bioihbjkbjnl/mcl2 huggingface dataset:
Nutrition Effects on Fatigue During Tennis Playing
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The main objective of this study is to investigate the effects of ingestion of different
      sports drinks (Nutrattente / Nutraperf / Nutrarecup) on fatigue induced by a tennis
      tournament simulation.
    


Intervention name(s): Nutrattente / Nutraperf / Nutrarecup; Nutrattente placebo / Nutraperf placebo / Nutrarecup placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mL of Nutrattente before each match 500 mL/h of Nutraperf during each match 250 mL of Nutrarecup after each match; 500 mL of Nutrattente placebo before each match 500 mL/h of Nutraperf placebo during each match 250 mL of Nutrarecup placebo after each match
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Fatigue; Tennis; Nutrition; Tournament simulation; Delivery of Health Care
Atorvastatin for the Prophylaxis of Acute GVHD in Patients Undergoing Matched Sibling Allogeneic Transplantation
Condition: Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Atorvastatin for prevention of acute GVHD
    

Detailed description: 
      This is a phase II study of atorvastatin for the prophylaxis of acute GVHD in patients
      undergoing matched-sibling allogeneic HSCT. This study will explore a two-pronged acute GVHD
      prophylaxis strategy, consisting of pre-treating consenting sibling donors with atorvastatin
      before stem cell collection, followed by the addition of atorvastatin to
      methotrexate/tacrolimus-based GVHD prophylaxis.
    

Intervention name(s): Atorvastatin calcium (Lipitor)
Intervention type(s): Drug
Intervention description(s): 40 mg PO daily
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin; Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HSCT; HPC; HCT; BMT; lipitor; atorvastatin; HMG-CoA Reductase Inhibitor; Hematopoietic stem cell transplant; allogeneic transplant; GVHD; graft-versus-host-disease; Graft vs Host Disease
Evaluation of Two Different Diet Regimen Prior to Colonoscopy in Children
Condition: Children Prior to Colonoscopy
Study type: Interventional

Summary: 
      Colonoscopy is a routinely performed procedure in children and adolescents. Proper
      visualization of the intestinal mucosa is highly dependent on the quality of the bowel
      preparation. European Society of Gastrointestinal Endoscopy (ESGE) emphasizes that the timing
      of bowel preparation is the key factor and recommends that the delay between the last dose of
      bowel preparation and colonoscopy should be minimized. Timing of bowel preparation prior to
      colonoscopy has not been studied in children population, yet. The diet regimen before
      colonoscopy is likely less important than the timing of bowel preparation, however may
      influence the well-being of children.
    


Intervention name(s): polyethylene glycol 3350
Intervention type(s): Device
Intervention description(s): Patients received a polyethylene glycol 3350 solution starting at afternoon the day before the colonoscopy at a dose of 1000 ml/15 kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours.
Other intervention name(s): Forlax
Intervention MeSH terms: Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: colonoscopy, pediatric, preparation, diet
Combined NMES,FEES and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia
Condition: Stroke
MeSH terms: Deglutition Disorders; Stroke
Study type: Interventional

Summary: 
      The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing
      rehabilitation in stroke patients with moderate-to-severe dysphagia.
    

Detailed description: 
      Neuromuscular electrical stimulation (NMES)and Fiberoptic endoscopic evaluation of swallowing
      (FEES) are both promising approaches to enhance swallowing recovery for dysphagic patients.
      However, there is no literature on the effectiveness of combined application of these
      modalities in the treatment of patients with poststroke dysphagia. The purpose of this study
      was to prospectively investigate whether combined NMES, FEES and traditional swallowing
      rehabilitation can improve swallowing functions in patients with moderate-to-severe dysphagia
      after stroke.
    

Intervention name(s): the combination group
Intervention type(s): Procedure
Intervention description(s): Patients received 12 sessions of NMES for 1 hour /day, 5 days/week within a period of 2-3 weeks. FEES was done before and after NMES for evaluation and guiding therapy. All patients subsequently received 12 sessions of traditional swallowing rehabilitation (50 minutes/day, 3 days/week) for 4 weeks.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: dysphagia,endoscopy, electrical stimulation,stroke
Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery
Condition: Surgery
Study type: Observational

Summary: 
      This study represents the first step for testing this device in patients in real-life
      situations to evaluate the technological capacities and usability by the patient
    


Intervention name(s): issued with SMART ANGEL device
Intervention type(s): Device
Intervention description(s): patients will use the technology at home to record and transmit data for blood pressure and oxygen saturation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients screened at CHU Nimes for consultation for preoperative anesthesia for surgery as
        an outpatient for foot, shoulder, gall bladder (cholecystectomy) or uterus (hysterectomy,
        ovariectomy).
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
Condition: Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to assess the safety profile of IC51 in a pediatric population from
      regions where JEV is not endemic
    


Intervention name(s): IC51; IC51; IC51
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.25 ml, 2 i.m. vaccinations at Day 0 and 28; 0.5 ml, 2 i.m. vaccinations at Day 0 and 28; 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pediatric; Japanese Encephalitis Vaccine; non-endemic countries; to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51
N-acetylcysteine and NMDA Antagonist Interactions
Condition: Cognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study tests the hypothesis that extrasynaptic mechanisms are critically linked with
      cognitive effects of NMDA antagonism as evidenced by event-related potentials (ERPs) in
      healthy humans.
    


Intervention name(s): N-acetylcysteine and ketamine; placebo and ketamine
Intervention type(s): Drug; Drug
Intervention description(s): Active drug (N-acetylcysteine); placebo N-acetylcysteine
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; Ketamine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: NMDA; glutamate; N-acetylcysteine; P3
Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery
Condition: Anesthesia; Child
Study type: Observational

Summary: 
      The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors
      agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in
      relationship with the age in the pediatric surgery setting.

      Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established
      in adult general anesthesia.

      Their utility is yet undefined in the pediatric population as age seems to affect their
      ability to track the cerebral hypnotic state in children.
    

Detailed description: 
      All patients monitored applying standard device for blood pressure, electrocardiogram and
      pulse oximeter for routine monitor of anesthesia in pediatric surgery. Bispectral VISTA
      monitor and Entropy monitor applied for monitoring the depth of anesthesia. The investigators
      will not assign any specific interventions to the subjects of the study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients with age ≤ 12 years old scheduled to undergo general anesthesia and
        mechanical ventilation for elective surgery
      
Keywords: Depth anesthesia monitors; Children anesthesia; Bispectral monitor; Entropy monitor
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial investigates the immunogenicity of FE 999049 in repeated cycles.
    


Intervention name(s): Follitropin Delta (FE 999049); Follitropin Alfa (GONAL-F)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children
Condition: Pneumococcal Vaccines
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate
      Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will
      also assess the immunological response (measure the amount of antibodies, i.e. proteins that
      fight off germs) produced by children after they have been given the 13-valent pneumococcal
      vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site
      will be assessed during the study.
    


Intervention name(s): 13vPnC; 13vPnC
Intervention type(s): Biological; Biological
Intervention description(s): 13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.; 13vPnC will be administered by intramuscular injection at approximately 12 months of age.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy Subjects; Vaccines; Pneumococcal
Comparison of Hemodynamic Stability and Pain Control
Condition: Percutaneous Nephrolithotomy
Study type: Interventional

Summary: 
      This study was designed to evaluate whether patient position (lateral vs. prone) has affect
      on the need for analgesia and onset of pain after surgery.
    

Detailed description: 
      Percutaneous Nephrolithotomy is the preferred surgical treatment in many cases of kidney
      stones which is performed in different positions such as prone, lateral, and supine. However,
      we do not have enough evidence comparing prone and lateral positioning regarding the need for
      analgesia and onset of pain after surgery. This study was designed to evaluate whether
      patient position (lateral vs. prone) has affect on the need for analgesia and onset of pain
      after surgery.
    

Intervention name(s): Pain; Hemodynamic changes
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Patient's pain in order to VAS; changes in hemodynamic states
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Percutaneous Nephrolithotomy; Analgesic; hemodynamic status
a Study to Investigate the Efficacy, and Safety of the Colovac Colorectal Anastomosis Protection Device.
Condition: Gastrointestinal Anastomotic Complication
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate theColovac device, a single use, temporary
      intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic
      site, following colorectal surgery (open or laparoscopic).
    


Intervention name(s): COLOVAC
Intervention type(s): Device
Intervention description(s): The intervention consists in the placement of the Colovac device, during the colorectal surgery, Once the colorectal anastomosis has been completed as per standard care and the water-thightness of the anastomosis has been verified.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: anastomotic leakage; fistula
Longitudinal Study of the Default-mode Network Connectivity in Brain Injured Patients Recovering From Coma
Condition: Coma
MeSH terms: Coma
Study type: Observational

Summary: 
      Several studies in healthy volunteers have suggested that the synchronized functional
      connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and
      when required, a switch in the activity between the DMN and other networks involved in
      specific congnitive functions, would occur. This interaction permit to make the hypothesis,
      that baseline brain activity is likely to shape our ongoing " stream of consciousness " and
      could correlate with conscious perception. The investigators hypothesized that DMN
      connectivity strength would be related to the level of consciousness of brain-damaged
      patients. The investigators will follow severely brain-injured patient in coma. Clinical
      examination using standardized behavioural scales: FOUR score (Full Outline of
      UnResponsivess), Coma Recovery Scale-Revised); and brain imaging assessesments using MRI
      (functional and anatomical connectivity, cortical thickness) will be performed at: 3 to 30
      (visit 1), and 60 (visit 2) days after insult. If patient recover a normal conscious state
      between 30 and 60 days, an additional clinical and brain imaging assessment will be performed
      to identify related changes in brain activity (visit 1*) Monitoring of vital parameters will
      be performed in patients by a senior anaesthesiologist throughout the experiment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will analyse DMN functional and anatomical connectivity in severely brain-injured
        patients in coma and during the first two month following brain injury. All patients will
        be admitted from one of the four Critical Care Units of University Teaching Hospital of
        Toulouse, France.
      
Keywords: Default-mode network; Difussion tensor imaging; Cortical thickness; Coma; Vegetative state; Minimally conscious state; Neural correlate of consciousness
Autologous Bone Marrow Mesenchymal Stem Cells Transplantation for Articular Cartilage Defects Repair
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a non-randomized study aimed to determine the safety and efficacy of intra-articular
      injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee
      articular cartilage defects.
    

Detailed description: 
      Osteoarthritis is the most prevalent joint disease, create articular cartilage defects is a
      frequent cause of joint pain, functional loss, and disability. Osteoarthritis often becomes
      chronic, and conventional treatments seek to ameliorate pain or improve mobility. However,
      these treatments rarely modify the course of the disease.Recent studies cell-based have shown
      encouraging results in both animal studies and a few human case reports. We designed a study
      to assess the safety and efficacy of osteoarthritis treatment with intra-articular injection
      of autologous bone marrow-derived mesenchymal stem cells.
    

Intervention name(s): Bone marrow aspiration
Intervention type(s): Procedure
Intervention description(s): Single intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cartilage injury; Osteoarthritis; Mesenchymal stem cells
Susceptibility to Chronic Post-Traumatic Extremity Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain; Disease Susceptibility
Study type: Observational

Summary: 
      The association between the COMT haplotypes and the presence or absence of CPSP or CRPS will
      be assessed stratifying the patients based on the individual categories of trauma or elective
      surgery.
    

Detailed description: 
      This will be a prospective association study in which we will recruit patients who have
      experienced single extremity trauma, or who have scheduled elective surgery on a single
      extremity. HRQoL will be determined at recruitment. We will identify their haplotypes and
      genotypes for 4 linked SNPs in the coding region of COMT as described by Diatchenko [2].
      Patients will receive follow-up at 3 and 6 months following trauma or surgery. Individuals
      who report either neuropathic pain or a reduced HRQoL score will be more closely examined, in
      order to identify CPSP or CRPS. Statistical analyses will be performed to determine whether
      haplotypes are associated with the development of either condition, and to determine the
      strength of this association.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing shoulder surgery
      
Biospecimen description: 
      Whole blood serum
    
Keywords: Complex Regional Pain Syndrome; Chronic Post-surgical Pain; Genetic susceptibility; COMT
OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults
Condition: HIV Prevention
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a monocentric phase I study in open-label and randomized, double-blind,
      placebo-controlled cohorts of HIV-1 seronegative adults to evaluate the safety,
      acceptability, and pharmacokinetic of OB-002H Gel administrated vaginally and rectally.
    


Intervention name(s): OB-002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): vaginal or rectal administration; vaginal or rectal administration
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients With Perennial Allergic Rhinitis (PAR) (BY9010/M1-408)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate that there are no clinically relevant
      additive inhibitory effects on the HPA-axis when ciclesonide nasal spray is concomitantly
      administered with orally inhaled HFA-BDP. The secondary objectives are to evaluate safety and
      tolerability of the combined dosing regimen of orally inhaled HFA-BDP and ciclesonide nasal
      spray.
    


Intervention name(s): Ciclesonide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ciclesonide 200µg versus Placebo; placebo
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Perennial Allergic Rhinitis; Ciclesonide; PAR
Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery
Condition: Laparoscopy
Study type: Interventional

Summary: 
      There have been reports that abdominal binder use after laparoscopic or open surgery affects
      postoperative respiratory function, walking performance, and pain but no study has evaluated
      binder use solely for laparoscopic cholecystectomy surgery. Therefore, the investigators
      performed a randomized controlled trial to evaluate the effect of abdominal binders after
      laparoscopic cholecystectomy by comparing postoperative outcomes in two patient groups.
    

Detailed description: 
      Abdominal binders help to prevent postoperative complications, however, their use is
      controversial because of a lack of evidence for their effectiveness and because they also
      confer disadvantages. The purpose of this randomized controlled trial was to compare the
      effects of abdominal binder after laparoscopic cholecystectomy on pain, degree of comfort,
      time until ambulation, walking ability, return of bowel function, and diet resumption.
    

Intervention name(s): abdomen binder (Sejung Korea, Seoul, Republic of Korea)
Intervention type(s): Device
Intervention description(s): abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Low- or High-glycemic Index Diets on Metabolic and Inflammatory Responses in Diabetics
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Background/Aims: Verify the effects of glycemic index (GI) on body composition, and on
      inflammatory and metabolic markers concentrations. Methods: Eighteen type 2 diabetics, (aged
      42.4 + 5.1 years, BMI 29.2 + 4.8 kg.m-2) were randomly allocated to low GI (LGI) or high GI
      (HGI) groups. High or low GI meals were provided in the laboratory twice a day during 30
      consecutive days. The other meals were consumed under free living condition and subjects were
      instructed to select foods presenting GI values corresponding to the allocated group. Body
      composition (body mass index, body fat percentage, waist circumference and waist-hip ratio),
      and inflammatory markers concentrations (interleukin-6, tumor necrosis factor-alpha, high
      molecular weight adiponectin, ultra-sensitive C-reactive protein and fibrinogen) and
      metabolic markers (glucose, insulin, total cholesterol, HDL cholesterol, free fatty acids,
      triglycerides and fructosamine) were assessed at baseline and after intervention. Food intake
      was monitored during the study. The criterion for statistical significance was P<0.05.
    


Intervention name(s): Low GI index diet; High GI diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Low glycemic index diet; High glycemic index diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment