bioihbjkbjnl/mcl2 huggingface dataset:
Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD)
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Intervention: PF 04457845; Placebo Oral Tablet
Intervention description: Study medication will be administered at 4mg by mouth daily for eight weeks.; Placebo comparator will be administered by mouth daily for eight weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2B
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      A Phase 2B, 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to
      Evaluate the Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH)
      Inhibitor PF-04457845 in Adults with DSM-5 Current Cannabis Use Disorder (CUD)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages 18-60 years, inclusive.

          2. Male or Female.

          3. Individuals with DSM-V criteria for Cannabis Use Disorder .

          4. Positive for urinary THC-COOH at both screening visits.

          5. Must express a willingness at screening to set a date within the first week of
             randomization to attempt to quit using cannabis.

        Exclusion Criteria:

          1. Clinically significant unstable medical disorders (as determined by the site
             investigator).

          2. Laboratory tests with clinically significant abnormalities (as determined by the site
             investigator)

          3. Pregnancy by history and or laboratory confirmation (serum HCG).

          4. Lactation.

          5. Physiological dependence on another substance.
Effects of Cholinergic Augmentation on Measures of Balance and Gait
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Donepezil
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      This study will compare the effects of placebo and donepezil, a drug that helps conserve
      concentrations of the neurotransmitter, acetylcholine, on measures of balance and gait in
      subjects with Parkinson's disease (PD). This study is a double-blind, placebo controlled,
      cross-over randomized clinical trial. Short-latency afferent inhibition (SAI), a
      physiological index of cholinergic function will be measured to determine if the deficits in
      balance and gait correlate with abnormalities of the SAI and if SAI is altered by donepezil
      as a measure of drug efficacy. Cognitive tests like the Attention Network Test (ANT) will be
      administered to determine if changes in gait and balance are mediated by changes in
      attention.

      The results of this study will be the most direct test of the hypothesized role of
      cholinergic neurons and the neurotransmitter, acetylcholine in terms of gait and balance. The
      study is exploratory because it is not known whether donepezil will affect gait, balance or
      attention, nor which measures of gait, balance or attention will be sensitive to drug
      manipulation. The study's immediate goal is to determine the potential utility of cholinergic
      manipulation as a strategy for preventing or treating balance and gait dysfunction in PD. The
      findings of this trial are intended to lead to more sharply focused questions about the role
      of cholinergic neurons in balance and gait and eventually to Phase II B trials to determine
      clinical utility of cholinergic manipulation to prevent falls and improve mobility.
    

Eligibility criteria:

        Inclusion Criteria:

          -  30 years old or older

          -  Diagnosis of idiopathic Parkinson's disease

          -  Stand unassisted (without use of an assistance device) and walk continuously for at
             least 2 minutes.

        Exclusion Criteria:

          -  musculoskeletal disorders that affect standing and walking

          -  Uncorrected vision disturbance

          -  Vestibular problems

          -  Major depression

          -  Hallucinations or other psychiatric disturbances

          -  Tachycardia

          -  Bradycardia

          -  Arrhythmias

          -  Peptic ulcer disease

          -  Use of anticholinergics

          -  Use of cholinesterase inhibitors

          -  Use of bladder antispasmodics

          -  Use of tricyclic antidepressants
PF-06741086 Multiple Dose Study in Severe Hemophilia
Condition: Hemophilia A or B
MeSH terms: Hemophilia A
Intervention: PF-06741086; PF-06741086; PF-06741086; PF-06741086
Intervention description: PF-06741086 subcutaneous (SC) injection; PF-06741086 SC injection; PF-06741086 SC injection; PF-06741086 SC injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Male
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: hemophilia

Summary:

      This study is designed to evaluate the safety, tolerability, pharmacokinetics,
      pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of
      PF-06741086 in subjects with severe hemophilia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe hemophilia A or B (Factor VIII or Factor IX activity ≤ 1%), including patients
             with inhibitors to Factor VIII or Factor IX

          -  Episodic (on-demand) treatment regimen prior to screening

          -  At least 6 acute bleeding episodes during the 6-month period prior to screening

        Exclusion Criteria:

          -  Known coronary artery, thrombotic, or ischemic disease

          -  Currently receiving treatment for acute bleeding episodes with APCC and cannot
             substitute treatment with rFVIIa
A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: GLPG1690
Intervention description: film-coated tablets of GLPG1690 to be administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study was the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The
      main purpose of the study was to see how GLPG1690 was tolerated in participants with systemic
      sclerosis and whether there were any side effects in a long-term treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants who completed the 24-week treatment period of Study
             GLPG1690-CL-204 and who according to the investigator's judgment may benefit from
             long-term treatment with GLPG1690.

        Exclusion Criteria:

          -  Any condition or circumstances that, in the opinion of the investigator, may make a
             participant unlikely or unable to complete the study or comply with study procedures
             and requirements.
Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
Condition: Chronic Myelogenous Leukemia; Chronic Myeloid Leukemia; Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Intervention: Dasatinib; Imatinib Mesylate; Nilotinib
Intervention description: Given orally; Given orally; Given orally
Intervention MeSH terms: Imatinib Mesylate; Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well dasatinib, nilotinib, and imatinib mesylate works in
      treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in
      which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature
      blood cells) (chronic phase). Dasatinib, nilotinib, and imatinib mesylate may stop the growth
      of cancer cells by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed, previously untreated chronic phase chronic myeloid leukemia (CP-CML)
             (by World Health Organization [WHO] definition) (hydroxyurea permitted up to 7 days
             prior to enrollment)

          -  Clinically significant gastrointestinal disease, digestive dysfunction, or surgery
             that would compromise absorption of oral administration of medications

          -  Able to give written informed consent and comply with all study visits and procedures

        Exclusion Criteria:

          -  Chronic myeloid leukemia (CML) in AP or BP

          -  Unable to receive TKI for insurance reasons (uninsurable)

          -  Refuse or unable to perform telephone or video conferences with research coordinator

          -  Subjects who are pregnant, breast feeding or sexually active and unwilling to use
             effective birth control while on treatment with TKI

          -  Any medical or psychological condition that, in the opinion of the investigator, might
             interfere with the subject's participation in the trial, poses any additional risk for
             the subject, or confounds the assessment of the subject
Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Tamoxifen; Vorinostat; Antiretroviral drugs
Intervention description: 20 mg orally; 400 mg orally; Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.
Intervention MeSH terms: Tamoxifen; Anti-Retroviral Agents; Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study evaluated the effects of tamoxifen exposure in combination with vorinostat on
      viral reactivation among HIV-1 infected post-menopausal women with virologic suppression on
      antiretroviral therapy (ART), when compared to vorinostat alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infection

          -  Postmenopausal at study entry with agreement not to participate in assisted
             reproductive technology in the future.

          -  CD4+ cell count greater than 300 cells/uL obtained within 90 days prior to study
             entry.

          -  Continuous antiretroviral therapy (ART) for at least 2 years prior to enrollment with
             no known interruption in therapy for greater than 7 days within 90 days prior to study
             entry.

          -  Plasma HIV-1 RNA level of less than 20 copies/mL obtained by Roche HIV-1 viral load
             assay or less than 40 copies/mL obtained by the Abbott assay, within 90 days prior to
             study entry.

          -  Ability and willingness of potential participant to provide written informed consent.

        Exclusion Criteria:

          -  History of venous thromboembolism.

          -  History of stroke.

          -  Known history of hypercoagulable state.

          -  Tobacco smoking or e-cigarette use within 90 days prior to study entry.

          -  History of any malignancy requiring systemic chemotherapy or systemic immunotherapy.

          -  History of endometrial or breast cancer or known genetic testing with BRCA positive
             results indicating an increased risk for breast and ovarian cancer.

          -  Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine,
             or investigational therapy within 60 days prior to study entry.

