bioihbjkbjnl/mcl2 huggingface dataset:
Extension Trial of Deforolimus (Ridaforolimus, MK-8669) in Participants With Advanced Cancer (MK-8669-038)
Condition: Advanced Cancers
MeSH terms: Neoplasms
Intervention: Ridaforolimus Tablet; Ridaforolimus Intravenous (IV) Infusion
Intervention description: Ridaforolimus 10 mg oral tablet; Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).
Intervention MeSH terms: Sirolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      To describe the long-term safety of deforolimus (ridaforolimus, MK-8669) in participants for
      whom a clinical benefit has been established in a prior parent trial (MK-8669-013,
      NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054) with deforolimus and/or
      in those who remain in long-term follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have participated on a deforolimus (ridaforolimus) parent trial

          -  Must have derived a clinical benefit from the parent trial

          -  Is not on any other anti-cancer treatment(s) unless the therapy was allowed on the
             parent protocol

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
             if the participant is scheduled to receive treatment with deforolimus; no requirement
             if the participant is included for follow-up purposes only

          -  Participant of childbearing potential must have a negative pregnancy test within 7
             days prior to screening and must use approved contraceptive from screening until 30
             days after the last dose of study drug

          -  Signed informed consent

        Exclusion Criteria:

          -  Has not participated on a parent trial

          -  Women who are to receive study drug who are pregnant or lactating

          -  Any condition in the Investigator's judgment that renders the participant unable to
             fully understand and provide informed consent and/or comply with the protocol
Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fludarabine; Melphalan; Stem Cell Infusion
Intervention description: 30 mg/m^2 intravenously Daily for 5 Days; 70 mg/m^2 intravenously Daily for 2 Days; Stem Cell Infusion on Day 0.
Intervention MeSH terms: Fludarabine; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Breast Cancer; PBPC Transplantation; Stem Cell Infusion; Fludarabine; Melphalan

Summary:

      Primary Objectives:

        1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC)
           transplantation in patients with recurrent or metastatic breast cancer.

        2. To determine the success rate (complete remission without severe toxicity or death) at
           100 days after the transplant and long-term progression free survival (PFS) rate.

        3. To examine the graft vs. breast cancer effect of allogeneic PBPC transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent or residual metastatic breast carcinoma

          -  Zubrod performance status less than 2

          -  18-60 years old

          -  Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation
             or unrelated HLA-compatible donor.

          -  No major organ dysfunction or active infection

        Exclusion Criteria: None
An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Intervention: tamsulosin
Intervention description: 0.4 mg
Intervention MeSH terms: Tamsulosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 689.0
Sex: Male
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      Multicenter trial conducted in Pharmacy retail centers
    

Eligibility criteria:

        Inclusion criteria:

          1. Men 18 years of age and older.

          2. Able to speak, read and understand English.

          3. Willing to participate in the study and voluntarily sign an informed consent document.

        Exclusion criteria:

        1. Subject or anyone in their household is currently employed by a marketing or marketing
        research company, and advertising agency or public relations firm, a pharmacy or
        pharmaceutical company, a manufacturer of medicines, a managed care or health insurance
        company as a healthcare professional or healthcare practice.
A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Intervention: OnabotulinumtoxinA; Normal Saline
Intervention description: OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.; Placebo (normal saline) injected into specified muscle per protocol on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature
      ejaculation (PE) in male participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of premature ejaculation

          -  Stable monogamous sexual relationship with female partner for at least 6 months, and
             intends to continue with the same partner for the duration of the study

          -  Participant has ability to follow study instructions and complete study assessment
             tools

        Exclusion Criteria:

          -  Premature ejaculation caused by medical or surgical issues, or is related to stress or
             other issues (eg, relationship problems)

          -  Pain with ejaculation

          -  Planned use of topical penile treatments (eg, anesthetics, herbal treatments) or
             penile injections during the study

          -  Prior genital, prostatic or lower urinary tract surgery (other than vasectomy or
             circumcision)

          -  Previous or current usage of botulinum toxin therapy of any serotype for any
             urological condition

          -  Use of botulinum toxin therapy of any serotype for any nonurological condition (eg,
             cosmetic, chronic migraine) during the 12 weeks prior to screening, or planned usage
             during the study

          -  Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials
Condition: Neoplasms
Intervention: Screening Platform
Intervention description: Eligible participants who qualify as per this screening protocol may be referred to evaluate adoptive cell therapy in participants with various malignancies, on a separate treatment trial. No study treatment will be administered in this screening study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Adoptive T-cell therapy; Hematologic Malignancy; Human leukocyte antigen; Screening study; Solid Tumors; T-cell receptors

Summary:

      This screening study is intended to determine preliminary eligibility of participants who may
      be potential candidates for GlaxoSmithKline's Adoptive T-cell therapy studies by screening
      for appropriate biomarkers. No treatment intervention will occur as part of this screening
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of locally advanced high-risk
             eligible tumor types .

          -  Participant must be greater than or equal to (>=)18 years of age (or >=10 years of age
             with synovial sarcoma or myxoid/round cell liposarcoma [MRCLS])

          -  Participants with life expectancy of greater than 6 months

          -  Performance status: Eastern Cooperative Oncology Group 0-1.

        Exclusion Criteria:

          -  Any prior treatment with oncology cell and/or gene therapy (unless agreed in advance
             with Sponsor)

          -  Prior malignancy not in complete remission.

          -  Clinically significant systemic illness

          -  Serious active infections or significant cardiac, pulmonary, hepatic or other organ
             dysfunction,

          -  Prior or active demyelinating disease

          -  Previous New-York Esophageal Antigen-1 (NY-ESO-1)-specific T cells, NY-ESO-1 vaccine,
             or NY-ESO-1 targeting antibody.

          -  Previous allogeneic hematopoietic stem cell transplant within the last 5 years or
             solid organ transplant.
6-week Safety and PD Study in Adults With NAFLD
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Placebo; PF-06835919 Low Dose; PF-06835919 High Dose
Intervention description: 0 mg; 75 mg once daily; 300 mg once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY,
      SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS
      WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI at least 28 kg/m2

          -  Type 2 diabetes and/or metabolic syndrome

        Exclusion Criteria:

          -  Liver disease

          -  Type 1 diabetes

          -  Recent heart attack or stroke

          -  Inability to have an MRI scan
A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Etrasimod 1 mg; Etrasimod 2 mg; Etrasimod matching placebo
Intervention description: Etrasimod 1 mg tablet taken by mouth, once daily; Etrasimod 2 mg tablet taken by mouth, once daily.; Etrasimod matching placebo tablet by mouth, once daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Moderate-to-severe atopic dermatitis; Etrasimod; APD334

Summary:

      The purpose of this study is to determine whether etrasimod is a safe and effective treatment
      for moderate-to-severe atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with chronic atopic dermatitis, defined by Hanifin and Rajka criteria,
             that has been present for at least 1 year prior to the Screening Visit

          -  Participants with Eczema Area and Severity Index (EASI) ≥ 12 at the Screening Visit
             and ≥ 16 at the Baseline Visit

          -  Participants with validated Investigator's Global Assessment (vIGA) score ≥ 3 (on the
             0 to 4 vIGA scale, in which 3 = moderate and 4 = severe) involvement at the Screening
             and Baseline visits

        Exclusion Criteria:

          -  Presence of skin comorbidities that would interfere with study assessments of the
             underlying disease.
Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Condition: Cardiovascular Disease; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Cardiovascular Diseases
Intervention: angiotensin converting enzyme inhibitor; lisinopril
Intervention description: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day; 1 x 40 mg per day
Intervention MeSH terms: Lisinopril; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 60 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cardiovascular disease; angiotensin converting enzyme inhibitors; chronic kidney disease; cardiovascular disease in elderly patients with CKD

Summary:

      The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs
      primarily used to treat hypertension or congestive heart failure) to prevent or delay
      cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining
      their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 60 years

          -  BP 120/80 or higher *(bps will be checked weekly first 4 weeks to ensure < 130/80 - IF
             bp remains > 130/80 we will administer other bp meds per JNC VII guidelines)

          -  CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group

        Exclusion Criteria:

          -  Known significant CVD (history of Myocardial infarction (MI), recurrent stroke, or New
             York Heart Association (NYHA) class III or greater).

          -  Serum potassium > 5.2 meq/L

          -  Known allergy or hypersensitivity to ACE inhibitor or ARB

          -  Female of childbearing age not practicing contraception

          -  Current treatment with an Angiotensin Converting Enzyme Inhibitors (ACE-I) or
             Angiotensin-Receptor Blockers (ARB) (Note: can participate if on ACE-I after 6 week
             washout period)

          -  History of ACE-I induced angioedema

          -  History of angioedema, hereditary or idiopathic

          -  Persons lacking consent capacity

               -  500 mg/dL proteinuria on 2 consecutive spot urine protein/creat ratios
Atacicept in Subjects With Optic Neuritis
Condition: Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Intervention: Atacicept; Placebo matched to atacicept
Intervention description: Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.; Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 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: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: atacicept; neuritis

Summary:

      This study was intended to evaluate the efficacy, safety and tolerability of atacicept
      compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT
      in subjects with ON as CIS. The study was randomized. Study medication was administered via
      subcutaneous (under the skin) injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation
             within 28 days between onset of symptoms and study Day 1

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Pre treatment with immunosuppressants and immunomodulating drugs

          -  Relevant cardiac, hepatic and renal diseases

          -  Clinical significant abnormalities in blood cell counts and immunoglobulin levels

          -  Clinical significant acute or chronic infections

          -  Other protocol defined exclusion criteria could apply
Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy
Condition: Pain; Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: AZD2066; Placebo
Intervention description: Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.; Capsule, once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pain; Diabetic Neuropathy; PDN; Analgesia; Efficacy

Summary:

      The purpose of this study is to investigate if AZD2066 can relieve the pain arising from
      painful diabetic neuropathy compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures.

          -  Clinical diagnosis of painful diabetic neuropathy.

          -  non-fertile females

        Exclusion Criteria:

          -  Other pain that may confound assessment of neuropathic pain.

          -  Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the
             lower extremities.

          -  History of psychotic disorders among first degree relatives.
A Study of Pregnenolone in the Treatment of Individuals With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: Pregnenolone
Intervention description: With Baseline serving as approximately day 1, twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.
Week 1 and 2: 100 mg
Week 3 and 4: 200 mg
Week 5 and 6: 300 mg
Week 7 and 8: 400 mg
Week 9 -12: 500 mg
At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.
If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: autism

Summary:

      This study will assess the tolerability and effectiveness of pregnenolone in the treatment of
      behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone
      found in the body which has been shown to help with the function of nerve cells. It is also
      shown to modulate the activity of certain brain receptors implicated in autism. We hope to
      examine the tolerability of pregnenolone in adults with autism.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Outpatients 18-45 years of age;

          2. Males and females who are physically healthy;

          3. Diagnosis of autism based on Diagnostic and Statistical Manual (DSM-IV-TR) criteria,
             the Autism Diagnostic Interview-Revised, and expert clinical evaluation;

          4. Total Aberrant Behavior Checklist (ABC) greater then 21;

          5. Care provider who can reliably bring subject to clinic visits, can provide trustworthy
             ratings, and interacts with subject on a regular basis;

          6. Ability of subject to swallow the compound;

          7. Stable concomitant medications for at least 2 weeks; and

          8. No planned changes in psychosocial interventions during the open-label pregnenolone
             trial.

        Exclusion Criteria:

          1. Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of schizophrenia,
             schizoaffective disorder, or psychotic disorder, not otherwise specified;

          2. Prior adequate trial of pregnenolone;

          3. Active medical problems: unstable seizures, significant physical illness (e.g.,
             serious liver or renal pathology);

          4. Pregnancy or sexually active females (as determined by a urinary pregnancy test in the
             beginning of the study); and

          5. Subjects taking oil or fat based nutritional supplements will be excluded from the
             study unless they have been off these compounds for at least 4 weeks
Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: (CP-6890,550) Tofacitinib; Placebo; (CP-690,550) Tofacitinib; Placebo
Intervention description: 2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks; 2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks; 2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 weeks; 2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque psoriasis; tofacitinib; biopsy; Janus Kinase; randomized placebo controlled clinical trial; psoriasis vulgaris

Summary:

      There are cells in the skin and blood of humans with chronic moderate to severe plaque
      psoriasis with specific activities that may determine the effectiveness of treatment. These
      activities may be described by obtaining samples of skin and blood and analyzing them using a
      variety of tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults over 18 years of age with a diagnosis of chronic moderate to severe plaque
             psoriasis for at least 12 months; in generally good health; on stable dose of
             non-prohibited medications; able to stop current psoriasis therapy (systemic or
             topical) for several weeks prior to and during study participation.

        Exclusion Criteria:

          -  Serious underlying disease including viral disorders such as hepatitis or HIV or skin
             condition that would interfere with skin biopsies or evaluation of psoriasis;
             conditions that could interfere with drug absorption after oral administration;
             history of malignancy or auto-immune disease.

          -  Use of oral or injected corticosteroids (steroids).