bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      Randomized controlled, single-center trial randomizing patients with chronic kidney disease
      and symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve
      implantation (TAVI). Patients are randomized in a 1:1 ratio to periprocedural intravenous
      hydration matched to urine output using the RenalGuard system and to standard hydration. The
      purpose of the study is to test, wether the controlled intravenous hydration with the
      RenalGuard system is superior to standard hydration to prevent acute kidney injury after
      TAVI.
    

Detailed description: 
      Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is associated
      with worse outcome. The RenalGuard system was developed to prevent AKI by a controlled
      furosemide-induced diuresis with matched isotonic intravenous hydration. It is based on the
      theory, that a high urinary output prevents contrast media-induced nephropathy (CIN).

      The present study is a prospective, randomized trial to investigate wether a matched
      intravenous hydration using the RenalGuard system is superior to standard pre- and
      postprocedural intravenous hydration in patients with severe aortic valve stenosis and
      chronic kidney disease undergoing TAVI. Primary endpoint is the occurrence of AKI after TAVI.
    

Intervention name(s): RenalGuard system
Intervention type(s): Device
Intervention description(s): Periprocedural intravenous hydration matched to urinary output.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Transcatheter aortic valve stenosis; Chronic kidney disease; Acute kidney injury
Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures
Condition: Orthopedic Disorders; Tibial Fractures
MeSH terms: Musculoskeletal Diseases; Fractures, Bone; Tibial Fractures
Study type: Observational

Summary: 
      This is a study intended to evaluate a non-invasive device that uses light to measure the
      amount of oxygen in the muscles of injured and non-injured legs in specific situations. The
      name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to
      collect the information necessary to understand the use of the NIRS monitoring system to
      diagnose and direct treatment decisions in case of complications sometimes experienced in
      traumatic tibia fracture, such as excessive swelling called acute compartment syndrome (ACS).
    

Detailed description: 
      This study seeks to further develop the use of NIRS technology in the diagnosis of acute
      compartment syndrome. NIRS values normally increase in traumatized legs compared to the
      contralateral uninjured leg or forearm, indicative of a hyperemic response. The investigators
      hopes to build upon the current knowledge and verify the ability to accurately detect ACS
      using two easily identified and accessible leg compartments, the anterior and superficial
      posterior utilizing the Nonin 7600 oximeter with the Sensor Model 8004CV. Additionally, since
      this device was originally designed with brain tissue in mind, the NIRS device will collect
      vital engineering data that will be used to validate the algorithm used to produce the
      oxygenation values in injured muscle tissue.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from the trauma bay, surgical wards and ICU of Grady Memorial
        Hospital.
      
Keywords: acute compartment swelling (ACS); near-infrared spectroscopy (NIRS)
Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are to evaluate the safety and tolerability of multiple
      oral doses of selgantolimod and to evaluate the antiviral activity of selgantolimod in adult
      participants with chronic hepatitis B (CHB) who are viremic and not currently being treated.
    


Intervention name(s): Placebo; Selgantolimod; TAF
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet(s) administered orally every 7 days for 24 doses in fasted state; Tablet(s) administered orally every 7 days for 24 doses in fasted state; Tablet(s) administered orally once daily with food
Other intervention name(s): GS-9688; Vemlidy®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Gout Dose Response Study
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28
      days of dosing by treatment group.
    


Intervention name(s): RDEA594; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Uricosuric agent for the treatment of gout; Matching placebo
Intervention MeSH terms: Lesinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Quality of Life and Depression in Dialysis Patients
Condition: Chronic Kidney Disease Stage 5
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Depression
Study type: Observational

Summary: 
      The aim of this study is to evaluate quality of life (QOL) and depression in peritoneal
      dialysis patients compare to hemodialysis patients and assess hydration effect on QOL and
      depression over time.
    

Detailed description: 
      In dialysis patients, low QOL and depression affects clinical outcomes such as morbidity and
      mortality.

      Therefore at the point of treating dialysis patients, It is important to provide not only
      physical health but also psychosocial health.

      QOL could be decided by physical health (i.e. sign and symptom, laboratory results, death)
      and psychological health (i.e. fatigue, pain, consciousness of health and satisfaction).

      And also generally it is well known that physical and psychological functions in dialysis
      patients are decreased.

      And especially depression is common disease in dialysis patients. It is also well known that
      about from 25 to 50 percent of dialysis patients have depression which could result in low
      QOL moreover hospitalization, complication, and mortality.

      But there is no QOL and depression study with hydration status. Therefore the investigators
      would like to explore it.

      The objective of the study is to evaluate quality of life (QOL) and depression in dialysis
      patients and assess the hydration effect on QOL and depression over time
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Incident PD patients group : 250 subjects, First treatment for ESRD by any peritoneal
             dialysis modality within 30 days prior to or following enrollment (patients may be
             enrolled prior to commencing first treatment if there is clear indication that the
             treatment modality is CAPD or APD and they consent in advance to enter the study) and
             patients who don't have any experience of dialysis treatment before this study

          2. Prevalent PD patients : 250 subjects, Prevalent peritoneal dialysis(PD) patients who
             are under peritoneal dialysis treatment more than 6 months

          3. Prevalent HD patients : 250 subjects, Prevalent hemodialysis(HD) patients who are
             under hemodialysis treatment more than 6 months
      
Keywords: quality of life; depression; BCM (body composition minitor); hydrational status
Phase I Safety, Pharmacokinetics and Bioavailability Study Comparing Rate and Extent of Absorption of Two Different Forms of Tafamidis (PF-6291826)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      2 different formulations and 4 different single doses of tafamidis will be compared. All
      subjects will receive both formulations and 3 different doses. Subjects will be fasted before
      taking the drug. After swallowing single dose of tafamidis, tafamidis blood concentrations
      will be measured periodically for 8 days. After another 16 days, all subjects will repeat the
      procedure twice, each time with the other formulation/dose.
    


Intervention name(s): Tafamidis
Intervention type(s): Drug
Intervention description(s): bioavailability study
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Randomized Controlled Study of MEFP for Preschool Children With ADHD
Condition: ADHD; Child, Only
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The goal of this study is to provide a new, early treatment approach for preschoolers with
      ADHD, which could facilitate the EF developing well to achieve better outcome.
    

Detailed description: 
      ADHD in preschoolers has become established as a valid psychiatric disorder with
      characterized core deficits of executive function (EF). The EF impairments occurred in
      preschool period could persist to childhood, adolescent and adulthood, causing extensive and
      deep damage of individual's academic and career achievement, social function, and peer
      relationship. Psychostimulants remain a controversial opinion for preschoolers and appear
      less efficacious and more common side effects. It is very important to explore the effective
      nonpharmacological intervention targeting the EF deficits and appropriately tailored to young
      children. Therefore, the investigators conduct this randomized and controlled study to find
      out the therapeutic efficacy of metacognitive Executive Function Training for Preschool
      Children with ADHD (MEFP), and follow the subjects to observe whether the therapeutic
      efficacy would persist. In the mean time, the investigators also observe the factors which
      can influence the therapeutic efficacy. The goal of this study is to provide a new, early
      treatment approach for preschoolers with ADHD, which could facilitate the EF developing well
      to achieve better outcome.
    

Intervention name(s): Metacognitive Executive Function Training
Intervention type(s): Behavioral
Intervention description(s): Training the executive funtions of preshcool ADHD children through tasks and games repeatly but with fun. Giving the parents strategies to help the prechool ADHD childred coping the symptoms and develop EF in the reallife.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: ADHD; executive function; preschool; intervention
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Have to be Vaccinated MenBVac®
Condition: Vaccination
Study type: Observational

Summary: 
      The main objective of the study is to estimate the proportion of children, born between the
      06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with
      a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4),
      before the first vaccination (T0), after the second MenBvac vaccination (6 weeks after the
      second vaccination), before the third MenBvac vaccination and after the third MenBvac
      vaccination (6 weeks after the second vaccination) and one year after the third menBvac
      vaccination.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children born between 06/04/2004 and 17/04/2008, living Neufchatel en bray.
      
Biospecimen description: 
      blood samples
    
Keywords: Neisseria meningitidis B:14, P1-7, 16; Serum bactericidal activity; Menbvac
Proof-of-concept Study to Assess the Efficacy, Tolerability and Safety of a Single Intraarticular Dose of GZ389988 Versus Placebo in Patients With Painful Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To assess the efficacy of a single intraarticular dose of GZ389988 compared to placebo for
      relief of knee pain in patients with osteoarthritis (OA) of the knee.

      Secondary Objectives:

      To assess the safety and tolerability of a single intraarticular dose of GZ389988 in patients
      with painful OA of the knee.

      To assess the pharmacokinetic parameters of a single intraarticular dose of GZ389988 in
      patients with painful OA of the knee.
    

Detailed description: 
      Screening will be performed within 21 days of dosing. Following the single dose of study
      medication, the study period for each patient will be 84 ± 7 days up to the end-of-study
      visit.

      Total duration for one patient will be up to 16 weeks (up to the end-of-study visit), not
      including the long-term observational safety follow-up phone call for 12 additional weeks.

      The collection of primary endpoint data up to Week 4 for futility analysis is optional.
      Assuming a possible step-down in dose due to safety/tolerability reasons, the total expected
      maximum number of included patients could be increased up to a maximum of 182 patients.
    

Intervention name(s): placebo; GZ389988; acetaminophen or paracetamol; fixed combination of paracetamol + codeine; fixed combination of paracetamol + tramadol hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:solvent for parenteral use
Route of administration: intraarticular; Pharmaceutical form:suspension for injection
Route of administration: intraarticular; Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: capsule
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: Acetaminophen; Tramadol; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine
Condition: Migraine; Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Study type: Interventional
Phase: Phase 3

Summary: 
      Study STS101-007 is a randomized, double-blind, parallel group, placebo-controlled,
      multicenter study to evaluate the efficacy, safety, and tolerability of single doses of
      STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.
    

Detailed description: 
      Study STS101-007 is a multi-center, single-dose, randomized, double-blind,
      placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65
      years).
    

Intervention name(s): Dihydroergotamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.; Placebo for STS101
Other intervention name(s): Dihydroergotamine Mesylate; STS101 Placebo
Intervention MeSH terms: Dihydroergotamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: dihydroergotamine; dihydroergotamine mesylate; migraine
Study to Compare Pharmacokinetic Property of SYO-1644 Tab. and Nexavar Tab. in Healthy Male Volunteers
Condition: Healthy, Male
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics characteristics ,tolerability,
      and safety after orally administrating SYO-1644 to healthy male volunteers in randomized,
      active-controlled, open-label clinical study.
    

Detailed description: 
      After orally administrating SYO-1644 and Nexavar 200 mg to healthy male participants , the
      safety, tolerability, and pharmacokinetic characteristics are to be compared while testing
      pharmacokinetic characteristics based on the dosage.
    

Intervention name(s): SYO-1644; Nexavar tab
Intervention type(s): Drug; Drug
Intervention description(s): 100mg: SYO-1644 tablet, PO, 1 100mg tablet
150mg: SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet
200mg: SYO-1644 tablet, PO, 2 100mg tablet; Nexavar 200mg/tablet, PO, 1 tablet
Other intervention name(s): SYO-1644 100, 150, 200mg; Sorafenib 200mg
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Male Volunteers; Evaluation of the Pharmacokinetic Property; A Dose-block Randomized, Active-controlled, Open-label
Effects of Exercise on Abdominal Obesity and Risk Factors for Cardiovascular Disease
Condition: Obesity; Metabolic Syndrome; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Obesity; Metabolic Syndrome; Obesity, Abdominal
Study type: Interventional

Summary: 
      The investigators will randomize abdominally obese men and women at increased health risk to
      one of the following 4 conditions: 1) No-exercise, wait list controls (C), 2) Low volume, low
      intensity exercise (LVLI), 3) High volume, low intensity exercise (HVLI), 4) Low volume, high
      intensity exercise (LVHI).

      The primary aim of the trial is to determine the effects of varying exercise dose (energy
      expenditure, kcal) or intensity (relative to VO2max (cardiorespiratory fitness)) on waist
      circumference and glucose tolerance. The investigators will test the following hypotheses: 1)
      That the reduction in waist circumference and improvement in glucose tolerance in response to
      all treatments will be greater than controls. 2) That reduction in waist circumference and
      improvement in glucose tolerance in HVLI and LVHI will be greater than LVLI. 3) That
      hypotheses 1 and 2 are true independent of gender.
    


Intervention name(s): Exercise: LVLI; Exercise: HVLI; Exercise: LVHI
Intervention type(s): Other; Other; Other
Intervention description(s): low volume, low intensity; high volume, low intensity; low volume, high intensity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: exercise; physical activity; diet; metabolic risk; visceral fat; Insulin Resistance
The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool
Condition: Lung Collapse; Lung Diseases; Atelectasis; Atelectasis Without Respiratory Distress Syndrome; Atelectases, Resorption; Air Test; Pediatric Disorder
MeSH terms: Lung Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Pulmonary Atelectasis; Shock
Study type: Interventional

Summary: 
      HYPOTHESIS:

      During anesthetic pre-oxygenation with high FiO2, pulmonary atelectasis occur, especially in
      patients < 6 years old, where FRC and pulmonary closing volume may overlap. New borns and
      children <1 year old are especially vulnerable.

      OBJECTIVES:

        1. Validate "air test" as a individualized and non-invasive diagnostic method of clinically
           significant atelectasis in pediatrics.

        2. Determine what other factors contribute to atelectasis development in pediatrics

      METHODS:

      30 pediatric patients will be studied with ages ranged between 45 postconceptional weeks
      and16 years old.

      Baseline SpO2 and lung ultrasound will be performed for each patient upon arrival at the
      operating theatre before preoxygenation with FiO2 of 1.0 SpO2 will be measured 15 min after
      intubation during a 5 min long "air test" trial (FiO2 0.25). lung collapse will be verified
      by lung ultrasound at the end of the 15 min trial. Lung collapse will be eventually granted
      upon lung US verification by a blind researcher.
    


Intervention name(s): Air test
Intervention type(s): Diagnostic Test
Intervention description(s): Patients will breathe 0.21 < FiO2 < 0.25 during 5 min and have a lung ultrasound perfomed at the end of the 5 min trial.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: air test; atelectasis; pediatric; non-invasive; lung collapse
Different Doses of Dexmedetomidine Added to Bupivacaine in Transversus Abdominis Plane Block in Caesarean Delivery
Condition: Analgesia
Study type: Interventional

Summary: 
      Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may
      delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not
      adequately controlled. Postpartum analgesia has become a common concern.

      Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor
      antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine)
      Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist, exerts its
      sympatholytic effect by inhibiting the release of noradrenaline from central and peripheral
      sympathetic nerve endings. It is considered to be a useful agent with a wide safety margin,
      excellent sedative capacity and moderate analgesic properties
    

Detailed description: 
      This prospective double-blinded randomized controlled study will be done on parturients that
      are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy
      of two different doses (0.5 mcg/kg and 1mcg/kg) of dexmedetomidine as an adjuvant to isobaric
      bupivacaine in TAPB compared to a control group on the postoperative analgesia in cesarean
      section under spinal anaesthesia
    

Intervention name(s): Dexmedetomidine 0.5 mcg; Dexmedetomidine 1 mcg
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mcg/kg; 1 mcg/kg
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: according to the computer-generated random number codes that will be placed in sealed envelopes, the patients will be randomly allocated into three groups; Group-Control, Group-Dexmedetomidine 0.5 and Group-Dexmedetomidine 1 according tho the local anesthetic injected in Ultrasound-guided bilateral Tranversus abdominis plane block
Masking: Double (Participant, Investigator)
Primary purpose: Prevention