bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Boceprevir on HCV-specific T Cell Responses
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Observational

Summary: 
      Analysis of HCV-specific T cell responses in patients treated with boceprevir to assess
      whether therapy can induce restoration of the T cell function and to what extent this
      recovery can be achieved
    

Detailed description: 
      Reconstitution of the antiviral T cell function may represent a component of the anti-viral
      effect of protease inhibitors. If T cell responsiveness is restored under therapy,
      potentiation of anti-viral T cell functions by exogenous T cell stimulation might be
      exploited to complement and to further improve response to available therapies. Monitoring
      the T cell function might also be useful to predict more accurately response to therapy.

      To address these issues, phenotype and function of HCV-specific T cells will be analyzed
      longitudinally before, during and after therapy in naïve genotype 1 chronic hepatitis C
      patients treated with peginterferon plus ribavirin or with peginterferon and ribavirin plus
      boceprevir. To analyze the global CD4 and CD8 reactivity against all structural and
      non-structural HCV proteins a wide panel of peptides corresponding to the whole HCV genome of
      genotype 1 will be employed. To further analyze CD8 reactivity, HLA-A2/peptide tetramers will
      be used in HLA-A2 positive patients to directly quantify ex vivo HCV-specific CD8 cells
      circulating in the peripheral blood.The T cell function will be analyzed as capacity of
      expansion in vitro, cytokine production and cytotoxicity.
    

Intervention name(s): Boceprevir
Intervention type(s): Drug
Intervention description(s): In the experimental arm boceprevir (800 mg orally three times daily), PEG-IFN and ribavirin will be given for 24 weeks after the lead-in; the patients who will have undetectable HCV-RNA at week 8 will stop treatment at week 28; those who will be HCV-RNA positive at any visit between week 8 and 24 will receive an additional 20 weeks of PEG + RBV. Treatment will be discontinued if HCV-RNA is positive at week 24.
Immunological analysis will be performed longitudinally at the following time points: week -4, 0, 4 (end of lead-in), 8, 12, 24, 48, week 24 of follow-up. HCV-RNA will be quantified at the same time points and viremia will be correlated with immunological data.
Other intervention name(s): Peginterferon alfa-2b and ribavirin
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Naïve genotype 1 chronic hepatitis C patients
      
Biospecimen description: 
      Sera and peripheral blood lymphomononuclear cells
    
Keywords: HCV; T cells; cytokines; cytotoxicity; proliferation
The TANTALUS® II for the Treatment of Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Evaluation of the safety and efficacy of gastric contractility modulation (GCM) stimulation
      using the TANTALUS System in the improvement of glycemic control measured by changes in
      HbA1c. Effects of GCM on weight loss and associated co-morbid conditions will also be
      evaluated
    

Detailed description: 
      This is a multi-center, single blind, randomized, cross-over study. Subject enrollment will
      continue until forty (40) eligible participants have been randomized into one of the two
      groups. Subjects will undergo baseline valuation (Visit 1) during which the stability of
      their glycemic parameters, medical treatment and medical condition will be assessed. Subjects
      meeting all inclusion/exclusion criteria at Visit 2 will be implanted. Approximately three
      days prior to their implantation, subjects will be seen for their 'pre-implant' medical
      evaluation (Visit 3). One week after implant (Visit 5, Week 1)subjects will be randomized
      into one of two groups (A and B).

      "Group A" subjects will have their device programmed to deliver GCM signal including the
      setting of automatic eating detection parameters for the first 24 week period (Period 1). At
      Visit 10, (week 25 and end of Period 1), Group A subjects will have their devices turned
      "OFF" for the next 24 weeks period (Period 2). At Visit 15, (week 49 and end of Period 2),
      Group A subjects will have their devices turned "On" for the next 24 weeks period (Period 3)
      "Group B" subjects will not have their device activated for the first 24 weeks (Period 1) of
      their study. At Visit 10 (week 25 end of Period 1), Group B subjects devices will have their
      device turned "ON" (i.e. activated to deliver CGM signals) for the 24 weeks period (Period
      2). At Visit 15, (week 49 and end of Period 2), Group B subjects will have their devices
      turned "OFF" for the next 24 weeks period (Period 3).
    

Intervention name(s): Tantalus System; TANTALUS system
Intervention type(s): Device; Device
Intervention description(s): The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes; The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes. In the sham comparator the device is off.
Other intervention name(s): TANTALUS II; TANTALUS II
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: C19 246 300
Dose Escalation Study of PF-06741086 In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind,
      placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of PF-06741086.
    


Intervention name(s): PF-06741086; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s); Placebo for PF-06741086, single dose
Other intervention name(s): saline placebo
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: safety; tolerability; pharmacokinetics; pharmacodynamics; Phase 1; first in human; monoclonal antibody; tissue factor pathway inhibitor; japanese
Buy 1 Get 1: Role of Grocery Coupons in Promoting Obesogenic Home Food Environments and Eating Behaviors
Condition: Obesity
Study type: Interventional

Summary: 
      The prevalence of overweight and obesity among older adults has reached an all-time high,
      which puts this age group at high risk for associated comorbidities such as type 2 diabetes,
      cardiovascular disease, and certain forms of cancer. Confronted with declining incomes and
      economic uncertainty, many middle-aged and older Americans tried to save on their food
      purchases during the 2007-2009 recession. Grocery coupons, available through newspapers,
      mail, and increasingly online, are one of several promotional tools that supermarkets and
      warehouse clubs use to promote sales. It is estimated that nationally 27% of households are
      frequent grocery coupon users who shop at a variety of retailers. Despite the increasing
      popularity of grocery coupons, little is known about the extent to which they may promote
      obesogenic home food environments and eating behaviors. Many coupons advertise the purchase
      of large quantities of prepackaged and processed foods and often reward shoppers by adding
      'free' products if they purchase certain quantities. Availability and easy accessibility of
      large portions of energy dense foods in the home has been shown to promote increased intake.
      The proposed study seeks to examine the effects of frequent grocery coupon usage on dietary
      intake, weight status, and home food availability among middle-aged and older adults. A
      second aim of this study is to test, in a randomized-controlled trial, the effects of
      incentivizing grocery coupon use for the purchase of healthy foods on 3-month changes in
      dietary intake, body mass index/waist circumference, home food availability, and grocery
      coupon use among frequent coupon users and non-coupon users.
    


Intervention name(s): Financial incentives
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: grocery purchases; financial incentives; obesogenic home food environment
CeraVe Diabetes Mellitus
Condition: Diabetes Complications
MeSH terms: Diabetes Mellitus; Diabetes Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the CeraVe Diabetic Skin
      Line for the improvement of skin condition in patients with diabetes mellitus.
    


Intervention name(s): CeraVe Hydrating Cleanser; CeraVe Moisturizing Cream
Intervention type(s): Drug; Drug
Intervention description(s): topical cleanser applied twice a day for 28 days; topical cream applied twice a day for 28 days
Intervention MeSH terms: Dimenhydrinate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cutaneous complication of DM
Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome; Inflammation
Study type: Interventional

Summary: 
      Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2
      diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and
      low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA)
      which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this
      trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and
      vascular inflammation in patients having Mets
    


Intervention name(s): green coffee extract
Intervention type(s): Dietary Supplement
Intervention description(s): Patients in treatment group take 400 mg GCE supplements twice a day for tow month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Stylistic Memory Enhancement
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional

Summary: 
      Impairments in higher level cognitive processing, such as new learning and memory, are common
      in Multiple Sclerosis (MS) and negatively impact multiple aspects of everyday life, including
      occupational and social functioning. Despite this, few studies have attempted to remediate
      these cognitive deficits in order to improve everyday functioning. While not applied in
      traditional rehabilitation protocols as of yet, many techniques from cognitive psychology
      significantly improve learning and memory in healthy persons. These techniques include the
      generation effect (GE), the spacing effect (SE), and the testing effect (TE). These
      techniques have recently been incorporated into an 8-session treatment protocol, Stylistic
      Memory Enhancement (SME), designed to teach participants about each of the techniques, train
      them on how to apply the techniques in daily life and practice their application to daily
      life memory demanding situations. The protocol includes teaching participants how to
      restructure a memory demanding situation in order to make optimal use of self-generation,
      spaced learning and self-testing. The objective of the study is to test the efficacy of the
      SME in an MS population.
    


Intervention name(s): Stylistic Memory Enhancement
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind placebo controlled randomized control trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Memory; Cognition
Using Capnography to Reduce Hypoxia During Pediatric Sedation
Condition: Hypoventilation; Hypoxia
MeSH terms: Hypoventilation; Hypoxia
Study type: Interventional

Summary: 
      The investigators hypothesize that the addition of capnography during moderate sedation will
      improve recognition of hypoventilation and apnea. This will lead to an increased frequency of
      staff interventions such as verbal or physical stimulation for these events in order to
      improve ventilation which will in turn lead to a reduction in the frequency of oxygen
      desaturations. If capnography proves to be effective in creating earlier detection and
      intervention for hypoventilation and apnea during moderate sedation provided by
      non-anesthesiologists, this device can be used in a variety of clinical settings to enhance
      patient safety.
    


Intervention name(s): Nellcor NPB-70 Capnograph
Intervention type(s): Device
Intervention description(s): Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Hypoventilation during sedation; Hypoxia associated with hypoventilation
Alitretinoin in the Treatment of Chronic Hand Eczema
Condition: Eczema
MeSH terms: Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic
      hand eczema that is refractory to topical corticosteroids.
    

Detailed description: 
      Chronic hand eczema is a frequent and distressing disease. The course of the disease is of
      chronic-relapsing nature. In a phase III study alitretinoin was clinically effective for
      patients with severe chronic hand eczema refractory to topical treatment. This study
      investigates the safety and efficacy of alitretinoin who previously have participated in a
      clinical trial involving alitretinoin.
    

Intervention name(s): alitretinoin
Intervention type(s): Drug
Intervention MeSH terms: Alitretinoin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hand eczema; Chronic hand dermatitis; Patients with chronic hand eczema, who are refractory to topical corticosteroids
Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
Condition: Inflammation; Crohn's Disease
MeSH terms: Crohn Disease; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe and North America. The aim of the trial is to assess
      disease activity and safety in subjects with moderately to severely active Crohn's disease
      (CD) when treated with NNC 0142-0000-0002.
    


Intervention name(s): NNC 0142-0000-0002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose administered subcutaneously (s.c., under the skin); A single dose administered subcutaneously (s.c., under the skin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Tepotinib on the PK of the P-gp Substrate Dabigatran Etexilate
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigated the effect of Tepotinib on the pharmacokinetics (PK) of the
      p-glycoprotein (P-gp) probe substrate Dabigatran etexilate.
    


Intervention name(s): Dabigatran Etexilate; Tepotinib
Intervention type(s): Drug; Drug
Intervention description(s): Participants received single oral dose of Dabigatran etexilate on Day 1 of Treatment period 1 and co-administration of Dabigatran with Tepotinib on Day 8 of Treatment period 2.; Participants received single oral dose of Tepotinib for 8 days in Treatment period 2.
Intervention MeSH terms: Tepotinib; Dabigatran
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Non-small cell lung cancer (NSCLC); P-glycoprotein; Tepotinib; Dabigatran Etexilate
Oxidative Stress in Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries Lesions
Condition: Polycystic Ovary Syndrome; Dental Caries
MeSH terms: Polycystic Ovary Syndrome; Dental Caries; Periodontal Diseases; Syndrome
Study type: Observational

Summary: 
      This study evaluates the oxidative stress parameters in females with polycystic ovary
      syndrome (PCOS) and clinically healthy. Because of the fact that both oral disease included
      periodontitis and dental caries, and metabolic syndrome are associated with systemic
      inflammation, these two disorders may be linked through a common pathophysiologic pathway
    

Detailed description: 
      Power analysis was performed with the G-Power software package to determine sample size. To
      cover possible data loss, 10% of a group were added to each group. Medical and dental
      examination will be performed both of control and experimental groups. Age and body mass
      index (BMI) will be recorded.

      In dental examination decayed, missing, or filled teeth (DMFT) index will be used according
      to World Health Organization (WHO 1997) criteria. All teeth were visually using the
      International Caries Detection and Assessment System (ICDAS-II). To analyze the correlation
      between oral health status and polycystic ovary syndrome linear regression test and for
      comparison of both the groups (case and control), two sample t test and chi square test were
      used.
    

Intervention name(s): polycystic ovary syndrome
Intervention type(s): Diagnostic Test
Intervention description(s): 3 to 5th day of the women's normal cycle, we will perform a routine gynecological examination, a basic vaginal ultrasound, a basal hormone profile evaluation
Other intervention name(s): [LH],; [total T],; [free T],; [DHEA-S],; 17-OH-progesterone; [FSH],
Intervention MeSH terms: Progesterone
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients were aged from 18 to 24 years, 206 females
S1119 Peruvian H. Pylori Water Contamination Study
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections
Study type: Observational

Summary: 
      The objective of this study is to elucidate the role of drinking water derived from the
      public source in Lima, Peru and transmission of H. pylori infection using genotypic
      techniques.
    

Detailed description: 
      The objective of this study is to detect the presence of Helicobacter Pylori in the drinking
      water derived from the public network by molecular and genomic techniques in districts of
      Lima (Brena, Chorrillos, Comas, El Agustino, La Victoria, Lince, Los Olivos, Miraflores,
      Puente Piedra, Rimac, San Isidro, San Juan de Lurigancho, San Martin de Porres, Villa El
      Salvador, and Villa Maria del Triunfo) with high and low incidence of gastric carcinoma. The
      secondary objective of this study is to establish correlations between the findings in water
      and those of the stomach of patients with symptoms of dyspepsia who live in those districts.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Residents of the following districts of Lima, Peru: Brena, Chorrillos, Comas, El Agustino,
        La Victoria, Lince, Los Olivos, Miraflores, Puente Piedra, Rimac, San Isidro, San Juan de
        Lurigancho, San Luis, San Martin de Porres, Via El Salvador, Villa Maria del Triunfo.
      
Biospecimen description: 
      tissue
    
Keywords: Helicobacter pylori; water contamination; Lima, Peru
Effects of Chronic Acid-Base Changes on Ventilatory and Perceptual Responses
Condition: Healthy
Study type: Interventional

Summary: 
      Approximately 30% of people aged 65 years and older experience breathlessness (perceived
      respiratory difficulty) during daily activity. The main causes of increased breathlessness in
      the healthy elderly are poorly understood and are the main focus of the proposed study. Some
      possible contributing factors include abnormalities in the control and/or mechanics of
      breathing. To evaluate these possible contributory factors, the investigators will compare
      ventilatory and perceptual responses to: 1) exercise, 2) increased levels of inspired carbon
      dioxide, and 3) reduced levels of inspired oxygen under strictly-controlled experimental
      conditions where the investigators increase or decrease breathing requirements by altering
      dietary salt intake in healthy 40-80 year old men and women.

      Exercise and rebreathing tests will be performed at baseline and at the end of each 3 day
      treatment period. Breathlessness intensity will be measured and compared at a standardized
      work rate, ventilation or end-tidal PCO2 during these tests.
    


Intervention name(s): NH4Cl (ammonium chloride); placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 0.2 g/kg/day of NH4Cl (ammonium chloride); 0.025 g/kg/day of NaCl (sodium chloride)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: acid-base balance; ventilatory control; dyspnea; exercise; modified rebreathing procedure; Normal; older
Fenofibrate in Type 2 Diabetes
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Diabetic complications affecting the eyes, kidneys, and nerves are difficult to arrest once
      in progress. Recent evidence that fenofibrate confers a robust yet unexpected benefit in
      diabetic retinopathy offers an important translational research opportunity. The
      investigator's global proteomic study will provide new clues as to how fenofibrate protects
      vulnerable tissues, and will spur discovery of targets for new therapeutic interventions.
    


Intervention name(s): Fenofibrate
Intervention type(s): Drug
Intervention description(s): 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides >150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.
Other intervention name(s): Trilipix; Triglide; Antara
Intervention MeSH terms: Fenofibrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science