bioihbjkbjnl/mcl2 huggingface dataset:
Unexplained Infertility Treated by Hysteroscopy-laparoscopy
Condition: Unexplained Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Retrospective study, including patients from january 2013 to december 2018, who were
      diagnosed with unexplained infertility : spontaneously ovulating women with normal pelvic
      ultrasound scan, patent tubes on hysterosalpingography and normal pelvic exam or pelvic MRI
      normal. Semen analyses were normal according to the World Health Organization criteria.
      Couples were referred for diagnostic laparoscopy and hysteroscopy. They were then addressed
      for spontaneous fertility or ART to conceive. The investigators would like to see how many
      surgeries were useful to assess a diagnostic, and if operating allows a satisfying pregnancy
      rate. The investigators would like to assess how many diagnosis was done after surgery and
      how many pregnancy were obtained. The investigators search other prognostic factors than age
      or parity.
    


Intervention name(s): Laparoscopy-hysteroscopy
Intervention type(s): Procedure
Intervention description(s): Under general anesthesia, we start by a first look in laparoscopy, to look for endometriosis mainly, tubal infertility, ovarian cysts or any abnormalities that may not have been suspected on the first exam. Then we check tubal patency after a look at the uterine cavity by hysteroscopy. Then we treat everything possible to treat to improve fertility, spontaneous or with ART.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        In Montpellier University center only, France : from january 2013 to december 2018
        unexplained infertile couple, trying to conceive for more than one year and operated by
        laparoscopy-hysteroscopy
      
Biospecimen description: 
      some endometrial biopsy
    
Keywords: Ovulation; semen analysis; tubal patency; pelvic ultrasound scan
Complementary Weaning With Adult Food Typical of the Mediterranean Diet
Condition: Weaning
Study type: Interventional

Summary: 
      A Randomized Controlled Clinical Trials was conducted to study the medium-long term impact of
      a complementary weaning using adult foods typical of Mediterranean Diets (MD) on children
      taste development and eating habits, and on the microbiota composition.

      Main objectives were to assess the effect of such weaning scheme on:

        1. medium-long term adherence of the children to the MD (Primary aim).

        2. familial eating habits to verify how many changes may come from an early education of
           the kid toward a Mediterranean eating style

        3. the BMI of the children

        4. gut microbiota composition
    


Intervention name(s): Mediterranean Diet weaning scheme
Intervention type(s): Dietary Supplement
Intervention description(s): Kids in experimental group were weaned by using fresh foods traditionally used in MD and appropriately adapted to infants including seasonal fruit and vegetables, various kinds of fresh blue fish, spices and herbs. No salt was used while a small amount of Parmesan cheese was added. No sugar was added to any meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Complementary feeding; Mediterranean Diet; Microbioma
Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation
      System, known as IpsiHand, on improving functional motor control for post-stroke patients
      with hemiparesis. The Neurolutions System is a brain-computer interface (BCI) comprised of a
      robotic orthosis, worn on the hand and wrist, and operated by the patient's brain waves which
      are measured by EEG electrodes. The system also utilizes a tablet interface to provide
      therapy instructions to the patient.
    

Detailed description: 
      Participants will complete 12 weeks of home therapy with the Neurolutions IpsiHand System.
      Outcomes will be based on a comparison of the patient's baseline measurements to post-therapy
      assessments.
    

Intervention name(s): IpsiHand Therapy
Intervention type(s): Device
Intervention description(s): The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of hometherapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rehabilitation; Brain-Computer Interface
Feasibility of Smartphone-based Measurement on Badminton Footwork
Condition: Sports Physical Therapy
Study type: Observational

Summary: 
      To evaluate the feasibility of a smartphone-based measurement on badminton footwork. The
      performance of footwork will be collected utilizing a smartphone app and further investigate
      the validity, reliability and discrimination of the measurement.
    


Intervention name(s): footwork
Intervention type(s): Other
Intervention description(s): six-point footwork
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        people who familiar with badminton six points foot work.
Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once
      a day for the prevention of migraine in participants with episodic migraine.
    


Intervention name(s): Atogepant
Intervention type(s): Drug
Intervention description(s): Atogepant Tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Aura
Insulin Glargine in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary:

        -  To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline
           to endpoint A1c < 7%)

      Secondary:

        -  To investigate the safety of insulin glargine (in terms of hypoglycaemia, including
           symptomatic, non-symptomatic and nocturnal hypoglycaemia)

        -  To investigate whether beta cell function is preserved if this therapy is initiated
           before 2nd OAD (oral anti-diabetic drug) failure
    


Intervention name(s): Insulin Glargine; Glyburide; Glyclazide; Glimiperide; Glipizide; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Throughout study period; Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.; Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.; Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.; Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.; Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Intervention MeSH terms: Metformin; Insulin Glargine; Glyburide; Glipizide; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stepping Up 4 Your Child
Condition: Parenting Education Curriculum; Parenting Education Curriculum + Case Management; Waiting List Control
Study type: Interventional

Summary: 
      Through Stepping Up 4 Your Child, non-custodial fathers will be provided with a
      comprehensive, solution-oriented program featuring group based parent education and
      individualized case management to help them achieve financial independence, increase their
      parenting skills, and develop a co-parenting alliance.
    

Detailed description: 
      Fathers' involvement in their children's lives has received increased attention in recent
      years. In response, support has grown for responsible fatherhood programs aimed at improving
      the quantity and quality of fathers' involvement. Research on these programs has concluded
      that factors such as fathers' parenting skills, co-parenting relationship quality, and
      socioeconomic status all impact fathers' ability to contribute to their children's growth and
      development. Using this previous research as a foundation, the Stepping Up 4 Your Child
      project will go beyond traditional fatherhood initiatives by integrating the provision of
      responsible parenting, economic stability, and relationship education services to fathers at
      risk for paternal disengagement. To do so, the University of Louisville's Kent School of
      Social Work will leverage its existing relationship with the Kentucky Office of Child Support
      Enforcement. Specifically, through Stepping Up 4 Your Child, non-custodial fathers will be
      provided with a comprehensive, solution-oriented program featuring group based parent
      education and individualized case management to help them achieve financial independence,
      increase their parenting skills, and develop a co-parenting alliance. Given that each of
      these focus areas have all been cited as three of the strongest predictors of paternal
      engagement, Stepping Up 4 Your Child and the results of its evaluation will have significant
      implications for the families it serves, as well as the practitioners, researchers, and
      policymakers interested in responsible fatherhood. 1
    

Intervention name(s): 4 Your Child Program
Intervention type(s): Behavioral
Intervention description(s): Integrates the provision of responsible parenting, economic stability, and relationship education services to fathers at risk for paternal disengagement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: single father; parenting behavior
Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study
Condition: Coronary Artery Disease; Acute Coronary Syndrome
MeSH terms: Coronary Artery Disease; Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, randomized, single-center, single blind, investigator initiated, two
      period study of crossover design. Diabetic patients with Acute Coronary Syndrome (ACS),
      treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month and subjected
      to percutaneous coronary intervention (PCI), will be randomized after a baseline platelet
      reactivity (PR) assessment (24 hours post PCI) while under clopidogrel in a 1:1 ratio to
      either prasugrel 10mg or ticagrelor 180mg for 15 days followed by crossover directly to the
      alternate therapy for an additional 15 days without an intervening washout period.
    


Intervention name(s): Prasugrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 10mg/day; Ticagrelor 90mg twice a day
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Optimizing Vitamin D Nutrition in Healthy Adults
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to determine the average dosage of oral vitamin D
      supplementation to maintain optimal vitamin D levels in the body and to see if there are
      differences in the response to oral vitamin D supplementation between African-American and
      Caucasian subjects.
    

Detailed description: 
      There is ample evidence that improvement in vitamin D nutrition retards bone loss and
      prevents fractures in the elderly. It is clear that many people living in areas of northern
      latitude have less than optimal levels of vitamin D. The current recommendations for vitamin
      D intake are not enough to bring a large majority of the population to the desired adequate
      level. Furthermore, differences have been observed in the amount of Vitamin D produced in the
      skin in whites and blacks.

      Based on the evidence from literature and our experience from prior studies we hypothesize
      that:

        1. the dose of oral vitamin D3 supplement exceeds current recommendations to achieve
           adequate desired level;

        2. there may be differences in the dose-response to vitamin D supplement between Blacks and
           Whites; and

        3. vitamin D supplementation that produces serum 25-hydroxyvitamin D (25-OHD) levels in the
           range proposed is safe.

      The aims for this pilot study are to determine:

        1. the average dose of vitamin D3 needed to attain 25-OHD levels between 80-140 nmol/L in a
           healthy population of mixed races; and

        2. if there are differences in response to vitamin D3 supplementation between African
           American and Caucasians subjects.
    

Intervention name(s): Oral Vitamin D Supplementation
Intervention type(s): Drug
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men
Condition: Obesity
Study type: Interventional

Summary: 
      Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions
      and over a meal in obese and normal-weight men subjects, to research a dysfunction in the
      negative feed-back between pregnenolone and CB1 ligand in obese subjects. This dysfunction
      could participate to the hyperactivity of endocannabinoid system saw in obesity.
    

Detailed description: 
      Endocannabinoid system is an orexigenic key system, controlling the energy balance. It is
      composed of receptors (ex: CB1), of endogenous ligands, the endocannabinoids (ex: anandamide
      and 2- arachidonoylglycerol) and of enzymes implied in the synthesis and the degradation of
      the endocannabinoids. Researches resulting from our group highlighted anomalies of the
      plasmatic concentrations of endocannabinoid, in obese subject compared to normal-weight
      subject. Those being higher in obese subject with a flatness of post prandial reduction of
      AEA, so maintenance of elevated levels which can facilitate the food catch and create a
      metabolic vicious circle. In addition, prestigious research resulting from our collaborators
      highlighted in the animal that exposure to tetrahydrocannabinol (THC, ligand exogenic of CB1)
      induced the synthesis of pregnenolone (neurosteroid) which, by an autocrine effect on the
      CB1, inhibited the effects of the THC. In particular one of the principal behavioural
      effects: the food intake.

      We want to measure pregnenolone and endocannabinoid concentrations in men blood samples, to
      observe if this association exists in fasting conditions and over a meal in normal-weight and
      obese subjects. Obese subjects will be recruited during an hospitalization, while normal
      subject will be recruited by a poster at Bordeaux university and Haut-Leveque hospital. They
      will be included at Haut-Leveque hospital during morning at hospital.
    

Intervention name(s): Obese men; Normal-weight men
Intervention type(s): Other; Other
Intervention description(s): Biological measures before, just before, and after lunch, in obese men; Biological measures before, just before, and after lunch, in normal-weight men.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Obese men versus normal-weight men
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: pregnenolone; endocannabinoid; food intake; type-1 cannabinoid receptor
Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
Condition: Intestinal Diseases
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      To assess the efficacy of the NaviAid™ BGE Device, while used in conjunction with a standard
      endoscope for the diagnosis and treatment of the small intestine.
    

Detailed description: 
      Smart Medical Systems has developed the NaviAid™ Balloon Guided Endoscopy (BGE) Device, an
      innovative medical device for the GI tract diagnosis and treatment. The Balloon Guided
      Endoscopy (BGE) is a procedure intended for the examination of the small intestine, which
      utilizes the NaviAid™ BGE Device in conjunction with a standard endoscope.

      The objectives of this prospective controlled study are to evaluate the safety and efficacy
      of using the NaviAid™ BGE device in the examination of the small intestine in conjunction
      with a standard endoscope.

      Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference
      Enteroscopy procedure.
    

Intervention name(s): NaviAid™ BGE Device
Intervention type(s): Device
Intervention description(s): NaviAid™ Balloon Guided Endoscopy Device
Other intervention name(s): NaviAid™ Balloon Guided Endoscopy Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NaviAid™ BGE Device; Small Intestine; Intestinal Diseases
Lifestyle Intervention for Weight Gain Management for Patients With Schizophrenia
Condition: Schizophrenia; Obesity
MeSH terms: Weight Gain; Schizophrenia
Study type: Interventional

Summary: 
      The aims of this study were to evaluate the efficacy of an intervention for weight gain
      management for patients from schizophrenia spectrum compared to treatment as usual (TAU), and
      to evaluate the effects of this program on metabolic profile, symptoms and quality of life.
    

Detailed description: 
      The study took place on four institutions: Schizophrenia Program (PROESQ- Universidade
      Federal de São Paulo), Schizophrenia Program of Institute of Psychiatry PROJESQ (Universidade
      de São Paulo), CAISM (Centro de Atenção Integrada à Saúde Mental) from Irmandade Santa Casa
      de Misericórdia de São Paulo, and CAPS Luiz da Rocha Cerqueira, all in the city of São Paulo.
      Participants were randomly assigned to an intervention group or a standard care group using
      table of randomization from web site www.randomization.com. The patients' weights were
      recorded monthly. All patients were weighed in the morning, on the same scale, without shoes,
      with the individuals wearing light clothes. Waist was considered at the level of the navel.
      Measures were collected by the same investigator in all assessments. Body mass index (BMI)
      was calculated as the weight in kilograms divided by the square of the height in meters. The
      investigators recorded sociodemographic data, clinical data and physical exam (weight,
      height, BMI, waist circumference and blood pressure). Patients were diagnosed as having
      schizophrenia by the SCID-P (REF). Severity of the disease was assessed using PANSS, Calgary
      Depression Scale, CGI-S and CGI-I. GAF, ILSS-BR, and he following self-rated scales:
      WHOQoL-BREF, Rosenberg self-esteem scale, IPAQ, DINE and Fagerstrom were used to evaluate
      functionality (GAF), independent living skills (ILSS-BR), quality of life (WHOQoL-BREF), self
      esteem (Rosenberg self-esteem scale), physical activity (IPAQ- short version), fat and fibers
      ingestion (DINE), and smoking (Fagerstrom). Raters were kept blind for patient's treatment
      condition. Fasting glucose, total cholesterol, HDL, LDL, triglycerides, insulin, and HOMA-IR
      index were assessed at baseline, and 3 months.
    

Intervention name(s): wellness program
Intervention type(s): Behavioral
Intervention description(s): 12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
Other intervention name(s): brazilian wellness program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: schizophrenia; weight gain; intervention
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, extension, Phase III study to evaluate the long-term safety and
      efficacy of MRA in patients with RA who participated in Study MRA213JP.
    


Intervention name(s): MRA (Tocilizumab)
Intervention type(s): Drug
Intervention description(s): 8mg/kg/4 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and
      effective therapy to improve glycemic control in patients with type 1 diabetes.
    

Detailed description: 
      Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
    

Intervention name(s): Dapagliflozin; Placebo for dapagliflozin
Intervention type(s): Drug; Other
Intervention description(s): Tablets; Tablets
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dapagliflozin; Efficacy; Safety; Add on to insulin; Oral Antidiabetic; Type 1 diabetes