bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of CAI in Adults With PWS.
Condition: Central Adrenal Insufficiency; Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Adrenal Insufficiency; Syndrome
Study type: Observational

Summary: 
      Introduction: The prevalence and clinical significance of central adrenal insufficiency (CAI)
      in adult patients with Prader Willi Syndrome (PWS) remains unclear.

      Aim: To assess the prevalence of CAI in adults with PWS and to analyse the effects of
      replacement therapy with hydrocortisone (HCT) in patients with suspected CAI.

      Material and Methods: Twenty one adult patients with PWS were evaluated. Based on peak
      cortisol at the 30 minute of the high dose short Synacthen test (HDSST), patients were
      divided into three groups: CAI (central adrenal insufficiency) - peak cortisol <500nmol/L,
      intermediate (partial AI) - peak cortisol ≥500 nmol/L and <600 nmol/L and AS (adrenal
      sufficiency) - peak cortisol ≥ 600 nmol/L. In patients with diagnosed CAI HCT replacement
      treatment was initiated. Body weight, body fat percentage, signs, and symptoms of CAI were
      evaluated after 6 and 12 months of treatment.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients with PWS, referred to the Department of Endocrinology Medical
        University of Warsaw.
      
Biospecimen description: 
      whole blood, serum
Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Evaluation
Condition: Pharmacokinetics and Pharmacodynamics in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs),
      this study, to be conducted in approximately 36 NHVs, will provide pertinent information in
      determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12
      receptor inhibition effects and in selection of doses that match the antiplatelet effects of
      300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK),
      safety and tolerability of single doses of MDCO-157.
    


Intervention name(s): MDCO-157; PLAVIX
Intervention type(s): Drug; Drug
Intervention description(s): intravenous administration; oral administration
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Type 2 Diabetic Subjects on Stable Metformin Therapy to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administering Single and Multiple Oral Doses of GSK1292263
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A study in type 2 diabetic subjects on stable metformin therapy to investigate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of co-administering single and multiple
      oral doses of GSK1292263
    

Detailed description: 
      This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics
      of GSK1292263 when co-administered with metformin. The study will be in 2 parts. Part A will
      determine the PK of GSK1292263 following single day dosing of type 2 diabetes (T2DM) subjects
      on metformin. Part B will investigate the effects of 14d of co-dosing of GSK1292263 BID, 50mg
      BID of sitagliptin or placebo to 48 T2DM subjects taking metformin.
    

Intervention name(s): GSK1292263; GSK1292263 matching placebo; Sitagliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Tablet
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Glucose; Safety; Male; Female; Metformin; Pharmacodynamics; Tolerability; Type II Diabetes
Urdu Version Of The Bournemouth Questionnaire For Neck Pain: A Reliability And Validity Study
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      The aim of study is to translate & culturally adapt Neck Bournemouth Questionnaire into Urdu
      language along with investigation of the reliability & validity of Neck Bournemouth
      Questionnaire in General Population of Pakistan and to correlate with Neck Disability Index,
      Visual Analogue Scale, Neck Pain and Disability Scale and Rand 36-Item Health Survey
    

Detailed description: 
      The English version of the Bournemouth Questionnaire for Neck Pain will be translated and
      culturally adapted as per as previous recommendations. In the general population with neck
      pain, Urdu Version Of The Bournemouth Questionnaire For Neck Pain will be distributed among
      participants by choosing convenience sampling technique based on predefined inclusion and
      exclusion criteria. Test inter and intra- observer reliability of the final Urdu Version Of
      The Bournemouth Questionnaire For Neck Pain with Neck Disability Index, Neck Pain and
      Disability Scale, Visual Analogue Scale, and RAND will be filled with same day, by two
      observers and for the inter-observers assessment, with an interval of 45 minutes between the
      first and second application. Third assessment will be carried out after 7 days by
      Observer-1(re-intra-observers assessment. Data will be entered and analyzed by Cronbach alpha
      value. Test -retest reliability will be assessed using interclass correlation coefficient.
      The Urdu Version Of The Bournemouth Questionnaire For Neck Pain will be evaluated for content
      validity, construct validity, criterion validity and responsiveness.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        General Population of Pakistan with Neck Pain was included in the study
      
