bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Thiazolidinedione Treatment Vascular Risk Markers
Condition: Diabetes Mellitus, Type 2; Vascular Diseases
MeSH terms: Vascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the effects of two diabetes medications,
      rosiglitazone and pioglitazone, on markers of vascular disease in subjects with type 2
      diabetes.
    

Detailed description: 
      Diabetes is a common disease in the United States, affecting over 10 million Americans.
      Vascular disease, including heart attack and stroke, affects many diabetic patients and will
      cause the death of three-fourths of these patients. Because the majority of diabetic patients
      will suffer complications or death from vascular disease, we will explore treatments that
      have the potential to reduce or prevent vascular disease in type 2 diabetes patients. Our
      study will examine the effects of two diabetes medications, rosiglitazone (ROSI) and
      pioglitazone (PIO), on markers of vascular disease in 20 subjects with type 2 diabetes. It is
      thought that these two medications will reduce the risk of vascular disease by affecting the
      platelets and proteins that that regulate the processes involved in clot formation. One-half
      of the subjects enrolled in our study will take ROSI and the other half will take PIO. We
      will measure the clumping ability of these subjects' platelets before, during, and after
      three months of treatment with ROSI or PIO. We will measure the blood concentrations of
      several proteins (fibrinogen, PAI-1, CRP, adiponectin, and leptin) before and after treatment
      with the study drugs. These experiments will give us information about any beneficial effects
      of ROSI and PIO on the clot-forming ability in diabetes patients. We expect that treatment
      with ROSI and PIO will result in improvement of the disturbed clot-forming processes that
      predispose diabetic patients to vascular disease.
    

Intervention name(s): Rosiglitazone; Pioglitazone
Intervention type(s): Drug; Drug
Intervention description(s): Rosiglitazone 4 mg tablets by mouth daily for 3 months; Pioglitazone 30 mg tablet by mouth once daily
Other intervention name(s): Avandia; Actos
Intervention MeSH terms: Pioglitazone; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Vascular Diseases; Thiazolidinediones; Platelet Aggregation
PK Comparisons of Bepotastine Besilate 10 mg and Bepotastine Salicylate 9.64 mg
Condition: Allergic Rhinitis; Urticaria; Pruritus
MeSH terms: Rhinitis; Rhinitis, Allergic; Pruritus; Urticaria
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the relative bioavailability and pharmacokinetic characteristics of a newly
      developed bepotastine formulation, bepotastine salicylate, with a conventional formulation,
      bepotastine besilate, in healthy subjects with a single dose, randomized, open-label,
      2-sequence -2period crossover study.
    


Intervention name(s): Test-Bepotastine salicylate 9.64 mg; Reference-bepotastine besilate 10 mg
Intervention type(s): Drug; Drug
Other intervention name(s): Berion; Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea; Tarion; Manufactured by Dong-A Pharm. Co., Ltd, Seoul, Korea
Intervention MeSH terms: Bepotastine besilate; Salicylates
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Dolutegravir Pediatric Liquid Formulation Study
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-center, single dose, non-randomized, sequential, fixed-sequence
      study, which will evaluate pharmacokinetics (PK) of dolutegravir (DTG) in healthy adult
      subjects. The study will contain 6 periods with five prototype liquid formulations for
      evaluation in fasted state. In period 1, 2 and 3 single reference dose of 2 dispersible
      tablets of 5 milligram DTG will be administered and at least 2 liquid prototype DTG
      formulations (containing a target total dose of 10mg DTG). There will be a wash-out period of
      7 days between each period. In period 4 through 6, there would be options to evaluate
      additional prototype liquid formulations. The total duration of study will be up to 17 weeks.
      DTG has been found to be safe and effective in adults infected with human immunodeficiency
      virus (HIV). DTG dispersible tablets have been developed primarily for use in children from 4
      weeks to 6 years of age, and a DTG liquid formulation are is being developed to study the
      appropriate dose needed for the HIV-exposed and infected neonatal population in the first
      four weeks of life. Approximately 18 subjects will be enrolled in this study.
    


