bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a 12-week Home-based Yoga on Bone and Cardiovascular Health
Condition: Osteoporosis; Cardiovascular Risk Factor
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      While effects of specific exercise interventions on bone and CVD in postmenopausal women have
      been demonstrated and evaluated, the effects of randomized controlled exercise interventions,
      particularly in middle-aged premenopausal women are sparse. Therefore, it is imperative to
      examine the relation between behavioral interventions and bone and cardiovascular outcomes in
      premenopausal women as this understudied group is at high risk for the initial stages of bone
      loss and cardiovascular disease development.
    

Detailed description: 
      Presently, it is not clear whether the intensity of Yoga interventions is high enough to
      induce positive effects on bone and cardiovascular health in a healthy population. For
      example, Hagins et al. (2007) reported that the metabolic costs of Hatha Yoga, averaged
      across the entire session, represent low levels of physical activity (walking). On the other
      hand, Ashtanga Yoga, or power Yoga, is performed at a higher intensity than Hatha Yoga and
      has been shown to elicit significantly higher heart rates than either Hatha or gentle Yoga
      (Cowen and Adams, 2007). Sun Salutations (SS) are an example of an Ashtanga Yoga sequence,
      where yoga postures are performed dynamically with combinations of forward and backward
      bending poses (Omkar et al., 2011). A previous 8-month yoga intervention found that regular
      long-term Ashtanga yoga had a small positive effect on bone formation in premenopausal women.
      Although Yoga has the potential to be an alternative physical activity to improve bone health
      and arterial stiffness, there is a lack of high-quality evidence for this type of
      intervention. Thus, the purpose of this study is to assess the feasibility of a 12-week
      home-based dynamic yoga intervention designed to improve bone metabolism and arterial
      stiffness in healthy premenopausal women.
    

Intervention name(s): Yoga group
Intervention type(s): Behavioral
Intervention description(s): During the in-home yoga intervention, participants performed 30 to 50 minutes of yoga postures three to five times a week for 12 weeks, including 5 minutes of warm-up exercise, 15 to 30 minutes of dynamic flow yoga postures, 10 minutes of weight barring standing postures, and 5 minutes of cool-down. These in-home sessions were a repeat of what participants learned during the first week of training session at UML. We progressively increased the intensity of the home practice sessions by adding the number of sun salutation (SS) over the 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned either a yoga intervention group or a control group.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Yoga; Bone markers; Arterial stiffness; Premenopausal women
An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the pharmacokinetics and evaluate the safety
      following a single dose of azithromycin 2g extended-release powder for oral suspension with a
      3-day dosing regimen of azithromycin 500mg tablet in Chinese healthy male subjects. This
      study data will be used to support azithromycin NDA in China.
    


Intervention name(s): azithromycin (Zithromax); azithromycin (Zithromax)
Intervention type(s): Drug; Drug
Intervention description(s): a single dose of azithromycin ER 2g
3-day regimen of azithromycin tablet 500mg; 3-day regimen of azithromycin tablet 500mg
a single dose of azithromycin ER 2g
Other intervention name(s): Zithromax; Zithromax
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: azithromycin, pharmacokinetics
Study of NGX-1998 for the Treatment of Postherpetic Neuralgia
Condition: Postherpetic Neuralgia; Pain
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy, safety and tolerability of NGX-1998
      applied for 5 minutes for the treatment of postherpetic neuralgia (PHN).
    

Detailed description: 
      This study is a 12-week multicenter randomized, double-blind, controlled evaluation of the
      efficacy, safety and tolerability of NGX-1998 for the treatment of postherpetic neuralgia
      (PHN). Eligible subjects will have pain from PHN, with average numeric pain rating scale
      (NPRS) scores during screening of 4 to 9 (inclusive). Painful areas of up to 1500 cm2 will be
      treated during a single Test Article application. Subjects will be randomly assigned to
      receive NGX-1998 (10% or 20% w/w) or placebo according to an unequal allocation scheme of
      2:2:1. Subjects will also be stratified by gender.
    

Intervention name(s): NGX-1998; Placebo Liquid
Intervention type(s): Drug; Drug
Intervention description(s): Capsaicin topical liquid to be applied for 5 minutes one time only.; Placebo topical liquid to be applied for 5 minutes one time only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: postherpetic neuralgia; PHN; capsaicin; herpes zoster; shingles; analgesics; neuropathy
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Primary Objective:

      To evaluate safety (4 weeks)

      Secondary Objectives:

        -  To evaluate the long-term safety (12 weeks)

        -  To evaluate the efficacy

        -  To characterize the pharmacokinetic profile
    

Detailed description: 
      The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase,
      up-to 8-week extension phase, and up-to 5-day post-treatment phase.
    

Intervention name(s): fexofenadine/Allegra (M016455)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:dry syrup formulation to be suspended in water
Route of administration: oral
Intervention MeSH terms: Fexofenadine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Relevance of Performing Lumbar Puncture in Infants Aged 3 to 12 Months With First Episode of Febrile Convulsion
Condition: Febrile Convulsions
MeSH terms: Seizures; Seizures, Febrile; Hyperthermia; Fever
Study type: Observational

Summary: 
      The actual recommendations for infants aged 3 to 12 months presented with first episode of
      Febrile Convulsions highly recommend performing lumbar puncture in order to rule out
      Bacterial Meningitis. On the other hand, recent studies in the era of anti Pneumococcal
      vaccination arise the question if in the presence of a normal physical examination those
      recommendations are still relevant. The purpose of this study is to summarized
      retrospectively the clinical records of all the infants admitted to the pediatric wards in
      the ten years period since 2000 to 2010 in order to record the incidence of Bacterial
      Meningitis among infants admitted with the First episode of Febrile Convulsions.
    

Detailed description: 
      Demographic data, including ethnic origin, age an gender will be recorded. The type of
      Convulsions (Simple or Complex), duration, and time since the fever was noticed will be also
      recorded. Another data that will be summarized included: previous antibiotic treatment,
      physical examination with special emphasis on neurological examination and meningeal signs,
      routine laboratory analysis including blood count and cerebrospinal fluid (CSF) results and
      the final diagnosis including the cause of fever.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Infants aged 3 to 12 months who presents with First Episode of Febrile Convulsions
      
Keywords: Infants
Pulsed Electromagnetic Field Therapy in the Refractory Migraine
Condition: Refractory Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of
      migraine or decrease them even in the patients with refractory migraine.
    

Detailed description: 
      Migraine is most common among patients who seek medical care for headache. The prevalence of
      migraine is around 10 % in Iran. The many studies of migraine pathophysiology imply that the
      brain of migraine patient is impaired in term of cerebral circulation and baseline activity
      of brain stem, monoaminergic system and cortex. Then headache is only a sign of the changes
      that occur in the brain to rid hazardous conditions. Based on this theory many
      electrophysiological and imaging abnormalities that were appeared in the brain before the
      aura or the headache were diminished in the early phases of the attack. It means the changes
      concurrent with headache are associated with a quasi normalization of cortical information
      processing. The different pharmacological and non-pharmacological treatments have proposed
      for migraine management. But some patients do not satisfactorily respond to or cannot
      tolerate current evidence-based treatments. This group of patients is often said to have
      refractory migraine (RM). Thus according to the enigmatic pathophysiology of migraine, a
      comprehensive treatment that affected all contributing factors in the migraine with minimal
      side effects is not provided yet.

      Extremely low frequency magnetic fields (ELF MFs) as non-pharmacological treatment of
      migraine had good effect with weak evidence in the control of migraine. Recently based on
      extensive studies in the bioeffects of the low frequency electromagnetic field we can hope
      that this method can respond to many human disorders is unsolvable. The purpose of this study
      is to apply the best effective treatment protocol of ELF-MF on brain and circulatory system
      is extracted by using the latest findings of studies of low-frequency electromagnetic fields
      as intervention and apply it for refractory migraine patients in the form of a randomized
      one-blind placebo- controlled trial study. The evaluation of interventions is done
      subjectively (migraine dairy and MIDAS). Also we consider follow up period to confirm
      results.
    

Intervention name(s): pulsed electromagnetic field
Intervention type(s): Procedure
Intervention description(s): parameters of the pulsed electromagnetic field are frequency:10 Hz, intensity 4-5 mT, 6 sessions( 2 week) for placebo and phase 1 treatment ( 3 sessions in week) and added 6 sessions for phase 2 treatment. the solenoid diameter of instrument is 70 cm is placed around the head.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: RM; R-CM; based on ICHD-2 criteria
Kinesio Taping Effectiveness on Idiopathic Toe Walking
Condition: Idiopathic Toe Walking
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Idiopathic Toe Walking (ITW) is a diagnosis normally of exclusion and likely, consequently,
      is approached in vastly varying ways of intervention, including serial casting, Botox
      injections and physical therapy. There is some evidence in the literature that children with
      ITW can somewhat correct their lack of heel-strike gait pattern at least temporarily. Kinesio
      Taping (KT) method is an intervention that is used in the outpatient physical therapy setting
      for various conditions such as post-operative edema, muscle facilitation of weakened rotator
      cuff muscles, and functional corrections in children with torticollis. This pilot study will
      strive to determine if KT may be effective by providing proprioceptive and neuromuscular
      re-education through thermal and mechanical fascial impositions, thereby improving passive
      joint range of motion (ROM) through reduction of passive muscle stiffness and improving
      ambulation through neuromuscular re-education in children with idiopathic toe walking. We
      will quantify passive muscle stiffness of the gastrocnemius and opposing anterior tibialis
      using non-invasive Shear Wave Elastography (SWE). Further we look at the kinematics and
      kinetics of the child's ankle during the gait cycle to further determine any effect(s) of KT
      on functional walking outcome measures. The intent is that the results from this study will
      serve as a platform from which to expound look at the long-term, if any, effects of KT on the
      muscle property and gait cycle pattern in children with ITW.
    


Intervention name(s): Kinesio Tape of the Ankle
Intervention type(s): Device
Intervention description(s): Tibialis anterior facilitation/ gastrocnemius inhibition: Taping to be worn 3-5 days and repeated x 1
Other intervention name(s): Kinesio Tape
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: idiopathic toe walking; gait disorder; gait analysis; kinesio taping; ultrasound elastography; pediatric; children; muscle stiffness; muscle elasticity
Efficacy of Intermittent ThetaBurst Stimulation Compared to 10 Hz Stimulation on Dorsolateral Prefrontal Cortex in Treatment Resistant Major Depressive Disorder: a Double-blind Randomized Study
Condition: DEPRESSION
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This trial will compare innovating stimulation parameters, intermittent Theta Burst
      Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral
      prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both
      treatment conditions. The study seeks to determine if there is a superiority in therapeutic
      efficacy with iTBS protocol compared to conventional one.
    


Intervention name(s): Transcranial magnetic stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
LearningRx Cognitive Training for ADHD
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this investigation is to conduct a series of case studies on the impact of
      LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for
      participants with ADHD.
    

Detailed description: 
      Using a multiple baseline design across cases with start point randomization, the proposed
      study will examine the outcomes from LearningRx one-on-one cognitive training across domains
      on standardized measures used to monitor treatment effectiveness for ADHD.
    

Intervention name(s): LearningRx cognitive training
Intervention type(s): Behavioral
Intervention description(s): A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)
Condition: Atrial Fibrillation; Arrhythmia; Stroke, Cardiovascular
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Atrial Fibrillation; Arrhythmias, Cardiac; Myocardial Infarction
Study type: Interventional

Summary: 
      The purpose of this research study is to learn about arrhythmia detection in obstructive
      sleep apnea (OSA). For several years patients with OSA have an increased likelihood of having
      irregular heartbeats. This study will determine how often patients with OSA have irregular
      heartbeats. This study will also define which OSA patients are most likely to have irregular
      heartbeats.

      The participant is being asked to be in the study because the participant has been diagnosed
      with obstructive sleep apnea (OSA).
    


Intervention name(s): The Lifestar Act III
Intervention type(s): Device
Intervention description(s): The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: sleep apnea; arrhythmia detection
A Molecular and Functional Brain Imaging Study in Individuals With Down Syndrome and Healthy Controls Following Single Dose RG1662
Condition: Healthy Volunteer, Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, single-blind, placebo-controlled, parallel-group study with crossover
      component will evaluate the GABAAalpha5 receptor expression, occupancy and functional
      connectivity in the brains of individuals with Down syndrome and healthy controls following
      single dose RG1662. Participants will receive a single dose of placebo before the imaging
      session (PET and MRI), and a single dose of RG1662 before the second imaging session.
    


Intervention name(s): RG1662; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Single oral dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Broccoli Sprout Intervention in Qidong, P.R. China
Condition: Environmental Carcinogenesis
MeSH terms: Carcinogenesis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be
      conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships
      will be screened and three hundred eligible individuals will be enrolled in the study.
      Participants will be randomized into two treatment groups: one will receive a juice beverage
      containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice,
      lime juice, and water and the other will receive a placebo beverage containing pineapple
      juice, lime juice and water. Participants will drink their assigned beverage every evening
      and provide biweekly urine samples and monthly blood samples. The principal endpoints of this
      study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their
      metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of
      exposure biomarkers for dietary and air-borne toxins, which are known to be high in this
      population.
    


Intervention name(s): Broccoli Sprout Extract Beverage; placebo beverage
Intervention type(s): Drug; Drug
Intervention description(s): Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.; 100 mL of dilute pineapple and lime juice daily for 84 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: glucoraphanin; sulforaphane; pharmacokinetics; pharmacodynamics; broccoli sprout; carcinogens, environment
Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a
      four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates
      are inadequate and persistence of immunity remains a challenge.

      This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune
      persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three
      injections at months 0, 1, and 6 in hemodialysis patients.
    

Detailed description: 
      Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine
      group or 60µg recombinant hepatitis B vaccine group.The 20 µg group will receive three
      intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group
      will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6,
      respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions
      will be recorded after vaccination.
    

Intervention name(s): 60 µg dose hepatitis B vaccine; 20 µg dose hepatitis B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): three-dose, 60 µg per dose; three-dose, 20 µg per dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hepatitis B, Vaccine; Randomized Controlled Trial; Hemodialysis; Immunogenicity
An Artificial Intelligence Assisted Telehealth Intervention to Promote Self-Management in Patients With Type 2 Diabetes Mellitus (Qualitative Interview)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This protocol involves a qualitative study of the needs/preferences of people with diabetes
      and health coaches regarding a telehealth coaching platform for glycemic control in people
      with diabetes.
    


Intervention name(s): Semi-structured Interview
Intervention type(s): Behavioral
Intervention description(s): One-on-one semi-structured interviews
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        There will be a total of two 2 groups - one group comprising of 10 health experts and
        another group 2comprising of 10 patient/caregiver dyads (20 people). There is no treatment
        or intervention offered, only the interview questionnaire will differ based on the group.