bioihbjkbjnl/mcl2 huggingface dataset:
Extended-release Naltrexone for Alcohol Dependence in Primary Care
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Extended release injectable naltrexone (Vivitrol)
Intervention description: Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months.
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol dependence

Summary:

      Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The
      efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has
      been demonstrated in clinical trials, raising the prospect of integrating pharmacologic
      treatment for alcohol dependence into general medical care settings. However, the feasibility
      of implementing this United States Food and Drug Administration approved treatment in the
      front-line settings in which it is most needed has not been demonstrated. This is an
      open-label pilot feasibility study of implementing treatment with Vivitrol in primary care
      medical clinics in a safety net hospital system affiliated with an urban academic center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current alcohol dependence

          -  Age 18 or older

          -  English or Spanish-speaking

          -  Without untreated severe mental illness

          -  Liver enzymes (alanine aminotransferase and aspartate aminotransferase) ≤ 3x normal

          -  Kept 2 of last 3 clinic primary care appointments and/or has a working telephone
             number at which can be contacted directly

          -  Either a) currently abstinent (e.g., referred from an inpatient 'detox' setting) or b)
             with the ability, in the clinician's judgment, to achieve and maintain abstinence

          -  If female of child-bearing potential, must be using adequate contraception

          -  Able to understand study procedures

        Exclusion Criteria:

          -  Currently opioid dependent or requiring ongoing treatment with opioids for any
             indication
ROMEO (Rosuvastatin in Metabolic syndrOme)
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: Rosuvastatin; Atorvastatin
Intervention description: 10mg; 10mg
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rosuvastatin; lipoprotein; metabolic syndrome

Summary:

      The primary objective of this study is to compare the effect of rosuvastatin 10mg with
      atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with
      metabolic syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of 3 or more of the following criteria;

               -  Abdominal obesity (men >90cm women >80cm)

               -  Triglycerides ≥ 150 mg/dL

               -  HDL-C: men < 40 mg/dL, women < 50 mg/dL

               -  BP ≥130/≥85 mmHg or anti-hypertensive treatment

               -  Fasting blood glucose ≥100 mg dL or anti-diabetic treatment

          -  Elevated LDL-C ;

               -  ≥130 mg/dL to < 220 mg/dL in lipid lowering agent naive subjects

               -  ≥100 mg/dL to < 200 mg/dL in subjects who have taken a lipid lowering drug(s)
                  within 4 weeks of visit 1.

          -  Triglyceride < 500 mg/dL
13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India
Condition: Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC
MeSH terms: Pneumonia
Intervention: 13-valent Pneumococcal conjugate vaccine; Blood sample collection
Intervention description: 1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1; 10 mL of blood will be collected just before and approximately 1 month after vaccination.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Masking: None (Open Label)
Enrollment: 1200.0
Sex: All
Minimum age: 6 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 13-valent pneunococcal conjugate vaccine; pneumococcal disease prevention; safety and immunogenicity study

Summary:

      This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65
      years of age and in Indian children 6 to 17 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

        Indian adults subjects between 50 and 65 years of age and indian children between 6 and
        17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.

        Exclusion Criteria:

        Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine
        within the last year
Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
Condition: Peripheral Arterial Occlusive Disease
MeSH terms: Arterial Occlusive Diseases; Peripheral Arterial Disease
Intervention: Alprostadil; Placebo
Intervention description: Active Substance: Prostaglandin E1
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion; Active Substance: Lactose
Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion
Intervention MeSH terms: Alprostadil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 840.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Alprostadil; Prostavasin; PAOD; Fontaine Stage IV

Summary:

      The study is to confirmatorily show a superior effect of Alprostadil compared to placebo on
      the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency
      and height of major amputations in patients suffering from PAOD stage IV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is at least 45 years of age

          -  Subjects with macro-angiopathy, proven PAOD Stage IV with up to 2 ischaemic skin
             lesions for more than 2 weeks

          -  Subject has a complete angiography of pelvis, thigh and calf within one month of
             inclusion

          -  Systolic ankle pressure ≤ 70 mmHg in subjects without media sclerosis of the lower
             limb artery or systolic big toe pressure ≤ 50 mmHg in diabetics with media sclerosis
             of the lower limb artery

          -  Subject is not in the position to be primarily revascularized or refuses surgery

        Exclusion Criteria:

          -  Imminent or foreseeable amputation

          -  Major amputation on the affected extremity

          -  History of chronic alcohol or drug abuse

          -  More than two ischemic ulcerations

          -  One ulcer ≥ 6 cm^2, both ulcers ≤ 1 cm^2 or at least one ulcer affecting the bone or
             tendons

          -  Acute ischemia and peripheral vascular disorders of inflammatory or immunologic origin

          -  Neuropathic or venous ulcers

          -  Buerger's disease

          -  Septic gangrene

          -  Use of vasoactive medication or prostaglandins

          -  Treatment with prostanoids within 3 months prior to inclusion

          -  Surgical or interventional measures performed on the affected extremity within 3
             months prior to study drug treatment
Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux.
Condition: Major Orthopaedic Surgery and Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: fondaparinux 1.5 mg/day
Intervention description: Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 451.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: major orthopaedic surgery; venous thromboembolic events prevention; renal impairment; Arixtra; anti-Xa activity

Summary:

      Fondaparinux is an antithrombotic agent having already received a regulatory approval by the
      European Authorities in venous thromboembolic event prevention after major orthopaedic
      surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The
      bleeding risk associated with this prescription is highly related to renal function evaluated
      by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to
      prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of
      2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated
      pharmakinetic data without any support of clinical data.

      prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5
      mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl
      between 20 and 30 ml/min and undergoing a major orthopaedic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • age > 18 years old,

               -  undergoing a major orthopaedic surgery (THR, TKR, HF) whatever procedure
                  techniques are used, 1st indication or 2nd indication,

               -  requiring an antithrombotic prophylaxis,

               -  presenting a renal impairment defined by a creatinin clearance (CrCl) between 20
                  and 50 ml/min calculated by Cockcroft and Gault's formula,

               -  having signed the inform consent form.

        Exclusion Criteria:

          -  contra-indications to fondaparinux,

          -  history of heparin inducted thrombopenia (HIT),

          -  platelets < 100 g/l.
Anti-platelet Effects of Colchicine in Healthy Volunteers
Condition: Healthy
Intervention: Colchicine
Intervention description: Colchicine 1.2 mg followed by 0.6 mg one hour later
Intervention MeSH terms: Colchicine
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: Accepts Healthy Volunteers
Keywords: colchicine; platelet activity; neutrophil

Summary:

      This is a pilot study. Volunteers will be given 1.8 mg (1.2 mg followed by 0.6 mg one hour
      later), 1.2 mg, or 0.6 mg of colchicine. Blood will be collected prior to drug
      administration, 2 hours after colchicine administration, and 24 hours after colchicine
      administration via the antecubital vein and evaluated for markers of platelet activity and
      inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be more than 18 years of age

        Exclusion Criteria:

        1) history of cardiovascular disease, including myocardial infarction, history of
        percutaneous coronary angioplasty or stent, peripheral vascular disease or stroke; 2)
        history of myelodysplasia; 3) medications known to affect platelet function, including
        non-steroidal anti-inflammatory drugs, antihistamines, and selective serotonin reuptake
        inhibitors, during the 5 days prior to participation; 4) medications known to interact with
        colchicine; 5) history of intolerance to colchicine; 6) acute or chronic symptoms of
        diarrhea, nausea, or vomiting within 1 month prior to enrollment; 7) known anemia or
        hemoglobin <10mg/dL; 8) platelet count <100,000 or > 450,000; 9) creatinine clearance
        <30cc/minute; 10) any known hemorrhagic diathesis; 11) pregnant; 12) Unable to consent; or
        13) Participating in a competing study.
The Muscle Relaxation-study
Condition: Cholecystectomy, Laparoscopic
Intervention: Rocuronium; Rocuronium
Intervention description: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h; Intravenous use: 0,3 mg/kg followed by NaCl-infusion
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this investigation is to compare the surgical conditions during laparoscopic
      cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation.

      The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are
      better with deep muscle relaxation than moderate muscle relaxation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients older than 18 years

          -  Scheduled for elective laparoscopic cholecystectomy

          -  Can read and understand danish

          -  Women must be post-menopausal, sterilized or use safe contraception in the form of a
             coil or oral anti-contraceptives

        Exclusion Criteria:

          -  Known allergy to medications that are included in the project

          -  Presence of severe renal disease, neuromuscular disease, reduced liver function

          -  Nursing or pregnant

          -  Indication for crash induction

          -  For fertile women: Missing negative pregnancy-test
Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training
Condition: Age-related Cognitive Decline
MeSH terms: Cognitive Dysfunction
Intervention: Vortioxetine 10 mg; Cognitive training program
Intervention description: Online training program, 30 minutes a day, 5 times a week
Intervention MeSH terms: Vortioxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vortioxetine; Elderly; Online cognitive training

Summary:

      The purpose of this research study is to examine the potential benefits of vortioxetine in
      combination with at-home computerized cognitive training program to improve cognition, such
      as memory, attention, and concentration. This study will compare the effectiveness of
      vortioxetine plus cognitive training versus placebo plus cognitive training.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Community-living men and women age 65 and older

          -  Age-related cognitive decline as defined by (a) self-reported cognitive dysfunction
             that is attributed to the aging process (in response to screening questions to the
             participant); (b) ability to complete cognitive battery, but still scoring less than 1
             standard deviation above age-matched norms at both baseline and after the two-week
             cognitive training lead-in.

        Exclusion Criteria:

          -  Known dementia or other clinical neurodegenerative illness (e.g., Parkinson's disease,
             cerebrovascular disease) per self-report, informant report, medical records, or
             neuropsychological testing

          -  Any current psychiatric disorder

          -  Medical conditions that suggest shortened lifespan, such as metastatic cancer; or
             would prohibit safe participation in the interventions, including cardiovascular
             disease or musculoskeletal conditions; or with the assessments.

          -  Sensory impairment that would prevent participation

          -  IQ < 70 as estimated by the Wechsler Test of Adult Reading

          -  Alcohol or substance abuse within 6 months

          -  Concurrent cognitive training, such as brain-training software, or other interventions
             expected to affect neuroplasticity

          -  Psychotropic medications or those with likely CNS effects (none within 4 weeks prior
             to study entry)
Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
Condition: HIV; Contraception
Intervention: Depot medroxyprogesterone acetate (DMPA); Etonogestrel implant (Eng-Implant); Levonorgestrel intrauterine device (Lng-IUD); ParaGard® T 380A Intrauterine Copper Contraceptive
Intervention description: DMPA will be administered every 12 weeks at the standard dose of 150 mg IM, beginning from week 3 of study enrollment and repeated at week 15.; A standard nexplanon rod implant will be placed at study week 3 by a trained clinician.; A standard Mirena IUD will be placed at study week 3 by a trained clinician.; A standard ParaGuard IUD will be placed at study week 3 by a trained clinician.
Intervention MeSH terms: Copper; Medroxyprogesterone Acetate; Contraceptive Agents; Levonorgestrel; Medroxyprogesterone; Etonogestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV-negative

Summary:

      This is a prospective cohort study focusing on HIV negative women. The investigators want to
      learn how the contraceptive methods of depot medroxyprogesterone acetate (DMPA), etonogestrel
      implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and the ParaGard® T 380A
      Intrauterine Copper Contraceptive impact the vaginal immune environment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Age 18-45 years

          -  Normal menses (22-35 day intervals) for at least 3 cycles

          -  Intact uterus and cervix

          -  Interested in to DMPA, Eng-Implant or Lng-IUD or ParaGuard

          -  Willing to delay initiation of hormonal contraception for up to 1 month

          -  Willing to use condoms or abstain from sexual intercourse for at least 48 hours before
             each genital tract sampling (condoms will be made available)

          -  Able and willing to provide informed consent, and undergo serial blood and
             cervicovaginal lavage (CVL) sampling

          -  Negative HIV screening

        Exclusion Criteria:

          -  Pregnant within the last 3 months

          -  Breastfeeding

          -  History of loop electrosurgical excision procedure, conization, or cryosurgery within
             the past year

          -  Use of hormonal contraception or IUD in the past 6 months

          -  Known history of medical condition that would interfere with the conduct of the study

          -  Symptomatic vaginal infection or genital ulcer disease at screening

          -  Taking medications that interact with selected contraceptive

          -  Contraindications to selected contraceptive per the Centers for Disease Control and
             Prevention (CDC) medical eligibility criteria or judgment of clinician
Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers
Condition: Severe Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Pitavastatin 4mg
Intervention description: Pitavastatin 4mg single dose
Intervention MeSH terms: Pitavastatin
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are
      planned (8 subjects in Group A and 8 subjects in Group B):

      The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the
      ranges for comparison will be obtained from the pooled demographic data of the renally
      impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A,
      the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men
      to women in Group B will be the same as in Group A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is an adult male or female subject aged 18 years or older. Females of
             childbearing potential must have a negative pregnancy test before beginning the study.

          -  Subject has no clinically significant medical conditions (other than renal impairment
             and associated diseases, such as hypertension, diabetes, and dyslipidemia, for
             subjects in Group A) as determined by medical history, physical examination, 12-lead
             ECG, clinical laboratory results (hematology, serum chemistry, and urinalysis [if able
             to pass urine]), and serology results (hepatitis B surface antigen, hepatitis C virus
             antibody, and human immunodeficiency virus types 1 and 2 antibody). Subjects with
             positive results for hepatitis C virus but who have normal liver enzymes will not be
             excluded. Any subjects who have impaired hepatic function that will potentially affect
             drug metabolism should be excluded.

          -  Subject provides written informed consent before any study-specific evaluation is
             performed.

          -  Subject is able and willing to comply with the protocol and study procedures.

        Exclusion Criteria:

          -  Subject is on maintenance hemodialysis.

          -  Subject has a BMI of >37 kg/m2.