bioihbjkbjnl/mcl2 huggingface dataset:
Reduction of Occurence of Acute Kidney Injury (AKI) Through Administration of Glutamine
Condition: Cardiac Surgery; Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate whether the application of glutamine versus control in
      patients with high risk for AKI identified by biomarkers can reduce kidney damage after
      cardiac surgery.
    

Detailed description: 
      Cardiac surgery is characterized by an increased production of free radicals as a consequence
      of surgical trauma, ischemia-reperfusion injury, inflammatory response syndrome in response
      to the use of the extracorporeal circulation. This results in an increased production and
      release of free radicals which may lead to an exhaustion of antioxidants and organ failure
      since the lungs, kidneys, liver and gastrointestinal tract are particularly susceptible to
      reactive oxidant species. Glutamine is considered as a conditionally indispensable amino acid
      in catabolic states of critically ill patients. It belongs, together with other mediators, to
      the host defense as major intracellular direct free radical scavengers. Its depletion has
      been demonstrated to be an independent predictor of mortality in a group of ICU (intensive
      care unit) patients. Clinical studies showed a positive outcome effect. In animal models,
      glutamine reduces the occurrence of AKI after ischemia-reperfusion injury. This could be
      demonstrated through reduced functional markers as well as reduced renal biomarker levels.
      Preliminary data suggest that glutamine has pleiotropic effects since it has effects on the
      immune system (reduced expression of cytokines) as well as on tubular epithelial cells
      (unpublished animal data from our laboratory).

      Thus, a randomized-controlled trial to analyze the effects of glutamine supplementation in
      high risk patients identified by renal biomarkers undergoing cardiac surgery with
      cardiopulmonary bypass (CPB) on the effects of kidney damage is urgently needed.
    

Intervention name(s): L-Alanyl/L-Glutamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Immediately after randomization (not longer than 30 min after fulfilling eligibility criteria), patients will receive intravenous infusions with the investigational drug; Immediately after randomization (not longer than 30 min after fulfilling eligibility criteria), patients will receive intravenous infusions with the placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac surgery; glutamine
A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients
Condition: Cognitive Impairment; Relapse; Bipolar Disorder
MeSH terms: Recurrence; Bipolar Disorder
Study type: Interventional

Summary: 
      This study will investigate the effect of Repetitive transcranial magnetic stimulation (rTMS)
      on cognition and long-term clinical outcomes of bipolar patients.
    

Detailed description: 
      Cognitive deficits are core features of bipolar disorder. Preliminary evidence shows that
      repetitive transcranial magnetic stimulation (rTMS) might have positive effects in enhancing
      cognition and improving clinical symptoms in patients with depression. This study will
      investigate the effect of rTMS on cognition and long-term outcomes (12 month) of bipolar
      patients.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation; Sham repetitive transcranial magnetic stimulation
Intervention type(s): Device; Device
Intervention description(s): Daily left DLPFC, at 110% motor threshold, with a frequency of 10 Hz. Stimulation will be applied in 3-second trains with a 15-second inter-train interval, for 50 trains per session; Sham Transcranial Magnetic Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Endometriosis Trial: Study of NBI-56418 in Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group
      study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in
      a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at
      the end of Week 12, follow-up continued every 4 weeks for 12 weeks.
    


Intervention name(s): NBI-56418 (GnRH antagonist); placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: endometriosis; pelvic pain; painful periods; dysmenorrhea; painful menstruation; GnRH; agonist; antagonist; menstrual pain
Compare the Effect of Exercise Program Plus Dry Needling Versus Elastic Taping
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is a common musculoskeletal health condition in society. It is a leading cause
      of disability globally and has created a significant burden in terms of work disability and
      high healthcare costs.

      Studies on the treatment of combined therapies for non-specific low back pain are scarce, so
      it is not known in depth which intervention is the best for reducing pain. For this reason,
      the objective of this study was to evaluate and compare the effect of physical exercise plus
      dry needling versus physical exercise plus elastic bandage. For this, a randomized clinical
      trial was carried out with a total of 22 people, where pain was evaluated using the ENA scale
      and functionality using the Oswestry test. Participants received CORE stabilization
      exercises. CORE stability training has become a popular training trend and has begun to be
      applied in rehabilitation programs and sports medicine (1).

      The expected results of the study are that the group that receives the physical exercise
      intervention plus dry needling will have better results in reducing the pain and
      functionality variable, evaluated with ENA and Oswestry in 4 sessions.
    


Intervention name(s): physiotherapy techniques
Intervention type(s): Other
Intervention description(s): Dry neeling: invasive physiotherapy technique where an acupuncture needle is used on painful points Elastic taping: physiotherapy technique where elastic bandage is used on the skin Exercise program: physical exercise prescription
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children
Condition: Vomiting in Infants and/or Children; Acute Gastroenteritis
MeSH terms: Gastroenteritis; Vomiting
Study type: Interventional

Summary: 
      Most of the trials conducted comparing ondansetron and domperidone have been conducted among
      children aged below 5 or 6 years of age while no study from Pakistan has compared efficacy of
      these antiemetic agents among children up to 12 years of age. The findings of present study
      will give valuable evidence about the effectiveness of these antiemetic agents to prevent
      vomiting among children suffering with acute gastroenteritis at a resource limited setting of
      South Punjab, Pakistan.
    

Detailed description: 
      to compare the efficacy of ondansetron versus domperidone for treating vomiting in acute
      gastroenteritis in children at a resource limited emergency setting of South Punjab,
      Pakistan.
    

Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): Ondansetron group received oral suspension of ondansetron as 0.15mg per body weight
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia
Condition: Depth of Anaesthesia
Study type: Interventional
Phase: Phase 1

Summary: 
      Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect
      of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our
      hypothesis is that this new method will more accurately predict depth of anaesthesia than the
      Bispectral Index (BIS) monitor in patients having elective surgery.
    

Detailed description: 
      Patients aged 18-60 years presenting for elective surgery under general anaesthesia will be
      recruited. They will be randomised to receive remifentanil effect-site target 0, 2 or 4
      ng/ml. Then anaesthesia will be induced with propofol. Loss of the eyelash reflex, response
      to command and response to electrical stimulation will be measured. The raw EEG will be
      recorded and analysed off-line using our new method and also for BIS values. Anaesthesia will
      then proceed according to the needs of the patient and the surgery.
    

Intervention name(s): remifentanil
Intervention type(s): Drug
Intervention description(s): target effect site concentration during induction
Other intervention name(s): No other names
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742
      inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This
      study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate
      knee osteoarthritis.
    

Detailed description: 
      Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in
      osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially
      limiting cartilage degradation and disease progression. This study will test the efficacy and
      safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.
    

Intervention name(s): PG-530742; Placebo; 50 mg PG-530742; 100 mg PG-530742; 200 mg PG-530742
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): One 25 mg PG-530742 tablet, twice daily for for one year; One placebo tablet, twice daily for for one year; One 50 mg PG-530742 tablet, twice daily for for one year; 100 mg PG-530742 tablet, twice a day for one year; 200 mg PG-530742 tablet, twice a day for one year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary Disease: Knee Primary Osteoarthritis
Glycemic Load, Metabolism & Obesity in Pregnancy
Condition: Obesity; Insulin Resistance
MeSH terms: Obesity; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of the study is to determine if a low glycemic load diet reduces the gain of body
      fat and insulin resistance during the last half of pregnancy in obese women.
    

Detailed description: 
      Obese women will be recruited to participate in the study between 14-18 weeks gestation.
      After determining usual dietary intakes, visceral fat thickness, and the metabolic response
      to a 100g oral glucose tolerance test (OGTT) at 20 weeks gestation, 45 of the women will be
      randomly assigned to a low glycemic load (GL) diet and 65 women to a regular low fat diet
      (current standard care). They will follow their assigned diet for the last 20 weeks of
      gestation. A dietitian will advise the women and will monitor them throughout the study. At
      28 and 34 weeks gestation, the women will come to the General Clinical Research Center (GCRC)
      at San Francisco General Hospital in the fasting state and the hormonal and metabolic
      response will be measured to another 100g oral glucose tolerance test (OGTT), and total body
      fat will be measured. Additional measurements include: 1) longitudinal measurements of
      maternal visceral fat thickness and fetal size and adiposity at 20 and 34 weeks gestation by
      ultrasound, 2) collection of cord blood and placental tissue, and 3) measurement of neonatal
      body composition by dual-energy x-ray absorptiometry and anthropometry at 2-3 weeks of age.
      Birth outcome data for mother and infant will be collected. To determine the metabolic
      response to the study diet, 25 women from each of the two diet groups will be assigned to a
      metabolic subsample for measuring rates of hepatic glucose production and lipolysis at 34
      weeks.
    

Intervention name(s): Low Glycemic Load diet; Low Fat Diet
Intervention type(s): Other; Other
Intervention description(s): Pregnant women were counseled to consume a diet with a glycemic load per 1000 kcal of less than 55.; Pregnant women were counseled to consume diets providing less than 25% of the energy as fat.
Other intervention name(s): LGL Diet; LF Diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy; obesity; diet glycemic load; body composition; body fat; gestational weight gain; insulin resistance
Drug-drug Interaction Study(Lobeglitazone, Warfarin)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate a pharmacokinetic drug interaction between
      lobeglitazone and warfarin in healthy subjects.
    

Detailed description: 
      From day 1 to day 12, lobeglitazone 0.5mg is administered daily to Group 1 subjects during
      period 1. Then on day 5,warfarin 25mg is co-administered Group 1 subjects at period 1. After
      10 day-break, warfarin 25mg is administered Group 1 subjects at period 2. On period 2,
      lobeglitazone is not administered.

      Group 2 is administered in reverse order.
    

Intervention name(s): Lobeglitazone; Warfarin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lobeglitazone; Warfarin; Type 2 Diabetes Mellitus; Drug-Drug interaction; Phase 1
Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional

Summary: 
      Impact of the hemoadsorption with Cytosorb on hemodynamic in pediatric patients with septic
      shock: a prospectic pediatric pilot study
    

Detailed description: 
      Prospective interventional pilot study included children with septic shock, weight ≥ 10 Kgs
      and requiring continuous kidney replacement therapy. Cytosorb (CytoSorbents Inc, New Jersey,
      USA) cartridge was added to CKRT every 24 hours for a maximum of 96 hours. A control group of
      matched patients was also identified from an external database. The primary outcome of the
      study was the proportion of patients who achieved an equal or more than 50% relative
      reduction in vasopressors or inotropes dose from baseline to the end of treatment. Secondary
      outcomes included doses of vasopressors and inotropes, hemodynamic and biological changes,
      changes in severity scores and 28-day mortality.
    

Intervention name(s): Cytosorb
Intervention type(s): Device
Intervention description(s): Cytosorb cartridge It is composed of polystyrene divinylbenzene and polyvinylpyrrolidone copolymers and targets molecules in the 5-50 kDa range, which includes the molecular mass of several cytokines
Other intervention name(s): CKRT
Intervention model: Single Group Assignment
Intervention model description: a two-stage plan by Simon
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Septic Shock; Blood Purification; AKI; Pediatric Critical Care; Hemoperfusion; CKRT
Beneficial Effects of Probiotics on Improvement of Gut Dysbiosis and Ascending Cholangitis in Patients Received Pancreaticoduodenectomy
Condition: Precancerous Lesions
Study type: Interventional

Summary: 
      To determine whether probiotics have beneficial effect on gut dysbiosis and postoperative
      ascending cholangitis in patients with pancreaticoduodenectomy.
    

Detailed description: 
      Gut dysbiosis and postoperative ascending cholangitis (POAC) occurred after
      pancreaticoduodenectomy (PD). To date, no clinical trial has evaluated the association
      between gut dysbiosis, POAC and probiotics. POAC is a common morbidity after
      pancreaticoduodenectomy or in obstructive jaundice patients with endoscopic retrograde
      biliary drainage (ERBD). It frequently induces longer hospital stay and makes the major
      obstacle for postoperative chemotherapy. This phenomenon reveals the important role of
      ampullary vater in control of retrograde bacterial inflow into bile duct. However, the exact
      difference of gut microbiota after pancreaticoduodenectomy is still unknown. Probiotics is
      reported efficacy in restore the normal flora of gut microbiota. So, this study is to
      evaluate the effects of probiotics consumption, Yugart 2 bottles per day for 1 month on gut
      microbiota in control of ascending cholangitis before and after pancreaticoduodenectomy
      through the analysis of microbial community by next generation sequencing.
    

Intervention name(s): Yugart
Intervention type(s): Dietary Supplement
Intervention description(s): Yugart 2 bottles per day for 1 month
Intervention model: Single Group Assignment
Intervention model description: Single intervention arm with trial treatment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ampullary; Pancreas
Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers
Condition: Coagulation Defects
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, single-center, open-label, ascending dose study which will assess
      the safety and tolerability of 5 doses of spray-dried solvent/detergent treated plasma
      (Resusix®) in healthy volunteers.
    


Intervention name(s): Spray-dried S/D-treated Plasma; Spray-dried S/D-treated plasma; Spray-dried S/D-treated Plasma; Spray-dried S/D-treated Plasma; Spray-dried S/D-treated Plasma
Intervention type(s): Biological; Drug; Biological; Biological; Biological
Intervention description(s): Infusion of 100 mL Spray-dried S/D-treated Plasma; Infusion of 200mL Spray-dried S/D-treated plasma; Infusion of 500 mL Spray-dried S/D-treated plasma; Infusion of 750 mL Spray-dried S/D-treated Plasma; Infusion of 800 mL Spray-dried S/D-treated Plasma
Other intervention name(s): Resusix; Resusix; Resusix; Resusix; Resusix
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Entegrion; Spray-dried Solvent/Detergent Plasma; Fresh Frozen Plasma; Transfusion; Resuscitation; Hemorrhage; Coagulopathy
Effects of High Intensity Laser on Mechanical and Physiological Findings in Pregnant Women With Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome; Pregnancy Related
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study will propose a novel approach to treat pregnant women with mild to moderate carpal
      tunnel syndrome (CTS) using the recently introduced High intensity laser therapy with its
      deep penetration and high-power characteristics. It's hopeful that the results of this study
      can fill the gap of knowledge surrounding the conservative treatment options for CTS in order
      to help patients restore their nerve function properly and promote new ways of addressing
      CTS.
    


Intervention name(s): High intensity laser therapy; Conventional Physical Therapy
Intervention type(s): Device; Other
Intervention description(s): Fifteen treatment sessions with pulsed Nd: YAG laser were applied to the subjects of the study group, three sessions per week, over 5 weeks in succession via EXAND MY 1064 nm Laser system, Mectronic Medicale, Italy. Patients in group (A) received HILT along with the conventional physical therapy program. The session involved 3 subphases: (1) The Initial phase "Analgesic phase", (2) In the intermediate phase "Trigger point phase"and (3)The final phase "Bio-stimulation phase" was applied for 6 minutes with a slow scanning in several parallel longitudinal lines.; Fifteen treatment sessions that involved using a neutral custom volar splint alongside neural and tendon gliding exercises. the splint was used at night and while performing strenuous activities during the day for 5 weeks. While nerve and tendon gliding exercises was repeated 10 times at each session and patients were encouraged to apply exercise 3-5 times per day for 5 weeks.
Other intervention name(s): High power laser therapy; Standard Physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: carpal tunnel syndrome; high intensity laser therapy; electrophysiology; pregnant women
Association Between Telomere Length and Risk of Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Observational

Summary: 
      Compelling epidemiological evidence indicates that alterations length of telomere, are
      associated with the initiation and development of ischemic heart disease. This study was
      undertaken to investigate whether mtDNA copy number in peripheral blood leukocyte could be
      used as a risk predictor for acute coronary syndrome.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        A total of 200 eligible ACS patients were anticipated to include in this study.Moreover,
        The 200 healthy controls without previous CHD history were also recruited from individuals
        who visited investigator's hospital for physical examination during the same time period.
      
Biospecimen description: 
      Telomeres consist of a tandem TTAGG repeat located at ends of linear chromosomes of eukaryote
      cells that often decrease in length over time (largely due to oxidative damage and the end
      replication problem during cell division) and may trigger cellular senescence once telomere
      become critically short
    
Keywords: acute coronary syndrome, telomere length, predictive factor