bioihbjkbjnl/mcl2 huggingface dataset:
Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women
Condition: Pregestational Obesity (BMI > 27kg/m2); History of Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Diabetes, Gestational
Study type: Interventional
Phase: Phase 4

Summary: 
      Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that
      affect between 1 to 14% of population around the world.

      There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican
      population.

      Metformin has been used during pregnancy in women with gestational diabetes and women with
      polycystic ovary syndrome, with acceptable security for mother and fetus.

      Metformin decrease the insulin resistance and weight gain, we believe that metformin may be
      decrease the risk of gestational diabetes mellitus in high risk women.
    


Intervention name(s): medical nutrition therapy + metformin; Medical nutrition therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): medical nutrition therapy
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity, polycystic ovary syndrome, gestational diabetes
Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance
Condition: Hypertension; Impaired Glucose Tolerance
MeSH terms: Hypertension; Glucose Intolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH
      enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with
      impaired glucose tolerance and mild to moderate hypertension.
    


Intervention name(s): AR9281; AR9281; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): AR9281 taken in BID dosing regimen for 28 days; AR9281 taken in TID dosing regimen for 28 days; Placebo taken in BID dosing regimen for 28 days; Placebo taken in TID dosing regimen for 28 days
Intervention MeSH terms: 1-(1-acetyl-piperidine-4-yl)-3-adamantan-1-yl-urea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hypertension; impaired glucose tolerance; s-EH enzyme inhibition; pre-diabetes
Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression
Condition: Acute Low Back Pain; Depression
MeSH terms: Back Pain; Low Back Pain; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Shared decision making (SDM) has been advocated as an appropriate approach for physician
      patient communication. Positive effects of SDM are e.g higher patient satisfaction, greater
      treatment adherence, lower decisional conflict and better clinical outcomes. The Section of
      Clinical Epidemiology and Health Services Research at the University Medical Center in
      Freiburg (Germany) is developing and evaluating a web-based interactive decision aid
      ("patient dialogue") to support shared decision making in cooperation with the Techniker
      Krankenkasse, a large German health insurance company. Both development and evaluation are
      conducted along the International Patient Decision Aid Standards (IPDAS).

      The decision aid contains information on acute low back pain and depression and addresses
      insurance members who are facing a treatment decision in one of the indications. It aims at
      the development of patient competencies for participating in decision making, the support of
      constructive health behavior and patients' acceptance of evidence based treatment options.

      In an RCT the decision aid will be compared to a regular patient information on a sample of
      N=500 patients in each group. Data collection will take place at three points of time: before
      and after use of the decision aid as well as 3 months later.
    


Intervention name(s): patient dialogue; patient information
Intervention type(s): Other; Other
Intervention description(s): Information on shared decision making, how to participate in medical decision making, information on acute low back pain, information on depression; Information on acute low back pain, information on depression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Early Cardioprotective Effect of Sevoflurane
Condition: Coronary Artery Disease; Off Pump Coronary Artery Bypass Surgery
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      In vitro studies and in vivo animal experiments have shown that halogenated volatile
      anesthetics have a protective effect on the ischemic myocardium. In clinical settings
      however, anesthetic preconditioning may be of more interest. The aim of our study was to
      evaluate the cardioprotective effect of sevoflurane in patients undergoing off-pump coronary
      artery bypass surgery. We proposed that a cardioprotective effect of sevoflurane would save
      myocardial function, which we measured acceleration by esophageal Doppler and cardiac index
      with bolus thermodilution methods, both during brief ischemia and reperfusion.
    

Detailed description: 
      Studies have been performed on human patients undergoing CABG surgery with cardiopulmonary
      bypass (CPB). Only a few studies however have evaluated the effects of volatile anesthetics
      during coronary artery bypass grafting on a beating heart (OPCABG) with conflicting results
      as far as cardiac biomarker release is concerned.

      Because CPB is known to have a profound impact on cardiac function, studies performed on
      patients scheduled for OPCABG could evaluate more specifically the effects of the anesthetic
      agents themselves. Patients undergoing OPCABG have a predictable and predefined ischemic zone
      during surgery and represent an extremely interesting and safe model for the study of
      ischemia and cardiac damage in humans.

