bioihbjkbjnl/mcl2 huggingface dataset:
Rosiglitazone and Exercise Training: Effects on HIV-Infected People With Insulin Resistance, Hypertriglyceridemia, and Adipose Tissue Maldistribution
Condition: HIV Infections; Insulin Resistance
MeSH terms: Insulin Resistance; Hypertriglyceridemia
Study type: Interventional

Summary: 
      Several complications have become prevalent in people living with HIV/AIDS, including
      increased blood sugar, increased blood fats and cholesterol, and fat tissue redistribution.
      The causes of these complications are not well understood and effective treatments have not
      been identified. We propose to test the efficacy and safety of 2 treatments for these
      complications in people living with HIV/AIDS: aerobic, weight lifting exercise training, and
      a new insulin-sensitizing agent called rosiglitazone (Avandia). Exercise and rosiglitazone
      have been effective and moderately safe when used in HIV-seronegative people with diabetes,
      but a specific trial is needed to test efficacy and safety in people living with HIV/AIDS.
    

Detailed description: 
      We propose a 12wk controlled, randomized trial that compares the effects of rosiglitazone
      therapy, exercise training and combined rosiglitazone and exercise training. We hypothesize
      that rosiglitazone will lower blood sugar, insulin, blood fats, muscle and liver lipid
      content and composition in HIV-infected people. Exercise training will induce the same
      benefits, but will also reduce abdominal fat mass. We hypothesize that combining exercise
      training with rosiglitazone therapy will be most effective at reducing blood sugar, insulin,
      lipids, muscle and liver lipid contents, and restoring body fat distribution than either
      intervention alone. At baseline and after 12 wk of treatment we will measure: the ability of
      insulin to promote the clearance of sugar from the blood, the clearance rate of blood sugar,
      the rate of glucose production by the liver, blood fat and cholesterol concentrations, body
      fat content and fat distribution in the arms, legs, trunk regions, muscle and liver lipid
      content and composition.
    

Intervention name(s): rosiglitazone (Avandia); Aerobic and weight lifting exercise training
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Primary purpose: Treatment
Assessment of Gastro-Intestinal Function to a Mixed Meal by Non-invasive Imaging
Condition: Functional Dyspepsia; Diabetic Gastroparesis
MeSH terms: Gastroparesis; Dyspepsia
Study type: Interventional

Summary: 
      Dyspeptic symptoms, such as pain after eating, bloating and nausea all have major impact on
      quality of life and health care costs. When no structural cause is identified, patients are
      diagnosed with functional dyspepsia. This trial aims to identify objective abnormalities of
      stomach function that explain patient's symptoms and establish diagnosis. Another group are
      diabetic patients who can often develop similar symptoms, labelled as diabetic gastroparesis.
      In some cases this is associated with delayed gastric emptying but not all.

      24 patients with functional dyspepsia will be studied and 24 healthy controls (to establish
      normal ranges) and 24 diabetic patients with symptoms of functional dyspepsia.

      The utility of 3 different non-invasive investigations will be assessed. At screening the
      nutrient drink test (NDT) asks the patient to drink 40ml of milkshake (0.75kcal/ml) every
      minute and score symptoms every 5 minutes. The patient continues until they reach the maximum
      tolerated volume.

      Participants will then be randomized to undergo non-invasive imaging on two separate test
      days by magnetic resonance imaging (MRI) and gastric scintigraphy MRI will be completed with
      the patient ingesting 400ml of milkshake (identical to NDT) and 12 agar beads (no additional
      calories) of known breaking strength. The emptying of the stomach will be visualised with the
      MRI alongside symptom recording.

      Gamma scintigraphy will ingest the same meal as for the MRI scan but radioactive labelling
      will allow the rate of liquid and solid meal emptying to be visualised alongside symptom
      recording.

      Additionally, blood sugars will be recorded before nutrient drink test and at 15 and 30
      minutes following ingestion of 400ml of milkshake and 12 agar beads.

      Data will be analyzed to assess the association of objective abnormalities of gastric
      function and patient symptoms. Additionally the results of non-invasive imaging by MRI and GS
      will be compared to assess the optimal measurement of gastric function and emptying in this
      clinical scenario.
    


Intervention name(s): Magnetic Resonance Imaging MRI; Gamma Scintigraphy; Assessment of Gastric motor and sensory function
Intervention type(s): Other; Other; Procedure
Intervention description(s): 400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier.; 400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Side Specific Withdrawal Times for Colonoscopy: Impact on Adenoma Detection in the Proximal and Distal Colon
Condition: Colon Adenoma
MeSH terms: Adenoma
Study type: Observational

Summary: 
      Adenoma detection in the main goal of screening colonoscopy. In order to detect adenomas it
      is mandatory to spend a long enough time investigating the colonic mucosa. A minimum
      observation time of 6 minutes has been proposed as a quality criterion for screening
      colonoscopy. However, different locations of the colon (proximal, distal) may require
      specific observation time periods. The colon can be divided into a proximal (right) and
      distal (left) part. Until now, it is unclear whether observation time has a significant
      impact on adenoma detection in both parts of the colon. The aim of this study therefore is to
      conduct a trial in which side-specific observation times and adenoma detection rates are
      measured in order to investigate this correlation in particular for the right colon.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients receiving colonoscopy at the study site are eligible for participation.
      
Biospecimen description: 
      Colon polyps
    
Keywords: Adenoma; Colonoscopy; Withdrawal; Proximal; Observation Time
Effect of Auricular Vagus Stimulating in Non Specific Chronic Neck Pain
Condition: Neck Pain; Vagus; Autonomic Nervous System
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of our study is to compare the efects of conventional treatment and vagus nerve
      stimulation on pain, normal joint movement, disability and sleep in non-specific chronic neck
      pain.

      36 patients aged between 18 and 65 years with non-specific neck pain participated in our
      randomly planned study. All these patients were divided into 2 groups. Demographic and
      physical characteristics of the patients were recorded. The first group was treated with
      auricular vagus nerve stimulation. Conservatire treatment that consists of hotpack,
      transcutaneous electrical nerve stimulation (TENS) and therapeutic ultrasound was applied to
      the second group. In addition to their treatment, some home exercises were given and tought.
      Pain was assessed with a visual analog scale (VAS). Muscle strength was evalvated with a
      digital hand dynamometer. Neck normal joınt motion was evaluated with goniometer clinometer
      which is a mobile phone application. While disability was mensured with the neck disability
      index, sleep quality was evalvated with the Pittsburg sleep questionnaire. All the
      measurements were recorded before the trearment and after the 15 session treatment.
    


Intervention name(s): Vagus stimulation; Consevative treatment
Intervention type(s): Other; Other
Intervention description(s): The Vagus Stimulation Group received auricular vagus stimulation for a total of 15 sessions of 25 minutes 5 days a week. The patients were applied with vagustim device consisting of TENS device with electrodes placed bilaterally in the outer ear with headphones that can be selected according to ear size. During the application, the gel was used to avoid causing any damage and to ensure conductivity. It is placed so that tragus and konkaya are facing. The pulse duration of the TENS device is less than 500 microseconds, the frequency is 10 Herzt, the module was applied in TENS mode and in the form of a biphasic asymmetric wave.; A total of 15 sessions 5 days a week, 20 minutes of hotpack, 20 minutes of TENS, 5 minutes of 1,3 watt/cm2 ultrasound consisting of a total of 25 minutes of treatment was applied to the neck area.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Neural Activation and Connectivity in Response to Exercise and Cognitive Training
Condition: Neural Connectivity
Study type: Observational

Summary: 
      The goal of this pilot study is to evaluate whether healthy, sedentary older adults have
      increased activation of specific brain areas, in response to exercise and cognitive training,
      in comparison to a control group, and whether improvements in psychometric test performance
      are related to increased activation of brain networks. Participants, between age 55-75 years
      will be recruited from an ongoing study of exercise and cognitive training, to undergo Blood
      Oxygen Level Dependent (BOLD) functional magnetic imaging (fcMRI).
    


Intervention name(s): Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI)
Intervention type(s): Other
Intervention description(s): All participants complete MRI scans at baseline and at the end of month 6. Scanning sessions last approximately 30 minutes each and consist of two components: (1) High resolution T1-weighted MPRAGE anatomic images to provide detailed anatomy and maximum gray-white matter contrast for images and to allow any estimate of regional or whole-brain volume, and (2) Resting BOLD functional images to allow assessment of the functional connectivity in large scale networks.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will include 24 adults, male and female, aged 55-75 years who meet
        eligibility criteria for and are enrolled in the parent study, Combining Exercise and
        Cognitive Training to Improve Everyday Function (EXACT), Unique Protocol ID 201102416.
        Participants will be sedentary (not exercising regularly) but otherwise generally healthy.
      
Keywords: Adult; Exercise; Cognition; MRI
Assessment of the Health Improvement of Obese Patients After Fecal Microbiota Transplantation (FMT)
Condition: Obesity; Familial
Study type: Interventional

Summary: 
      Search for mechanisms of the effect of fecal microbiota transplantation on patients with
      obesity
    

Detailed description: 
      1. To select recipients of fecal samples according to eligibility criteria;

        2. To perform fecal microbiota transplantation for patients with obesity;

        3. To analyze the efficacy of fecal microbiota transplantation for patients with obesity
           within six months after therapy.
    

Intervention name(s): Fecal microbiota
Intervention type(s): Other
Intervention description(s): Transplantation of fecal microbiota of healthy donor with normal body mass index
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two obese patients selected according to the inclusion criteria will undergo fecal microbiota transplantation from a healthy donor with a normal body mass index against the background of glucose-lowering therapy
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Dicloxacillin on Oral Absorption of Drugs
Condition: Healthy Volunteers; Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Worldwide there is an increase in antibiotic resistance which may have fatal long-term
      consequences. This is due to extensive use and sometimes misuse of antibiotics in the
      treatment of harmless infections.

      The primary aim of this study is to investigate if treatment with dicloxacillin can lead to
      drug-drug interactions through induction of the efflux transporter P-glycoprotein (P-gp). In
      this study it will also be investigated whether dicloxacillin induces its own metabolism.

      The hypothesis is based on a previous in vivo study showing that rifampicin induces the
      intestinal P-gp transporter, through activation of the pregnane X receptor (PXR).
      Dicloxacillin also activates the PXR receptor in vitro, which could result in an induction of
      P-gp in vivo.

      Trial subjects will ingest dicloxacillin for 30 days and at day 10 and 28 ingest dabigatran
      etexilate to determine if the P-gp transporter has been induced. Plasma and urine will be
      drawn over 32 hours to determine the concentration of dabigatran.

      Change in dicloxacillin concentration will also be measured at day 9 and 27 to establish if
      dicloxacillin induces its own metabolism.
    


Intervention name(s): Dicloxacillin
Intervention type(s): Drug
Intervention description(s): Healthy volunteers will take 2x500 mg dicloxacillin 3 times a day for 30 days. The investigators will measure the baseline concentration of dabigatran and dicloxacillin before start of 30 days of dicloxacillin treatment. On day 9 and 27 the investigators will measure the concentration of dicloxacillin. On day 10 and 28 the investigators will measure the concentration of dabigatran.
Other intervention name(s): Dabigatran etexilate
Intervention MeSH terms: Dicloxacillin; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: P-gp transporter, Induction of P-gp transporter
Escalating, Constant and Reduction Energy Output in SWL for Renal Stones
Condition: Renal Stones
MeSH terms: Kidney Calculi; Nephrolithiasis
Study type: Interventional

Summary: 
      Research Problem: Shock wave lithotripsy (SWL) dramatically changed the management of renal
      and ureteral calculus disease. In vitro studies suggest that progressive increase in
      lithotripter energy output voltage could produce the best overall stone comminution in
      comparison with constant or deescalating energy output. However, it is possible that the
      beneficial impact of slow rate SWL on comminution of stones and stone free rates has masked
      any marginal benefits for energy output escalation. The Escalating SW method adds the benefit
      of less renal tissue injury.

      Research Significance:The present study will signifies and evaluates the stone free rates of
      three groups of patients with renal stones treated with different SWL energy outputs
      (Escalating, Constant and Reduction energy output).

      Research Objectives: The aim of this research project is to study the effect of dose
      adjustment strategies on success rate of Shock Wave Lithotripsy in the clinical setting and
      to optimize the conditions for successful Shock Wave Lithotripsy.

      Research Methodology: This clinical trial will be conducted at a tertiary care university
      hospital. 150 patients referred to the Shock wave lithotripsy unit will be evaluated for
      eligibility to be randomized into three groups (Dose Escalation, Dose reduction and constant
      dose). Parameter of the three groups will be compared to detect the treatment difference.
    

Detailed description: 
      Escalating SW amplitude treatment protocols have been shown to be safe on long-term with less
      harm to kidney tissue. This clinical trial will be conducted at a tertiary care university
      hospital. All patients referred to the SWL unit will be evaluated for eligibility to be
      randomized. Randomization process "complete" or "unrestricted" randomization was used to
      allocate patients to the three arms of the clinical trial where one patient was randomly
      assigned to one of the three arms blindly.
    

Intervention name(s): Escalating Energy SWL; Constant Energy SWL; Reduction Energy SWL
Intervention type(s): Radiation; Radiation; Radiation
Intervention description(s): Dose escalation, 1500 SW at 18 kv, followed by 1500 SW at 20 kv and the following 1500 SW at 22 kv.; Constant dose at 20 kv; Dose reduction, 1500 SW at 22 kv, followed by 1500 SW at 20 kv and the following at 18 kv.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Renal stones; SWL
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
Condition: Atopic Dermatitis Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day
      for 4 weeks by subjects with atopic dermatitis (eczema).
    

Detailed description: 
      This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or
      vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis.
    

Intervention name(s): ARQ-151 Active; ARQ-151 Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): ARQ-151 Cream 0.05% - Active; ARQ-151 Cream - Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya
Condition: Rotavirus
MeSH terms: Diarrhea
Study type: Observational

Summary: 
      Rotavirus is the most common cause of severe infantile diarrhoea disease in infants and young
      children below five years worldwide. It is associated with high cases of morbidity and
      mortality and it is estimated that up to 600,000 deaths in young children occur annually in
      the less developed countries and approximately 150,000-200,000 deaths occur in Africa alone.
      In Kenya, most rotavirus surveillance work has been done in Nairobi (an urban setting). Other
      parts e.g eastern Kenya, limited data is available and hence the prevalence and burden of
      rotavirus disease is under-estimated. We therefore hypothesize that rotavirus prevalence is
      high in Meru,Maua (a rural setting)and hence we designed a study to evaluate this.

      This is a prospective study to determine, the rotavirus disease burden and epidemiology in
      infants and children with severe diarrhoea hospitalized in three sentinel hospital in the
      eastern part of Kenya (Maua Methodist hospital) will be carried out during the period January
      2009 to December 2010.

      Faecal samples will be collected from infants and children admitted with acute diarrhoea and
      screened first for the presence of human serotype A rotavirus antigen using commercially
      available enzyme linked immunosorbent assay kit (ELISA).

      The positive samples will be evaluated by sodium dodecyl polyacrylamide gel electrophoresis
      (SDS-PAGE) to determine the electropherotypes and genotyped using reverse transcriptase
      polymerase chain reaction (RT-PCR) on VP7 and VP4 gene.

      These data/ results generated from this project will add crucial information on the rotavirus
      strains circulating in the eastern part of Kenya.
    


Intervention name(s): oral rehydration therapy for diarrhea cases
Intervention type(s): Other
Intervention description(s): Since rotavirus infection is a viral infection with no drug remedy, diarrhea cases will be managed according to the standard WHO protocol for the management of diarrhea. This will include oral rehydration treatment.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Stool specimens will be collected from infants and young children below 5 years of age with
        severe diarrhea hospitalized in two government hospital (Maua Methodist hospital, during a
        two (2) year period
      
Biospecimen description: 
      The positive samples will be evaluated by sodium dodecyl polyacrylamide gel electrophoresis
      (SDS-PAGE) to determine the electropherotypes and genotyped using reverse transcriptase
      polymerase chain reaction (RT-PCR) on VP7 and VP4 gene and sequencing. Also, these positive
      samples will be retained for quality assurance and quality control.
    
Keywords: Genotypes; Epidemiology; Diarrhea
Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac
Condition: Vaccination
Study type: Observational

Summary: 
      The main objective of the study is to estimate the proportion of children, born between the
      01/01/2002 and the 06/23/200, living around Dieppe (cantons Dieppe est, Dieppe Ouest and
      Offranville), vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16
      clone related to a protection (>= 4), before and after the third MenBvac vaccination.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and
        Offranville
      
Keywords: Neisseria meningitidis B:14, P1-7, 16; Serum bactericidal activity; Menbvac