bioihbjkbjnl/mcl2 huggingface dataset:
Improvement of Insulin Resistance After Bariatric Surgery
Condition: Obesity; Bariatric Surgery Candidate; Insulin Tolerance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Non-randomized open label study to investigate factors mediating changes in insulin
      sensitivity, glucose tolerance and other metabolic outcomes after bariatric surgery.
    

Detailed description: 
      Bariatric and weight loss surgery is an effective treatment for severe obesity. Bariatric
      surgery also decreases insulin resistance and improves diabetes. Our study enrolled
      individuals approved for bariatric surgery to collect data on modifiable predictors and
      laboratory outcomes. These data would allow us to systematically assess clinical outcomes
      over one year post bariatric surgery and elucidate how insulin resistance is decreased and
      diabetes is improved.

      The type of surgery was selected by the subjects between Roux-en-Y gastric bypass or a
      laparoscopic adjustable gastric banding. Participation in the study involved having a small
      sample of tissue obtained from the abdomen and subjects were also given the option to have a
      biopsy performed in the thigh area during their elective surgical procedure (optional adipose
      and muscle tissue biopsies).

      Subjects were examined prior to surgery and at 2, 3, 6 months after intervention.
      Anthropometric and body composition measurements were performed using the Bioelectrical
      Impendence Analysis (BIA) before surgery and 6 months post operatively. Morning blood was
      collected after overnight fasting during each visit. Some of the non-diabetic subjects
      completed a mixed nutrient stimulation study during the baseline and 6-month visit. Blood
      samples were collected immediately prior to drinking the liquid drink, and every 30 minutes
      after the meal ingestion for 2 hours.
    

Intervention name(s): Roux-en-Y gastric bypass; Laparoscopic adjustable gastric banding
Intervention type(s): Procedure; Procedure
Intervention description(s): Creation of a small pouch from the stomach and connection of the newly created pouch directly to the small intestine so that swallowed food bypasses most of the stomach and the first section of the small intestine.; Placement of a soft silicone ring with an expandable balloon in the center, around the top part of the stomach to create a two-compartment stomach, with a much smaller top part above the band. The subject will eat enough food only to fill the top part of the stomach decreasing caloric consumption.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible patients were consecutively recruited and treatment allocation was decided after clinical evaluation.
Masking: None (Open Label)
Primary purpose: Basic Science
A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis
Condition: Allergic Rhinitis; Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an 8 day, randomised, double blind, 2-way crossover trial of repeat doses of
      intranasal GSK256066 and azelastine hydrochloride in the Vienna Challenge Chamber in subjects
      with seasonal allergic rhinitis (SAR). Laboratory safety assessments, 12-lead
      electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the
      study. Nasal examination, symptom scores, and allergen challenge assessments will also be
      performed at various time points throughout the study.
    


Intervention name(s): GSK256066; azelastine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 200mcg bd; 140mcg
Other intervention name(s): GSK256066
Intervention MeSH terms: Azelastine; 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic rhinitis,; Vienna Challenge Chamber
Canola Oil Multi-center Intervention Trial II
Condition: Cardiovascular Disease; Metabolic Syndrome
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Building on the findings from the investigators previous study, COMIT I, the purpose of the
      COMIT II study is to supplement the DEXA measurement of body composition with a supplementary
      DEXA measurement of visceral adipose tissue and to specifically target the impact of oleic
      acid consumption on body composition as the primary objective. COMIT II also will include
      analysis of fatty acid ethanolamines (FAEs) and their precursors to elucidate the mechanisms
      by which canola oil may be modifying body composition, measurement of endothelial function,
      inflammatory, adiposity and insulin sensitivity biomarkers, and genetic analyses.
    


Intervention name(s): Canola Oil; High oleic acid canola oil; Western diet oil combination
Intervention type(s): Other; Other; Other
Intervention description(s): Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.; High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.; A typical "Western diet" fat intake as a control treatment, comprised of 11% MUFA, 11% PUFA (9% omega-6 fatty acids and 2% omega-3 fatty acids), and 13% SFA, will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety and Efficacy of TXA127 and Neupogen to Increase Peripheral Blood Stem Cells (PBSCs)
Condition: Miscellaneous Peripheral Blood Cell Abnormalities
MeSH terms: Congenital Abnormalities
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I Study to be conducted in 18 healthy volunteers. Each will receive daily
      injections for 5 days of TXA127 alone, or Neupogen alone, or TXA127 plus Neupogen together.

      The aim of the study is to determine the safety of the TXA127 alone and in combination with
      Neupogen, and to determine whether the use of TXA127 alone or in combination with Neupogen
      enhances peripheral blood stem cell (CD34+)mobilization.
    

Detailed description: 
      In this double-blinded comparison study, healthy volunteers will be randomized to one of 3
      treatment groups: (Group A) TXA127 at 300 mcg/kg once a day for 5 days or (Group B) Neupogen
      10 mcg/kg once a day for 5 days or (Group C) both together once a day for 5 days, these
      treatments administered by subcutaneous injection, to increase peripheral blood stem cell
      (CD34+) concentrations in healthy volunteers.

      A minimum of 18 healthy male and female volunteer Subjects (6 in each treatment group) who
      meet all inclusion and none of the exclusion criteria will be enrolled in this study.
      Subjects will be recruited from the study center's existing database of healthy volunteers
      and/or by advertising. A sufficient number of alternate volunteers will be screened and
      checked-in on Day 0 to ensure 6 eligible healthy volunteers are enrolled on Day 1 in each
      treatment group. Subjects will remain housed in teh Unit during the conduct of this study.

      Safety: Predose blood samples will be collected immediately prior to receiving the study
      medication(s), as well as at 4 hours, 8 hours, 12 hours and 16 hours post-dose.
    

Intervention name(s): TXA127; Neupogen (filgrastim)
Intervention type(s): Drug; Drug
Intervention description(s): TXA127 : 300mcg/kg per day for 5 days, injection; Neupogen : 10mcg/kg per day for 5 days, injection
Other intervention name(s): filgrastim; angiotensin 1-7; filgrastim; angiotensin 1-7
Intervention MeSH terms: Angiotensin I (1-7); Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peripheral blood stem cell mobilization; CD34+ count
Study of Adjuvant ONO-4538 With Resected Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant
      chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1
      therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in
      combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including
      esophagogastric junction cancer) after D2 or more extensive lymph node dissection.
    


Intervention name(s): Nivolumab; Tegafur-gimeracil-oteracil potassium; Oxaliplatin; Capecitabine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).; Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off; Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.; Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.; Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Other intervention name(s): BMS-936558; ONO-4538; MDX-1106
Intervention MeSH terms: Capecitabine; Tegafur; Oxaliplatin; Nivolumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX
Efficacy of Injectable Vitamin C on Accelerating Canine Movement: A Clinical Study
Condition: Palatally Impacted Canines
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      efficacy of the injectable vitamin C to reduce the time of canine traction
    

Detailed description: 
      Objective. The purpose of this study is to investigate the role and efficiency of the locally
      injected vitamin C in the enhancement of the palatally impacted canine movement.

      Design. Twelve adult patients with unilateral palatally impacted canines were included in
      this study. The enrolled patients were randomly allocated into the study groups; control
      group; orthodontic traction and he test group: orthodontic traction enhanced by
      intraepidermic vitamin C injection. The study duration was 12 months.
    

Intervention name(s): vitamin C
Intervention type(s): Drug
Intervention description(s): 25 IU of vitamin C injected intraepidermally for 6-8 visits till eruption achieved
Other intervention name(s): ascorbic acid
Intervention MeSH terms: Ascorbic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: vitamin C; palatally impacted canines; intraepidermal injection
A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT)
Condition: Supra-ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular; Tachycardia, Supraventricular
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to compare non inferiority of giving adenosine with the simplified method vs the AHA
      method
    

Detailed description: 
      tle: A randomised controlled trial of the standard versus a simplified adenosine
      administration method in the treatment of adult patients with supra- ventricular tachycardia
      (SVT
    

Intervention name(s): Adenosine
Intervention type(s): Drug
Intervention description(s): A vial of adenosine with 6mg
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomizes Control trial
Masking: None (Open Label)
Primary purpose: Treatment
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301
Condition: Renal Transplant
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim of study is to collect long term safety and tolerability data on enteric-coated
      mycophenolate sodium with regard to adverse events, serious adverse events, and patient and
      graft survival. After successful completion of study CERL080A301 study, patients who
      previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to
      remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated
      mycophenolate sodium.
    


Intervention name(s): Mycophenolate sodium (enteric coated)
Intervention type(s): Drug
Intervention MeSH terms: Mycophenolic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Transplant, adults, immunosuppressant
PK, Tolerability and Safety of the co-Administration of Sancuso® (Transdermal Granisetron) and IV Granisetron
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has been designed to investigate the pharmacokinetic and safety profile of the
      co-administration of intravenous (IV) and transdermal granisetron, as well as characterise
      the pharmacokinetics of multiple transdermal dosing.
    

Detailed description: 
      Sancuso® is designed to provide antiemetic prophylaxis for chemotherapy of up to 5 days
      duration. In exceptional clinical situations in which the patch is not applied at the
      appropriate time (i.e. 24-48 hours pre-chemotherapy), clinicians might use a single IV dose
      of granisetron to provide prophylaxis while the granisetron from the patch reaches a
      therapeutic plasma concentration.

      Most chemotherapeutics are dosed in a single day, with a 2- or 3-week interval between doses;
      however, several regimens are administered over more than 5 days and others are given at
      frequencies (e.g. every 5 days). Thus, more than one patch may be required to provide
      continuous antiemetic prophylaxis. Characterisation of the pharmacokinetics of multiple
      transdermal dosing offers useful information for clinicians who treat patients with the
      latter types of regimens.
    

Intervention name(s): granisetron
Intervention type(s): Drug
Intervention description(s): Sancuso® 3.1 mg/24 hours; transdermal. One patch applied to healthy intact skin on the upper outer arm and worn for 7 days (168 hours) followed by a second patch applied to the opposite arm at 168 hours for a further 7 days (168 to 336 hours).
Kytril® (granisetron hydrochloride) 1 mg/mL; IV; 0.01 mg/kg (maximum 1 mg) administered over 30 seconds immediately following patch application on Day 1 only.
Other intervention name(s): Granisetron Transdermal System; Sancuso® patch; Kytril®; Granisetron Injection
Intervention MeSH terms: Granisetron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Co-administration of transdermal and intravenous granisetron; Granisetron; Healthy subjects; Intravenous; Pharmacokinetic profile; Sancuso® patch; Transdermal; Pharmacokinetics
Study of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation With Edoxaban
Condition: Anticoagulation Reversal
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the establishment of anticoagulation ("re-anticoagulation") of
      subjects with edoxaban following reversal by PER977 and will identify a dose regimen of
      PER977 that reverses the effects of edoxaban for up to 21 hours.
    

Detailed description: 
      This is a randomized, single-blind, sequential group, ascending PER977 reversal dose study in
      healthy volunteers. Subjects will be randomized in a 4:1 ratio to receive either PER977 or
      placebo. All subjects will receive a single dose of edoxaban 60 mg on Days 1-4. On Days 3 and
      4, study drug will be administered 3 hours following edoxaban. Beginning with Cohort 2, study
      drug will be administered only to those subjects with a minimum increase in whole blood
      clotting time >25% above baseline.

      Pharmacokinetic assessment of PER977 and tis metabolite, and edoxaban and its metabolite will
      be performed. Pharmacodynamic assessment of WBCT and Point of Care prothrombin time will be
      performed. Safety will be assessed throughout the study.
    

Intervention name(s): PER977; Placebo; Edoxaban
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Reversal of edoxaban-induced anticoagulation; Reversal of edoxaban-induced anticoagulation
Intervention MeSH terms: Edoxaban
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: PER977; anticoagulation reversal; pharmacokinetics; edoxaban; whole blood clotting time; D-dimer; prothrombin fragments 1 and 2; tissue factor pathway inhibitor; prothrombin time
A Clinical Investigation Into the Effectiveness and Safety of Five Water Based Personal Lubricants.
Condition: Dyspareunia; Vaginal Dryness
MeSH terms: Dyspareunia
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical investigation will look at the safety of five water based personal lubricants,
      and teir effectiveness the relief of intimate discomfort associated with vaginal dryness.
    

Detailed description: 
      This is an open label, five-arm, parallel-design clinical investigation determining the
      effectiveness and safety of five personal lubricants. This clinical investigation consists of
      two phases, a Tolerance Phase and a Treatment Phase, whereby a sub-set of subjects will enter
      both the Tolerance Phase followed by the Treatment Phase. The remaining subjects will enter
      the Treatment Phase only.
    

Intervention name(s): Lubricant A; Lubricant B; Lubricant C; Lubricant D; Lubricant E
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.; Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.; Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.; Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.; Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
Other intervention name(s): Durex Play Feel; Durex Naturals Moisture
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The personal lubricants will be tested in a 5-arm parallel-design, where subjects will be randomised to an arm/lubricant. This follows an initial tolerance phase conducted in a sub-set of the population which will be tested in a 5-arm parrallel design,where subjects will be randomised to an arm/lubricant. Note: subjects participating in the both the tolerability and treatment phases will be enrolled into an arm for each which includes the same IP/lubricant throughout both phases.
Masking: None (Open Label)
Primary purpose: Prevention
Brugada Ablation of VF Substrate Ongoing MultiCenter Registry
Condition: Brugada Syndrome
MeSH terms: Brugada Syndrome
Study type: Observational

Summary: 
      Current treatment of high-risk Brugada Syndrome (BrS) patients (pts) with recurrent VF is
      limited. Catheter ablation (CA) has been performed for BrS but a large study with long-term
      outcomes of CA in BrS ablation are lacking.
    

Detailed description: 
      Brugada syndrome (BrS) patients who undergo BRS substrate ablations from tertiary centers for
      catheter ablations of complex arrhythmias from three continents - Asia, Europe and North
      America - are registered in a common database. The investigators exclude patients who were
      lost to follow up in the outpatient clinic.
    

Intervention name(s): Catheter Ablation
Intervention type(s): Procedure
Intervention description(s): Ventricular fibrillation substrate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have positive Brugada ECG pattern and have underwent catheter ablation of VF
        substrates prior to enrollment.
Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      AD is a disease found in children; the focus of the study is the mechanisms associated in
      children with AD induced by food allergies.

      This study will be a randomized, double-blind, placebo-controlled, parallel group trial
      conducted in participants diagnosed with atopic dermatitis and food allergies. The study
      duration for participants will be approximately 9 weeks. A total of 20 participants will be
      recruited for the entire study. Each arm will consist of 10 participants.The study will
      enroll 20 children, male or female, 1 - 8 years of age with atopic dermatitis (AD) associated
      with food allergens, previously documented by skin or RAST test, before enrollment. Atopic
      dermatitis and gastrointestinal (GI) symptoms will be scored and followed throughout the
      study.
    


Intervention name(s): Montelukast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age; Oral granules or chewable tablet, PO QD (given oral daily)
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis (Eczema) associated with food allergies