bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Exercise-Induced Weight Loss on Energy Metabolism
Condition: Metabolism; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Observational

Summary: 
      The E-MECHANIC Ancillary Study will measure changes in 24-hour energy expenditure and
      spontaneous physical activity in a subset of 60 obese individuals enrolled in the main study.
      We aim to determine if changes in energy metabolism might explain why people don't lose the
      expected amount of weight in an exercise program.
    

Detailed description: 
      This is an ancillary study to E-Mechanic, which is an National Institutes of Health study in
      198 individuals with the objective to understand why certain people fail to lose weight in
      exercise programs. In E-Mechanic changes in body weight, body composition, energy intake and
      energy expenditure are measured before and after 3 different exercise programs of 24 weeks in
      duration. The 3 exercise programs being compared are self-directed exercise, low dose
      exercise and high dose exercise. The goal of this ancillary study is to undertake
      comprehensive assessments of energy metabolism in a metabolic chamber in a group of 60 obese
      individuals enrolled in the main study. We will compare differences in the changes in 24h
      energy expenditure and spontaneous physical activity between the 3 exercise programs. We will
      also test if changes in energy metabolism might explain why people don't lose the expected
      amount of weight after 24 weeks of exercise.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and Women enrolled in E-MECHANIC
      
Keywords: Energy; Metabolism; Weight Loss; Exercise
Sphenopalatine Ganglion Block for Nasal Surery
Condition: Intraoperative Bleeding; Postoperative Delirium
MeSH terms: Emergence Delirium; Blood Loss, Surgical
Study type: Interventional

Summary: 
      nasal surgery carries many perioperative challenges, intraoperative bleeing and its effect on
      surgical field i the main intraoperative concern an postoperative agitation and its serious
      complications is the main postoperative challenge.
    


Intervention name(s): Bupivacaine 0.5% Preservative-Free Injectable Solution; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 ml of Bupivacaine 0.5% Preservative-Free Injectable Solution used transnasally to block the sphenopalatine ganglion; 1.5 ml of normal saline is delivered transnasally to the sphenopalatine ganglion
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparison of the Effectiveness of Virtual Reality and Video Assisted Exercises in Pediatric Chronic Kidney Disease.
Condition: Pediatric Kidney Disease; Physical Activity; Exercise Addiction
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      In this study, we aim to improve respiratory function and balance of decreased muscle
      strength, decrease fatigue values, improve quality of life, improve inflammation findings and
      GFR ( Glomerular filtration rate) values in pediatric chronic kidney patients with virtual
      reality exercise applications.
    

Detailed description: 
      1.Group - Working group: Virtual reality technology (Nintendo Wii Fit Plus) exercise group
      2.Group-Control group: home-based video games will be divided into groups that exercise.

      Measurements of functional capacity, muscle strength, quality of life, depression, fatigue
      and physical activity levels, medical values (pulmonary function test values, inflammation
      level values, glomerular filtration rate level values) of both groups will be recorded before
      and after treatment.

      In the study group treatment protocol; patients will complete 12 sessions of virtual reality
      exercise application-Nintendo Wii Fit Plus 30-minute training sessions with strengthening
      exercises for the lower extremities and upper extremities, aerobic and balance exercises.
      They will do 5 minutes warm-up exercises before the session and 5 minutes cool-down exercises
      as well as breathing exercises at the end of the session and will participate in a 50-minute
      treatment session in total.

      In the control group treatment protocol, patients will follow the 30-minute video exercise
      practices for the lower and upper extremities that are similar to Nintendo Wii Fit exercises
      for the control group at home two days a week. exercises will complete the 50-minute training
      session. Apart from exercise sessions, patients will record their activities (walking,
      cycling, swimming…) in daily life forms with their own pedometers. Thus, changes in physical
      activity levels will be monitored.
    

Intervention name(s): study group; control group
Intervention type(s): Other; Other
Intervention description(s): The treatment protocol will consist of Nintendo wii fit virtual reality exercises (yoga,aerobic exercises,muscle strengthening exercises); The treatment protocol will consist of home based video exercises ;yoga,aerobic exercises,muscle strengthening exercises
Other intervention name(s): virtual reality based therapy -aerobic exercises, stretching exercises; home based video exercise group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric Chronic Kidney Disease,; virtual reality; physical therapy; exercise; Nintendo wii; Video based exercise
Efficacy of External Oblique Intercostal Block in Laparoscopic Bariatric Surgery
Condition: Bariatric Surgery Candidate; Pain, Postoperative; Narcotic Use; Analgesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Laparoscopic bariatric procedures nowadays are employed under ERAS protocol as an ambulatory
      surgery. Pain after laparoscopic procedures arises significantly from port site incisions in
      the anterior abdominal wall, and shoulder pain (referred from visceral pain). Narcotic
      medications are utilized to manage postoperative pain, but its disadvantages include,
      increased post-operative nausea and vomiting (PONV), ileus, sedation and delayed hospital
      discharge.

      Oblique subcostal transversus abdominis plane block (OSTAP) had been studied before and found
      to be effective in reducing post-operative morphine usage and produce good analgesia for
      about 24hours postoperatively.

      The ultrasound-guided external oblique intercostal (EOI) block is a new technique which
      proved to produce unilateral analgesia at thoracic dermatomes supplying the anterior and
      lateral aspects of the upper abdomen.

      The aim of this study was to test the hypothesis that US-guided EOI blocks can produce more
      reduction in opioid usage during the first 24 h after of laparoscopic bariatric surgeries
      when compared to oblique subcostal TAP (OSTAP) block.
    


Intervention name(s): External oblique intercostal block; Oblique subcostal TAP block; Posterior Rectus sheath block
Intervention type(s): Other; Other; Other
Intervention description(s): EOI block:Under guidance of the linear high frequency transducer, sagittal plane between anterior axillary line and midclavicular line at the level of the 6th rib, In-plane approach between external oblique and intercostal muscles Hydrodissection with 30 ml of 0.25% bupivacaine hydrochloride .; OSTAP block: The needle was inserted in plane through the rectus adjacent to costal margin Once the tip of the needle was visualized in between the rectus muscle and transversus abdominus muscle and negative pressure aspiration was demonstrated, 30 ml bupivacaine 0.25% was deposited within the plane and hydrodissection was noted.; Posterior rectus sheath block: Under linear ultrasound probe, the needle was advanced gradually through the rectus muscle posteriorly toward its medial edge, approaching the rectus sheath. After negative aspiration,12.5 mL bupivacaine 0.25% was injected until the rectus muscle was separated from the posterior rectus sheath by hydrodissection.
Other intervention name(s): EOI; OSTAP; PRSB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Sensitivity of Alternative NRL972 Detection Methods in Healthy Subjects
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The disposition of NRL972 after a 15-second intravenous injection of 2 mg NRL972 is
      distinctly slower in patients with hepatic cirrhosis and acute hepatitis than in healthy
      control subjects. NRL972 appears to be a suitable investigational marker of hepatic
      transporter clearance dysfunction.

      Although the pharmacokinetics of NRL972 provide a reliable differentiation between subject
      groups, this approach relies on precisely timed sampling of venous blood, cautious
      preparation, handling and on-site storage of plasma samples, the transfer of samples to a
      central laboratory for analysis, and the availability of a validated assay procedure.

      For these reasons, there is interest in developing and validating alternative methods for
      determining the concentration of NRL972 in venous blood. Two such methods have been developed
      to date, but their utility in determining NRL972 pharmacokinetics has yet to be established.
    


Intervention name(s): NRL972
Intervention type(s): Other
Intervention description(s): Two-hour intravenous infusion of 5 and 15 mg per hour
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Headache Inducing Effects of Cilostazol on Migraine Patients
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      We will use Cilostazol as a tool to investigate its headache inducing effects in migraine
      patients.
    


Intervention name(s): Cilostazol; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Pletal
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of trimetrexate glucuronate, fluorouracil,
      and leucovorin in treating patients with recurrent or metastatic colorectal cancer.
    

Detailed description: 
      OBJECTIVES: I. Evaluate tumor response and duration, one-year progression-free survival, and
      one-year overall survival in patients with recurrent or metastatic colorectal carcinoma when
      treated with trimetrexate glucuronate, fluorouracil, and leucovorin calcium.

      OUTLINE: Patients receive trimetrexate glucuronate (TMTX) IV over 1 hour on day 1. Beginning
      18 hours after the TMTX dosage, patients receive leucovorin calcium (CF) IV over 2 hours.
      Immediately after the completion of the CF infusion, patients receive an IV bolus injection
      of fluorouracil (5-FU). Beginning 4 hours after the 5-FU infusion, patients receive oral CF
      every 6 hours for 6 doses. Treatment repeats every 14 days in the absence of disease
      progression or unacceptable toxicity or as long as the disease remains inoperable. Patients
      are followed every 3 months for 1 year, every 6 months for 3 years, and then annually
      thereafter.

      PROJECTED ACCRUAL: A total of 18-45 patients will be accrued for this study within 15 months.
    

Intervention name(s): fluorouracil; leucovorin calcium; trimetrexate glucuronate
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Trimetrexate; Fluorouracil; Calcium; Levoleucovorin
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer
A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation
Condition: Atrial Fibrillation; Thromboembolism
MeSH terms: Atrial Fibrillation; Thromboembolism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to assess the safety of a potential new drug DU-176b for the prevention of
      stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation
      (AF). The duration is 3 months of treatment and a 30 day follow-up visit.
    


Intervention name(s): Edoxaban (DU-176b); Edoxaban (DU-176b); Edoxaban (DU-176b); Edoxaban (DU-176b); warfarin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 30mg tablet once daily; 60mg tablet once daily; 30mg tablet two times a day; 60mg tablet two times a day; warfarin tablets
Intervention MeSH terms: Warfarin; Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Anti-coagulant; Non-valvular; Venous Thromboembolism; Prevention of Blood Clots; Atrial Fibrillation; Non-valvular atrial fibrillation
The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      To assess the potential effect of oral Clarithromycin on the single-dose pharmacokinetics of
      Givinostat.

      Secondary objective:

      To assess the safety and tolerability of concomitant administration of Givinostat plus
      Clarithromycin.
    

Detailed description: 
      This study was planned as a phase I, open-label, 3-part, fixed-sequence, non-randomized study
      in healthy male and female subjects. The study (Part 2) aimed at assessing the potential
      effect of Clarythromycin on the single dose pharmacokynetics of Givinostat.

      The total duration of Part 2 was divided as follows:

        -  Screening: up to 21 days.

        -  Treatment Period: Days 1 to 11.

        -  Safety follow-up visit: 12±2 days.

      Subjects were confined at site from Day -1 to Day 11. On Days 1 and 8, a single dose of 50 mg
      Givinostat, as oral suspension, was administered 1 hour after the planned morning time of
      Clarithromycin administration.

      From Day 4 to Day 10, clarithromycin 500 mg film-coated tablets were administered twice a
      day, in the morning and in the evening.

      The following assessments were performed:

        -  Blood collection for pharmacokinetic analysis on Days 1 to 4 and 8 to 11.

        -  Vital signs measurements on Days 1 and 4 to 10.

        -  12-lead ECG on Days 1, 3, 7 and 8.

        -  Blood collection for laboratory tests (hematology and biochemistry) on Day 3.

      Subjects were discharged in the morning of Day 11 after completing end of study procedures.
    

Intervention name(s): Givinostat; Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): ITF2357 Givinostat 10mg/mL. Dose: 10 mg/mL; Dosage form: oral suspension.; Clarithromycin 500 mg immediate-release oral film-coated tablet (Klacid®) was administered twice a day, in the morning and in the evening.
Other intervention name(s): ITF2357; Klacid®
Intervention MeSH terms: Clarithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PK; Pharmacokinetics; Givinostat; Clarythromycin
Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth
Condition: Pulp Necroses
MeSH terms: Dental Pulp Necrosis; Thrombosis; Necrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the present study is to assess clinically and radio-graphically the regenerative
      potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich
      fibrin scaffolds.
    

