bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-3577; Placebo to MK-3577; Metformin; Placebo to Metformin
Intervention description: MK-3577 oral tablets totaling 6 mg in the evening (PM), 10 mg in the morning (AM), or 25 mg twice daily (BID) depending upon randomization, administered during a 4 week treatment period.; Dose-matched placebo tablets to MK-3577 administered during a 4 week treatment period; Two 500 mg tablets of metformin were administered twice daily (2000 mg total daily dose) to domiciled participants during a 4 week treatment period.; Two placebo tablets to metformin were administered twice daily (2000 mg total daily dose) to domiciled participants during a 4 week treatment period.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study assessed the safety and efficacy of MK-3577. The primary efficacy hypothesis was
      that, after 4 weeks of treatment, either the morning (AM) administration or the evening (PM)
      administration of MK-3577 provides superior reduction of 24-hour weighted mean glucose (WMG)
      levels compared to placebo (PLA). The primary safety hypothesis was that MK-3577 is well
      tolerated compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has type 2 diabetes

          -  Participant is either not taking antihyperglycemic medications for the last 10 weeks
             OR is taking a single oral antihyperglycemic medication (but not a Peroxisome
             Proliferator-Activated Receptor gamma [PPARg] agonist) OR is taking a low-dose
             combination oral antihyperglycemic medication (not a PPARg agonist) at dose less than
             or equal to 50% of the maximum dose

          -  Female participant is unable to have children

        Exclusion Criteria:

          -  Participant has a history of type 1 diabetes or ketoacidosis

          -  Participant has been treated with a PPARg agonist in the last 12 weeks

          -  Participant has been treated with insulin in the last 12 weeks

          -  Participant has had prescription lipid-modifying drug therapy in the last 12 weeks

          -  Participant has a history of coronary artery disease

          -  Participant has had a stroke or transient ischemic attack

          -  Participant has congestive heart failure
Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma
Condition: Liposarcoma,Myxoid
MeSH terms: Liposarcoma; Liposarcoma, Myxoid
Intervention: Trabectedin; Dexamethasone
Intervention description: Trabectedin 1.5 mg/m^2 over a 24-hour iv infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles of trabectedin.; Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion
Intervention MeSH terms: Dexamethasone; Trabectedin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myxoid; Liposarcoma; Trabectedin; Dexamethasone

Summary:

      The purpose of this study is to evaluate the safety and efficacy of trabectedin for the
      treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor
      derived from primitive or embryonal lipoblastic cells).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of
             pathology specimens for central review and pharmacogenomic studies

          -  Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including
             locally recurring disease after initial surgery

          -  Measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST])

          -  No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2

        Exclusion Criteria:

          -  Known hypersensitivity to any of the components of the trabectedin intravenous (iv)
             formulation or dexamethasone

          -  Pregnant or lactating women and women of reproductive potential who are not using
             effective contraceptive methods

          -  History of another neoplastic disease (except basal cell carcinoma or cervical
             carcinoma in situ adequately treated) unless in remission for 5 years or longer

          -  Known distant metastases

          -  Other serious illnesses such as congestive heart failure or angina pectoris,
             myocardial infarction within 1 year before enrollment, uncontrolled arterial
             hypertension or arrhythmias
Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: radiotherapy
Intervention description: prostate radiation to 70Gy; nodal radiation to 56Gy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to
      escalate the biologically effective dose to the pelvic lymph nodes in a short course of
      radiation therapy. An increased total and biologically effective dose will be delivered to
      the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short
      course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prostate cancer stage T-T3

          -  Predicted risk of lymph node involvement > 15%

          -  Gleason > 7

        Exclusion Criteria:

          -  Distance metastases

          -  Use of anti-coagulant therapy
Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; Anastrazole
Intervention description: 500 mg intramuscular injection; oral tablet
Intervention MeSH terms: Fulvestrant; Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: Female
Healthy volunteers: No

Summary:

      To compare the anti-tumour effects as measured by changes in various biomarkers, of a
      combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal
      women patients with primary breast cancer who are awaiting curative-intent surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women.

          -  Biopsy confirmation of primary breast cancer.

          -  Oestrogen receptor positive tumour.

          -  Fit for surgery within one month.

          -  Written informed consent to participate in the study

        Exclusion Criteria:

          -  Previous treatment with any anti-hormonal therapy for breast cancer.

          -  Previous radiotherapy to the primary tumour.

          -  Previous chemotherapy for the primary tumour.
Prescription Opioid Effects in Abusers Versus Non-Abusers
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Intervention: oxycodone 15 mg; oxycodone 30 mg; Placebo 0 mg
Intervention description: 15 mg/70 kg oxycodone administered once per day, orally.; 30 mg/70 kg oxycodone administered once per day, orally.; 0 mg placebo dose administered once a day, orally.
Intervention MeSH terms: Oxycodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opiate; Opioid; Abuse Liability; Abuse Potential

Summary:

      The purpose of this study is to examine the abuse liability of oxycodone in individuals with,
      and without, a history of prescription opioid abuse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good physical health

          -  Women reporting regular menstrual cycles lasting between 24 to 35 days

          -  Able to perform study procedures

          -  Normal body weight

          -  Use of opioids for medical purposes (cough, pain, or diarrhea) or recreational
             purposes at least twice in lifetime with no serious adverse effects

          -  Current opioid abuse, but not opioid dependence (drug abusers only)

        Exclusion Criteria:

          -  On parole or probation

          -  Recently convicted of a crime of violence

          -  History of significant violent behavior

          -  Current Axis I psychopathology

          -  Significant Axis II disorder

          -  Pregnancy

          -  Women who have irregular menstrual cycles, or who are dysmenorrheic, amenorrheic, or
             menopausal

          -  Women who have been pregnant or breastfeeding within the past 6 months

          -  Women who have had a miscarriage or abortion within the past 6 months

          -  Women who meet DSM-IV criteria for premenstrual dysphoric disorder

          -  Women who report suffering from moderate to severe premenstrual symptoms

          -  Women seeking treatment for premenstrual problems

          -  Taking prescription or over-the-counter psychotropic medication

          -  History of chronic pain, or routinely uses over-the-counter analgesics (more than 4
             days per month)

          -  Blood pressure greater than 150/90 mm Hg

          -  Reports of sensitivity, allergy, or contraindication to opioids

          -  Non-drug abusers:

               1. Current or lifetime history of substance abuse or dependence according to DSM-IV
                  criteria (those requiring detoxification)

               2. Consumes more than 500 mg caffeine daily

               3. Seeking treatment for substance use
Treating Anorectal Dysfunction in MS
Condition: Constipation; Fecal Incontinence; Multiple Sclerosis
MeSH terms: Fecal Incontinence; Multiple Sclerosis; Sclerosis; Constipation
Intervention: Bisacodyl; Placebo
Intervention description: Rectal suppository; Rectal suppository
Intervention MeSH terms: Bisacodyl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The investigators seek to test whether incorporating the scheduled dosing of a bisacodyl 10
      mg rectal suppository every other day improves bowel-related symptoms in patients with
      multiple sclerosis. Patients will be randomized to receive either a placebo suppository or
      bisacodyl suppository dosed every other day for 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MS patients with mild to moderately severe disease (Multiple Sclerosis Impact Scale
             [MSIS-29] physical domain scores <61 or equivalent Extended Disability Severity Score
             [EDSS] < 6.5) of any age, gender, disease subtype, duration of illness, current use of
             MS disease modifying therapy, or comorbid medical condition AND who also have
             anorectal dysfunction (chronic constipation and/or fecal incontinence) are eligible.

        Exclusion Criteria:

          -  MS patients with severe disease (MSIS-29 physical domain scores greater than 61 or
             equivalently severe EDSS greater than 6.5), patients with surgically altered anorectal
             anatomy (i.e. proctectomy/partial colectomy, ostomy creation), active enteric
             infection (i.e., Clostidium Difficile), or inflammatory bowel disease (i.e. ulcerative
             proctitis, ulcerative colitis) will also be excluded.
Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: TER-101; Vehicle
Intervention description: Active Comparator; Placebo Comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and
      vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic
      dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adolescent or adult subject aged 12 - 65 years.

          -  Overall IGA score of 2 (mild) or 3 (moderate) at baseline on a 5-point IGA

        Exclusion Criteria:

          -  AD with known hypersensitivity to excipients of TER-101 Ointment

          -  Subjects who are immunocompromised
Cysteamine Eye Drops to Treat Corneal Crystals in Cystinosis
Condition: Cystinosis
MeSH terms: Cystinosis
Intervention: Cysteamine
Intervention MeSH terms: Cysteamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 328.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Cysteamine Eye Drops; Nephropathic Cystinosis; Corneal Crystals; Benzalkonium; Toxicity; Efficacy; Cystinosis

Summary:

      Cystinosis is an inherited disease that results in poor growth and kidney disease, among
      other things. The damage to the kidneys and other organs is thought to be due to accumulation
      of cystine inside the cells of various body tissues. This chemical also accumulates in the
      cornea-the covering of the eye over the pupil and iris. After 10 to 20 years, the corneas of
      some patients become so packed with crystals that the surfaces may become irregular,
      occasionally causing small, painful breaks.

      Patients enrolled in a NIH study on cystinosis are receiving the drug cysteamine. Taken by
      mouth, this drug reduces cystine in some tissues, but not in the cornea. This study began in
      1986 to test whether cysteamine eye drops could prevent or reduce corneal cystine crystals in
      these patients. The drops have been very effective in removing crystals and reducing pain in
      patients who take the medication as directed. Patients who do not take the medication as
      prescribed do not benefit.

      After the effectiveness of the drops was proven, the main purpose was modified to continue to
      evaluate the long-term safety and effectiveness of cysteamine eye drops for treating cystine
      crystals in the corneas of patients with cystinosis until the drops are approved by the Food
      and Drug Administration (FDA). When the New Drug Application (NDA) for the Sigma-Tau standard
      formulation is granted, this protocol will be terminated.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Patients must have a documented clinical diagnosis of cystinosis.

          -  Patients should be 2 years old or older.

        EXCLUSION CRITERIA:

          -  Inability to travel to NIH for a baseline examination, after 1 year, and every two
             years thereafter for follow-up

          -  Inability to cooperate for slit-lamp examination
MDD POC Study GSK372475 Subjects Depressive Disease
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Intervention: GSK372475; Paroxetine; Placebo
Intervention description: GSK372475 1.0-1.5 mg/day; Paroxetine 20-30 mg/day; Placebo to Match
Intervention MeSH terms: Paroxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 492.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: MDD; flexible-dose; Major Depressive Disorder; paroxetine; GSK372475

Summary:

      To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the
      treatment of outpatients subjects with major depressive disorder to exhibit decreased
      pleasure, interest and energy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR
             criteria)

          -  Duration of current episode is at least 12 weeks duration and less than 2 years

          -  Symptoms of decreased energy, pleasure, and interest

          -  Female subjects who agree to use acceptable methods of birth control throughout the
             study

        Exclusion criteria:

          -  Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic
             attacks that could interfere with their ability to complete the trial

          -  Symptoms of MDE better accounted for by another diagnosis

          -  Diagnosis of panic disorder / attacks, generalised anxiety, borderline or antisocial
             personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of
             screening), bipolar disorder, schizophrenia or any other psychotic disorder(s).

          -  Started psychotherapy within 3 months prior to the Screening

          -  Received electroconvulsive therapy or transcranial magnetic stimulation within 6
             months prior to screening

          -  Received psychoactive drugs within 4 weeks of randomization

          -  Positive urine drug screen or positive blood alcohol

          -  Suicidal risk or has had any previous suicide attempt, a family history of suicide
             attempt

          -  Positive pregnancy test

          -  History of seizure disorder, myocardial infarction (< 1yr), or unstable medical
             condition

          -  Failed to respond to an adequate course of pharmacotherapy of at least 2 different
             antidepressants
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: LDV/SOF
Intervention description: 90/400 mg FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: renal transplant

Summary:

      This study will evaluate the safety, tolerability, and antiviral efficacy of
      ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults
      with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney
      transplant.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Genotype 1 or 4 chronic HCV infection

          -  Have received a kidney transplant more than 6 months before the Baseline visit

          -  Cirrhosis determination

          -  Screening laboratory parameters within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Key Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain
             -resolved skin cancers)

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol

          -  Planned or anticipated second kidney transplant

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.