bioihbjkbjnl/mcl2 huggingface dataset:
Citalopram for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Citalopram; Citalopram; Placebo
Intervention description: 20 mg once per day for 9 weeks; 40 mg per day for 9 weeks; 0 mg per day for 9 weeks
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Cocaine; citalopram; treatment; serotonin

Summary:

      This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine
      dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent
      patients will be assigned equally to one of three medication conditions: placebo or the
      Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or
      40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase
      periods of sustained abstinence substantially more than placebo. Performance on a set of
      behavioral tasks of impulsivity will be analyzed as potential predictors of treatment
      response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  between 18 and 60 years of age

          -  meet Diagnostic and Statistical Manual 4 (DSM-IV) criteria for current cocaine
             dependence

          -  be in acceptable health on the basis of interview, medical history and physical exam

          -  able to provide the names of at least 2 persons who can generally locate their
             whereabouts.

        Exclusion Criteria:

          -  diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or
             nicotine

          -  have a psychiatric disorder or neurological disease or disorder requiring ongoing
             treatment and/or making study participation unsafe

          -  medical conditions contraindicating citalopram pharmacotherapy

          -  taking medications known to have significant drug interactions with the study
             medication

          -  pregnant or nursing for female patients

          -  having plans to leave the immediate geographical area within 3 months
A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Condition: Palmar Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: Glycopyrronium cloth, 2.4%; Vehicle
Intervention description: Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium; Pre-saturated 100% polypropylene, nonwoven, fabric cloth
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the efficacy and safety of glycopyrronium cloth,
      2.4% when used to treat palmar hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent and assent (for subjects under legal adult age).

          2. Age ≥9 years.

          3. Primary palmar hyperhidrosis for at least 6 months duration.

          4. Average sweat severity score of ≥4 at Baseline.

          5. Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline.

          6. Willing to comply with the protocol. Subjects under legal adult age will be assessed
             by the investigator as to their ability to comply with the protocol.

          7. Male or non-pregnant (negative urine pregnancy test in female subjects of
             child-bearing potential), non-lactating females.

        Exclusion Criteria:

          1. Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.

          2. Prior surgical procedure for hyperhidrosis.

          3. Iontophoresis for the palms within 4 weeks of Baseline.

          4. Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year
             of Baseline.

          5. Open wounds or inflammatory lesions on the hands or, any condition that may alter the
             barrier function of the skin on the hands.

          6. Secondary palmar hyperhidrosis or presence of a condition that may cause secondary
             hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication,
             carcinoid syndrome, substance abuse, hyperthyroidism).

          7. Known history of Sjögren's syndrome or Sicca syndrome.

          8. History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile
             illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe
             ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia
             gravis.

          9. Men with a history of urinary retention requiring catheterization due to prostatic
             hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Vericiguat (BAY1021189) (1.25 mg); Vericiguat (BAY1021189) (5 mg); Placebo
Intervention description: 1.25 mg BAY1021189 tablets; 5 mg BAY1021189 tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 477.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Worsening Heart Failure; Heart Failure with Preserved Ejection Fraction

Summary:

      Objective of the study is to find the optimal dose of the once daily oral soluble guanylate
      cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard
      diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous
             diuretic treatment for HF without hospitalization) with initiation of study treatment
             after clinical stabilization

          -  Left ventricular ejection fraction (LVEF) >/= 45% by echocardiography at randomization

        Exclusion Criteria:

          -  Intravenous inotropes at any time after hospitalization
A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Emibetuzumab; Erlotinib
Intervention description: Administered IV; Administered Orally
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the efficacy of the study drug known as
      LY2875358, administered alone or in combination with a second drug named Erlotinib, in
      participants affected by a defined type of lung cancer (MET biomarker diagnostic positive
      Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent
      treatment with Erlotinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of metastatic Stage IV NSCLC

          -  At least 1 measurable extra-central nervous system (CNS) lesion

          -  Documented radiographic progression while on continuous treatment with erlotinib
             monotherapy

          -  Objective clinical benefit from erlotinib treatment as defined by either documented
             partial or complete response or stable disease ≥6 months or, if most recent erlotinib
             treatment has been initiated based on documented epidermal growth factor receptor
             mutation (EGFRmt) status, at least 12 weeks stable disease

