bioihbjkbjnl/mcl2 huggingface dataset:
Study of Aripiprazole to Treat Children and Adolescents With Autism
Condition: Autistic Disorder; Asperger Syndrome; Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Asperger Syndrome
Intervention: aripiprazole
Intervention description: aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months
Intervention MeSH terms: Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 30 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: open label; aripiprazole; children; adolescents; autism spectrum disorders

Summary:

      The purpose of this open label study in children and adolescents is to examine the acute and
      long-term effects of aripiprazole on problem behaviors associated with autism spectrum
      disorders and development in areas which appear to be affected by autism spectrum disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be between 30 months and 17 years 11 months, male or female, of any
             ethnicity and of any cognitive level

          -  Meet criteria for diagnosis of autism, Asperger's Disorder or Pervasive Developmental
             Order NOS (i.e. an autism spectrum disorder) based on clinical evaluation and either
             the Autism Diagnostic Interview - Revised (ADI-R) or the Autism Diagnostic Observation
             Scale (ADOS)

          -  Have a guardian who is able and willing to give written informed consent

          -  If competent, subject able and willing to give written assent for their own
             participation

          -  If on anticonvulsants, subject have been seizure-free and on a stable anticonvulsant
             regimen for at least 6 months

          -  Subjects may receive other nonpharmacologic treatment including dietary treatments

        Exclusion Criteria:

          -  Diagnosis of Rett's syndrome or Child Disintegrative Disorder

          -  Taken psychotropic medications other than clonidine or diphenhydramine within 2 weeks

          -  Previous trial of aripiprazole

          -  Pregnant or nursing

          -  Epilepsy or another significant chronic medical illness
FM 140 vs FM100 Study in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Melphalan; Fludarabine; Stem Cell Infusion; Rituximab
Intervention description: Arm 1 = 140 mg/m^2 intravenous over 20 Minutes on Day -1; Arm 2 = 100 mg/m^2 intravenous over 20 Minutes on Day -1.; 30 mg/m^2 intravenous daily over 30 Minutes for 4 Days (Beginning Day -4).; Stem Cell Infusion on Day 0.; 375 mg/m^2 intravenous on Day -5, +2 +9 and +16.
Intervention MeSH terms: Rituximab; Fludarabine; Fludarabine phosphate; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Fludarabine; Fludara; Fludarabine Phosphate; Melphalan; Alkeran; Stem Cell Infusion; Stem Cell Transfusion; SCT; Allogeneic Peripheral Blood Stem Cell Transfusion; APBSCT; Bone Marrow Transplantation; BMT; Rituxan; Rituximab; FM140; FM100

Summary:

      The goal of this clinical research study is to learn if there is a difference in transplant
      outcomes between two different doses of melphalan given in combination with fludarabine
      followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone
      marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma.
      This study will also look at whether treatment with a antibody called rituximab against a
      specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host
      disease after transplant. The safety of these treatments will also be compared.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with Multiple Myeloma in any of the following disease categories: a) Primary
             Refractory considered poor candidate for autologous transplant, b) Remission
             Consolidation in patients with Chromosome 13 abnormalities or plasma cell leukemia, c)
             All relapsing patients.

          2. Age up to 70 years.

          3. Related or unrelated donor who is HLA-compatible in at least 9/10 alleles (A,B, C,
             DRB1 and DQ) by molecular techniques.

          4. Zubrod Performance Score (PS)<2.

          5. Life expectancy is not severely limited by concomitant illness. Left ventricular
             ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
             Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusing
             capacity of the lungs for carbon monoxide (DLCO) >40%.

          6. Patient and donor or guardian willing and able to sign informed consent.

        Exclusion Criteria:

        1) Patients with active central nervous system (CNS) disease are ineligible for this study
        as documented by clinical symptoms and/or testing.
Effects of Treating Obstructive Sleep Apnea in Epilepsy
Condition: Epilepsy; Sleep Apnea; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Epilepsy
Intervention: continuous positive airway pressure (CPAP); Placebo-CPAP
Intervention description: a mask treatment for sleep apnea; Placebo-CPAP
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: epilepsy; sleep apnea; obstructive sleep apnea; continuous positive airway pressure; CPAP

Summary:

      The purpose of this trial is to work out design issues prior to conducting a definitive phase
      3 trial to determine whether treating sleep-related breathing disorders in people with
      epilepsy results in improvement in seizure control or an improvement in alertness during the
      day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age of 18 years or older.

          -  A history supportive of obstructive sleep apnea.

          -  Subject is able and willing to provide informed consent and to cooperate with
             polysomnography.

          -  Four or more quantifiable seizures per month.

          -  Subjects and their physicians agree to have their medication regimens optimized so
             that they are on the best regimen titrated to therapeutic benefit prior to the
             baseline phase of the study.

        Exclusion Criteria:

          -  Seizures secondary to drugs, alcohol, infection, neoplasia, demyelination, metabolic
             illness, or progressive degenerative disease.

          -  Non-epileptic spells (e.g., pseudoseizures) alone or in combination with epileptic
             seizures.

          -  Narcolepsy or another primary sleep disorder that requires intervention with
             medications and which may affect results of study (e.g., severe periodic limb movement
             disorder).

          -  Effectively treated OSA or prior exposure to continuous positive airway pressure.

          -  History of poor compliance with antiepileptic medications.

          -  Current treatment with the vagus nerve stimulator.

          -  Pregnancy.

          -  A significant history of medical or psychiatric disease which may impair participation
             in the trial.

          -  A history of alcohol or drug abuse during the one-year period prior to trial
             participation.

          -  Evidence of medical instability (e.g., congestive heart failure, cardiac arrhythmias,
             pulmonary disease) due to obstructive sleep apnea.

          -  Subjects who are unaware of the majority of their seizures and lack a reliable
             witness.

          -  Greater than ten seizures a day.
Repetitive Transcranial Magnetic Stimulation for "Voices"
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: repetitive transcranial magnetic stimulation (rTMS); sham stimulation
Intervention description: a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site; 132 minutes of stimulation given at 80% motor threshold with coil tilted "single wing" 45 degrees away from scalp deliverd to TP3 site
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: neurologic and psychiatric disorders; rare disease; schizophrenia

Summary:

      OBJECTIVES:

      I. Determine the effect of repetitive transcranial magnetic stimulation on treatment
      refractory auditory hallucinations of patients with schizophrenia.
    

Eligibility criteria:

        PROTOCOL ENTRY CRITERIA:

        Inclusion criteria:

          -  Diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV version of SCID

          -  Auditory hallucinations of spoken speech occurring at least 5 times per day where
             subject able to discern verbal content

          -  Right-handed

          -  At least 4 weeks on stable antipsychotic medication

        Exclusion criteria:

          -  history of seizure (unless due to drug withdrawal or medication that is no longer
             prescribed)

          -  history of epilepsy in first degree relatives

          -  estimated IQ less than 80

          -  unable to provide informed consent

          -  significant unstable medical condition

          -  current treatment with clozapine or bupropion

          -  cochlear implants or other metal in the head (surgical, etc.)

          -  history of cardiac arrhythmia

          -  cardiac pacemaker

          -  active drug or alcohol abuse within prior 6 weeks

          -  pregnancy
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: BMS-986165; Placebo
Intervention description: Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Deucravacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in
      participants with moderate to severe ulcerative colitis (UC).
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and
             confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization
             visit

          -  Must have documented diagnosis of UC of at least 3 months' duration prior to screening

          -  Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9
             points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal
             bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2

        Exclusion Criteria:

          -  Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis,
             or pseudomembranous colitis (other than associated with Clostridium difficile [C.
             difficile])

          -  Stool positive for C. difficile toxin at screening visit

          -  Current or recent (within 12 weeks prior to the randomization visit) evidence of
             fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation

        Other protocol-defined inclusion/exclusion criteria apply
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Intervention: bevacizumab [Avastin]; capecitabine [Xeloda]
Intervention description: 7.5mg/kg iv on day 1 of each 3 week cycle.; 1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.
Intervention MeSH terms: Bevacizumab; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus
      intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The
      anticipated time on study treatment is 3-12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  advanced or metastatic liver cancer;

          -  >=1 measurable lesion.

        Exclusion Criteria:

          -  current radiotherapy, chemotherapy, or other experimental therapies;

          -  prior cytotoxic chemotherapy;

          -  major surgery, open biopsy, or traumatic injury within 28 days of study entry;

          -  history of a malignancy during the last 5 years, other than cutaneous basal cell
             cancer or in situ cervical cancer.
Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease
Condition: Chronic Graft-versus-host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: Interleukin-2
Intervention description: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
Intervention MeSH terms: Interleukin-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stem cell transplant; GVHD; bone marrow transplant; cord blood transplant; regulatory T cell; interleukin

Summary:

      Chronic GVHD is a medical condition that may occur after a bone marrow, stem cell or cord
      blood transplant. The donor's immune system may recognize the your body (the host) as foreign
      and attempt to 'reject' it. This process is known as graft-versus-host-disease. It is thought
      that IL-2 may help control chronic GVHD by stopping the donor's immune system from
      'rejecting' your body. In this research study, we are looking to see how IL-2 can be used in
      combination with steroids to treat cGVHD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient of allogeneic stem cell transplantation with myeloablative or
             non-myeloablative conditioning regimens

          -  Steroid refractory cGVHD with systemic therapy onset within the prior 6 months

          -  No more than 2 prior lines of cGVHD therapy

          -  Estimated life expectancy > 3 months

          -  Adequate organ function

        Exclusion Criteria:

          -  Ongoing prednisone requirement > 1 mg/kg/day (or equivalent)

          -  Concurrent use of calcineurin-inhibitors plus sirolimus

          -  History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic
             thrombocytopenic purpura

          -  Active malignant relapse

          -  Active uncontrolled infection

          -  Uncontrolled cardiac angina or symptomatic congestive heart failure

          -  Organ transplant (allograft) recipient

          -  HIV-positive on combination antiretroviral therapy

          -  Active hepatitis B or C

          -  Pregnant or breast-feeding
A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ombitasvir/paritaprevir/ritonavir and dasabuvir; Sofosbuvir; Ribavirin
Intervention description: tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir; tablet; tablet
Intervention MeSH terms: Ritonavir; Ribavirin; Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Hepatitis C; Interferon-Free; Treatment Experienced; Chronic Hepatitis C; Hepatitis C Virus

Summary:

      The purpose of this study is to evaluate the safety and efficacy of
      ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and
      ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus
      infection. This study will contain 2 parts.

      Part 1: Approximately 20 participants and at least 10 of the 20 participants previously
      treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or
      without RBV, and experienced treatment failure.

      Part 2: Approximately 10 participants and all participants previously treated with
      SOF/ledipasvir and experienced treatment failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of previous direct acting antiviral (DAA) therapy failure; Part 2 only:
             history of previous direct acting antiviral (DAA) therapy failure and received at
             least 8 weeks of SOF/ledipasvir; participant must be treatment naïve to all other
             anti-HCV therapies

          -  HCV genotype 1 infection

          -  Females must be post-menopausal, of non-child bearing potential or practicing specific
             forms of birth control

        Exclusion Criteria:

          -  Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus
             antibody

          -  Discontinuation of the prior DAA treatment for reasons other than virologic failure

          -  Confirmed presence of hepatocellular carcinoma

          -  Abnormal lab tests
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Intervention: 25 mg Androxal; Testim 1%
Intervention description: 25 mg Androxal capsules, 1 capsule daily for 6 months; Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene; Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Male
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH); Secondary hypogonadism; Semen volume; Sperm count; Sperm motility

Summary:

      The study was designed to determine if Androxal® would affect sperm parameters (count,
      concentration, volume) in men with secondary hypogonadism who have been previously treated
      with topical testosterone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.

          -  Subjects must have been treated with a topical testosterone replacement therapy
             (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more
             than 2 years.

        Exclusion Criteria:

          -  A history of idiopathic infertility due to primary hypogonadism, testicular failure,
             Kallmann's syndrome or any other infertility condition.

          -  Subjects demonstrating any clinically significant medical condition rendering the
             subjects infertile or marginally fertile other than AIHH.

          -  Men with a history of, known, or suspected prostate disease not ruled out by a
             prostate biopsy, or a prostate specific antigen (PSA)>3.6 or clinical suspicion of
             current prostate disease.

          -  Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
Condition: Arthritis, Gouty
MeSH terms: Arthritis; Arthritis, Gouty
Intervention: canakinumab; dexamethasone; placebo matching canakinumab; placebo matching dexamethasone
Intervention description: 10 mg/kg intravenous infusion 250 mL over 2 hours.; 12 mg intravenous infusion 50 mL over 30 minutes.; 5% glucose in water intravenous infusion.; Placebo intravenous infusion.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Arthritis Gouty; ACZ885; IL1B protein; Pain

Summary:

      This is an exploratory proof-of-concept study to evaluate the safety and efficacy of
      canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  score over 50 on the 0-100 VAS pain scale

          -  acute, confirmed gout flare for no longer than 3 days

        Exclusion Criteria:

          -  Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3
             months

          -  Anti-inflammatory medication for the treatment of acute gout within the previous 24
             hours

          -  Pregnant or breastfeeding women

          -  Major surgery with high infection risk

          -  History of severe allergy to food or drugs

          -  History or risk of tuberculosis

          -  Active infection

        Other protocol-defined inclusion/exclusion criteria may apply