bioihbjkbjnl/mcl2 huggingface dataset:
Gabapentin for Alcohol Relapse Prevention
Condition: Alcohol Use Disorder; Alcohol Withdrawal
MeSH terms: Alcoholism
Intervention: Gabapentin; Placebo
Intervention description: gaba potentiating medication; a pill that looks exactly like the active medication but does not contain medication
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol
      dependence will get medication, which might help them to reduce or stop their drinking, or a
      placebo ( placebo is a capsule that looks the same as the investigational drug, but has no
      real medication. It is a "sugar pill").
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meets criteria for alcohol use disorder based on DSM-5 criteria

          2. Meets criteria for history of alcohol withdrawal based on DSM-5 criteria

          3. Able to maintain abstinence for a minimum of 3 days prior to randomization as verified
             by self report, urine ETG, and breathalyzer.

        Exclusion Criteria:

          1. Significant psychiatric or medical illness

          2. No other substance abuse

          3. Taking other medications known to treat alcohol use disorder

          4. Unstable living arrangements

          5. Significant legal problems pending
Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Fluticasone; Comparator: Placebo
Intervention description: fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.; Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.
Intervention MeSH terms: Fluticasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      To test the effect of the research study drug, inhaled fluticasone on lung function in
      exercising patients with Chronic Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  40 years and older

          -  Clinical diagnosis of COPD for greater than one year

          -  History of cigarette smoking

        Exclusion Criteria:

          -  Other lung diseases (not including COPD), such as asthma

          -  A condition that could interfere with your ability to perform exercise tests
Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: cariprazine; cariprazine; placebo
Intervention description: Drug: cariprazine (0.25 - 0.75 mg/day); Drug: cariprazine (1.5 - 3.0 mg/day); placebo capsules, oral administration, once daily dosing
Intervention MeSH terms: Cariprazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: bipolar; depression

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine in the treatment of outpatients with bipolar depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-65 years old

          -  Currently meet the DSM-IV-TR criteria for Bipolar I or II Disorder without psychotic
             features, with a current depressive episode

          -  A verified previous manic, hypomanic, or mixed episode

          -  Score of 20 or higher on the HAMD-17

          -  Score of 2 or higher on Item 1 of the HAMD

        Exclusion Criteria:

          -  Score greater than 12 on the Young Mania Rating Scale

          -  Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed
             state) within the 12 months prior to Visit 1

          -  Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder
             (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety
             Disorder, or specific phobias is acceptable)
3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: 3K3A-APC Protein
Intervention description: 3K3A-APC with intravenous dosing of five doses of either 15mg or 30mg at 12 hourly interval. The first 8 patients will receive 15mg dose, and the next 8 patients will receive 30mg dose.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ALS; Amyotrophic Lateral Sclerosis; MND; Motor Neurone Disease; 3K3A-APC

Summary:

      Phase 2 open label trial to investigate the safety and potentially efficacy of 3K3A-APC in
      patients with Amyotrophic Lateral Sclerosis (ALS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have clinically definite ALS (Awaji Criteria)

          2. Male or female age 18 years and less than 75 years at time of ALS study

          3. Symptom onset less than 36 months before screening

          4. Diagnosis of ALS less than 24 months before screening

          5. Clinically definite Upper Motor Neuron signs

        Exclusion Criteria:

          1. Current treatment with anticoagulants (e.g., warfarin, novel oral anticoagulants,
             heparin) that might preclude safe completion of the lumbar puncture

          2. Condition that precludes the safe performance of routine lumbar puncture, such as
             prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant
             coagulopathy or thrombocytopenia

          3. Use of investigational drugs or devices within 60 days prior to Baseline (dietary
             supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme
             Q10)

          4. Prolonged prothrombin time or activated partial thromboplastin time >2xULN

          5. Severe hypertension or hypotension

          6. Glomerular filtration rate (GFR) <35 mL/min

          7. Forced vital capacity (FVC) at screening of <50% of predicted

          8. Prior exposure to any exogenous form of APC

          9. Inability to lie flat for procedures (MRI, PET, LP)

         10. Pregnant or lactating during the study period
A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
Condition: Lipoma
MeSH terms: Lipoma
Intervention: Collagenase Clostridium Histolyticum
Intervention description: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Lipoma; Fatty Tumor

Summary:

      The purpose of this research is to evaluate the safest and most effective dose of a Food and
      Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of
      varying sizes that occur commonly in the adult population). The fat in the lipoma is like
      normal fat except that it is enclosed in a balloon-like structure which is made of collagen
      (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks
      down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size
      of the lipoma or removing it.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical history lipoma at least one year and no treatment within last 90 days

          -  Lipoma diagnosed as benign

          -  Lipoma is a single mass with easily definable edges

          -  Lipoma has an area of 2.0 to 17 cm squared

          -  Women of childbearing potential must use an acceptable method of birth control

        Exclusion Criteria:

          -  Lipomas on the head, neck, hand or foot, or female breast

          -  Women who are nursing or pregnant

          -  Subjects who have participated in any investigational drug trial within 45 days of
             enrollment in this study

          -  Subjects with known allergy to collagenase or any of the inactive ingredients in
             XIAFLEX

          -  Subjects with diabetes or any medical condition that would make the subject unsuitable
             for enrollment.

