bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Latent TB Infection for Jailed Persons
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: Isoniazid; Rifampin
Intervention description: Isoniazid 900 mg twice weekly; Rifampin 600mg once per day
Intervention MeSH terms: Rifampin; Isoniazid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 364.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: LTBI, tuberculosis, rifampin, isoniazid, prisoners

Summary:

      The purpose of this study is to determine whether an alternative drug, (rifampin) given
      daily, is better at treating tuberculosis (TB) and more tolerable than the usual drug
      treatment, isoniazid (INH). Study participants will include 972, TB infected, San Francisco
      Jail inmates, aged 18 or older. One group of volunteers will take INH two times a week for 9
      months, and the other group will take rifampin daily for 4 months. Medication will be
      administered in jail and at the San Francisco TB Clinic if the volunteer is released from
      jail prior to completing the study. Participants will be seen daily for 4 months (rifampin
      group), and 2 times a week for 9 months (INH group) for directly observed therapy. Study
      procedures will include 5 symptom review visits and blood samples for lab testing. Follow-up
      will continue for each subject for five years after enrollment into the study.
    

Eligibility criteria:

        Inclusion Criteria:

        The inclusion criteria for this study will be San Francisco Jail inmates, age 18 or older
        (the jail does not house juveniles) having evidence of M. tuberculosis infection by
        positive tuberculin skin test (a documented reactive tuberculin skin test to 0.1 mL
        containing 5 Tuberculin Units) who meet current national criteria for therapy for
        tuberculosis infection and can provide informed consent.

        Exclusion Criteria:

          -  Ineligible for either therapy regimen for any of the following reasons:

               1. history of treatment-limiting reaction to isoniazid or rifamycins;

               2. pregnancy or breast feeding;

               3. active tuberculosis;

               4. an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times
                  the upper limit of normal;

               5. bilirubin >2 times the upper limit of normal;

               6. platelets <150 K/mm3;

               7. taking protease inhibitors or nonnucleoside reverse transcriptase inhibitors
                  (NNRTIs);

          -  Unable to communicate in English or Spanish;

          -  Unable or unwilling to provide informed consent;

          -  Not in the routine level of jail security for any reason (housed in "special security"
             areas);

          -  Any condition that, in the best judgment of the investigator, would pose a risk to the
             subject during the study.
Heart Rate Reduction in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: ivabradine; "Drug:Carvedilol" and "Drug:Ivabradine"; Carvedilol
Intervention description: 7.5 mg bd; up to 12.5/5 mg bd; 25 mg bd
Intervention MeSH terms: Carvedilol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: heart failure; heart rate; ivabradine; carvedilol

Summary:

      Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological
      interventions have been proven effective in improving exercise capacity. At the presence
      there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity.
      Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left
      ventricular dysfunction and heart rate > 70 bpm. The association of ivabradine and atenolol
      has been proven effective in increasing exercise tolerance in patients with ischemic heart
      disease. Aim of the present study is to evaluate the effect of heart rate reduction with
      ivabradine, carvedilol or their combination in patients with heart failure of ischemic
      origin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  heart failure II-III

          -  ischemic origin

          -  stable medications from at least 3 months

          -  > 3 months from an acute ischemic syndrome or revascularization procedure

          -  naive on heart rate reducing agents

        Exclusion Criteria:

          -  bradycardia

          -  hypersensitivity or contraindications to study drugs

          -  exercise tolerance at 6 minute walking test <100 m or >400 m
Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy
Condition: Endocrine System Diseases
MeSH terms: Dwarfism; Endocrine System Diseases
Intervention: Somatropin
Intervention description: liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 11 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      -  To assess the effect of a long-term treatment by Genotonorm on linear growth in children
           with short stature receiving steroid therapy

        -  To assess the effect of a long term treatment with Genotonorm on bone mineralisation

        -  To assess the effect of a long term treatment with Genotonorm on body composition
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with juvenile arthritis or nephrotic syndrome

          -  Before or during puberty

        Exclusion Criteria:

          -  Diabetes Type 1 and 2

          -  Endocrine disease, except well substituted hypothyroidism
Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: albiglutide; sitagliptin; glimepiride; metformin; placebo albiglutide; placebo sitagliptin; placebo glimepiride
Intervention description: albiglutide; sitagliptin; Glimepiride; Metformin; placebo to match albiglutide; placebo to match sitagliptin; placebo to match glimepiride
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Glimepiride; rGLP-1 protein; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1049.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes

Summary:

      The purpose of this study is to determine if albiglutide is safe and effective in the
      treatment of type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes

          -  BMI 20-45kg/m2 inclusive

        Exclusion Criteria:

          -  females who are pregnant, lactating or <6 weeks post-partum

          -  current symptomatic heart failure (NYHA Class III or IV)
Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis
Condition: Inborn Errors of Bile Acid Synthesis
Intervention: Cholic acid
Intervention description: The IUPAC name for cholic acid is 3 alpha,7alpha,12 alpha-trihydroxy-5 beta-cholanoic acid. The international nonproprietary name (INN) is cholic acid.
Each patient will be given a box containing a 1 month supply of study drug. Each bottle will contain 90 capsules; each capsule will contain either 50 or 250 mg of manufactured cholic acid depending upon the child's weight. The study drug will be taken orally, in divided doses (as determined by the investigator), for a total daily dose of 10-15 mg/kg body weight. Parents of infants and young children who are unable to swallow the TBM cholic acid capsule will be instructed to sprinkle the contents of the capsule over 1-2 teaspoons of plain applesauce and feed it to the child.
Intervention MeSH terms: Cholic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Healthy volunteers: No
Keywords: Inborn Errors; Bile Acid; Pediatrics; Liver Disease

Summary:

      This is a study in a small population of children who have inborn errors of bile acid
      synthesis who are currently taking established doses of the currently used cholic acid
      capsules prepared at the Cincinnati Children's Hospital Pharmacy. The study is designed to
      compare the efficacy of these currently used capsules with the efficacy of the same treatment
      provided in a cholic acid capsule that is made by a company that will be marketed after FDA
      approval.

      At baseline, patients receive established doses of cholic acid capsules prepared at the
      Cincinnati Children's Hospital Medical Center Pharmacy. During the study, patients receive
      the same treatment provided in the to-be-marketed (TBM) cholic acid capsule. Hence, patients
      serve as their own controls, with baseline values presenting the reference value (CCHMC
      cholic acid capsule) and values after 30 days treatment presenting the value for the
      investigational treatment (TBM cholic acid capsule).
    

Eligibility criteria:

        Inclusion Criteria:

          -  must have stable transaminase levels within 2 times the upper limits of the normal
             range.

          -  must have a diagnosis of an inborn error of bile acid synthesis.

          -  must have signed the written informed consent/assent document before study start.

          -  must be currently receiving currently used cholic acid therapy under IND 45,470.

          -  must be willing and able to comply with all study assessments and procedures.

          -  must be able to make two visits (Visit 1 and Visit 2) to the study site.

        Exclusion Criteria:

          -  is not currently receiving cholic acid therapy for inborn errors of bile acid
             synthesis under IND 45,470.

          -  is unable or unwilling to comply with study requirements.
Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.
Condition: Covid19
MeSH terms: COVID-19
Intervention: sotrovimab; sotrovimab; sotrovimab; sotrovimab; Sotrovimab; Sotrovimab; Sotrovimab
Intervention description: Sotrovimab 500 mg given by intravenous infusion over 15 min; Sotrovimab 500 mg given by intramuscular injection; Sotrovimab 250 mg given by intramuscular injection; Sotrovimab 2000 mg given by intravenous infusion over 60 min; Sotrovimab 2000 mg given by intravenous infusion over 30 min; Sotrovimab 2000 mg given by intravenous infusion over 15 min; Sotrovimab up to 3000 mg given by intravenous infusion over 90 min
Intervention MeSH terms: Sotrovimab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1065.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; coronavirus disease 2019; COVID-19; early treatment; coronavirus

