bioihbjkbjnl/mcl2 huggingface dataset:
1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy
Condition: Diabetic Nephropathies; Hypertension
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in
      hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure
      beyond the target of 130/80 mmHg after one year of treatment.

      The primary objective of this study is to show that telmisartan 80 mg is at least as
      effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour
      proteinuria after one year of treatment.
    

Detailed description: 
      This is a randomised, double-blind, double-dummy, forced titration, multicentre, parallel
      group trial in patients with essential hypertension, diabetes mellitus type 2 and diabetic
      nephropathy.

      After a 4-6 week Run-in period, patients are randomised to one of the treatment groups and
      receive either Telmisartan 40 - 80 mg or Valsartan 80 - 160 mg. The treatment regimen is a
      forced titration with the lower dose given for 2 weeks and the higher dose given for the rest
      of the treatment period summing up to 52 weeks of treatment. During the treatment period, 8
      visits to the investigator are scheduled in order to control blood pressure, renal function
      parameters and safety. In addition, parameters of endothelial function and oxidative stress
      are measured at baseline, 6 months and after one year of treatment.

      Study Hypothesis:

      Non-inferiority of telmisartan 80 mg compared to valsartan 160 mg will be tested using the
      following set of hypotheses:

      Null Hypothesis:

      The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for
      telmisartan 80 mg is inferior to that for valsartan 160 mg by 0.5 g/day or more.

      Alternative Hypothesis:

      The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for
      telmisartan 80 mg is less than 0.5 g/day worse than that for valsartan 160 mg.

      Comparison(s):

      In order to test the non-inferiority hypothesis, analysis of covariance with treatment and
      centre as main effects and baseline as a covariate will be performed. Time-to-event data will
      be analysed using the log-rank test.
    

Intervention name(s): Telmisartan; Valsartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Valsartan; Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to analyze the variation of adiponectinemia and its molecular forms
      in RA patients receiving tocilizumab therapy.
    

Detailed description: 
      Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with cardiovascular
      morbidity. Tocilizumab (TCZ), a monoclonal antibody against the interleukin-6 receptor is an
      effective new biotherapy for the treatment of RA. This treatment is associated with increased
      LDL and HDL-cholesterol lipid parameters. Adipokines are adipose tissue-specific secreted
      molecules, which have many functions such as regulation of appetite, blood glucose or immune
      response. Among the adipokines, adiponectin exerts beneficial effects on the cardiovascular
      system. Patients with RA also exhibit body composition changes, including an increase in
      abdominal visceral fat. The impact of tocilizumab therapy in RA patients on adipokines and
      body composition is not known.

      This project aims to explore the evolution of circulating adiponectin and other adipokines
      during tocilizumab therapy in RA. Body composition and its variations under tocilizumab
      therapy will also be analyzed.
    

Intervention name(s): Tocilizumab
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adipokines; Tocilizumab
Low Dose hCG in the Late Follicular Phase
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study,the investigators compared two protocols for controlled ovarian
      hyperstimulation in infertility patients requiring IVF. In the control group, the patient
      undergoes a standard antagonist protocol. In the study group, the administration of
      gonadotropins is stopped in the late follicular phase and replaced by low dose human
      chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved
      in both groups.
    


Intervention name(s): human chorionic gonadotropin; recombinant gonadotropins
Intervention type(s): Drug; Drug
Intervention description(s): hCG 200IU in the late follicular phase; 200 IU per day during controlled ovarian stimulation
Other intervention name(s): Pregnyl, NV Organon, Oss, The Netherlands; Puregon, NV Organon, Oss, The Netherlands
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: infertility; IVF; hCG; primary infertility; secondary infertility; patients requiring in-vitro fertilisation
PK of JULUCA in Hemodialysis
Condition: HIV/AIDS; ESRD
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the pharmacokinetics of the component drugs in JULUCA, and HIV
      combination treatment pill, in HIV-negative patients who require hemodialysis with those with
      normal renal function.
    

