bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: OPC-34712; Placebo; ADT
Intervention description: Tablets, Oral, 1 - 3 mg OPC-34712; Placebo
Intervention MeSH terms: Antidepressive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 773.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-34712; Major Depressive Disorder; Adjunctive Treatment

Summary:

      This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will
      receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive
      substance) in addition to an FDA approved antidepressant in order to determine if the study
      medication is effective as an add on treatment of MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18 and 65 years of age, with diagnosis of major
             depressive disorder, as defined by DSM-IV-TR criteria

          -  The current depressive episode must be equal to or greater than 8 weeks in duration

          -  Subjects must report a history for the current depressive episode of an inadequate
             response to at least one and no more than three adequate antidepressant treatments.

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving study drug.

          -  Subjects who report an inadequate response to more than three adequate trials of
             antidepressant treatments during current depressive episode at a therapeutic dose for
             an adequate duration.

          -  Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic
             or other cognitive disorder Schizophrenia, schizoaffective disorder, or other
             psychotic disorder Bipolar I or II disorder

          -  Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of
             borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality
             disorder.
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: riluzole
Intervention description: 100 mg orally twice daily
Intervention MeSH terms: Riluzole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage III melanoma; stage IV melanoma; recurrent melanoma

Summary:

      RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective
      treatment for melanoma.

      PURPOSE: This phase II trial is studying how well riluzole works in treating patients with
      stage III or stage IV melanoma that cannot be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed malignant melanoma

               -  Unresectable stage III or stage IV disease

          -  Measurable disease according to RECIST criteria, defined as ≥ 1 unidimensionally
             measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan

          -  No known brain metastases unless treated and stable for ≥ 2 weeks by MRI evaluation

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  ANC ≥ 1,000/μL

          -  Platelet count ≥ 50,000/μL

          -  Total bilirubin ≤ 2 times upper limit of normal (ULN)

          -  AST/ALT ≤ 3 times ULN

          -  INR ≤ 1.5 times ULN

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 2 weeks after
             completion of study treatment

          -  No second primary malignancy, except carcinoma in situ of the cervix, adequately
             treated nonmelanoma carcinoma of the skin, or other malignancy treated ≥ 5 years ago
             with no evidence of recurrence

          -  No concurrent serious systemic disorders (including active infections) that, in the
             opinion of the investigator, would compromise the safety of the patient or compromise
             the patient's ability to complete the study

          -  No history of allergic reactions attributed to riluzole

          -  No known history of hepatitis B or C

        PRIOR CONCURRENT THERAPY:

          -  No more than 1 prior therapeutic chemotherapy regimen for advanced melanoma

          -  Prior treatment with riluzole on clinical trial CINJ-090603 allowed

          -  No other concurrent investigational or commercial agents or therapies for the
             treatment of the malignancy
The Effects of Oxytocin in Obese Adults
Condition: Obesity
Intervention: oxytocin nasal spray; Placebo
Intervention description: oxytocin intranasal spray; Placebo nasal spray
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: weight loss; body mass index; oxytocin; magnetic resonance imaging

Summary:

      This is a randomized, double blind, placebo-controlled study of the effects of intranasal
      oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of
      intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study
      visits include screening to determine eligibility, a 2-part baseline visit, and visits every
      2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose
      of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine
      assessments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-45 years old;

          -  BMI greater than or equal to 30 kg/m2

        Exclusion Criteria:

          -  Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose
             and weight are stable for at least 3 months);

          -  history of medication changes within 4 weeks of enrollment;

          -  active substance use;

          -  history of cardiovascular disease, gastrointestinal disorders, bariatric surgery,
             epilepsy, untreated thyroid disease;

          -  hematocrit >2% below normal;

          -  fasting glucose > 125 mg/dL or hemoglobin A1c ≥ 7% ;

          -  ALT or AST >2.5 times upper limit of normal;

          -  Cr >1.5 mg/dL; hyponatremia;

          -  pregnancy or breastfeeding;

          -  unwilling to use medically acceptable form of contraception (females only)

          -  follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo,
             Atkins, raw diet, macrobiotic diet)

          -  current smoking or tobacco use
Bosutinib For Autosomal Dominant Polycystic Kidney Disease
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Bosutinib; Bosutinib; Placebo
Intervention description: Once daily oral dose of 200 mg of bosutinib; Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day; Once daily oral dose of placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Bosutinib; Autosomal Dominant Polycystic Kidney Disease

Summary:

      This purpose of this study is to determine if bosutinib reduces the rate of kidney
      enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering
      the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or
      equal to 60 mL/min/1.73m2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 18 to 50 years old at the time of consent.

          -  Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed).

          -  Total kidney volume ≥ 750 cc, as measured by centrally evaluated MRI.

        Exclusion Criteria:

          -  eGFR < 60 mL/min/1.73m2.

          -  Uncontrolled hypertension (defined as systolic blood pressure ≥140 or diastolic blood
             pressure ≥90 mm Hg).

          -  Any previous exposure to the bosutinib test article or receipt of other polycystic
             kidney disease (PKD) therapies.
A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r; ABT-267; Ribavirin (RBV)
Intervention description: Tablet; ABT-450; Capsule; ritonavir; Tablet; Tablet
Intervention MeSH terms: Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 316.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus; Ribavirin-Free; Hepatitis C Genotype 1; Hepatitis C; Interferon-Free; Chronic Hepatitis C; Compensated cirrhosis; Hepatitis C Genotype 4; Paritaprevir; Ombitasvir; Ritonavir; Ribavirin

Summary:

      The purpose of this study is to evaluate the safety and efficacy of co-administration of
      ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as
      ombitasvir) in adults with chronic hepatitis C virus infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be practicing specific forms of birth control on study treatment, or be
             postmenopausal for more than 2 years or surgically sterile

          -  Subjects must meet one of the following:

               -  Treatment-naive: Subject has never received antiviral treatment for hepatitis C
                  infection OR

               -  Treatment Experienced (Prior null responders, Partial responders or Relapsers to
                  pegIFN/RBV);

          -  Body mass index (BMI) is ≥ 18 to < 38 kg/m^2.

          -  Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4
             infection/without cirrhosis for at least 6 months prior to study screening.

          -  Subject has plasma HCV RNA level > 10,000 IU/mL at Screening

        Exclusion Criteria:

          -  History of severe, life-threatening or other significant sensitivity to any drug.

          -  Females who were pregnant or planned to become pregnant, or breastfeeding, or
             GT4-infected males whose partners were pregnant or planning to become pregnant within
             7 months (or per local RBV label) after their last dose of study drug/RBV.

          -  Recent history of drug or alcohol abuse that could preclude adherence to the protocol.

          -  Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency
             Virus (HIV) antibodies.
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: DCV/ASV/BMS-791325; Ribavirin; Sofosbuvir; Peginterferon α-2a
Intervention MeSH terms: Ribavirin; Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether the combination of Daclatasvir (DCV),
      Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C
      virus.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Males and Females ≥18 years of age, inclusive

          -  Chronic HCV infection Genotype 1 only

          -  Non-cirrhotic

          -  Treatment naive subjects with no previous exposure to an Interferon formulation (ie,
             IFNα, pegIFNα), ribavirin (RBV) or HCV Direct Acting Antiviral (DAA) (protease,
             polymerase inhibitor, etc.)

        Exclusion Criteria:

          -  HCV Genotype other than Genotype 1

          -  Documented or suspected hepatocellular carcinoma

          -  Evidence of decompensated liver disease

          -  Contraindication(s) to Peg/RBV therapy
Defibrotide TMA Prophylaxis Pilot Trial
Condition: Thrombotic Microangiopathies
MeSH terms: Thrombotic Microangiopathies
Intervention: Defibrotide
Intervention description: Defibrotide is an anticoagulant and fibrinolytic agent that has been shown to be an effective treatment in other endothelial disorders such as hepatic veno-occlusive disease.
Intervention MeSH terms: Defibrotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Defibrotide 6.25mg/kg administered intravenously for 28-35 days
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Maximum age: 30 Years
Healthy volunteers: No
Keywords: hematopoeitic stem cell transplant; prophylactic defibrotide

Summary:

      Thrombotic microangiopathy (TMA) is a common complication in the stem cell transplant
      population. Certain populations within the hematopoietic stem cell transplant (HSCT)
      population are at a higher risk than others. Defibrotide is an endothelial stabilizing agent
      which may prevent the endothelial damage that triggers TMA in HSCT patients. The feasibility,
      safety, and efficacy of defibrotide prophylaxis in a pediatric transplant population is
      unknown. Twenty five patients age 0 to 30 years receiving autologous or allogeneic
      hematopoeitic stem cell transplant who meet TMA high risk criteria will be enrolled. Patients
      will receive Defibrotide for 28-35 days starting before conditioning, and will be closely
      monitored for any adverse events up through 6 months post-transplant. The feasibility of
      administering defibrotide will be evaluated as well as incidence of TMA.
    

Eligibility criteria:

        Inclusion Criteria

          1. Age 0-30 years of age

          2. Life expectancy > 6 months

          3. Eastern Cooperative Oncology Group or Karnofsky Performance Status >40

          4. Meets minimum organ function requirements per institutional standard of care guiding
             clearance for autologous or allogeneic stem cell transplantation.

          5. Patients must meet TMA High-Risk criteria 5A or 5B below:

        5A. Patients undergoing tandem autologous transplant with thiotepa in one or more of the
        conditioning regimens

        OR:

        5B. . Patients with at least 3 of the following characteristics:

          1. >10 years of age

          2. Non-Caucasian race/ Hispanic ethnicity

          3. Undergoing haploidentical transplant

          4. Minor ABO blood group mismatch

        Exclusion Criteria:

          1. Age >30 years

          2. Life expectancy < 6 months

          3. Known bleeding diathesis or bleeding risk deemed by the treating physician to be a
             contraindication to administration of anticoagulants.

          4. Known hypersensitivity reaction to defibrotide

          5. Any patient not meeting TMA High-Risk criteria

          6. Pregnant women are excluded from this study because they will be receiving teratogenic
             therapy as part of the stem cell transplant.
New Technologies to Determine Carotid Plaque Vulnerability in Patients With Significant Carotid Plaques
Condition: Carotid Artery Plaque
MeSH terms: Carotid Stenosis
Intervention: Contrast-enhanced ultrasound; Shear Wave Elastography; Ultrasound Examination
Intervention description: Subjects will receive a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.; Shear wave elastography will be performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. In each plane 10 measurements will be made and the in-phase/quadrature (IQ) data will be saved for further analysis. The plaque area in the imaging plane will be user-defined to extract the wave velocity values for a ROI analysis.; A standard carotid US examination using Duplex imaging will performed using a linear array transducer to obtain longitudinal and transverse images. All ultrasound measurements will be made by a trained registered vascular technologist. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carotid Plaque; Contrast Enhanced Ultrasound; Shear Wave Elastography; Endarterectomy; Stenosis

Summary:

      The researchers are trying to determine if the characterization of "vulnerable" carotid
      artery plaques can be accomplished with ultrasound-based methods that look for vessels in the
      plaque and measure the plaque stiffness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has carotid plaque with > 50% stenosis

          -  Subject is able to understand the study procedure and provide informed consent

        Exclusion Criteria:

          -  Subject is pregnant or breast feeding

          -  Subject is unable to provide informed consent

          -  Subject has contraindication to the use of the Lumason contrast agent.
Efficacy Study in Patients With Acne Vulgaris.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: ADPS topical product; Placebo Control
Intervention description: topical product; topical product
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 294.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety and efficacy study in patients with acne vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or non pregnant female aged ≥ 9 years with a clinical diagnosis of acne
             vulgaris

        Exclusion Criteria:

          -  Female Subjects who are pregnant, nursing or planning to become pregnant during study
             participation.
A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: GLPG1972; Placebo
Intervention description: Film-coated tablets of GLPG1972 for oral use.; Film-coated tablets of matching placebo for oral use.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 932.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is a phase 2, 52-week international, multi-regional, multi-center, randomized,
      double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male participants or female participants of non-childbearing potential and not
             breastfeeding.

          -  Body weight > 40 kg, body mass index (BMI) < 40 kg/m^2.

          -  Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the
             American College of Rheumatology.

          -  History of knee pain for at least 6 months and on the majority of days (> 50%) during
             the preceding month.

          -  Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS,
             100 mm) at screening and inclusion visits.

          -  Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the
             target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other
             analgesics

        Exclusion Criteria:

          -  Severe clinical knee malalignment according to the investigator.

          -  Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral
             side).

          -  Knee prosthesis already foreseen within the study period (whichever side).

          -  Hip prosthesis recently implanted (< 1 year) or foreseen within the study period
             (whichever side).

          -  Previous osteotomy on the inferior limbs (whichever side).

          -  Surgical operation on the target knee within the 12 months prior to the screening
             visit or planned during the study.

          -  Diagnostic arthroscopy of the target knee within the 6 months prior to the screening
             visit or planned during the study.

          -  Other pathologies affecting the target knee.

          -  Any contraindication to magnetic resonance imaging (MRI) including the inability to
             undergo a knee MRI exam because of inability to fit in the scanner or knee coil.