bioihbjkbjnl/mcl2 huggingface dataset:
Ehealth: Second Life Impacts Diabetes Education & Self-Management
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to to develop and evaluate the feasibility, usability, and
      effect of participation in SLIDES (a virtual diabetes community in Second Life) for providing
      interactive diabetes education, support, and resources.
    


Intervention name(s): eHealth program in the Virtual Environment (VE) platform Second Life
Intervention type(s): Behavioral
Intervention description(s): determine the feasibility and acceptability of an eHealth program that provides diabetes education and self-management support.
Other intervention name(s): Second Life
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes; Second Life; virtual community; diabetes education; diabetes support group
Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation
Condition: Stroke
Study type: Interventional

Summary: 
      tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used
      in chronic stroke patients to improve a variety of functions with upper limb.
    

Detailed description: 
      tDCS and RAT will be used in chronic stroke patients to improve a variety of functions such
      as motor functions with upper limb.

      tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. A session of
      RAT will be associated with tDCS/placebo. Behavioural data will be collected before and after
      tDCS, associated with RAT.
    

Intervention name(s): tDCS (ELDITH) and RAT (REAplan)
Intervention type(s): Device
Intervention description(s): Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Effect of Multiple Doses of Tradipitant on CYP3A4 Using Midazolam as a Substrate in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the potential effect of administration of tradipitant on
      CYP3A4 using midazolam pharmacokinetics as markers.

      The study will also further characterize the pharmacokinetics of tradipitant.
    


Intervention name(s): tradipitant; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): test agent; substrate for drug-drug interaction assessment
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Posterior Nasal Nerve (PNN) Rhinitis Study
Condition: Chronic Rhinitis
MeSH terms: Rhinitis
Study type: Interventional

Summary: 
      Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis
    

Detailed description: 
      This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate
      the safety and efficacy of the Aerin Medical device (InSeca Stylus) when used to deliver
      radiofrequency (RF) energy to the posterior nasal nerve area to improve symptoms in those
      diagnosed with chronic rhinitis.
    

Intervention name(s): InSeca Stylus
Intervention type(s): Device
Intervention description(s): Low power radiofrequency energy delivery to the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus).
Intervention model: Single Group Assignment
Intervention model description: All enrolled subjects will be treated with the InSeca Stylus
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Preoperative Anxiety on Postoperative Delirium in Children
Condition: Preoperative Anxiety; Postoperative Delirium
MeSH terms: Delirium; Emergence Delirium; Anxiety Disorders
Study type: Observational [Patient Registry]

Summary: 
      Investigation of the effect of preoperative anxiety on postoperative delirium in children who
      will undergo circumcision operation
    

Detailed description: 
      In order to determine the effect of circumcision on preoperative anxiety and postoperative
      delirium, patients will be divided into two groups who will undergo circumcision surgery and
      who will undergo inguinal hernia surgery.

      Modified Yale Preoperative Anxiety Scores (m-YPAS), Visual Analogue Scale Anxiety
      (VAS-anxiety) will be evaluated when patients are taken to the preoperative waiting room.

      After awakening, patients will be taken to the postoperative wake-up room where Pediatric
      Anesthesia Recovery Delirium Scores (PAED), Recovery Agitation 5-point Scores (EA), FLACC
      scores will be evaluated every 5 minutes and mean arterial pressure, pulse, SPO2 values will
      be recorded. Duration of stay in recovery unit will be recorded
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        First 60 patients coming to the operating room who met the study criteria
Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period
Condition: Weight Change
MeSH terms: Body Weight; Body Weight Changes
Study type: Observational

Summary: 
      The purpose of this study is to learn whether women who use progestin-only methods of birth
      control such as the contraceptive implant (Implanon), the levonorgestral-releasing IUS
      (Mirena), or depot medroxyprogesterone acetate(DMPA) will experience weight change compared
      to women using the non-hormonal copper IUC (ParaGard).

      The investigators primary hypothesis is that users of DMPA will gain excess weight and
      increase their BMI above the copper-IUC users; secondarily, the investigators will compare
      users' data in the LNG-IUC and ENG implant groups to the copper-IUC group.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants already enrolled in the Contraceptive CHOICE Project will be offered
        participation during their 12-month follow up window if they had originally selected one of
        the four methods being studied during CHOICE enrollment.
      
