non-invasively measure hepatic fatty acid handling.

      Aim: To determine how 3 months metformin treatment (1000 mg twice daily) affects hepatic
      lipid and glucose metabolism in patients with newly diagnosed type 2 diabetes.

      Design: Randomized, placebo controlled, double-blind parallel study with patients receiving
      either metformin or placebo. A control group of BMI and age-matched non-diabetic individuals
      will receive metformin for 3 months.

      Hypothesis: Metformin lowers VLDL-TG secretion and circulating triglycerides by increasing
      hepatic fatty acid oxidation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recently diagnosed type 2 diabetes

          -  Age 50-70 years

          -  BMI<40

        Exclusion Criteria:

          -  Insulin treatment

          -  NASH (non alcoholic steatohepatitis)

          -  Cancer

          -  Anemia

          -  HbA1C>8.5 %

          -  Chronic or acute pancreatitis

          -  Alcohol or medicine abuse

          -  Allergy towards metformin

          -  Claustrophobia

          -  Severe obesity (weight >130 kilogram)
Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
Condition: Smoking Cessation
Intervention: varenicline tartrate (CP-526, 555-18); Placebo
Intervention description: 1 mg twice a day for 12 weeks, starting with a 1-week titration period.; matching placebo 1 tablet twice a day for 12 weeks
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 593.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline
      compared to placebo for smoking cessation. Abstinence from cigarette smoking and other
      tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period
      will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current male or female cigarette smokers who are motivated to stop smoking.

          -  Smoked an average of 10 cigarettes per day during past year and the month prior to
             first visit.

        Exclusion Criteria:

          -  Patients who have used a nicotine replacement product, bupropion, clonidine or
             notriptyline within the past 6 months.

          -  Patients currently with depression or diagnosed with depression in past 12 months.

          -  Past or present history of psychosis, panic disorder, or bipolar disorder.
A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia
Condition: Anemia
MeSH terms: Anemia
Intervention: Dialysis; methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: regular haemodialysis or peritoneal dialysis; once monthly, subcutaneously or intravenously, for 32 weeks
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open label, single arm study will assess the efficacy for long-term maintenance of
      haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin
      beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term
      haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera
      for 6 months. Target sample size is <200 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >/=18 years of age

          -  chronic renal anaemia

          -  haemoglobin 10.0-12.0g/dl at screening

          -  adequate iron status

          -  continuous stable ESA (erythropoietic stimulating agent) therapy for >/= 2 months

          -  regular haemodialysis or regular peritoneal dialysis for >/= 3 months

        Exclusion Criteria:

          -  uncontrolled hypertension

          -  haemoglobinopathy

          -  anaemia due to haemolysis

          -  pure red cell aplasia (PRCA)