bioihbjkbjnl/mcl2 huggingface dataset:
Observational Study to Develop Dosing Chart
Condition: Infertile Women Undergoing IVF or ICSI
MeSH terms: Infertility
Study type: Observational [Patient Registry]

Summary: 
      To confirm the predictors based on patient specific characteristics and ovarian response and
      develop dosing chart when Follitrope™ PFS is administered to infertility women patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infertile women undergoing In vitro fertilization(IVF) or Intracytoplasmic sperm injection
        (ICSI) for controlled ovarian stimulation
Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
Condition: Postoperative Pain Management
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To prove pregabalin's efficacy and safety in Thai patients scheduled for arthroscopic ACL
      reconstruction
    

Detailed description: 
      Only eligible patients with willingness to join this study are included. Eligible patients
      are those aged 18-65 years of either sex, American Society of Anesthesiologists (ASA)
      physical status I & II, and body mass index (BMI) between 16-35. The exclusion criteria are
      patients who are allergic to pregabalin, with impaired hepatic and renal functions, alcohol
      or substance abuse, chronic pain (except pain in the knee joint) or daily intake of
      analgesics, uncontrolled medical disease (hypertension and diabetes mellitus) and inability
      to operate patient-controlled analgesia (PCA) device.

      Data analysis

        -  Student t-test for continuous data with normal distribution

        -  Mann-Whitney U test for continuous data with non-normal distribution

        -  Chi-square test for categorical data
    

Intervention name(s): Pregabalin
Intervention type(s): Drug
Intervention description(s): 75 mg po 2 hrs before surgery
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: perioperative; pregabalin; arthroscopic anterior cruciate ligament reconstruction; postoperative pain management
Sustainability of Vaginal Estrogen Therapy in Postmenopausal Women
Condition: Atrophy of Vagina; Postmenopause
MeSH terms: Atrophy
Study type: Observational

Summary: 
      Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women
    

Detailed description: 
      Within this trial 50 postmenopausal women receive a vaginal estrogen therapy as treatment for
      symptomatic vaginal atrophy. The sustainability of vaginal estrogen therapy after the end of
      therapy has not yet been investigated.

      All participants will be asked to come for the following 7 visits.

        -  Visit 1: Standard Gynecological examination; Inclusion and exclusion criteria check

        -  Visit 2: Handing out of Gynoflor (estrogen) for a 6 weeks treatment.

        -  Visit 3 (Study Start): After using the vaginal estrogen for 6 weeks, a vaginal swap will
           be done to measure the vaginal maturation index (VMI). The participants will also
           receive a questionnaire to define some subjective parameters. The parameters measured at
           visit 1 will count as reference. The estrogen therapy will now be sustained.

        -  Visit 4-6: Measuring of the VMI and handing out the questionnaires to define subjective
           parameters.
    

Intervention name(s): Gynoflor
Intervention type(s): Drug
Intervention description(s): 1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday) for 6 weeks
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        postmenopausal women
Intervention for Diabetes With Education, Advancement and Support
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study aims to evaluate a culturally appropriate, low cost and sustainable management
      plan for patients with type 2 diabetes mellitus (T2DM). Various randomized controlled trials
      confirmed that T2DM can be delayed with lifestyle intervention and programmes which promote
      improvements in diet, increased physical activity and weight loss. Translation of lifestyle
      intervention to real-life settings however remains a major challenge.

      The investigators therefore propose a diabetes management trial for T2DM patients using
      telemedicine. This project's innovations include the use of information technology to deliver
      messages to the physicians while similarly involving family members of diabetics to manage
      the patient's condition collectively. This creates a sense of well-being, empowering the
      individual as well as the community to be responsible for their own health and well-being
    


Intervention name(s): Telemedicine; Usual care
Intervention type(s): Device; Other
Intervention description(s): A diabetes self-management and education program delivered via telemedicine; A 15-30 minute diabetes self-management session. Continued care, as usual, from their primary care provider throughout duration of active 12 month intervention period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2; NIDDM
Health-related Quality of Life and Psychosocial Aspects of Diabetes Technology (Insulin Pumps)
Condition: T1DM; Health Related Quality of Life; Insulin Pump
Study type: Observational [Patient Registry]

Summary: 
      This study will be prospective comparative trial comparing between insulin pumps vs Multiple
      daily injections (MDI) in treatment of type 1 diabetes mellitus (T1DM) in terms of health-
      related quality of life (HRQL) and efficacy of glycemic control (HbA1c level )

      Hypothesis:

      Type 1 diabetes is characterized by autoimmune destruction of insulin-secreting pancreatic b
      cells leading to disturbed glucose regulation and overt hyperglycemia which leads to variable
      consequences and complication. Consequently, individuals with type 1 diabetes have a lifelong
      dependency on insulin replacement therapy.

      Aim of the Work:

      To compare the psychosocial impact of insulin pumps versus multiple daily injections in
      treatment of type 1 diabetes mellitus (Via questionnaire) in terms of health-related quality
      of life and efficacy of glycemic control (HbA1c level).
    


Intervention name(s): Health related quality of life
Intervention type(s): Other
Intervention description(s): Confidence in diabetes self care questionnaire the socioeconomic level of the family scale MINI-KID the Peds-QL
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients from Ain shams pediatric and adolescent diabetes unit(PADU)
      
Keywords: Insulin pump; T1DM; HRQL
Power Training Versus Strength Training in the Elderly
Condition: Healthy
Study type: Interventional

Summary: 
      The inexorable decline in motor skills during aging provides the investigators with an
      elderly population with various functional limitations. Among these, the ability to walk,
      being associated with the risk of falling has been studied by several authors. The adoption
      of strength and power training as an intervention strategy to reduce the negative effects
      arising from the physiological or pathological process of aging has been widely discussed in
      these studies. However, the effects of these interventions on biomechanical gait indicators
      have not been fully debated yet. Therefore, this study aimed to compare the effects of these
      two training protocols on functional capacities and biomechanical gait parameters of elderly
      women.
    

Detailed description: 
      Three female groups, homogenized by age, body mass index and physical activity level, were
      formed: the control group (GC: n=8, 69±4 years old), the strength training group (GF: n=6,
      67±4 years old) and the power training group (GP, n=7, 68±4 years old). No extra activity was
      induced to GC's routine. Meanwhile, GF and GP underwent 12 weeks of strength and power
      training, respectively, with three weekly sessions. While GF performed the exercises with
      moderate speed (70-90% of 1RM), the GP executed them in fast speed (40-60% of 1RM). A
      kinematic and electromyographic gait evaluation, as well as balance and functional capacity
      evaluations, were conducted prior and after the intervention period.
    

Intervention name(s): Power Training; Strength Training
Intervention type(s): Other; Other
Intervention description(s): This experimental groups underwent an intervention period of power training; This experimental groups underwent an intervention period of strength training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: elderly; strength training; power training; functional capacity; gait biomechanics
Evaluate Safety and Pharmacokinetic To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the steady-state intrapulmonary disposition of
      delafloxacin in healthy adult participants.
    

Detailed description: 
      This study will evaluate the safety and pharmacokinetics (PK) of delafloxacin in healthy
      adult participants by assessing the intrapulmonary disposition in adults receiving 300 mg
      delafloxacin IV every 12 hours for a total of 7 doses over 4 days.
    

Intervention name(s): Delafloxacin
Intervention type(s): Drug
Intervention description(s): In this study, thirty subjects who meet the entry criteria will be assigned to 1 of 5 groups (A, B,C, D, or E) to receive 300 mg delafloxacin IV every 12 hours for a total of 7 doses over 4 days
Intervention MeSH terms: Delafloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      An unblinded, randomized, cross-over design with each patient participating in two 40-hour
      outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b)
      Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a
      hospital based clinical research center. The principal goal is to validate a smart
      phone-based control-to-range (CTR) system for ambulatory use and to estimate the effect of
      CTR vs. sensor-augmented pump therapy, thereby providing justification for further larger
      home-based trials of CTR.
    

