bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Quetiapine on Marijuana Withdrawal and Relapse
Condition: Marijuana Smoking
MeSH terms: Marijuana Abuse; Marijuana Use
Intervention: Marijuana; Quetiapine; Placebo oral capsule
Intervention description: 0,6.2% THC; 200 mg/day
Intervention MeSH terms: Riboflavin; Quetiapine Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: quetiapine; smoked marijuana; marijuana use

Summary:

      The objective of this study is to investigate the interaction between marijuana and
      quetiapine, with the goal of using this information to improve marijuana treatment outcome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current marijuana use:average of 2 marijuana cigarettes per day at least 4 times per
             week for the past 4 weeks

          -  Able to perform study procedures

          -  21-45 years of age

          -  Women practicing an effective form of birth control (condoms, diaphragm, birth
             control, pill, IUD)

          -  Normal body weight

        Exclusion Criteria:

          -  Current, repeated illicit drug use (other than marijuana)

          -  Presence of significant medical illness (e.g., diabetes, cardiovascular disease,
             hypertension, clinically significant abnormalities)

          -  History of heart disease or current conduction system disease as indicated by QRS
             duration > 0.11

          -  Request for drug treatment

          -  Current parole or probation

          -  Pregnancy or current lactation

          -  Recent history of significant violent behavior

          -  Major current Axis I psychopathology (major depressive disorder, bipolar disorder,
             suicide risk, schizophrenia)

          -  Current use of any prescription or over-the-counter medication

          -  Prior allergic or otherwise serious adverse reaction to quetiapine
Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923)
Condition: Leukemia
MeSH terms: Leukemia
Intervention: Dasatinib; BMS-833923
Intervention description: Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response; Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelogenous; Chronic; BCR-ABL Positive

Summary:

      The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP)
      CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥ 18 years of age who have signed informed consent

          -  Philadelphia positive Chronic Myeloid Leukemia (CML) in chronic phase

          -  Previously untreated chronic phase CML, except for Anagrelide or Hydroxyurea.

          -  Eastern Co-Operative Group (ECOG) Performance Status (PS) Score 0 - 2

        Exclusion Criteria:

          -  Known Abl-kinase T315I or T315A mutation

          -  Serious or uncontrolled medical disorder (including infection or cardiovascular
             disease) or dementia or other serious psychiatric condition

          -  Prior chemotherapy.

          -  Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP)
             who are unwilling or unable to use an acceptable method to avoid pregnancy during the
             entire study period.
A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK8245 5 mg (twice a day) b.i.d.; MK8245 50 mg b.i.d.; Placebo
Intervention description: All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.
Patients randomized to the 5 mg b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.; All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.
Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.; All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.
Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have Type 2 Diabetes Mellitus

          -  18 to 65 years of age

        Exclusion Criteria:

          -  History of Type 1 Diabetes or ketoacidosis

          -  Have been treated with lipid lowering medications 4 weeks before starting the study

          -  Have started on a weight loss program and not in the maintenance phase or have started
             weight loss medication within the last 12 weeks

          -  Have had surgery in the last 30 days

          -  History of active liver disease

          -  History of coronary heart disease or congestive heart failure

          -  Have had a stroke or transient ischemic neurological disorder in the past 6 months

          -  Are Human Immunodeficiency Virus (HIV) Positive
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis
Condition: Lupus Arthritis
MeSH terms: Arthritis; Lupus Erythematosus, Systemic
Intervention: Laquinimod; Placebo
Intervention description: Laquinimod will be administered per dose and schedule specified in the arm description.; Placebo matching to laquinimod will be administered per schedule specified in the arm description.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus (SLE); Lupus Arthritis; Laquinimod

Summary:

      The study aims to evaluate the safety and clinical effect of daily oral treatment with
      laquinimod capsules (0.5 milligrams [mg] and 1 mg) in participants with active lupus
      arthritis. Laquinimod is a novel immunomodulating drug which is currently in advanced stages
      of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with SLE.

          -  Participants with active lupus arthritis as evident by at least 4 tender and 4 swollen
             joints at screening and baseline visits, and moderate or severe arthritis with active
             synovitis in at least 1 joint, with some loss of functional range of movement present
             at screening and baseline visits.

        Exclusion Criteria:

          -  The participant's estimated glomerular filtration rate (eGFR) was less than or equal
             to 30 milliliters (mL)/minute/1.73 square meter (m^2), as calculated by the
             Modification of Diet in Renal Disease (MDRD) formula at the screening visit.

          -  Participants with severe, unstable and/or progressive central nervous system (CNS)
             lupus and/or associated with significant cognitive impairment (upon the investigators'
             judgement).

