bioihbjkbjnl/mcl2 huggingface dataset:
Isometric Handgrip Exercise -MRI in Children and Adolescents
Condition: Type 1 Diabetes Mellitus; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This project aims to assess coronary vessel response to isometric handgrip exercise (IHE)
      during magnetic resonance imaging (MRI) in children with T1D children and healthy controls.
      The investigators will compare the groups in terms of surrogate markers of intima media
      alteration and arterial stiffness, i.e. carotid intima media thickness (CIMT) and aortic
      pulse wave velocity (PWV).
    

Detailed description: 
      Background Type 1 diabetes mellitus (T1D) in children and adolescents is associated with
      significant cardiovascular morbidity and mortality. Early detection of vascular dysfunction
      is key to management yet assessment is invasive - which is particularly challenging when
      considering pediatric patient populations. Recently, a novel approach using isometric
      handgrip exercise (IHE) during magnetic resonance imaging (MRI) has been developed to
      evaluate coronary endothelial function in adults.

      This project aims to assess coronary vessel response to IHE using MRI in children with T1D
      children and healthy controls. In addition, the investigators will compare the groups in
      terms of surrogate markers of intima media alteration and arterial stiffness, i.e. carotid
      intima media thickness (CIMT) and aortic pulse wave velocity (PWV).

      Community-dwelling healthy volunteers (<18 years-old) and children with type 1 diabetes
      mellitus (disease duration ≥ 5 years) are recruited. IHE-MRI studies are conducted and
      measurements are recorded at rest (baseline) and under stress (IHE at 30% maximal effort).
      Carotic Ultrasound and Sphygmocor CPV System are used to assess CIMT and PWV respectively.
      Student's T-tests are used to compare results between groups.
    

Intervention name(s): Isometric Handgrip Exercise during magnetic resonance imaging
Intervention type(s): Diagnostic Test
Intervention description(s): Coronary endothelial function are assessed by MRI with imaging studies done at baseline (at rest) and during IHE (under stress). Maximum grip strength is determined using an MRI-compatible dynamometer (Grip Force Fiber Optic Response Pad, Current Designs Inc., Philadelphia, USA) prior to baseline imaging.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Type 1 Diabetes Mellitus; MRI; Isometric handgrip exercise; Children; Adolescents
Effects of Coffee on Hepatic Steatosis Induced by a High Fructose Diet
Condition: Hepatic Steatosis
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      This study will assess

        -  whether coffee consumption protects against fructose-induced hepatic steatosis in
           healthy humans

        -  whether the protective effect of coffee is dependent on it's antioxidant composition
    

Detailed description: 
      Epidemiological studies suggest that coffee consumption improves glucose homeostasis in
      insulin resistant subjects. An increase in intrahepatic lipids (hepatic steatosis) is highly
      prevalent in patients with the metabolic syndrome and may be used as a marker of altered
      hepatic lipid metabolism. Such an increased hepatic lipids content can be experimentally
      produced in healthy humans by a 6-day high fructose diet.

      The purpose of this study is to evaluate whether coffee prevents hepatic lipid deposition in
      healthy male subjects fed a fructose-rich hypercaloric diet. Both caffeine and antioxidants
      (yet unspecified) may be involved.. To sort out the role of caffeine and antioxidants, we
      will test 3 different soluble coffee, ie fully torrefied decaffeinated coffee , partially
      torrefied decaffeinated coffee, and partially torrefied caffeinated coffee.
    

Intervention name(s): Ctl; High fructose diet; no coffee; fully torrefied, caffeine-free coffee; partially torrefied, caffeine-free coffee; Partially torrefied, caffeinated coffee
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Control, isocaloric diet; no coffee; Hypercaloric, high fructose diet; no coffee; Hypercaloric, high fructose diet + coffee; Hypercaloric, high fructose diet + coffee; Hypercaloric, high fructose diet + coffee
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hepatic steatosis; coffee; fructose; lipids
The Effect of the E-Mobile Health Application on Postpartum Adaptation
Condition: Postpartum Period; Pregnant Women; Adaptation; Mobile Applications
Study type: Interventional

Summary: 
      The purpose of this research is to determine the effect of the e-mobile health application on
      postpartum adaptation. The study will consist of two groups: Experimental group and control
      group.
    

Detailed description: 
      This is a randomized controlled trial. A questionnaire and The Postpartum Self-Evaluation
      Questionnaire will be used to collect data. The main hypothesis of the research: Postpartum
      Self-Evaluation Questionnaire total mean score of women who use e-mobile health application
      created according to Roy's Adaptation Model is not different from the total mean score of
      women in the control group.

      Research sample will consist of a total of 62 pregnant women, 31 in the experimental group
      and 31 in the control group. The data will be evaluated with the SPSS (Statistical Package of
      SocialSciences) 24.0 package program.
    

Intervention name(s): E-Mobile Health Application
Intervention type(s): Behavioral
Intervention description(s): The e-mobile health application prepared by the researcher will be used. E-mobile health application include information about postpartum care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consists of two groups: Experimental group and control group.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Mobile Applications; Postpartum Period; Adaptation; Randomized Controlled Trial
Novel Head Protection Prototype Device for Decompression Craniectomy
Condition: Brain Injuries; Stroke
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      A proof-of-concept (POC) proposal to study the feasibility of customized head protection
      prototype device (HPPD) using 3D printed externally-applied moulded skin prosthesis
      integrated to the craniectomy bony skull defect.
    

Detailed description: 
      A proof-of-concept (POC) proposal to study the feasibility of customized head protection
      prototype device (HPPD) using 3D printed externally-applied moulded skin prosthesis
      integrated to the craniectomy bony skull defect. The proposed material is a bio-compatible,
      light-weight rigid /semi rigid material which can be fitted to the skull defect and
      interfaced with the subject's bony rim using soft, deformable material (e.g. silicon) and
      attached using an elastic head band or other acceptable means. The prosthesis is removable
      for skin and prosthesis cleansing and ventilation.

      Study Specific Objectives:

      (i) Primary Objectives

      These are to:

        1. test the feasibility and safety of customised 3D printed HPPD,

        2. integrate the prostheses to the skull defect in removable manner and discharge patient
           with appropriate education,

        3. to systematically monitor subjects for symptoms, compliance, complications and
           subjective feedback during the outpatient phase where progressive wear of HPPD and
           monitoring of acceptability will be monitored.
    

Intervention name(s): Head protection prototype device
Intervention type(s): Device
Intervention description(s): The proposed experimental HPPD uses biocompatible material using FDMÔNylon which has high fatigue resistance, chemical resistance with impact resistance and toughness which is free of powders. It is HSA unclassified as yet and the FDMONylon is not FDA approved yet.
Intervention model: Single Group Assignment
Intervention model description: Customised head protection prototype device.
Masking: None (Open Label)
Primary purpose: Other
Hip-spine Intervention for Older Adults With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain (LBP) is extremely common in older adults and is associated with a host of
      negative consequences, including decreased physical function and increased healthcare
      utilization. Among older adults with LBP, hip impairments indicative of hip joint disease are
      more prevalent and associated with greater disability than among older adults without LBP.
      This study will investigate a novel intervention designed to improve LBP-related disability
      by combining a typical spine-focused exercise program with a hip-focused intervention.
    


Intervention name(s): SFEX+H; SFEX
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist), hip-focused strengthening exercises and a trunk muscle training program including exercises for the abdominal and low back muscles. The intervention will be delivered twice weekly for 8 weeks.; Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist) and a trunk muscle training program including exercises for the abdominal and low back muscles. The intervention will be delivered twice weekly for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The impact of a bilberry-based probiotic drink on the postprandial levels of serum glucose
      and insulin have already been study in the past. The aim of the current study is to evaluate
      the long term effect of the probiotic bilberry drink on glucose tolerance and insulin
      resistance in healthy adults and in comparison to a control drink.
    


Intervention name(s): Bilberry; beverage without bilberries or probiotics
Intervention type(s): Other; Other
Intervention description(s): A bilberry based probiotic beverage; A control beverage without bilberries or probiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of trospium chloride
      (Sanctura XR™) and metformin hydrochloride (Glucophage) when co-administered.
    


Intervention name(s): Trospium Chloride (Sanctura XR®); Metformin hydrochloride (Glucophage®)
Intervention type(s): Drug; Drug
Intervention description(s): extended release, 60 mg, oral daily; immediate release, 500mg
Other intervention name(s): Sanctura XR® 60 mg; Glucophage®
Intervention MeSH terms: Metformin; Trospium chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Adults
A Study to Test the Safety/Tolerability of Increasing Doses of LNP1892 Versus Placebo in Healthy Male/Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of single and multiple ascending oral dose LNP1892 in healthy males and
      female subjects
    

Detailed description: 
      This is first in human, Phase 1 study. Primary purpose is to assess safety, tolerability,
      pharmacodynamic and pharmacokinetic of the LNP1892. Study will be conducted in healthy human
      subjects. Pharmacokinetic will be studied in the subjects after administration of single and
      multiple doses.
    

Intervention name(s): LNP1892; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets of two strengths (5 and 25 mg); Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 1, safety, tolerability, PK, PD
Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User
Condition: Substance Use Disorder; Drug Dependence,; Alcohol Dependence
MeSH terms: Substance-Related Disorders; Alcoholism
Study type: Interventional

Summary: 
      Substance Use Disorder has been showing a rising trend all over the world including India.
      The project tested whether a Integrated community wide effort of Prevention and Awareness
      Groups (PAG) to manage substance use would have a greater effect on treatment attendance and
      drug abstinence than a de-addiction program alone.
    


Intervention name(s): Prevention Awareness Groups (PAG); Standard Care
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prevention and Awareness Groups (PAG),; Substance Use Disorder,; Community based intervention
Effect of Intravenous Dexamethasone on Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery
Condition: Spinal Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The use of dexamethasone, administered either systemically or perineurally, as an adjunct to
      peripheral or neuraxial regional blocks, is currently one of the hottest topics in the field
      of regional anesthesia.
    

Detailed description: 
      A large number of clinical studies have investigated this off-label application of
      dexamethasone in recent years, with many reporting enhanced sensory block and/or improved
      postoperative analgesia following either intravenous (i.v.) or perineural dexamethasone.
      Dexamethasone is potent, selective glucocorticoid having minimal mineralocorticoid action.
      Systemic anti-inflammatory and immunosuppressive properties may be responsible for the
      prolongation of analgesia when administered intravenously. Various studies proved the
      efficacy of steroids for the prolongation of the effects of regional nerve blocks. We decided
      to conduct the present study to evaluate the effects of intravenous (IV) dexamethasone on the
      subarachnoid block.
    

Intervention name(s): Placebo; i.v dexmethasone
Intervention type(s): Drug; Drug
Intervention description(s): while patients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes, after spinal anesthesia; patients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline after spinal anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients will be scheduled for lower abdominal surgery under spinal anesthesia will randomly be allocated into two groups, group SD and group SN, After placement of standard monitors and peripheral IV access, with aseptic technique we will insert, a 25-G pencil-point Pencan(B. Braun, Mississauga, Ontario, Canada) needle intrathecally at the L4-5 or L3-4 interspace, with the patient in a seated position. We will confirm Intrathecal positioning by observation of cerebrospinal fluid return through the needle. Then we will inject the hyperbaric bupivacaine. All patients will receive spinal anesthesia with 12-mg hyperbaric bupivacaine 0.5%. Patients will be randomly assigned to one of the 2 Groups. Beginning during the intrathecal injection, patients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline (total, 502 mL), while patients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes,
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: i.v dexamethasone; hyperparic bupivacaine
A Study to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.
Condition: Pain
MeSH terms: Tooth, Impacted
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for
      postoperative analgesia after impacted teeth removal surgery.
    


Intervention name(s): HRS4800 tablets; Placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): Dosing frequency: single dose; Route of administration: oral; Dosing frequency: single dose; Route of administration: oral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A multicenter, randomized, double-blind, placebo-controlled, phase IIa clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adjuvant Colon Cancer w/ ELOXatin®/5 FU Based Regimen: ACCELOX
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX
    

Detailed description: 
      It's a study of adjuvant colon carcinoma using ELOXatin/5-FU based chemotherapeutic regimen
      called ACCELOX as a definitive curative therapy.
    

Intervention name(s): Registry
Intervention type(s): Other
Intervention description(s): Registry
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Colon Cancer Registry
      
Keywords: Adjuvant Colon Cancer
Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of NGM282, both single
      dose and multiple doses, in normal healthy adult participants.
    


Intervention name(s): NGM282; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Ergonomic Classroom Furniture on the Printing Legibility of Elementary Students With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this pilot study is to gather the data needed to do a larger research study to
      determine whether children with cerebral palsy print better sitting at an
      ergonomically-designed, custom-fitted school desk or at an oversized, standard school desk.
    

Detailed description: 
      This pilot study will allow us to gather information for a high-quality randomized controlled
      trial to study the efficacy of ergonomic school furniture as a remedial handwriting
      intervention for young students with cerebral palsy. We will conduct the study in two parts.
      In the first part, 30 children with Gross Motor Function Classification System (GMFCS) Level
      I and II cerebral palsy will each provide manuscript handwriting samples using two different
      school furniture configurations. A blinded assessor will score the legibility of handwriting
      samples using the Minnesota Handwriting Assessment (MHA) as a primary outcome measure. In the
      second part, seven occupational therapy experts will attend a focus group to help us
      determine the minimal clinically important difference score for the MHA. We will use the data
      collected to determine the sample size requirements for a proposed randomized controlled
      trial.
    

Intervention name(s): ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk); ergonomic desk and chair (Q-Learn Desk)
Intervention type(s): Device; Device
Intervention description(s): ergonomic school chair and desk adjusted to fit the child user as per the manufacturer's instructions; child sits on chair and desk for 5 minutes, then provides handwriting sample at one desk, then repeats this for the other desk
Other intervention name(s): Q-Learn Classic Chair and Q-Learn Desk; Q-Learn Desk
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: handwriting; child; primary school; posture; assistive device
Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths
Condition: Unexplained Stillbirth
MeSH terms: Stillbirth
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound
    

Detailed description: 
      152 women with history of unexplained stillbirths were identified , umbilical arty Doppler
      ultrasound was conducted for them at 20-22 weeks gestation . they were divided into two group
      , group one are those with abnormal resistant index (= or more than 0.6) thy received
      Bemiparin 2500 IU subcutaneously daily up to 24 hours before delivery .

      Group 2 with normal umbilical artery resistant index received no any interventions just
      routine antenatal follow up .
    

Intervention name(s): Bemiparin; multivitamins and routine antenatal follow up
Intervention type(s): Drug; Other
Intervention description(s): second generation low molecular weight Heparin; multivitamins and routine antenatal follow up
Other intervention name(s): Hibor
Intervention MeSH terms: Bemiparin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: pregnant women with history of unexplained fetal death
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Unexplained stillbirth; Low molecular Weight Heparin; Umbilical artery; Doppler Ultrasound; Antenatal care
Safety of CERE-120 (AAV2-NTN) in Subjects With Idiopathic Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I dose escalating open-label study designed to assess the safety,
      tolerability and biologic activity of an in vivo AAV2 mediated delivery of the gene encoding
      NTN (CERE-120).

      Twelve (up to 18) subjects will receive one of two open-label doses of CERE-120 via bilateral
      stereotactic injections targeting the putaminal region of the brain. Subjects will be
      enrolled in one of two cohorts, a low-dose cohort of six subjects followed by a high dose
      cohort of six subjects.

      The design of this study is such that the primary objective, the evaluation of safety and
      tolerability, will be assessed by frequent observations for adverse events, clinical
      laboratory test results, imaging (MRI), neuropsychometric testing, and evaluations of disease
      status.
    


Intervention name(s): CERE-120: AAV2-NTN
Intervention type(s): Genetic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Gene Transfer