bioihbjkbjnl/mcl2 huggingface dataset:
Craving and Lifestyle Management Through Mindfulness Study
Condition: Obesity
MeSH terms: Obesity
Intervention: Craving and Lifestyle Management through Mindfulness
Intervention description: A preliminary, novel intervention was developed drawing on components from Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Cognitive Therapy (MBCT), and Mindfulness-Based Eating Awareness Training (MB-EAT). The intervention program consisted of nine 2.5-hour classes and one 7-hour silent day of guided meditation practice after class 6.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: Female
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Mindfulness based stress reduction; Mindful eating; Stress; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms

Summary:

      The purpose of this study is to determine whether a mindfulness-based stress reduction and
      mindful eating program will lead to reductions in abdominal fat and total weight and improve
      cell aging in overweight and obese women compared to a waitlist control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal

          -  BMI (25 - 40)

          -  Weight < 300 lbs.

          -  Negative urine glucose test

        Exclusion Criteria:

          -  Inability to provide informed consent

          -  Age < 21 or menopausal as determined by self-report

          -  DSM-IV diagnosis of an eating disorder

          -  Any substance abuse, mental health, or medical condition that, in the opinion of
             investigators, will make it difficult for the potential participant to participate in
             the intervention

          -  Factors that confound relations between stress and eating, including, drug abuse and
             use of medications containing corticosteroids.

          -  Diabetes

          -  Polycystic Ovary Syndrome

          -  CHD

          -  Breastfeeding (due to interference with stress hormone measurement)

          -  Non English speaker

          -  Pregnant as determined by pregnancy test at screening visit or planning to get
             pregnant in the next 6 months

          -  Previous MBSR training and/or current meditation, yoga, or other mind-body practice

          -  Initiation of new class of psychiatric medications in past 2 months.

          -  Currently on a weight loss diet
Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Placebo; SAM-531 1.5 mg; SAM-531 3.0 mg; SAM-531 5.0 mg; Donepezil
Intervention description: Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks.; Capsules SAM-531 1.5 mg, once a day during 52 weeks.; Capsules SAM-531 3.0 mg, once a day during 52 weeks.; Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks.; Encapsulated Donepezil 5 mg tablets, once a day during 52 weeks. After Day 42, the dose can up titrated up to 10 mg of Donepezil.
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 526.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at
      three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531,
      donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive
      placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the
      remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage
      levels or donepezil in period I will continue with the same study drug (period II).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer Disease according to the National Institute of
             Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related
             Disorders Association (NINCDS-ADRDA) criteria.

          -  Mini-Mental State Examination (MMSE) score of 12 to 24 at screening

          -  Rosen Modified Hachinski Ischemic score < or equal to 4 at screening.

        Exclusion Criteria:

          -  Relevant neurologic disease other than Alzheimer Disease that may affect cognition or
             ability to complete the study.

          -  Current major depressive disorder or other current major psychiatric disorder.

          -  History of clinically evident stroke or clinically important carotid or
             vertebrobasilar stenosis or plaque.

          -  Use of prescription or nonprescription medications for cognitive enhancement
             (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors)
             within 3 months before the baseline visit.
The Use of Heliox in Obstructive Sleep Apnea Syndrome
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Intervention: Heliox
Intervention description: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heliox; Obstructive Sleep Apnea

Summary:

      The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep
      apnea syndrome (OSAS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 18 or older with obstructive sleep apnea syndrome (OSAS) presenting for CPAP
             titration.

        Exclusion Criteria:

          -  Professional singers.

          -  Television or Radio hosts.

          -  Disk Jockeys.

          -  Subjects requiring oxygen therapy.

          -  Subjects younger than 18 year old.

          -  Pregnant women.

          -  Patients with chronic obstructive pulmonary disease (COPD) with forced expiratory
             volume 1 (FEV1) less than 50%.

          -  History of anatomic upper airway obstruction.