          -  Any systemic hormonal therapy defined as oral or injectable contraceptives, estrogen
             and combined estrogen-progesterone replacement therapy in the prior 12 months, or a
             hormone containing intrauterine device (IUD) within 6 months prior to study entry.

          -  Known allergy/sensitivity or any hypersensitivity to components of study drugs or
             their formulations.
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
An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis
Condition: Endometriosis, Pain
MeSH terms: Endometriosis
Intervention: Elagolix; placebo
Intervention description: Elagolix tablets administered orally; Placebo tablet administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: bone mineral density; Pelvic Pain; estradiol; NBI-56418

Summary:

      This study is designed to see how elagolix works compared to placebo in women with
      endometriosis and to see the effect, if any, on bone mineral density.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be female, aged 18 to 49 years, inclusive

          -  Have moderate to severe pelvic pain due to endometriosis

          -  Have been surgically (laparoscopy) diagnosed with endometriosis within the last 8
             years and have recurrent or persistent endometriosis symptoms

          -  Have regular menstrual cycle

          -  Have a body mass index (BMI) of 18 to 36 kg/m², inclusive

          -  Agree to use two forms of non-hormonal contraception during the study

        Exclusion Criteria:

          -  Are currently receiving gonadotropin-releasing hormone (GnRH) agonist or GnRH
             antagonist or have received any of these agents within 6 months of the start of
             screening

          -  Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or
             intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these
             agents within 3 months of the start of screening

          -  Are currently using hormonal contraception or other forms of hormonal therapy or
             received such treatment within the last month

          -  Have had surgery for endometriosis within the last month

          -  Have had a hysterectomy or bilateral oophorectomy

          -  Are using systemic steroids on a chronic or regular basis within 3 months

          -  Have uterine fibroids ≥ 3 cm in diameter

          -  Have pelvic pain that is not caused by endometriosis

          -  Have unstable medical condition or chronic disease

          -  Have been pregnant within the last six months

          -  Currently breast feeding
Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Pembrolizumab; Ibrutinib
Intervention description: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.; Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphocytic; Leukemia; CLL; Blood disease; White blood cells; Bone marrow disease; Immunotherapy

Summary:

      The purpose of this study is to evaluate the impact of sequential overlapping treatment with
      PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous
      immune function in previously untreated, high-risk CLL patients. Immune function will be
      evaluated through various laboratory correlative tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have high risk CLL

          -  Have documented previously untreated CLL according to IWCLL criteria

          -  Willing and able to provide written informed consent

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Demonstrate adequate organ function

          -  Able to take oral medication and willing to adhere to the medication regimen

        Exclusion Criteria:

          -  Currently participating in or has participated in a study of an investigational agent
             or using an investigational device within 4 weeks of the first dose of treatment

          -  Meets IWCLL criteria to start therapy

          -  Has had any treatment for CLL including any investigational agent, chemotherapy, mAb,
             anti-PD-1, anti-PDL-1, or anti-CTLA-4

          -  Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic
             leukemia)

          -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the
             projected duration of the trial, starting with the pre-screening or screening visit
             through 90 days after the last dose of trial treatment

          -  Major surgery or a wound that has not fully healed within 4 weeks of first dose

          -  Additional criteria may apply
Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Bepotastine besilate formulation; Fluticasone propionate; Bepotastine besilate-fluticasone propionate; Placebo Comparator
Intervention description: Nasal Spray; Nasal Spray; Nasal Spray; Nasal Spray
Intervention MeSH terms: Fluticasone; Xhance; Bepotastine besilate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 606.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a clinical study to evaluate the safety and efficacy of a bepotastine
      besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic
      rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of
      Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from
      baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom
      scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination
      nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared
      to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in
      screening period dosing with placebo nasal spray and then a 14-day treatment period where
      subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective
      and instantaneous scores for both nasal and ocular symptoms prior to each dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 12 years of age with a demonstrated history of Mountain Cedar
             pollen allergy

        Exclusion Criteria:

          -  No active nasal infection or nasal abnormality that would affect subject safety or
             symptom assessments