bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous Thyroxine for Heart-Eligible Organ Donors
Condition: Brain Death; Heart Failure
MeSH terms: Brain Death
Intervention: Thyroxine; Saline
Intervention description: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.; The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 838.0
Sex: All
Minimum age: 14 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Organ donor

Summary:

      This randomized controlled trial will evaluate whether intravenous thyroxine infusion given
      to brain-dead organ donors who are eligible to donate hearts for 12 hours will result in more
      hearts transplanted than saline placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Declared dead by neurologic criteria (brain dead)

          -  Authorization for organ donation and research

          -  On one or more vasopressors and/or inotropes

        Exclusion Criteria:

          -  Brain death declared more than 24 hours prior

          -  Only vasopressor is vasopressin

          -  Weight < 45 kg (100 lbs)

          -  Known coronary artery disease or history of myocardial infarction

          -  Known valvular heart disease

          -  Prior sternotomy or cardiac surgery

          -  Donor at VA hospital

          -  Received intravenous or oral thyroxine within past month

          -  Known HIV+ status

          -  Other reason donor is unable to receive study drug (determined by on-site personnel)
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)
Condition: Macular Edema Secondary to Branch Retinal Vein Occlusion
MeSH terms: Neoplasm Metastasis; Macular Edema; Retinal Vein Occlusion; Edema
Intervention: Ranibizumab 0.5 mg; Sham injection
Intervention description: intravitreal injection of 0.05 ml; Sham intravitreal injection
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 283.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BRVO; macular edema; vision impairment; retinal vein occlusion; ranibizumab; branch retinal vein occlusion; anti-VEGF therapy; RFB002

Summary:

      Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in
      patients with visual impairment due to macular edema secondary to BRVO
    

Eligibility criteria:

        Inclusion Criteria:

        • Patients with visual impairment secondary to branch retinal vein occlusion (BRVO) with a
        BCVA between 19 and 73 letters in one eye and at least 35 letters in the other eye.

        Exclusion Criteria:

          -  Pregnant or nursing women or women of child bearing potential without unless using an
             effective contraception

          -  Stroke or myocard infarction within 3 months prior to study

          -  History of malignancy within the past 5 years

          -  Uncontrolled hypertension

          -  Active infection or inflammation in any eye

          -  use of corticosteroids for at least 30 days in the last 6 months

          -  treatment with anti-angiogenic drugs in any eye within last 3 months

          -  Panretinal or focal/drid laser photocoagulation within the last few months
Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution
Intervention description: One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Bimatoprost; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the safety and efficacy of Triple Combination Therapy
      (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients
      with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on
      brimonidine/timolol ophthalmic solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Glaucoma and/or ocular hypertension in both eyes

          -  Requires IOP-lowering treatment in both eyes

        Exclusion Criteria:

          -  Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis,
             ocular infections or severe dry eye)

          -  Current or anticipated use of ocular medications other than study medications, except
             for intermittent use of artificial tears

          -  Use of oral, injectable or topical corticosteroids within 21 days

          -  Iridectomy or laser peripheral iridotomy in the study eye within 3 months

          -  Uncomplicated cataract surgery in the study eye within 6 months

          -  Incisional glaucoma surgery in the study eye within 12 months
Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence
Condition: Prostate Cancer
MeSH terms: Recurrence
Intervention: Ga-68 labeled PSMA-11 PET
Intervention description: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Intervention MeSH terms: Edetic Acid; Gallium 68 PSMA-11
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 346.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators are imaging patients with prostate cancer using a new PET imaging agent
      (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients
      with biochemical recurrence after prostatectomy and radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria

          -  Histopathologically proven prostate adenocarcinoma.

          -  Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after
             definitive therapy with prostatectomy or radiation therapy (external beam or
             brachytherapy).

               -  Post radical prostatectomy (RP) - American Urological Association (AUA)
                  recommendation for biochemical recurrence after radical prostatectomy

                    -  PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.

               -  Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical
                  recurrence after radiation therapy

                    -  Nadir + greater than or equal to 2 ng/mL rise in PSA

          -  Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group
             (ECOG)/World Health Organization (WHO) equivalent).

          -  Age >= 18.

          -  Ability to understand a written informed consent document, and the willingness to sign
             it.

        Exclusion Criteria

          -  Unable to lie flat, still or tolerate a PET scan.

          -  Concomitant investigational therapy.

          -  Patient undergoing active treatment for non-prostate malignancy, other than skin basal
             cell or cutaneous superficial squamous cell carcinoma that has not metastasized and
             superficial bladder cancer.

          -  Contraindication to furosemide administration including prior allergy or adverse
             reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed
             if Furosemide is omitted as part of the PET imaging protocol if a second-generation
             scatter correction is available for the used PET device).
Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
Condition: Smoking
Intervention: Transdermal Nicotine Patch
Intervention description: Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Behavioral Activation

Summary:

      The primary purpose of this study is to develop a specialized behavioral activation treatment
      for smoking in youths ages 18-21 with elevated depressive symptoms. In the first phase we
      utilize focus groups and pilot testing with 15 youths to develop the behavioral activation
      smoking treatment for youth. In Phase II, we will conduct an open-label trial of the new
      treatment that will include 8 weeks of transdermal nicotine patch, which will begin at the
      time of quitting smoking. Participants will be followed over 26 weeks post-quit date. A
      subset of participants will also undergo an fMRI session to examine reward sensitivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  between 18 and 21 years of age

          -  a regular smoker for at least 6 months

          -  currently smoking an average of at least 5 cigarettes per day

          -  want to quit smoking

          -  report current elevated depressive symptoms

        Exclusion Criteria:

          -  current Axis I disorder

          -  psychoactive substance dependence (excluding nicotine dependence) within the past 6
             months

          -  current use of psychotropic medication or participation in any form of psychotherapy

          -  a history of significant medical condition (e.g., cardiovascular , neurological,
             gastrointestinal), pregnancy and/or breast feeding, or other systemic illness

          -  limited mental competency [Mini Mental State Examination score < 23] and/or the
             inability to give informed, voluntary, written consent to participate

          -  current use of any pharmacotherapy for smoking cessation not provided by the
             researchers during the quit attempt

        Additional Exclusion criteria only for the fMRI portion:

          -  cerebrovascular disease

          -  high blood pressure

          -  diabetes

          -  use of psychotropic medications in 3 weeks prior to participation in fMRI protocol

          -  exposure to extreme trauma

          -  lifetime history of mania, psychosis, or pervasive developmental disorder,

          -  being ambidextrous or left handed

          -  any metal implants, heart pacemaker, permanent retainer

          -  tattoos containing metal dyes

          -  claustrophobia.
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BI 1744; bi1744; Placebo; Foradil
Intervention description: BI1744 Respimat Med Dose Once Daily; 1744 low dose; Placebo Respimat and Foradil Placebo; Foradil 12 mcg twice daily and Placebo Respimat
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 99.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The study is intended to characterize the lung function profile of BI1744 in COPD patients
      where patients will perform pulmonary function tests at regular intervals for 24 hours at the
      end of a 6 week treatment period. Each patient will receive all four treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients willing to participate with confirmed diagnosis of COPD

          -  40 years of age or older

          -  having a 10 pack year smoking history

          -  able to perform serial pulmonary function tests

          -  able to use both a DPI and Respimat device

        Exclusion Criteria:

          -  Significant other disease

          -  clinically relevant abnormal hematology, chemistry, or urinalysis

          -  history of asthma

          -  diagnosis of thyrotoxicosis

          -  paroxysmal tachycardia related to beta agonists

          -  history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure
             within 1 year

          -  active tuberculosis, cystic fibrosis, clinically evident bronchiectasis

          -  significant alcohol or drug use

          -  pulmonary resection

          -  taking oral beta adrenergics

          -  taking unstable oral steroids

          -  daytime oxygen

          -  enrolled in rehabilitation program

          -  enrolled in another study or taking investigational products

          -  pregnant or nursing women, women of child bearing potential not willing to use two
             methods of birth control

          -  those who are not willing to comply with pulmonary medication washouts
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis
Intervention: SOF/VEL; SOF; RBV
Intervention description: SOF/VEL (400/100 mg) FDC tablet administered orally once daily; SOF 400 mg tablet administered orally once daily; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; HCV; cirrhosis; Sofosbuvir; Sovaldi; SOF/VEL; GS-5816; GS-7977; liver; Treatment naive; Treatment Experience; genotype 2

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks
      compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants
      with chronic genotype 2 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL

          -  HCV genotype 2

          -  Chronic HCV infection (≥ 6 months)

          -  Females of childbearing potential must have a negative serum pregnancy test

          -  Males and females of childbearing potential who engage in heterosexual intercourse
             must agree to use protocol specified method(s) of contraception

          -  Must be of generally good health, with the exception of chronic HCV infection, as
             determined by the investigator.

        Exclusion Criteria:

          -  Current or prior history of clinically-significant illness (other than HCV that may
             interfere with treatment, assessment or compliance with the protocol;

          -  Screening electrocardiogram (ECG) with clinically significant abnormalities

          -  Laboratory results outside of acceptable ranges at Screening

          -  Pregnant or nursing female or male with pregnant female partner

          -  Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease,
             alfa-1 antitrypsin deficiency, cholangitis)

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: bimatoprost /timolol formulation A fixed combination ophthalmic solution; bimatoprost/timolol fixed combination ophthalmic solution
Intervention description: One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.; One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Intervention MeSH terms: Timolol; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 561.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A
      ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once
      daily for 12 weeks in patients with glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has ocular hypertension or glaucoma in both eyes

          -  Requires IOP-lowering therapy in each eye

        Exclusion Criteria:

          -  Active or recurrent eye disease that would interfere with interpretation of study data
             in either eye

          -  History of any eye surgery or laser in either eye within 6 months

          -  Required chronic use of other eye medications during the study

          -  Anticipated wearing of contact lenses during the study.

          -  Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Tenofovir DF; Placebo
Intervention description: Tenofovir DF 300-mg tablet, administered orally, daily + OBR; Tenofovir DF Placebo administered orally, daily + OBR
Intervention MeSH terms: Tenofovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Phase 3; Randomized, Double-Blind; Control; Treatment-Experienced; OBR; Optimized background regimen; Highly Active Antiretroviral Therapy; HAART; HIV; HIV-1; AIDS Virus; Human Immunodeficiency Virus; Acquired Immune Deficiency Syndrome Virus; Virus; Human Immunodeficiency; Pediatrics

Summary:

      The purpose of this study is to assess the safety and efficacy of tenofovir disoproxil
      fumarate (tenofovir DF; TDF) plus a genotype-guided optimized background regimen (OBR)
      compared to placebo plus OBR in the treatment of human immunodeficiency virus type 1 (HIV-1)
      infected antiretroviral treatment-experienced adolescents with plasma HIV-1 ribonucleic acid
      (RNA) levels greater than or equal to 1000 copies/mL.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Weight ≥ 35 kg

          -  Documented laboratory diagnosis of HIV infection

          -  Plasma HIV-1 RNA ≥ 1000 copies/mL

          -  Prior antiretroviral treatment experience with at least 2 antiretroviral drug classes

          -  Naive to tenofovir DF

          -  Absence of K65R mutation on genotypic testing

        Exclusion Criteria:

          -  Patients requiring didanosine in background regimen

          -  Prior history of significant renal disease

          -  Prior history of significant bone disease
A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL)
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Cladribine; Cyclophosphamide; Rituximab
Intervention description: Cladribine will be adminiatered at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4 of each 28-day cycle during induction phase.; Cyclophosphamide will be administred at a dose of 250 mg/m^2/day as IV infusion over 15-30 minutes on Days 2-4 of each 28-day cycle during induction phase.; Rituximab will be administered at a dose of 375 mg/m^2 as IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 as IV infusion on Day 1 of Cycles 2-6 during induction phase. Rituximab will be administered at a dose of 375 mg/m^2 as IV infusion on Day 1 of each 12-week cycle during maintenance phase.
Intervention MeSH terms: Cyclophosphamide; Rituximab; Cladribine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the effect of maintenance treatment with rituximab in comparison with
      observation period (no treatment), in participants with progressive B-cell CLL who have had
      previous first-line induction treatment with rituximab, cladribine and cyclophosphamide (RCC
      regimen). After 6 months of RCC induction therapy, participants will be randomized either to
      receive maintenance treatment with rituximab or to receive no treatment (observation only)
      for 96 weeks. Participants completing maintenance/observation period will be followed-up for
      approximately 3 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Immunologically confirmed diagnosis of B-cell CLL

          -  Rai stage I-IV disease with evidence of progression

          -  No previous chemotherapy, radiotherapy, or immunotherapy for B-cell CLL

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

        Exclusion Criteria:

          -  Active secondary malignancy or transformation to aggressive lymphoma

          -  Medical condition requiring chronic use of oral corticosteroids at a dose of 1 mg/kg
             or 60 mg/m^2 over 2 weeks

          -  Prior treatment with interferon, rituximab or another monoclonal antibody,
             immunosuppressive treatment or radiotherapy before inclusion to the study

          -  History of other malignancies within 2 years before study entry, except for dequately
             treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low
             grade, early stage localized prostate cancer treated surgically with curative intent;
             good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy
             alone with curative intent