Detailed description: 
      30 immature necrotic permanent teeth in patients will be allocated and divided into two
      groups. Group 1 will be treated by regenerative procedure using blood clot as a scaffold and
      Group 2 will be treated with regenerative procedures using combined blood clot and Platelet
      rich fibrin as a scaffold.
    

Intervention name(s): Blood clot scaffold; Blood clot scaffold combined with PRF
Intervention type(s): Biological; Biological
Intervention description(s): Bleeding will be induced in the canal by passing a size 30 sterile K-file 3 mm beyond the apex with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. Bleeding will be stopped just below the cemento enamel junction.
Biodentine will be placed approximately 3-4 mm below the cementoenamel junction.; Platelet-rich fibrin will be prepared by drawing the patient blood into a 10mL test tube without the addition of an anticoagulant. To prevent the blood from coagulating after coming in contact with the glass tube, it will be centrifuged immediately using a table top centrifuge** at 400 g force for 12 minutes. Then platelet-rich fibrin membrane will be placed into the canal space to a level 3 mm below the cemento-enamel junction using hand plugger following the induction of apical bleeding by passing a number 30 sterile hand file 3 mm beyond the apex of the tooth. Biodentine cap will be placed over the platelet-rich fibrin scaffold.
Intervention MeSH terms: Clotrimazole; Miconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Regenerative endodontics; Open apex; Immature necrotic teeth
Parent-targeted Mobile Phone Based Intervention to Increase Physical Activity in Children (P-Mobile)
Condition: Physical Activity
Study type: Interventional

Summary: 
      This study is designed to determine if parents can deliver an intervention that will help
      increase physical activity in their children. The parents will be given the intervention
      through their mobile phones.
    

Detailed description: 
      Most children engage in insufficient amounts of moderate-to-vigorous physical activity. These
      low levels of moderate-to-vigorous physical activity are associated with adverse health
      consequences including increased risk for obesity, and cardiovascular and diabetes risk
      factors. Therefore, there is a need for studies that can increase physical activity levels in
      children. Mobile phones are a way to deliver behavioral interventions. Mobile phones are
      portable, allow for real-time data collection, and can potentially reach large numbers of
      people. Text messages can also be utilized to promote behavior change. Few mobile phone based
      interventions have specifically targeted child physical activity.

      The aims of this pilot study were to determine the feasibility and efficacy of a physical
      activity promotion program targeting 6-10 year old children that is delivered to parents
      through mobile phones.
    

Intervention name(s): Intervention: limited behavioral strategies; Intervention: advanced behavioral strategies
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parents are given access to a website, formatted for a mobile phone. The website provides parents with a target steps/day goal for their child and parents are instructed to use their mobile phone to access the study website to record their child's step count each night. Parents are also sent monthly healthy nutrition tips via text message targeting the child in order to provide these families with potentially health promoting information.; Parents are given access to a website, formatted for a mobile phone. The website provides parents with a target steps/day goal for their child and parents are instructed to use their mobile phone to access the study website to record their child's step count each night. Parents also receive additional behavioral strategies based on the Social Cognitive Theory. The strategies are delivered through weekly articles posted on the website. Text messages are designed to prompt parents to encourage their child's physical activity, remind parents of behavioral concepts presented in the articles (article tip), and motivate parents to foster behavioral change in their child.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; physical activity
Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source
Condition: Fever Without Source
MeSH terms: Fever
Study type: Interventional

Summary: 
      Detecting serious bacterial infections (SBI) in children presenting to the Pediatric
      Emergency Department (PED) with fever without source (FWS) is a frequent diagnostic
      challenge. The recently described Lab-score, based on the combined determination of
      Procalcitonin, C-Reactive Protein (CRP) and urine dipstick results, has been shown an
      accurate tool for SBI prediction on retrospective cohorts. The investigators aimed to assess
      the usefulness of the Lab-score in safely decreasing unnecessary antibiotic prescriptions in
      children with FWS, and to prospectively determine the diagnostic characteristics of the
      Lab-score compared to other classically used SBI biomarkers (white blood cell (WBC) count,
      band count and CRP).
    


Intervention name(s): Allocation to the Lab-score group; Allocation to the control group
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Fever without source; Antibiotic prescription; Serious bacterial infection