      Presently, there is still no consensus on the method of administration of volatile
      anesthetics, including the time to begin administration, its duration, the dosage and
      selection of volatile anesthetics.
    

Intervention name(s): Sevoflurane; propofol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: cardioprotection; sevoflurane; esophageal Doppler; thermodilution; coronary artery bypass
Statin and Epidural Steroid Injection
Condition: Low Back Pain After Epidural Steroid Injection; Quality of Life After Epidural Steroid Injection
MeSH terms: Back Pain; Low Back Pain
Study type: Observational [Patient Registry]

Summary: 
      The impact of statin use on response to epidural steroid injections remains unknown and may
      well increase the effect considering the substantial anti-inflammatory properties. We thus
      tested the primary hypothesis that patients taking statins before and after the procedure
      will have lower VAS scores compared to patients not on statins. Secondarily we tested the
      hypothesis that statin users will have improved quality of life evaluated with Short Form 36
      (SF 36).
    

Detailed description: 
      Low back pain is one of the most common complaints for physician office visits and is the
      most common disorder requiring interventional pain treatment in USA. Fluoroscopy-assisted
      transforaminal anterior epidural steroid injections (TAESI) are more commonly preferred for
      treatment of low back pain. Most of the time epidural steroid injections are supplemented
      with different analgesic combinations due to insufficient analgesia. Recent reports have
      revealed immunomodulatory and anti-inflammatory activities for statins in vivo and in vitro.
      Statins have very recently been shown to alleviate neuropathic pain in the rat model.
      However, the impact of statin use on response to epidural steroid injections remains unknown
      and may well increase the effect considering the substantial anti-inflammatory properties. We
      thus tested the primary hypothesis that patients taking statins before and after the
      procedure will have lower VAS scores compared to patients not on statins. Secondarily we
      tested the hypothesis that statin users will have improved quality of life evaluated with
      Short Form 36 (SF 36).
    

Intervention name(s): Visual analogue score; The SF 36 test
Intervention type(s): Other; Other
Intervention description(s): Visual analogue score vas used to evaluate pain.; The SF 36 test (SHORT FORM 36) was used to evaluate quality of life.
Other intervention name(s): VAS score; SHORT FORM 36
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients coming to the Algology Department with complaints of low back pain and
        scheduled to receive Transforaminal epidural steroid injection. Statin users (Group 1) and
        non-statin users (Group 2) will be record.
      
Keywords: low back pain; epidural steroid injection; statin; quality of life
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single
      dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed
      conditions.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, four-period, two-sequence, single dose,
      crossover, fully replicated oral bioequivalence study of Tetrabenazine Tablets 25 mg of Dr.
      Reddy's Laboratories Limited, India comparing with XENAZINE® (tetrabenazine) Tablets 25 mg of
      Lundbeck Inc., USA in healthy, adult, human subjects under fed conditions.
    

Intervention name(s): Tetrabenazine Tablets 25 mg
Intervention type(s): Drug
Other intervention name(s): Xenazine
Intervention MeSH terms: Tetrabenazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Education and Counseling Based on HypnoBreastfeeding
Condition: Hypno-breastfeeding Education
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of education and counseling based on the
      hypno-breastfeeding philosophy given in the antenatal period on only breastfeeding status,
      breastfeeding self-efficacy and breastfeeding motivation.
    

Detailed description: 
      This is a non-randomized experimental study. Data were collected from 80 women who attended
      hypno-breastfeeding-based education or standart breastfeeding education from Turkey between
      September 2021 and February 2022. Participants who met the inclusion criteria were informed
      about the purpose of the study and hypno-breastfeeding-based education or standart
      breastfeeding education, informed consent was obtained from those who agreed to participate.
      Data were collected at the time of consent to the study, pre-education, post-education, 1
      week and 8 weeks after birth. Collected by the first author. The CONSORT directive was
      followed in the planning, implementation and writing of the research.
    

Intervention name(s): Hypno-breastfeeding Education; Experimental: Standart Breastfeeding Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The hypnobreastfeeding education program consists of 4 sessions and 12 hours. It includes information about breastfeeding, mental preparation for the breastfeeding experience, emotional studies, motivational practices, awareness and self-compassion practices.; The standard breastfeeding education program consists of 1 session and 3 hours. It contains only information and applications about breastfeeding.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Changes in Serum Electrolytes at Different Glucose Concentrations + Impact on a Non-invasive Glucose Monitoring Method
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      In healthy subjects: Continuous monitoring of the glucose concentration in the skin by means
      of a non-invasive glucose sensor during a glucose clamp when systematically changing the
      blood glucose concentration (e.g. to hyperglycemia). Simultaneous frequent determinations of
      serum electrolytes.
    

Detailed description: 
      Non-invasive continuous glucose monitoring is a promising approach in diabetes therapy. It is
      known that changes in glucose concentration in the skin can be registered by means of
      optical, spectroscopic measures in subjects with diabetes. The precision of such measures,
      however, so far has been unsatisfactory.

      This study evaluates the changes in skin glucose concentration by means of a non-invasive
      glucose sensor and compares these to blood glucose concentrations during a glucose clamp. It
      is also known that with hyperglycemic blood glucose concentrations there is a consecutive
      hyponatraemia. This study shall evaluate to which extent and how fast serum electrolyte
      parameters change when establishing a hyperglycaemic blood glucose level. This shall help
      estimate which impact these changes in electrolytes have on the non-invasive glucose sensor.
    

Intervention name(s): Non-invasive CGMS; Hyperglycemic glucose clamp
Intervention type(s): Device; Procedure
Intervention description(s): A non-invasive continuous glucose monitoring device measured was applied at the wrist and measured skin glucose as an indirect measure of blood glucose every 10 min.; The automated glucose clamp technique was used to control glucose levels at baseline glycemia for 1h, hyperglycemia (16.7 mmol/L) for at least 2.5h and euglycemia (5 mmol/L) for another 2.5h. A continuous somatostatin infusion was initiated after 1h to suppress endogenous insulin secretion. A glucose solution was infused to increase the blood glucose towards the hyperglycemic target level. At approximately t=3.5h the somatostatin infusion was stopped and blood glucose was controlled at the euglycemic target level.
Other intervention name(s): PendraWatch; Biostator; Somatostatin
Intervention MeSH terms: Somatostatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes
Low Level Laser Therapy to Reduce Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether low level laser light directed at the neck
      and shoulders could be effective in the temporary reduction of chronic pain in the neck and
      shoulder region.
    

Detailed description: 
      Chronic neck and shoulder pain arising from osteoarthritis, chronic muscle spasms or thoracic
      or cervical spine sprain strain can be seriously debilitating. Currently available treatment
      options such as pain relief medication, ice pack, massage, physical therapy and chiropractic
      are typically of limited effectiveness. More permanent options such as surgery are invasive
      with long recovery periods and side-effects and complications of their own. Low level laser
      light therapy, with its proven anti-inflammatory ability, offers a simple non-invasive option
      for the reduction of chronic neck and shoulder pain.
    

Intervention name(s): Erchonia PL2000 Laser; Placebo laser
Intervention type(s): Device; Device
Intervention description(s): Low level laser light therapy device that emits 1 mW of red (635 nm wavelength) light. It is a hand-held device that uses rechargeable batteries or a separate power adapter.; Inactive laser light.
Other intervention name(s): Erchonia PL5000; Erchonia EVRL Laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases
Condition: Human Papillomavirus Infection; Genital Warts
MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections; Condylomata Acuminata
Study type: Observational

Summary: 
      primary purpose:Evaluate the prevalence and incidence of HPV infection and related diseases
      in subjects.

      Secondary purpose:Analyze risk factors of HPV infection and related diseases.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        5000 healthy volunteers will be recruited from the residents of Liuzhou through
        advertisment.
      