Detailed description: 
      The overall objective of this project is to sequentially test, validate, obtain regulatory
      approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system for optimal
      blood glucose (BG) regulation in people with type 1 diabetes. The CTR system is comprised of
      two algorithmic layers: a Safety Supervision Module (SSM) and Insulin on Board Tracking and
      Safety Module (ITSM), and an automated Range Correction Module (RCM). Both modules will
      receive continuous glucose monitoring (CGM) and insulin delivery data. The SSM and ITSM will
      monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to
      prevent hypoglycemia. The RCM will be responsible for optimizing BG control and mitigating
      postprandial hyperglycemic excursions through series of insulin boluses. To run CTR, we will
      use our wearable artificial pancreas platform, known as DiAs (Diabetes Assistant), which
      consists of a smart phone running CTR and connected to standard insulin delivery and CGM
      devices.
    

Intervention name(s): Diabetes Assistant (DiAs)
Intervention type(s): Device
Intervention description(s): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Continuous Glucose Monitor; Artificial Pancreas; Insulin Pump; Closed Loop control; Open Loop treatment
The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      This study seeks to assess the durability of response and persistence of resistance to
      ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3
      clinical study with these agents for the treatment of chronic hepatitis C.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Participants who were treated in Study M12-536 or M13-004 with 2D regimen (ombitasvir/
        paritaprevir/ritonavir) and completed 48 weeks of follow-up.
      
Keywords: Hepatitis C; Follow-up; Observation; Japanese
Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objectives of this study are to estimate the efficacy and safety of the daily
      administration for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried
      out to estimate how the effects of mifepristone are kept in time.

      The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma
      up to 50% in six months treatment.
    

Detailed description: 
      Women, in fertile age or premenopausal status, presenting symptomatic myomaswere randomly
      assigned to receive 5 or 10 mg of mifepristone for six months.

      The decreasing in the prevalence of symptoms attributable to myomas is an important goal to
      achieve under both treatments. Another goal is to maintain for more than 6 months the
      benefits of the treatment with mifepristone.
    

Intervention name(s): Mifepristone
Intervention type(s): Drug
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Uterine fibroids; Mifepristone; Antiprogestins
Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate whether visual interpretation of flortaucipir-PET (positron emission
      tomography) scans, examining patterns of tracer uptake at baseline, can predict the rate of
      clinically-meaningful cognitive decline due to AD after 18 months. All scans are acquired
      from cohorts of a previously completed study, I8D-MC-AZES (NCT02245737, lanabecestat, Eli
      Lilly and Company sponsor).
    


Intervention name(s): flortaucipir F18; Brain PET Scan
Intervention type(s): Drug; Procedure
Intervention description(s): No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) at baseline will be read by independent, blinded readers. IV injection, 240 megabecquerel (MBq) (6.5 mCi), single dose in AZES; positron emission tomography (PET) scan of the brain
Other intervention name(s): 18F-AV-1451; [F-18]T807; LY3191748
Intervention model: Single Group Assignment
Intervention model description: Physician PET scan readers are participants, blinded to demographic and clinical data from the source PET scans.
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effects of VEGF-B Signaling Pathway in Obesity and Metabolic Disease
Condition: Obesity; Metabolic Disease
MeSH terms: Obesity; Metabolic Diseases
Study type: Observational

Summary: 
      The investigators will enroll about 120 subjects from the hospital's healthcare center. The
      investigators will collect the basic informations, blood pressure, body mass index, fasting
      blood glucose and fasting blood lipids of each subject. The investigators will collect the
      blood samples and then test them for fasting insulin levels, VEGF-B levels, the gene promoter
      region methylation status and the genomic protein methylation levels of the VEGF-B gene of
      the cells，and finally do the statistical analysis.
    

Detailed description: 
      The investigators will enroll about 120 subjects from the hospital's healthcare center, and
      these 120 subjects will be divided into four groups: normal weight with or without metabolic
      diseases and obesity with or without metabolic diseases. Each group has 30 subjects. The
      investigators will collect the basic information(name, gender，age, medical history，family
      history, etc.), blood pressure, body mass index, fasting blood glucose and fasting blood
      lipids of each subject from the healthcare center. The investigators will collect the blood
      samples of each subject,separate the plasma and then test the fasting insulin, VEGF-B levels
      by ELISA. The investigators will separate the peripheral blood mononuclear cells from the
      blood, and then test the gene promoter region methylation status of the VEGF -B gene by PCR
      and the bisulfite-modified sequencing and test the genomic protein methylation level of the
      VEGF-B gene by chromatin immunoprecipitation assay(CHIP) and real-time quantitative PCR of
      the cells，and finally do the statistical analysis.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        subjects without metabolic diseases , subjects with metabolic diseases
      
Biospecimen description: 
      Plasma，Peripheral blood mononuclear cells
    
Keywords: VEGF-B
Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention
Condition: ADHD
Study type: Interventional

Summary: 
      An initial evaluation of Little Flower Yoga for Kids will be conducted in a small sample of
      18-30 Kindergarten and First Grade students (3-5 per class) enrolled in Girls Preparatory
      Charter School of the Bronx. The overall aim of this study is to ascertain the short and
      longer-term effects of Little Flower Yoga for Kids, a promising yoga and mindfulness program
      for children, which incorporates five elements (connect, breathe, move, focus, relax) to
      improve the child's ability to sustain attention and regulate emotions.
    

Detailed description: 
      The overall aim of this project is to ascertain the effects of Little Flower Yoga for Kids, a
      promising yoga and mindfulness program for children developed by Jennifer Cohen Harper, MA,
      E-RCYT, which incorporates five elements (connect, breathe, move, focus, relax) to improve
      the child's ability to sustain attention and regulate emotions. While research supports that
      yoga programs and mindfulness programs yield positive outcomes on numerous factors, there are
      no independent studies presently examining the effects of a combined yoga and mindfulness
      intervention (like Little Flower Yoga for Kids) on both emotion regulation and sustained
      attention.

      The investigators propose conducting an initial evaluation of Little Flower Yoga for Kids in
      a small sample of 18-30 Kindergarten and First Grade students (3-5 per class) enrolled in
      Girls Preparatory Charter School of the Bronx. Little Flower Yoga for Kids is currently part
      of the curriculum at Girls Preparatory Charter School of the Bronx and implemented by Kelli
      Love, M.Ed., 500 RYT, received her certification from the Little Flower Yoga for Kids Teacher
      Training Program. Specifically, the investigators will conduct a preliminary trial with a
      sample of 5-7 year olds (Kindergarten/First Grade), who meet a predetermined threshold of
      having either emotional regulation and/or attentional difficulties, to determine the effects
      of Little Flower Yoga for Kids on sustained attention and emotion regulation. Measures of
      these outcomes will occur at initial participant screener, baseline, mid-treatment (4.5
      months after the start of the program), and post-treatment (after 9 months).
    

Intervention name(s): Little Flower Yoga For Kids
Intervention type(s): Behavioral
Intervention description(s): Little Flower Yoga for Kids is a promising yoga and mindfulness program for children developed by Jennifer Cohen Harper, MA, E-RCYT, which incorporates five elements (connect, breathe, move, focus, relax) to improve the child's ability to sustain attention and regulate emotions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Increasing Physical Activity to Reduce Children's Visceral Fat
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this trial is to examine whether adding greater physical activity to standard
      family-based behavioral pediatric obesity treatment decreases the amount of visceral fat
      among treated overweight children.
    

Detailed description: 
      Adult studies suggest that greater visceral fat confers more health risk than peripheral fat
      accumulation and that physical activity interventions (as part of general weight control
      interventions) are efficacious in reducing adults' visceral fat. There are few studies
      examining the impact of physical activity and/or general weight loss on children's visceral
      fat accumulation. The present study compares standard family-based behavioral weight control
      treatment for pediatric obesity (STANDARD) with standard treatment plus added emphasis on
      participants attaining high levels of physical activity (ADDED). Both conditions receive the
      same behavioral dietary intervention and therapeutic contact and attention. The ADDED
      condition receives the recommendation and goal to be active at least 90 minutes per day, with
      behavioral strategies targeting increasing and sustaining these high levels of physical
      activity.
    

Intervention name(s): Pediatric Obesity Intervention (STANDARD); Pediatric Obesity Intervention + High Activity (ADDED)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes); 14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric obesity; Physical activity; Visceral fat; Weight