bioihbjkbjnl/mcl2 huggingface dataset:
Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication in ASD
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Observational [Patient Registry]

Summary: 
      This study aims to identify clinical and biological markers which would allow to evaluate
      precisely the evolution of children with autism spectrum disorders throughout intervention.
    

Detailed description: 
      200 children with autism spectrum disorders (1-12 years old) will be included in a 2 years
      follow-up study. Both clinical and neurophysiological evaluations (electrophysiological and
      eye tracking) will be completed at different times of the follow-up. This integrative
      approach, combining clinical and biological markers, will allow the identification of
      different developmental trajectories and then a better individuation of treatment in autism
      spectrum disorders.
    

Intervention name(s): functional rehabilitation of social communication
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with autism spectrum disorders
      
Keywords: neurophysiology
Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy
Condition: Kidney Stones
MeSH terms: Kidney Calculi
Study type: Observational

Summary: 
      The investigators main hypothesis is that the stone free rate will be much higher (95%) in
      patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to
      determine which treatment is safe and prevent less stone recurrence.
    

Detailed description: 
      Extracorporeal shock wave lithotripsy is preferred for small stones less than 10 mm in size.
      Percutaneous nephrolithotomy is the standard therapy used for large kidney stones greater
      than 20 millimeters or stones in the lower kidney. For moderate sized kidney stone (10-20
      mm),currently the options for treatment include both methods. However, no studies have proven
      that one procedure is better than the other. So, we will compare both the procedures for
      breaking the kidney stone. Our main outcome measures will be the stone-free status after the
      procedure. Other outcome measures are assessment of morbidity associated with use of the
      procedures i.e. any minor or major complications within 3 months of initial treatment.
      Patient will be assessed for infection at post-operative office visits to include a basic
      urinalysis only if they have systemic indicators of infection (fever, dysuria, frequency,
      etc.). Pain will be monitored with the scale of 0-10 points. Also we will review of stone
      density on Computerized Tomography (CT) scans and the effect this has on success of both
      procedures. We hope with PCNL stone-free rates will be minimum with minimal morbidity and
      ultimately improve patient care.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community patients who present to Charleston Area Medical Center (CAMC) or the private
        urology clinics of Drs. Tierney, Martinez or Davalos with kidney stones between 10 and 20
        mm in size would be screened based on inclusion criteria for possible enrollment in the
        study.
Pharmacist-driven CGM Use in the Uninsured Population
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      This is a pilot study. The purpose is to (1) provide access to continuous glucose monitoring
      (CGM) to patients (purchased through a grant) and (2) systematically record and analyze the
      results of the glucose monitoring by the clinical pharmacists at the clinic.
    


Intervention name(s): FreeStyle LibrePro CGM
Intervention type(s): Device
Intervention description(s): a professional CGM device will be worn by the participant for up to 14 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: continuous glucose monitoring
Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin Temperature.
Condition: Foot Ulcer, Diabetic
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      A randomised controlled pilot study on the feasibility of introducing a skin temperature
      device (Temp Touch) in secondary prevention of foot ulcers in people with diabetes who have
      had a foot ulcer in Norway.
    

Detailed description: 
      Diabetes mellitus is linked to late complications from kidneys, eyes, nerves, feet, and an
      increased risk of cardiovascular disease.

      Approximately 170 000 people in Norway suffer from diabetes, and diabetic foot disease is one
      of the most common complications.

      It is estimated that between 400 and 500 amputations are performed yearly in Norway, and most
      of the amputations are due to non-healing diabetic foot ulcers.

      Efficient prevention in high-risk individuals includes follow-up in specialist foot clinics
      including training in self-care, adaptation of preventive footwear and insoles.

      A randomised trial testing the use of skin temperature measurement in addition to routine
      foot care for preventing new foot ulcers showing a highly significant reduction in recurrent
      foot ulcers in the temperature measuring group, has previously been performed in USA (Lavery
      et al. Diabetes Care 2007;30:14).

      This study is planned as an open, randomised pilot study of minimum 40 patients testing the
      feasibility of implementing the use of skin temperature measurement for prevention of
      recurrent diabetic foot ulcers in a specialist clinical setting in Norway.

      If this is the case, we are planning a larger study to examine if these measurements can
      contribute to reducing the number of recurrent ulcers in clinical practice in Norway.

      We are in addition using a cognitive motivational method to examine if this model can
      increase the use of the temperature measuring device.
    

Intervention name(s): "Temp Touch" Diabetica Solutions inc.; Inspection
Intervention type(s): Device; Other
Intervention description(s): Daily measurement of skin temperature on feet for one year; Inspection of feet daily for one year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to
      that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of
      GERD.
    


Intervention name(s): 10 mg ilaprazole; 40mg esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) being taken orally each morning on an empty stomach for 8 weeks; One 20-mg omeprazole capsule (AstraZeneca, Losec) being taken orally each morning on an empty stomach for 8 weeks
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GERD
Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma.
Condition: Asthma; Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis for this study is that potent anti-secretory therapy with high dose PPI
      improves asthma control regardless of either asthma severity or the presence of GERD
      symptoms.
    

Detailed description: 
      Many patients with GERD do not experience heartburn symptoms. Barium esophagram, endoscopy
      and/or overnight esophageal pH monitoring are commonly relied upon to objectively establish
      the diagnosis of GERD. In general, overnight esophageal pH monitoring is the most sensitive
      and specific test available to confirm GERD. However, the literature exploring GERD as a
      cause of chronic cough suggests that the currently accepted criteria for defining abnormal
      overnight esophageal pH may not be adequately sensitive. It is therefore possible that
      aggressive GERD therapy may improve asthma control in patients with "normal" overnight
      esophageal pH probe results. To our knowledge, there are no published data addressing this
      question.

      Primary Objective The primary objective is to compare asthma control in asthmatic subjects
      treated with high dose PPI with asthmatic subjects taking placebo PPI. The primary outcome
      variables will be measurements of asthma symptoms and asthma quality of life.

      Secondary Objectives Secondary objectives include evaluating the effect of this aggressive
      anti-secretory therapy on lung function, asthma medication use (including both baseline and
      rescue medication), and GERD symptoms. An additional secondary objective will be to evaluate
      whether the presence or absence of GERD symptoms at baseline (prior to proton pump inhibitor
      therapy) will independently associate with improvement in any of the other outcomes measured.

      Measurements will include: Juniper Asthma Control Questionnaire (visits 2 and 5), Juniper
      Asthma Quality of Life Questionnaire (visits 2 - 5), GSAS gastroesophageal reflux instrument
      (visit 2, visit 5), the occurrence of adverse events, change in FVC, FEF25-75%, MIF50 /
      MEF50, peak expiratory flow rate, FEV1 reversibility, and the physical exam.

      Additional measurements will include methacholine challenge and eosinophilia in induced
      sputum specimens. Induced sputum will be offered to all patients, though it is anticipated
      that only approximately 50% will agree to this procedure.
    

Intervention name(s): rabeprazole
Intervention type(s): Drug
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: GERD; Gastroesophageal reflux disease; Asthma symptoms
A Study to Assess Pharmacokinetics and Pharmacodynamics Following Administration of BAY1093884 in Patients With Severe Hemophilia
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the pharmacokinetics in patients with severe
      hemophilia.

      The secondary objective is to assess the pharmacodynamics of BAY1093884 based on tissue
      factor pathway inhibitor activity
    


Intervention name(s): BAY1093884; BAY1093884
Intervention type(s): Drug; Drug
Intervention description(s): 0.3 mg/kg given intravenously; 1 mg/kg given intravenously
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Improving the Efficacy of Anti-Nicotine Immunotherapy
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out how vaccine-induced antibodies change the way the
      body processes nicotine from cigarettes. These antibodies absorb nicotine and can reduce
      nicotine levels in the brain. In this way, the vaccination may help to quit smoking. The
      central hypothesis is that anti-nicotine antibodies change kinetics of brain nicotine
      accumulation and distribution of nicotine between the brain and other body tissues. This
      vaccine is investigational which means that it is still being tested in research studies and
      is not approved by the U.S. Food and Drug Administration (FDA) to help people quit smoking.
    


Intervention name(s): NIC002 in Aluminum hydroxide (Alum); Placebo Vaccine - Aluminum hydroxide
Intervention type(s): Biological; Biological
Intervention description(s): Fifty-five subjects will receive 4 subcutaneous injections of 0.1 mg Nicotine-QB (NIC002) in Alum vaccine with a 4-week interval between injections.; Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.
Other intervention name(s): CYT002-NicQb (Nicotine-Qbeta); Anti-Nicotine Vaccine
Intervention MeSH terms: Aluminum Hydroxide; Vaccines; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Evaluation of a Low Fluoride Dentifrice for Caries Control
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this randomized clinical trial is to evaluate the effect of pH and fluoride
      concentration in liquid dentifrices in the control of dental caries in early childhood, in
      non-fluoridated area. This study also aims to assess the effect of the consistency of liquid
      dentifrices in the fluoride uptake in the plaque and the fluoride concentration in the
      toenails, to estimate the fluoride intake from these formulations.
    

Detailed description: 
      The study was carried out with schoolchildren living in a non-fluoridated area, with (A) or
      without (I) active caries lesions, were randomly allocated into 3 groups according to the LD
      used over 12 months: Group 1 (n=39-A/38-I): 550µgF/g-pH4.5, Group 2 (n=33-A/35-I)
      1100µgF/g-pH7.0, Group 3 (n=33-A/34-I): 550µgF/g-pH7.0.
    

Intervention name(s): Low-fluoride acidic dentifrice; conventional dentifrice; neutral pH and low-fluoride dentifrice
Intervention type(s): Other; Other; Other
Intervention description(s): 550 ppm (mg/L) of sodium fluoride in pH 4,5; 12 months , 3 times a day.; 1100 ppm (mg/L) of sodium fluoride, pH 7 , 3 times a day for 12 months; 500 ppm sodium fluoride, pH 7 , 3 times a day for 12 months
Other intervention name(s): G1; G2; G3
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dentifrices; Dental Caries; Fluorides; Nails; pH
Trial on The Efficacy of Hypertonic Saline on Non-CF CSLD.
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of
      life, in children with non-CF CSLD.

      Secondary Aims:

      To determine the:

        1. Efficacy of nebulized 5% hypertonic saline on airway microbiome, pulmonary exacerbation
           rate, healthcare utilization, and rescue antibiotics.

        2. Efficacy of nebulized 5% hypertonic saline on lung function

        3. Adverse effects of nebulized 5% hypertonic saline in children
    

Detailed description: 
      Primary Aim:

      To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of
      life, in children with non-CF CSLD.

      Here the investigators will be using validated pediatric cough questionnaires to asses this.
      Patients will answer these questionnaires at first recruitment ( -1 mth), at randomization (0
      month) and after 3 mths of use of the nebulized study drug (+ 3 mths)

      Secondary Aims:

      To determine the:

        1. Efficacy of nebulized 5% hypertonic saline on the airway microbiome, pulmonary
           exacerbation rate, healthcare utilization, and rescue antibiotics.

           Here the investigators will be taking history on the exacerbations, use of antibiotics
           and healthcare utilization before and after use of the hypertonic saline. Furthermore,
           Nasopharyngeal swabs will be done to review possible changes in microbiota, again before
           and after use of the 5% HS.

        2. Efficacy of nebulized 5% hypertonic saline on lung function. Here is investigators will
           be doing portable spirometry ( pre and post bronchodilator).

           Patients will perform at randomization (0 month) and after 3 mths of use of the
           nebulized study drug (+ 3 mths)

        3. Adverse effects of nebulized 5% hypertonic saline in children HS has been associated
           with side-effects. The investigators will monitor this. We will asses presence of these
           symptoms at randomization (0 month) and after 3 mths of use of the nebulized study drug
           (+ 3 mths) to ensure these are from the nebulizer.
    

Intervention name(s): Nebulized 5% Hypertonic saline
Intervention type(s): Drug
Intervention description(s): nebulized 0.9% saline
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind Placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CSLD; Child; Nebuliser; Hypertonic Saline; Outcome; Chronic cough
The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty
      acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.
    

Detailed description: 
      The study is testing the hypothesis that there is no interaction between Epanova and
      concomitant administration of simvastatin and aspirin. No drug interaction will be claimed
      if, following concomitant administration of simvastatin, aspirin and Epanova or only
      simvastatin and aspirin, the 90% confidence intervals (CIs) for the geometric mean ratios
      (GMRs) of the back-transformed PK parameters, area under the plasma concentration versus time
      curve (AUC0-tau) and concentration at the end of a dosing interval (Cmax,ss), for simvastatin
      and beta- hydroxysimvastatin acid,fall within 80%-125%.
    

Intervention name(s): Simvastatin; acetylsalicylic acid (ASA); omefas
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 mg (1 tablet) simvastatin once a day; 81 mg aspirin (1 tablet), once a day, co-administered with simvastatin; 4 g (4 capsules) Epanova once a day, co-administered with simvastatin and aspirin
Other intervention name(s): aspirin; Epanova
Intervention MeSH terms: Aspirin; Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eicosapentaenoic acid; docosapentaenoic acid; arachidonic acid; hypertriglyceridemia; simvastatin
Protected Pea Protein Extract and Satiety Hormone Release
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The increasing prevalence of overweight and obesity among the population contributes to
      increased incidences of chronic metabolic diseases. Healthcare costs related to these
      diseases are rising; prevention or delay of onset of disorders associated with overweight is
      needed. Food ingestion exerts a transient suppressive effect on appetite and further food
      intake by releasing gastrointestinal hormones. Proteins have been shown to be more satiating
      than carbohydrates and fat. Intraduodenal administration (via a naso-duodenal intubation) of
      pea protein has been shown to reduce food intake and increase satiety hormone levels in
      humans, in contrast to orally dosed (unprotected) pea protein. In the present study we aim to
      investigate the effects of human gastric fluid on the degradability of five different
      protected pea protein products. Further, in an ex vivo experiment on freshly obtained human
      duodenum tissue applying Ussing chamber technology; we aim to investigate the intestinal
      satiety hormone release by the five different prototypes. The prototype that is less degraded
      by human gastric fluid and is most effective in intestinal satiety hormone release will be
      used in a future clinical trial.
    


Intervention name(s): Saturn
Intervention type(s): Dietary Supplement
Other intervention name(s): Protected pea protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pea protein; Satiety hormone; Ussing Chamber
Non-invasive Diagnosis of Pulmonary Hypertension by Impedance Cardiography
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      The goal of the study is to prospectively evaluate Impedance Cardiography as a tool to detect
      pulmonary hypertension. According to our hypothesis Impedance Cardiography is a valuable
      method to differentiate patients without pulmonary hypertension from patients with pulmonary
      hypertension. The main objective is to determine the sensitivity and specificity in
      comparison to the gold standard right heart catheterization.
    


Intervention name(s): Impedance Cardiography
Intervention type(s): Diagnostic Test
Intervention description(s): Impedance Cardiography will be conducted in patients with suspected Pulmonary Hypertension within an interval of 24 hours to right-heart catheterization. Usually, 8 electrodes will be attached on the neck and thorax of the patient. These electrodes will produce current (max 400µA) and measure the voltage which is produced by the current running through the body. The Signal will be analyzed for specific signs of Pulmonary Hypertension.
At the same time electrocardiography and non-invasive continuous blood pressure will be measured.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of the clinical department of Pulmonology of the Medical University of Graz
        undergoing right heart catheterization for clinical reasons will be included
      
Keywords: impedance cardiography
Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to assess efficacy and safety of SHR4640 in subjects with
      hyperuricemia.
    


Intervention name(s): Placebo; SHR4640; benzbromarone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo once daily for 5 weeks; 1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks; 25mg benzbromarone once daily for a week, 50mg benzbromarone once daily for 4 weeks
Intervention MeSH terms: Benzbromarone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SHR4640, Phase II, monotherapy, dose-finding