bioihbjkbjnl/mcl2 huggingface dataset:
A Novel Diet-Phenotype Interaction Affecting Body Weight
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Body Weight
Study type: Interventional

Summary: 
      The primary aim of the study is to examine insulin secretion as an effect modifier of the
      efficacy of a low-fat vs. low-glycemic load diet for weight loss among overweight/obese young
      adults in an 18-month, prospectively stratified, multi-center randomized controlled trial.
    

Detailed description: 
      In recent years, diets of widely varying composition have been used in the treatment of
      obesity. While none of these diets has produced consistent, long-term weight loss, some
      individuals on virtually all types of diets do remarkably well. One explanation for this
      variation among individuals is differences in motivation and behavior. However, underlying
      biological differences may also play an important role. Previous work has identified insulin
      secretion (as quantified by serum insulin concentration at 30 minutes following a standard
      75-gram oral glucose load) as an important biological determinant. This
      randomized-controlled, multi-center trial aims to test the hypothesis that insulin secretion
      will predict which type of diet will work best for each individual. A total of 160 obese
      young adults (18 to 40 years) will be assigned to one of two diets: low-fat (60%
      carbohydrate, 20% fat, 20% protein) or low-glycemic load (45% carbohydrate, 35% fat, 20%
      protein). Participants will be enrolled at two sites (Children's Hospital Boston or
      University of North Carolina-Chapel Hill) and assigned to diet groups according to baseline
      insulin secretion status. The protocol will include an intensive 6-month intervention period
      and a 12-month follow-up period. Registered dietitians will provide nutrition education and
      behavioral counseling during group workshops and scheduled telephone calls. In an effort to
      avoid confounding, close attention will be paid to control for treatment intensity, physical
      activity prescriptions, and behavioral methods between groups. The primary endpoint will be
      percent body fat by DXA scan. Secondary endpoints will include cardiovascular and diabetes
      risk factors. Repeated, 24-hour dietary and physical activity recall interviews will provide
      process data. Metabolomic profiling and molecular analysis of identified metabolites will be
      conducted to characterize phenotype and explore potential physiological mechanisms. A
      successful outcome of this work will inform the practice of "personalized" nutritional
      therapy, enhancing the ability to select the most efficacious weight loss diet for an
      individual based on underlying biological differences.
    

Intervention name(s): Dietary counselling
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine in Pediatric Subjects With Attention-deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will evaluate the pharmacokinetics, safety, and tolerability of centanafadine in
      pediatric subjects with ADHD.
    


Intervention name(s): Centanafadine
Intervention type(s): Drug
Intervention description(s): Extended release capsule
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Modification of Posttetanic Count (PTC) for Monitoring Deep Neuromuscular Block II
Condition: Neuromuscular Blockade
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the relationship between post-tetanic count (PTC) and
      time to first response to Train of four (TOF) stimulation during deep neuromuscular blockade
      induced by rocuronium.
    


Intervention name(s): Post-tetanic count frequency
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Acceleromyography; TOF-Watch; Posttetanic count; Train of four; Neuromuscular blockade
Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      There has been little research on the third area of impairment noted in the Diagnostic and
      Statistical Manual of Mental Disorders - "occupational functioning." Individuals with ADHD
      experience job-related impairments including a greater likelihood of being unemployed and not
      enrolled in school and for those that were employed they were in a lower status occupation,
      relative to typically-developing comparison peers. The current literature on analogue
      workplace settings and the effects of lisdexamfetamine dimesylate includes office-based tasks
      similar to school seat work. Unfortunately, this is inconsistent with the typical work
      environment most common for individuals with disabilities such as ADHD where food preparation
      is the most common job following high school. Therefore, medication effects in this type of
      setting, most common for individuals with ADHD entering the workforce, need to be studied.
      The investigators propose to study workplace behavior in an analogue work setting in a
      laboratory "pizza place." Individuals with ADHD will participate in an interview with a
      supervisor each day, have a list of deliveries that need to be managed, deal with situations
      that require occupational judgment and appropriate customer service, and drive to make
      deliveries accurately and on-time. These behaviors can be reliably assessed within the
      laboratory. Twenty young adults will participate in two "workdays" within a randomized,
      double-blind, placebo-controlled design wherein participants will be administered placebo and
      .3 mg/kg lisdexamfetamine dimesylate in a counter-balanced order.
    


Intervention name(s): Lisdexamfetamine Dimesylate 40 MG; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lisdexamfetamine Dimesylate 40 MG administered orally; Placebo capsule administered orally
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants received placebo and 40 mg Vyvanse in a cross-over design. Order of administration was randomly assigned and counter-balanced across participants
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Otherwise Healthy Overweight and Obese Participants With Likely Insulin Resistance
Condition: Insulin Resistance
MeSH terms: Overweight; Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability profile of BFKB8488A following
      subcutaneous (SC) administration in overweight and obese participants (body mass index [BMI]
      greater than [>] 27 to less than or equal to [</=] 40 kilograms per square meter [kg/m^2])
      with markers of insulin resistance. Single ascending fixed doses of BFKB8488A will be
      evaluated. Participants will be randomized into 7 sequential ascending fixed-dose cohorts of
      BFKB8488A SC or placebo and safety reviews will be performed before escalation to higher dose
      cohorts. Additionally, following the ascending fixed-dose SC cohorts, a separate cohort will
      open to evaluate the PK of BFKB8488A after intravenous (IV) administration.
    


Intervention name(s): BFKB8488A; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive either a single escalated dose of BFKB8488A administered SC or a single dose of BFKB8488A administered IV on Day 1.; Participants will receive a single dose of placebo on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Locally Delivered Aloe Vera Gel in the Treatment of Chronic Periodontitis Patients With Diabetes Mellitus
Condition: Diabetes Mellitus; Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root
      planing in the treatment of chronic periodontitis patients with controlled type II diabetes
      mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative
      Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline
      and 3 months.
    

Detailed description: 
      Aloe vera gel was locally delivered in the periodontal pockets of ≥ 5mm bilaterally in
      chronic periodontitis patients with diabetes under control.(HbA1c-6.6-8.6%).The study design
      had two groups-one in which scaling and root planing and local delivery of aloe vera gel and
      the other only scaling and root planing.

      The evaluation of clinical parameters of PI, GI, PPD and RAL at baseline, 6 weeks and 3
      months.

      HbA1c evaluated at baseline and 3 months.
    

Intervention name(s): SRP + Aloe; SRP
Intervention type(s): Drug; Procedure
Intervention description(s): Scaling and root planing along with aloe vera application was done; Scaling and root planing was done
Other intervention name(s): Korphad Ghar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: clinical trial
Intensive Care Unit (ICU) Diary Project
Condition: PTSD; Post ICU Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      Psychological morbidity in both patients and family members related to the intensive care
      unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem
      recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS).
      ICU diaries are an intervention increasingly under study with potential to mitigate
      ICU-related psychological morbidity, include ICU-related PTSD (post-traumatic stress
      disorder), depression and anxiety.
    

Detailed description: 
      The investigators compared the efficacy of the ICU diary, prospectively written by
      third-parties during the patient's intensive care course, versus education-alone, on reducing
      acute PTSD symptoms after discharge. Patients with an ICU stay greater than 72 hours, and who
      were intubated and mechanically ventilated over 24 hours, were recruited and randomized to
      either receive a diary at bedside with psychoeducation, or psychoeducation alone.
      Intervention patients received their ICU diary within the first week of admission into the
      intensive care unit. Psychometric testing with IES-R, PHQ-8, HADS and GAD-7 was conducted at
      weeks 4, 12, and 24 after ICU discharge.
    

Intervention name(s): Diary (blank journal) plus PTSD psycho-education; PTSD psycho-education alone
Intervention type(s): Other; Other
Intervention description(s): A blank journal where a prospective account of a patient's ICU course (everyday events) can be documented by family members and healthcare providers; We administered a pamphlet to patients with information regarding PTSD symptoms, potential psychiatric complications after discharge, and available mental health resources.
References for our education include the following which are included in our references section: Jensen 2015, Jones 2010, Knowles 2009, Parker 2015, Wintermann 2015.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: psychocognitive morbidity; narrative medicine; ICU-related PTSD; Post-ICU Syndrome (PICS); ICU Diary
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
Condition: Chronic HBV Infection
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in
      adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with
      an oral antiviral (OAV) medication.
    


Intervention name(s): GS-4774; OAV Regimen
Intervention type(s): Biological; Drug
Intervention description(s): Administered as a subcutaneous injection every 4 weeks for a total of 6 doses; Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B (HBV); Oral antiviral (OAV); GS-4774
Maximizing Outcomes in Treating Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan,
      which is being developed for the acute treatment of migraine with or without aura in adults.
      AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This
      study is designed to evaluate the efficacy and safety of AXS-07 compared to meloxicam,
      rizatriptan, and placebo for the treatment of a migraine attack.

      This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled
      trial. Subjects who successfully complete screening and continue to meet all entry criteria
      will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or
      placebo upon the occurrence of a qualifying migraine.
    


Intervention name(s): AXS-07 (MoSEIC meloxicam and rizatriptan); Meloxicam; Rizatriptan; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): AXS-07 taken once upon onset of a qualifying migraine.; Meloxicam taken once upon onset of a qualifying migraine.; Rizatriptan taken once upon onset of a qualifying migraine.; Placebo taken once upon onset of a qualifying migraine.
Intervention MeSH terms: Meloxicam; Rizatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine; AXS-07; Meloxicam; Rizatriptan; Axsome; Axsome Therapeutics; MoSEIC meloxicam
Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is intended to assess the effect on glycaemic control of AZD9567, as measured by
      the glucose AUC(0-4) versus baseline following a standardised mixed meal tolerance test
      (MMTT), compared to prednisolone in adults with type 2 diabetes mellitus (T2DM). The study
      will also evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD9567.
    

Detailed description: 
      This is a randomised, double blind, multi-centre, double dummy, and two-way cross-over study.

      There will be a total of three cohorts. Each cohort will be treated for two 72-hour periods
      in a cross-over design, with a 3-week washout period between treatment periods. The total
      length of participant engagement (from screening to follow-up) is 79 days.
    

Intervention name(s): AZD9567; Prednisolone; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants will receive 72 mg/day (oral suspension) of AZD9567 for 3 consecutive days of each treatment period in Cohort 1 and 40 mg/day for 3 consecutive days of each treatment period in Cohort 2.; Participants will receive 40 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 1, 20 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 2, and 5 mg/day prednisolone for 3 consecutive days of each treatment period in Cohort 3.; Participants will receive placebo for 3 consecutive days of each treatment period in Cohort 3.
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Glucose Homeostasis; Pharmacodynamic; AZD9567; Prednisolone
Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients
Condition: Renal Transplantation
Study type: Observational

Summary: 
      An evaluation of the effects of genetically determined variant metabolizing and transporting
      proteins involved in the disposition of the immunosuppressive drug tacrolimus in renal
      transplant recipients. In a five year follow-up study tacrolimus dose-corrected exposure
      changes significantly and the effect(s) of single nucleotide polymorphisms of the
      CYP3A4/CYP3A5 and MDR1 genes on the latter is assessed in this study.
    

Detailed description: 
      A 5-year pharmacokinetic follow-up study in 95 renal allograft recipients assessing
      tacrolimus exposure using repeated abbreviated Area-Under-the-Concentration-time (AUC) curve
      measurements at regular time points after grafting. The effects of the CYP3A5*1, CYP3A4*1B,
      MDR1 G2677T/A and C3435T single nucleotide polymorphisms on the evolution of tacrolimus
      disposition are studied over 5 years in order to clarify the interrelationship between
      CYP3A5, CYP3A4 and MDR1 genotypes, time-dependent exposure and tacrolimus-related toxicity.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: tacrolimus pharmacokinetics; CYP3A4 - CYP3A5; P-glycoprotein; single nucleotide polymorphisms; renal transplantation; calcineurin-inhibitor-associated nephrotoxicity
Adenoma Detection Rate Using AI System in China
Condition: Colorectal Neoplasms; Colonic Polyp; Adenoma
MeSH terms: Adenoma; Colorectal Neoplasms; Colonic Polyps
Study type: Interventional

Summary: 
      The primary aim of this study is

      - to explore the usefulness of Artificial Intelligence system in colonoscopy on adenoma
      detection rate (ADR). Other aims include to explore the data below when Artificial
      Intelligence is used.

      Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp
      detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure,
      MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
    

Detailed description: 
      Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes
      cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and
      remove them. Removing adenomas is known to reduce the chances of a person developing
      colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot
      of researches into how to improve "adenoma detection rates".

      A new AI system, called the CSK endoscopic diagnosis and treatment system has been designed
      to improve the rate of polyp detection at colonoscopy. Previous tests have shown that there
      is a significant improvement in detection of adenomas when the system is used. This study
      will randomize patients coming for colonoscopy to have their procedure performed as usual or
      as an AI-assisted colonoscopy. The investigators will record polyp and adenoma detection
      rates, duration of procedure, participant comfort levels, and complications. All patients
      referred for colonoscopy will be invited in 4 centers, recruiting a total of 800
      participants.
    

Intervention name(s): CSK AI system; Standard Colonoscopy
Intervention type(s): Device; Device
Intervention description(s): CSK system is equipped with the endoscopic mainframe and alarms the examiners when suspect lesions appear.; This is the routine examination in nowadays clinical practice. Both the equipment and the procedure are as usual as clinical routine.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: CSK endoscopic diagnosis and treatment system a new system of artificial intelligence. It is manufactured by Tianjin Yujin Limited in China. It is equipped with the endoscopic mainframe and has the access to the endoscopic video and image. When lesion-like objects appear in the real-time video, the system will alarm the examiners by sound.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: adenoma detection rate
Place of the Video-laryngoscope in Learning Intubation by Simulation
Condition: Airway Management; Intubation, Intratracheal; Simulation; Laryngoscopy
Study type: Observational

Summary: 
      The aim of the study was to determine the impact of the videolaryngoscope on reducing the
      time needed to intubate on a low-fidelity manikin for beginners.

      The investigators conducted a randomised crossover study, which took place in the simulation
      department of the medical school of Tunis. They used a low-fidelity manikin designed for
      learning airway management. The first part of our session consisted in a theoretical
      training. The second part was the practical training with procedural simulation.
    

Detailed description: 
      Simulation is nowadays a widespread teaching method, particularly in airway management. The
      direct laryngoscope is the most commonly used device for learning intubation. As for the
      videolaryngoscope, it is mostly used on an advanced level, for teaching difficult
      laryngoscopy to professionals. Its impact on teaching intubation to beginners remains
      unclear.

      The aim of the study was to determine the impact of the videolaryngoscope on reducing the
      time needed to intubate on a low-fidelity manikin for beginners.

      The investigators conducted a randomised crossover study, which took place in the simulation
      department of the medical school of Tunis. They used a low-fidelity manikin designed for
      learning airway management. They included 35 trainees.

      The first part of our session consisted in a theoretical training, during which one single
      instructor exposed the anatomical basis and the material needed: a direct laryngoscope
      (Macintosh) with a number 3 curved blade, a videolaryngoscope (Med-Captain) with a number 3
      curved blade and a number 7 tracheal tube with a stylet.

      The second part was the practical training with procedural simulation. The investigators
      randomized the trainees in two groups.

      Each trainee proceeded to three intubations with each device, in the specified order.

      The investigators used the SPSS software for data analysis. The investigators considered a
      p-value < 0.05 as statistically significant.
    

Intervention name(s): Videolaryngoscope first; Direct laryngoscope first
Intervention type(s): Device; Device
Intervention description(s): started the session with 3 intubations using the videolaryngoscope; started the session with 3 intubations using the Direct laryngoscope
Other intervention name(s): VL; DL
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We included 35 trainees. they were aged between 22 and 24 years old.