bioihbjkbjnl/mcl2 huggingface dataset:
New Medication Treatment for Stimulant Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Ondansetron; Placebo
Intervention description: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy; twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Intervention MeSH terms: Ondansetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cocaine dependence; cocaine abuse; cocaine; crack

Summary:

      This study will evaluate the efficacy of ondansetron compared with placebo in the treatment
      of cocaine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females who have given written informed consent.

          -  Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg.

          -  Good physical health as determined by a complete physical examination, an EKG within
             normal limits, and laboratory screening tests within acceptable parameters.

          -  Current DSM-IV diagnosis of cocaine dependence.

          -  At least one positive urine drug screen for cocaine at screen or baseline prior to
             randomization.

          -  The pregnancy test for females at intake must be negative.

          -  Literacy in English and ability to read, understand, and complete the ratings scales
             and questionnaires accurately, follow instructions, and make use of the behavioral
             treatments.

          -  Answered an advertisement in the newspaper/radio/television, and expressing a wish to
             stop using cocaine.

          -  Willing to participate in behavioral treatments for cocaine dependence.

        Exclusion Criteria:

        Please contact site for additional information
Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: OC-01 0.1% 0.6 mg/ml; OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml); placebo comparator
Intervention description: OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml); OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml); vehicle control
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the chronic safety and effectiveness of OC-01
      Nasal Spray as compared to placebo on signs of dry eye disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have used and/or desired to us an artificial tear substitute for dry eye symptoms
             within 6 months prior to Visit 1

        Exclusion Criteria:

          -  Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such
             as blepharoplasty) in either eye within three months or refractive surgery (e.g.
             laser-assisted in-situ keratomileusis, laser epithelial keratomileusis,
             photorefractive keratectomy or corneal implant) within twelve months of Visit 1

          -  Have a history or presence of an ocular disorder or condition in either eye that
             would, in the opinion of the Investigator, likely interfere with the interpretation of
             the study results or participant safety such as significant corneal or conjunctival
             scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis,
             or inflammation not associated with dry eye; anterior (epithelial) basement membrane
             corneal dystrophy or other clinically significant corneal dystrophy or degeneration;
             ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring
             treatment and mild meibomian gland disease that are typically associated with DED are
             allowed.

          -  Have a systemic condition or disease not stabilized or judged by the Investigator to
             be incompatible with participation in the study or with the lengthier assessments
             required by the study (e.g., current systemic infection, uncontrolled autoimmune
             disease, uncontrolled immunodeficiency disease, history of myocardial infarction or
             heart disease, etc.)

          -  Have a known hypersensitivity to any of the procedural agents or study drug components

          -  Have any condition or history that, in the opinion of the investigator, may interfere
             with study compliance, outcome measures, safety parameters, and/or the general medical
             condition of the subject
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ALX-0061; Placebo; Tocilizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is:

      - To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered
      subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).

      The secondary objectives of this study are:

        -  To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK),
           pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose
           regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical
           development.

        -  To obtain parallel descriptive information concerning the efficacy and safety of
           tocilizumab (TCZ) s.c. in the same clinical trial RA population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR)
             classification criteria) for at least 6 months prior to screening, and ACR functional
             class I-III.

          -  Received previous or current treatment with methotrexate (MTX), and is considered
             intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has
             contraindications for MTX use.

          -  Subjects must not have received MTX for at least 4 weeks before first administration
             of the study drug.

          -  Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the
             time of screening and baseline

          -  Others as defined in the protocol

        Exclusion Criteria:

          -  Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic
             immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine,
             chloroquine, or leflunomide (except when an adequate wash-out procedure for
             leflunomide was completed), prior to first administration of study drug.

          -  Have received approved or investigational biological or targeted synthetic DMARD
             therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept,
             rituximab, or Janus kinase [JAK]-inhibitors) less than 6 months prior to screening.

          -  Have a history of toxicity, non-tolerance, primary non-response or inadequate response
             to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for
             RA.

          -  Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.

          -  Others as defined in the protocol.
A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo Cream; Ruxolitinib Phosphate
Intervention description: Cream with no active drug; Ruxolitinib phosphate cream
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study was double-blind, randomized, vehicle-controlled study with application of
      Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis
      applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups
      anticipated to have 50 participants in each.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plaque psoriasis involving up to 2 to 20% Body Surface Area

        Exclusion Criteria:

          -  Lesions solely involving intertriginous areas, the scalp or the face

          -  Systemic therapy for their psoriasis

          -  Pustular psoriasis or erythroderma

          -  Currently on other topical agents or Ultraviolet B (UVB) therapy within 2 weeks of the
             first dose of study medication

          -  Started or discontinued therapy within 2 months of Screening with agents that can
             exacerbate psoriasis

          -  Receiving systemic triazole antifungals except fluconazole
Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Albuminuria
Intervention: TMX-049; Placebo
Intervention description: A certain dose of TMX-049 to be taken orally, once daily; Matching placebo to be taken orally, once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Kidney Disease; XO inhibitor; UACR

Summary:

      The primary objective of this study is to assess the effect of 2 dose levels of TMX-049 on
      urinary albumin excretion in subjects with Type 2 diabetes and albuminuria (a urinary
      albumin-to-creatinine ratio (UACR) 200 to 3000 mg/g and an estimated glomerular filtration
      rate (eGFR) ≥30 ml/min/1.73m2). Effects of each TMX-049 dose on UACR will be assessed in
      terms of ratios using log-transformed UACR at Baseline and after a 12-week period of
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes treated with ≥1 glucose-lowering medication for at least 12 months

          -  UACR 200 to 3000 mg/g

          -  eGFR ≥30 ml/min/1.73m2

          -  Treated with at least the minimal recommended dose of an angiotensin converting enzyme
             inhibitor (ACEI) or an angiotensin II receptor blocker (ARB), but not both

        Exclusion Criteria:

          -  History of Type 1 diabetes

          -  Women who are breast feeding

          -  Treatment with any uric acid-lowering therapy within previous 2 weeks

          -  History of intolerance to any XO (xanthine oxidase) inhibitor

          -  History of a gout flare requiring pharmacologic treatment

          -  History or presence of tophaceous gout

          -  History of immunosuppressant treatment for any known or suspected renal disorder

          -  History of a non-diabetic form of renal disease

          -  Glycosylated hemoglobin (HbA1c) >11%

          -  sUA <4.0 mg/dL or >10.0 mg/dL

          -  Positive urinary pregnancy test

          -  Dialysis for acute renal failure within previous 6 months

          -  Renal allograft in place or a scheduled kidney transplant within the next 22 weeks

          -  Congenital or acquired solitary kidney
Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.
Condition: Plasmodium Falciparum
MeSH terms: Malaria
Intervention: RTS, S/AS01B; RTS, S/AS02A; Rabipur (Rabies) Vaccine
Intervention description: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.; 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.; 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30%
      efficacy against clinical episodes of malaria and approximately 58% efficacy against severe
      malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine
      RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army
      Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B
      vaccine to the African adults to establish safety and immunogenicity in this population.
      Preliminary indication of vaccine efficacy with this adjuvant will be established by
      monitoring the time to the first infection with Plasmodium falciparum.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male or female volunteers aged between 18 and 35 years at the time of first
             vaccination who have given written consent for their participation in the study were
             included

          -  If the volunteer is female, she must be of non-childbearing potential, i.e. either
             surgically sterilized or one year post-menopausal; or, if of childbearing potential,
             she must be abstinent or have used adequate contraceptive precautions for 30 days
             prior to vaccination, have a negative pregnancy test and must agree to continue such
             precautions for two months after completion of the vaccination series

        Exclusion criteria:

          -  If a subject plans to take vaccine not foreseen by the study protocol within 30 days
             of the first dose of vaccine(s) with the exception of tetanus toxoid will be excluded

          -  Volunteers with any confirmed or suspected immunosuppressive or immunodeficient
             conditions

          -  Family history of congenital or hereditary immunodeficiency

          -  History of allergic reactions to previous immunizations

          -  HBsAg positive subjects

          -  History of splenectomy

          -  Pregnant or lactating females will be excluded from the study
Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery
Condition: Surgical Procedure, Unspecified
Intervention: ketamine, propofol; ketamine, propofol, lidocaine
Intervention description: anesthesia with ketofol in pediatric surgery; anesthesia with ketofol plus lidocaine in pediatric surgery
Intervention MeSH terms: Lidocaine; Ketamine; Propofol
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 1 Year
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      Two hundred children aged 1-12 years undergoing short surgery will be randomized into two
      groups. Ketofol will be used for induction and maintenance of anesthesia in group l. .Ketofol
      with lidocaine will be prepared for group ll. A reducted McFarlan infusion dose will be used.
      Extubating time, duration of anesthesia, length of stay in post-anesthesia care unit (PACU)
      will be recorded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  surgical procedures max 60 min ASA I and II

        Exclusion Criteria:

          -  ASA > II surgical procedures longer than 60 min
Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)
Condition: B-cell Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Neoplasm, Residual
Intervention: Blinatumomab
Intervention description: Continuous intravenous infusion
Intervention MeSH terms: Blinatumomab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Blinatumomab; MRD; B-ALL; Minimal residual disease; adult ALL; Leukemia; ALL; Lymphatic diseases; Lymphoproliferative disorders; bispecific antibody; anti-CD19; Immunotherapeutic treatment

Summary:

      The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab
      (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal
      residual disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with B-precursor ALL in complete hematological remission after at least 3
             intense chemotherapy blocks

          -  Presence of minimal residual disease at a level of ≥ 10^-3

          -  Availability of bone marrow specimen from primary diagnosis for clone-specific MRD
             assessment

          -  Negative human immunodeficiency virus (HIV) test, negative hepatitis B (HbsAg) test
             and hepatitis C virus (anti-HCV) test

          -  Negative pregnancy test in women of childbearing potential

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Exclusion Criteria:

          -  Presence of circulating blasts or current extra-medullary involvement by ALL

          -  History of relevant central nervous system (CNS) pathology or current CNS pathology

          -  Prior allogeneic hematopoietic stem cell transplant (HSCT)

          -  Eligibility for treatment with tyrosine-kinase inhibitors (TKI)

          -  Systemic cancer chemotherapy within 2 weeks prior to study treatment

          -  Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to
             study treatment

          -  Previous treatment with blinatumomab
Apnea, Bariatric Surgery Versus Continuous Positive Airway Pressure (CPAP) Trial
Condition: Obstructive Sleep Apnea; Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Laparoscopic Gastric Banding; Continuous Positive Airway Pressure
Intervention description: Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.; Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the feasibility of conducting a comparative
      effectiveness study comparing a medical versus surgical approach to the initial management of
      obstructive sleep apnea (OSA) in the setting of obesity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe sleep apnea with at least 1 referable symptom

          -  Obesity (BMI 35-45 kg/m2)

        Exclusion Criteria:

          -  Prior use of CPAP within the last two years or prior bariatric surgery

          -  Hypoxemia or hypercapnia

          -  Elevated peri-operative risk

          -  Drowsy driving in past year

          -  Unstable medical or psychiatric conditions