bioihbjkbjnl/mcl2 huggingface dataset:
Time Restricted Feeding on Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that
      involves eating a daily period of 8 hours or less. This is a randomized controlled trial to
      evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and
      cardiometabolic risk factors in obese adults over 6 months compared to continuous energy
      restriction (CER).
    


Intervention name(s): Time restricted feeding; Continuous Energy Restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).; Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on feeding time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nonalcoholic Fatty Liver Disease; Obesity; Time restricted feeding; Calorie restriction
Orthoptic Changes Following Photorefractive Keratectomy
Condition: Orthoptic Changes
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose: To detect orthoptic changes in patients undergoing photorefractive keratectomy
      (PRK). Method: This interventional case series was performed on 297 eyes of 150 patients who
      were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations
      were performed before and 3 months after PRK. Results: Before PRK, two (1.3%) patients had
      esotropia that remained unchanged postoperatively. However, 3 (2%) patients had distance
      exotropia preoperatively which improved after PRK. Of 12 cases (8%) with preoperative
      exotropia at near, 3 (2%) cases became orthophoric. Six patients (4%) developed postoperative
      near exotropia. A significant reduction in means of convergence and divergence amplitudes
      (P<0.001) and a meaningful increase in mean of near point of convergence (NPC) (P<0.006) were
      noticed after PRK. A reduction of ≥10 PD in convergence amplitude and ≥5 PD in divergence
      amplitude were detected in 10 and 5 patients, respectively. Four patients had an preoperative
      NPC>10 cm which was not changed by the surgery. Out of 9 (6%) patients with baseline
      stereopsis >60 seconds of arc, 2 (1.33%) cases showed an improvement in stereopsis following
      PRK. None of the patients complained of postoperative diplopia. Conclusion: Eye deviation in
      patients undergoing PRK may improve or remain unchanged after operation and postoperative
      deviations can develop following this surgery. Diminishing of fusional amplitude and
      increasing of NPC as well as improving of stereopsis may also happen after PRK. Therefore, a
      preoperative orthoptic examination in patients with any concerning histories and/or motility
      issues on routine exam is recommended before performing PRK.
    


Intervention name(s): Kerato refractive Surgery
Intervention type(s): Procedure
Intervention description(s): This interventional case series was performed on 297 eyes of 150 patients who were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations were performed before and 3 months after PRK.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Primary purpose: Supportive Care
Effect of Novel High-intensity Interval Training on Health and Fitness Outcomes in English Adolescents
Condition: High-intensity Interval Training
Study type: Interventional

Summary: 
      Low-volume high-intensity interval exercise training may improve aspects of health and
      fitness in young people, but interventions must be practical and engaging. The investigators
      examined the effect of a novel school-based low-volume high-intensity interval training
      programme on health, fitness and physical activity outcomes in adolescent school pupils. 101
      English adolescents aged 13-14 years took part in the study. Participants were healthy male
      and female volunteers, recruited from four schools in Northeast England. Using a
      non-randomised design, two schools took part in the intervention, and two were assigned to
      the control. Those in the intervention group completed a 10-week school-based high-intensity
      interval exercise training programme. The intervention took place three times per week, and
      comprised of 4-7 repetitions of 45 s maximal effort exercise (boxing, dance, soccer and
      basketball drills), each interspersed with 90-s rest. Participants were encouraged to work
      maximally during the 45-s repetitions. Control participants were instructed not to change
      their lifestyle, dietary or physical activity habits during the intervention period, and
      maintain their normal school physical education routine. Study outcomes were blood lipid and
      glucose levels, body composition, cardiorespiratory fitness, carotid intima-media thickness,
      physical activity levels, serum C-reactive protein levels and blood pressure.
    


Intervention name(s): Novel high-intensity interval exercise training
Intervention type(s): Other
Intervention description(s): Please see information already included in the 'intervention' arm description.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: high-intensity interval training; adolescents; school-based exercise; cardiometabolic health
Use of Hydroxyurea and Magnesium Pidolate for Treatment of Sickle Cell Disease
Condition: Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the MTD of Mg pidolate in combination with HU in
      patients with sickle cell disease who have been on a therapeutic dose (15-30 mg/kg/day) of HU
      for at least 6 months.
    

Detailed description: 
      This is a Phase I clinical trial evaluating the combination of hydroxyurea and magnesium
      pidolate for patients with sickle cell disease with either hemoglobin SS disease or
      hemoglobin S beta thalassemia. Hydroxyurea and magnesium pidolate will be tested in pediatric
      and adolescent patients with sickle cell disease who already have been treated with
      hydroxyurea for a minimum of six months. Magnesium pidolate will be given in combination with
      hydroxyurea for six months. In successive small groups of patients, the dose of magnesium
      will be increased in order to eventually determine the maximum tolerated dose (MTD) and dose
      limiting toxicity (DLT) for magnesium when given in combination with hydroxyurea. The maximum
      tolerated dose is the highest drug dose that can be given safely to participants. The dose
      limiting toxicity is determined when drug side effects prevent an increase in dose.
    

Intervention name(s): Magnesium Pidolate, Hydroxyurea
Intervention type(s): Drug
Intervention description(s): Intervention Description: Mg pidolate in combination with HU in patients with sickle cell disease who have been on a therapeutic dose (15-30 mg/kg/day) of HU for at least 6 months. Mg pidolate will be given at an initial dose of 0.6 mEq/kg/day divided into 2 daily doses for the first cohort of patients. This dose will be escalated for the subsequent patient cohorts as defined by a classic Phase I design (according to toxicity).
Intervention MeSH terms: Hydroxyurea
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematologic Diseases; Anemia, Sickle Cell
Validation of the French Version of Ask Suicide-Screening Questions (ASQ) in Adolescents Managed in Pediatric Emergency Unit
Condition: Suicidal Ideation
MeSH terms: Suicide; Suicidal Ideation
Study type: Interventional

Summary: 
      The ASQ-Fr study aims at validating the French version of Ask Suicide-Screening Questions
      composed of 5 items in adolescents managed in pediatric emergency department. Therefore, use
      of this brief valid screening instrument could assess the risk for suicide in pediatric
      patients and then improve the prevention of suicidal tendencies in this population.
    

Detailed description: 
      ASQ-Fr is a prospective, cross-sectional instrument-validation study evaluated 5 candidate
      screening questions assessing suicide risk in adolescents between 10 and 18 years of age
      managed in two urban, pediatric emergency departments associated with tertiary care
      hospitals.

      ASQ-Fr questionnaire is conducted by a psychologist before or after the French version of the
      SIQ/SIQ Junior (Suicidal Ideation Questionnaire), depending on the randomisation in the unit.
      SIQ is composed of 30 items and valid for adolescents aged 15 years or more. SIQ Junior is
      composed of 15 items and valid for children up to 14 years old.

      Questionnaires are followed by an interview in adolescents and parents separately by the
      psychologist to evaluate perceptions, feasibility and acceptability of questionnaires.

      It is planned a convenience sample of 200 patients aged 10 to 18 years who presented with
      either medical or surgical chief concerns to the emergency department.
    

Intervention name(s): Suicide screening
Intervention type(s): Behavioral
Intervention description(s): Patients of the emergency unit usually do not pass this kind of questionnaire in the absence of warning signs. Then it could result in adverse effects on behavior and ideation.
The study had to be declared as an interventional study according to French law.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Psychiatry; Pediatrics; Suicide
Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics
Condition: Second Generation Antipsychotic Induced Metabolic Adverse Effects
Study type: Interventional
Phase: Phase 4

Summary: 
      Schizophrenia and bipolar disorder are frequently associated with an elevated risk for
      obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic
      disturbances. Second Generation Antipsychotics (SGA) have a demonstrated efficacy in acute
      and long term treatment of these disorders and are considered a first option on most
      treatment guidelines. Unfortunately the use of SGA is associated to drug induced weight gain,
      disturbed glucose and lipid regulation and an increase of cardiovascular risk and mortality
      as well as non- adherence to treatment. There are several hypotheses attempting to explain
      the complex pathways that lead to antipsychotic therapeutic effects and their accompanying
      adverse effects. Recently, in animals receiving SGA, melatonin prevented to a large extent
      the body weight increase, which indicates a possible role for biological rhythms in SGA
      induced body weight accumulation. Melatonin is a hormone secreted by the pineal gland that
      follows a circadian rhythm with an increased secretion in the middle of the night. This
      hormone acts importantly on the suprachiasmatic nucleus and other areas in the brain and
      periphery. Thus melatonin is involved in a series of biological functions such as sleep
      regulation, blood pressure, regulation of circadian rhythms, mood, behavior, and more
      recently in the regulation of metabolic processes including insulin, leptin, and lipid
      regulation.

      Given previous results in experimental animals, the purpose of the present study is to test
      the potential effect of melatonin in reducing or preventing some of the metabolic
      disturbances associated with SGA
    


Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A capsule of melatonin was administered nightly (20:00hrs).; Placebo capsules were administered at 20:00hrs for eight weeks
Other intervention name(s): Melatonin 5mg capsules were administered at 20:00hrs during the follow up period.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Melatonin; Second generation antipsychotic; bipolar disorder; schizophrenia; Metabolic
Ketamine Compared to Propofol for Pediatric GI Endoscopy
Condition: Endoscopy
Study type: Observational

Summary: 
      Elective outpatient endoscopy for children can be safely performed under general anesthesia
      with either propofol (1) or ketamine (2) infusions. Both infusions have an advantage over
      general anesthesia with volatile agents because they do not require intubation. The goal of
      both infusions is to have the patient breath spontaneously without reacting to the endoscopy
      which is a noxious stimulus. Patient movement, stridor and vomiting are can interrupt the
      procedure and increase overall OR time. Propofol also carries the added risk of causing
      apnea. This side effect is not commonly seen with Ketamine. Our hypothesis is that Ketamine's
      profile makes it a superior drug to Propofol for elective outpatient endoscopy because of
      reduced profound intra-operative interruptions and faster recovery time. We plan a study of
      pediatric patients ages 1 to 10 years old undergoing elective outpatient endoscopy. The
      patients will be randomized to receiving either a Ketamine or Propofol infusion, and the
      intra-operative interruptions will be documented by the anesthesiologist. The Post Anesthetic
      Care Unit (PACU) time to recovery will be monitored and recorded by a third party.
    


Intervention name(s): Ketamine; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Weight based dosage for Peds subjects, used for duration of the endoscopy.; Weight based dosage for Peds subjects, used for duration of the endoscopy.
Intervention MeSH terms: Ketamine; Propofol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pre-op setting, previously scheduled for GI Endoscopy
      
Keywords: Child age 1-10 years having a GI Endoscopy with sedation
Evaluation of the Efficacy of the AIM (Adult Identity Mentoring) 4 Teen Moms Program
Condition: Pregnancy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of the AIM 4 Teen Moms program in
      increasing the use of long-term contraceptives, in improving adherence to contraceptives and
      in preventing rapid repeat pregnancies among parenting adolescents.
    

Detailed description: 
      This study uses a randomized controlled design to evaluate the efficacy of AIM (Adult
      Identity Mentoring) 4 Teen Moms in reducing the incidence of rapid repeat pregnancies and
      associated sexual risk behavior. The AIM 4 Teen Moms program is a combination of individual
      and small group sessions intervention that encourages parenting young women ages 15-19 years
      old to delay rapid repeat pregnancies for 24 months or later. It consists of seven individual
      1-hour long sessions (generally conducted in the participant's home) and two 90-minute group
      sessions delivered over a 12 week period. Study participants will be adolescent mothers
      receiving services from California's Adolescent Family Life or Cal-Learn programs in the Los
      Angeles County area. There will be no intervention delivered to members of the control group.
      This study is being conducted as part of the national Evaluation of Adolescent Pregnancy
      Prevention Approaches funded by the U.S. Department of Health and Human Services' Office of
      Adolescent Health.
    

Intervention name(s): AIM 4 Teen Moms
Intervention type(s): Behavioral
Intervention description(s): The AIM (Adult Identity Mentoring) 4 Teen Moms program is a combination of individual and small group sessions intervention that encourages parenting young women ages 15-19 years old to delay rapid repeat pregnancies for 24 months or later.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: adolescent pregnancy; adolescent birth; rapid repeat pregnancy; rapid repeat birth; youth development; Pregnancy in Adolescence
Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is randomized, placebo-controlled, double blind, double dummy, multi-centre trial.

        -  Screening period (4 week)

        -  Double blind treatment period (16 weeks)
    

Detailed description: 
      1. Usage: 16 week, BID, Prescribed Oral with the breakfast and dinner

        2. Dosage:Placebo group: placebo 2 tablets, 16 weeks Probucol 250mg group: probucol 125mg 2
           tablets, 16 weeks Probucol 500mg group: probucol 250 mg 2 tablets, 16 weeks
    

Intervention name(s): Probucol 250mg/day; Probucol 500mg/day; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Probucol 250mg + Placebo; Probucol 500mg + Placebo; Probucol matching placebo
Other intervention name(s): Probucol 250mg group: probucol 250mg 2 tablets, 16 weeks; Probucol 500mg group: probucol 250mg 2 tablets, 16 weeks; placebo 2 tablets, 16 weeks
Intervention MeSH terms: Probucol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic nephropathy; Albumin creatinine ratio; Probucol
Study to Evaluate Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers
Condition: Achlorhydria
MeSH terms: Achlorhydria
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to evaluate the effects of food or proton pump inhibitor on the
      pharmacokinetics of itraconazole in healthy volunteers.
    

Detailed description: 
      Evaluation criteria

        -  Pharmacokinetic assessment with plasma concentrations of itraconazole and
           hydroxy-itraconazole

        -  Safety assessments with adverse event monitoring including subjective/objective
           symptoms, physical examination, vital signs, and laboratory tests
    

Intervention name(s): Itraconazole 200 mg; Esomeprazole 40 mg
Intervention type(s): Drug; Drug
Intervention description(s): Itraconazole 100 mg capsule x 2; Esomeprazole 40 mg tablet x 1
Other intervention name(s): Sporanox capsule; Nexium
Intervention MeSH terms: Itraconazole; Esomeprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of CT 3D on the Learning Curve of Laparoscopic Colorectal Resection
Condition: Learning Curve of Laparoscopic Colorectal Resections
Study type: Observational

Summary: 
      Laparoscopic colorectal surgery has been widely accepted worldwide; however, despite the
      well-known benefits and comparable oncological outcomes, it is still limited by a lack of
      tactile sensation and a reduced operative field view. In addition, the inconsistency in the
      number and course of the mesenteric vessels significantly influences the learning curve with
      30 to 70 cases required for proficiency. To overcome these limitations, the vascular anatomy
      can be mapped using CT-angiography, and the images can be processed with rendering software
      to reconstruct a three-dimensional model of the mesenteric vessels. The aim of this study was
      to assess the influence of visualizing the three-dimensional vascular anatomy on the learning
      curve for laparoscopic colorectal surgery.All patients who underwent laparoscopic left or
      right hemicolectomies between January 2012 and January 2014 were evaluated for inclusion in
      this study. To assess the influence of preliminary knowledge of colonic vascular anatomy on
      the learning curve, we considered 2 groups of two surgeons with different levels of
      experience. In the first group (group A), the surgeons were able to view 3D reconstructions
      before and during the surgery, while the surgeons in Group B were only able to view the 3D
      reconstructions after surgery.
    


Intervention name(s): multi-slice Computed Tomography angiography and three-dimensional reconstruction software
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We included only patients in which standard laparoscopic right or left hemicolectomy was
        planned and who needed a CT scan but had not received a scan prior to their first office
        visit.
Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, longitudinal observational study evaluating the imaging
      characteristics of the tau positron-emission tomography (PET) radioligand [18F] Genentech Tau
      Probe 1 (GTP1) in the brain of participants with prodromal, mild, and moderate Alzheimer's
      disease (AD) compared to healthy participants. The overall goal of this protocol is to
      evaluate the longitudinal change in tau burden using [18F]GTP1, a tau targeted
      radiopharmaceutical.
    


Intervention name(s): [18F]GTP1
Intervention type(s): Drug
Intervention description(s): Participants will receive [18F]GTP1 as per the schedule specified in the arm description.
Other intervention name(s): [18F]G02941054; [18F]MNI-798; [18F]RO6880276
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Intraperitoneal Instillation of Levobupivacaine With Morphine Versus Levobupivacaine With Magnesium Sulfate for Postoperative Analgesia
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective randomized study that included 60 patients and was divided into two
      equal groups of patients who were scheduled for LC, Ages 18 and 60 years, both sexes, ASA
      I-II and BMI 19 - 39. Group A received 30 ml levobupivacaine (0.25%) plus 3 mg morphine
      intraperitoneal at the site of surgery in the bed of the gallbladder via the navel port with
      the patient in a Trendelenburg position, Group B received 30 ml levobupivacaine (0.25%) plus
      50 mg/kg magnesium sulfate in the same pattern as in the A group.
    


Intervention name(s): intraperitoneal levobupivacaine and morphine
Intervention type(s): Drug
Intervention description(s): istillation of the peritoneum with levobupivacaine mixture with morphine
Intervention MeSH terms: Morphine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention