bioihbjkbjnl/mcl2 huggingface dataset:
CHOCOlate MeLatonin for AdolescenT MigrainE
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Melatonin
Intervention description: melatonin
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Existing treatments for acute migraine are not effective for all children and adolescents,
      and can cause side effects. Investigator propose a dose-finding study of melatonin for acute
      migraine treatment in children and adolescents to determine the best dose to bring forward in
      a future fully-powered efficacy trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meet ICHD criteria for episodic migraine in children and adolescents, with at least 1
             migraine attack per month on average.

          2. Age 3-17 years

          3. Dissatisfaction with previous acute treatments, for one or more of the following
             reasons: a) One or more previously tried acute medications have not been effective, or
             adequately effective, b) previously tried acute treatments have caused side effects,
             or C) patient/family would prefer a natural supplement for acute treatment over
             medication treatment

          4. If of driving age, teen participant agrees not to drive for at least 8 hours after
             treating with melatonin.

        Exclusion Criteria:

          1. Allergy or intolerance to melatonin, or to chocolate.

          2. Opioid or barbiturate overuse as defined in ICHD

          3. Pregnant/lactating
Gabapentin Treatment of Alcohol Dependence
Condition: Alcoholism; Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Gabapentin 900mg; behavioral counseling; placebo; gabapentin 1800mg
Intervention description: 900 mg gabapentin daily for 12 weeks; The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.; lactose capsule compounded to mimic gabapentin capsules; 1800 mg gabapentin daily for 12 weeks
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol; Alcohol treatment; Alcoholism; Alcohol Dependence

Summary:

      Gabapentin treatment for alcohol dependence
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women over age 18 with alcohol dependence

        Exclusion Criteria:

          -  Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria
             for dependence on illicit substances

          -  Significant medical disorders that will increase potential risk or interfere with
             study participation

          -  Women with childbearing potential who are pregnant, nursing, or refuse to use a
             reliable method of birth control

          -  Treatment with an investigational drug in the last month.
Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble
Condition: Pathological Gambling
MeSH terms: Gambling
Intervention: Ecopipam
Intervention description: 50mg tablets
Intervention MeSH terms: Ecopipam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pathological Gambling; ecopipam; Dopamine

Summary:

      This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble
      in patients diagnosed with Pathological Gambling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be diagnosed with Pathological Gambling according to DSMIV criteria

          -  Subject must have at least 2 episodes of gambling behavior within the previous 2 weeks
             before screening

          -  Subject must have gambling urges of at least moderate intensity

        Exclusion Criteria:

          -  Subjects must not have unstable medical illness or clinically significant
             abnormalities on lab tests, ECG, or physical exam

          -  Subjects with major depressive episode within the last 2 years

          -  Subjects with a history of attempted suicide

          -  Subjects with first degree relative with major depressive episode that resulted in
             hospitalization, attempted or completed suicide

          -  Subjects with a history of epilepsy or seizures

          -  Subjects with a myocardial infarction (heart attack) with in the last 6 months

          -  Subjects with a lifetime history of bipolar disorder, dementia, schizophrenia, or any
             psychotic disorder

          -  Subjects with current of recent DSM-IV diagnosis of substance abuse or dependence
             (with the exception of nicotine)
Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Tiagabine; Placebo
Intervention description: GABA reuptake inhibitor; Placebo comparator
Intervention MeSH terms: Tiagabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: arousal threshold; phenotype; tiagabine; slow wave sleep

Summary:

      Obstructive sleep apnea (OSA) is common and has major health implications but treatment
      options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep
      (called "slow wave sleep"), potentially via an increase in the stimulus required to arouse
      from sleep. Here the investigators test the idea that the medication called "tiagabine"
      improves slow wave sleep and reduces OSA severity. The investigators will also test whether
      tiagabine raises the arousal threshold (more negative esophageal pressure), and whether
      detailed OSA "phenotyping" characteristics can predict the improvement in OSA severity with
      this intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)

        Exclusion Criteria:

          -  History of seizures
Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
Condition: Impetigo; Secondarily Infected Traumatic Lesions
MeSH terms: Impetigo
Intervention: TD1414 2% cream; TD1414 2% cream; Bactroban® (mupirocin) 2% cream
Intervention description: BID 7 days; TID 7 days; BID 7 days
Intervention MeSH terms: Mupirocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 773.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      An international, multi-centre, prospective three arm parallel-group, phase II proof of
      concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7
      days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2%
      cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an
      evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A
      total of 664 patients will be enrolled in a stepwise manner according to age groups starting
      with the oldest age group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent from patient and/or legally acceptable
             representative has been obtained

          -  Outpatients of any sex or ethnic origin

          -  Patients >= 2 years of age (depending on study step)

          -  Patients must be suffering from primary bullous/non-bullous impetigo or SITL

        Exclusion Criteria:

          -  Presence of skin diseases at or near the investigational area

          -  Immunosuppressed state or other serious systemic disease

          -  Signs and/or symptoms of systemic infection

          -  Presence of skin infection/disorder not amenable to topical antibacterial treatment
             only

          -  Presence of secondarily-infected animal/human bite

          -  Presence of secondarily infected burnwound

          -  Topical or systemic use of medicinal or other products before or during the study
             which in the investigators opinion could confound the evaluation of the effect of the
             study drugs

          -  Known or suspected hypersensitivity to TD1414 or any of the excipients in the TD1414
             2% cream

          -  Known or suspected hypersensitivity to mupirocin or any of the excipients in the
             Bactroban® (mupirocin) 2% cream

          -  Participation in any other investigational drug study or use of (an) investigational
             drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to
             randomisation

          -  Patients previously enrolled/randomised in this study

          -  Abnormal ECG at baseline though the PR interval may be up to 220 ms, the QRS interval
             up to 110 ms and the QTc interval up to 450 ms
Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 150 μg; Indacaterol 300 μg; Placebo
Intervention description: Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; QAB149; indacaterol; long acting β2-agonist

Summary:

      The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol
      (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD)
      so that optimal dose(s) could be chosen for testing in later studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female Japanese aged 40 to 75 years old

          -  Moderate to severe chronic obstructive pulmonary disease (COPD) with smoking history
             of at least 20 pack years

        Exclusion Criteria:

          -  History of hospitalization for COPD exacerbation within past 6 months

          -  Use of long-term oxygen therapy

          -  History of asthma

          -  Respiratory tract infection within past 1 month

          -  Consistently very high or low blood sugar

          -  Clinically abnormal laboratory values or significant condition

          -  History of heart failure or heart attack within past 6 months

          -  History of long QT syndrome or long QT interval in electrocardiogram recorded at
             screening

        Other protocol-defined inclusion/exclusion criteria applied to the study.
ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: ELND005 (scyllo-inositol)
Intervention description: Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks
After 15Dec2009: ELND005 250 mg PO BID for 48 weeks
Intervention MeSH terms: Inositol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of ELND005
      beyond the 18 months of treatment in original randomized and blinded clinical trail
      ELND005-AD201.
    

Eligibility criteria:

        Inclusion Criteria:

          -  This study is open only to subjects who have completed the week 78 visit in Study
             ELND005-AD201 while taking their assigned dose of study drug medication.

        Exclusion Criteria:

          -  Subject has no new medical contraindications to continued participation in the study.
Olanzapine in the Treatment of Patients With Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Intervention: Olanzapine; Day Hospital
Intervention description: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.; Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Intervention MeSH terms: Olanzapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pilot Project,; Clinical Trial,; Treatment Outcome,; Psychopharmacology

Summary:

      The purpose of the study is to evaluate the efficacy of an anti-psychotic medication,
      Olanzapine, in achieving desired weight gain in patients identified as having Anorexia
      Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible
      beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety
      symptoms associated with this disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  those who meet DSM IV criteria of Anorexia Nervosa- either restricting or binge/purge
             subtype

        Exclusion Criteria:

          -  patients who are actively self destructive and/or suicidal

          -  patients whose medical status is seriously compromised

          -  patients whose eating disorder is superimposed on a major psychiatric disorder such as
             schizophrenia, major affective disorders, dissociative disorder or an active substance
             abuse disorder.
ITI-007 (Lumateperone Tosylate) for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ITI-007
Intervention description: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open-label
Masking: None (Open Label)
Masking description: None (open label)
Enrollment: 4.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to offer open label ITI-007 treatment to patients who poorly
      respond or poorly tolerate approved medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis
             of schizophrenia or schizoaffective disorder

          -  Has capacity to provide informed consent

          -  Medically stable for study participation

          -  Judged clinically not to be at significant suicide or violence risk

          -  Inadequate response or tolerability to previously antipsychotic therapy, as defined by
             at least one of the following: prior clozapine failure, a PANSS>80 despite at least
             six weeks of a current antipsychotic therapy, a Clinical Global Impressions
             scale-Improvement (CGI-I) of 4 after at least two six week trials of antipsychotics
             (retrospective assessment) or failure to tolerate an adequate dose of at least
             antipsychotics (as defined by the Physicians Desk Reference)

        Exclusion Criteria:

          -  Substance abuse within last 90 days

          -  ECG abnormality that is clinically significant

          -  Pregnancy, lactation, or lack of use of effective birth control

          -  Presence or positive history of significant unstable medical or neurological illness
             (including any history of seizure disorder, hepatitis, renal insufficiency or mental
             retardation), history of HIV

          -  Clinically significant abnormal laboratory tests, positive for hepatitis B or C or
             liver function tests (LFTs) > 2x Upper Limit of Normal, use of strong CYP3A4
             inhibitors or inducers

          -  History or presence of concomitant major psychiatric illness.

          -  Use of other antipsychotic medications at baseline.

          -  Use of another investigational medication in the previous 4 weeks
Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: Euthyroid Group
Intervention description: Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: thyroid cancer; PET scan; recombinant thyrotropin; thyroglobulin; Thyroid cancer, differentiated epithelial

Summary:

      The purpose of this study is to determine [for patients with previously treated
      well-differentiated thyroid cancer and evidence of residual disease based on serum
      thyroglobulin (Tg) level] whether positron emission tomography-computed tomography (PET-CT)
      fusion scanning performed after recombinant thyroid-stimulating hormone (TSH) (rTSH,
      thyrotropin alfa for injection) will be more sensitive for the detection of disease sites
      than PET-CT scanning without rTSH. The study will also determine if this information will
      significantly alter the therapeutic approach in some patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (aged ≥ 18 years) with history of treated well-differentiated epithelial
             thyroid carcinoma (papillary, follicular or Hurthle cell), for which total or near
             total thyroidectomy plus postoperative radioiodine remnant ablation with 131-I has
             either been performed or found to be unnecessary by radioiodine imaging after TSH
             stimulation.

          -  Serum thyroglobulin (Tg) concentration ≥ 10 ng/mL (in the absence of interfering Tg
             autoantibodies).

          -  No findings of a "qualifying" radioiodine whole body scan that are sufficient to
             localize the disease suspected on the basis of the serum Tg.

          -  Inconclusive disease localization despite clinical assessment, cervical sonography, CT
             or magnetic resonance (MR) of the chest, and when appropriate other imaging and biopsy
             procedures. Patients must have no more than three foci of known or suspected
             extra-cervical metastasis.

          -  Must be in stable medical condition.

          -  Must be able to fully understand the protocol and be compliant with instructions.

        Exclusion Criteria:

          -  Diabetes mellitus, due to interference with fluorodeoxyglucose (FDG) PET scanning.

          -  Claustrophobia, inability to lay supine, or other factors preventing cooperation with
             scanning procedures.

          -  Withdrawal of thyroid hormone or rTSH administration within the preceding month.

          -  Presence of circulating Tg autoantibodies interfering with serum Tg measurement.

          -  Women who are pregnant or breastfeeding
Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma, Renal Cell
Intervention: Sunitinib Malate Continuous Daily Dosing; Sunitinib Malate Schedule 4/2
Intervention description: Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.; Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 317.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial has two parts. The purpose of the first part of the trial is to determine the
      doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in
      combination. This part is currently closed to enrollment.

      The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2
      schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying
      progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule.
      The trial will also determine the number of patients whose cancer responds to the treatments,
      whether life of patients can be extended, what the side effects are of the treatments, how
      bothersome disease or treatment-related symptoms are to patients, and whether tests can be
      found that will predict which patients may or may not respond to these treatments in the
      future.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced renal cell carcinoma of clear cell origin or a component of clear cell
             histology.

          -  Measurable disease

        Exclusion Criteria:

          -  Prior systemic therapy of any kind for advanced renal cell cancer

          -  History of brain metastases

          -  Uncontrolled hypertension