Keywords: Bournemouth Questionnaire For Neck Pain; Neck Pain; Cultural adaptation; Validity; Urdu Version; Reliability
Vision Restoration Training in Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Importance: Visual field loss after retinal damage in glaucoma is considered irreversible and
      methods are needed to achieve vision restoration. Behavioral vision restoration training
      (VRT), shown to improve visual fields in hemianopia and optic nerve damage, might comprise
      such a method.

      Objective: To determine if behaviorally activating areas of residual visual (ARV) using VRT
      by daily one hour training for 3 months improves detection performance in perimetry compared
      to a vision discrimination task in the intact visual field sector.
    

Detailed description: 
      Design: Prospective, randomized, double-blind, placebo controlled trial. Setting: Ambulatory
      care and home training Participants: Volunteer sample of glaucoma patients (25-80 yrs old)
      with stable visual fields and well controlled intraocular pressure (IOP).

      Intervention: Computer-based home training with VRT (n=15) or placebo discrimination training
      (n=15).

      Main Outcome Measures: The primary endpoint is change in detection performance in High
      Resolution Perimetry (HRP). Secondary endpoints are 30° white/white and 30° blue/yellow
      near-threshold perimetry. Further measures are eye movements, vision-related quality of life
      (vQoL) as assessed with (NEI-VFQ) and health-related quality of life (hQoL) using SF-36
      Health Survey-Short Form.

      Investigators hypothesize that VRT will improve visual performance in glaucoma
    

Intervention name(s): vision restoration training; Discrimination Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): visual stimuli repetitively presented to stimulate areas of residual vision. The training consists of luminance increment stimuli similar to perimetry and the task isa simple detection task (pressing a key whenever a target stimulus was detected).; the stimulus is a line segment (bar) which is always presented within the central ±5° visual field in one of four possible random orientations: horizontal, vertical, oblique to the right or oblique to the left. If the patient has visual field defects in this central area, 80% of the stimuli are presented in the intact part of the training region. The task is to identify the orientation of the line segment and press, as fast as possible, one of 4 assigned buttons on the keyboard.
Other intervention name(s): gVRT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vision; restoration; visual field
Effect of Gastric Bypass Surgery on Energy Metabolism
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the short term and long term effects of Roux-en-Y
      gastric bypass (RYGB) surgery on energy expenditure, gastrointestinal and appetite regulating
      hormone levels, and appetite sensation. We hypothesize that following RYGB surgery,
      metabolism will be elevated in comparison to patients who have not yet had RYGB but who are
      losing weight simultaneously using a low calorie diet. We further hypothesize that this
      higher metabolism will be associated with alterations in fasting and postmeal levels of
      gastrointestinal and appetite regulating hormones. Long term (1.5 years after RYGB), we
      hypothesize that differences in metabolism, body composition, and hormone levels will
      distinguish between patients who have maintained their weight loss after RYGB vs those who
      have regained weight.
    


Intervention name(s): Roux-en-Y gastric bypass surgery; low calorie diet (1,000 kcal/day)
Intervention type(s): Procedure; Dietary Supplement
Intervention description(s): Briefly, RYGB is characterized first by creation of a small stomach pouch. The small intestine is then divided approximately 75 cm distal to the ligament of Treitz, creating a proximal intestinal limb that transports the secretions from the stomach remnant, liver, and pancreas, and a 'Roux' limb, that is attached to the new stomach pouch to drain consumed food. The distal end of the proximal limb is then reattached approximately 100 cm distal to the new stomach drainage site, creating a common channel where digestive enzymes mix with ingested food.; Patients will consume a daily diet composed of:
4 powder diet portions (Cambridge Diets, UK)
plain yogurt (100-125g)
skim milk (1L)
a limited variety of vegetables
The diet will be consumed by both groups for a 10 week period.
Other intervention name(s): Cambridge Weight Plan, Northants, UK.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: obesity; bariatric surgery; energy expenditure; incretins; appetite regulation; body composition; GLP-1
Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils
Condition: Allergic Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This research is being done to test whether differences in blood cells at baseline (start of
      the study) can be used to predict how well omalizumab will work in a patient. Omalizumab
      (Xolair) is a drug approved by the U.S. Food and Drug Administration (FDA) to treat asthma.
      Studies show that omalizumab improves the symptoms of asthma but some people experience
      better improvement than others.
    

Detailed description: 
      From a therapeutic perspective, the study will determine whether changes in the peripheral
      blood basophil response to crosslinking anti-IgE Ab during treatment with omalizumab predicts
      the clinical efficacy of treatment with the drug. Secondary outcomes measures would focus on
      whether the starting level of anti-IgE-mediated histamine release, or the changes syk
      expression or its starting level would be sufficient to predict the clinical outcome.

      The study is a single-site trial to evaluate the utility of baseline basophil measures to
      predict the efficacy of subcutaneously administered omalizumab as an add-on therapy for the
      treatment of adult patients 18-75 years old who have been diagnosed with moderate to severe
      asthma according to current approved guidelines. Patients will be treated with omalizumab
      according to the standard FDA approved dosing table for a period of 16 weeks.
    

Intervention name(s): Omalizumab
Intervention type(s): Drug
Other intervention name(s): xolair
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)
Condition: Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of intravitreal Lucentis® (Ranibizumab)
      and investigate the anatomical and functional improvement following this treatment in
      patients with macular edema due to retinal vein occlusion (RVO).
    


Intervention name(s): ranibizumab
Intervention type(s): Drug
Intervention description(s): ranibizumab 0.5mg (0.05ml volume), intravitreal injection first 3 injection every 4 weeks additional injection (optional) according to the judgement of doctor
Other intervention name(s): Lucentis®
Intervention MeSH terms: Ranibizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional

Summary: 
      Rationale: Nutrition and lifestyle interventions are currently not implemented in usual
      clinical care of PAH-patients. Mainly because there is little known on the relation between
      pathology, nutrition and lifestyle. Patients who suffer from Pulmonary Arterial Hypertension
      feel insecure about their nutrition and lifestyle. The investigators hypothesize that an
      intervention on nutrition and lifestyle can improve the patients' quality of life.

      Objective: To explore the effect of a nutrition and lifestyle intervention on quality of life
      for patients suffering from PAH.

      Study design: Investigator initiated intervention study with control group. Study population:
      investigators aim to include 70 patients (18 - 80 years) with idiopathic, hereditable or drug
      related PAH, who have been stable for at least three months and are self-sufficient and/or
      have a family who's willing to participate in the lifestyle changes.

      Intervention (if applicable): Nutritional status, - education, - intervention and -
      compliance.

      Main study parameters/endpoints: This is an intervention study in which the investigators
      will asses the effect of a nutrition and lifestyle intervention on quality of life measured
      by SF-36 overall outcome with a significant difference of 6.35.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: The burden for the patient exists of 12 extra visits to the hospital and contact
      moments, over a period of 11 months, as well compliance to the diet and lifestyle. There is
      minimal risk in participation.
    

Detailed description: 
      Baseline nutritional assessment

      Nutritional education:

      8 online lessons containing information about nutrition, lifestyle and general health with
      complementary tips regarding PH. All participants recieve workbook with assignments.

      Nutritional intervention:

      Group A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Group B:
      MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) Control group: no diet.

      Follow-up:

      Patients in intervention arm followed for a period of 6 months to assess compliance.
    

Intervention name(s): E-learning; Diet
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): 8 lessons about nutrition and lifestyle; Diet A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Diet B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Nutrition; Lifestyle
Effect of Cannula Size on Oxygen Saturation During Nasal High Flow Therapy in Newborns
Condition: RDS - Infants; TTN
MeSH terms: Hyaline Membrane Disease
Study type: Interventional

Summary: 
      Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory
      support in newborns.

      Safe and effective use of NHF requires selection of an appropriate nasal prong-to-nares ratio
      because leak can influence the delivered pressure.

      To the best of our knowledge, this is the first study to investigate the effect of using
      different NHF cannula size on peripheral oxygen saturation in newborns with respiratory
      distress.
    

Detailed description: 
      NHF will be applied at 8 L/min using the AIRVO 2 through smaller and larger Optiflow nasal
      cannula. The study will have a randomized crossover design. The larger or smaller cannula
      size will be applied as the first intervention during each experiment. During each
      experiment, if the larger cannula is applied first, then the smaller cannula will be applied
      second and if the smaller cannula is applied first, then the larger cannula will be applied
      second. Each experiment will last for 1.5 hour.

        -  During baseline, supplemental oxygen will be added during NHF therapy to keep SpO2 in
           normal ranges (90%-94%). When the SpO2 has stabilized then the level of supplemental
           oxygen will be set for the entire experiment unless there is a significant change in
           SpO2 as determined by the attending consultant.

        -  There will be three consecutive 30-min periods of recording during each experiment and
           each experiment will last approximately 1.5 hour.

        -  Ventilation will be assessed by Respiratory Inductance Plethysmography (Respitrace) and
           transcutaneous carbon dioxide and oxygen.

        -  Recordings will be made using ADInstruments Powerlab and Labchart software with video
           recording of the patient.

        -  Routine measurement of heart rate, respiratory rate and oxygen saturations will be
           performed as per standard neonatal practice.

      The researcher is an experienced neonatal consultant who will be directly observing the baby
      throughout the study.
    

Intervention name(s): Change of cannula size
Intervention type(s): Device
Intervention description(s): During nasal High Flow Therapy with fixed flow of 8 l/min, the cannula size will be changed from smaller-to-larger or larger-to-smaller
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RDS; TTN; Nasal High Flow Therapy; Newborn
Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      COPD is one of the most important causes of morbidity and mortality and supposes a sanitary
      problem in Europe and USA. Patients with COPD usually have 1-2 episodes of acute exacerbation
      of COPD (AECOPD) per year, being these the principal causes of of hospitalizations,
      respiratory problems and medical visits. After an episode of AECOPD, the majority of patients
      develop a transitory (or permanent) worsening in their quality of life and 50% of them will
      require a new hospitalization. Globally, a 75%& of the exacerbations might be associated with
      a respiratory tract infection, and among them, 50% might be related to bacteria and in 45% an
      evidence of viral infection could be documented. Even though the antibiotic treatment might
      not be useful for a majority of patients with AECOPD, is generalized its use(almost an 85% in
      some series) in hospitalized patients. The non-controlled use of antibiotics in AECOPD
      results in a very expensive disease and raises the rate of resistance of bacteria. The
      available literature have shown that there's a relation between exacerbations and infections,
      based on sputum samples.

      In summary, is well known that at least a 50% of the episodes of AECOPD might be associated
      with pathogenic bacteria in the lower respiratory tract. Prescription of antibiotics is wide
      and generalized in hospitalized patients. Clinical trials have shown correlation between
      AECOPD with sputum purulence (which correlates with presence of bacteria), however they've
      not included NON-purulent AECOPD, even though they're a significative group of patients
      hospitalized by this cause too. It's necessary to evaluate the efficacy nor the security of
      antibiotic treatment in this group of patients in a well designed trial.
    


Intervention name(s): Moxifloxacin
Intervention type(s): Drug
Intervention description(s): Moxifloxacin 400 mg administered once a day for 5 days
Other intervention name(s): Actira
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD