bioihbjkbjnl/mcl2 huggingface dataset:
Urinary Biomarkers for AKI Diagnosis in Patients With SARS-CoV-2 (COVID-19)
Condition: COVID-19; Renal Replacement Therapy; Acute Kidney Injury
MeSH terms: COVID-19; Acute Kidney Injury
Study type: Observational

Summary: 
      Among patients with SARS-CoV-2 pneumonia, approximately 20% have an acute kidney injury (AKI)
      and 5% require renal replacement therapy. Occurrence of AKI in patients with COVID-19 is
      associated with increased morbidity and mortality. Early detection of patients at risk of AKI
      would allow to prevent onset or worsening of AKI. The aim of this study is to determine if
      urine biomarkers of renal tubular damage such as TIMP-2 and IGFBP7 could early identify
      patients with SARS-CoV-2 pneumonia at risk of developing AKI.
    


Intervention name(s): [TIMP-2]*[IGFBP-7]
Intervention type(s): Other
Intervention description(s): [TIMP-2]*[IGFBP-7] mesurement in urine sample relicates of COVID-19 patients admitted to the Montpellier University Hospital
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        COVID-19 patients admitted to the Montpellier University Hospital with at least one rine
        sample drawn
      
Biospecimen description: 
      NC
    
Keywords: Acute Kidney Injury; SARS-CoV-2; Renal Replacement Therapy
Integrated Management Enhances Functional Gains in Children With Cerebral Palsy Treated by BoNT-A
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb
      spasticity management in children with cerebral palsy (CP). Constraint Induced Movement
      Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and
      complimentary treatments to improve motor function in these children. In a recent trial
      combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains.

      In this clinical trial the aim was to evaluate the effects of transcranial direct current
      stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when
      integrated with BoNT-A treatment in children with unilateral CP.
    

Detailed description: 
      Although BoNT-A is effective in spasticity management there is inconclusive evidence to
      support its usage for improvement in upper limb activity and function. Combination of BoNT-A
      and occupational therapy (OT) is found to be more effective then OT alone in reducing
      impairment, improving activity level and goal achievement. Intensive hybrid training models
      of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning
      in children with CP. The aim of this clinical trial is to show the additional gains that
      could be provided by an integrated treatment of transcranial direct current stimulation
      (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in
      children with unilateral CP.
    

Intervention name(s): Botulinum toxin type A; transcranial direct current stimulation; hybrid training model of CIMT and BIT; usual care
Intervention type(s): Drug; Device; Other; Other
Other intervention name(s): Botox, Dysport; noninvasiv brain stimulation; physical therapy
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: cerebral palsy; botulinum toxin A; constraint induced movement therapy; transcranial direct current stimulation
A Feasibility Study to Assess Critical Aspects of Fluorescence Affinity Sensor (FAS) Performance and Safety Over Several Hours
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical research study is to learn about a new minimally invasive glucose
      monitoring device called Fluorescence Affinity Sensor (FAS). In this study, the FAS will be
      used to determine its effectiveness for glucose monitoring. Researchers want to find out how
      the device performs at two different body sites (forearm and abdomen) over 4 hours. The
      safety and comfort level of the device will also be studied.
    

Detailed description: 
      The FAS glucose monitoring system is a minimally invasive glucose monitoring device which is
      not yet approved by the FDA. The FAS system will be used in this study to monitor glucose
      levels during a glucose tolerance test (GTT) performed in Dr.Orzeck practice. The FAS
      measures glucose levels in skin tissue of the forearm or the abdomen at a depth of less than
      1 mm by inserting a small needle-like device. During the 4-hour GTT, the needle-like FAS is
      left in the skin tissue. The FAS performance has indicated in prior experiments that it is
      more stable than competitive commercial glucose-sensing devices. Due to its unique design,
      its glucose response is more accurate, and less affected by certain drugs (such as pain
      medicine).
    

Intervention name(s): Subcutaneous glucose monitoring device
Intervention type(s): Device
Intervention description(s): monitor interstitial glucose level every 5 min over 4 hours
Other intervention name(s): Fluorescence Affinity Sensor (FAS)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: subcutaneous glucose monitoring; diabetes; fluorescence; affinity; biosensor; type I Diabetes; type II diabetes
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
Condition: Chronic Myeloid Leukemia; Gastrointestinal Stromal Tumor
MeSH terms: Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Investigational Product

             1. Imatinib mesylate tablet 400 mg

             2. Glivec film-coated tablet 100 mg (Comparator)

        2. Expected target disease

             1. chronic myeloid leukemia

             2. Gastrointestinal stromal tumors

        3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study

             1. 36 healthy subjects, 2 groups (18 subjects/group)

             2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))

             3. wash-out period : 14 days

        4. Evaluation on pharmacokinetics(PKs) and safety

             1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2

             2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test

        5. Statistical method

             1. Demography Characteristics

             2. Pharmacokinetic parameters

             3. Safety data
    


Intervention name(s): Imatinib mesylate tablet 400 mg, 1 Tablet; Glivec film-coated tablet 100 mg, 4 Tablets
Intervention type(s): Drug; Drug
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CML; GIST
Load During Sweep Rowing and the Influence on the Posture
Condition: Muscle Hypertonia; Postural Scoliosis; Postural; Defect
MeSH terms: Scoliosis; Muscle Hypertonia
Study type: Observational [Patient Registry]

Summary: 
      The aim is to assess the influence of asymmetric training on the locomotor system in sweep
      rowers. To analyse possible changes objectively, the axial position of the hull will be
      assessed using Moiré topography, and the symmetry of foot loading will be monitored with a
      pedobarograph. Furthermore, the Visual Analog scale and Cluster of Laslett will determine
      whether an asymmetric load can provoke pain in the lumbar region or cause a blockage in the
      SI joint. In the experimental study, there will be three different groups of participants.
      Selected sweep rowers will make the first study group. The second group will consist of scull
      rowers, and the last control group will consist of people with no experience with rowing. The
      selected participants will undergo the first measurement at the turn of the spring and summer
      seasons when intensive preparation for rowing competitions begins, in which sweep rowers
      train mainly on water and asymmetrically. The measurement results in the three groups will be
      further compared with each other to evaluate whether statistically significant differences
      can be found.
    

Detailed description: 
      Methods: 21 sweep rowers, 20 scull rowers and 23 non-rowing peers were enrolled on the study
      of this diploma thesis. Each subject was assessed using DIERS formetic 4D and DIERS pedoscan
      devices. Additionally, participants in each group were assessed by FAIR test, Cluster of
      Laslett, trigger point palpation of the m. piriformis and Visual analogue scale were used to
      assess pain intensity in the lumbar region.
    

Intervention name(s): DIERS formetic 4D
Intervention type(s): Diagnostic Test
Intervention description(s): Assessment of mentioned tests and their comparison.
Other intervention name(s): trigger point palpation of the m. piriformis; DIERS pedoscan device; Visual analogue scale; FAIR test; Cluster of Laslett test
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Rowers training in the junior and senior category of competitive rowing together with
        probands from the general population and students of UK FTVS who have never rowed.
      
Keywords: sweep rowing; pedobarography; moiré topography; asymmetrical loading
Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations
Condition: Pain; Procedural Pain
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      The study explores the potential benefits of a sugar water solution for decreasing pain in
      infants during routine immunizations.
    

Detailed description: 
      Acute pain during early life may alter infant pain responses, cognitive development, and
      behavioral outcomes. Immunization injections represent a relatively brief exposure to acute
      pain, yet assessment studies demonstrate that infants respond with significant distress
      during the injections. This study will examine the analgesic potential of oral sucrose in
      diminishing the pain associated with immunization injections in 6 week to 4-month-old
      infants. The proposed mechanism of action is via the activation of endogenous opioids that
      attenuate nociceptive information at the level of the dorsal horn.

      Comparison: Administration of oral sucrose 2 minutes prior to immunizations compared to
      administration of sterile water 2 minutes prior to immunizations
    

Intervention name(s): Sucrose
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pain; Procedural Pain; Sucrose; Infant; Newborn
Study Evaluating The Tolerability Of Multiple Doses Of HKI-272
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the occurence of diarrhea after either once daily or twice daily dosing
      for 14 days.
    


Intervention name(s): neratinib
Intervention type(s): Drug
Intervention description(s): HKI-272
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Evaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
Condition: Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Interventional

Summary: 
      Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1
      presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM
      (CAD/NAM). The aim of the study is to compare between short term clinical effects of both
      interventions as regards alveolar alignment, nasal esthetics and interlabial gap.
    


