bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Three Single Oral Doses of Trazodone on the QTc Interval Duration in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study has been designed to evaluate the effect of three doses of trazodone (20,
      60 and 140 mg), in comparison to placebo, on the QT/QTc interval of healthy volunteers.
      Trazodone oral drops 6% formulation has been selected in order to evaluate the three doses
      using the same formulation, because the lowest available strength for the tablet formulations
      is 50 mg. According to the E14 guideline on the evaluation of QT/QTc interval prolongation
      and proarrhythmic potential of antiarrhytmic drugs, a negative control (placebo) and a
      positive control (moxifloxacin) will also be assessed.
    

Detailed description: 
      Twenty (20) healthy volunteers (about 50% males and 50% females) will be randomised.

      Primary end-point:

        -  Evaluation of the relationship between the plasma concentration of trazodone (free base)
           and the change from baseline in QTc, placebo-adjusted and corrected for HR based on the
           Fridericia correction method (QTcF) method (∆∆QTcF).

        -  Trazodone can be declared to have no influence on QTc if the null hypothesis, that the
           upper bound of the two-sided 90% CI of the predicted mean placebo corrected change from
           baseline for QTcF is greater than 10 msec at the observed mean Cmax for the therapeutic
           dose of trazodone, can be rejected.
    

Intervention name(s): Trazodone 20 mg; Trazodone 60 mg; Trazodone 140 mg; Placebo; Moxifloxacin 400mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral drops; Oral drops; Oral drops; Oral drops; Tablet
Other intervention name(s): Avalox
Intervention MeSH terms: Moxifloxacin; Trazodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Trazodone; QTc interval; Moxifloxacin
Investigation of Dental Plaque and Gingival Index
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via
      modified gingival margin plaque index method.
    


Intervention name(s): Sodium Monofluorophosphate; Triclosan/Fluoride/Copolymer
Intervention type(s): Drug; Drug
Intervention description(s): Brush teeth and evaluate plaque score after one use of the study toothpaste; Brush teeth and evaluate plaque score after one use of the study toothpaste
Other intervention name(s): Colgate Great Regular Flavor toothpaste; Colgate Total toothpaste
Intervention MeSH terms: Listerine; Triclosan; Fluorides; Sodium Fluoride; Fluorophosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated
      in comparison with sodium hyaluronate ophthalmic solution.
    


Intervention name(s): diquafosol ophthalmic solution; 0.1% sodium hyaluronate ophthalmic solution.
Intervention type(s): Drug; Drug
Intervention description(s): DE-089 topical ocular application, 6 times daily for 4 weeks.; 0.1% HA topical ocular application, 6 times daily for 4 weeks.
Other intervention name(s): HA
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on
      maintaining the function and health of the insulin producing beta cells. This hormone is
      known to increase the production rate of new insulin as well as increase the release of
      insulin into the blood. We will measure the rate of new insulin production in subjects with
      Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2
      diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.
    


Intervention name(s): glucagon like peptide-1; glucose control
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): GLP-1 1 pmole/kg/min; glucose without GLP-1
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Type 2 diabetes; Insulin; biosynthesis; Non diabetic control
Approach to Hiatal Hernia Repair Based on Collagen Study
Condition: Hiatal Hernia; Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Hernia; Hernia, Hiatal
Study type: Interventional

Summary: 
      Groups of patients who underwent laparoscopic repair of large hiatal hernias by primary
      posterior crural repair and crural repair with ProGrip™ mesh techniques were examined for
      recurrence rate of hiatal hernias, quality of life according to the GERD-HRQL questionnaire.
      Clinical evaluation was performed at 3, 6, 12, 24, 36, and 48 months after surgery.
    

Detailed description: 
      The laparoscopic repair of large hiatal hernias is mostly performed by cruroraphy or
      cruroraphy with mesh reinforcement techniques.

      Cruroraphy it is suturing of the right and left diaphragmatic crura using nonabsorbable
      stitches. Main disadvantage of such technique is the high hiatal hernia recurrence rate after
      surgery.

      Cruroraphy with mesh reinforcement technique followed by relatively less hiatal hernia
      recurrence rate but associated with a large number of mesh-related complications.
    

Intervention name(s): Laparoscopic hiatal hernia repair with ProGrip™ mesh; Laparoscopic primary posterior crural repair
Intervention type(s): Procedure; Procedure
Intervention description(s): Suturing of the right and left diaphragmatic crura using 3 to 4 interrupted nonabsorbable stitches with additional reinforcement of crura repair with ProGrip™ mesh; Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures
Other intervention name(s): Laparoscopic mesh hiatoplasty; Laparoscopic mesh hiatal closure; Laparoscopic posterior crurorrhaphy; Laparoscopic posterior crural closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients
Condition: Postoperative Nausea and Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      This is a randomised controlled double blinded clinical trial to determine the antiemetic
      efficacy and safety of either 8 mg of dexamethasone or normal saline (placebo) given 1 hour
      before induction of either spinal or general anaesthesia in 2 arms (of 150 each).
    


Intervention name(s): dexamethasone; normal saline
Intervention type(s): Drug; Other
Intervention description(s): single Bolus dose of dexamethasone 8mg; 2 ml 0.9% saline
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: PONV
The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This is a behavioral randomized controlled trial of adults with uncontrolled persistent
      asthma that tests if the Propeller Health sensor, mobile application, and dashboard can
      improve adherence to ICS.
    


Intervention name(s): Electronic Medication Monitors on ICS and SABA - Active Mode; Electronic Medication Monitors on ICS and SABA - Silent Mode; Asthma App Tracking of ICS/SABA Usage - Active Mode; Asthma App Tracking of ICS/SABA Usage - Silent Mode; NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes; NorthShore Connect Real Time ICS and SABA Usage Feedback - No; Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - Yes; Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - No
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The patients in the intervention group will have sensors that are "active", so that these patients receive reminders about when to use their inhalers medications.; The patients in the control group will have sensors that are "silent", so that these patients do not receive reminders about when to use their inhalers medications.; Patients in the intervention group will have access to their medication usage information (as collected by their sensors) via their Propeller Health applications.; Patients in the control group will not have access to their medication usage information (as collected by their sensors) via their Propeller Health applications.; Patients in the intervention will receive feedback from the Research Nurse about their medication use and asthma control status.; Patients in the intervention will not receive feedback from the Research Nurse about their medication use and asthma control status.; Patients in the intervention group will receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.; Patients in the control group will not receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.
Other intervention name(s): MDI, Diskus; MDI, Diskus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; uncontrolled asthma; asthma medication adherence; Propeller Health; Connected Inhaler System
Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma
Condition: Asthma; Insomnia Chronic
MeSH terms: Asthma; Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of the proposed study are to explore changes in sleep and asthma outcomes from
      baseline to post-treatment in adults with asthma and comorbid insomnia who underwent
      Internet-based cognitive-behavioral treatment for insomnia (CBT-I).
    


Intervention name(s): Internet-based CBT-I
Intervention type(s): Behavioral
Intervention description(s): Internet-based cognitive-behavioral treatment for insomnia
Other intervention name(s): Sleep Healthy Using the Internet (SHUTi)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; insomnia; cognitive-behavioral treatment
Comparison of Hemodynamic Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy
Condition: Pancreaticoduodenectomy
Study type: Interventional
Phase: Phase 3

Summary: 
      From postoperative patients having undergone pancreaticoduodenectomy;

        1. To compare the hemodynamic parameters from the patient administrated 5% HA and 6%
           Voluven

        2. To assess the efficacy of the treatment as regards the clinical outcomes and laboratory
           parameters of the patient

        3. To compare the safety of the 2 intravenous colloids in the patient population
    


Intervention name(s): 6% hydroxyethyl starch 130/0.4; Albumin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pancreaticoduodenectomy; postoperative patient; colloid; albumin; hetastarch
TAURINE and HCC PATIENTS
Condition: Taurine in HCC
Study type: Interventional

Summary: 
      Serum taurine level beside (AFP and AFU) are of great value in early diagnosis in HCC
      Egyptian patients and may have a rule in identifying end-stage liver disease (ESLD) patients
      candidate for LDLT.
    

Detailed description: 
      Taurine has been demonstrated to have a direct and indirect antioxidant effect and to display
      antineoplastic activity by preventing angiogenesis and enhancing tumor cell apoptosis. Also
      it was suggested that measurement of serum taurine level in hepatic patients beside fibroscan
      is of great value in the early diagnosis of any fibrotic and cancerous liver changes.Aim of
      the work was to correlate serum taurine level with the levels of the specific tumor markers
      (α- fetoprotein and α-L-fucosidase ) for early diagnosis of different stages of HCC in
      Egyptian patients.

      This observational case-control study was conducted in the Tropical Medicine Department,
      Ahmed Maher Teaching Hospital. Eighty hepatic patients were assigned to three groups (Chronic
      hepatitis, Cirrhosis and HCC). Twenty healthy subjects were enrolled as a control group.
      Serum levels of AFP, AFU, and taurine beside complete biochemical analysis and liver biopsies
      from all selected patients were done. Patients who accepted to be a candidate for living
      donor liver transplant (LDLT) were referred to Ain Shams University Specialized Hospital
      (ASUSH) liver transplant unit.
    

Intervention name(s): taurine level
Intervention type(s): Diagnostic Test
Intervention description(s): Taurine: determined by High-Performance Liquid Chromatography according to the pre-column extraction and derivatization methodology of McMahon et al. in the present work we use the Shimadzu, Japan HPLC model LC-10 AT.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Comparison of Core Strength Training Using Stable Versus Unstable Surfaces
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      This study will address the scarcity of research and the variations in recommendations
      regarding core strengthening and stability programs. As physical fitness is a major concern
      of individuals and mostly people refer gym for fitness enhancement, this study will thus
      provide a guideline for effective core strength training program
    

Detailed description: 
      Male clients, aged 19 to 44 years, coming to the gym for strength training will be
      purposively selected based on the inclusion criteria and then randomly assigned into two
      groups. They will undergo a series of pre-intervention tests that would assess their strength
      using Bourbon TMS and standing long jump tests; flexibility using stand and reach test;
      balance using Y balance test; coordination using jumping sideways test and speed using 20-m
      sprint test. After initial assessment, they will be advised and demonstrated for curl-up,
      side-bridging and quadrupled exercises. The experimental group will perform these exercises
      on Thera-Band© Exercise Ball while the control group will perform the same exercises on gym
      floor. The clients will have sessions on preferably the first day and 4th day of the week but
      is subject to their attendance at the gym. There will be interval assessments at 2nd and 4th
      week based on the tests mentioned above to record changes at these intervals. After 6 weeks
      of bi-weekly sessions, the clients will undergo post-intervention tests that will be the same
      as pre-intervention tests.
    

Intervention name(s): Core strength training using unstable surface; The stable surface would be gym floor.
Intervention type(s): Other; Other
Intervention description(s): Training would include "big 3" exercises as described by McGill. These include the curl-up, side bridge, and quadruped position on unstable surface; Training would include "big 3" exercises as described by McGill. These include the curl-up, side bridge, and quadruped position on stable gym Floor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Core Strength Training; Flexibility; Balance; Coordination; Speed
Promoting Wellbeing for Women With Depression: A Pragmatic Randomised Controlled Trial (RCT) of an Exercise Programme
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators want to find out if their specially designed exercise programme will be
      more successful at helping women with depression to feel better than a basic programme will,
      by measuring the effect the programme has on mood, physical health, and social wellbeing.
      Their specially designed exercise programme will involve physical exertion at the
      participants' chosen level of intensity (how hard the body has to work during exercise), and
      will include motivational support. By contrast, the basic exercise programme will be at an
      intensity recommended by national guidelines, of the type that may be prescribed by a general
      practitioner (GP), and will include no extra motivational support.
    


Intervention name(s): Psychosocial support exercise programme; Prescribed exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The experimental arm will experience 12 sessions of intervention, at a rate of three sessions a week for four weeks, exercising in groups of ten women. Each session will comprise: fifteen minutes of psychosocial and motivational support, run by a qualified rehabilitation psychologist and overseen by a qualified health psychologist; a half hour preferred intensity exercise session run by a qualified sports physiotherapist. Participants preferred intensity (chosen exertion level) will be established using the Borg RPE scale (Borg G 1998).; This group will experience 12 sessions of intervention, at a rate of three sessions a week for four weeks, exercising in groups of ten women. Each session will be an half hour exercise session, at a typically (GP) prescribed level, designed in accordance with national guidelines and run by a qualified sports physiotherapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Depression; Mental health; Exercise; Prescribed exercise; Physical health; Social wellbeing
ARDSnet Protocol vs. Open Lung Approach in ARDS
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is
      provided by a machine called a ventilator or respirator. The purpose of this study is to find
      out if a new method of setting the ventilator for patients with severe ARDS is better than
      the standard, commonly used way of setting the ventilator.
    

Detailed description: 
      The ARDSnet protocol is the current, standard of care for ARDS. Mechanical ventilation is
      managed using low tidal volumes, relatively high respiratory rates, with oxygenation managed
      according to PEEP and FIO2 relationships as defined in a table. This study compares the
      ARDSnet protocol with an open lung approach to mechanical ventilation. The open lung approach
      uses a technique to recruit collapsed lung areas and then uses the lowest PEEP level that
      prevents recollapse of recruited lung units. The best PEEP level is determined by a
      decremental PEEP trial involving a series of pressure measurements taken after the
      recruitment maneuver. Both the ARDSnet protocol and the open lung approach require low tidal
      volumes and plateau pressures.

      Evidence suggests that using a mechanical ventilation strategy of recruitment maneuvers (to
      open the collapsed lung) followed by high PEEP (to prevent collapse of the opened lung) with
      control of transpulmonary pressure through lower plateau pressures would maximize homogeneity
      within the lung and as such, minimize shearing forces in the lung parenchyma, thus improving
      ventilation and outcome in mechanically ventilated ARDS patients.
    

Intervention name(s): Different Mechanical Ventilation Protocols
Intervention type(s): Other
Intervention description(s): OLA Group: Open lung approach protocol and recruitment maneuvers
ARDSnet Group: ARDSnet protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Respiratory Distress Syndrome; ARDS; Respiratory failure; Mechanical Ventilation; Positive end expiratory pressure; Lung recruitment maneuver
Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity and the safety of candidate
      vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
    


Intervention name(s): Fluarix™; GSK1247446A
Intervention type(s): Biological; Biological
Intervention description(s): GlaxoSmithKline Biologicals' licensed influenza vaccine; Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza vaccine; Prophylaxis Influenza vaccine
Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa
Condition: Moderate Depression; Clinical Depression; Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The objective of this randomised controlled trial (RCT) is to determine the effectiveness and
      cost-effectiveness of a task sharing counseling intervention for maternal depression in South
      Africa(i.e. provided by non-specialist health workers)
    

Detailed description: 
      Specific Objectives:

        1. To determine the effectiveness and cost-effectiveness of task sharing care to community
           health workers (CHWs), compared to enhanced usual care in South Africa, on both primary
           outcome measures (severity of prenatal maternal depression symptoms) and on a series of
           secondary outcome measures (functional status, health care utilization, social support
           and postnatal infant growth).

        2. To examine factors influencing the implementation of the task sharing intervention and
           future scale up, by assessing feasibility, sustainability, quality, and safety, and by
           qualitative exploration of the experience of task sharing from the perspectives of both
           CHWs and patients.
    

Intervention name(s): basic counselling by lay-health workers; Enhanced usual care
Intervention type(s): Behavioral; Other
Intervention description(s): 6 sessions of manual based counselling by trained lay health workers; 3 monthly phone calls by trained lay health workers (without counselling)
Other intervention name(s): task sharing intervention for maternal depression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: task sharing; task shifting; prenatal depression; counselling; lay health workers