Intervention name(s): Dolutegravir dispersible tablet; Dolutegravir oral suspension; Dolutegravir oral solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DTG will be available as an oral tablet with dosing strength of 5 mg 2 tablet will be dispersed in water will be administered orally for prescribed regimen.; DTG will be available as an oral suspension with dosing strength of 5 mg per milliliter (ml) or 2 mg per ml with miglyol 812N or ethyl cellulose in miglyol 812N as vehicle for suspension administered orally for prescribed regimen.; DTG will be available as an oral solution with dosing strength of 2 mg per ml will be administered orally for prescribed regimen.
Intervention MeSH terms: Dolutegravir
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The study is non-randomized 6 period, 6 way fixed sequential design.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dolutegravir; Human immunodeficiency virus; Sequential study; Dispersible tablet; Suspension; Liquid solution
Comparative Bioavailability Study Between Etoricoxib and Tramadol, Administered Individually or in Combination
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study carried out in the Clinical and Analytical Unit of the Department of Pharmacology and
      Toxicology of the Faculty of Medicine of the Autonomous University of Nuevo León, with the
      objective of comparing the bioavailability (Cmax, AUC) of an oral formulation containing
      Etoricoxib 90 mg / Tramadol 50 mg in combination with that of two oral formulations,
      Etoricoxib 90 mg or Tramadol 50 mg, administered as a single dose, in healthy subjects under
      fasting conditions.
    

Detailed description: 
      The study design was a crossover, 3 x 6 x 3, open-label, prospective and longitudinal,
      truncated, single-dose combination of Etoricoxib 90 mg / Tramadol 50 mg administered orally
      versus each component administered individually, with three treatments, three periods. , six
      sequences with an elimination period (washout) of 14 days and with a total of 42 healthy
      subjects, of both genders, under fasting conditions. Among the objectives were the
      characterization of the pharmacokinetic parameters, Cmax, AUC 0-72, Tmax, Ke and T1/2 of
      Etoricoxib and Tramadol after oral administration in a single dose, in combination: sachet
      with granules equivalent to Etoricoxib 90 mg/ Tramadol 50 mg manufactured by Laboratorios
      Silanes, S.A. of C.V. versus each component administered individually: Etoricoxib 90 mg
      tablet (Arcoxia®) manufactured by Schering Plough S.A de C.V. and Tramadol 50 mg capsule
      (Tradol®) made by Grunenthal GMBH (private company).
    

Intervention name(s): A1: Etoricoxib / Tramadol Fixed dose combination; A2: Etoricoxib; A3: Tramadol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sachet with granules (Laboratorios Silanes S.A. de C.V.). Formula : 90 mg/ 50 mg Pharmaceutical Form: Sachet with granules Dosage: 100 mL (90 mg/ 50mg) Administration way: oral; Arcoxia®, Schering Plough S.A. de C.V. A2: Pharmaceutical Form: Tablet Formula: 90 mg Dosage: 1 tablet of 90 mg Administration way: oral; Tradol®, from Grünenthal GMBH. Pharmaceutical Form: Capsule Formula: Each capsule contains 50 mg Dosage: 1 capsule of 50 mg Administration way: oral
Other intervention name(s): E/T; Arcoxia®; Tradol®
Intervention MeSH terms: Etoricoxib; Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; Bioavailability; Fixed-dose combination (FDC); Etoricoxib; Tramadol; Pain
The Effect of Dairy Fat and Inulin on Fasting Induced Adipose Factor (FIAF) Blood Concentrations
Condition: Obesity
Study type: Interventional

Summary: 
      The objective of this study is to investigate whether intake of a diet with a high content of
      butyrate (from dairy fat) can affect blood FIAF concentration compared to a control diet.
      Further to examine whether high intake of inulin (a prebiotic) can increase the proportion of
      butyrate-producing bacteria in the gut and thereby affect blood FIAF concentration. In
      addition, the correlation between FIAF blood concentrations and resting energy expenditure,
      blood lipid profile and gut microbiota composition will be investigated.

      Furthermore, this study will investigate whether the source of FIAF can be determined. To
      this end, adipose tissue biopsies will be analyzed and an in vitro experiment with fecal
      water samples will be carried out.

      The study is a crossover randomized controlled trials with 3 arms. Each arm has a duration of
      3 weeks. 20 overweight/obese subjects will be enrolled into the study and randomized to the
      order of interventions. Before and after each intervention period, blood samples will be
      collected and the participants will have their resting metabolic rate measured. At the end of
      each intervention period, the participants will collect feces for 5 consecutive days. In
      addition, adipose tissue biopsies will be taken after each intervention period.
    


Intervention name(s): Inulin; Complete diet; Whole milk
Intervention type(s): Other; Other; Other
Intervention description(s): The participants will be given all dietary items in their diet. In the inulin arm, approximately 15 grams of inulin will be included in the diet.; The participants will be given all dietary items in their diet with no additional products.; The participants will be given all dietary items in their diet. In the whole milk arm, approximately 1 liter of whole milk will be included in the diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Therapeutic Intensification Plus Immunomodulation to Decrease the HIV-1 Viral Reservoir
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to discover a new approach in which human immunodeficiency
      virus (HIV) can be eradicated from an infected individual by intensified antiretroviral
      treatment coupled with immunomodulation. The hypothesis is that eradication is possible only
      if very potent antiretroviral drugs are delivered in conjunction with an immunomodulatory
      agent that simultaneously attack the viral reservoirs.
    