Summary:

      The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab
      versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In
      the safety substudy, the aim is the evaluation of the safety and tolerability of sotrovimab
      across a single ascending dose level and over different infusion times when given for the
      treatment of mild/moderate COVID-19 to participants at high risk of disease progression

      The safety sub-study was discontinued early in the context of ongoing concerns regarding the
      continuous change in the SARS-CoV-2 circulating variants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Main Study participant must be aged 12 years or older AND at high risk of progression
             of COVID-19 or > 55 years old

          -  Sub-Study participants must be aged 18 years or older at time of consent AND at high
             risk of progression of COVID-19 or ≥ 55 years old

          -  Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on
             room air and have COVID-19 symptoms and be less than or equal to 7 days from onset of
             symptoms

        Exclusion Criteria:

          -  Currently hospitalized or judged by the investigator as likely to require
             hospitalization in the next 24 hours

          -  Symptoms consistent with severe COVID-19

          -  Participants who, in the judgement of the investigator are likely to die in the next 7
             days

          -  Known hypersensitivity to any constituent present in the investigational product
A New Pharmacotherapy for Alcohol Dependence: Olanzapine
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: 2.5 mg Olanzapine; 5mg Olanzapine; placebo
Intervention description: 2.5 mg; 5 mg; placebo
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 304.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Olanzapine

Summary:

      Craving for alcohol has been related to loss of control drinking and is a major target of
      biological and behavioral interventions for alcohol dependence. Our previous research has
      demonstrated that olanzapine (a dopamine antagonist) attenuates craving for alcohol, that a
      variant in the gene that expresses D4 receptors influences craving for alcohol, and that
      olanzapine is particularly effective at reducing craving among individuals with this variant.
      Pilot data from a recent 12 week trial of olanzapine indicates that olanzapine is well
      tolerated and that olanzapine reduces drinking, particularly among individuals with the
      aforementioned genetic variant. The objective of the present application is to examine the
      effectiveness of olanzapine (5 mg/day), as compared to olanzapine (2.5 mg/day) and a placebo
      control, in terms of reducing craving and alcohol use behavior among treatment seeking
      alcoholics. Furthermore, the present application will examine whether the effects of
      olanzapine on drinking outcomes are mediated by its effects on a specific putative mechanism
      (i.e., cue-elicited craving for alcohol) and determine whether the DRD4 VNTR polymorphism is
      a marker for the effectiveness of olanzapine. To that end, 202 alcohol dependent subjects
      will be randomly assigned to medication group and receive 12 weeks of medication. Subjects
      will complete follow-up assessments at 3 and 6 months after the end of the treatment. It is
      expected that olanzapine will significantly reduce cue-elicited craving and alcohol use
      behavior in a dose dependent fashion over the course of the 12 week trial and follow-up
      period, as compared to the placebo condition. Furthermore, it is expected that the effects of
      olanzapine on alcohol use behavior will be mediated by the effect of olanzapine on
      cue-elicited craving and that the effects of olanzapine on cue-elicited craving and alcohol
      use behavior will be moderated by the DRD4 VNTR, such that olanzapine will be more effective
      among individuals with the 7 repeat allele. The successful completion of the proposed
      research is expected to advance a new medication for alcohol dependence and advance genetic
      markers that predict the effectiveness of this medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21-55 years of age with

          -  Alcohol Dependence

        Exclusion Criteria:

          -  Medical Contraindications
Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: AMR101 (ethyl icosapentate) - 4 g/day; AMR101 (ethyl icosapentate) - 2 g/day; Placebo
Intervention description: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks; AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks; Placebo 4 capsules/day for 12 weeks
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 702.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertriglyceridemia; omega-3 fatty acids; statin; triglycerides; lipids; EPA; docosahexaenoic acid; fish; fatty acids; fibrates; niacin; lipid; atorvastatin; Lovaza; simvastatin; lovastatin; pravastatin; fluvastatin; rosuvastatin; Trilipix; Vytorin; Simcor; Niaspan; ezetimibe; Zetia; ethyl-EPA; ethyl icosapentate; Crestor; Zocor; Lipitor; LDL; HDL; cholesterol; dyslipidemia; VASCEPA; icosapent ethyl

Summary:

      The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to
      placebo in lowering high fasting triglyceride levels in patients with high risk for
      cardiovascular disease and fasting triglyceride levels ≥ 200 and < 500 mg/dL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, ages >18

          -  Fasting triglyceride ≥200 mg/dL and <500 mg/dL

          -  LDL-C (low density lipoprotein - cholesterol) ≥40 mg/dL and <100 mg/dL

          -  High risk for coronary heart disease

          -  On stable dose of statin (atorvastatin, rosuvastatin or simvastatin)

          -  Provide written informed consent and authorization for protected health information
             disclosure

        Exclusion Criteria:

          -  Women who are pregnant or lactating, or planning to become pregnant

          -  Use of non-statin lipid-altering drugs which cannot be stopped including fibrates,
             niacin, fish oil and other products containing omega-3 fatty acids or other dietary
             supplements with potential lipid-altering effects

          -  History of bariatric surgery or currently on weight loss drugs

          -  Uncontrolled hypertension (BP > 160/100)

          -  HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or
             isotretinoin

          -  Consumption of more than 2 alcoholic beverages per day

          -  History of cancers (except if been disease free for >5 years OR history was basal or
             squamous cell skin cancer)

          -  Participation in another clinical trial involving an investigational agent in the last
             30 days

          -  Other parameters will be assessed at the study center to ensure eligibility for this
             study.
A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: AC-170 0.24%; AC-170 0%
Intervention description: 1 drop in each eye at 2 separate times during a 14 day period; 1 drop in each eye at 2 separate times during a 14 day period
Intervention MeSH terms: Cetirizine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%
      compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in
      the conjunctival allergen challenge (CAC) model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  positive bilateral conjunctival allergen challenge (CAC)reaction

        Exclusion Criteria:

          -  known contraindications or sensitivities to the study medication or its components

          -  any ocular condition that, in the opinion of the investigator, could affect the
             subjects safety trial parameters

          -  use of disallowed medication during the period indicated prior to the enrollment or
             during the study
Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Intervention: Clopidogrel (SR25990); placebo
Intervention description: Form: reconstituted solution using Clopidogrel powder
Route: oral or enteric
Frequency: once daily
Dose: daily dose adjusted for weight; Form: reconstituted solution using matching placebo powder
Route: oral or enteric
Frequency: once daily
Dose: daily dose adjusted for weight
Intervention MeSH terms: Clopidogrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 906.0
Sex: All
Maximum age: 92 Days
Healthy volunteers: No
Keywords: cyanotic congenital heart disease; shunt palliation; thrombosis; clopidogrel

Summary:

      Contemporary management of cyanotic congenital heart disease includes three stages of
      surgery. Incidence of shunt thrombosis and death between the two first stages of palliation
      remains important.

      The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day
      for the reduction of all cause mortality and shunt related morbidity in neonates or infants
      with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt
      (e.g. modified Blalock Taussig Shunt [BTS]).

      The secondary objective was to assess the safety of Clopidogrel in the study population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cyanotic congenital heart disease treated by any palliative systemic-to-pulmonary
             artery shunt.

        Exclusion Criteria:

          -  Active bleeding or increase risk of bleeding,

          -  Allergy to 2 or more classes of drug,

          -  Unable to receive drug orally or enterically,

          -  Current clinically significant or persistent thrombocytopenia, neutropenia, severe
             hepatic or renal failure.