bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate bioequivalence of the metformin component of the
      Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablets
      co-administered with canagliflozin in healthy fed and fasted participants.
    


Intervention name(s): Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]; Canagliflozin; Metformin Extended Release (XR)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 1 XR FDC tablet containing canagliflozin 50 mg and metformin 1000 mg orally under fed (Treatment B) or fasted (Treatment D) condition in a given treatment period as per treatment sequence.; Participants will receive canagliflozin 50 mg oral tablet) under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.; Participants will receive 2 metformin XR tablets of each 500 mg orally under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Prebiotic and Synbiotic Supplementation in Individuals Undergoing Roux-en-y Gastric Bypass.
Condition: Obesity
Study type: Interventional

Summary: 
      The study will recruit patients submitted to bariatric surgery. Individuals will be
      supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days.
      Immunological, metabolic and anthropometric parameters will be assessed before and after the
      supplementation. Our hypothesis is that prebiotic or synbiotic supplementation modulate
      plasma concentrations of immunological and metabolic parameters and anthropometric measures
      of subjects undergoing gastric bypass Roux-Y.
    

Detailed description: 
      The study will recruit patients submitted to roux-en-y gastric bypass. Individuals that meet
      the inclusion criteria will be randomized by means of a computer program on three study
      groups: 1) Prebiotic group: Oral supplementation with 6g/day of prebiotic for 15 days. 2)
      Synbiotic group: Oral supplementation with 6g/day of synbiotic for 15 days. 3) Placebo group
      (control): Oral supplementation with 6g/day of placebo (maltodextrin) for 15 days. Will be
      assessed the effects of supplementation on the plasma cytokines, plasma lipopolysaccharide
      (bacterial endotoxin), plasma cellular fatty acid profile, metabolic parameters (lipid
      profile, glycemic status and insulin resistance) and nutritional status. Blood samples will
      be collected before the surgery and the supplementation will begin 30 days after surgery.
    

Intervention name(s): Prebiotic; Synbiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Fructooligosaccharides; Fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Roux-en-y gastric bypass; Inflammatory markers; Nutritional status; Fatty acids; Glucose; Prebiotic; Synbiotic
Ultrasound Guided Median Nerve Hydrodissection Using Dextrose
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      to compare the efficacy of dextrose 5% with steroid hydrodissection in patients with carpal
      tunnel syndrome
    

Detailed description: 
      in some cases there is prohibition to use steroid with example the patient rejection to use
      steroid the maneuver planned median nerve hydrodissection using ultrasound and 10 mld of
      dextrose 5%, unleash the median nerve for the surrounding structure and short follow up
      planned to be 2 weeks
    

Intervention name(s): dextrose 5% median nerve hydrodissection
Intervention type(s): Procedure
Intervention description(s): planned to be a good alternative to steroid hydrodissection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups comparing the efficacy of dextrose water 5 % in median nerve hydrodissection
Masking: None (Open Label)
Primary purpose: Treatment
Folic Acid Supplementation in Women of Child Bearing Age
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The objective of this study is to identify genes whose expression is potentially modifiable
      due to changes in folate intake and help delineate mechanisms accounting for the variability
      in individual response to folic acid supplementation. The study will be conducted in normal
      weight and obese women of childbearing age, supplemented for 8 weeks with 800 mcg/day folic
      acid.

      It is hypothesized that (1) a change in folate status, induced by the supplementation, will
      influence the DNA methylation of specific genes and (2) the DNA methylation response to folic
      acid supplementation may differ between the normal weight and the obese women of childbearing
      age.
    

Detailed description: 
      This study will be conducted in two phases. An initial screening study will be performed to
      determine folate status, MTHFR677 genotype and body composition of potential participants of
      the intervention study. Both folate status and MTHFR677 genotype are known independent
      predictors of response to folic acid supplementation. Blood samples will be collected, after
      an overnight fast, for determination of serum folate concentration and for MTHFR677
      genotyping. Body composition and 24-hr dietary recalls will also be conducted during the
      screening visit.