Detailed description: 
      The objective of this study is to measure the impact of immunomodulation plus treatment
      intensification on the HIV reservoir in HIV-infected patients who have viral suppression on
      combination antiretroviral therapy. Treatment regimens first will be intensified by the
      addition of raltegravir and maraviroc for 8 week followed by immunomodulation with the NIH
      HIV-rAd5 vaccine plus DNA prime-boost for 24 weeks. The primary endpoint is measurement of
      change in peripheral cellular HIV DNA. A decrease of 0.5 log is considered significant. A
      secondary endpoints include change in HIV DNA in the rectal mucosa, immunologic changes in
      the peripheral blood and safety.
    

Intervention name(s): DNA + HIV-rAd5 vaccine; ART intensification (raltegravir); ART intensification (maraviroc)
Intervention type(s): Biological; Drug; Drug
Intervention description(s): 4 mg subcutaneous injection at weeks 8 (DNA prime), 12 (DNA prime), 16 (DNA prime), and 32 (HIV-rAd5); raltegravir 400 mg PO BID for 56 weeks; maraviroc 150, 300, or 600 mg PO BID (depending on PK interactions with other medications) for 56 weeks
Other intervention name(s): Isentress; Selzentry; Celsentri
Intervention MeSH terms: Raltegravir Potassium; Maraviroc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1 infection; Treatment intensification; Immunomodulation; HIV-rAd5 vaccine
Phase 1b/2, Open Label, Repeat Dose, Dose Escalation Study of ND-L02-s0201 Injection in Subjects With Moderate to Extensive Fibrosis (METAVIR F3-4)
Condition: Moderate to Extensive Hepatic Fibrosis (METAVIR F3-4)
MeSH terms: Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of multiple doses of
      ND-L02-s0201 in subjects with moderate to extensive hepatic fibrosis.
    


Intervention name(s): ND-L02-s0201 Injection
Intervention type(s): Drug
Other intervention name(s): BMS-986263
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Viusid in Adults With Acute Fever of Viral Etiology
Condition: Acute Fever of Viral Etiology
MeSH terms: Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the safety and effect of Viusid (bags of 4 grams)
      administration in the treatment of acute fever of viral etiology as diagnosed by clinical,
      hematologic and serologic parameters. The duration of this open and randomized phase 2
      clinical trial will be 6 days. The estimated number of persons with acute fever of viral
      etiology to be recruited and randomized for the study is 200. The primary outcome measure:
      platelet, leukocyte and granulocyte count will be assessed at the beginning and the end of
      the study.
    


Intervention name(s): Viusid; Conventional treatment
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): One Viusid bag (4 grams, orally administered) every 8 hours, for 6 days in combination with the conventional treatment consisting in: intramuscular injection of one bulb of Dipyrone (600 mg) every 8 hours if fever is greater or equal to 38 ºC; intramuscular injection of one bulb of dimenhydrinate (50 mg) every 8 hours if vomiting; oral rehydration solution (8 ounce) after each diarrhea.; Conventional treatment consisting in: intramuscular injection of one bulb of Dipyrone (600 mg) every 8 hours if fever is greater or equal to 38 ºC; intramuscular injection of one bulb of dimenhydrinate (50 mg) every 8 hours if vomiting; oral rehydration solution (8 ounce) after each diarrhea.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Viusid; Dietary supplements; Acute fever; Viral etiology
Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to test the meal anticipation module on a closed loop algorithm,
      assessing efficacy and safety.
    

Detailed description: 
      This is a pilot study to assess glycemic responses to three different approaches to insulin
      dosing for carbohydrate ingestion, with different approaches to a closed-loop system in
      random order;

        1. without the meal anticipation module and without carbohydrate announcement (FCL)

        2. with the meal anticipation module and without carbohydrate announcement (FCL+)

        3. without the meal anticipation module and with carbohydrate announcement (HCL),

      This study will target completion of up to 36 adults in a randomized cross-over trial,
      comparing blood glucose time in range 70-180 mg/dL following meals with and without the meal
      anticipation module in use (FCL+ vs FCL), and comparing to a system with carb announcement
      instead of a meal anticipation module (HCL). The study will also assess safety when dinner is
      consumed later than usual and when a lunch is consumed without having been entrained in the
      meal anticipation module. Each participant will complete each of the 3 modules in random
      order.
    

Intervention name(s): Fully Closed Loop (FCL); Fully Closed Loop with meal anticipation module (FCL+); Hybrid Closed Loop (HCL)
Intervention type(s): Device; Device; Device
Intervention description(s): Closed loop without a meal anticipation module without announced carbohydrate; Closed loop with a meal anticipation module and without announced carbohydrate; Closed loop without a meal anticipation module with announced carbohydrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes (T1D); Continuous Glucose Monitor (CGM); Insulin Pump; Fully Automated Closed Loop (FCL); Hybrid Closed Loop (HCL)
Signaling Mechanisms and Vascular Function in Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Ruboxistaurin is being tested to see if it is effective in treating certain diabetic
      complications, such as diseases of the blood vessels.
    

Detailed description: 
      To test the hypothesis that activation of protein kinase C impairs vascular reactivity in
      patients with diabetes.

      A major cause of death and disability in patients with diabetes mellitus is atherosclerosis.
      Endothelial dysfunction is an important, if not primary, factor in atherogenesis. Nitric
      oxide is an important substance made and released by the endothelium. Many prior studies in
      animals and humans have shown that the ability of the blood vessel to dilate is impaired in
      diabetes. This process of vasodilation is mediated by a substance, nitric oxide, which is
      thought to be highly susceptible to destruction by oxidant molecules. In previous studies, we
      found that acute administration of the antioxidant, vitamin C, improves endothelium-dependent
      vasodilation in blood vessels of patients with type 1 and type 2 diabetes. This suggests that
      by scavenging oxidants, such as superoxide, vitamin C may reduce the destruction of nitric
      oxide and thereby preserve endothelial function. Additional mechanisms, including activation
      of a substance called protein kinase C, and oxidant stress from excess soluble peroxides may
      be present in diabetes and interact with oxidant stress to cause endothelial dysfunction in
      patients with diabetes. Accordingly, we would like to study both of these mechanisms to
      determine their contribution to endothelial dysfunction.
    

Intervention name(s): Ruboxistaurin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 32 mg daily for 2 weeks; 1 tab po QD for 2 weeks
Other intervention name(s): LY-333531
Intervention MeSH terms: Ruboxistaurin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Long-term Outcome After Isolated Tricuspid Valve Repair
Condition: Tricuspid Valve Insufficiency
MeSH terms: Tricuspid Valve Insufficiency
Study type: Observational

Summary: 
      Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is
      known to cause significant morbidity and mortality, no good guidelines are available to guide
      intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral
      valve repair. Treatment options for isolated repair have not been investigated thoroughly.

      The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve
      repair, performed in our center. By doing this, the investigators want to evaluate predictors
      of outcome after repair.
    


Intervention name(s): follow-up of isolated tricuspid valve repair
Intervention type(s): Procedure
Intervention description(s): follow-up of patients that underwent TV repair in the past.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing isolated tricuspid valve repair
The EndoGastric Solutions TEMPO Trial
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy and safety of Transoral Incisionless
      Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI)
      therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with
      refractory symptoms on Proton Pump Inhibitors (PPIs).
    

Detailed description: 
      The objective of this study is to assess the efficacy and safety of TIF performed with
      EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic GERD
      patients with medically refractory GERD symptoms other than heartburn.

      Primary hypothesis: TIF will be superior to PPIs in eliminating or significantly improving
      daily bothersome GERD symptoms and/or troublesome regurgitation, if present, at 6-month
      follow-up. Secondary hypotheses: TIF will be superior to PPIs in eliminating or significantly
      improving daily bothersome GERD symptoms and/or troublesome regurgitation, if present, at
      12-, 24-, 36-, 48- and 60-month follow-up. The majority of surgical patients will have
      normalized or 50% improved esophageal acid exposure compared to baseline at 6-month
      follow-up. The majority of surgical patients will be completely off PPIs at 6-, 12-, 24-,
      36-, 48- and 60-month follow-up compared to baseline. The majority of crossover patients will
      be completely off PPIs at 6-, 18-, 30-, 42- and 54-month follow-up compared to baseline. A
      statistically greater proportion of crossover patients treated with TIF will be free of daily
      bothersome symptom(s) or will experience clinically significant improvement at 6-, 18-, 30-,
      42- and 54-month follow-up.
    

Intervention name(s): EsophyX System with SerosaFuse fasteners; PPI
Intervention type(s): Device; Drug
Intervention description(s): Transoral Incisionless Fundoplication (TIF)/Transoral incisionless esophago-gastric fundoplication using the EsophyX System with SerosaFuse fasteners; Control Arm participants will take maximum standard dose of PPI during Initial Study period
Other intervention name(s): same brand of PPI used by all Control Arm participants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TEMPO; TIF; Transoral Incisionless Fundoplication; EsophyX System; refractory symptoms; proton pump inhibitors; EndoGastric Solutions; EGS; Acid Reflux; Heartburn; Regurgitation