bioihbjkbjnl/mcl2 huggingface dataset:
Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain
Condition: Crohn's Disease; Abdominal Pain
MeSH terms: Crohn Disease; Abdominal Pain
Intervention: Olorinab
Intervention description: Olorinab active treatment for 8 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this randomized, open-label, parallel, phase 2a study is to determine the
      tolerability, pharmacokinetics, and efficacy of olorinab in participants with Crohn's disease
      experiencing abdominal pain.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A clinical diagnosis of Crohn's disease for at least 3 months prior to screening
             corroborated by prior endoscopic and histopathologic documentation consistent with
             Crohn's disease.

          -  Quiescent to mildly active inflammatory Crohn's disease defined with a total of simple
             endoscopy score for Crohn's disease (SES-CD) score of < 10 or fecal calprotectin < 500
             mcg/g within 4 weeks before Screening.

          -  Moderate to severe abdominal pain as defined by average abdominal pain score (AAPS) of
             >/= 4points on 7 consecutive days of the screening period up to Day -2. AAPS will be
             based on the 11-point numeric rating scale where 0 (no abdominal pain) to 10 (worst
             possible abdominal pain).

        Key Exclusion Criteria:

          -  Female participants who are lactating or have a positive serum pregnancy test during
             the screening period or a positive urine pregnancy test on Day 1 prior to study drug
             administration.

          -  Recent history (within 6 months of screening visit) of cerebrovascular disease, Acute
             Coronary Syndrome, Cerebrovascular accident, Transient ischemic attack, Myocardial
             infarction, unstable angina.

          -  Other significant chronic pain conditions that in the opinion of the Investigator may
             influence the abdominal pain score.

          -  History of extensive colonic resection, subtotal or total colectomy.

          -  History of >3 small bowel resections or diagnosis of short bowel syndrome or who have
             undergone bowel resection within 6 months prior to randomization.

          -  Chronic active hepatitis B within the last year (unless shown at the time of study
             entry to be hepatitis B antigen negative) or any history of hepatitis C.

          -  Evidence of current gastro-intestinal infection (bacterial or parasitic) or
             significant infection within 45 days of screening.

        Note: other protocol defined Inclusion/Exclusion criteria may apply.
COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure
Condition: Modified Release Oral Formulation; Left Ventricular Systolic Dysfunction; Chronic Heart Failure; History of Chronic Heart Failure; Left Ventricular Ejection Fraction; Pharmacokinetics; Echocardiogram
MeSH terms: Heart Failure; Ventricular Dysfunction, Left; Systolic Murmurs
Intervention: Omecamtiv Mecarbil Matrix F1 Formulation; Omecamtiv Mecarbil Matrix F2 Formulation; Placebo; Omecamtiv Mecarbil Swellable Core Technology F2
Intervention description: Modified release tablets for oral administration; Modified release tablets for oral administration; Modified release tablets matching to omecamtiv mecarbil; Modified release tablets for oral administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 544.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Pharmacokinetics; Omecamtiv mecarbil; AMG 423; Double-blind; Randomized; Placebo-controlled; Oral forumlation; CK-1827452; Cardiac myosin activator

Summary:

      The primary objectives of this study are (i) to select an oral modified release (MR)
      formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults
      with heart failure and left ventricular systolic dysfunction and (ii) to characterize its
      pharmacokinetics (PK) over 20 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of chronic heart failure (HF), defined as requiring treatment for HF for a
             minimum of 4 weeks prior to screening

          -  Treated with stable, optimal pharmacological therapy for ≥ 4 weeks

          -  History of left ventricular ejection fraction (LVEF) ≤ 40%

          -  Elevated N-terminal prohormone B-type natriuretic peptide (NT-proBNP)

        Exclusion criteria:

          -  Severe uncorrected valvular heart disease

          -  Hospitalization within 30 days prior to enrollment

          -  Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive
             pericarditis, or clinically significant congenital heart disease

          -  Acute myocardial infarction, unstable angina or persistent angina at rest within 30
             days prior to randomization

          -  Systolic blood pressure > 160 mmHg or < 90 mmHg or diastolic blood pressure > 90 mmHg

          -  Total bilirubin ≥ 2 x upper limit of normal (ULN); aspartate aminotransferase (AST) or
             alanine aminotransferase (ALT) ≥ 3 x ULN

          -  Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2
Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Ketorolac tromethamine; Placebo
Intervention description: 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride); Intranasal (IN) placebo
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; Ketorolac

Summary:

      The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute
      treatment of migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of migraine with or without aura (IHS criteria 1.1 and 1.2.1);

