bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: placebo/dalfampridine-ER; dalfampridine-ER/placebo
Intervention description: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart; Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a multi-center, safety and tolerability study in subjects with chronic stable
      sensorimotor deficits after ischemic stroke. It has been designed as a double-blind,
      placebo-controlled, 2-period crossover study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of a stable sensorimotor deficit due to an ischemic stroke, as confirmed by
             the Investigator with supportive prior imaging findings (MRI/ CT scan)

          -  ≥ 6 months post-stroke

          -  Have a body mass index (BMI) ranging between 18.0 - 35.0 kg/m,2 inclusive

          -  Stable concomitant medication therapy regimen within 4 weeks of screening visit

        Exclusion Criteria:

          -  History of seizures, except simple febrile seizures

          -  Moderate or severe renal impairment as defined by a calculated creatinine clearance of
             ≤ 50 mL/minute using the Cockcroft-Gault Equation

          -  Botulinum toxin use within 2 months prior to the Screening Visit

          -  Orthopedic surgical procedures in any of the extremities within the past 6 months

          -  Diagnosis of multiple sclerosis
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Condition: Jet Lag Disorder
MeSH terms: Jet Lag Syndrome
Intervention: Tasimelteon; Placebo
Intervention description: capsule; capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With
      Jet Lag Disorder
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability and acceptance to provide written consent

          -  Men or women between 18-75 years

          -  Body Mass Index of ≥ 18 and ≤ 30 kg/m2

        Exclusion Criteria:

          -  History (within the 12 months prior to screening) of psychiatric disorders

          -  Major surgery, trauma, illness or immobile for 3 or more days within the past month

          -  Pregnancy or recent pregnancy (within 6 weeks)

          -  A positive test for drugs of abuse at the screening visit

          -  Any other sound medical reason as determined by the clinical investigator
Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Pembrolizumab; Ibrutinib
Intervention description: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.; Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphocytic; Leukemia; CLL; Blood disease; White blood cells; Bone marrow disease; Immunotherapy

Summary:

      The purpose of this study is to evaluate the impact of sequential overlapping treatment with
      PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous
      immune function in previously untreated, high-risk CLL patients. Immune function will be
      evaluated through various laboratory correlative tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have high risk CLL

          -  Have documented previously untreated CLL according to IWCLL criteria

          -  Willing and able to provide written informed consent

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Demonstrate adequate organ function

          -  Able to take oral medication and willing to adhere to the medication regimen

        Exclusion Criteria:

          -  Currently participating in or has participated in a study of an investigational agent
             or using an investigational device within 4 weeks of the first dose of treatment

          -  Meets IWCLL criteria to start therapy

          -  Has had any treatment for CLL including any investigational agent, chemotherapy, mAb,
             anti-PD-1, anti-PDL-1, or anti-CTLA-4

          -  Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic
             leukemia)

          -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the
             projected duration of the trial, starting with the pre-screening or screening visit
             through 90 days after the last dose of trial treatment

          -  Major surgery or a wound that has not fully healed within 4 weeks of first dose

          -  Additional criteria may apply
Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
Condition: Cannabis Dependence; Alcohol Dependence; Cannabis Use Disorder; Alcohol Use Disorder
MeSH terms: Marijuana Abuse; Alcoholism
Intervention: aprepitant; Placebo; Manual-guided behavioral counseling
Intervention description: 125 mg daily for 8 weeks.; Placebo daily for 8 weeks.; Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.
Intervention MeSH terms: Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Cannabis Treatment; Alcohol Treatment; Alcohol-Related Disorders; Cannabis-Related Disorders; Substance-Related Disorders; Emend; NK1 receptor antagonist; Alcohol; Cannabis; aprepitant

Summary:

      The primary aim of the supplemental study is to provide POC testing of aprepitant as a
      treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in
      the parent grant will likewise be applied to the supplemental project to test for effects of
      aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The
      primary hypothesis is that subjects treated with aprepitant will have significantly less
      alcohol and marijuana use than subjects treated with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females from 18-70 years of age

          -  Meets DSM IV criteria for current alcohol and cannabis dependence

          -  Seeking research-based outpatient treatment for alcohol and cannabis dependence that
             involves daily oral medication

          -  Negative BAC and a CIWA score < 9 at randomization

        Exclusion Criteria:

          -  Significant medical disorders or use of medications that will increase potential risk
             or influence study outcomes

          -  Females who are pregnant, nursing or who are sexually active with child-bearing
             potential and refuse to use an effective, non hormonal method of birth control during
             the study and for up to 4 weeks after study termination• Treatment with an
             investigational drug during the previous month

          -  Prior treatment with NK1 antagonists

          -  Participants for whom treatment is being mandated by a legal authority• Inability to
             understand and/or comply with the provisions of the protocol and consent form
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
Condition: Clostridium Difficile Associated Disease
MeSH terms: Clostridium Infections
Intervention: Clostridium difficile vaccine; Clostridium difficile vaccine; Placebo
Intervention description: 0.5 mL intramuscular injection on day 1, day 8, and day 30.; 0.5 mL intramuscular injection on day 1, day 8, and day 30.; Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 185.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clostridium difficile; vaccine

Summary:

      This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85
      years, who will each receive 3 doses of vaccine. The study will assess the safety and
      tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy male and female subjects aged 50 to 85 years

        Exclusion Criteria:

        Proven or suspected prior episode of Clostridium difficile associated diarrhea.

        Unstable chronic medical condition or disease requiring significant change in therapy or
        hospitalization for worsening disease within 8 weeks before receipt of study vaccine.

        Any contraindication to vaccination or vaccine components, including previous anaphylactic
        reaction to any vaccine or vaccine-related components.
A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Tanezumab; Placebo
Intervention description: 15 mg IV single dose; Placebo IV single dose
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Endometriosis; pain; tanezumab; nerve growth factor; questionnaires

Summary:

      The purpose of this study is to determine whether tanezumab is effective and safe in the
      treatment of pain associated with endometriosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menstrual women with moderate to severe endometriosis. The diagnosis of
             endometriosis must have been confirmed surgically within the last 8 years.

          -  Subjects should have regular menstrual cycle (21 - 35 days) and must be willing to use
             adequate contraception (2 forms of birth control, one of which must be a barrier
             method). Contraception is required throughout the study (screening to 16 weeks post
             treatment), even if subjects discontinue prematurely.

        Exclusion Criteria:

          -  Previous hysterectomy

          -  Surgical treatment for endometriosis within last 6 months.

          -  Medical treatment for endometriosis other than combined oral contraceptive pill within
             the last 3 months

          -  Current use of the coil or progesterone only contraceptive (the combined oral
             contraceptive pill is allowed).

          -  Any history of malignant disease (cancer)
Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
Condition: Scar Prevention
Intervention: EXC 001; Placebo
Intervention description: Intradermal injections of EXC 001 and placebo given on various schedules.; Intradermal injections of EXC 001 and placebo given on various schedules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Scarring

Summary:

      This study will compare how well EXC 001 works versus placebo in reducing the appearance of
      scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety
      of EXC 001 in healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have sufficient excess abdominal tissue to qualify for a standard
             elective abdominoplasty

          -  Subject has chosen to have an elective abdominoplasty

          -  Medically healthy with normal screening results

          -  Subjects must not be pregnant or lactating

        Exclusion Criteria:

          -  Subjects with existing scars or significant striae on the abdominal pannus

          -  Females who are currently pregnant or pregnant during the 12 months prior to inclusion
             in the study, or lactating

          -  Participation in another clinical trial within 30 days prior to the start of the study

          -  Any other condition or prior therapy, which, in the opinion of the PI, would make the
             subject unsuitable for this study
Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: Bortezomib; Dexamethasone; Rituximab
Intervention description: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles; Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles; Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Rituximab; Bortezomib; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bortezomib; dexamethasone; rituximab

Summary:

      The purpose of this study is to find out if the combination of bortezomib (Velcade),
      dexamethasone (Decadron) and rituximab (Rituxan) is effective in treating Waldenstrom's
      macroglobulinemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinicopathological diagnosis of Waldenstrom's macroglobulinemia (WM)

          -  No previous therapy for WM

          -  Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a
             minimum IgM level of greater than or equal to 2 times the upper limit of each
             institution's normal value

          -  CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow
             cytometric analysis performed up to 3 months prior to enrollment

          -  Karnofsky performance status > 60

          -  Life expectancy > 3 months

          -  AST (SGOT) < 3 x ULN

          -  ALT (SGPT) < 3 x ULN

          -  Total bilirubin < 2 x ULN

          -  Calculated or measured creatinine clearance > 30mL/minute

          -  Serum sodium > 130 mmol/L

          -  Female subject is either post-menopausal or surgically sterilized or willing to use an
             acceptable method of birth control

          -  Male subject agrees to use an acceptable method for contraception for the duration of
             the study

        Exclusion Criteria:

          -  Previous therapy for Waldenstrom's macroglobulinemia

          -  Myocardial infarction within 6 months prior to enrollment or has New York Hospital
             Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled
             ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active
             conduction system abnormalities.

          -  Hypersensitivity to dexamethasone, boron or mannitol

          -  Pregnant or breast-feeding women

          -  Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study
A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: Baricitinib; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the
      treatment of participants with mild to moderate diabetic kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with Type 2 diabetes treated with at least one antihyperglycemic medicine
             for 12 months

          -  Have diabetic kidney disease and receiving one of two specific medicines used to treat
             high blood pressure or diabetic kidney disease for at least 3 months

          -  Estimated Glomerular Filtration Rate (eGFR) of 25 to 70 milliliter per minute per 1.73
             square meter (mL/min/1.73 m²) (as determined by the Chronic Kidney Disease
             Epidemiology Collaboration equation) and a urinary albumin/creatinine ratio (UACR)
             >300 milligram per gram (mg/g) and <5000 mg/g

        Exclusion Criteria:

          -  Too high blood pressure when you enter the study

          -  Some specific medicines used to treat high blood pressure or diabetic kidney disease

          -  Frequent high blood glucose levels

          -  Renal transplant or past history of dialysis

          -  Nonsteroidal anti-inflammatory drugs (NSAIDs)

          -  Had a special X-ray in the past 30 days which involved also receiving an injection of
             dye into the vein

          -  Major surgery within 8 weeks of study entry or will require major surgery during the
             study

          -  Some types of vaccination

          -  Shingles or currently have symptoms of a cold sore

          -  Serious viral, bacterial, fungal, or parasitic infection, or a urinary infection,
             Tuberculosis (TB)

          -  Human immunodeficiency virus (HIV) infection- the virus that causes Acquired
             immunodeficiency syndrome (AIDS)

          -  Have or had some blood disorders, enlarged lymph glands or spleen, or some cancers.

          -  Serious circulatory, breathing, liver, stomach or bowel problems, neurological or
             psychiatric disorders

          -  Heart attack or heart failure, or a stroke

          -  Other serious disorders or illnesses

          -  Electrocardiogram (ECG) heart trace abnormalities

          -  Alcohol or illegal drug abuse

          -  Donated more than 500 mL of blood in the last 30 days (no blood donations allowed
             during the study)

          -  Pregnant or breastfeeding
A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).
Condition: Renal Cell Cancer
MeSH terms: Carcinoma, Renal Cell
Intervention: bevacizumab [Avastin]; interferon alfa-2a
Intervention description: 10mg/kg iv infusion every 2 weeks; 3 MIU sc t.i.w.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess progression free survival, tumor response and safety of
      Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with
      metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every
      2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week
      (t.i.w.). The anticipated time on study treatment is until disease progression, and the
      target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  metastatic RCC with majority (>50%) of conventional clear-cell type;

          -  prior total nephrectomy for primary RCC;

          -  at least one measurable or non-measurable lesions;

          -  ECOG performance score of 0 or 2.

        Exclusion Criteria:

          -  prior systemic treatment for metastatic RCC;

          -  current or previously treated but non-stable CNS metastases or spinal cord
             compression;

          -  major surgery (including open biopsy) or radiation therapy within 28 days prior to
             enrollment;

          -  significant cardiovascular disease within 6 months prior to enrollment.