Intervention name(s): Naso-alveolar molding (NAM); Computer aided design NAM (CAD/NAM)
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes
Condition: Diabetes Mellitus; Overweight; Obesity
MeSH terms: Diabetes Mellitus; Overweight; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      Canadian statistics indicate that the incidence of obesity is increasing and that the
      occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy
      weight, making weight control in this population particularly relevant. Preliminary clinical
      data has shown that the whole grain, Salba, may improve type 2 diabetes control, reduce
      after-meal blood glucose, cardiovascular disease (CVD) risk factors and suppress appetite.
      Its use may therefore have potential implications in long-term weight management, while
      improving diabetes.

      The objective of this research (weight loss) is to evaluate whether adding Salba to an energy
      reduced diet for six months will result in greater weight loss compared to control in
      overweight and obese individuals with type 2 diabetes. The study recruited 77 overweight or
      obese individuals with type 2 diabetes. They were instructed to follow a calorie restricted
      diet and their regular diabetes therapy together with regular exercise. Participants were
      randomly assigned to receive 30 g Salba/1000 kcal of daily energy requirements, or an oat
      bran control supplement matched for energy. The effect of the supplements on weight-loss
      (including waist circumference, % body fat) and glucose control (A1c, fasting glucose levels)
      will be assessed. In addition, related outcomes such as low-grade body inflammation,
      hunger-regulating hormones (ghrelin, adiponectin), safety measures (urea, creatinine, ALT and
      prothrombin time) and satiety scores were evaluated.

      Modest weight loss has been associated with improved glucose control in individuals with type
      2 diabetes. Addition of Salba to an energy reduced diet may facilitate greater weight loss
      and improve glycemic control and CVD risk factors compared to such a diet alone. Salba may
      also promote maintenance of weight loss and therefore help prevent weight gain by providing
      feelings of fullness that reduce appetite. In light of the high incidence of obesity in
      individuals with diabetes, Salba grain may be a useful addition to the diet.
    


Intervention name(s): Salba (Salvia hispanica L.); Oat-based Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 30g/1000kcal/day over 24 wks; Placebo: 36g/1000kcal/day over 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Contractile Properties of Hypertrofic Muscles in Patients With Non-Dystrophic Myotonia
Condition: Non-Dystrophic Myotonia; Myotonia Congenita
MeSH terms: Myotonia Congenita; Myotonia
Study type: Observational

Summary: 
      In myotonia congenita (MC), mutations in the CLCN1 gene coding a key chloride channel
      expressed in muscle cells cause myotonia. On examination, the myotonia can be demonstrated as
      delayed muscle relaxation of muscle contractions after mechanical stimulations. Existing
      literature describe no muscle weakness in MC patients, however a recent muscle MRI study in
      non-dystrophic myotonia patients found structural abnormalities in affected muscles when
      examined using T1 and STIR imaging. The question remains whether the signs of structural
      changes in the muscle are merely due to the myotonia, or long-term effects of elevated stress
      of the tissue, and if so, whether those changes lead to clinically significant loss of
      contractile properties of the muscle.

      This study examines if the contractile properties of myotonic muscles are impaired in MC
      patients. 40 patients with Thomsens disease (n=20) and Beckers disease (n=20), respectively,
      will be included along with 20 healthy controls. Peak muscle torque is measured in the hand
      by hand dynamometer and in the thigh and calf muscles with a Biodex System 4 Pro Dynamometer
      and the cross-sectional area of the muscles are examined on T1-weighed and Dixon-MRI-scan.
      With the obtained data peak torque in strength tests, muscle hypertrophy, fat fraction in
      muscle tissue and contractility of the muscles, compared with healthy controls, will be
      assessed.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        40 patients (Thomsens MC, n=20; Beckers MC, n=20) will be included along with 20 healthy
        age- and gender-matched controls. Inclusion criteria are age >18 years, verified MC
        diagnosis. Exclusion criteria areknown competing disorders that can interfere with the
        results (ie. muscular diseases or arthritis) or MRI contraindications.

        Before participation patients are asked about medication status. Participants who are
        treated for their myotonic symptoms with either Mexiletin or Lamotrigin are asked to pause
        their medication four days prior to participation.