          -  Uncontrolled asthma.
A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Condition: Palmar Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: Glycopyrronium cloth, 2.4%; Vehicle
Intervention description: Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium; Pre-saturated 100% polypropylene, nonwoven, fabric cloth
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the efficacy and safety of glycopyrronium cloth,
      2.4% when used to treat palmar hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent and assent (for subjects under legal adult age).

          2. Age ≥9 years.

          3. Primary palmar hyperhidrosis for at least 6 months duration.

          4. Average sweat severity score of ≥4 at Baseline.

          5. Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline.

          6. Willing to comply with the protocol. Subjects under legal adult age will be assessed
             by the investigator as to their ability to comply with the protocol.

          7. Male or non-pregnant (negative urine pregnancy test in female subjects of
             child-bearing potential), non-lactating females.

        Exclusion Criteria:

          1. Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.

          2. Prior surgical procedure for hyperhidrosis.

          3. Iontophoresis for the palms within 4 weeks of Baseline.

          4. Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year
             of Baseline.

          5. Open wounds or inflammatory lesions on the hands or, any condition that may alter the
             barrier function of the skin on the hands.

          6. Secondary palmar hyperhidrosis or presence of a condition that may cause secondary
             hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication,
             carcinoid syndrome, substance abuse, hyperthyroidism).

          7. Known history of Sjögren's syndrome or Sicca syndrome.

          8. History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile
             illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe
             ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia
             gravis.

          9. Men with a history of urinary retention requiring catheterization due to prostatic
             hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
Condition: Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant
Intervention: TMC207; Background Regimen (BR) for MDR-TB
Intervention description: TMC207 400mg once daily for 2 weeks then 200mg three times a week for 22 weeks.; Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as specified in the protocol for up to 96 weeks.
Intervention MeSH terms: Bedaquiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tuberculosis; TMC207-TiDP13-C209; TMC207-C209; TMC207; TB; MDR-TB

Summary:

      The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207
      in combination with an individualized background regimen (BR) of antibacterial drugs as
      treatment for MDR-TB
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of child-bearing potential must be using and are willing to continue using
             effective birth control methods, or be willing to practice sexual abstinence
             throughout treatment or be nonheterosexual active

          -  Confirmed pulmonary MDR-TB infection including those infected with XDR (extensively
             drug resistant)-TB

          -  Positive for acid-fast bacilli (AFB) on direct smear examination of expectorated
             sputum specimen (= 1+ smear-positive)

          -  HIV-positive patients are eligible, provided they meet the requirements as described
             in the protocol

          -  Must voluntarily sign the Informed Consent Form (ICF) prior to starting any study
             activities

          -  Willing to comply with protocol requirements

          -  Willing to comply with NTP treatment guidelines

        Exclusion Criteria:

          -  Patients having a known or suspected hypersensitivity or serious adverse reaction to
             TMC207

          -  Patients with significant cardiac arrhythmia requiring medication

          -  Patients with complicated or severe extrapulmonary manifestations of TB, including
             central nervous system infection

          -  Patients with certain QT/QTc interval characteristics as described in the protocol

          -  Patients having participated in other clinical studies with investigational agents,
             within 8 weeks prior to trial start

          -  Women who are pregnant or breastfeeding

          -  Patients who have previously received treatment with TMC207 as part of a clinical
             trial.
Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Bleomycin; Rituximab; Dacarbazine; Doxorubicin; Vinblastine
Intervention MeSH terms: Rituximab; Doxorubicin; Dacarbazine; Bleomycin; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Giving rituximab together with combination chemotherapy may kill more
      cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with combination
      chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV
      Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed classical Hodgkin's lymphoma

               -  No lymphocyte-predominant histology

               -  Stage II, III, or IV disease

               -  Newly diagnosed disease

        PATIENT CHARACTERISTICS:

          -  Performance status 0-2

          -  Creatinine < 2.0 mg/dL

          -  Bilirubin < 5 mg/dL

          -  Not pregnant or nursing

          -  No HIV positivity

          -  Hepatitis B surface antigen negative

          -  No active concurrent malignancy except for superficial nonmelanoma skin cancer or
             cervical carcinoma in situ

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for Hodgkin's lymphoma

          -  Steroids allowed if medically required before chemotherapy initiation
Evaluation of an Internet-based Intervention for Hazardous Drinkers
Condition: Hazardous Alcohol Consumption
MeSH terms: Alcohol Drinking
Intervention: interactive online programme to reduce alcohol consumption; Minimum information
Intervention description: The programme includes several steps:
personalized feedback on alcohol consumption and related risks
reviewing motivations and fears regarding drinking reduction
analyse of drinking habits
reduction goal setting
follow-up tools (alcohol diary, craving scales, well-being scales)
a final screen allowing participants to monitor their progress through graphs and automatically adapted comments.; This intervention includes:
information about hazardous drinking
an alcohol diary
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1157.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the investigators internet-based
      intervention is effective to help hazardous drinkers reducing their alcohol consumption.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Alcohol Use Disorders Identification Test (AUDIT) score from 6 (female) or 7 (male) to
             12
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: Placebo; dalcetrapib
Intervention description: po daily for 24 weeks; 900mg po daily for 24 weeks
Intervention MeSH terms: Dalcetrapib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with
      coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12
      weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily
      for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level
      and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12
      months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-75 years of age;

          -  CHD or CHD risk equivalent;

          -  body weight <125kg at visit 1.

        Exclusion Criteria:

          -  recent (within 3 weeks of screening) clinically significant coronary events;

          -  history of statin-associated myopathy, or intolerance to statin;

          -  history of malignancy (except for curatively treated basal cell or squamous cell
             cancer of the skin) during the 3 years prior to screening;

          -  exposure to RO4607381 in past 12 months.
Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: ODM-201
Intervention description: ODM-201 administered orally daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with
      castrate resistant prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Successful completion of study protocol 3104001

          -  Response or stable disease in study 3104001 at week 12

        Exclusion Criteria:

          -  New serious concurrent medical condition

          -  Not able to swallow the study drug
Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Condition: Cancer Survivor; Prevention of Human Papillomavirus Infection
MeSH terms: Infections; Papillomavirus Infections
Intervention: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58); laboratory biomarker analysis; survey administration; medical chart review
Intervention description: Given IM; Correlative studies; Ancillary studies; Ancillary studies
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1499.0
Sex: All
Minimum age: 9 Years
Maximum age: 26 Years
Healthy volunteers: No

Summary:

      This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer
      survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine
      initiation among young cancer survivors, and (2) determining the immune response to and
      safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  AIM 1 (SURVEY) (AIM 1 is closed to enrollment)

          -  Cancer survivor

          -  Between 12 and 60 months after completion of cancer therapy (chemotherapy, radiation,
             hematopoietic cell transplant [HCT])

          -  Scheduled for a return clinic visit at one of the participating institutions

          -  English or Spanish-speaking

          -  Willing to provide informed consent/assent for study participation

          -  AIM 2 (VACCINE EVALUATION)

          -  Meets all inclusion criteria outlined in Aim 1

          -  Survey response indicated no prior history of HPV vaccination OR patient has no prior
             history of HPV vaccination by self - or parent/caregiver-report

          -  English or Spanish-speaking

          -  Medical clearance from treating clinician for study participation

          -  Agrees to return to participating institution for 3 HPV vaccine injections

          -  Willing to provide informed consent/assent for study participation

        Exclusion Criteria:

          -  AIM 2 (VACCINE EVALUATION)

          -  Allergy to any component of the HPV vaccine including yeast and aluminum

          -  Thrombocytopenia (platelet count < 50K) or coagulation disorder that would
             contraindicate intramuscular injection

          -  Transfusion of blood products or intravenous immune globulin within 3 months of study
             entry

          -  Female, and a) currently pregnant or lactating, or b) of childbearing potential and
             unwilling to avoid pregnancy during the vaccine phase of study (beginning at Day 1 and
             continuing until at least 4 weeks after all 3 vaccine doses have been administered)