          -  Participants with a clinically significant or unstable medical or surgical condition
             that, in the investigator's opinion, would preclude safe and complete study
             participation.

          -  Women who are pregnant or nursing or who intend to be during the study period.

          -  Women of child-bearing potential who do not practice an acceptable method of birth
             control.
Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses
Condition: Abdominal Abscess; Pelvic Abscess
MeSH terms: Abscess; Abdominal Abscess
Intervention: Alteplase; saline
Intervention description: 2mg or 4mg given twice daily for three days into loculated abscess; saline injection twice daily for three days
Intervention MeSH terms: Tissue Plasminogen Activator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will
      reduce the duration of percutaneous drainage and increase the proportion of successful
      drainages.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study.

          -  Age > 18 years

          -  Adult, non-gravid patients with loculated abdominopelvic abscesses immediately after
             percutaneous drainage will be eligible to participate. A loculated abscess is defined
             as an abscess whose contents cannot be completely drained at the time of initial
             catheter placement as documented on CT.

        Exclusion Criteria:

          -  Active internal bleeding, involving intracranial and retroperitoneal sites, or the
             gastrointestinal, genitourinary, or respiratory tracts

          -  History of stroke within 6 months

          -  Uncorrectable bleeding diathesis (INR > 1.3 despite therapy)

          -  Recent intracranial or intraspinal surgery or trauma

          -  Pregnancy (positive pregnancy test)

          -  Pancreatic abscesses

          -  Any other condition that the investigator believes would pose a significant hazard to
             the subject if the investigational therapy were initiated

          -  Participation in another simultaneous medical investigation or trial

          -  Participation in another clinical investigation within previous 30 days of catheter
             placement

          -  Prior enrollment in the study

          -  Known allergy to Alteplase or any of its components
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
Condition: Choroidal Melanoma
MeSH terms: Melanoma
Intervention: Ranibizumab 2 mg; 0.5 mg Ranibizumab
Intervention description: intravitreal injections of ranibizumab once a month, times 3.; 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 10.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Choroidal melanoma; Ranibizumab; Transpupillary Thermotherapy; CSTIP; Indocyanine Green

Summary:

      Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients
      with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help
      reduce the number of laser treatments that might be needed to control the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the
             largest basal diameter and 6 mm or less in the apical height.

          -  Location of the tumor, posterior to the equator of the eye.

          -  Documented growth of tumor by A-B scan.

          -  Ability to provide written informed consent and comply with the study assessment for
             the full duration of the study.

        Exclusion Criteria:

          -  Pregnancy or lactation.

          -  Premenopausal women not using adequate contraception.

          -  Current infection or inflammation in either eye.

          -  Extension of tumor into the orbit.

          -  Regional spread or metastatic disease.

          -  Any other condition that the investigator believes would pose a significant hazard to
             the subject if the investigational therapy were initiated.

          -  Any known allergy to any of the components to be used in the study.

          -  Participation in another simultaneous medical investigation or trial.
Pegylated Interferon Lambda Treatment for COVID-19
Condition: COVID-19; COVID
MeSH terms: COVID-19
Intervention: Pegylated interferon lambda
Intervention description: 180 mcg subcutaneous injection of pegylated interferon lambda
Intervention MeSH terms: Interferons
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Single blind
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID; Coronavirus

Summary:

      Prospective randomized trial to assess the antiviral efficacy of Pegylated Interferon Lambda
      (180 mcg SC injection) vs.placebo in up to 20 subjects with COVID-19 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent

          -  Confirmed COVID-19 diagnosis based on PCR analysis of respiratory secretions

          -  Positive SARS-CoV-2 RT-PCR test must be within 48 hours of randomization

        Exclusion Criteria:

          -  Clinically-significant illness or any other major medical disorder that in the opinion
             of the investigator, may interfere with subject treatment, assessment or compliance
             with the protocol

          -  Treatment with IFN or other immunomodulatory/immunosuppressive agent within 12 months
             before screening.

          -  Respiratory compromise requiring ventilatory support other than nasal cannula (mask,
             bipap or intubation and mechanical ventilation)

          -  History of treatment with any of the following medications within five half-lives or
             30 days before administration of the study drug (whichever is longer): anti-IL-6,
             anti-IL6R antagonists, Janus kinase inhibitors, ustekinumab (anti-IL-12/23), or anti
             IL-23 agents (guselkumab).

