bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D Supplementation and CD4 Count in HIV-Infected Children
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      To find out if vitamin D supplementing can lead to an improvement in immunological status in
      HIV-infected children as part of routine clinical care
    

Detailed description: 
      The objective of this study is to determine the impact of vitamin D on immunological status
      in HIV-infected children as measured by CD4 count (CD4 percent). We will determine if vitamin
      D supplementation leads to a measurable change in CD4 count (CD4 percent) in HIV-infected
      children in the context of routine clinical care.

      Specific study questions are:

        1. Does vitamin D supplementation lead to a change in CD4 percent (CD4 count) in
           HIV-infected children?

        2. Do the serum levels of the active form of vitamin D [1, 25(OH)2D and 25(OH)D] correlate
           with CD4 percent (CD4 count) in HIV-infected children?
    

Intervention name(s): Vitamin D; No supplementation; Vitamin D
Intervention type(s): Dietary Supplement; Drug; Dietary Supplement
Intervention description(s): Weekly dose of 5600 IU (800 IU per day); Control; Weekly dose of 11,200 IU (1600 IU per day)
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vitamin D; HIV-Infected children; CD4 count
Pain Post Abdominal Laparoscopy Prevention With Arcoxia
Condition: Laparoscopic Surgery for Appendicitis; Laparoscopic Surgery for Cholecystitis; Laparoscopic Surgery for Ovarian Cysts
MeSH terms: Appendicitis; Ovarian Cysts; Cholecystitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the
      already known effect when administered after such a procedure. Patient will be receiving
      either etoricoxib or the respective placebo one hour before surgery, then two hours after
      those receiving the active will receive placebo and those that received placebo will be given
      etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be
      available all the time.
    


Intervention name(s): etoricoxib 120 mg
Intervention type(s): Drug
Intervention description(s): etoricoxib 120 mg, tablet, orally, OD
Other intervention name(s): Arcoxia
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Re-Inventing Yourself After Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a replicable, psychologically-based
      group education intervention, Re-Inventing Yourself after Spinal Cord Injury (SCI), which
      aims to enhance personal self-efficacy. A structured six-week, manualized, group therapy
      intervention that delivers positive psychology concepts within a cognitive-behavioral
      therapy-based model has been created for the purpose of developing a resilient and optimistic
      sense of efficacy for people with SCI. Concepts covered within this intervention include:
      reframing and restructuring a person's method of looking at events, building confidence by
      focusing on personal strengths, developing methods of recognizing and appreciating the good
      in one's life and expressing gratitude for positive attributes. The goals of this
      intervention are to increase personal self-efficacy, enhance emotional well-being and improve
      participation in society for people with SCI living in the community. The investigators
      hypothesize that persons receiving the intervention will demonstrate improved SCI-specific
      and overall self-efficacy as compared to waitlist controls.
    


Intervention name(s): SCI Reinvention Protocol Participants; Waitlist Group
Intervention type(s): Behavioral; Other
Intervention description(s): The intervention involves participation in a six week psychologically-based educational intervention. During the course, 8 specific skills are reviewed in order to specifically address reframing a person's method of looking at events, build confidence by focusing on personal strengths, develop methods of recognizing and appreciating the good in one's life and express gratitude for positive attributes. These skills are presented in a specific sequence so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex.; Wait list arm will begin study intervention after 4 1/2 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Self-Efficacy; Life Satisfaction; Community Participation
Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction
Condition: Pancreatic Carcinoma; Biliary Obstruction
MeSH terms: Carcinoma; Pancreatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to compare the clinical effectiveness and long-term outcomes
      between patients with pancreatic carcinoma and biliary obstruction who are treated by stent
      insertion with or without high-intensity focused ultrasound ablation.
    

Detailed description: 
      Distal malignant biliary obstruction is a common problem in patients with pancreatic
      carcinoma. In unresectable pancreatic carcinomas, percutaneous stent placement has been
      pivotal in providing relief from obstructive jaundice, improving the quality of life, and
      allowing the maintenance of anticancer treatment.

      Venous chemotherapy, transcatheter arterial chemoembolization, or radiotherapy have been used
      to prolong stent patency and survival after stent insertion for patients with pancreatic
      carcinoma and biliary obstruction. High-intensity focused ultrasound ablation is a
      noninvasive and atoxic treatment of malignant tumor using focused ultrasound energy from an
      extracorporeal source that is targeted within the body resulting in thermally induced
      necrosis and apoptosis.

      The purpose of this study is to compare the clinical effectiveness and long-term outcomes
      between patients with pancreatic carcinoma and biliary obstruction who are treated by stent
      insertion with or without high-intensity focused ultrasound ablation.
    

Intervention name(s): biliary stent and high-intensity focused ultrasound ablation system; biliary stent
Intervention type(s): Device; Device
Intervention description(s): Self-expandable biliary nitinol alloys stent and YDME FEP-BY02 high-intensity focused ultrasound equipment; Self-expandable biliary nitinol alloys stent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot: Group Therapy for Children Who Stammer
Condition: Stammering
MeSH terms: Stuttering
Study type: Interventional

Summary: 
      The aim of the study is to answer the question: Is a large-scale research study of the
      effectiveness of group speech and language therapy (SALT) for young people who stammer
      possible?

      The study will look at the issues involved in setting up a large-scale investigation of
      treatment for young people who stammer. It will inform the investigators whether larger
      studies would be possible and give some early-stage information on the effectiveness of group
      SALT for these young people. The findings will pave the way for building and testing out
      treatment programmes where there will be clear positive benefit for young people who stammer
      and their families.

      To answer the research question, the study will tell the investigators (a) how easy/difficult
      it was to get people to take part, (b) young people and parents'/carers' views on taking part
      and (c) whether the assessments were able to pick up changes in speech and attitudes towards
      stammering reported by the young people and their carers.

      Sufficient numbers of participants were not recruited to carry out the intended rehearsal
      pilot RCT study design.
    


Intervention name(s): One-week speech therapy group
Intervention type(s): Behavioral
Intervention description(s): One-week cross-district speech therapy group for older children (aged 8 to 15) who stammer
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: pilot; stammer; stutter; children; randomised controlled trial; RCT; Speech and Language Therapy; Stuttering
Clinical Relevance of Thoracic Echography for the Early Diagnosis of Interstitial Lung Disease in Systemic Scleroderma - Pilot Study
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse
Study type: Interventional

Summary: 
      Diffuse interstitial lung disease (PID) is the leading cause of death in systemic scleroderma
      (SSc). Major progress has recently been made in its therapeutic management. Early diagnosis
      is essential to optimize this management. Current diagnostic techniques are based on
      high-resolution computed tomography on the thorax (HRCT) and pulmonary functional tests
      (PFT). However, these explorations have their limitations. Thus, there is a need for new
      techniques for a very early diagnosis of PID-SSc.

      Thoracic ultrasound (TUS) is an innovative, easily accessible, non-irradiating, inexpensive
      and painless tool. It is an emerging technique for the diagnosis of PID and has already
      proven its sensitivity for the detection of interstitial damage, as defined by HRCT.

      The main objective of the PRECOSS study is to describe the prevalence of an ultrasound
      interstitial syndrome in patients with SSc, free of PID-SSc (defined by the Goh criteria)
      detectable by HRCT.
    


Intervention name(s): thoracic echography
Intervention type(s): Other
Intervention description(s): The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
Condition: Generalized Pustular Psoriasis (GPP); Adalimumab; Japanese
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to investigate the efficacy, safety, and pharmacokinetics of
      adalimumab in Japanese participants with generalized pustular psoriasis (GPP) who did not
      have an adequate response to their currently approved treatment.
    

Detailed description: 
      This was a Phase 3, multicenter, open-label, single-arm study of adalimumab in Japanese
      participants with generalized pustular psoriasis (GPP). The study included a 30-day screening
      period, a 52-week treatment period, and a 70-day follow-up period. The dose regimen of
      adalimumab used in this study was 80 mg at Week 0 by subcutaneous (SC) injection, followed by
      40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow
      was allowed for participants who did not have adequate response on or after Week 8.
    

Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): Adalimumab pre-filled syringe, administered by subcutaneous injection
Other intervention name(s): Humira; ABT-D2E7
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: efficacy; safety
Substrate Metabolism During Exercise Following Ingestion of Ethanol
Condition: Exercise Metabolism Following Ethanol Ingestion
Study type: Interventional

Summary: 
      This study will investigate how ethanol (pure alcohol) influences carbohydrate and fat
      metabolism during prolonged, moderate intensity exercise. Participants will perform two bouts
      of cycling exercise with or without prior ingestion of ethanol, in a randomised order,
      separated by one week.
    

Detailed description: 
      Very little research has investigated the influence of ethanol on metabolism during prolonged
      exercise. Evidence suggests that delivery of fat to the working muscles during exercise may
      be limited with ethanol and therefore this may shift the relative proportions of energy
      derived from muscle stores of carbohydrate as a result (Jorfeldt & Juhlin-Dannfelt, 1976).

      The current study aims to investigate how a small-moderate dose of ethanol influences where
      energy is derived from during a prolonged bout of moderate intensity cycling exercise.

      Participants will visit the lab on three occasions, once for preliminary measurements of
      fitness and body composition, and twice for the experimental bouts of exercise. Body
      composition will be assessed using a dual-energy x-ray absorptiometry (DEXA) scan, which will
      measure lean mass, fat mass, and bone mineral density. Participants will then perform an
      incremental maximal oxygen uptake test to determine intensity for the experimental bouts of
      exercise.

      The two experimental bouts of exercise include cycling on an exercise bike for 2 hours at 55%
      of their maximal oxygen uptake (i.e. fitness) following 1 hours rest. This will be performed
      under two conditions: with and without ethanol ingestion. Pre and post exercise muscle
      biopsies will be collected to assess muscle metabolism, with regular blood samples and
      expired breath samples being collected to further investigate fuel delivery and use by the
      working tissues. The experimental bouts of exercise will be performed 1 week apart in a
      randomised order.
    

Intervention name(s): Ethanol
Intervention type(s): Dietary Supplement
Intervention description(s): For one exercise session, participants will be asked to ingest a quantity of ethanol (in the form of vodka) sufficient to maximally stimulate liver alcohol metabolism.
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exercise; Metabolism; Nutrition
Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Lateral Epicondylitis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      Objectives: The purpose of this study was to investigate the efficacy of continuous and
      pulsed ultrasound treatments in lateral epicondylitis and to compare the efficacy of these
      two treatments against each other and placebo.

      Patients and Methods: Fifty one patients diagnosed with lateral epicondylitis were included
      to the study. Patients were randomised to continuous ultrasound, pulsed ultrasound and
      placebo groups by using closed envelop method. First group received continuous ultrasound
      treatment. Second group received pulsed ultrasound treatment in proportion as. Third group
      received of placebo treatment. Resting and moving pain levels of the patients were evaluated
      by using visual analog scale. Muscle strength was evaluated by using dynamometer. For
      functional evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE)
      scales were used. Evaluations were made at baseline, at the end of the therapy, and one month
      after the therapy. In addition, at baseline and at the end of the therapy, the thickness of
      the common extensor tendon was measured by using ultrasonic imaging (USG).
    

Detailed description: 
      The purpose of this study was to investigate the efficacy of continuous and pulsed ultrasound
      treatments in lateral epicondylitis and to compare the efficacy of these two treatments
      against each other and placebo.

      Fifty one patients (33 women, 18 men) diagnosed with lateral epicondylitis were included to
      the study. Patients were randomised to continuous ultrasound (n=17), pulsed ultrasound (n=17)
      and placebo (n=17) groups by using closed envelop method. First group received 10 sessions of
      1 W/cm2 and 1,5 MHz continuous ultrasound treatment. Second group received 10 sessions of 1
      W/cm2 and 1,5 MHz pulsed ultrasound treatment in proportion as 1:4. Third group received 10
      sessions of placebo treatment with the same device seemed to be working but without
      delivering any output. Resting and moving pain levels of the patients were evaluated by using
      visual analog scale. Muscle strength was evaluated by using dynamometer. For functional
      evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE) scales were
      used. Evaluations were made at baseline, at the end of the therapy, and one month after the
      therapy. In addition, at baseline and at the end of the therapy, the thickness of the common
      extensor tendon was measured by using ultrasonic imaging (USG).
    

Intervention name(s): ultrasound
Intervention type(s): Device
Intervention description(s): therapeutical ultrasound were applied to the patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: lateral epicondylitis, therapeutical ultrasound
3-D Transcranial Ultrasound Analysis Study
Condition: Cerebrovascular Accident; Intracranial Hypertension
MeSH terms: Stroke; Intracranial Hypertension; Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate real time 3-D ultrasound imaging of the brain for
      the diagnosis and evaluation of stroke.
    

Detailed description: 
      The objective of this proposal is to extend our previous advances to investigate real time
      3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke. Over the last
      decade, with the availability of color flow Doppler combined with effective ultrasound
      contrast agents, a renaissance has occurred in transcranial sonography as a low cost, bedside
      method for evaluation and management of patients with cerebrovascular disease in spite of the
      image degrading properties of the skull. Our hypothesis is that we can combine new
      generations of 2D array transducers with ultrasound contrast agents and phase aberration
      correction to enable real time 3D ultrasound imaging and 3D color flow Doppler of the brain
      with a factor of 10 improvement in spatial resolution compared to conventional transcranial
      sonography for improved diagnosis and evaluation of stroke.
    

Intervention name(s): 3-D ultrasound scanner; Perflutren Protein-Type A Microspheres for injection
Intervention type(s): Device; Drug
Intervention description(s): The availability of color flow Doppler combined with effective ultrasound contrast agents in transcranial sonography serves as a low cost, bedside method for evaluation and management of patients with cerebrovascular disease in spite of the image degrading properties of the skull.; Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.Bolus: The recommended dose for activated DEFINITY® is 10 microliters (μL)/kg of the activated product by intravenous bolus injection within 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 microliters (μL)/kg dose followed by a second 10 mL saline flush may be administered 30 minutes after the first injection to prolong contrast enhancement. Infusion: The recommended dose for activated DEFINITY® is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute.
Other intervention name(s): Definity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cerebrovascular Accident; Intracranial Hypertension
Drug Penetration Into Bone After Repeated Oral Administration of Debio 1450 to Patients Undergoing Hip Replacement Surgery
Condition: Bone Diseases, Infectious
MeSH terms: Communicable Diseases; Infections; Bone Diseases, Infectious; Bone Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Debio 1450 is being developed for the treatment of staph (staphylococcal) infections. How
      fast and completely an antibiotic penetrates into bone is used to determine how effective it
      might be to treat infections related to bones or joints. Since bone has fewer blood vessels
      than other tissue (for example lung tissue or the skin), drugs have a harder time getting
      into them. It is important to find out how much of the antibiotic can get into the bone to
      help patients with bone infections.
    


Intervention name(s): Debio 1450
Intervention type(s): Drug
Intervention description(s): Debio 1450, 40 mg, powder for oral solution, for reconstitution in 5% dextrose in water.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness
Condition: Muscle Weakness
MeSH terms: Muscle Weakness; Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      Assessment of Effectiveness of combined high protein intake with early physical exercise by
      ultrasound measurement of rectus femoris muscle thickness in Intensive Care Unite
      mechanically ventilated patients.
    

Detailed description: 
      Muscle wasting and weakness is a frequent finding in critically ill patients and is
      associated with worse short- and long-term outcomes like delayed liberation from mechanical
      ventilation, longer Intensive Care Unit and hospital stay, worse physical function and
      quality of life.
    

Intervention name(s): Amino Acid; Physical exercise
Intervention type(s): Drug; Procedure
Intervention description(s): Amino acid enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day.; The physical exercise intervention will be delivered by trained nursing staff, and started as close to the time of randomization as feasible (within 24hours of randomization). The intervention group will receive exercise sessions, for up to 20 min duration (as tolerated by patient).The implementation of physical exercise intervention will be protocolized to provide passive exercise early before weaning and shift to active exercise after weaning and also graduated resistance during each session and between daily sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will receive the amino acid intervention that is provided in addition to 'usual care' enteral and/or parenteral nutrition either enteral or parenteral to target a total protein delivery of 2.0g/kg/day. The physical exercise intervention will be delivered by trained nursing staff,and started as close to the time of randomisation as feasible (ie, within 24hours of randomization). The intervention group will receive exercise sessions, for up to 20 min duration.
Masking: None (Open Label)
Primary purpose: Treatment