Detailed description: 
      The pharmacokinetics of dolutegravir and rilpivirine, the components of JULUCA, in patients
      with end stage renal disease requiring hemodialysis have not previously been adequately
      studied. It is possible that the PK of these drugs are affected by renal failure which may
      then compromise effectiveness and safety. This trial will rigorously assess the plasma PK and
      protein-binding of these two drugs in 10 HIV-negative patients requiring hemodialysis with 10
      matched persons with normal renal function. All participants will receive JULUCA for up to 14
      days and then undergo a 24 hour intensive PK evaluation.
    

Intervention name(s): JULUCA 50Mg-25Mg Tablet
Intervention type(s): Drug
Intervention description(s): One dose of JULUCA will be taken daily for up to 14 days
Intervention MeSH terms: Dolutegravir, rilpivirine drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Matched case-control
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; ESRD; Hemodialysis; Pharmacokinetics
A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the
      effect of liraglutide on gastric emptying, energy expenditure and appetite, and to evaluate
      liraglutide pharmacokinetics in non-diabetic obese volunteers. The trial is designed as a
      two-period, six-sequenced, crossover trial where the trial participant will enter two
      treatment periods with a wash-out period of 6-8 weeks.
    


Intervention name(s): liraglutide; liraglutide; liraglutide; liraglutide; liraglutide; liraglutide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): High dose liraglutide treatment (3.0 mg) followed by low dose liraglutide treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.; Low dose liraglutide treatment (1.8 mg) followed by high dose liraglutide treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.; Low dose liraglutide treatment (1.8 mg) followed by high placebo treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.; High placebo treatment (3.0 mg) followed by low dose liraglutide treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.; High dose liraglutide treatment (3.0) followed by low placebo treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening.; Low placebo treatment (1.8 mg) followed by high dose liraglutide treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery
Condition: Mitral Regurgitation; Mitral Stenosis; Tricuspid Regurgitation
MeSH terms: Mitral Valve Insufficiency; Tricuspid Valve Insufficiency; Mitral Valve Stenosis
Study type: Interventional

Summary: 
      Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating
      cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well
      established.

      Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly
      allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced
      hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied.

      After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are
      analyzed.

      As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be
      determined at 10 min after ANH in Group-ANH and that at control.
    

Detailed description: 
      Background: Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before
      initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not
      been well established.

      Method: Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are
      randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a
      balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH is not applied.

      Intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed. after
      anesthesia induction (control) and after weaning form CPB and protamine neutralization
      (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH).

      As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM is
      determined at 10 min after ANH in Group-ANH and that at control.

      As secondary outcomes, intergroup differences of Hematocrit (Hct), Na+, K+, HCO3-, Ca2+,
      osmolarity, s-Cr are determined Intergroup difference of data at T2 are performed.
    

Intervention name(s): Acute normovolemic hemodilution (ANH); hydroxyethyl starch (HES 130/0.6)
Intervention type(s): Procedure; Drug
Intervention description(s): applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: rotational thromboelastometry; cardiac surgery; acute normovolemic hemodilution
Effects of Butyrate on Affective Processes
Condition: Emotions; Stress; Fear
Study type: Interventional

Summary: 
      The effects of butyrate on psychobiological processes are examined in a sample of healthy
      volunteers.
    

Detailed description: 
      The study is an interventional triple-blind, placebo-controlled, parallel group design with 2
      arms (placebo, butyrate). Healthy male participants adhere to a low-fiber diet for the
      duration of the study (11 days). At the baseline study visit, measurements are taken in the
      lab, including biological samples and psychophysiological measurements. Participants then
      consume placebo or butyrate for 1 week and revisit the lab on day 11 for a second measurement
      of the outcomes of interest. Specifically, we investigate the effect of colonic butyrate
      administration on affective processing, including stress sensitivity and fear-related
      processes (e.g. extinction learning). Volunteers also respond to questionnaires in relation
      to mood and GI symptoms, and provide biological samples (saliva, blood, and faecal samples)
      for analysis of cortisol levels, circulating short chain fatty acids and serum BDNF, and
      faecal SCFA, respectively.
    

Intervention name(s): Placebo; Butyrate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cellulose; Sodium butyrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
Condition: Barrett Esophagus
MeSH terms: Barrett Esophagus
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall aim of this feasibility study is to develop new technologies for improved
      detection of Barrett's neoplasia using the scanning fiber endoscope(SFE) multiplexed imaging
      system. This study will combine the use of fluorescent-labeled peptides that bind
      specifically to pre-cancerous mucosa in the esophagus for use as novel imaging agents to
      guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1 study will be
      used to provide early evidence of efficacy for the topical application of a panel of two
      peptides that bind to molecular targets that are specific for esophageal dysplasia. A panel
      is needed because cancer in the esophagus is genetically heterogeneous. The study will look
      at peptide binding in subjects with known or suspected Barrett's esophagus.
    


Intervention name(s): Multiplexed heptapeptides
Intervention type(s): Drug
Intervention description(s): Heptapeptides QRH and KSP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
Condition: Mastectomy Flap Necrosis
MeSH terms: Necrosis
Study type: Interventional

Summary: 
      Background:

      Mastectomy flap necrosis (MFN) is a common complication that affects recovery, reconstructive
      success and aesthetic outcome. Nitroglycerin (NTG) ointment is a potent topical vasodilator
      that increases local blood flow by dilating arteries and veins without altering the ratio of
      pre- to post-capillary resistance. There are no studies that evaluate whether the application
      of NTG ointment in patients undergoing Skin-sparing mastectomy (SSM) or nipple-sparing
      mastectomy (NSM) and immediate reconstruction decreases the rate of mastectomy flap necrosis.

      Objective:

      To evaluate if the post-operative application of NTG ointment improve rates of MFN in
      patients undergoing SSM or NSM with immediate breast reconstruction compared to patients
      receiving placebo.

      Hypothesis:

      In patients undergoing SSM and immediate breast reconstruction there will be a decrease in
      the rate of MFN in those who receive NTG ointment compared to those who receive placebo.
    


Intervention name(s): nitroglycerin ointment; Polysporin ointment
Intervention type(s): Drug; Drug
Intervention description(s): Nitroglycerin ointment will be applied to mastectomy skin flaps at the end of surgery. A maximum of 7.5cm strip of 2% Nitroglycerin ointment will be applied (equivalent to a maximal dose of 45mg); Polysporin ointment will be applied as the control ointment on the mastectomy flap skin at the end of surgery. A maximum of 7.5cm strip of ointment will be applied to the skin.
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Theory of Planned Behavior and Implementation Intentions
Condition: Dietary Modification
Study type: Interventional

Summary: 
      Diet quality has been associated with a variety of chronic diseases including obesity. One
      measure that has been studied as an indicator for diet quality is fruit and vegetable intake.
      Although the US government has suggested that American's increase their intake of fruit and
      vegetables, epidemiological data suggest that most Americans have not been successful doing
      do, with the strongest disparity seen in people of low socioeconomic status (SES). This
      disparity in fruit and vegetable intake is thought to be the result of both individual and
      environmental factors that influence this health behavior. To help decrease the disparate
      rise in incidence of chronic disease in people of low SES, effective, cost-efficient and easy
      to implement interventions to improve fruit and vegetable intake and diet quality are needed.

      Theoretical models of health behavior change have been successfully used in research
      targeting individual factors associated with health behaviors. One theory, the Theory of
      Planned Behavior (TPB), and a proposed extension of this model (implementation intentions)
      have been shown to be effective to increase fruit and vegetable intake in (mostly) white
      adults of average socioeconomic status. It is not know whether an implementation intention
      intervention to increase fruit and vegetable intake would be effective in women who are of
      low socioeconomic status. The primary aim of this research is to study (using quantitative
      and qualitative analysis) an implementation intention intervention to produce a positive
      change in fruit and vegetable intake. We theorize that the setting of an implementation
      intention in this group will be effective, cost-effective, and easy to implement intervention
      to promote an increase in fruit and vegetable intake.
    

Detailed description: 
      Theory of Planned Behavior Variables (attitude, perceived behavioral control, intention)
      measured via survey using 1 question each, bivariate semantic differential scale.

      Main outcomes measure is fruit and vegetable intake. Behavioral Risk Factor Surveillance
      System Fruit and Vegetable Module (6-item screener) + pictorial of serving sizes.

      Demographic data measured via survey. Height measured via tape measure. Weight measured using
      a standing scale.
    

Intervention name(s): Implementation intention
Intervention type(s): Behavioral
Intervention description(s): The intervention consists of an implementation intention whereby subjects create a unique plan to increase their fruit and vegetable intake by planning the where, when, and what to increase their fruit and vegetable intake.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Fruit; Vegetable
Handheld Technology for Speech Development in Students With Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The proposed study will result in a software application compatible with the Apple iPad,
      iPhone and iPod Touch (hereafter termed "iOS devices") which addresses several aspects of
      prosodic deficits common in speakers with Autism Spectrum Disorders (ASDs) and other
      communication disorders, using a developmentally appropriate, intuitive interface that
      requires little technical skill and which can be managed by educators and parents. The
      program will contain elements that aid in tracking and maintaining individual student
      progress records, and will be designed for use in the classroom, at home, and in other
      environments. This study's intended focus is on the feasibility and usability of the software
      application.
    


Intervention name(s): iPad software
Intervention type(s): Other
Intervention description(s): A specialized iPad application, entitled SpeechPrompts, has been developed to treat prosodic difficulties commonly seen in ASDs. SpeechPrompts provides the SLPs that work with students with ASDs an additional tool to treat prosody. The SpeechPrompts software offers visual support and biofeedback to change prosody. These two tools are not typically available for school-based SLPs.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autism; prosody; speech; autism spectrum disorder
Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath
      Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
    

Detailed description: 
      Pediatric subjects with indication for H.pylori testing, will be tested with both stool
      antigen as a reference standard and a urea breath test using the BreathID® Hp and BreathID®
      Hp Lab Systems. The BreathID® Hp system continuously measures breath via a nasal cannula and
      the BreathID® Hp Lab System measures breath collection bags before and after ingestion of a
      solution with enriched carbon 13 urea and citric acid. The stool sample will be provided
      within a week of the breath tests and will be analyzed by a central laboratory. Safety and
      overall efficacy will be assessed.
    

Intervention name(s): BreathID® Hp System; BreathID® Hp Lab System; Stool Test
Intervention type(s): Device; Drug; Diagnostic Test
Intervention description(s): Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea; Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea; Each subject was asked to perform a stool test in parallel to the breath test.
Other intervention name(s): Stool Antigen Test
Intervention model: Single Group Assignment
Intervention model description: A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.
Masking: None (Open Label)
Primary purpose: Diagnostic
Varenicline Treatment of Alcohol Dependence in Smokers
Condition: Alcoholism; Alcohol Abuse; Smoking; Alcohol Drinking
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether varenicline is effective in the treatment
      of alcohol dependence in smokers.
    

Detailed description: 
      Building upon knowledge about the role of nicotinic acetylcholine receptors in alcohol
      drinking and smoking, varenicline, a smoking cessation treatment that targets these
      receptors, will be tested as a potential treatment for alcohol dependent smokers seeking
      alcohol treatment.
    

Intervention name(s): Varenicline
Intervention type(s): Drug
Intervention description(s): 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol-related disorders; Cholinergic Drugs; varenicline; Chantix