bioihbjkbjnl/mcl2 huggingface dataset:
Omega-3 for Depression and Other Cardiac Risk Factors - 2
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Omega-3 supplement; Placebo
Intervention description: Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks; Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: Antidepressive agents; Coronary disease; Depression; Depressive disorder; Fatty Acids, Omega-3

Summary:

      The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to
      determine whether antidepressant augmentation with two grams of EPA omega-3 per day is
      superior to antidepressant therapy alone for major depression in patients with coronary heart
      disease (CHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented coronary heart disease

          -  Diagnosis of major depression based on structured interview

        Exclusion Criteria:

          -  Moderate to severe cognitive impairment

          -  Meets DSM-5 criteria for depressive disorder due to a general medical condition or
             medication

          -  Major Axis I psychiatric disorder other than unipolar depression or an anxiety
             disorder, a high risk of suicide, or current substance abuse other than tobacco;

          -  Not expected to survive one year or physically unable to tolerate the study protocol

          -  Known sensitivity to sertraline or omega-3, or an allergy to fish oil or shellfish

          -  Taking an antidepressant or an omega-3 supplement at baseline

          -  Exempted by their cardiologist or primary care physician

          -  Refuses to provide informed consent

          -  Participating in a competing protocol or trial
Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Arbaclofen
Intervention description: variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Autism; Autism Spectrum Disorders; irritability; aberrant behavior

Summary:

      The study objective is to explore the safety and tolerability of STX209 in subjects with
      Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in
      treating irritability. We hypothesize that STX209 will be safe and well-tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects 6 to 17 years of age, inclusive.

          -  Diagnosis of Autistic spectrum disorders

          -  Clinical Global Impression - Severity (CGI-S) rating for aberrant behavior of moderate
             or higher at screening and at Visit 1 (Day 1).

          -  An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score ≥16 at screening
             and at Visit 1 (Day 1).

          -  If the subject is already receiving stable non-pharmacologic educational, behavioral,
             and/or dietary interventions, participation in these programs must have been
             continuous during the 3 months prior to Screening (Visit 1) and subjects and their
             parent/caregiver/legally authorized representative (LAR) will not electively initiate
             new or modify ongoing interventions for the duration of the study.

          -  Exclusion Criteria:

          -  Subjects with known genetic disorders associated with PDD such as fragile X syndrome.

          -  Subjects with a history of a seizure disorder who are not currently receiving
             treatment with antiepileptic medication.

          -  Subjects with any medical condition, including alcohol and drug abuse that might
             interfere with the conduct of the study, confound interpretation of the study results,
             or endanger their own well-being.

          -  Subjects who plan to initiate or change pharmacologic or non-pharmacologic
             interventions during the course of the study.

          -  Subjects currently treated or have been treated in the last 2 weeks with any
             psychotropic medication except anti-epileptics or who have been treated with
             fluoxetine in the last 4 weeks.

          -  Subjects currently treated with vigabatrin or tiagabine.

          -  Subjects taking another investigational drug currently or within the last 30 days.

          -  Subjects who have a history of hypersensitivity to racemic baclofen.
Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: indacaterol maleate / mometasone furoate; placebo to indacaterol maleate/mometasone furoate
Intervention description: Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.; Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
Intervention MeSH terms: Mometasone Furoate; Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Asthma; spirometry; lung function; serum cortisol; serum potassium; plasma glucose

Summary:

      This study will investigate the safety and tolerability of indacaterol maleate/mometasone
      furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate
      asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adult patients aged 18-65 years (inclusive)

          -  Patients with mild-moderate asthma

          -  Forced expiratory volume in one second (FEV1) at Visits 1 and 2 are ≥60% of the
             predicted normal value for the patient.

          -  Body mass index (BMI) must be within the range of 18-32 kg/m^2.

          -  Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10
             pack years or less.

        Exclusion Criteria:

          -  Patients who suffer from chronic obstructive pulmonary disease (COPD)

          -  Patients who have been hospitalized or had emergency treatment for an asthma attack in
             the 6 months prior to study start

          -  QTcF interval > 450 msec in men and >470 msec in women

          -  Pregnant women or nursing mothers

          -  Females of childbearing potential, regardless of whether or not sexually active, if
             they are not using a reliable form of contraception (surgical contraception or double
             barrier methods (to be continued for at least two months following last dose) are
             acceptable).

          -  History of immunocompromise, including a positive human immunodeficiency virus (HIV)

          -  A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

          -  History of drug or alcohol abuse within 12 months of dosing

        Other protocol-defined inclusion/exclusion criteria may apply.
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
Condition: Secondary Hyperparathyroidism; Chronic Renal Insufficiency
MeSH terms: Neoplasm Metastasis; Renal Insufficiency; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: cinacalcet (AMG 073)
Intervention description: Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.
Intervention MeSH terms: Cinacalcet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess an investigational medication for patients with chronic renal
      insufficiency (pre-dialysis) who have secondary hyperparathyroidism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have chronic renal insufficiency (pre-dialysis)

          -  Have below normal creatinine clearance

          -  Have elevated parathyroid hormone levels

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Heart attack in the last 3 months.
Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Intervention: AR101 - Peanut protein capsule
Intervention description: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 4 Years
Maximum age: 26 Years
Healthy volunteers: No
Keywords: Characterized Peanut Allergen; Peanut; OIT; Oral Desensitization; Peanut Allergen; Peanut-Allergic Children; Children; Peanut-Allergic Adults

Summary:

      This is a multi-center, open-label, follow-on study to gather additional information on the
      safety and tolerability of oral desensitization with CPNA in the subjects who participated in
      ARC001.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completion of ARC001 study

          -  No change in the status of any longitudinally applicable ARC001 inclusion criteria

        Key Exclusion Criteria:

          -  Early termination from ARC001

          -  Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge

          -  A lapse in dosing of more than 10 days from completion of ARC001

          -  Change in the status of any longitudinally applicable ARC001 exclusion criteria
Study of Oral PG-116800 Following a Heart Attack
Condition: Myocardial Infarction; Heart Failure; Heart Enlargement
MeSH terms: Myocardial Infarction; Cardiomegaly; Infarction
Intervention: PG-116800 (given as PG-530742); Placebo tablet
Intervention description: 200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days; placebo tablet, twice a day for 90 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 253.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The main purpose of the study is to test whether a possible new drug (called PG-116800) can
      prevent some of the damage to heart muscle in patients who have had a heart attack. The study
      will also supply information regarding possible uses of this compound in cardiovascular
      disease.
    

Eligibility criteria:

        Inclusion:

          -  Be at least 18 years of age but not older than 80 years of age at screening;

          -  Be diagnosed with a heart attack based on electrocardiogram (ECG) and cardiac enzymes
             criteria;

          -  The qualifying heart attack has to be a first heart attack;

          -  The qualifying heart attack has to result in a left ventricular ejection fraction (a
             measure of the working efficiency of the heart) between 15% and 40%.

        Exclusion:

          -  Documented previous history of heart attack;

          -  Any past history of heart failure;

          -  Hemodynamic instability (no instability of circulatory system);

          -  History of congenital heart disease and cardiomyopathy (weakened heart muscle)
             associated with connective tissue disorders;

          -  Recent history or current moderate-to-severe kidney or liver impairment;

          -  Significant blood dyscrasias (disorders of the blood cells);

          -  Females who are currently: pregnant; breast-feeding; or are of childbearing potential.
Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)
Condition: Basal Cell Carcinoma; Gorlin Syndrome; Nevoid Basal Cell Carcinoma Syndrome
MeSH terms: Carcinoma; Carcinoma, Basal Cell; Basal Cell Nevus Syndrome; Syndrome
Intervention: LDE225; Placebo
Intervention description: supplied as 100 mg capsules; supplied in capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Basal Cell Carcinoma; Gorlin Syndrome,; Gorlin-Goltz Syndrome,; Basal Cell Nevus Syndrome,; Nevoid Basal Cell Carcinoma Syndrome,; Basal Cell Carcinoma Nevus Syndrome; Smo inhibitor,; Hedgehog pathway inhibitor; BCCs

Summary:

      This was a phase II, double-blind, randomized, proof-of-concept, dose-ranging trial
      evaluating the efficacy, safety and pharmacokinetics of oral LDE225 in treatment of adult
      patients with NBCCS. This was an exploratory study designed to demonstrate preliminary
      efficacy of LDE225 in this indication. This study included a Screening period of
      approximately 4 weeks, treatment period duration of 12 weeks with initial follow-up of
      approximately 6-8 weeks followed by a long-term follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with multiple basal cell carcinomas (at least two) and typical presentation
             of NBCCS.

          -  Female patients must be women of non-childbearing potential (WONCBP).

        Exclusion Criteria:

          -  Use of any topical treatment to treat BCCs, including prescription and over the
             counter in the 4 weeks prior to first dose of study drug.

          -  Use of photodynamic therapy (PDT), radiation or systemic treatment known to affect
             BCCs or neoplasm in the 12 weeks prior to first dose of study drug.

          -  Patients receiving medications that are recognized to cause rhabdomyolysis or patients
             with a prior history of rhabdomyolysis.

          -  Patients with a histologically confirmed diagnosis of locally advanced or metastatic
             BCC.

        Other protocol-defined inclusion/exclusion criteria may apply
Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma
Condition: Melanoma; Skin Neoplasms
MeSH terms: Melanoma; Skin Neoplasms
Intervention: Axitinib [AG-013736]
Intervention description: VEGFR [vascular endothelial growth factor Receptor] and PDGFR [Platelet-Derived Growth Factor Receptor] inhibitor: Single agent AG-013736 starting dose 5 mg BID +/- 20% according to toxicity. Treatment until progression or unacceptable toxicity occurs.
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: melanoma; antiangiogenesis

Summary:

      This is a Phase 2 study being conducted at multiple centers in the United States and France.
      Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are
      eligible to participate. Patients must have disease that has been treated with no more than 1
      prior treatment for metastatic disease (prior adjuvant treatment for localized disease does
      not count as prior treatment for metastatic disease). The purpose of the study is to test
      whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic
      melanoma as shown by the number of patients in the study who experience significant and
      durable tumor shrinkage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented melanoma with metastases

          -  No more than 1 prior systemic therapy for metastatic disease (prior adjuvant therapy
             with interferon does not count as prior therapy for metastatic disease)

        Exclusion Criteria:

          -  History of hemoptysis (coughing up of blood)

          -  Brain metastases
Green Tea and Ultraviolet Light-induced Skin Damage
Condition: Healthy
Intervention: Green Tea; Placebo
Intervention description: Green tea product (EGCG or caffeine) in vehicle will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED); Placebo (vehicle alone) will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Normal volunteer study

Summary:

      The purpose of this study is to investigate whether topically applied constituents of green
      tea [caffeine or (-)-epigallocatechin gallate; EGCG] have a protective effect on skin exposed
      to ultraviolet light (UV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subjects will be normal adult volunteers who are 18 to 65 years of age.

        Exclusion Criteria:

          -  Subjects who drink more than two cups of coffee, tea, or caffeinated soda/beverages
             per day.

          -  Subjects who are unable to get an erythemic response (i.e., a sunburn).
A Trial of Tisotumab Vedotin in Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: tisotumab vedotin
Intervention description: All patients will be treated with tisotumab vedotin once every three weeks until progression or toxicity
Intervention MeSH terms: Tisotumab vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in
      Previously Treated, Recurrent or Metastatic Cervical Cancer.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous
             cell, adenocarcinoma or adenosquamous histology who have experienced disease
             progressed on standard of care chemotherapy in combination with bevacizumab, if
             eligible.

          -  Measurable disease according to RECIST v1.1 as assessed by IRC.

          -  Age ≥ 18 years.

          -  Acceptable renal function

          -  Acceptable liver function

          -  Acceptable hematological status

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  A negative serum pregnancy test for patients of reproductive potential.

          -  All patients must provide a fresh or archival biopsy during screening.

          -  Following receipt of verbal and written information about the trial, patients must
             provide signed informed consent before any trial-related activity is carried out.

        Exclusion Criteria

          -  Have received no more than 2 prior systemic treatment regimens for recurrent or
             metastatic cervical cancer.

          -  Known past or current coagulation defects leading to an increased risk of bleeding;

          -  Ongoing major bleeding

          -  Active ocular surface disease

          -  Known past or current malignancy other than the inclusion diagnosis.

          -  Peripheral neuropathy grade ≥ 2
Safety and Efficacy of RAD001 + TACE in Localized Unresectable HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: everolimus; everolimus placebo
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Localised; unresectable; chemoembolization

Summary:

      This study will evaluate the role of everolimus in combination with local Transcatheter
      Arterial Chemoembolization (TACE) procedure in patients with localized unresectable
      Hepatocellular Carcinoma (HCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed hepatocellular carcinoma limited to liver and not suitable for
             resection, liver transplant, or radiofrequency ablation.

          -  Intermediate stage (stage B) (according to recognized guidelines) and suitable for
             TACE therapy

          -  At least one nodule between > 2cm and ≤ 15cm in diameter with no vascular invasion or
             abdominal lymph node or distant metastases.

          -  Must have 1 tumor which can be measured in 1 dimension according to specified criteria
             (RECIST and mRECIST) and has not previously been treated with any type of therapy.

          -  ECOG performance status < 2cm

          -  Cirrhotic status of Child-Pugh class A or early B

          -  HBV-DNA or HBsAg positive at screen or baseline: preventative treatment with
             anti-viral started 1-2 weeks prior to receiving study drug

        Exclusion Criteria:

          -  Any local and/or investigational drugs within 28 days prior to randomization

          -  Active bleeding during the last 28 days prior to screening including variceal bleeding

          -  Prior therapy with mTOR inhibitors

          -  Tumor burden of > 60% liver involvement

          -  Prior systemic or local therapy including TACE except for the first TACE at Day 0),
             surgery or liver transplantation

          -  Failed first TACE at Day 0, Cycle 1 for any reason

          -  Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not
             mandatory)

          -  Alcohol intake of 80 grams per day

          -  Undergone major surgery ≤ 3 weeks prior to starting study drug or who have not
             recovered from surgery

          -  Female patients who are pregnant or breast feeding, or adults of reproductive
             potential who are not using effective birth control methods

        Other protocol-defined inclusion/exclusion criteria may apply