bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Intervention: ambrisentan
Intervention description: All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
Intervention MeSH terms: Ambrisentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This Phase 2 study was to determine the incidence of increased serum aminotransferase
      concentrations (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]), as
      well as the overall safety and tolerability of ambrisentan, in participants with pulmonary
      arterial hypertension (PAH), idiopathic PAH (IPAH), or familial PAH (FPAH) who had previously
      discontinued ERA therapy (bosentan or sitaxsentan) due to increased serum ALT or AST
      concentrations.
    

Eligibility criteria:

        Summary of Inclusion Criteria:

          -  Males and Females between 12 and 75 years of age

          -  Current diagnosis of IPAH, FPAH, or PAH associated with collagen vascular disease,
             congenital systemic-to-pulmonary shunts, anorexigen use, HIV infection

          -  Must have previously discontinued bosentan or sitaxsentan therapy due to serum
             aminotransferase (ALT and/or AST) concentrations > 3 x ULN

          -  Must have normal (< 1 x ULN) serum ALT and AST concentrations at screening

          -  Six-minute Walk distance of at least 150 meters at screening

          -  If receiving sildenafil or a clinically approved prostanoid for PAH, must have been on
             stable therapy for at least 4 weeks prior to screening

          -  Subjects with a diagnosis of HIV must have stable disease status during the screening
             period
Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8
Condition: Cocaine Abuse; Opiate Dependence
MeSH terms: Opioid-Related Disorders; Cocaine-Related Disorders
Intervention: Modafinil 200mg; Modafinil 400mg; Citalopram 20mg; Citalopram 40mg; Placebo
Intervention description: 10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1/2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.; 10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.; 10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.; 10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.; Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
Intervention MeSH terms: Dexetimide; Modafinil; Citalopram; Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 22 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cocaine Abuse; Opiate Abuse

Summary:

      The purpose of this study is to examine two medications, modafinil and citalopram, in the
      treatment of cocaine dependent individuals who are maintained on methadone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets cocaine abuse and dependence criteria (as determined by the SCID)

          -  Meets opiate dependence criteria (as determined by the SCID)

          -  In good general physical and psychiatric health (except for possible acute drug use
             related problems)

        Exclusion Criteria:

          -  Meets diagnostic criteria for other psychiatric disorders, including other forms of
             drug dependence (other than nicotine)

          -  Current cardiovascular disease (as determined by an electrocardiogram)

          -  Circumstances will not allow for completion of study (on probation or parole)

          -  Ethical constraints of supervision do not allow confidentiality (on probation or
             parole)
Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: bromfenac ophthalmic solution 0.06%
Intervention description: bromfenac ophthalmic solution 0.06% bilaterally twice a day
Intervention MeSH terms: Bromfenac; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution
      in dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 18 years of age or older

        Exclusion Criteria:

          -  No active ocular conditions of disease
Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy
Condition: Colonoscopy Preparation
Intervention: 90 grams of Crystalline Lactulose; 135 grams of Crystalline Lactulose; 180 grams of Crystalline Lactulose
Intervention description: 15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses; 15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses; 15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses
Intervention MeSH terms: Lactulose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bowel Evacuation; Colonoscopy Preparation

Summary:

      The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with
      escalating doses of lactulose to be used as a preparation for colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients requiring bowel evacuation for colonoscopy.

        Exclusion Criteria:

          -  Patients with galactosemia (galactose-sensitive diet).

          -  Patients known to be hypersensitive to any of the components of lactulose for oral
             solution.

          -  Patients with a known abnormality on screening or a vital sign assessments that, in
             the Investigator's judgment, may pose a significant risk including those pertaining to
             dehydration or electrolyte shifts.

          -  Patients with a history of impaired renal function.

          -  Patients with current or recent history of hypotension, as defined by the
             Investigator.

          -  Patients with a history of long Q-T syndrome.

          -  Patients with a history of a failed bowel preparation.

          -  Patients with severe constipation, defined as those patients taking daily prescription
             or over-the-counter laxatives.

          -  Patients with possible bowel obstruction, gastric retention, bowel perforation, toxic
             colitis, toxic megacolon, ileus or previous colonic surgery (except hemorrhoidectomy
             and polypectomy).

          -  Patients on lactulose therapy or receiving any treatment for chronic constipation.

          -  Be pregnant or nursing.

          -  Patients expected to require electrocautery or argon plasma coagulation.

          -  Patients less than 18 years of age.

          -  Inability to understand the requirements of the study or be unwilling to provide
             written informed consent (as evidenced by signature on an informed consent document
             approved by an Institutional Review Board [IRB]) and agree to abide by the study
             restrictions.

          -  Be otherwise unsuitable for the study, in the opinion of the Investigator.
A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
Condition: Disease, Hodgkin
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: brentuximab vedotin
Intervention description: 1.8 mg/kg every 3 weeks by intravenous infusion
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Disease, Hodgkin; Hematologic Diseases; Lymphoma; monomethylauristatin E; Drug Therapy; Immunotherapy

Summary:

      This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the
      efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with
      relapsed or refractory Hodgkin lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with relapsed or refractory Hodgkin lymphoma who have previously received
             autologous stem cell transplant.

          -  Histologically confirmed CD30-positive disease; tissue from the most recent post
             diagnostic biopsy of relapsed/refractory disease must be available for confirmation of
             CD30 expression via slides or tumor block.

          -  Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease
             of at least 1.5 cm as documented by spiral computed tomography.

          -  At US sites patients greater than or equal to 12 years of age may be enrolled. At
             non-US sites patients must be greater than or equal to 18 years of age.

        Exclusion Criteria:

          -  Previous treatment with brentuximab vedotin.

          -  Previously received an allogeneic transplant.

          -  Congestive heart failure, Class III or IV, by the New York Heart Association criteria.

          -  History of another primary malignancy that has not been in remission for at least 3
             years.

          -  Known cerebral/meningeal disease.
A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
Condition: Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2
Intervention: PF-06882961; Placebo
Intervention description: PF-68882961 will be provided as tablets twice a day (BID); Placebo comparator will be provided as tablets twice daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess tolerability, safety, and pharmacodynamics (PD) of twice daily (BID)
      administration of PF- 06882961 in adult participants with Type 2 Diabetes Mellitus (T2DM) who
      are treated with metformin and in non-diabetic adults with obesity
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1
             (screening).

        Exclusion Criteria:

          -  Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes.

          -  History of myocardial infarction, unstable angina, arterial revascularization, stroke,
             New York Heart Association Functional Class II IV heart failure, or transient ischemic
             attack within 6 months of screening (Visit 1).

          -  Participants with a known medical history of active liver disease (other than non
             alcoholic hepatic steatosis), including chronic active hepatitis B or C, or primary
             biliary cirrhosis.

          -  History of major depressive disorder or history of other severe psychiatric disorders
             (eg, schizophrenia or bipolar disorder) within the last 2 years.

          -  Any lifetime history of a suicide attempt.
Effects of b3-Adrenergic Receptor Agonists on Brown Adipose Tissue
Condition: Obesity
MeSH terms: Obesity
Intervention: beta3-adrenergic receptor agonist
Intervention description: single dose. The subjects were randomized to receive placebo on one study day and active beta3-adrenergic receptor agonist on the other study day.
Intervention MeSH terms: Mirabegron; Adrenergic Agents; Adrenergic Agonists
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adipose tissue, brown; obesity; Adrenergic beta-3 Receptor Agonists; thermogenesis; metabolism

Summary:

      This study will test the hypothesis that human brown adipose tissue (BAT) can be activated
      using a β3-adrenergic receptor (AR) agonist. The efficacy of β3-AR agonist will be compared
      with cold exposure, which we have already shown can activate human BAT, as well as a placebo
      control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Male

          -  18-65 years old

          -  BMI between 18-40

          -  Not participated in clinical trial and received either an investigational or marketed
             drug within two months prior to the study

          -  Not donated blood in previous two months

        Exclusion Criteria:

          -  Women

          -  History of local or systemic infection disease with fever or requiring antibiotic
             within 4 weeks of drug administration

          -  Corrected QT interval above normal

          -  Laboratory test results that is more than 1.5 fold outside normal range and/or is
             judged to be clinically significant

          -  Current addition to alcohol or substances of abuse

          -  Mental incapacity, unwillingness or language barriers precluding adequate
             understanding or cooperation

          -  Use of system course of corticosteroids or other medication known to cause insulin
             resistance in previous 6 weeks

          -  Hyperthyroidism,hypothyroidism, hypertension (even if controlled with medications),
             heart disease (including CAD and CHF), cardiac arrhythmias, diabetes, unstable
             vasomotor system, or use of monoamine oxidase (MAO) inhibitors

          -  Diagnosis of bladder outlet obstruction or use of any medication to treat overactive
             bladder (e.g. Tolterodine, Solifenacin, Propiverine, Oxybutynin, and Fesoterodine)
Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Fluconazole; Vancomycin; Neomycin; Ciprofloxacin; Polyethylene Glycol 3350; Promethazine; Fluconazole placebo
Intervention description: 400mg orally once daily (Day 1-14); 500mg oral suspension 4 times daily (Day 1-14); neomycin 1000 mg orally three times daily (Days 1-3); ciprofloxacin 750 mg orally twice daily (Day 4-14); 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2; PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).; Once daily
Intervention MeSH terms: Promethazine; Diphenhydramine; Vancomycin; Ciprofloxacin; Neomycin; Fluconazole; Polyethylene glycol 3350
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage
      and antibiotics with or without an antifungal) in the management of active Crohn's Disease
      (CD) that is refractory to conventional, immunosuppressive therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is capable of giving informed consent

          -  Males or females 18-75 years of age

          -  Normal kidney function (defined by normal serum creatinine [male: <1.27 mg/dL; female:
             <1.03 mg/dL])

          -  Normal aspartate aminotransferase [AST] (<41 U/L), alanine aminotransferase [ALT] (<63
             U/L), and alkaline phosphatase (<126 U/L)

          -  Active CD defined as HBI ≥ 7

          -  CRP > 5 mg/dL or hs-CRP > 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) > - - 350
             mcg/g (within one month of enrollment)

          -  Have been treated with one of the following therapies** for at least 8 weeks with
             primary nonresponse or an initial response, followed by loss of response [LOR]
             (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine,
             methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab,
             vedolizumab, or ustekinumab **These medications must have been administered at
             standard, therapeutic dosages.

        Exclusion Criteria:

          -  Known or suspected stricturing disease producing obstructive symptoms

          -  Active Clostridium difficile infection

          -  Unwillingness to provide informed consent

          -  Allergy or intolerance to the medications used in this study

          -  History of kidney disease

          -  History of liver disease

          -  Pregnant or lactating females

          -  Baseline QTc interval on EKG > 430 in males or > 450 in females

          -  Participants who, in the opinion of the investigator, may be non-compliant with study
             schedules or procedures
Safety & Efficacy Study of ORGN001 (Formerly ALXN1101) in Pediatric Patients With MoCD Type A Currently Treated With rcPMP
Condition: Molybdenum Cofactor Deficiency, Type A
MeSH terms: Metal Metabolism, Inborn Errors
Intervention: ORGN001 (formerly ALXN1101)
Intervention description: IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Healthy volunteers: No
Keywords: Molybdenum cofactor deficiency (MoCD); molybdenum cofactor (MoCo) biosynthesis; sulfite oxidase (SO); xanthine dehydrogenase; aldehyde oxidase; S sulfocysteine (SSC)

Summary:

      This study will include a screening period, a 6-month treatment period, followed by long-term
      extension period expected to last approximately 72 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients with a genetically confirmed diagnosis of MoCD Type A (MOCS1
             mutation)

          -  Currently treated with rcPMP infusions

        Exclusion Criteria:

        - Current or planned treatment with another investigational drug or device, with the
        exception rcPMP treatment through Day -1.
A Pilot Study Evaluating Nicotine Lozenges and Self Help
Condition: Smokeless Tobacco Use
Intervention: nicotine replacement therapy; placebo NRT
Intervention description: 4 mg nicotine lozenges, ad lib, for 12 weeks.; Placebo nicotine lozenges
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tobacco; chew; nrt; nicotine lozenges; self-help

Summary:

      The investigators are hypothesizing that by offering both self-help materials and mailed
      nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users,
      as well as decrease tobacco withdrawal.
    

Eligibility criteria:

        Inclusion Criteria:

          1. male;

          2. ≥18 years of age;

          3. report ST as their primary tobacco of use;

          4. have used ST daily for the past 6 months;

          5. indicate that they want to quit;

          6. have been provided with, understand, and have signed the informed consent.

        Exclusion Criteria:

          1. previously enrolled in a study involving the use of the nicotine lozenge;

          2. currently using or have completed using (past 30 days) any other behavioral or
             pharmacologic tobacco treatment program;

          3. currently enrolled in another research study;

          4. describe having a medical history of: a) unstable angina; b) myocardial infarction
             within the past 6 months; c) cardiac dysrhythmia other than medication-controlled
             atrial fibrillation or PSVT; or d) medically-treated or untreated hypertension with BP
             ≥ 180 systolic OR ≥ 100 diastolic;

          5. have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized
             to phenylalanine and not processed in individuals with PKU];

          6. have another member of their household already participating in this study;

          7. have other medical or psychiatric conditions that would exclude the participant;

          8. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call
             pre-screen.