          -  Determined to be MET diagnostic positive (+)

          -  Availability of a tumor sample post-erlotinib progression

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2

          -  Have adequate organ function

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an investigational product or non-approved use of a drug or device

          -  Have previously been treated with LY2875358 or any other MET-targeting experimental
             therapeutic

          -  Have a serious concomitant systemic disorder or significant cardiac disease

          -  Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural
             effusion, pericardial fluids or ascites, requiring drainage every other week or more
             frequently

          -  Have a history of another malignancy except for basal or squamous cell skin cancer
             and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and
             without evidence of recurrence for at least 3 years prior to the study

          -  Have major surgery less than 2 weeks prior initiation of study treatment therapy

          -  Pregnant or lactating women

          -  Have symptomatic CNS metastasis
Role of Mirtazapine in Ameliorating Sleep Disordered Breathing
Condition: Spinal Cord Injuries; Sleep Disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Spinal Cord Injuries
Intervention: Mirtazapine; Placebo
Intervention description: 15 mg dose before bed-time; One placebo pill before bed-time
Intervention MeSH terms: Mirtazapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at the effect of using Mirtazapine to target a specific
      pathway in the body, that relies on a natural chemical the body produces called 'serotonin',
      in patients with spinal cord injury (SCI) and non-injured persons during sleep. During this
      part of the study participants will be asked to take Mirtazapine (15mg per day) and a placebo
      in a random fashion, each for a one week period (drug period) of time followed by one week
      without drugs (washout period). The drugs will not be taken all at the same time, but each
      will be taken separately for one weeks followed by a night study to look at the effect the
      Mirtazapine/placebo pill has on the way the body responds during sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with SCI (>6months after spinal cord injury) at the T6 level/above

          -  Non-injured adults

        Exclusion Criteria:

          -  Pregnant and lactating females

          -  Heart failure, vascular disease, or stroke

          -  Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic
             kidney disease

          -  BMI >38 kg/m2

          -  Mechanical ventilation dependence
A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)
Condition: Constipation Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: RDX5791
Intervention description: Capsule, QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of
      RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition
      of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery
      of screening procedures to determine eligibility for the trial.

      The study will consist of a 2-week treatment-free screening period, a 4-week blinded
      treatment period, and a 2-week treatment-free follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject meets Rome III criteria for IBS-C

          -  If > 50 years old, colonoscopy evaluation within 10 years

          -  All ages, negative colonoscopy if any "warning symptoms"

          -  Active disease during 2-week screening period

          -  Compliant with IVRS

        Exclusion Criteria:

          -  Subjects has IBS-D, IBS-M or un-subtyped IBS according to Rome III criteria

          -  Diagnosis or treatment of any clinically symptomatic biochemical or structural
             abnormality of the GI tract

          -  Use of medications that are known to affect stool consistency

          -  Subject has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments or prevent completion of study
Alimta Plus Gemcitabine for Advanced Sarcoma
Condition: Sarcoma, Soft Tissue
MeSH terms: Sarcoma
Intervention: Alimta; Gemcitabine
Intervention description: 500 mg/m2 via IV over 10 minutes
A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer.; 1000 mg/m2 via IV over 90 minutes
A nucleoside analog used as chemotherapy.
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In patients with unresectable soft tissue sarcoma, what is the response rate if treated with
      Alimta and gemcitabine?
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven soft tissue sarcoma (except the following histologies:
             gastrointestinal stromal tumors (GIST), Kaposi's Sarcoma, mesotheliomas).

          -  Age ≥ 18 years

          -  Recurrent or progressive disease defined as an increase in size of any existing tumor
             mass, or the development of new tumor mass or masses, which is not amenable to
             definitive surgical therapy.

          -  Patients may have had another cancer but there must be convincing clinical evidence
             that the sarcoma is the disease requiring therapeutic intervention. (i.e. Several
             sarcoma patients have had had a prior cancer [Hodgkin's disease or breast cancer]
             treated years previously and then developed a clinically active sarcoma.)

          -  Patients may have received no prior chemotherapy, or may have failed 0-2 prior
             cytotoxic regimens.

          -  Measurable disease defined as lesions that can be measured in at least one dimension
             by physical examination or by means of medical imaging techniques. Ascites and pleural
             effusions will not be considered measurable disease.

          -  Karnofsky performance status of greater than or equal to 60%.

          -  At least 3 weeks since prior chemotherapy or at least 6 weeks since prior radiation
             therapy.

        Exclusion Criteria:

          -  Soft tissue sarcomas with the following histologies: gastrointestinal stromal tumors
             (GIST), Kaposi's sarcoma, mesotheliomas.

          -  Active or uncontrolled infection

          -  Prior treatment with gemcitabine or Alimta

          -  Pregnant or lactating women

          -  Uncontrolled central nervous system metastases

          -  Inability to stop treatment with NSAIDs
Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome
Condition: Myelofibrosis
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Primary Myelofibrosis
Intervention: Busulfan; Fludarabine; Thymoglobulin (ATG)
Intervention description: Test dose = 32 mg/m^2 by vein x 1 day; 100 mg/m^2 by vein daily over 3 hours x 4 days; 40 mg/m^2 by vein daily over 1 hour x 4 days; 2.5 mg/kg by vein over 6 hours x 3 days if there is an unrelated or a mismatched donor
Intervention MeSH terms: Fludarabine; Fludarabine phosphate; Busulfan; Thymoglobulin; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Idiopathic Myelofibrosis; Myelofibrosis; Essential Thrombocythemia; Polycythemia Vera; Busulfan; Antithymocyte Globulin; ATG; Fludarabine; Thymoglobulin

Summary:

      The goal of this clinical research study is to learn if using a combination of fludarabine,
      busulfan, and antithymocyte globulin (ATG) can help to control myelofibrosis or
      myelodysplastic syndrome in patients receiving a bone marrow or blood stem cell transplant.
      The safety of these drugs will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Polycythemia Vera
             or Essential Thrombocythemia or Myelodysplastic syndrome with or without fibrosis.

          2. Patients 75 years or younger

          3. Patients must have an HLA matched or at least a 9/10 antigen (A, B, C, DQ or DR)
             matched related or unrelated donor.

          4. Patients must have a Zubrod PS 2 or less.

          5. Creatinine < 1.6 mg/dl

          6. Ejection fraction >/= 40%, unless cleared by cardiology

          7. Serum direct bilirubin < 2 mg/dl (unless due to Gilbert's syndrome), serum glutamate
             pyruvate transaminase (SGPT) </= 4 x normal values

          8. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC), or
             diffusing capacity of lung for carbon monoxide (DLCO) >/= 40% of expected.

          9. Negative Beta human chorionic gonadotropin (HCG) test in a woman with child bearing
             potential defined as not post-menopausal for 12 months or no previous surgical
             sterilization.

        Exclusion Criteria:

          1. Uncontrolled life-threatening infections

          2. HIV positive

          3. Patients with Active viral hepatitis
Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: GLPG0634; Placebo
Intervention description: GLPG0634 capsules.; Placebo capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 599.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Methotrexate inadequate responders

Summary:

      Participants suffering from active rheumatoid arthritis despite continued treatment with
      methotrexate were evaluated for improvement of disease activity (efficacy) when taking
      GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as
      once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks.

      •During the course of the study, patients were also examined for any side effects that could
      occur (safety and tolerability), and the amount of GLPG0634 present in the blood
      (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of
      action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects
      of different doses and dose regiments of GLPG0634 administration on participants' disability,
      fatigue, and quality of life were evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria
             of RA and ACR functional class I-III,

          -  have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint
             count) at Screening and at Baseline,

          -  Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range
             (ULN),

          -  have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of
             MTX for at least 4 weeks prior to Screening and willing to continue on their current
             regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are
             allowed when there is documented evidence of intolerance or safety issues at higher
             doses.

        Exclusion Criteria:

          -  current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than
             MTX,

          -  current or previous RA treatment with a biologic DMARD, with the exception of biologic
             DMARDs administered in a single clinical study setting more than 6 months prior to
             Screening (12 months for rituximab or other B cell depleting agents), where the
             biologic DMARD was effective, and if discontinued, this should not be due to lack of
             efficacy,

          -  previous treatment at any time with a cytotoxic agent, other than MTX, before
             Screening.