bioihbjkbjnl/mcl2 huggingface dataset:
Hydrotherapy With Hydrogen-rich Water vs. RICE Protocol Following Acute Ankle Sprain
Condition: Ankle Injuries
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      The traditional treatment of soft tissue injuries consists of the RICE protocol - rest, ice,
      compression, and elevation, followed for up to 72 hours after a trauma. Although designed as
      an immediate therapy to reduce inflammation that occurs after an acute injury, the RICE might
      not be the best way to promote healing due to limiting blood flow. Molecular hydrogen (H2)
      has recently been put forward as a possible adjuvant treatment in musculoskeletal medicine,
      yet limited data are available concerning its effectiveness as a first-aid intervention.
    

Detailed description: 
      Experimental protocol

        -  Randomized controlled parallel-group trial

        -  Acute (24 h) post-injury intervention:

             -  Hydrogen-rich water hydrotherapy

             -  RICE protocol

        -  First sessions given immediately after an initial examination (~ 60 min after the
           injury).

        -  Source of hydrogen-rich water = HRW Natural Health Products Inc. (New Westminster, BC,
           Canada)

           o Formulation (7g/ tablets, 800mg Magnesium) dissolved into a 3-L stationary whirlpool
           with water (20°C)

        -  No other interventions during the period of evaluation

      Outcomes assessed at baseline (pre-intervention) and at 24-h follow up:

        -  Figure-of-eight method of measuring ankle joint swelling

        -  Visual analogue score (VAS) score for pain at rest and during movement

        -  Weight-bearing lunge test (WBLT)

        -  Single leg balance test (SLBT) with eyes open and closed

        -  Serum inflammatory biomarkers (IL-1ß, TNF-α, CRP) • Early termination criteria: serious
           subjective side effects (e.g. tingling, discoloration of skin, burning, itching, rash)
    

Intervention name(s): Hydrogen-rich water; RICE
Intervention type(s): Procedure; Procedure
Intervention description(s): Hydrogen-rich water (one hydrotherapy every 4 hours); RICE protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Estimate the Effect of Formulation on the Relative Absorption of SB-751689 Administered to Healthy Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the effects of formulation on the relative bioavailability of
      SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a
      single oral dose of each formulation, with five formulations of SB-751689 tested in total.
      Blood samples will be taken up to 24 hours postdose after each dose administration. This
      study will provide information for future possible formulation development of SB-751689 for
      Phase III.
    


Intervention name(s): SB-751689 oral tablets (400 mg)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Formulation Drug Study
A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In
      healthy male volunteers
    


Intervention name(s): 30 mg PF-06412562; PF-06412562; PF-06412562
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subject will receive a single dose of 30 mg PF-06412562; The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.; The dose will be selected based on the results obtained for Cohort 1 and Cohort 2.
This Cohort is optional.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Receptor Occupancy; PET; D1 Receptor Agonist
Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients
Condition: Covid19; Corona Virus Infection; Cytokine Storm; Vitamin D Deficiency
MeSH terms: COVID-19; Coronavirus Infections; Vitamin D Deficiency; Cytokine Release Syndrome
Study type: Observational

Summary: 
      Vitamin D is a secosteroid hormone which may have beneficial role in reducing COVID-19
      adverse outcomes by first regulating the renin angiotensin system (RAS). Recent studies on
      animal in which acute respiratory distress syndrome (ARDS) was induced, showed that vitamin D
      lead to pulmonary permeability reduction by modulating RAS activity as well as the expression
      of the angiotensin-2 converting enzyme (ACE2). During COVID-19, downregulation of ACE2 leads
      to cytokine storm in the host, causing ARDS. In contrast, an experimental study conducted on
      mice in which ARDS was induced chemically, revealed that vitamin D admiration contributed to
      mRNA and ACE2 proteins levels improvement, ADRS milder symptoms as well as less lung damage.

      Additionally, vitamin D had shown antiviral effects on several previous studies, that though
      to be exerted either by antimicrobial peptides induction which subsequently had direct
      antiviral action or through immunomodulatory and anti-inflammatory effects.

      In addition, vitamin D stabilizes physical barriers which prevent viruses from reaching
      tissues susceptible to infection. Finally, previous studies demonstrated that hypovitaminosis
      D is accompanied by various comorbidities including diabetes mellitus, hypertension, chronic
      cardiovascular and respiratory diseases, and cancers, all medical conditions that are
      considered risk factors of COVID-19 infection deterioration and even high mortality rate.

      The objective of this study is to evaluate whether supplementation with high-dose vitamin D
      improves the prognosis of patients diagnosed with COVID-19 compared to a standard dose of
      vitamin D.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        All patients received the same background treatment for 5 days, following an Institutional
        protocol for standard of care: hydroxychloroquine 400 mg daily, lopinavir/ritonavir 400/100
        mg twice daily or/and remdisivir 200 mg LD then 100 once daily as a maintenance dose and
        anti-coagulation prophylaxis with enoxaparin subcutaneously once a day if D-dimmer between
        500-1000 or enoxaparin therapeutic subcutaneously twice daily if D-dimmer >1000.
      
Keywords: COVID-19; Cytokine Storm; Vitamin D
Longitudinal Follow-up of Brown Adipose Tissue Function and Structure
Condition: Obesity
MeSH terms: Obesity
Study type: Observational [Patient Registry]

Summary: 
      In Turku PET Centre, there have been 3 positron emission tomography studies on brown adipose
      tissue (BAT) activity in healthy adults. BATPET was performed between 2008 and 2009. FATBAT
      started in 2011 and Dixon-BAT in 2012 and they are both currently ongoing. In the current
      study, participants of BATPET, FATBAT and Dixon-BAT studies are recruited for a follow-up
      study to examine associations between obesity, cardiovascular risk factors, serum metabolic
      profile and BAT structure at baseline and during follow-up several years later. 43 BATPET
      participants will be called for follow-up in 2013 with a follow-up period of 5 years and 52
      FATBAT and Dixon-BAT participants in years 2014 and 2015 with a follow-up period of 3 years.
      The aim of this study is to examine longitudinal associations between BAT function and
      structure, liver adiposity and cardiovascular risk factors at baseline and during follow-up.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study subjects are healthy 22-55-year-old Caucasians. Population contains both lean and
        obese subjects.
      
Biospecimen description: 
      Blood samples, fecal samples, adipose tissue biopsies and skeletal muscle biopsies.
    
Keywords: positron emission tomography; magnetic resonance imaging; brown adipose tissue; obesity; cardiovascular disease; subclinical atherosclerosis
Fast Track Appendectomy for Suppurative Appendicitis
Condition: Suppurative Appendicitis
MeSH terms: Appendicitis; Suppuration; Infections
Study type: Interventional

Summary: 
      The literature has reported that fast track surgery can be safely applied to children
      undergoing appendectomy for acute appendicitis. There is no current evidence regarding the
      application of same day discharge protocol in children with intra-operative findings of
      suppurative appendicitis. The current standard of care for patients who present with
      intra-operative findings of suppurative appendicitis includes post-operative admission and
      treatment with intravenous antibiotics. Patients are discharged home once they have met the
      following discharge criteria: temperature less than 38.5 degrees Celsius, pain control with
      oral pain medication, and tolerating a liquid diet. Given the evidence in the literature that
      has shown that same day discharge of patients with acute appendicitis is safe and effective,
      we propose that fast track surgery protocol can be safely applied to patients with
      intraoperative findings of suppurative appendicitis. We hypothesize that this will result in
      a decreased postoperative length of stay, without an increase in 30-day complication rate.
    


Intervention name(s): Patients discharged home the same day following appendectomy
Intervention type(s): Other
Intervention description(s): Patients are discharged to home on the same day following appendectomy with oral antibiotics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Suppurative appendicitis, appendicitis, pediatric
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the impact of including exenatide once weekly in addition to usual
      care vs. usual care without exenatide on major cardiovascular outcomes as measured by the
      primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction
      (MI), or nonfatal stroke.
    


Intervention name(s): Exenatide Once Weekly; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection, 2 mg, administered once weekly.; Subcutaneous injection, matching volume of placebo, administered once weekly.
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: exenatide once weekly; cardiovascular; Bydureon; Amylin
A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections
Condition: Systemic Fungal Infections
MeSH terms: Infections; Communicable Diseases; Mycoses
Study type: Observational

Summary: 
      To collect and summarize information on the diagnosis, management, and clinical and
      mycological outcomes of patients with systemic fungal infections in order to better
      understand the effectiveness of antifungals in the treatment of Systemic Fungal Infections
      (SFI) in India.
    


Intervention name(s): voriconazole
Intervention type(s): Drug
Intervention description(s): Patients must have received (in the Intensive Care Unit [ICU] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection. The decision regarding choice of antifungal agent would lie with the treating physician and will necessarily precede and be independent of the decision to enroll a patient into the study.
Other intervention name(s): Vfend
Intervention MeSH terms: Voriconazole
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A database of outcomes in patients with proven or probable Systemic Fungal Infections (SFI)
        treated with antifungals in 5 centers across India.
      
Keywords: Observational study; Effectiveness; Safety; Tolerability; Systemic Fungal Infection
Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy
Condition: Pain, Postoperative; Surgery, Thoracic
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The study was performed in patients aged 6-18 years after the Ravitch procedure and
      thoracotomy. The primary aim of the study was to evaluate the efficacy and safety of pain
      control provided by the multimodal approach that involves the continuous infusion ropivacaine
      with fentanyl vs. bupivacaine with fentanyl through thoracic epidural catheter. Secondary
      aims were to identify the determinants of acute post-operative pain at rest, during deep
      breathing and coughing.
    

Detailed description: 
      The subjects were randomized to the Ropivacaine/Fentanyl (RF) or Bupivacaine/Fentanyl (BF)
      group.

      To perform a thoracic surgical procedure, all patients were premedicated with midazolam, and
      then, paracetamol, non-steroidal anti-inflammatory drugs, fentanyl, propofol, pancuronium or
      rocuronium (in children < 10 years old) and suprane were used to introduce and maintain the
      anesthesia. Thoracic epidural catheters were placed following induction of anesthesia and
      endotracheal intubation.

      Intraoperative analgesia was introduced by a single dose of lidocaine 2% (2 mg/kg). Then
      after 15 minutes, the patients from the RF group received ropivacaine 1% (1-3 mg/kg) and
      those from the BF group bupivacaine 0.5% (0.5-1 mg/kg). After 60 minutes 0.2% ropivacaine
      solution with fentanyl or 0.125% solution of bupivacaine with fentanyl was infused with the
      flow rate of 0.1 ml/kg/hr.

      Depending on the allocation to the group, postoperative analgesia was continued either with
      0.2% ropivacaine and fentanyl or 0.125% bupivacaine and fentanyl, based on the concentration
      and the flow rate described above. In addition, intravenous paracetamol was administered as
      standard every 6 hours (the maximum of 60 mg/kg daily) along with non steroidal
      anti-inflammatory drugs. In children > 14 years of age, ketoprofen was injected at the dose
      of 1 mg/kg (the maximum of 200 mg daily) and in younger children ibuprofen (orally or
      rectally, up to 30 mg/kg daily) every 8 hours. Metamizol was given as a "rescue drug" (20
      mg/kg).
    

Intervention name(s): Ropivacaine/Fentanyl; Bupivacaine/Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Ropivacaine 0.2% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr; Bupivacaine 0.125% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
Other intervention name(s): ROPIVACAINE HYDROCHLORIDE 10 mg/ml; BUPIVACAINE HYDROCHLORIDE 0.5%
Intervention MeSH terms: Fentanyl; Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multimodal analgesia; Thoracic epidural; Postoperative pain; Postoperative Complications; Patient Satisfaction
The Antioxidant Efficacy of a Product Probiotic in Research
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      Determine the efficacy of the investigational product versus placebo in reducing stress
      oxidative during the performance of a physical exercise of a certain intensity and duration.
    

Detailed description: 
      The effectiveness of a probiotic for oxidative stress after eight weeks of the product to
      study will be checked. the sample will be formed by cyclists that will submit to a baseline
      exercise and after the product is taken.
    

Intervention name(s): Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG); Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG); maltodextrin and sucrose (PLACEBO)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): six weeks of consumption; six weeks of consumption; six weeks of consumption
Intervention MeSH terms: Sulfalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Iovera° Device for Temporary Relief From Knee Pain
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This purpose of this study is to evaluate the effectiveness and safety of the iovera° device
      for the temporary reduction of pain associated with knee osteoarthritis.
    


Intervention name(s): iovera°; Sham Comparator
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators purpose is to offer active Transcranial Direct Current Stimulation (tDCS)
      in patients of the investigators previous study who received either placebo or sertraline and
      have not responded.
    


Intervention name(s): transcranial direct current stimulation
Intervention type(s): Procedure
Intervention description(s): Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior
      to surgery.
    

Detailed description: 
      Evaluate the effect of application procedure on the antimicrobial properties of a new product
      and a currently marketed product. Study will be conducted using methods dictated by the FDA.

      Study uses topical sampling from the abdomen and groin on intact skin and evaluates the
      germs. Effects of blotting versus not blotting will be assessed.
    

Intervention name(s): Chlorhexidine gluconate; Povidone iodine
Intervention type(s): Drug; Drug
Intervention description(s): Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.; Povidone iodine scrub and paint. Administer topically.
Other intervention name(s): ChloraPrep AQ; Betadine
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Antimicrobial; Antisepsis; Topical antisepsis
Effectiveness of Phototherapy With and Without Probiotics
Condition: Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Interventional

Summary: 
      Raised serum bilirubin levels can cause kernicterus and premature infants are at increased
      risk due to metabolic immaturity. The standard treatment for neonatal jaundice is
      phototherapy but probiotics along with it can reduce the duration of phototherapy and
      hospitalization stay, secondarily can reduce the risk of nosocomial infection.
    

Detailed description: 
      Raised serum bilirubin levels can cause kernicterus and premature infants are at increased
      risk due to metabolic immaturity. The comparative analytical study was conducted after the
      ethical approval for one year (Jan 2022-Jan 2023) in the neonatal unit of The University of
      Lahore Teaching Hospital, Lahore, Pakistan. 76 preterm neonates fulfilling the selection
      criteria were included in the study and divided into two groups.

      Standard phototherapy was applied in both groups and group A probiotic (Saccharomyces
      boulardii) 125mg, twice daily, orally (in 5cc of milk whichever the baby was taking) was
      given till discharge from the hospital. The primary outcome measurements were the duration of
      phototherapy and the length of hospitalization.
    

Intervention name(s): LED phototherapy
Intervention type(s): Other
Intervention description(s): LED phototherapy (430-470nm) alone will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Eflornithine to Prevent Skin Cancer in Patients With Previously Treated Early Stage Skin Cancer
Condition: Non-melanomatous Skin Cancer
MeSH terms: Skin Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. The use of eflornithine may be an effective way to
      prevent the recurrence of or further development of skin cancer.

      PURPOSE: Randomized phase III trial to determine the effectiveness of eflornithine in
      preventing skin cancer in patients who have previously received treatment for early stage
      skin cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the rate of new skin cancer in patients with previously treated stage
      0, I, or II basal or squamous cell skin cancer treated with eflornithine (DFMO) vs placebo.
      II. Determine whether inhibition of TPA-induced ornithine decarboxylase activity serves as an
      intermediary marker for response to DFMO in these patients. III. Determine whether inhibition
      of skin polyamine levels serves as an intermediary marker for response to DFMO in these
      patients. IV. Assess the long term toxic effects of this treatment in these patients.

      OUTLINE: This a randomized, double blind, placebo controlled, multicenter study. Patients
      receive oral placebo daily for the first 4 weeks. Patients who comply with taking 80-100% of
      placebo are randomized to one of two treatment arms. Arm I: Patients receive oral
      eflornithine (DFMO) daily. Arm II: Patients receive an oral placebo daily. Treatment
      continues for 3-5 years in the absence of unacceptable toxicity. Patients who develop skin
      cancer during study undergo surgical excision and continue treatment on the arm to which they
      were originally randomized. Patients are followed every 6 months through year 5.

      PROJECTED ACCRUAL: A total of 334 patients (167 per arm) will be accrued for this study over
      2 years.
    

Intervention name(s): eflornithine
Intervention type(s): Drug
Intervention MeSH terms: Eflornithine
Allocation: Randomized
Primary purpose: Prevention
Keywords: basal cell carcinoma of the skin; squamous cell carcinoma of the skin