Keywords: weight change; contraception; birth control; progestin; progestin only; weight gain; depo; Depo Provera; DMPA; IUD; IUC; Mirena; Paragard; Implanon; implant
A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian Participants
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I single-dose study to investigate the pharmacokinetics, safety, and
      tolerability of sotrovimab vs placebo by intravenous or intramuscular administration in
      healthy Japanese and Caucasian participants.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
      of a single fixed dose of sotrovimab administered intravenously (IV) or via intramuscular
      (IM) injection in Japanese and Caucasian healthy volunteers. This study will occur in two
      parts (Part 1 and Part 2).

      Part 1: Healthy Japanese and Caucasian participants will be randomized in a 4:1 ratio to
      receive a single IV infusion of sotrovimab or volume-matched saline placebo on Day 1.
      Participants will be blinded to study intervention. Safety, tolerability, immunogenicity, and
      PK of IV sotrovimab will be evaluated.

      Part 2: Healthy Japanese and Caucasian participants will be randomized in a 4:1 ratio to
      receive a single IM dose of sotrovimab or volume-matched saline placebo on Day 1.
      Participants will be blinded to study intervention. Safety, tolerability, immunogenicity, and
      PK of IM sotrovimab will be evaluated.

      The data from this study will be used to supplement data available from other clinical trials
      that were conducted in non-Japanese participants.
    

Intervention name(s): sotrovimab; Placebo to Biologic; sotrovimab; Placebo to Biologic
Intervention type(s): Biological; Other; Biological; Other
Intervention description(s): sotrovimab IV infusion, single dose; Sterile 0.9% (w/v) sodium chloride solution; Sotrovimab IM injection, single dose; Sterile 0.9% (w/v) sodium chloride solution
Intervention MeSH terms: Sotrovimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: SARS-CoV-2 coronavirus; coronavirus disease 2019; COVID-19; Japanese pharmacokinetics
Inhaled Allergen Challenge Methodology: Assessment of a Vibrating Mesh Nebulizer for Allergen Administration
Condition: Asthma
Study type: Interventional

Summary: 
      This study will assess the Aerogen Solo® (Solo®) vibrating mesh nebulizer as a potential new
      device for use in allergen challenge testing.
    

Detailed description: 
      This will be a multi-center, randomized, cross-over study utilizing the expertise of three
      Canadian academic centers (University of Saskatchewan, McMaster University, Laval University)
      that have been performing allergen inhalation challenges and other bronchoprovocation studies
      for more than forty years.

      Each participant will be required to attend the research lab on five occasions (Visits 1-5).
      At Visit 1, study staff will provide an overview of the study purpose and procedure and
      answer any questions the participant may have. The individual will then provide consent if
      they wish to participate (i.e. sign the consent form). Skin prick testing to determine
      relevant allergen sensitivities and to determine which allergen extract will be used for the
      skin test endpoint (STE) and allergen inhalation challenge will then be performed. The
      participant will be randomized with respect to which nebulizer (Solo® or Wright) will be used
      first. The choice of nebulizer for the first participant will be via blinded draw. Subsequent
      nebulizer assignments will alternate. Participants will undergo the STE procedure and
      methacholine challenge testing (MCT) at visit 2; an allergen challenge will be done the next
      day at Visit 3 using the same nebulizer as was used for the MCT at Visit 2. Visits 4 and 5
      will also be performed on consecutive days and will involve methacholine and allergen
      challenge testing, respectively, using the nebulizer that was not used at Visits 2 and 3. A
      minimum of two weeks must separate Visits 3 and 4.
    

Intervention name(s): Wright jet nebulizer; Aerogen Solo
Intervention type(s): Device; Device
Intervention description(s): Roxon Medi-Tech, Montreal, QC, Canada; Aerogen Ltd., Galway, Ireland
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: vibrating mesh nebulizer; allergen challenge
Guided Self-help for Families With an Overweight Child
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether a home based program can teach parents and
      moderately overweight kids who are of 8-12 years old with a BMI% between 85-97%, how to
      manage their child's weight. The study uses manuals and involves a short visit to the clinic
      every other week.
    

Detailed description: 
      An estimated 4-5 million children between the ages of 6-17 in the United States are obese.
      Children who are obese are at an increased risk for many negative health consequences in
      childhood and in adulthood. In addition, these children are at an increased risk for
      psychosocial consequences in childhood and adolescence, including poor self-esteem, teasing,
      verbal abuse and social isolation. Guided self-help offers an opportunity to provide
      empirically based programs to a larger amount of the target population. Once such treatment
      methods are available, it is possible that the guided self-help treatment for childhood
      obesity can be disseminated to primary care practitioners, psychologists, nurses, and health
      educators. Ultimately, the goal of this application is to develop a treatment protocol that
      can be used by clinics and lay health professionals to intervene with children who are
      overweight and their parents.
    

Intervention name(s): Immediate Treatment Group; Delayed Treatment Group
Intervention type(s): Other; Other
Intervention description(s): The immediate treatment group starts the 5-month treatment right after baseline assessment.; The delayed treatment group does not start treatment immediately after the baseline assessment. This group serves as the control group, by not receiving any treatment for 5 months. After the 5 months, the delayed group participants are asked to come in for a second assessment that involves completion of surveys and measurement of height, weight, and physical activity level. After this assessment is completed, the delayed group participants can begin the 5-month treatment.
Other intervention name(s): Delayed Treatment Group (Control)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; guided self help treatment; treatment method; overweight; overweight children and parents; families with overweight child; efficacy; body mass index; weight
Effect of the Omentectomy on the Hyperglycemia and the Resistance to the Insulin in Patients With Morbid Obesity
Condition: Obesity; Diabetes Mellitus Type 2
MeSH terms: Obesity; Hyperglycemia; Obesity, Morbid; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To determine if the omentectomy diminishes hyperglycemia and improves the resistance to the
      insulin in patients with morbid obesity and propensity to develop to Diabetes Mellitus type
      2.
    

Detailed description: 
      To determine the Blood levels of glucose, curve of tolerance to the glucose, hemoglobin
      glycosylated, insulin, triglyceride, cholesterol, HDL, LDL, leptin and Adiponectin in
      patients with Obesity Morbid and that will be put under umbilical surgery and cholecystectomy
      opened.

      To put under them umbilical surgery or Cholecystectomy open with and without omentectomy To
      compare the Blood levels of of glucose, curve of tolerance wing glucose, hemoglobin
      glycosylated, insulin, triglyceride, cholesterol, HDL, LDL, leptin and Adiponectin before and
      after the procedure
    

Intervention name(s): omentectomy
Intervention type(s): Procedure
Intervention description(s): surgery omentectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Role of Dry Needling in Hallux Valgus
Condition: Hallux Valgus; Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Hallux Valgus; Bunion
Study type: Interventional

Summary: 
      Forty Hallux valgus patients between the ages of 25-65 years, who are admitted to the
      Physical Medicine and Rehabilitation clinic with the complaint of 1st Metatarsophalangeal
      (MTF) pain and who meet the inclusion and exclusion criteria will be included. Hallux valgus
      (HV) angles will be measured by dorsoplantar radiography before the patients start the study.
      The HV angle was measured as the angle between the bisection line of the first metatarsal
      bone and the first proximal phalanx. Demographic data (age, gender, body mass index) will be
      recorded at the beginning of the study. Then, the initial Foot Functional Index (FFI) and
      Visual Analog Scale (VAS) scales were completed. The 1st MTF joint angle was also measured
      with a goniometer and recorded before starting the study. The patients were divided into two
      groups. The first group will be given 3 sessions of dry needling with Seirin branded 0.6*50
      mm acupuncture needles for trigger point in the abductor hallucis muscle and toe-spread-out
      exercise. The second group will receive only toe-spread-out exercises. After starting the
      treatment, FFI and VAS scores and 1st MTF angles will be measured and recorded weekly with a
      goniometer. At the end of the 3-week treatment, the FFI and VAS scores of the participants
      will be re-evaluated after 1 week and 1 month, and the participants will be re-evaluated with
      a goniometer. The hallux valgus angle will be re-evaluated with X-ray 4 weeks after the end
      of the treatment.
    


Intervention name(s): Toe spread out; Dry needling+Toe spread out
Intervention type(s): Other; Other
Intervention description(s): toe-spread-out exercise.; The group will be given 3 sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles for trigger pointe in the abductor hallucis muscle and additionally toe-spread-out exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Personal Activity Intelligence Versus 10,000 Steps Daily on Cardiorespiratory Fitness
Condition: Obesity; Physical Activity
Study type: Interventional

Summary: 
      A high physical fitness can prevent cardiovascular disease. Which form of exercise training
      is efficient at improving fitness is well known. The challenge is to get people to do it.
      Personal activity intelligence (PAI) is an algorithm developed for this challenge. It gives a
      score that tells the users whether they are active enough to achieve the maximum health
      benefit of exercise based on their heart rate. It has been shown that people who obtain 100
      PAI a week have less cardiovascular disease, but intervention studies showing that PAI can
      improve physical fitness are so far lacking.

      Step counters have received a lot of attention and 10 000 steps a day is a common
      recommendation, but little is known about the physiological adaptations to this intervention.

      This study will compare the effect of physical activity with a value of 100 PAI points a week
      with 10 000 steps a day in healthy, but overweight (body mass index > 25) participants
      between 30 and 50 years of age.
    


Intervention name(s): personal activity intelligence; 10,000 steps daily
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomized to the PAI intervention will receive a Mio Slice fitness bracelet and asked to install the Mio Pai 2.0 app on their smart phone. This tracks their fitness score based on the PAI algorithm where the goal is to maintain 100 PAI points a week. PAI is earned incrementally based on time spent in three different heart rate zones, low, medium and high intensity. PAI is recorded every day and added to the weekly total and the PAI earned on the same day the previous week is deleted (on Tuesday, the PAI earned the previous Tuesday will disappear).
Participants will be encouraged to maintain 100 PAI during the 8 weeks intervention by telephone messages (sms).; Participants randomized to the 10,000 step intervention will receive a fit bit zip step counter and asked to obtain 10.000 steps per day. Participants will be encouraged to obtain 10.000 steps per day by telephone messages (sms).
Other intervention name(s): PAI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Actigraphy; Prevention and Control; Cardiorespiratory Fitness
Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis
Condition: Secondary Progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine whether simvastatin at a dose of 80mg can reduce the rate of whole brain
      atrophy, as measured by MRI, over a 2-year time-period when compared to placebo.
    

Detailed description: 
      The study has now completed see Primary publication:

      Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive
      multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial.

      Chataway J, Schuerer N, Alsanousi A, Chan D, MacManus D, Hunter K, Anderson V, Bangham CR,
      Clegg S, Nielsen C, Fox NC, Wilkie D, Nicholas JM, Calder VL, Greenwood J, Frost C, Nicholas
      R.

      Lancet. 2014 Jun 28;383(9936):2213-21. doi: 10.1016/S0140-6736(13)62242-4.
    

Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80mg simvastatin oral once daily for 24 months; Oral placebo tablet once daily for 24 months
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Secondary progressive Multiple Sclerosis; Simvastatin; MRI
Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of a lifestyle intervention program on
      type 2 diabetes risk factors and quality of life in overweight Latino youth.
    

Detailed description: 
      With the increasing prevalence of obesity, the incidence of obesity-related co-morbidities
      including depression and type 2 diabetes have emerged as critical public health conditions.
      Furthermore, Latinos experience a disproportionately greater burden of these obesity-related
      disorders. Therefore, we have developed a 12-week community-based lifestyle intervention that
      includes weekly education sessions for children and their parents and 3 exercise sessions per
      week for youth. The program will be delivered at a local YMCA in the greater Phoenix
      Metropolitan area.
    

Intervention name(s): Lifestyle Education Sessions and Youth Exercise Sessions
Intervention type(s): Behavioral
Intervention description(s): The intervention will include a ~1-2 hour weekly education session to address the following constructs: health awareness, healthy eating, physical activity, roles and responsibilities, self-esteem, self-efficacy, diabetes knowledge, communication, and peer / family relationships. In addition to the education classes youth will participate in 3 exercise sessions per week (~1-1.5 hrs) that will consist of individual and group physical activities to include both aerobic and resistance exercises. The exercise intensity will progressively increase over the 12-week intervention. Both the education and activity sessions will be delivered at the Lincoln Family YMCA.
Other intervention name(s): ELSC; Every Little Step Counts
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention