bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain
Condition: Overweight; Obesity; Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The investigators will conduct a randomized trial to evaluate the effectiveness of 3 levels
      of recommended exercise in initially overweight and obese sedentary men and women on the
      prevention of weight regain. Participants will complete a 3 mo. weight loss intervention of
      decreased energy intake (EI) and increased energy expenditure (100 minutes of physical
      activity per week). Participants achieving clinically significant weight loss (> 5% of
      initial weight), will be randomly assigned to 12 mos. of exercise at levels of energy
      expenditure of exercise (EEEx) recommended by Health and Human Services (HHS), American
      College of Sports Medicine(ACSM), Institute of Medicine (IOM): 150, 225, or 300 minutes per
      week. Major outcome assessments will occur prior to weight loss (-3 mos.), at completion of
      weight loss (0 mos.), at the midpoint (6 mos.), and completion of weight maintenance (12
      mos.).
    

Detailed description: 
      The investigators propose a randomized trial in 287 overweight and obese, sedentary adults
      (at least 50% women). Participants achieving clinically significant weight loss (≥5%)
      following a 3 mo. reduced energy diet and a program of PA (100 min/wk) will be randomly
      assigned to either maintain exercise at 150 min/wk. or increase exercise to 225 min/wk or 300
      min/wk. while consuming a weight gain prevention diet over a 12 mo. period. Exercise will be
      verified (combination of on-site and HR monitor) and EEEx will be measured at 5 mo. intervals
      beginning at mo. 5. In-person behaviorally based clinic meetings will be conducted weekly
      during the 3 mo. weight loss period (-3 to 0 mos.) and during the first 3 mos. of the weight
      regain prevention period. During the final 9 mos. of weight regain prevention, clinics will
      be held bi-monthly using group conference calls. We have not proposed to randomize
      participants to a true control group (i.e. no exercise or diet) following the 3 mo. weight
      loss program as published data indicates significant weight regain in individuals receiving
      no follow-up treatment after weight loss.
    

Intervention name(s): 150 Min/Week; 225 Min/Week; 300 Min/Week
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Performs 150 min/wk of planned moderate intensity aerobic exercise.; Performs 225 min/wk of planned moderate intensity aerobic exercise.; Performs 300 min/wk of planned moderate intensity aerobic exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Exercise; Weight Loss
Isolite and Dental Treatment Under Conscious Sedation
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      Hypothesis

      The use of Isolite® system does not produce upper airway obstruction in the pediatric
      population during dental treatment with conscious sedation.

      Purpose:

      Report the changes in airway patency and pediatric patient's behavior when Isolite® system is
      used for dental treatment with conscious sedation.

      Objectives:

        1. Determine changes in pulse rate

        2. Determine changes in SpO2

        3. Recognize breath sound's changes possibly associated with airway blockage

        4. Evaluate if the isolite® system is well tolerate by the pediatric population for dental
           treatment under conscious sedation

        5. Relate the use of Isolite® with the frequency of head reposition to open the airway.
    

Detailed description: 
      Report the changes in airway patency and pediatric patient's behavior when Isolite® system is
      used for dental treatment with conscious sedation.
    

Intervention name(s): Isolite System
Intervention type(s): Device
Intervention description(s): A type of isolation system used in dentistry. It protects soft tissues, and also has a mouth prop, which helps keep mouth open.
Other intervention name(s): Isolite
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients in need of a sedation dental appointment
      
Keywords: pediatric; conscious sedation; mouthpiece; airway; isolite system
Parkinson's Disease (PD) Treated With Focused Ultrasound Subthalamotomy at an Early Stage
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease (PD) is a common, progressive, incurable neurodegenerative disease that
      can result in severe disability and impairment in health-related quality of life. Current
      medical and surgical therapies are aimed toward maximal symptom relief with minimal
      associated side effects or morbidity. It is generally accepted that a well-placed
      stereotactic lesion is comparable in its magnitude of clinical effect to the high frequency
      electrical stimulation of the same target.

      Exablate Neuro is intended to treat movement disorders with unilateral ablation of targets in
      the thalamus, subthalamic nucleus and globus pallidus nuclei.

      With the ExAblate system, transcranial high-intensity focused ultrasound has been coupled
      with high resolution MRI to provide precise, consistent treatments that can be monitored
      throughout the procedures.
    


Intervention name(s): ExAblate treatment
Intervention type(s): Device
Intervention description(s): Subthalamotomy using the ExAblate
Intervention model: Single Group Assignment
Intervention model description: Single-site open clinical investigation
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Manipulation of the Cervical Spine on Pain Biomarkers
Condition: Neck Pain, Posterior
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study evaluates the effect of high-velocity low-amplitude thrust (HVLAT) manipulation to
      the cervical spine on neuropeptide expression as determined by the plasma concentration of
      oxytocin, neurotensin, orexin A and cortisol; and Examine the effect of HVLAT manipulation on
      pain perception in symptomatic females with non-specific mechanical cervical spine pain
    

Detailed description: 
      A high-velocity low-amplitude thrust (HVLAT) manipulation or commonly known as a spinal
      manipulation, is an intervention frequently used by physical therapists and other healthcare
      practitioners as an alternative treatment to help relieve spinal pain The mechanism by which
      HVLAT manipulation modulates pain remains undefined, although this does not contradict the
      clinical effects from HVLAT manipulation. Furthermore, there is evidence that suggests
      analgesia after HVLAT manipulation. There is a variety of observed and proposed phenomena
      that can explain the mechanisms for the psychological, mechanical, or neurophysiological
      responses from a HVLAT manipulation associated with alterations in pain processing or
      sympathetic and motor systems' excitation.
    

Intervention name(s): HVLAT manipulation; Sham HVLAT manipulation
Intervention type(s): Procedure; Procedure
Intervention description(s): HVLAT will be performed 10 minutes after the first blood draw.; Sham HVLAT will be performed 10 minutes after the first blood draw.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental Group (HVLAT manipulation) Control Group (sham HVLAT manipulation)
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Increased Protein Intake on Colonic Metabolism
Condition: Protein Fermentation; Toxicity in the Colon
Study type: Interventional

Summary: 
      The purpose of this study is to modulate the protein fermentation and to investigate the
      effect on colon toxicity.
    


Intervention name(s): High protein intake; Low Protein intake
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 30% of energy intake coming from proteins; 9% of energy intake coming from proteins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who
      have recurrent, locally advanced, or metastatic soft tissue sarcoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of flavopiridol in terms of response rate in patients
      with previously untreated metastatic or locally advanced soft tissue sarcoma. II. Determine
      the toxicity of this regimen in these patients. III. Determine the time to progression, early
      progression rate, and response duration in patients treated with this regimen.

      OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour daily on
      days 1-3. Treatment continues every 3 weeks in the absence of disease progression or
      unacceptable toxicity. Patients are followed at 4 weeks and then every 3 months until disease
      progression or death.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-18
      months.
    

Intervention name(s): alvocidib
Intervention type(s): Drug
Intervention description(s): Flavopiridol 50 mg/m2 IV over 1 hour daily x 3 days every 3 weeks
Intervention MeSH terms: Alvocidib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma
Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This phase IV open study will evaluate the persistence of humoral antibodies against
      hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in
      adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals'
      recombinant hepatitis B vaccine (Engerix™-B) in infancy.
    


Intervention name(s): Engerix™-B Kinder
Intervention type(s): Biological
Intervention description(s): Intramuscular, one dose.
Other intervention name(s): HBV vaccine; Engerix™-B
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: persistence; HBV; Long-term; Engerix™-B Kinder; Hepatitis B; adolescent
The Effects of COVID-19 Infection on Respiratory Muscle Strength and Core Stabilization
Condition: COVID-19; Pandemic, COVID-19; Corona Virus Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections
Study type: Observational

Summary: 
      World Health Organization (WHO) Novel-19 Corrosion Disease (COVID) in 2019 without being used
      by a pathway caused by the SARS-CoV-2 virus. After the acute period in COVID-19 patients,
      muscle weakness may continue in breathing, weakness, and training. The effects on core
      stabilization, pulmonary functions, respiratory muscle strength, physical activity scores and
      quality of life in healthy adults who do not have COVID-19 who do regular exercise may be
      higher than in healthy adults who do regular exercise with COVID-19.
    

Detailed description: 
      The type of our study was planned as Case-Control. 50 exercises will be included in our
      study. The first COVID-19 (n= 25) is healthy, and the second group will come from the
      successful group without COVID-19 (n=25). Between February and April, a student will accept
      participating in the clinic at Bezmialem Foundation University. After being informed about
      it, the attached form will be signed. In addition, participants will be asked to fill in our
      attached document, including demographic and clinical studies, in a face-to-face interview.
      All body exercises, breathing muscle test, six-minute walking test, McGill core endurance
      test, short-form test, and quality of life test were planned in our two groups. The results
      of these tests will be evaluated by testing and checking.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Data will be evaluated in healthy adult volunteers who agreed to participate in the
        clinical study at Bezmialem Vakıf University Dragos Hospital between February and April.
      
Keywords: covid-19; coronavirus; respiratory physiotherapy; core stabilization
Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective interventional study to assess the effect of sarpogrelate compared with
      aspirin in Korean type 2 diabetic patients with atherosclerosis.
    