      The second phase is an eight week supplementation trial with 800 mcg/day folic acid. Screened
      individuals determined to have a serum folate < 30 nmol/L (< 50th percentile of NHANES
      1999-2004) and of the CC or CT genotype (for MTHFR677) will be eligible for inclusion in the
      supplementation trial. Participants will be instructed to avoid dietary supplements,
      fortified ready-to-eat cereals, and other high folate content foods during intervention.
      Blood samples will be collected, after an overnight fast, at baseline and after 4 and 8 weeks
      of supplementation for determination of primary (DNA methylation profile) and secondary
      (nutritional, metabolic and health status biomarkers) outcome measures.
    

Intervention name(s): Folic acid
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will be instructed to consume 2 tablets per day, a total of 800 micrograms folic acid. To facilitate compliance, participants will be instructed in the use of a compliance calendar and will receive frequent telephone and 'text' reminders from project staff. Additionally, compliance will be determined by return pill count.
Intervention MeSH terms: Folic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Folate Status; Folate Biomarkers
Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, 2-way crossover, comparative bioequivalence study.
    

Detailed description: 
      The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's
      Laboratories Ltd., India, desloratadine-pseudoephedrine and Schering Corporation,
      U.S.A.(Clarinex-D® 24-HOUR), desloratadine-pseudoephedrine, administered as a 1 x 5 mg/240 mg
      extended-release tablet under fed conditions. The treatment phases were separated by a
      washout period of 14 days. 44 subjects were dosed and were enrolled in the study; 43 of these
      enrolled subjects completed the study.
    

Intervention name(s): Desloratadine and pseudoephedrine
Intervention type(s): Drug
Intervention description(s): Desloratadine and pseudoephedrine 5/240 mg
Other intervention name(s): Clarinex D-24
Intervention MeSH terms: Pseudoephedrine; Ephedrine; Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Desloratadine and pseudoephedrine; crossover
Effect of Skate Skin Extract on Body Fat in Overweight Adults
Condition: Body Fat
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Comparison of a randomized, double-blind, and control-group study for the effect of oral
      ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in
      adults
    

Detailed description: 
      Our aim is to investigate the effect of oral ingestion of low-molecular collagen peptides
      derived from Skate Skin on body fat reduction in adults by a randomized, double-blind, and
      control-group study.
    

Intervention name(s): Skate Skin group; Control group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.; 2,000 mg of starch was orally administered per day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The Objectives of this study is to determine the effect(s) of daily non-caloric artificial
      sweetener (NAS) consumption (sucralose or aspartame) on the composition of the bacteria and
      also to determine the changes in glucose metabolism.
    

Detailed description: 
      The trial will be 12 weeks randomized, cross-over and double blinded with 2 treatment
      intervention ( sucralose and aspartame) , there will be a run in period (4 weeks), then phase
      1 treatment period for two weeks followed by four weeks washout period then phase 2 treatment
      period(2 weeks). Healthy, normglycemic (<5.6 mmol/L) males and females ( 17 total) of age
      18-45 y with a body mass index (BMI) 20-25 kg/m2 will be recruited.

      Each participants will be given the dose of sweetener aspartame or sucralose during the
      treatment phase in a double-blind procedure.

      the participant will be asked to consume the sweetener in a mixed flavoured beverage during
      each visit in the treatment phase.

      Blood and stool sample collection will take place before after the run-in period, and after
      the washout period, as well as after each two-week treatment period.

      glucose measurement: Capillary blood will be collected during each visit by registered nurse.
      Blood will be collected at fasting and at 12,30,45,60,90 and 120 minutes after the
      participants drink a glucose drink (75g glucose) for Oral glucose tolerance test.

      a food frequency questionnaire will be given to each participant in order to estimate how
      often each sweetener is consumed on a daily basis.

      Participants will also be asked to complete weekly food diaries of food and drink
      consumption.
    

Intervention name(s): Sucralose-Aspartame; Aspartame-Sucralose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sucralose or aspartame; Aspartame or sucralose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Non-Nutritive Sweeteners; Artificial Sweeteners; Glucose Metabolism; Microbiota; Dysbiosis
Enrichment & Purging of Stem Cells in Non-Hodgkin's Lymphoma
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional

Summary: 
      To evaluate the role of purging the hematopoietic cell graft on outcomes for non-Hodgkin's
      Lymphoma.
    

Detailed description: 
      To study the use of peripheral blood stem cells which have been treated in an effort to
      remove tumor cells. The researchers hope to learn whether or not this will be more effective
      in removing the tumor cells as compared to other methods of purging (the removal of cancer
      cells).
    

Intervention name(s): high dose chemo then auto hematopoietic cell transplant
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Voiding After Sling
Condition: Post-operative Voiding
Study type: Interventional

Summary: 
      The purpose of this study is to compare the incidence of catheterization from discharge to 6
      weeks postoperatively when using two methods of post-operative voiding evaluation after a
      mid-urethral sling procedure. The investigators' results may lead to a decreased use of
      indwelling catheters and their associated morbidity after outpatient sling surgery.
    

Detailed description: 
      Minimally invasive slings have demonstrated similar efficacy to earlier abdominal
      anti-incontinence procedures, but offer the benefit of shorter operating times, less voiding
      dysfunction, lower morbidity and are usually done as an outpatient procedure. Despite the
      advantages, about 35% of patients are discharged home with indwelling catheters. Indwelling
      catheters are bothersome for patients, costly to the healthcare system and are a source of
      significant morbidity. The challenge for pelvic surgeons performing anti-incontinence
      procedures is avoiding postoperative urinary retention while minimizing the use of catheters
      and their associated risks. A commonly described backfill-assisted voiding trial is used as a
      means of evaluating bladder function postoperatively. This method uses a low post-void
      residual as a specific criterion for discharge without a catheter. However, the validity of
      this method has never been critically evaluated. Our recent observational study suggests that
      patients may be safely discharged without a catheter after a midurethral sling procedure
      based on their subjective assessment of the force of stream. Our proposed study expands on
      this pilot data using a randomized trial to evaluate two methods of post-operative voiding
      evaluation. The results may lead to a decreased use of indwelling catheters and their
      associated morbidity after outpatient sling surgery.
    

Intervention name(s): Urinary voiding assessment after midurethral sling
Intervention type(s): Other
Intervention description(s): Both groups will undergo voiding trial in the similar manner. The decision to discharge based on an objective measure (voided amount) versus based on the subjective measure (force of stream self assessment).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Voiding trial; sling; post-operative assessment; urinary retention
STORIES-Stories to Communicate Risk About Tobacco
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to develop and test an intervention based on
      literacy-appropriate electronic tools, tailored to the demographics and readiness for change
      of the user, to promote tobacco smoking cessation in a low-literacy population.
    

Detailed description: 
      PROJECT STORIES:

      STORIES is one of two intervention trials conducted as part of the "Deep South Partnership
      for the Prevention of CVD Disparities" under the NHLBI Partnership Programs to Reduce
      Cardiovascular Disparities. STORIES is an innovative approach to smoking cessation programs
      provided in medical facilities for patients seeking assistance with quitting smoking. Our
      approach is to provide the patient with counseling prior to being discharged from the
      hospital in an effort to assist them with quitting smoking. The DVD will include current and
      previous smokers telling their stories regarding their tobacco use. We feel having the
      patient see other people similar to them express their views, struggles and successes with
      quitting smoking will motivate them to quit smoking. The patient will also receive 3 follow
      up telephone calls to check on their progress. Our hypothesis is that patients exposed to the
      interactive DVD will be more likely to quit, compared with those not exposed. The specific
      aims for this health communication project are: (1) to develop a series of interactive,
      testimonial-base stage of change-matched Health Communication DVD video interventions
      targeted at low-income, low-literacy African Americans in the Deep South and a health
      information interactive DVD for the patients selected in the randomized control group; (2) to
      train a peer health counselor/research assistant to counsel inpatient smokers to quit and
      assist the community members with learning to use the DVDs and then to follow-up by telephone
      at two weeks, three months and six months after discharge following enrollment in the
      project; and (3) to evaluate the impact of the intervention on processes of change and six
      month cessation rates among smokers using a group-randomized controlled trial.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Query View Report (QVR) record.
    

Intervention name(s): Health Communication DVD video
Intervention type(s): Behavioral
Intervention description(s): Interactive, testimonial-based, stage of change-matched Health Communication DVD video interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase I, open-label, single-dose, parallel-group study in participants with mild
      hepatic impairment (HI) and healthy matched control participants with normal hepatic function
      designed to evaluate the PK of pelacarsen following a single 80 mg s.c. dose. Participants
      were matched by gender, age (±10 years), and body weight (±15%).
    

Detailed description: 
      The study consisted of a Screening period of up to 28 days, followed by Baseline evaluations
      on Day -1. Participants who met the eligibility criteria at Screening were admitted to
      Baseline evaluations.

      On Day 1, participants received a single s.c. injection of 80 mg pelacarsen followed by PK
      sampling up to Day 60 (±3 days). Participants were domiciled for at least 4 overnight stays
      (Day -1 through Day 4) for PK sample collection up to 72 hours postdose and were to return to
      the study site on 3 occasions (Days 8, 30 [±2 days], and 60 [±3 days]) for additional PK
      sample collection.

      Study Completion evaluation occurred with the completion of Day 60 (±3 days) assessments. The
      total study duration for each participant was expected to be up to a maximum of 89 (±3) days,
      including the Screening period.

      A post study safety contact took place on Day 112, approximately 16 weeks after dosing.
    

Intervention name(s): Pelacarsen
Intervention type(s): Drug
Intervention description(s): Single subcutaneous injection of pelacarsen
Other intervention name(s): TQJ230
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a Phase I, open-label, single dose, parallel-group study in participants with mild HI (n=8) and matched healthy participants with normal hepatic function (n=8) designed to evaluate the PK of pelacarsen. Participants were matched by gender, age (± 10 years), and body weight (± 15%).
Masking: None (Open Label)
Primary purpose: Other
Keywords: CTQJ230; Hepatic Impairment; Subcutaneous injection; single-dose
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in
      children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to
      3 other antiepileptic drugs (AEDs).
    

Detailed description: 
      Six subjects aged 5-11 (Cohort 1) were initially enrolled at the 8 mg/kg/day dose level. Upon
      completion of the study for these subjects, pharmacokinetic and safety data were analyzed to
      determine the target dose for the remaining subjects (either 8, 10 or 12 mg/kg/day).
      Depending on the selected target dose, four additional age-based cohorts of subjects were to
      be enrolled. LCM was increased 2 mg/kg/day per week until the target dose or maximum dose
      able to be tolerated was achieved.
    

Intervention name(s): Lacosamide
Intervention type(s): Drug
Intervention description(s): Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL
Other intervention name(s): Vimpat
Intervention MeSH terms: Lacosamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lacosamide; Vimpat; Children; Epilepsy; Seizures; Anti-epileptic
Biomarkers of Muscle Anabolism (MK-0000-082)
Condition: Muscle Anabolism
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the ability of comparative proteomics to identify early biomarkers
      of muscle anabolism.
    


Intervention name(s): Comparator: low dose testosterone; Comparator: high dose testosterone; Comparator: placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 200 mg (0.8 mL) testosterone.; Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 600 mg (2.4 mL) testosterone.; Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 0.8 mL placebo saline solution.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Biomarkers of muscle anabolism