        All patients will be asked to evaluate the severity of their myotonic symptoms using the
        MBS (Myotonic Behaviour Scale) rating from 1 (least severe) to 6 (most severe).
Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research
Condition: Gastrointestinal Endoscopy
Study type: Interventional

Summary: 
      The purpose of this study is mainly about the feasibility and rationality of moderate
      sedation combined with acupuncture anesthesia in the application of gastroscopy and
      colonoscopy ,Then we evaluate the effectiveness and advantages of the combination of
      acupuncture anesthesia and drug anesthesia.
    

Detailed description: 
      With the increase of the proportion of the patients who crave for performing painless
      gastroscopy and colonoscopy in recent years, it is crucial to seek a more secure and
      effective method of anesthesia or sedation. At present, the universal anesthetic method on
      gastroscopy and colonoscopy in China is the general anesthesia without intubation which
      usually uses propofol and opioid analgesics,Although the satisfaction of patients is high,
      the incidence of anesthesia-related complications and drug-related adverse reactions is high
      .The incidence of adverse events during the gastroscopy and colonoscopy is high, and the
      medical expense of anesthesia is high. At present, more than 2/3 of the patients undergo
      painless gastroscopy or colonoscopy are middle-aged and elderly patients, so the overdose
      which prolongs the recovery time、discharge time of patients and reduces the recovery quality
      of patients is common. The moderate sedation, which fundmentally does not affect
      hemodynamics、autonomous respiration and protective reflexes, is incomparable to general
      anesthesia . And acupuncture anesthesia also acts as a safe anesthetic method can provide
      safer analgesic effect.Theoretically，the combination of both of them is a relatively perfect
      and safe painless method.
    

Intervention name(s): fentanyl; eletroacupuncture(transcutaneous electrical acupuncture point stimulation ); placebo needle; remimazolam
Intervention type(s): Drug; Procedure; Drug; Drug
Intervention description(s): The investigator 1 use fentanyl to sedate patients coordinate with remimazolam; The investigator 1 use electroacupunture(transcutaneous electrical acupuncture point stimulation )to coordinate with remimazolam; The investigator 1 use placebo needle to sedate patients coordinate with remimazolam; The investigator 1 use remimazolam to sedate patients coordinate with eletroacupuncture(transcutaneous electrical acupuncture point stimulation )or placebo needle
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: eletroacupuncture; moderate sedation; remimazolam; transcutaneous electrical acupuncture point stimulation
A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After a Peeling in the External Genital Area of Women
Condition: Skin Recovery
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, researchers want to learn more about the effect of dexpanthenol dermal spray
      on skin recovery after a dermatological procedure (peeling) in the intimate area of women.

      After the peeling, participants will return within 3 weeks for 4 visits to the study center
      to investigate the skin conditions such redness, irritation, softness and possible side
      effects. In addition, study participants will be asked about their general acceptance of
      dexpanthenol dermal spray.
    

Detailed description: 
      The primary objective is to evaluate the efficacy of the test product to aid skin recovery
      after peeling in the female intima and inguinal region.

      Secondary objectives comprise clinical efficacy with respect to skin hydration, softness,
      vitality, appearance etc. and skin recovery, consumer judgement of product performance and
      acceptability, and safety.
    

Intervention name(s): BAY207543 (Bepanthol, Bepantol® Derma Spray); Semisolid vaseline
Intervention type(s): Drug; Other
Intervention description(s): Product is applied to one side of the inguinal region.; Product is applied to the other side of the inguinal region.
Intervention MeSH terms: Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dermal spray; Peeling; Skin hydration; Consumer satisfaction; Sensorial perception
Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy
Condition: Nerve Block, Intercostal Nerve
Study type: Interventional

Summary: 
      Percutaneous nephrolitotomy (PCNL)is an endourological procedure for the management of
      patients with renal calculi. Postoperative pain around the surgical area and the nephrostomy
      tube can being a problem. We hypothesized that intercostal nerve block at 11th and 12th rib
      level would alleviate postoperative pain and reduce analgesic consumption.
    

Detailed description: 
      Patients admitted for the removal of renal stones by PCNL will included in this study.Primary
      outcome measure will be analgesic (tramadol )consumption and visual analog scale (VAS).
    

Intervention name(s): İntercostal nerve block
Intervention type(s): Other
Intervention description(s): Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: percutanous nephrolitotomy,intercostal nerve block, Ultrasound