          -  Onset of migraine prior to age 50;

          -  2-8 moderate to severe migraine headaches per month

        Exclusion Criteria:

          -  Subjects receiving any investigational drug within 30 days before study entry;

          -  More than 15 headache days per month;

          -  Known allergy or hypersensitivity to ketorolac and/or excipients;

          -  Allergy to aspirin or other NSAIDs;

          -  Currently receiving other NSAIDs or aspirin;

          -  Medical history that would preclude NSAID use
A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Cisplatin; Capecitabine; Epirubicin; Cisplatin; Capecitabine; Oxaliplatin; Docetaxel; Capecitabine
Intervention description: 80 mg/m2/day, intravenous (IV), every 3 weeks; 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle; 50 mg/m2/day, IV, every 3 weeks; 60 mg/m2/day, IV, every 3 weeks; 625 mg/m2, oral, twice daily per 3-week cycle; 130 mg/m2/day, IV, every 3 weeks; 60 mg/m2/day, IV, every 3 weeks; 825 mg/m2, oral, twice daily for 2 weeks
Intervention MeSH terms: Cisplatin; Docetaxel; Capecitabine; Oxaliplatin; Epirubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of Xeloda, given in combination with standard
      chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric
      cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy
      regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the
      chemotherapy regimen used. The anticipated time on study treatment is until disease
      progression, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  advanced or metastatic gastric cancer;

          -  Eastern Cooperative Oncology Group (ECOG) <=2.

        Exclusion Criteria:

          -  previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to
             study);

          -  evidence of central nervous system (CNS) metastasis;

          -  history of another malignancy within the last 5 years (except for successfully treated
             basal cell cancer of skin, or in situ cancer of the cervix);

          -  clinically significant cardiac disease.
Test of Novel Drug for Smoking Cessation
Condition: Smoking Cessation
Intervention: Active JNJ Drug; Placebo pill
Intervention description: 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.; Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover of active JNJ vs. placebo for 2 weeks each, involving 1 week of dose run-up and 1 week of attempting to quit each day on that drug condition. A one-week washout separates these drug conditions, which are administered in counter-balanced order.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: crossover

Summary:

      The study will assess a novel active drug vs. placebo on ability to reduce smoking and aid
      cessation during a one-week "practice" quit period for each condition in smokers with a high
      interest in quitting (i.e. crossover design). Medication effects on reducing withdrawal and
      cognitive impairment will help assess the mechanism to support quit smoking attempts.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy male and female dependent smokers wanting to quit soon

        -

        Exclusion Criteria:

          -  Use of non-smoked nicotine products

          -  Already enrolled in cessation program.

               -  Recent alcohol or substance dependence (≤ 3 months)

               -  Women who are pregnant, planning a pregnancy, or lactating; all female
                  participants shall undergo a pregnancy test at screening and will be excluded if
                  positive.

               -  Serious or unstable medical disorder within the past 3 months

          -  Epilepsy

               -  Current diagnosis (within last 6-months) of abnormal cardiac rhythms; unstable
                  cardiovascular disease e.g. stroke, myocardial infarction in the last 6 months

               -  Evidence impaired liver function test (LFT)

               -  Evidence of kidney failure

               -  Any subject with a history of hematological cancers examples: leukemia, lymphoma
                  etc.

               -  Any clinically significant hematological laboratory abnormality.
Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: florbetapir F 18; [11C]-PIB
Intervention description: 370 MBq (10 mCi), intravenous (IV) injection, single dose; 555 MBq (15 mCi), IV injection, single dose [11C]-PIB
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amyloid imaging; Positron Emission Tomography; 18F-AV-45; florbetapir F 18; Diagnostic imaging

Summary:

      This study will evaluate the performance characteristics of a novel [18F] amyloid detection
      ligand (18F]-AV-45) with respect to its ability to distinguish patients with
      clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects
      and to independently compare its diagnostic performance characteristics with the ability of
      [11C]PIB to correctly categorize the same subjects.

      SPECIFIC HYPOTHESES

        1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have
           increased brain retention of [18F]-AV-45 compared to cognitively normal elderly
           individuals.

        2. There will be no clinically meaningful difference in the amyloid retention performance
           characteristics of [18F]-AV-45 and [l1C]PIB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal subjects: mini-mental state examination (MMSE) 27-30, clinical dementia rating
             (CDR) = 0, no symptoms of depression

          -  Alzheimer's subjects: MMSE 18-26, CDR >=0.5, University of Pennsylvania Alzheimer's
             Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI

        Exclusion Criteria:

          -  other neurological disease

          -  evidence of MRI abnormality

          -  psychiatric disorder

          -  alcohol abuse

          -  clinically significant lab abnormalities

          -  residence in nursing facility

          -  participation in clinical trial with experimental medication in past 1 month
Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction
Condition: Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Intervention: 25 mg Omecamtiv Mecarbil; Placebo; 37.5 mg Omecamtiv Mecarbil; 50 mg Omecamtiv Mecarbil
Intervention description: oral tablet; oral tablet; oral tablet; oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Heart Failure

Summary:

      -  To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart
           failure (HF) with reduced ejection fraction

        -  To evaluate the safety and tolerability of oral omecamtiv mecarbil
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male or female ≥ 20 years and ≤ 85 years of age

          -  History of chronic stable heart failure (HF) with reduced ejection fraction, defined
             as requiring treatment for HF for a minimum of 4 weeks prior to screening

          -  Treated for HF with optimal pharmacological therapy

          -  Left ventricular ejection fraction ≤ 40% at screening

        Exclusion Criteria:

          -  Severe uncorrected valvular heart disease

          -  Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive
             pericarditis, or clinically significant congenital heart disease

          -  Acute myocardial infarction, unstable angina, or persistent angina at rest within 30
             days prior to randomization

          -  Systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg, or
             heart rate (HR) > 110 beats per minute (bpm) or HR < 50 bpm

          -  Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2

          -  Total bilirubin (TBL) ≥ 2x upper limit of normal (ULN), or alanine aminotransferase
             (ALT) or aspartate aminotransferase (AST) ≥ 3x ULN Other Exclusion Criteria may apply.
Neem Lotion With Combing for Lice
Condition: Pediculoses; Head Lice
MeSH terms: Lice Infestations
Intervention: Neem-based lotion plus louse comb; Neem-based lotion plus grooming comb
Intervention description: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb; Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This was a Phase IIa randomised, assessor blinded, parallel group study in which half the
      participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing with
      a head louse detection and removal comb and the remainder were treated with Nice 'n Clear
      plus combing with a normal grooming comb
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females who are found to have an active head louse infection, i.e. the
             presence of live lice. Detection combing will be done with a fine-toothed plastic
             detection comb, until at least one louse is found.

          -  People who give written informed consent and/or, if the participant is below 16 years
             of age, whose guardian gives written informed consent to participate in the study.
             Assent/verbal assent forms will be required for those between the ages of 4 and 16
             years of age. There is no maximum age limit.

          -  Participants must be available for the duration of the study i.e. 15 days.

        Exclusion Criteria:

          -  People who have been treated with other head louse products within the previous 2
             weeks (14 days).

          -  People who have undergone a course of antibiotic treatment using Cotrimoxazole,
             Trimethoprim or Septrin within the previous 4 weeks, or who are currently taking such
             a course.

          -  People whose hair has been bleached, colour treated, or semi-permanently waved within
             the previous 2 weeks, this includes the use of semi-permanent colouring agents. Home
             use wash in/wash out colouring agents are acceptable.

          -  People who have taken part in another clinical study within 4 weeks prior to entry to
             this one.

          -  Females who are pregnant or breast-feeding.

          -  Participants who have already taken part in this study.

          -  People who have a known allergy to any of the ingredients of Nice 'n Clear Lotion
             (including allergy to Paraben preservatives)

          -  Children under 6 months of age.
Mindfulness Meditation for Health
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Mindfulness Based Relapse Prevention for Alcohol Dependence; "Wait-list" control
Intervention description: All subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. Experimental subjects also receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. The intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and "traditional" cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the study.; 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol Dependence; Alcoholism; Substance Use Disorders; Substance Abuse

Summary:

      The purpose of this 52-week clinical trial is to see if the meditation-based intervention,
      adjunctive to standard of care therapy, can reduce relapse and improve psychological health
      among adults recovering from alcohol dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Alcohol dependence diagnosis

          -  Completed at least 2 weeks of IOP or (IOP equivalent=at least 2 days per week) for
             alcohol dependence

          -  Sober since beginning of outpatient treatment

          -  English fluency; ability to fill out surveys

          -  Permanent home address and telephone

          -  At least 18 years old

          -  Score >13 on the Perceived Stress Scale

        Exclusion Criteria:

          -  Pregnant

          -  Alcohol abstinence >14 weeks before enrollment

          -  Current, regular meditation

          -  Pre-existing bipolar, schizophrenia, or delusional disorder

          -  Regular drug use (other than tobacco) in last 2 weeks

          -  Inability to reliably participate