Biospecimen description: 
      Male:Two swabs were used to collect exfoliated skin cells from the coronal sulcus
      /glans/shaft and anal

      Female:Three swabs were used to collect exfoliated skin cells from the vagina，vulva and anal
    
Keywords: HPV; genital warts
DualSculpting the Abdomen Using CoolSculpting
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.
    

Detailed description: 
      The study will evaluate the safety and efficacy of non-invasive fat reduction in the abdomen
      using two applicators.
    

Intervention name(s): The ZELTIQ System
Intervention type(s): Device
Intervention description(s): The CoolSculpting System will be used to perform the treatments with the CoolAdvantage family of applicators.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Ofatumumab Versus Rituximab in Children With Steroid and Calcineurin Inhibitor Dependent Idiopathic Nephrotic Syndrome
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Open-label, two-parallel-arm, controlled randomized clinical trial testing the superiority of
      Ofatumumab over Rituximab in maintaining steroid- and calcineurin-inhibitor-free disease
      remission in SD-INS.

      Eligible participants will enter a 1-month run-in period, during which instruction on urine
      collection and dipstick readings will be carefully reviewed, compliance assessed, and therapy
      with RAS inhibitors withdrawn and, in hypertensive children replaced by other
      anti-hypertensive drug.

      After run-in period, children will be randomized to either the intervention arm (Ofatumumab)
      or the comparator arm (Rituximab).

      After infusion of intervention or comparator, steroids will be maintained at initial dose for
      30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.

      One week after the steroid withdrawal calcineurin inhibitors will be decreased by 50% and
      withdrawn within 2 additional weeks.

      All patients will be followed for up to 24 months. In case of relapses during the study (see
      outcome section for definition) patients will be treated with 60 mg/m2of prednisone p.o. in
      order to achieve remission. At remission, patients will be treated with another infusion of
      either Oftumumab or Rituximab, according to the initial randomization.

      After infusion of intervention or comparator, steroids will be maintained at initial dose for
      30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.

      One week after the steroid withdrawal calcineurin-inhibitors will be decreased by 50% and
      withdrawn within 2 additional weeks. This strategy will be repeated to treat full relapses
      during the study.
    


Intervention name(s): Ofatumumab; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): 1500 mg/1.73m2, administered once diluted in 1000 ml of normal saline; 375 mg/m2, administered once diluted in 100/250/500 ml of normal saline for dosage respectively between 100-250 mg, 260-500 mg, 510-1000 mg.
Other intervention name(s): Arzerra; Mabthera
Intervention MeSH terms: Rituximab; Ofatumumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomised, Double- Blind, Cross-over Efficacy and Safety Comparison of Three Different Doses of Tiotropium Administered Once Daily Versus Placebo in Patients With Moderate Persistent Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Rationale for the current trial is to evaluate the efficacy and safety of three doses (1.25
      µg, 2.5 µg and 5.0 µg ex mouthpiece) of tiotropium inhalation solution in patients with
      moderate persistent asthma who are still symptomatic despite regular maintenance therapy with
      inhaled corticosteroids (ICS).

      The data collected in the present trial will provide useful information to health care
      providers and patients regarding the efficacy and safety of a once daily inhalation of three
      different doses of tiotropium solution delivered by the Respimat® inhaler in addition to
      inhaled corticosteroids in the treatment of not fully controlled moderate asthma in
      comparison to placebo. The Pharmacokinetics (PK) of tiotropium is well established in COPD
      patients. However, there is currently no PK data available for the 3 doses of tiotropium
      being tested in this trial in patients with moderate persistent asthma. Tiotropium is a once
      daily drug. Hence, the rationale for blood and urine sampling for PK analysis over 24 hours
      in a subset of patients is to confirm the PK of the 3 doses in moderate asthma patients.
      Rationale for the 24-hour pulmonary function test sub-investigation is to demonstrate that a
      once daily dosing of tiotropium inhalation solution is effective and safe in the treatment of
      moderate persistent asthma.
    


Intervention name(s): tiotropium bromide 2.5µg once daily; Tiotropium matching Placebo once daily; tiotropium bromide high dose once daily; tiotropium bromide 1.25µg once daily
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo; Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo; Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo; IMP
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment