bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Spanish or English Language Versions of Mindfulness Meditation on Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study explores the differential efficacy of Spanish or English versions of a mindfulness
      intervention on Depression levels, using a pre test post test design and an active control
      condition (health education).
    

Detailed description: 
      This study is a randomized controlled trial (RCT) with an experimental condition (MAPs
      Mindfulness intervention) and an active control group (Health Education), using a pretest and
      immediate posttest research design. Both conditions are comprised of a 6-week group
      intervention, which will be administered at the UCLA Westwood Medical Campus. The sample
      (N=80) will be drawn from a population of adults (18-65 years old), residing within a 10mile
      radius of the UCLA Westwood Medical Campus. To determine initial eligibility, potential
      participants will self-select based on perceived high levels of stress. Participants will
      respond self-report questionnaires to assess for psychological symptoms and will be drawn
      blood samples (180ml total) to assess levels of pro inflammatory cytokines before and after
      the interventions. Participants will attend a total of 8 visits.
    

Intervention name(s): Mindful Awareness Practices- English; Mindful Awareness Practices- Spanish; Health Education - English; Health Education - Spanish
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The 6-week intervention aimed at teaching mindfulness-based strategies to participants (in English); The 6-week intervention aimed at teaching mindfulness-based strategies to participants (in Spanish); The health education condition is a weekly 2-hour, 6 session course aimed at knowledge acquisition in subjects related to health care in general (in English); The health education condition is a weekly 2-hour, 6 session course aimed at knowledge acquisition in subjects related to health care in general (in Spanish)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pretest and immediate postest design with an active control condition.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness; depression; Spanish
Impact of Clinical Pharmacist on the Quality and Cost of the Therapeutic Management of Patients in Two Medical Services of a Teaching Hospital
Condition: Admitted to Infectiology or Internal Medicine Wards
Study type: Interventional

Summary: 
      Incomplete information or poorly communicated to the transitional stages of the patient's
      drug therapy hospitalized cause medication errors. These steps are the admission, transfer
      within the institution and hospital discharge to home or another institution.

      The adequacy of the prescription recommendations of good practice is not always optimal.

      The cost of taking drug therapy and iatrogenic risks preventable drug-related weighs more and
      more heavily in health spending and in the prolongation of hospitalization or re
      hospitalization.

      Clinical pharmacy widely practiced in the Anglo-Saxon countries has demonstrated its
      effectiveness on these three themes; it seems appropriate to assess this practice in the
      environment of the French health system.
    


Intervention name(s): Pharmacist consultation
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: cost study; clinical pharmacist
Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Boron neutron capture therapy and radiation therapy use high-energy x-rays and
      other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as
      temozolomide, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving boron neutron capture therapy followed by
      radiation therapy and temozolomide may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects of giving boron neutron capture
      therapy together with radiation therapy and temozolomide in treating patients with newly
      diagnosed glioblastoma multiforme.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the overall survival of patients with newly diagnosed glioblastoma multiforme
           treated with boron neutron capture therapy, radiotherapy, and concurrent and adjuvant
           temozolomide.

        -  Evaluate tumor response in patients treated with this regimen.

        -  Evaluate the adverse effects of this regimen in these patients.

      OUTLINE: This is a multicenter study.

      Patients undergo boron neutron capture therapy followed by radiotherapy and concurrent and
      adjuvant oral temozolomide.
    

Intervention name(s): BNCT(boron neutron capture therapy); XRT(X-ray radiation treatment); TMZ(temozolomide)
Intervention type(s): Radiation; Radiation; Drug
Intervention description(s): BSH(sodium borocaptate) 100mg/kg iv for one hour starting 13 hours before irradiation, and BPA(p-boronophenylalanine) 500/mg/kg iv at a speed of 200mg/kg/hr for 2 hours starting 2 hours before irradiation. During irradiation, BPA iv continues at a speed of 100mg/kg/hr.; After BNCT, 2Gy irradiation every day for 12 days.; 75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days.
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult giant cell glioblastoma; adult glioblastoma; adult gliosarcoma
Study of Clinic-delivered Physical Activity Referrals to Cancer Survivors
Condition: Cancer; Physical Inactivity
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Background: Cancer survivors have a greater risk of cardiovascular disease (CVD) and have low
      physical activity levels. Physical inactivity is one modifiable risk factor for CVD, and
      increased physical activity has shown a cardioprotective effect on lowering CVD risk. The
      objective of ActivityLink is to use an electronic referral (e-referral) implementation
      program for clinic staff to refer survivors to an in-person and a virtual physical activity
      program.

      Methods: Participants in this study will include clinic staff and patients. Investigators
      will first conduct interviews with clinic staff and patients, followed by usability testing
      of a referral system with staff. The study team will then beta-test two rounds of testing
      using Plan, Do, Study, Act (PDSA) Cycles for clinic staff to refer patients in the clinic.
      Quantitative data and qualitative interviews will be collected following each PDSA cycle,
      with refinements made based on feedback.

      Outcomes: The proposed study addresses a critical need to implement physical activity
      referrals into routine cancer survivorship visits.
    


Intervention name(s): ActivityLink
Intervention type(s): Behavioral
Intervention description(s): ActivityLink is an implementation program using:
Didactic and experiential training sessions for clinic staff to conduct referrals
Secure electronic referral webform to refer patients using their email address and phone number
Messaging sent to the patient and provider that they have been referred to a program
Clinic visual cues (flyers and paper prescription pad) to reinforce referrals
Motivational messaging and booster sessions from study staff to encourage referrals and troubleshoot
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cancer; Physical Activity; Cardiovascular Disease; Referrals
Omacor Plus Standard Therapies In Post Myocardial Infarction (MI) Subjects Evaluation: The OPTIMISE Observational Study
Condition: Myocardial Infarction (MI)
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The OPTIMISE study is a prospective, multi-center, multi-national, structured data collection
      initiative, first compiling data on the current treatment of post myocardial infarction
      patients (screening-log) and then, prospectively evaluating only those patients being
      prescribed Omacor as part of their standard secondary prevention treatment. The aim is to
      observe the Omacor cohort of patients for a period of 12 months, collecting long term
      observational data as clinical and patient-reported outcomes, especially, but not
      exclusively, recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive
      Heart Failure (CHF). No predefined additional visits, medical tests, labs, procedures or
      interventions will be mandated. Only results from routinely performed tests, labs, procedures
      and/or interventions will be collected if available.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Keywords: Secondary prevention post MI
Neural Mechanisms of Change During the Treatment of Alcohol Use Disorders With Prazosin
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      The study uses neurobiological measures through brain imaging, neuropsychological measures,
      and selfreport measures to try to understand how an effective treatment for alcoholism works.
      On the whole, less than 50% of people with alcoholism get better with treatment. This study
      will help researchers develop better treatments for alcoholism because if the investigators
      know why the treatments the investigators use are working, and in whom the treatments work
      best, then the investigators may be able to make treatment more effective by targeting
      treatments to individuals who would be most likely to benefit and by guiding development of
      more effective treatments in the future.
    


Intervention name(s): Prazosin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Prazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single-dose pharmacokinetics (PK) of two
      formulations (Formulation 1 and Formulation 2) of AG-881 and to examine the effect of food
      and multiple-dose omeprazole on the single-dose PK of AG-881 Formulation 2 in healthy adult
      participants. This study will also assess the safety and tolerability of single-dose AG-881
      (Formulation 1 and 2) alone and of AG-881 Formulation 2 when administered with and without
      food and when coadministered with omeprazole in healthy adult subjects.
    


Intervention name(s): AG881 Formulation 1; AG881 Formulation 2; Omeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AG881 uncoated tablets; AG881 film-coated tablets; Omeprazole capsules
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability Study; Pharmacokinetic study; AG-881
Study to Evaluate the Effects of a Weight Management Program on Body Weight
Condition: Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The purpose of the study is to assess the safety and effectiveness of the Weight Management
      Program on body weight
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a
      Weight Management program on body weight. Each subject will receive a specific dose of the
      study product (A) to be taken twice daily with breakfast and dinner and a specific dose of
      the study product (B) to be taken 15 minutes before lunch daily for a total of 60 days. Each
      subject based upon the randomization will also receive a handout with suggestions for healthy
      eating and overall health.

      Participants receive questionnaires, assessments, blood tests, vital signs and a body
      composition analysis.

      The primary objective is the assessment of the change in body weight in response to the
      Weight Management program relative to baseline compared with placebo

      The secondary objective is the assessment of the change in waist circumference, parameters
      from the body composition analysis, appetite, the levels of blood lipids and C-reactive
      protein in response to the Weight Management program relative to baseline compared with
      placebo
    

Intervention name(s): Weight Management Formulation; Placebo; Handout with Suggestions for Healthy Eating and Overall Health; Handout with Suggestions for Healthy Eating and Overall Health
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other
Intervention description(s): Saffron extract and Gynostemma extract with hesperidin; Placebo; Suggestions for Healthy Eating and Overall Health; Suggestions for Healthy Eating and Overall Health
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Participants
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of the study is to evaluate the safety and tolerability of multiple oral
      doses of E6742 in participants with systemic lupus erythematosus (SLE).
    


Intervention name(s): E6742; Placebo
Intervention type(s): Drug; Other
Intervention description(s): E6742 tablet.; E6742-matching placebo tablet.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: E6742
The Effects of High Intensity Interval Exercise in Obese
Condition: Obesity; Endothelial Dysfunction
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity is a complex and multifactorial disease. Excess weight is related to endothelial
      dysfunction, inflammation and oxidative stress which increases the risk for cardiovascular
      diseases. High-intensity interval exercise can release vasodilatory substances and promote
      increased muscle blood flow.
    

Detailed description: 
      This study evaluated the effects of the recovery interval duration (1 vs. 3 min) in high
      intensity interval exercise (HIIE) on the hemodinamics responses in obese individuals. Twelve
      obese subjects (27 ± 3.8 yrs) were evaluated, who underwent three experimental sessions with
      a randomized crossover design: one control session (no exercise) and two HIIE sessions with
      the same workload (10 x 1min @92%VO2max / 1[HIIE 1] or 3[HIIE 3] min @0%). Forearm blood flow
      (FBF) and blood pressure (BP) were measured before and after the experimental sessions. Heart
      rate and relative perceived exertion were assessed during HIIE.
    

Intervention name(s): HIIE 1; HIIE 3; Control
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): In the HIIE 1 session, all the subjects performed 10 stimuli of 1 min at high intensity (92% of VO2Max) with passive recovery (without exercise) of 1 min.; In the HIIE 3 session, the subjects performed the same stimulus of the HIIE1, but with passive recovery of 3 min. Both protocols started with a warm-up of 5 min at 50% of the VO2Peak performed on a T2-100 GE Healthcare® treadmill (Lynn Medical, Wixon, Michigan, USA).; In the control session, participants remained seated for 30 min. During HIIE 1 and 2, HR and RPE were assessed immediately after stimulus intervals (ten measurements at each HIIE). In all sessions, the subjects remained in supine position to obtain hemodynamic measurements which were obtained before and at 10 min, 30 min and 60 min after the HIIE and control sessions.
Intervention model: Single Group Assignment
Intervention model description: The subjects were welcomed for a visit to the Laboratory of Studies of Physical Training Applied to Health, where they performed an evaluation of body composition, maximal ergospirometric exercise test, and three experimental sessions in a random order, which were performed with a 96 h interval between them. In order to obtain the experimental session order, the researcher asked each subject to pick out random numbers that were inside an opaque envelope generated at www.randomizer.org.
Before the experimental sessions, subjects were instructed to maintain a regular sleep pattern, and to not consume alcohol, caffeine or xanthines (coffee, chocolate, soft drinks and tea), take medication or exercise in the 24 h prior to the experimental protocol sessions. In addition, they were duly instructed to fill out the food registry (food recall).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; aerobic exercise; interval exercise
Airway Peak Pressure-directed Laryngeal Mask Airway Intracuff Pressure Setting
Condition: Laryngeal Mask Airway
Study type: Interventional

Summary: 
      The investigators aimed to explore the effects of airway peak pressure (Ppeak) guidance on
      the least laryngeal mask airway (LMA) intracuff pressure setting during general anesthesia
      and the effects on postoperative complications in the throat. One hundred and twenty patients
      (American Society of Anesthesiologists grades I or II) scheduled for elective laparoscopic
      cholecystectomy under general anesthesia were enrolled in our study. The patients were
      divided into pressure-regulated group (group P) and control group (group C) randomly. Supreme
      LMA was inserted in after general anesthesia induction. Air was injected into the cuff to
      make the intracuff pressure (ICP) achieve 60 cmH2O. Volume-controlled ventilation was
      selected and Ppeak was recorded. In group P, all the gas in the LMA cuff was sucked out, and
      then air was injected in during expiration phase to make ICP achieve the level of Ppeak. If
      there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth.
      After pneumoperitoneum, the cuff was inflated to make ICP achieve 60 cmH2O and Ppeak was
      recorded once more. Then all the gas in the LMA cuff was sucked out, and air was injected
      into the cuff during expiration phase to make ICP achieve the level of Ppeak as the above
      method till the end of operation. During pneumoperitoneum, the pressure of CO2 was set at 10
      cmH2O. In group C, ICP was maintained at 60 cmH2O. Ppeak, ICP and the intracuff gas volume
      were recorded before and after pneumoperitoneum. ICP during inspiratory phase in the two
      groups was measured. Tidal volume during inspiration (VTI) and expiration (VTE) in the two
      groups were recorded, and the leakage rate was calculated as [(VTI-VTE)/ VTI×100%]. Throat
      complications of all the patients in 24 hours after surgeries were also recorded.
    


Intervention name(s): Airway peak pressure
Intervention type(s): Procedure
Intervention description(s): Air was injected into LMA cuff during expiration phase to make intracuff pressure achieve the level of airway peak pressure. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI;
      PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with
      placebo.
    

Detailed description: 
      A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group,
      multi-center study to assess the efficacy and safety of glycopyrronium and formoterol
      fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005),
      and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe
      COPD, compared with placebo.
    

Intervention name(s): GFF MDI (PT003); FF MDI (PT005); GP MDI (PT001); Placebo MDI
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID); Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID); Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID); Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)
Other intervention name(s): Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol; Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol; Placebo (matching) for GFF MDI, FF MDI, and GP MDI
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody
      persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine
      with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young
      adults, and the comparative immunogenicity among the three groups will be measured at 1 mon
      post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore,
      the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.
    


Intervention name(s): Hepatitis B vaccine
Intervention type(s): Biological
Intervention description(s): Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hepatitis B; hepatitis B vaccine; immunogenicity; adults