          -  Life threatening SAE during the screening period

          -  Pregnant or Nursing Females

          -  Platelet count <90,000 cells/mm3

          -  WBC count <3,000 cells/mm3

          -  ANC <1,500 cells/mm3

          -  Hb <11 g/dL for women and <12 g/dL for men

          -  CrCl < 50 mL/min

          -  Bilirubin level ≥ 1.5x ULN

          -  INR ≥1.5 (except in the setting of concomitant anticoagulant use)

          -  CRP > 200 mg/L

          -  Clinically-relevant alcohol or drug abuse within 12 months of screening

          -  Known hypersensitivity to Interferons

          -  Current or planned participation in an investigational new drug (IND) trial from
             30-days prior to randomization through Day 14 post treatment
Study of Thymosin Beta 4 in Patients With Pressure Ulcers
Condition: Pressure Ulcers
MeSH terms: Pressure Ulcer; Ulcer
Intervention: Placebo; Thymosin Beta 4
Intervention description: Topical administration of 0.00% thymosin beta 4 qd up to 84 days; Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: pressure ulcers; cutaneous wound- healing; chronic wound-healing; Thymosin Beta 4; laminin-5

Summary:

      The purpose of this study is to evaluate the safety, tolerability and effectiveness of
      Thymosin Beta 4 administered topically in patients with Pressure Ulcers
    

Eligibility criteria:

        Inclusion criteria:

          -  Informed Consent Form signed by the patient or patient's legal representative

          -  Inpatients and outpatients

          -  At least 1 PU with full-thickness skin loss and no joint capsule or bone exposure

          -  Surface area between 5 and 70 cm2

          -  Ulcer present and stable for at least 1 month before enrollment

        Exclusion Criteria:

          -  Use of any experimental drug, or participation in any clinical study, within the 60
             days before enrollment

          -  Use of immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment.
             Systemic steroids not allowed 30 days prior to enrollment. Topical therapy other than
             steroidal is allowed up to 7 days prior to enrollment

          -  History of adverse events to any ingredients of study medication

          -  Neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely
             to interfere with the patient's participation in or completion of the study

          -  Arterial or venous disorder resulting in ulcerated wounds

          -  Diabetes mellitus except if disease is determined to be under control with a
             glycosylated hemoglobin ≤8.5% of total hemoglobin

          -  Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed
             at Screening for female patients of childbearing potential.)
Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
Condition: Internal Hemorrhoids
MeSH terms: Hemorrhoids
Intervention: Hydrocortisone Acetate Suppository, 25 mg (Nivagen); Placebo (Vehicle) Suppository (Nivagen)
Intervention description: One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).; One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A randomized, double-blind, placebo-controlled, multicenter, parallel group study of the
      safety and efficacy of Hydrocortisone Acetate Suppositories, 25 mg compared to placebo
      suppositories in the treatment of symptomatic internal hemorrhoids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  internal hemorrhoids.

          -  hemorrhoidal bleeding.

          -  male or female aged 18 years and older.

          -  willing to forego the use of non-prescription (OTC) and prescription medication or
             procedures for the treatment of hemorrhoidal disease and/or pain for the duration of
             the study.

          -  agree to not change their diet during the study.

        Exclusion Criteria:

          -  external hemorrhoids.

          -  using other OTC or prescription medications for treatment of hemorrhoidal disease
             and/or pain.

          -  pregnant or nursing female.

          -  received systemic glucocorticoids within the last 2 months prior to starting study.

          -  participated in an investigational drug study within 30 days prior to baseline.
Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Brazikumab IV Infusion; Brazikumab SC Injection; Placebo
Intervention description: Brazikumab IV infusion as per protocol specified dosing schedule.; Brazikumab IV infusion as per protocol specified dosing schedule.; Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: MEDI2070; inflammatory bowel disease; moderate to severe Crohn's Disease; IL-23

Summary:

      A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants
      with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor
      necrosis factor-alpha (anti-TNFα) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior
             to screening

          -  Men or women age 18 - 80 years at the time of screening

          -  Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI)
             and endoscopic demonstration of inflammation

          -  Stable dose of medications for Crohn's disease therapy

          -  Prior treatment failure or intolerance with at least one Anti-Tumor Necrosis
             Factor-Alpha Therapy (anti-TNF α) agent

          -  Effective contraception from screening, and for 36 weeks after the last dose of
             investigational product

          -  No known history of active tuberculosis (TB) & negative assessment for TB/latent TB

        Exclusion Criteria:

          -  Severe underlying immunosuppression

          -  Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing
             strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel
             perforation

          -  Significant infections at screening; Infected abscess, positive for Clostridium
             difficile, recent infectious hospitalization

          -  Recent treatment with approved or investigational biologic therapy for Crohn's disease

          -  Recent or planned live attenuated vaccine

          -  History of cancer, except for basal cell carcinoma or carcinoma in situ (CIS) of the
             cervix with apparent cure ≥ 12 months before screening

          -  Pregnancy/breast feeding

          -  Drug abuse