Detailed description: 
      Type 2 diabetes has been increased exponentially, arousing serious economic, social and
      health repercussions. Also, macrovascular complications of diabetes such as myocardial
      infarct or stroke have been increased. Individuals with diabetes have a greater risk of
      cardiovascular disease (CVD), approximately two to four times than that of those without
      diabetes. Currently, the U.S. Food and Drug Administration requires demonstration that new
      anti-hyperglycemic agents do not increase cardiovascular risk. The comprehensive and
      multifactorial management in type 2 diabetes, which includes control of hypertension,
      dyslipidemia and obesity, is known to significantly reduce the risk of CVD as shown in
      Steno-2 study. However, most anti-diabetic agents currently used in clinical practice do not
      seem to provide enough cardiovascular protection.
    

Intervention name(s): Sarpogrelate; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Sarpogrelate; Aspirin
Other intervention name(s): Anplag; Aspirin protect or Astrix
Intervention MeSH terms: Aspirin; Sarpogrelate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different
      concentrations) in healthy infants aged approximately 3 months previously uninfected with
      human rotavirus.
    


Intervention name(s): Rotarix
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Oral live attenuated human rotavirus vaccine; Gastroenteritis; Vomiting
Study To Describe The Safety Of 13-valent Pneumococcal Conjugate Vaccine In Children 6 To 17 Years Of Age In India
Condition: Vaccines
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, open-label, single-arm, multicenter study in which subjects 6 to 17 years
      of age will receive 1 dose of 13vPnC.
    

Detailed description: 
      A Phase 4, open-label, single-arm, multicenter study to describe the safety of 13-valent
      Pneumococcal Conjugate Vaccine in children 6 to 17 years of age in India.
    

Intervention name(s): 13vPnC
Intervention type(s): Biological
Intervention description(s): All subjects receive a single dose (0.5mL) of 13vPnC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators wish to investigate whether enhancement of SWS, which is seen after a drug
      called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function,
      specifically sleepiness and mental performance. This is a safe and well-tolerated drug that
      is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.

      The investigators will study 12 patients diagnosed with CFS using international diagnostic
      guidelines. The investigators will record overnight sleep with EEG (brainwave) measurement on
      the 1st and 4th nights of a 4 night period during which sodium oxybate and placebo will be
      taken nightly, and the investigators will measure next-day sleepiness, mental performance and
      fatigue, and compare drug and placebo nights.
    

Detailed description: 
      Chronic fatigue syndrome (CFS), characterised by chronic disabling fatigue, sleep impairment
      and other symptoms, is associated with neither a currently identifiable disease process nor
      major psychiatric illness, and has an estimated prevalence in primary care of 1-2%. Sleep
      impairment is common in nearly everyone with CFS, with both daytime sleepiness and
      unrefreshing nighttime sleep reported, and consequent impact on daytime function. It may be
      that fundamental regulatory processes that control sleep are disturbed in CFS, leading to
      different effects on sleep and daytime symptoms depending on the subject's prior sleep,
      daytime routine, medication and other factors. The investigators contacts with patient groups
      have indicated that patients are generally confident that on days when their sleep is better
      they perform better in the day. There is growing evidence that deep, slow wave sleep (SWS) is
      altered in CFS, and this may suggest impairment of build up of sleep pressure during the day.
    

Intervention name(s): Sodium Oxybate; placebo (fresh potable water)
Intervention type(s): Drug; Other
Other intervention name(s): Xyrem
Intervention MeSH terms: Sodium Oxybate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Chronic fatigue syndrome
Preliminary Evaluation of Alternative Approaches to Combustible Cigarette Cessation (Exchange Project Sub-Study)
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      This sub-study component (n = 60) of The Exchange Project will:

      characterize reductions in cigarette smoking following the provision of: 1) an e-cigarette
      device and supplies (device charger, pods), 2) e-cigarette + financial incentives for
      cigarette cessation, among homeless adults randomized to 1 of the 2 intervention arms.
    

Detailed description: 
      Sub-study participants will be randomly assigned to: 1) the provision of an e-cigarette
      device and supplies/pods through 4 weeks post-switch along with directions to switch over
      from combustible cigarettes to e-cigarettes exclusively, or 2) the combination of an
      e-cigarette device and supplies through 4 weeks post-switch and financial rewards to
      incentivize combustible cigarette abstinence. In all groups, cigarette smoking will be
      monitored over a 8-week period to characterize reductions in cigarette smoking and rates of
      smoking cessation. It is anticipated that individuals who are provided with an e-cigarette
      device and supplies, and are also incentivized for completely switching from cigarette
      smoking to e-cigarette use will show the greatest reductions in cigarette smoking and be the
      most likely to stop smoking combustible cigarettes altogether. The long-term objective of the
      sub-study is to identify strategies to help homeless adults quit smoking or switch to
      e-cigarettes as a harm reduction strategy.
    

Intervention name(s): E-cigarette; Financial incentives + E-cigarette
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive an e-cigarette device and pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.; Participants will receive an e-cigarette device and pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking cessation; Contingency management; Financial incentives; JUUL; VUSE