bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Progressive Elastic Band Resistance Training
Condition: Prader-Willi Syndrome; Resistance Training
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional

Summary: 
      Abnormal body composition with increased body fat mass and decreased lean body mass has been
      found in adults with Prader-Willi syndrome (PWS), contributing to reduced physical capacity
      and impairment. The aim of this study was to investigate whether progressive elastic band
      resistance training can improve physical motor performance and regional body composition in
      adults with PWS.
    

Detailed description: 
      Six participants were enrolled in this pilot study. Following 24 weeks of progressive elastic
      band resistance exercise training, significant reduction was observed in their body weight,
      BMI, and regional extremities fat mass and percentage. Regarding the functional performances,
      there were also significant improvements in their hand grip strength, 3 meter timed up and
      go, 30 seconds sit to stand, and 2-min step up tests, as early as the 8th week of training.
      Balance function achieved significant improvements after 16 weeks of training.
    

Intervention name(s): PWS elastic band training group
Intervention type(s): Device
Intervention description(s): PWS participants received 9 sets exercises for the major muscle groups, over 24 weeks, three times a week, for a total of 72 sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prader-Willi Syndrome; Resistance Training; Body Composition
Role of Calcium Channels in Vascular Function
Condition: Endothelium, Vascular
Study type: Interventional

Summary: 
      The purpose of this study is to examine the role of T-type calcium channels in endothelial
      dysfunction observed with ageing.
    


Intervention name(s): Efonidipine; Nifedipine
Intervention type(s): Drug; Drug
Intervention description(s): 8 weeks treatment with either efonidipine; 8 weeks treatment with either nifedipine
Other intervention name(s): Landel (efonidipine); Adalat (nifedipine)
Intervention MeSH terms: Efonidipine; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Receptors, Calcium Channel Blocker
Impact of Health Literacy and Other Factors on Glaucoma Patient Adherence in South India
Condition: Patient Noncompliance; Health Literacy; Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      The purpose of this study is to determine how health literacy impacts glaucoma patient
      adherence (as measured by following up with the doctor) in Tamil Nadu, India. We hypothesize
      that individuals with better health literacy will have higher rates of follow-up with their
      ophthalmologist.
    

Detailed description: 
      Many studies have shown the importance of health literacy on patient adherence in the United
      States (Juzych, M, et al., 2008; Muir, KW, et al., 2006). Low adherence in glaucoma patients
      leads to increased intraocular pressure, optic nerve damage, and blindness. To date, no
      research has been done with health literacy and patient adherence in the developing world.

      We will use TOFHLA and REALM to assess the health literacy of glaucoma patients in Tamil
      Nadu, India. We will also survey other demographic information and patient knowledge of
      glaucoma. This information will be compared with follow-up rates to identify barriers to
      patient adherence.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Glaucoma Patients from Aravind Eye Hospital at Madurai, Tamil Nadu, India
      
Keywords: Health Literacy; Patient Nonadherence; Patient Noncompliance; Follow Up; India; Glaucoma
Efficacy of Warming Garment in the Perioperative Period With Integrated Chemical Heat Packs to Maintain Normothermia
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      Efficacy of Stand-alone, Non-tethered, Self-applying Warming Garment in the Preoperative,
      Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack
      Construction, With a View to Maintaining Normothermia During the Peri-operative Period
    

Detailed description: 
      Subjects will be randomized into two groups. The first group will have the standard warming
      devices currently used which consists of a forced air warming device. This will be applied in
      the form of a gown in the pre-operative area. The device is called the Bair Paws. (Subjects
      will either continue with this or have a separate forced air warming device applied in the
      operating room called a Bair Hugger.) This device is non experimental and is FDA approved and
      used within the hospital to keep patients warm. They will then have their temperature taken
      and documented by the staff at various prescribed times.

      The second group will receive the warming devices being studied which consist of a jacket,
      pants, gloves and socks with integrated air-activated chemical heat packs. The garment is
      applied at least twenty minutes prior to surgery. The same warming device will be maintained
      in place throughout the surgery and the period of post-anesthesia.

      Intraoperative period: The participants temperature will be monitored and documented at
      prescribed times.

      Postoperative period: The participants will have temperature monitored in the post anesthesia
      care area. Your part in this study will last until you are admitted to your room after
      surgery or you change into your own clothes prior to discharge.
    

Intervention name(s): Air-Activated heating packs; Forced Air Warming Device
Intervention type(s): Device; Device
Intervention description(s): The subject disrobe and will dress in a jacket, pants, gloves and socks (ensemble) which will be removed from a vacuum pack. He will be assisted by the nurse in pre-operative area. The ensemble will remain in place until the subject is fully recovered from anesthesia.; forced air-warming inflatable device applied according to standard hospital protocol.
Other intervention name(s): Garment with heat packs - iron powder and activated charcoal; forced air-warming device
Intervention MeSH terms: Charcoal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: normothermia; hypothermia
Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit
Condition: Critical Illness
MeSH terms: Psychomotor Agitation; Critical Illness
Study type: Interventional

Summary: 
      The objective of this study is to administer music therapy to patients in the pediatric
      intensive care unit (PICU) in order to observe how music affects patient agitation, vital
      signs, and overall recovery in the unit.
    

Detailed description: 
      This study is a prospective randomized controlled study to observe patients who have been
      admitted to the PICU with an altered state of agitation according to the Richmond Agitation
      Sedation Scale (RASS). These patients will be administered music therapy during a controlled
      setting in the day to observe whether the introduction of music therapy helps reduce the
      patient's level of agitation, improving their vital signs and overall recovery in the unit.
      Once patients are enrolled and have signed consents, patients will receive a headset with
      music or dead air. Therapy times will be selected so that there are minimal disruptions.
      Total time will be 2 hours daily, once in the morning and once in the evening. The treatments
      for session 1 and session 2 of the day will be the same (i.e. Music/ Music, No music/No
      Music).

      The investigators hypothesize that applying music therapy in the PICU will decrease
      agitation, length of stay, and narcotic administration, and normalize heart rate, respiratory
      rate, and blood pressure.
    

Intervention name(s): Music Therapy
Intervention type(s): Other
Intervention description(s): Subjects will receive one hour of music twice a day for three days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PICU; critical care; music; music therapy; agitation
Home Administration of FluMist by Parents/Caregivers
Condition: Influenza
Study type: Interventional

Summary: 
      This study will examine the feasibility of having parents and caregivers administer FluMist
      live intranasal vaccine to their children at home outside the traditional medical environment
      and without the involvement of medical personnel.

      The study will recruit patients and families that are already eligible to receive the FluMist
      vaccine. After consent is obtained and vaccine is given to the family, they will go home to
      administer vaccine to other members within 24 hours. Telephone follow up within 48 hours will
      confirm that vaccine was given successfully and within 9-12 days to assess patient
      preferences for giving vaccine at home and if there were any adverse events.
    


Intervention name(s): FluMist
Intervention type(s): Biological
Intervention description(s): Subjects receiving Flumist vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial is aimed to investigate the safety, tolerability, PK and PD of multiple
      subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor
      glycemic control after lifestyle or metformin intervention
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled trial, the first trial to
      assess the safety, tolerability, and PK/PD of IBI362 administered as multiple injections in
      Chinese patients with type 2 diabetes. The investigators and subjects will be blinded to the
      study drug IBI362 and placebo. Dulaglutide will be used as an open-label active control
      group. In this trial, 42 eligible patients will be recruited and randomly allocated to three
      cohorts. Each corhot will be randomized as an 8:4:2 ratio to IBI362 (n = 8), placebo (n = 4),
      and Dulaglutide 1.5 mg (n = 2).
    

Intervention name(s): IBI362; Placebo; Dulaglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administrated by subcutaneous injection; Administrated by subcutaneous injection; Administrated by subcutaneous injection
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Metabolism and Pharmacokinetics of [14C]-BIIL 284 BS in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of this phase I study are to define the metabolism, excretion and pharmacokinetics
      of [14C]-BIIL 284 BS after administration of a single oral dose of 25 mg [14C]-BIIL 284 BS in
      6 healthy volunteers. Tolerability was also assessed.
    


Intervention name(s): [14C] BILL 284 BS
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to learn whether Saxagliptin can improve the
      body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes
    

Detailed description: 
      All subjects will participate in a lead-in period, and qualifying subjects will continue into
      a short-term randomized treatment period. Subjects who complete the short-term period will be
      eligible to enter the long term extension period. Also, subjects who have an elevated blood
      sugar that requires additional medication for blood sugar control will be eligible to receive
      open-label metformin added onto their blinded study medication
    

Intervention name(s): Saxagliptin; Placebo; Metformin (blinded); Metformin (open-label)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT); Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST); Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12); Tablets, Oral, 500-1500 mg, as needed (starting in LT)
Other intervention name(s): BMS-477118
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Experimental Study to Compare Treatment Response and Toxicities of Concurrent Chemoradiation With Weekly Cisplatin and Three Weekly Cisplatin in Locally Advanced Head and Neck Cancer.
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare treatment responses and toxicities of concurrent
      chemo-radiation with weekly and three weekly Cisplatin in locally advanced Head & Neck
      Cancer. Half of the participants received Cisplatin (40 mg/m2) weekly with radiotherapy,
      while the other half received Cisplatin (100 mg/m2) thrice weekly with radiotherapy.
      Radiotherapy continued five days per week for six and half weeks.
    


Intervention name(s): Cisplatin 40 mg/m2; Cisplatin 100 mg/m2
Intervention type(s): Drug; Drug
Intervention description(s): Cisplatin 40 mg/m2, weekly, concurrent with Radiotherapy; Cisplatin 100 mg/m2, three weekly, concurrent with Radiotherapy
Intervention MeSH terms: Cisplatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Locally advanced; Head and Neck Cancer; Concurrent; Weekly Cisplatin; Three weekly Cisplatin; Radiotherapy
Low and High Dose Zonisamide in Children as Monotherapy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in
      children with epilepsy.
    


Intervention name(s): zonisamide low dose group; zonisamide high dose group
Intervention type(s): Drug; Drug
Intervention description(s): Initial dose was 2mg/kg/day, increased after 1~2 weeks to 3~4mg/kg/day.; Initial dose was 2mg/kg/day, increased after 2~4 weeks to 6~8mg/kg/day.
Intervention MeSH terms: Zonisamide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation
Condition: Health; Mental Health
Study type: Interventional

Summary: 
      This study is focused on the brain mechanisms and peripheral biological correlates of two
      different forms of meditation--mindfulness-based and compassion/loving-kindness. Project 1 is
      focused on the impact of compassion/loving-kindness meditation on emotional reactivity and
      emotion regulation. Project 2 is focused on the neural and behavioral correlates of
      mindfulness meditation and attention and pain regulation. In addition, Project 2 will examine
      the relations between changes in oscillatory rhythms during meditation and attention and pain
      processing. Project 3 will examine the impact of meditation on spontaneous brain activity
      during sleep. This project will also examine the impact of intensive meditation on regional
      changes in slow wave activity during subsequent sleep. Each of these projects will be
      conducted on the same participants so that interrelations among the various measures
      collected in the different projects can be examined. We believe that this study will
      dramatically advance the understanding of the mechanisms by which meditation produces changes
      in behavioral and biological processes.
    


Intervention name(s): Day of intensive meditation practice; Mindfulness Based Stress Reduction (MBSR); Health Enhancement Program (HEP)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Long-term meditators practice for ~6 hours of meditation at each time point; 8-week class designed to enhance well-being through training in mindfulness meditation; 8-week class designed to enhance well-being through training in physical activity, functional movement, music therapy, and nutrition
Other intervention name(s): MBSR; HEP
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Effectiveness of Adherence Therapy for Schizophrenia
Condition: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      When compared with those in the control (usual care) group, participants in the AT group are
      expected to demonstrate significant improvements immediately and at three, six and 12 months
      after completion of the intervention in: level of medication adherence, readmission rate,
      mental status, insight into treatment, and level of functioning.
    

Detailed description: 
      When compared with those in the control (usual care) group, participants in the AT group are
      expected to demonstrate significant improvements immediately and at three, six and 12 months
      after completion of the intervention in the following aspects:

        1. level of adherence to antipsychotic medication,

        2. rate and length of psychiatric hospital readmission,

        3. mental status,

        4. insight and attitude into illness and treatment, and

        5. level of functioning.

      The primary outcomes are level of antipsychotic medication adherence, re-hospitalization
      rates and mental status; and the patients' drug attitude will be the mediating factor of the
      AT.
    

Intervention name(s): Adherence therapy
Intervention type(s): Behavioral
Intervention description(s): Systematic and highly structured medication adherence program using the motivational interviewing (MI) technique that focuses on six principles: expressing empathy, developing discrepancy between client's beliefs and evidence, supporting self-efficacy, avoiding argumentation, and rolling with resistance to behavioral change. MI is often able (with in-depth behavioral analysis) to focus on particular consequences of problem behavior, such as medication non-adherence, that have an obvious impact on patients.
Other intervention name(s): Medication adherence program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: schizophrenia; adherence therapy; medication; randomized controlled trial; cost-effectiveness
HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth
Condition: Acquired Immunodeficiency Syndrome; Stress Disorders, Post-Traumatic
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Stress Disorders, Post-Traumatic; Psychological Trauma
Study type: Interventional

Summary: 
      The investigators propose a prospective single arm pilot cohort study of 100 youth (ages
      15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be
      enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a
      district of the Southern province, in Rwanda.
    

Detailed description: 
      The investigators propose a prospective single arm pilot cohort study of 100 youth (ages
      15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be
      enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a
      district of the Southern province, in Rwanda. UYISENGA N'MANZI identified 400 youths in
      Nyanza region, organized in 4 groups, each of them between 160 to 100 youths. Many of those
      orphans go to school in any school in the country. This situation will be taken into account
      for the calendar of activities and for organization of the regular interviews and
      evaluations.

      Random selection of the participant will be ensured by choosing study subjects from a list
      and attributing them an arbitrary number. The random selection will be weighted by the size
      of the household group across the 4 groups in the Nyanza region. Selection will also be in
      proportion of sex and age groups. In this manner 100 youth will be picked with 20 "backup" to
      account for refusals and drop-outs. Those selected youth will be asked to participate to the
      pilot study and will fill the consent form under the guidance of an external observer (not
      one of the service providers of the project to avoid consent obtained by social pressure).

      Once enrolled, the subjects will be followed during 1 year with serial evaluations at
      baseline, 3, 6, 9 and 12 months.
    

Intervention name(s): Questionnaires
Intervention type(s): Behavioral
Intervention description(s): questionnaires at entry, month 4, 8 and 12
Other intervention name(s): trauma counseling
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration
Condition: Heart Failure
MeSH terms: Cheyne-Stokes Respiration; Heart Failure
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether oxygen therapy during sleep improves
      quality of life, exercise capacity and heart function among patients with chronic heart
      failure and central sleep apnea.
    

Detailed description: 
      Oxygen therapy reduces the number of central apneas among patients with congestive heart
      failure but it is unknown whether quality of life and heart function also improve. We aim to
      test whether the quality of life, exercise capacity and heart function are improved with
      nocturnal oxygen therapy during 6 weeks with nocturnal oxygen from oxygen concentrator or
      nocturnal air from placebo concentrator.
    

Intervention name(s): nocturnal oxygen treatment from oxygen concentrators
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment