bioihbjkbjnl/mcl2 huggingface dataset:
A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
Condition: Diabetic Macular Edema; Visual Impairment
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Edema
Intervention: Ranibizumab (RFB002); Laser; Sham injection; Sham laser
Intervention description: Ranibizumab 0.5 mg/0.05 mL for intravitreal injection; Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines; Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle; Imitation of an active laser
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 384.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DME; macular edema; vision impairment; Chinese; diabetes

Summary:

      Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular
      edema (DME)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with
             HbA1c ≤10.0%

          -  Stable medication for diabetes within 3 months prior to Visit 1

          -  Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by
             ETDRS-like charts at 4 meters

        Key Exclusion Criteria:

          -  Stroke or myocardial infarction less than 3 months prior to screening visit

          -  Uncontrolled hypertension

          -  Active ocular infection or intraocular inflammation in any eye

          -  Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in
             any eye

          -  Active proliferative diabetic retinopathy in study eye

          -  Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within
             6 months prior to baseline visit

          -  Prior laser photocoagulation or intraocular procedure within 3 months prior to
             baseline in study eye

          -  History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic
             or pseudophakic within 3 months prior to screening
Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation
Condition: Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: Methylnaltrexone; Placebo
Intervention description: Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg.
Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments).; Subjects received matching placebo injections.
Study duration: 2 weeks double-blind period (placebo treatments) followed by 12 weeks open-label extension period (MNTX treatments).
Intervention MeSH terms: Methylnaltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Opioid Induced Constipation

Summary:

      The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of
      subcutaneous (injection beneath the skin) MOA-728 versus placebo in adult Asian subjects with
      opioid-induced constipation associated with advanced illness (ie, a terminal illness such as
      incurable cancer or other end-stage disease) or chronic nonmalignant pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women who are at least 18 years of age, and who have a diagnosis of advanced
             illness with anticipated life expectancy >= 1 month;

          -  Is receiving a regular dose of opioids for the control of pain;

          -  Has a diagnosis of opioid induced constipation;

          -  Is on a stable laxative regimen.

        Exclusion Criteria:

          -  Has a known or suspected mechanical gastrointestinal obstruction, or any potential
             non-opioid cause of bowel dysfunction contributed to constipation;

          -  Has evidence of current fecal impaction;

          -  Has evidence of active diverticulitis, or peritonitis, or a history of bowel surgery
             within 30 days before test article administration;

          -  Has a body weight less than 27 kg

          -  Has any major illness/condition that, in the investigator's judgment, will
             substantially increase the risk associated with the subject's participation in and
             completion of the study, or could preclude the evaluation of the subject's response.
Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Condition: Growth Disorders; Intrauterine Growth Retardation
MeSH terms: Fetal Growth Retardation; Growth Disorders
Intervention: Genotonorm; Genotonorm; Genotonorm
Intervention description: 0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection; 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection; 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Short height; intra-uterine growth retardation; Genotonorm; continuous treatment; intermittent treatment

Summary:

      To evaluate the effect of continuous and intermittent administration of Genotonorm on stature
      in short prepubertal children with intra-uterine growth retardation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronological age (CA) between 3 and 10 for girls

          -  Chronological age between 3 and 12 for boys

          -  Height for CA below - 2 SD

          -  Birth length for CA below -2SD

        Exclusion Criteria:

          -  Endocrine disease except well-substituted hypothyroidism

          -  Sever chronic disease

          -  Skeletal dysplasia

          -  Known chromosomal aberration

          -  Ongoing treatment with steroids

          -  Known intrauterine infection
Chantix & Bupropion for Smoking Cessation
Condition: Smoking; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Bupropion SR & Varenicline
Intervention description: Bupropion SR 150 mg by mouth once day for 3 days then 150 mg by mouth twice per day.
Varenicline 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Intervention MeSH terms: Bupropion; Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking; Smoking cessation; Bupropion; Varenicline; Tobacco use disorder

Summary:

      The overarching goal of this line of research is to increase smoking abstinence rates using a
      combination of existing pharmacotherapies. The aim of the current study is to assess the
      safety and compliance as well as obtain preliminary estimates of efficacy and effect on
      craving and nicotine withdrawal of combination therapy with bupropion SR and varenicline. We
      will compare the efficacy estimates in this study with historical smoking abstinence rates
      with varenicline. To accomplish our aims, we will enroll 38 cigarette smokers in an
      open-label, phase II clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 18 years of age

          -  have smoked 10 or more cigarettes per day for at least 6 months

          -  are motivated to stop smoking.

        Exclusion Criteria:

          -  an unstable medical condition

          -  unstable angina, myocardial infarction, or coronary angioplasty within the past 3
             months or an untreated cardiac dysrhythmia

          -  personal history of seizures

          -  closed head trauma with any loss of consciousness or amnesia in the last 5 years

          -  ever history of closed head trauma with > 30 minutes of loss of consciousness or
             amnesia or resulting in skull fracture or subdural hematoma/brain contusion

          -  a history or psychosis, bipolar disorder, bulimia or anorexia nervosa)

          -  have current depression as assessed by Center for Epidemiologic Studies Depression
             (CES-D)

          -  have active substance abuse other than nicotine

          -  have used an investigational drug within the last 30 days

          -  are currently using a behavioral or pharmacologic tobacco treatment and unwilling or
             unable to discontinue use

          -  use of bupropion or varenicline in the previous 3 months

          -  current (past 14 days) use of antipsychotic or antidepressant

          -  an allergy to bupropion or varenicline

          -  untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100

          -  have another member of their household already participating in this study.
Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Zevalin; Rituximab
Intervention description: Zevalin administered intravenously.; Rituximab administered intravenously.
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of consolidation treatment Zevalin®
      versus maintenance treatment with Rituxan® on progression-free survival (PFS) following
      response induction with chemotherapy plus rituximab in previously untreated participants with
      follicular lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 75 years of age.

          -  Previously untreated with histologically confirmed grade 1, 2 or 3a cluster of
             differentiation-20 (CD20)-positive follicular lymphoma, with any of the GELF (Groupe
             d'Etude de Lymphomes Folliculaires) treatment criteria prior to induction.

          -  Achieved a response to induction treatment with either rituximab-cyclophosphamide,
             doxorubicin, vincristine, and prednisone (R-CHOP) (6 cycles of R-CHOP21 or R-CHOP14),
             rituximab-cyclophosphamide, vincristine and prednisone (R-CVP) (6 cycles), or
             rituximab-bendamustine (R-B) (4 to 6 cycles).

          -  Must have completed all doses of the induction treatment, except for the modifications
             allowed in the protocol.

        Exclusion Criteria:

          -  Transformation to high grade lymphoma (secondary to "low grade" follicular lymphoma
             [FL]).

          -  Grade 3b follicular lymphoma.

          -  Primary follicular lymphoma of the skin or gastrointestinal tract.

          -  Previous treatment of follicular lymphoma.

          -  Altered renal and hepatic function.

          -  Known human immunodeficiency virus (HIV) infection and/or active hepatitis B virus
             (HBV) and/or hepatitis C virus (HCV) infection

          -  Serious co-morbid conditions (for example, ongoing infection, uncontrolled diabetes
             mellitus, gastric ulcers, active autoimmune disease).

          -  Life expectancy < 6.

          -  Must have:

               -  Platelet count ≥ 100x10^9/L.

               -  Bone marrow infiltration <25%.
A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed-dose combination tablets for oral administration.; Tablets for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of elexacaftor
      (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in participants with CF who are 12 years of age or
      older.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completed study drug treatment in parent study (VX19-445-117 [NCT04599465] or
             VX20-445-126 [NCT04969224]), or had study drug interruption(s) in parent study but
             completed study visits up to the last scheduled visit of the treatment period in the
             parent study

        Key Exclusion Criteria:

          -  History of drug intolerance in a parent study

        Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
Condition: Immunologic Deficiency Syndromes
MeSH terms: Immunologic Deficiency Syndromes
Intervention: GC5107
Intervention description: GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)
Intervention MeSH terms: Immunoglobulins; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 2 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune
      Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency
             Disease as defined by IUIS (International Union of Immunological Societies) and
             require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia

          -  Male or Female, ages 2 to 70 years

          -  The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day
             intervals for at least 3 months prior to this study

          -  At least 2 documented IgG trough levels of ≥ 500 mg/dL are obtained at two infusion
             cycles (21 or 28 days) within 12 months prior to study enrollment

        Exclusion Criteria:

          -  Subject has secondary immunodeficiency

          -  Subject was newly diagnosed with PHID and has not yet been treated with immunoglobulin

          -  Subject has been diagnosed with dysgammaglobulinemia or isolated IgG subclass
             deficiency or isolated IgA deficiency with known anti-IgA antibodies

          -  History of severe reaction or hypersensitivity to IGIV or other injectable form of IgG

          -  Subject has a lifetime history of at least one thrombotic event including deep vein
             thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks,
             or myocardial infarction

          -  Subject has received blood products other than human albumin or human immunoglobulin
             within 12 months prior to enrollment
A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: S5G4T-1
Intervention description: Once a day topical cream
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 547.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the safety of S5G4T-1 when applied once daily for up to 40 weeks in participants
      with papulopustular rosacea who completed either Study SGT-54-01 (NCT03448939) or Study
      SGT-54-02 (NCT03564119).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must sign an Institutional Review Board (IRB) approved written informed
             consent for the extension study.

          2. Participants must complete 12 weeks or within the Week 12 window time (± 4 days) of
             the double-blind treatment period of Study SGT-54-01 or Study SGT-54-02 and missed not
             more than 1 visit of Visits 3, 4 or 5 in Study SGT-54-01 or Study SGT-54-02.

        Exclusion Criteria:

        -
AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Intervention: 10mg Rosuvastatin; Placebo
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 2776.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: End Stage Renal Failure

Summary:

      The purpose of this study is to see if rosuvastatin helps to reduce the number of heart
      attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects with end-stage renal failure aged 50-80 years, who have
             received regular haemodialysis treatment for at least 3 months

        Exclusion Criteria:

          -  Subjects will have no underlying condition that is expected to limit survival to less
             than 1 year and is also unrelated to end-stage renal disease (ESRD). Subjects should
             not have received a statin therapy within the past 6 months
Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis
Condition: Uveitis; Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis
MeSH terms: Uveitis; Panuveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Uveitis, Anterior
Intervention: 4 mg CLS-TA Suprachoriodal Injection
Intervention description: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uveitis; UME; Posterior Uveitis; Anterior Uveitis; Intermediate Uveitis; Panuveitis; Non-infectious Uveitis; Triamcinolone; Choroid; Choroidal Injection; Suprachoroidal; Microneedle; Microinjection; Triamcinolone acetonide

Summary:

      This open-label study is designed to evaluate the safety of suprachoroidally administered
      triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis
      with and without macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of active or inactive non-infectious uveitis (pan, anterior, intermediate
             and posterior)

          -  ETDRS BCVA score of ≥ 5 letters read in the study eye

        Exclusion Criteria:

          -  Any active ocular disease or infection in the study eye other than uveitis

          -  Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; patients
             with IOP of 22 or less in the study eye not excluded with no more than 2 IOP-lowering
             medications.

          -  Any uncontrolled systemic disease that, in the opinion of the Investigator, would
             preclude participation in the study

          -  Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or
             periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX
             implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years
             prior to baseline.
Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Intervention: Adrenaline; Vasopressin
Intervention description: 1 mg; 40 IU
Intervention MeSH terms: Vasopressins; Arginine Vasopressin; Epinephrine; Racepinephrine; Epinephryl borate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 727.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No
Keywords: Vasopressin; Adrenaline; Survival; Return of spontaneous of circulation

Summary:

      The effectiveness of medications in cardiac arrest has been greatly debated and questioned.
      Historically intravenous adrenaline has been the drug of choice since 1906. There have been
      few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical
      trials have not been able to show any benefit with intravenous adrenaline (compared to
      placebo or no treatment) in the field.

      Thus the purpose of this study is to compare vasopressin and adrenaline in the treatment of
      cardiac arrest to answer the question whether there is an improvement in survival between
      vasopressin and adrenaline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with cardiac arrest as confirmed by the absence of a pulse, unresponsiveness
             and apnea

          -  Age above 16 (Age 21 and above for CGH only)

        Exclusion Criteria:

          -  Traumatic cardiac arrest

          -  Age 16 and below (Age 20 and below for CGH only)

          -  CPR is contraindicated