bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Canagliflozin on C-peptide Clearance in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess whether treatment with a single oral 300 mg dose of
      canagliflozin alters the kinetics (ie, clearance/removal from body) of serum C-peptide (a
      protein released from the pancreas during insulin secretion) in healthy adult volunteers.
    

Detailed description: 
      This is a double-blind (neither the volunteer nor the study doctor/staff will know the
      identity of the assigned treatments) study to assess the effect of single oral (taken by
      mouth) dose of canagliflozin on clearance (removal from the body) of C-peptide in healthy
      adult volunteers. Healthy volunteers will be randomly (by chance) assigned to receive a
      single oral dose of canagliflozin followed by a single oral dose of placebo (inactive
      substance) or a single dose of placebo followed by a single dose of canagliflozin with a
      period of 7-10 days between treatments. Healthy volunteers will also receive intravenous
      (i.v.) infusion (injection in the vein) of somatostatin for 4 hours and a single dose i.v.
      injection of synthetic human C-peptide following administration of canagliflozin or placebo
      during each treatment period. Somatostatin will suppress the normal secretion of C-peptide, a
      protein that is released from the pancreas during insulin secretion, so that the human
      C-peptide administered to volunteers can be accurately measured. The total study duration for
      each volunteer will be approximately 44 days. During the study, blood and urine samples will
      be drawn (collected) for clinical laboratory evaluations.
    

Intervention name(s): Canagliflozin 300 mg; Placebo; Somatostatin; C-peptide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Singe over-encapsulated 300 mg tablet of canagliflozin administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.; Singe capsule of placebo administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.; A primed (50 mcg in 1 mL sterile 0.9% NaCl solution i.v. injection over 1 minute) constant (500 mcg/hour) i.v. infusion of somatostatin for 4 hours approximately 2 hours after canagliflozin or placebo dosing on Day 1 of Treatment Period 1 and Day 1 of Treatment Period 2. The total dose of somatostatin administered during each period will be 50 mcg + 500 mcg/hour x 4 hours = 2050 mcg.; Single bolus dose of 150 mcg synthetic human C-peptide in 1 mL water for injection administered i.v. (in the vein) approximately 3 hours after canagliflozin or placebo dosing on Day 1 of Treatment Period 1 and Day 1 of Treatment Period 2.
Intervention MeSH terms: Canagliflozin; Somatostatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Healthy; Clearance; Canagliflozin; JNJ-28431754; Placebo; Somatostatin; C-peptide
Registry of Pediatric Patients Diagnosed With Crohn's Disease in Belgium
Condition: Description of Disease Course, Disease Fenotype, Medication, Safety, Analysis for Possible Associations
MeSH terms: Crohn Disease; Disease Progression
Study type: Observational

Summary: 
      A registry of pediatric patients (under 18 yrs of age) diagnosed with Crohn's disease was
      created in Belgium. Over a 2 year period 257 patients are included. These patients will be
      follow up prospectively during 5 years. Demographic data, family history, disease
      presentation and disease course including medication are registered in CRF's.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        subjects under 18 yrs of age diagnosed with Crohn's disease, living in Belgium
      
Keywords: pediatrics, crohn's disease, disease course, therapy
Latiglutenase as a Treatment for Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Single Center, Randomized, Double-Blind, Placebo Controlled, Gluten Challenge Trial in
      Patients with Well-Controlled Celiac Disease
    

Detailed description: 
      This is a phase 2, single-center, prospective, randomized, double-blind, placebo-controlled,
      study in patients with well-controlled celiac disease. Patients with confirmed CD diagnosis
      (biopsy) will be recruited to participate in the study. Informed consent must be obtained
      prior to performing any screening procedures. Patients who meet Visit 1 protocol enrollment
      criteria will be enrolled and begin the screening period. Patients that fail to meet
      screening period eligibility will be discontinued from study participation at Visit 2. At
      Visit 2, eligibility will be confirmed, adverse events will be documented at Visit 2.
      Patients who continue to meet eligibility requirements at Visit 3 will begin the next
      treatment phase. During the treatment phase patients will self-administer treatment and
      gluten daily with their evening meal. At the end of the treatment period, Visit 4, patient
      eligibility will be confirmed and adverse events will be documented. The final visit, Visit
      5, will be a safety follow-up visit.
    

Intervention name(s): Latiglutenase; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Latiglutenase administered orally (daily); Placebo administered orally (daily)
Other intervention name(s): IMGX003
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Celiac
Quantitative Sensory Testing and PET/CT Scanning in Assessment of Surgical Outcome for Lumbar Disc Herniation
Condition: Lumbar Disc Herniation; Radiculopathy Lumbar
MeSH terms: Intervertebral Disc Displacement; Radiculopathy; Hernia
Study type: Interventional

Summary: 
      Patients with lumbar disc herniation suffer from pain and morbidity. Surgical intervention
      can be a quick and effective relief, however some individuals experience less favorable
      outcome.

      This study tries to investigate and test the differences in pain perception and pain
      modulation between individuals. Using PET/CT scans the investigators try to visualize pain
      perception and -modulation in the CNS. This is subsequently correlated with a battery of pain
      tests and the surgical outcome of disc herniation surgery.
    


Intervention name(s): PET/CT scan; Quantitative Sensory Testing
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Patient receive a PET/CT scan of their cerebrum and lumbar spine prior to surgery, 4-6 weeks after surgery and 6 months after surgery; Patients undergo a battery of quantitative sensory tests prior to surgery, 4-6 weeks after surgery and 6 months after surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PET/CT
A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG).
Condition: Obesity
Study type: Interventional

Summary: 
      Advances in endoluminal devices are now allowing clinicians the ability to begin exploring
      bariatric procedures performed via flexible endoscopy. Although these procedures may not be
      as effective as their surgical counterparts, these less-invasive options may relieve patients
      of the significant risks associated with surgery (1).

      Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is CE mark device that may be attached
      to an endoscope inside the body and allows remote manipulation of the arms of the device
      during a peroral intervention. It offers the possibilities of making transoral surgical full
      thickness sutures and may allow performing endoscopic therapeutic interventions, via a
      transoral route.

      A first trial including 11 patients assessed feasibility and safety of the technique (2).
      There were no complications and the short-term results were encouraging. Then a multicentric
      efficacy study was conducted, including 51 patients (3). The results where EWL of 31% at one
      year and TBWL of 9% without complications.

      Finally a randomized controlled study was done including 73 patients in a 2/1 randomized
      fashion with a crossover at 6 months. Treated group was with the endomina device and
      controlled group was diet only. The follow-up was the same in each group. Primary endpoint
      was to reach the ASGE guideline "difference between a control group and a treatment group of
      minimum 15%" (4).

      Technique and suture pattern have evolved since the first study. The aim of this prospective
      evaluation is to compare different suture patterns and their mechanism of action.
    


Intervention name(s): Endomina
Intervention type(s): Device
Intervention description(s): The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of transmural anterior-posterior sutures in the stomach in order to achieve a gastric remodelling. Patient will be kept overnight after the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Endoscopy; Mini invasive
Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake
Condition: HPV-Related Cervical Carcinoma
Study type: Interventional

Summary: 
      This study aims to assess the effectiveness of targeted educational interventions in
      increasing the acceptability and knowledge of the HPV vaccine among females ages 12 through
      26. Subjects will be randomized to one of three study arms (no intervention, viewing an
      educational video or reading an educational handout) and then a questionnaire will be
      administered to assess knowledge and acceptability of the HPV vaccine. Subject charts will be
      reviewed to assess for initiation of the HPV vaccine.
    


Intervention name(s): Educational video; Educational handout; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Approximately 7 minute video on the HPV vaccine; One page handout on the HPV vaccine; Control
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Resistance Training During Maintenance Dialysis
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      There is a rising incidence of kidney failure in the US, with poor outcomes and high cost.
      End-stage renal disease (ESRD) affects almost 375,000 individuals in the US at a cost of more
      than $14 billion per year. Despite advances in dialysis and transplantation therapies, kidney
      failure leads to poor outcomes, poor prognosis and high health care costs. Malnutrition and
      the underlying systemic inflammatory response developed during the course of chronic kidney
      disease, worsen during ESRD, and lead to adverse outcomes, increased morbidity and mortality.
      Muscle wasting, impaired functional capacity and poor quality of life are the most important
      factors associated with malnutrition and inflammation in renal failure. We have shown in pre
      dialysis patients with moderate chronic renal insufficiency that the anabolic effects of
      resistance exercise training result in significant improvements in protein utilization,
      nutritional status and functional capacity even in the context of anorexia and prescribed low
      protein diets. Therefore, we propose to develop, test and implement a progressive resistance
      exercise routine for ESRD patients during the hemodialysis session. By implementing such
      intervention, we hope to offer a therapeutic strategy that can be incorporated to the
      standard of care of ESRD patients by working in conjunction with the dialysis unit staff.
    

Detailed description: 
      The hypotheses to be investigated are that, compared to ESRD patients on maintenance dialysis
      receiving stretches only, the addition of 30-45 min of progressive resistance training during
      the hemodialysis session will counteract the burden of renal disease and will result in:

        1. A feasible and safe exercise modality for ESRD patients.

        2. Will contribute to improved nutritional status and reduced systemic inflammation

        3. Will result in improved quality of life
    

Intervention name(s): Resistance exercise
Intervention type(s): Behavioral
Intervention description(s): resistance exercise vs sham comparison
Other intervention name(s): strength training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: End stage renal disease; Maintenance dialysis; Resistance exercise; Muscle wasting; Disability
Biological Evaluation of Dietary Supplement Liposomal Glutathione
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Low levels of antioxidant molecules such as glutathione have been found in people with a
      diagnosis of schizophrenia. However, oral glutathione is not well absorbed because the
      compound is mostly broken down in the gastrointestinal system. Liposomes are tiny droplets of
      oil particles that encapsulate and protect the glutathione. In this study we will evaluate a
      liposomal formulation of glutathione for tolerability and to examine if this formulation
      serves the function of increasing glutathione in the brain and body.
    

Detailed description: 
      Additional information about this dietary supplement:

        -  Glutathione is an antioxidant naturally produced in our body. Glutathione protects the
           brain and other organs from oxidative stress.

        -  Low glutathione is associated with high oxidative stress, which has been linked to aging
           and many illnesses. Schizophrenia is a mental illness that doctors still do not fully
           understand. Individuals with schizophrenia often have low levels of glutathione.

        -  Glutathione can be supplied through dietary supplement. However, if taken plainly, it
           easily breaks down in our gut.

        -  Scientists have now found a way to wrap glutathione in tiny drops of oil particles
           called liposomes. That way, the gut cannot break it down so it is absorbed into our
           body. Once inside the body, our cells can take in the liposomes and use the glutathione
           to reduce oxidative stress.

        -  Liposome-wrapped glutathione is not a drug or medicine.
    

Intervention name(s): Liposomal glutathione; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Escalating dose steps; escalating dose steps
Other intervention name(s): ReadiSorb glutathione; Readisorb solution without glutathione
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Sugammadex Hypersensitivity Study (Study P06042)
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted to study the potential for hypersensitivity symptoms at the time of
      initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the
      frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a
      prolonged period.

      In total 450 participants (all healthy subjects) were to be randomized to receive one of
      three study treatments: three repeated doses of either sugammadex 4 mg/kg, sugammadex 16
      mg/kg, or placebo. Participants were to receive one dose of study treatment on Day 8, Day 36,
      and Day 78 of the study in order to determine the safety of each treatment dose.
    

Detailed description: 
      All subjects were to be admitted to the study center the day before each scheduled dose and
      were to leave the unit the morning of the day after each dose. In cases of suspected
      hypersensitivity symptoms, healthy subjects were to remain confined to the study center until
      all signs and symptoms regressed, the subject was stable, and the investigator considered it
      safe for the subject to leave the study center. Four sites participated in this trial.
    

Intervention name(s): Placebo run-in dose; Sugammadex 4 mg/kg; Sugammadex 16 mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single-blind placebo intravenous bolus injection on Day 1 of the study, 7 days prior to randomization; Sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study; Sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study; Placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study
Other intervention name(s): SCH 900616, Org 25969, Bridion®; SCH 900616, Org 25969, Bridion®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term
      safety, tolerability and efficacy profile of aliskiren compared to the active comparator
      enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age,
      gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive
      either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be
      administered once daily and children will receive study medication in a double-blind manner.
      This study is being conducted to support monotherapy registration of aliskiren for the
      treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study
      CSPP100A2365).
    


Intervention name(s): Aliskiren; Enalapril
Intervention type(s): Drug; Drug
Intervention description(s): Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg
Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg
High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg; Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg
Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg
High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
Intervention MeSH terms: Enalapril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pediatric hypertension; primary hypertension; secondary; hypertension
Home Exercise Intervention in Persons With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The objective of this study is to determine the effect of home-based, aerobic exercise
      training on subclinical atherosclerosis and mobility disability in persons with Multiple
      Sclerosis (MS). Our central hypothesis is that aerobic exercise training reduces both
      subclinical atherosclerosis and mobility disability.
    

Detailed description: 
      This study will use a two-arm randomized control trial (RCT) design to examine the effect of
      a home-based exercise training program versus a minimal exercise, attention control condition
      on markers of subclinical atherosclerosis and mobility disability in persons with MS. The
      primary outcomes will be subclinical atherosclerosis including measures of arterial structure
      and function and measures of mobility disability including the six-minute walk and timed
      25-foot walk, GaitRite walking assessment and one week of accelerometry data.

      Fifty-four persons with MS who have an Expanded Disability Status Score (EDSS) score between
      0 and 4.0 will be randomized into either the home-based exercise training condition or the
      attention control condition. Participation in this study will include a 3-month exercise
      program to be completed at home. In addition, participants will need to come to University of
      Illinois at Chicago (UIC) three times to undergo testing. Each visit will take about 3-4
      hours to complete. Testing that will take place during these three visits include blood
      pressure measurement, six vascular (artery) measurements, heart measurements, short walking
      tests, peak aerobic capacity test, blood draw, five quality of Life questionnaires and two
      cognitive function tests.

      The home-based exercise regimen will include cycle ergometry as an aerobic mode of training 3
      times per week with a gradual progression of duration and intensity across a 12-week period.
      Exercise prescription will be based on the peak aerobic capacity cycling test conducted
      during the first visit. The attention control will involve stretching using the same
      frequency and duration across a 12-week period with exercises recommended by the National
      Multiple Sclerosis Society (NMSS). Both arms will receive weekly internet "coaching" sessions
      via video chatting.

      Subclinical atherosclerosis and mobility disability data will be collected before, after 6
      weeks of training and immediately after the 12-week intervention.
    

Intervention name(s): home-based exercise training condition
Intervention type(s): Other
Intervention description(s): Home based endurance exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention