bioihbjkbjnl/mcl2 huggingface dataset:
Lifestyle, Exercise and Nutrition Study 2 (LEAN 2)
Condition: Breast Cancer; Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The specific aims of this study are to determine the efficacy and cost-effectiveness of a
      weight loss program compared with usual care (control) treatment on 6-month changes in body
      weight, body fat, serum hormones, and breast tissue markers associated with prognosis in
      breast cancer survivors.
    

Detailed description: 
      We will conduct a two-armed study comparing a combination of an in-person and telephone
      weight loss program compared to usual care/wait list in 100 breast cancer survivors. Women
      will be randomized into one of the study arms using a random permuted block design. Research
      staff collecting body composition data, as well as reviewing forms and entering data, will be
      blinded to the participant's study group.
    

Intervention name(s): Weight Loss Counseling
Intervention type(s): Behavioral
Intervention description(s): The intervention will be based on the Diabetes Prevention Program weight loss program, which uses a combination of reduced caloric intake, increased physical activity, and behavior therapy. The content of the weight loss program will be similar for the in-person and telephone interventions, but the approach will vary (i.e., in-person vs. telephone counseling). The weight loss intervention will be conducted by a Registered Dietitian, who has training in exercise physiology and behavior modification.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast Cancer; Survivorship; Weight Loss
Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures
Condition: Epilepsy; Simple Partial Seizures; Complex Partial Seizures; Partial Seizures With Secondary Generalization
MeSH terms: Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine weather Remegal in fixed dosage 1500 mg/daily is
      effictive and safe in patients with epilepsy with partial seizures
    

Detailed description: 
      Phase III
    

Intervention name(s): Remegal
Intervention type(s): Drug
Intervention description(s): Remegal 1500 mg for 12 weeks
Other intervention name(s): Beprodon; AED
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epileptic seizures, Partial seizures
To Evaluate the Pharmacokinetics and Safety/Tolerability of Lacosamide in 3 Dosages in Healthy Male Korean Subjects
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective of this trial was to investigate the pharmacokinetics of single dose and
      repeated dose applications of lacosamide in healthy male Korean subjects.
    


Intervention name(s): Lacosamide; Lacosamide; Lacosamide; Placebo; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Other; Other; Other
Intervention description(s): Lacosamide 50 mg, tablet, once in the morning on Day 1; Lacosamide 100 mg, tablet, once in the morning on Day 1 Lacosamide 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9; Lacosamide 200 mg, tablet, once in the morning on Day 1 Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9; Placebo matched with Lacosamide 50 mg tablet once in the morning on day 1.; Placebo matched with Lacosamide 100 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamode 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9; Placebo matched with Lacosamide 200 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
Other intervention name(s): Vimpat®; Vimpat®; Vimpat®
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Lacosamide
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Condition: Advanced Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blinded, placebo controlled trial in
      pre-menopausal women with advanced breast cancer.

      The purpose of this study is to assess the efficacy of Ribociclib (LEE011), as measured by
      progression free survival (PFS), in premenopausal women with HR positive, HER2 negative
      advanced breast cancer
    


Intervention name(s): LEE011; Tamoxifen; Letrozole; Anastrozole; Goserelin; LEE011 Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): LEE011 600 mg daily oral; tamoxifen 20 mg daily oral; letrozole 2.5 mg daily oral; anastrozole 1 mg daily oral; Goserelin 3.6 mg subcutaneous injection; LEE011 placebo 600 mg daily oral
Intervention MeSH terms: Tamoxifen; Letrozole; Anastrozole; Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LEE011; ribociclib; HR-positive; HER2-negative; Advanced breast cancer; Letrozole; Anastrozole; Tamoxifen; Goserelin; CDK; CDK4; CDK6; CDK4/6; Phase III; ER-positive; PR-positive; Premenopausal
A New Pelvic Osteotomy Method for Open Reduction
Condition: Developmental Dysplasia of the Hip
MeSH terms: Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
Study type: Observational

Summary: 
      Developmental dysplasia of the hip (DDH) was one of the most common hip disorders disease in
      children. Pemberton osteotomy (PO) was one of the most widely used by the pediatric
      orthopedic surgeons. In our clinical work, the investigators found some defect the operation
      procedure. When the surgeons were not familiar to the PO, it may injured the triradiate
      cartilage or easily be absorbable of the distal iliac. Here, the investigators found a new
      pelvic osteotomy just from the inner "L shaped" iliac osteotomy (ILSO) to treat DDH. This
      approach was in a visible part of the sciatic notch and not presumed to be in the ischium,
      completely out of sight. Comparing to the PO method, the investigators' operation method was
      easy to master and had less complications.
    


Intervention name(s): a new osteotomy from the inner "L shaped" iliac osteotomy
Intervention type(s): Procedure
Intervention description(s): There were two ostectomies were used in the osteotomy. The first was was a cured and 5mm width and the second one was straight 1.5cm width. All the directions was started from the inner to outer just a bove the triradiate cartilage and its shape like"L"
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients were evaluated and treated in the same hospital and the same surgeon did all
        the operation. The study was carried out between Mar 2016 and May 2018.
Multimodal Approach to Testing the Acute Effects of Mild Traumatic Brain Injury (mTBI)
Condition: Concussion, Mild
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      The objective of the study is to determine the relative roles for various testing modalities
      in the diagnosis and prognosis of mild traumatic brain injury.
    

Detailed description: 
      Subjects will undergo functional brain testing (magnetoencephalography,
      electroencephalography), anatomical brain imaging (diffusion tensor imaging,
      susceptibility-weighted imaging), neuropsychological testing (memory, language, processing
      speed), sleep patterns using actigraphy, and blood testing of candidate biomarkers. Testing
      will be done at 3 time points post-injury: 1 day, 14 days, and 30 days post-injury. Analysis
      of these tests collectively will be used to develop diagnostic tools for acute mTBI.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants (control, mTBI) will be referred by the Huntington Hospital Emergency
        Department staff. ED staff will determine the eligibility criteria. If consent is achieved,
        testing will occur at pre-determined times: 1 day, 14 days, and 30 days post-injury.
      
Biospecimen description: 
      Blood will be retained for future analysis.
    
Keywords: Mild traumatic injury to extremity (for controls); mTBI; concussion; MEG; EEG; Blood; MRI; DTI; biomarkers
Bile Duct Injury Digestif
Condition: Surgery; Biliary Disease; Bile Duct Injury; Sepsis; Jaundice, Obstructive
MeSH terms: Gallbladder Diseases; Jaundice; Jaundice, Obstructive
Study type: Observational

Summary: 
      Data accumulated from medical record collected from January 2008 until December 2018
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients who experienced complication after performed cholecystectomy, open or
        laparoscopy, related to biliary duct
The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
Condition: Medication Adherence; Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Improving adherence to inhaled corticosteroids (ICS) medication in urban minority pediatric
      populations is a clinical and population health priority. Financial incentives have been
      shown as a compelling method to engage a high-risk asthma population in regular ICS use, but
      whether and how adherence can be maintained and lead to sustained high adherence trajectories
      is unknown.
    

Detailed description: 
      Investigators propose to enroll 125 children and their parents in a six-month intervention
      with a six month follow-up period. Children will be ages 5-12, and must have two or more
      visits to any combination of the outpatient, Emergency Department (ED) or hospital setting in
      the past year for asthma exacerbations at Children's Hospital of Philadelphia (CHOP).

      The study intervention will include daily automated medication reminders (either via text
      message or push reminder), an app to track daily medication use, and nominal incentives to
      promote daily controller use. Inhaled controller medication adherence and rescue medication
      use will be measured using electronic monitors affixed to the inhalers. Factors associated
      with differential adherence will be assessed using surveys administered during enrollment,
      the experiment interval (months 1 through 3), the observation interval (months 4 through 6),
      and study completion (months 12-13). Efficacy outcomes will include change in parent-reported
      asthma control and mean adherence to ICS between study arms during the experiment interval,
      as well as the observation interval.

      Patients will be considered enrolled when they fulfill the requirements of the Run-in period
      (sensor data uploaded to research platform AND text message receipt confirmed by caregiver)
      and are subsequently randomized.
    

Intervention name(s): Nominal Financial Incentives; Daily Adherence Reminders/Adherence Performance Feedback
Intervention type(s): Other; Other
Intervention description(s): The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.; Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Effects of Walking and Heating on Vascular Function in Diabetic Patients
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the present study is to determine the effects of increased walking and lower
      body heating on leg vascular function in patients with type 2 diabetes (T2D).
    

Detailed description: 
      The notion that habitual aerobic exercise increases insulin-induced vasodilation is largely
      founded on rodent studies, hence the urgent need for human studies, especially in patients
      with type 2 diabetes (T2D). For example, it remains unknown if increased walking, the most
      common form of physical activity, enhances skeletal muscle vasodilator actions of insulin in
      T2D. In addition, the molecular mechanisms by which exercise improves vasoreactivity to
      insulin have not been examined in humans. The investigators propose that in T2D patients who
      are sedentary (i.e., the vast majority), increased leg blood flow with walking or local
      heating signifies a vital strategy to correct vascular insulin resistance. This study will
      establish whether increased physical activity and associated hemodynamic forces (e.g., shear
      stress) are a direct form of vascular medicine in humans.
    

Intervention name(s): Walking; Lower body heating
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.; This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be assigned to either a walking, a lower body heating, or no intervention.
Masking: None (Open Label)
Primary purpose: Treatment
High-dose Prednisone in Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will help to determine whether a high-dose weekly course of prednisone therapy is
      safer than and at least as effective as daily dose therapy for people with Duchenne muscular
      dystrophy (DMD). Boys who are enrolled in this study should not have taken carnitine, other
      amino acids, creatine, glutamine, Coenzyme Q10 or any herbal medicines within the last three
      months. There will be a two-visit screening to take place in one week to ensure a
      reproducible manual muscle test. The subject will then be randomized and put into either the
      daily or weekly regimen. The duration of the study is twelve 28-day treatment cycles
      (approximately 12 months) with follow-up visits at month one, three and then every three
      months.
    

Detailed description: 
      Duchenne muscular dystrophy (DMD) is the most common lethal inherited disorder worldwide.
      Despite the exponential increase in our understanding of the disorder since the discovery and
      characterization of the causative gene and its product dystrophin in 1987, current
      therapeutic management remains largely supportive. Awaiting a final genetic cure to be
      available in the future, further investments in developing better drug therapies for DMD
      remain important. The effect of a high dose prednisone regimen will be evaluated in
      comparison to a daily dose regimen in a multi-center, randomized, double-blind
      placebo-controlled 4-arm study. Ambulant children aged 4-10 years with an established DMD
      diagnosis will be studied. Patients will undergo 2 screening evaluations within 1 week.
      Patients will be randomized into treatment groups on the second screening visit, followed by
      a 12-month treatment period. During the treatment period, patients will be evaluated at
      monthly intervals. The primary endpoints are percentage change in average muscle strength
      score and QMT performance for specific muscle groups. Secondary endpoints include timed
      function tests, functional grades for arms and legs, and pulmonary function tests.
    

Intervention name(s): Prednisone
Intervention type(s): Drug
Intervention description(s): Prednisone and dummy preparations for this study will be obtained from Frank's Pharmacy in Ocala, FL and will be supplied as a tablet containing 2.5mg, 5mg, 10mg, 20mg or 50mg Prednisone. Inactive "dummy" pills of similar look/taste will be supplied to maintain blinding.
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Muscular dystrophy, Duchenne and Beckers; Beckers Muscular dystrophy
Comparison of Recovery Profile After TIVA Between Remimazolam With Flumazenil and Propofol
Condition: Anesthesia, Intravenous
Study type: Interventional

Summary: 
      This prospective, randomized, single-blinded study is designed to compare the recovery
      profile between propofol-based total intravenous anesthesia (TIVA) and remimazolam-based TIVA
      in patients undergoing thyroidectomy. In the remimazolam group, its antagonist, flumazenil,
      is administered at the end of surgery. We hypothesize that remimazolam-based TIVA antagonized
      by flumazenil can significantly shorten the time from the end of anesthetic administration to
      eye-opening compared to propofol-based TIVA.
    

Detailed description: 
      Adult patients undergoing elective thyroidectomy are randomly allocated to receive
      propofol-based TIVA (n=35) or remimazolam-based TIVA (n=35). The recovery profile including
      the time from the end of anesthetic administration to eye-opening, the time from the end of
      anesthetic administration to extubation, hemodynamic stability, stability of anesthetic
      depth, duration of post-anesthetic care stay, the incidence of postoperative nausea and
      vomiting during the first 24 hours, and the quality of recover 24 hours after surgery using
      the quality of recovery-15 was assessed by an investigator. The primary outcome is the time
      from the end of anesthetic administration to eye-opening.
    

Intervention name(s): remimazolam-based TIVA; propofol-based TIVA
Intervention type(s): Drug; Drug
Intervention description(s): In the remimazolam-based TIVA group, general anesthesia is induced and maintained with a continuous infusion of remimazolam using an infusion pump. In the remimazolam group, its antagonist, flumazenil, is administered at the end of surgery.; In the propofol-based TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using an infusion pump (Orchestra®; Fresenius Vial, France).
Other intervention name(s): remimazolam group; propofol group
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective randomized single-blinded study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anesthetics; Anesthetics, General; Benzodiazepines; Flumazenil
An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the safety profile of Androxal in men with secondary hypogonadism.
    

Detailed description: 
      This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on
      continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The
      study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration.
      Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week
      6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg.
      Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy,
      refraction eye exams, clinical laboratory tests and adverse event reporting.
    

Intervention name(s): Androxal
Intervention type(s): Drug
Other intervention name(s): enclomiphene citrate
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring and Assessment of Psychological Determinants
Condition: Arterial Hypertension; Metabolic Syndrome
MeSH terms: Hypertension; Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to assess whether, in patients at high cardiovascular risk
      (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most
      effective when based on home blood pressure telemonitoring and on the feedback to the patient
      by the doctor between visits, or when based only on blood pressure determination during
      quarterly office visits.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients referring to 12 Hypertension Centers (Hospitals) and suffering from arterial
        hypertension associated to metabolic syndrome
      
Keywords: arterial hypertension; metabolic syndrome; home blood pressure; ambulatory blood pressure; office blood pressure; telemedicine
Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers
Condition: Irritable Colon; Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a three-period crossover study to compare GW876008 and placebo to see if GW876008
      will normalise blood flow responses after different emotional stimuli.
    


Intervention name(s): GW876008 200mcg; GW876008 20mcg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): GW876008; GW876008 20mcg; placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBS fMRI