          -  Subjects having a history of trauma in the area of the lipoma

          -  Subjects with a history of connective tissue diseases or rheumatological diseases.

          -  Subjects with uncontrolled hypertension

          -  Subjects currently receiving or planning to receive anticoagulant medication except
             for less than 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory
             drugs) within 7 days before injection of study drug

          -  Subjects having the following laboratory abnormalities:

          -  ALT/AST greater than 3 times the upper limit of normal

          -  Creatinine greater than 2

          -  Hemoglobin/hematocrit and WBC outside the normal range
Pupil Dilation for Treatment of IFIS
Condition: Intraoperative Floppy Iris Syndrome
MeSH terms: Mydriasis; Syndrome
Intervention: Brimonidine Tartrate
Intervention description: All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a single arm study in which all enrolled subjects will receive eye drops to only one eye. The alternative eye will serve as the control for efficacy.
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Adults (18 years old or greater) 3. History of having taken, or currently taking any
        systemic alpha blocker 2. Ability to consent themselves 3. Ability to apply eye drops
        themselves TID for 7 days

        Exclusion Criteria:

          1. Subjects with untreated hypertension or baseline BP >160

          2. Subjects with Thyrotoxicosis

          3. Pregnant women or women trying to conceive

          4. Prisoners

          5. Inability consent

          6. Subjects with anatomical narrow angles or who have never had a dilated eye exam

          7. Subjects currently prescribed brimonidine tartrate for glaucoma

          8. Subjects who take topical or systemic alpha agonists

          9. Patients who take monoamine oxidase (MAO) inhibitors

         10. Patients with known severe cardiovascular disease
Paracervical Block During Office Hysteroscopy
Condition: Paracervical Block
Intervention: Lidocaine paracervical block; Normal Saline
Intervention description: 5cc 1% lidocaine injection in each paracervical region; 5cc Normal Saline injection in each paracervical region
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hysteroscopy; Pain medication; Lidocaine; Office Procedures

Summary:

      The purpose of this study is to determine the effectiveness of paracervical block for pain
      relief in office hysteroscopy - particularly with the placement of the Essure device.
      Subjects will be randomized to receive either paracervical block or saline, and will have
      pain assessments performed throughout the procedure. Subjects and physicians will be blinded
      to group assignments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women eligible and scheduled for office hysteroscopic placement of essure devices

        Exclusion Criteria:

          -  Planned secondary procedures

          -  Lidocaine allergy

          -  Repeat procedures
Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myelomonocytic, Juvenile
Intervention: Etanercept
Intervention description: 0.8 mg/kg Subcutaneously Once A Week for 90 Days
Intervention MeSH terms: Etanercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Juvenile Myelomonocytic Leukemia; JMML; Leukemia; Etanercept; Enbrel

Summary:

      Primary Objectives:

      1.1 Estimate rate of response and define acute toxicity to etanercept used in an up-front
      phase II window in newly diagnosed or relapsed JMML.

      1.2 Determine if response to Tumor Necrosis Factor (TNF) blockade correlates with genetic
      basis of Juvenile Myelomonocytic Leukemia (JMML) [mutations in NF1, Ras, SHP2] or levels of
      TNFa.

      1.3 Determine if TNF blockade by etanercept results in inhibition of free levels of TNFa and
      other cytokines by ELISA and bioassay and improves blood counts.

      1.4 Estimate the two year event free survival and overall survival in JMML patients following
      etanercept and allogeneic hematopoietic stem cell transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All children greater than 6 months of age and less than 18 years of age with
             newly-diagnosed previously untreated or previously diagnosed JMML, which has
             reoccurred after treatment with chemotherapy, stem cell transplantation, and/or
             cis-retinoic acid.

          2. A diagnosis of JMML is confirmed only if the following criteria for JMML are met: a)
             ALL of the following: Absence of t(9;22) or BCR-ABL by PCR or FISH; Absolute monocyte
             count >1000 (1 X 109/µL); <20% bone marrow blasts; b) At least 2 of the following:
             Elevated Hb F hemoglobin; Myeloid precursors in peripheral blood; WBC >10,000 (10 X
             109/µL); GM-CSF hypersensitivity in methylcellulose culture of bone marrow progenitors
             cells.

          3. Adequate hepatic function (bilirubin equal or less than 2.0 mg/dl; ALT equal or less
             than 3x normal)

          4. Adequate renal function (serum creatinine equal or less than 2 x normal)

          5. Performance Status: Have a Karnofsky score >50.

          6. Written, informed consent according to institution guidelines.

        Exclusion Criteria:

          1. Pregnant or lactating.

          2. Receiving any other chemotherapy. Patients must have been off chemotherapy for at
             least 2 weeks and must have recovered from acute toxicity of all previous therapy
             prior to enrollment.

          3. Febrile neutropenia at study entry.
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mirikizumab; Placebo
Intervention MeSH terms: Mirikizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: IL-23 antibody

Summary:

      The main purpose of this study is to test the hypothesis that treatment with mirikizumab is
      superior to placebo in providing clinical benefit to participants with moderate to severe
      ulcerative colitis (UC). This study will also investigate how the body processes the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an
             endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note:
             a partial Mayo score of at least 4 and other eligibility criteria must have been met
             before endoscopy is performed as a study procedure)

          -  Have evidence of UC extending proximal to the rectum (≥15 centimeters [cm] of involved
             colon)

          -  Up-to-date colorectal cancer surveillance (performed according to local standard), for
             subjects with family history of colorectal cancer, personal history of increased
             colorectal cancer risk, age >50 years, or other known risk factor

          -  Participants must either: be naive to biologic therapy (eg, tumor necrosis factor
             [TNF] antagonists or vedolizumab) and have at least 1 of the following: inadequate
             response or failure to tolerate current treatment with oral or intravenous
             corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of
             corticosteroid dependence (an inability to successfully taper corticosteroids without
             return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF
             antagonists or vedolizumab) at doses approved for the treatment of UC with documented
             history of failure to respond to or tolerate such treatment

        Exclusion Criteria:

          -  Have been diagnosed with indeterminate colitis, proctitis (distal disease involving
             the rectum only; less than 15 cm from the anal verge) or Crohn's Disease

          -  Have had surgery for treatment of UC or are likely to require surgery for UC during
             the study

          -  Have received any of the following for treatment of UC: cyclosporine or thalidomide
             within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or
             topical treatment with 5-aminosalicyclic acid within 30 days of screening
A Study To Evaluate The Efficacy And Safety of The Investigational Drug PF-03446962 (A Monoclonal Antibody With Antiangiogenic Features) In Combination With Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients Affected By Recurrent Liver Cancer
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: PF-03446962; Best Supportive Care; Placebo; Best Supportive Care
Intervention description: PF 03446962 7 mg/kg, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first; BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life; Placebo will consist of Saline (0.9% w/v Sodium Chloride Injection, USP or NS); BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatocellular carcinoma; monoclonal antibody; ALK-1; best supportive care

Summary:

      The primary purpose of the study is to explore whether treatment with PF-03446962 and best
      supportive care is better than placebo plus best supportive care in prolonging survival of
      patients affected by recurrent liver cancer. In addition, the study will explore if adding
      PF-03446962 to best supportive care is safe, how PF-03446962 is metabolized, if there are
      patients' characteristics (biomarkers) that may predict response to PF-03446962, and if
      PF-03446962 has any effect on the patients' quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of locally advanced or metastatic liver cancer obtained by
             histology/cytology or by imaging

          -  Documented progression on or after treatment with sorafenib, confirmed by the
             Investigator upon review of appropriate imaging documentation

          -  Child Pugh Class A disease

          -  ECOG [Eastern Cooperative Oncology Group] Performance Status (PS) 0 or 1

          -  Mandatory tumor biopsy at study entry (pre-randomization, unless already collected
             after sorafenib progression but within 3 months of enrollment and no systemic
             anticancer therapies received)

        Exclusion Criteria:

          -  Prior systemic treatment for advanced liver cancer other than sorafenib-including
             therapy

          -  Prior local therapy within 2 weeks of starting the study treatment

          -  Presence of main portal vein invasion by liver cancer
Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
Condition: Gastroduodenal Ulceration
MeSH terms: Ulcer
Intervention: PL2200; Aspirin tablets
Intervention description: PL2200, containing 325 mg aspirin active ingredient; 325 mg aspirin tablets (USP)
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 247.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteer; comparison of incidence of; treatment groups.

Summary:

      This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury
      after the oral administration of an investigational product, PL2200, and a marketed 325 mg
      immediate-release aspirin product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers, ≥50 and ≤75 years of age.

          -  No endoscopically observed baseline gastrointestinal lesions.

        Exclusion Criteria:

          -  Baseline gastrointestinal lesions or abnormal screening/baseline laboratory parameters
             deemed clinically significant by the Investigator.

          -  Significant history of substance abuse or uncontrolled acute or chronic medical
             illness.

          -  Active H. pylori infection.

          -  Current use of low-dose aspirin for cardioprevention, or other ulcerogenic
             medications, gastroprotective, or anti-platelet agents.

          -  Hypersensitivity to aspirin or other NSAIDs.