bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Accelerometric Measurement Devices for Gait Analysis
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study is to obtain normative accelerometry data during the six minute
      walk test and a 30 second walk test on healthy subjects in order to determine the
      accelerometric variables that are the most relevant to describe gait disorders in patient
      populations. Secondary objectives of this study are to investigate the impact of walking
      speed and muscle strength on the accelerometric parameters, to assess the reproducibility of
      the method and to compare accelerometric data obtained with two different devices.
    


Intervention name(s): Different walk tests with an accelerometer device
Intervention type(s): Other
Intervention description(s): Subjects will performed three walk tests of 50 meter at different speeds, a six minute walk test, a walking test of 30 seconds then a test to measure the maximum force of extension and knee flexion on each leg. The walk tests will be performed with the accelerometer device (Locometrix) worn in a belt
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Accelerometer; gait analysis; Healthy subjects
Vitamin D Deficiency in Adolescent Girls
Condition: Healthy; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Fibroblast growth factor 23 (FGF23) is a newly discovered hormone which regulates phosphate
      and vitamin D levels. In this study, we are looking at what the normal levels of FGF23 are in
      adolescent girls and how these levels vary with other hormonal measurements. We will also be
      looking at whether vitamin D supplementation in adolescents who are deficient in vitamin D
      alters the levels of FGF23 and other factors including insulin resistance.
    

Detailed description: 
      Fibroblast growth factor 23 (FGF23) is a newly discovered hormone. Its primary function is to
      regulate phosphate metabolism, which it does both by directly regulating phosphate excretion
      through the kidney as well as by regulating vitamin D activity. What controls FGF23 levels is
      still under investigation; potential factors include dietary phosphate intake and vitamin D
      levels.

      In this pilot study, we aim to investigate what the normal levels of FGF23 are in healthy
      girls and how these are related to other measurements of bone and mineral metabolism. Since
      vitamin D deficiency is very common in healthy girls, we expect a subset of the subjects in
      this study to be vitamin D deficient. We will then randomize these girls to vitamin D
      repletion or placebo and follow changes in FGF23 levels. Vitamin D deficiency has also been
      implicated in insulin resistance which is a precursor to diabetes. We will therefore also
      look at changes in insulin resistance with vitamin D repletion.
    

Intervention name(s): ergocalciferol; placebo pill
Intervention type(s): Dietary Supplement; Other
Intervention description(s): ergocalciferol (a dietary form of vitamin D). 50,000 units by mouth once a week for 16 weeks.; placebo pill once weekly for 16 weeks. At the end of the study, subjects in this arm will receive vitamin D repletion
Other intervention name(s): vitamin D
Intervention MeSH terms: Vitamin D; Ergocalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: FGF23; FGF-23; vitamin D; vitamin D deficiency; insulin resistance; Healthy volunteers
Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in
      healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to determine
      the safety and tolerability of MORAb-022.
    


Intervention name(s): MORAb-022; MORAb-022
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline); IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline)
Intervention MeSH terms: Gimsilumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE) and Ethinyl Estradiol/Norethindrone in HIV-1 Infected Women
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the effects of nevirapine treatment on the pharmacokinetics of ethinyl
      estradiol (EE)/norethindrone (NET).
    


Intervention name(s): Nevirapine; EE/NET
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nevirapine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
How Should Surgical Residents Be Educated About Patient Safety
Condition: Medical Education; Patient Safety; Educational Safety Curriculum; Surgical Resident
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of two methods, safety curriculum
      in addition to online training alone, for teaching patient safety to surgery residents.
      Despite multiple studies evaluating educational safety curricula, the best methods for
      teaching residents about patient safety is unknown. It is hypothesized that empowering
      surgery residents to actively engage in behaviors to increase patient safety may lead to a
      higher quality perioperative care and communication.
    


Intervention name(s): Education - BIPS course; Formal safety curriculum; Ongoing evaluation and feedback
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The guiding principles behind the BIPS program include: (1) explaining how complex systems cause human error and how human error can lead to patient harm in complex systems; (2) diagnosing human error and identifying a prevention behavior for each of the three types: skill, rule, and knowledge; and (3) preventing error by promoting safety behaviors, such as having attention to detail, communicating clearly, having a questioning attitude, and speaking up for safety; The educational program is designed to improve patient safety by informing residents about safe operating room behaviors.; The feedback program is designed to encourage the use of safe behaviors and to discourage unsafe behaviors taught in the workshops.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Effect of VeSTAL Device in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve
      stimulation (VeNS), together with a lifestyle modification program, as a method of reducing
      HbA1c, as compared to a sham control with both study arms incorporating a lifestyle
      modification program.

        -  Allocation: Randomized

        -  Endpoint classification: Efficacy Study

        -  Intervention Model: Parallel Assignment in 1:1 active to control allocation
    

Detailed description: 
      There is an ongoing and worsening problem with type 2 diabetes mellitus (DM) in the
      developed, and much of the developing world. Although it has long been realized that Western
      diets that are rich in sugar and fat play an important role in this, it has only recently
      been realized that exposure to these diets, particularly in childhood, can damage the part of
      the brain that determines how much fat there is in the body, which may well play a role in
      the development of metabolic syndrome, deranged glycemic control and type 2 DM. It is
      believed, based on animal and human work, that VeNS pushes the set-point for fat downwards to
      cause fat loss, possibly because this indicates to the brain a state of increased physical
      activity. VeNS may additionally have other direct, yet to be quantified, effects on glycemic
      control.

      The sponsors have unpublished pilot data from Dr Saisailesh Kumar at RDG Medical College in
      India that show an improvement in glycemic control can be achieved by one hour a day of VeNS
      over a three month period. Both groups received a hypocaloric diet tailored to diabetics. The
      aim of this study is to determine whether this effect can be replicated in a slightly larger
      European based population.
    

Intervention name(s): Vestal Device; Placebo device
Intervention type(s): Device; Device
Intervention description(s): Vestibular nerve stimulator; Sham nerve stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment in 1:1 active to control allocation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Probiotics in the Atopic Dermatitis
Condition: Atopic Dermatitis, Probiotics
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to evaluate the efficacy of probiotics in the treatment of atopic
      dermatitis. Probiotics in AD patients were effective in reducing SCORAD index levels, but not
      effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum
      total and specific IgE levels.
    

Detailed description: 
      Frequently encountered in clinical practice, in the last 30 years, the prevalence of AD has
      rapidly increased as a result of industrialization. Thus, a new wave of quests for the
      treatment and prevention of AD has pushed forward. For the randomized, double-blinded, and
      placebo-controlled study this study was designed to evaluate the efficacy of probiotics in
      the treatment of AD. SCORAD positivity index of decline rates decline rates of the probiotic
      group of patients after treatment and skin prick tests were higher than that of the control
      group. While serum levels of IL-2-4-5-6-10, TNF-α, IFN-γ, ECP decreased in the probiotic
      group, only levels of IL-2-4-5, TNF-α decreased in the control group. The IgE decrease rate,
      the skin prick test, the serum total and specific of the probiotic group showed no difference
      from those of the control group. Probiotics in AD patients were effective in reducing SCORAD
      index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α,
      IFN-γ, ECP, and serum total and specific IgE levels.
    

Intervention name(s): probiotic ® pur
Intervention type(s): Drug
Intervention description(s): daily, four types of probiotic bacteria ( Bifidobacterium bifidity, Lactobacillus acidophilus, Lactobacillus casei and Lactobacillus salivarium) 2 bags (two billion bacteria) (probiotic ® pur) for a total of 8 (eight) weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Atopic dermatitis, probiotic, SCORAD index, prick tests, cytokines
Use of NGS Cell-free Pathogen Test for Identification of Low Risk Fever & Neutropenia in Pediatric Patients
Condition: Neutropenia; Fever
MeSH terms: Neutropenia; Fever
Study type: Observational

Summary: 
      Febrile neutropenia is a common complication in pediatric oncology patients. Standard of care
      requires admission of all patients for intravenous antibiotics until cultures are negative,
      patients are afebrile and there are signs of bone marrow recovery. This often results in
      prolonged hospital admissions with significant financial costs, decreased quality of life and
      potential secondary infections. More recent data suggests it may be possible to identify a
      "low risk" group that can be discharged prior to signs of bone marrow recovery. At this time,
      researchers have been unable to identify a model that is safe for early discharge across
      institutions.
    

Detailed description: 
      1. Conduct a pilot study to determine the feasibility of using the Karius Assay to risk
           stratify pediatric oncology patients admitted with febrile neutropenia. This will
           provide preliminary data for a larger study which would randomize patients to early
           discharge vs. usual care.

        2. Evaluate the Klaasen and SPOG clinical decision rules with and without the Karius Assay
           to predict patients at low risk for adverse infectious outcomes during admission.
           Adverse infectious outcome will be defined as: positive blood or urine culture,
           radiographic evidence of infection, admission to the intensive care unit or death.

        3. Model potential cost savings of early discharge for patients deemed low risk for an
           adverse infectious outcome.
    

Intervention name(s): Karius Test
Intervention type(s): Diagnostic Test
Intervention description(s): Next Generation Sequencing
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children being admitted for inpatient treatment with fever and neutropenia.
      
Biospecimen description: 
      Plasma
LTAP Block in Endometriosis Surgery - a Randomised Controlled Double-blind Trial
Condition: Endometriosis; Peritoneum; Postoperative Pain
MeSH terms: Endometriosis; Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy and safety of laparoscopically inserted
      transversus abdominis plane block (LTAP) in comparison to local wound analgesia in
      laparoscopic surgery due to suspected or diagnosed peritoneal endometriosis.
    

Detailed description: 
      The LTAP-trial is a prospective randomized controlled double-blinded study comparing the
      efficacy and safety of LTAP with local wound analgesia in laparoscopic endometriosis surgery.
      Patients are randomized to receive LTAP with levobupivacain and wound infiltration with
      placebo or wound infiltration with levobupivacain and LTAP with placebo. The primary outcome
      is postoperative opioid consumption measured by Patient Controlled Analgesia -pump (PCA).
      Secondly, subjective postoperative pain up to 24 h postoperatively will be measured by
      Numeric Rating Scale (NRS). Additional outcome measures are factors related to recovery and
      length of stay in the hospital as well as a 6 month follow-up survey regarding pain and
      general wellbeing after surgery. A total of 46 patients will be randomized in a proportion of
      1:1.
    

Intervention name(s): Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine
Intervention type(s): Procedure
Intervention description(s): Postoperative pain management
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: endometriosis; postoperative pain management; laparoscopic surgery; gynecological surgery
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Condition: Gynecology; Surgery
Study type: Observational

Summary: 
      The researchers traveled to University Hospital Mirebalais in Haiti and provided a one week
      long laparoscopic training and simulation course to the 7 OBGYN faculty there. The
      researchers used novel checklists to help the faculty to set up for laparoscopic cases and
      care for the equipment needed. The researchers then asked the physicians their opinion of the
      checklists.
    


Intervention name(s): Surgical training
Intervention type(s): Procedure
Intervention description(s): This was a gyn laparoscopy training and simulation course
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        OBGYN attendings and residents practicing at University Hospital of Mirebalais
A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin
      versus rosuvastatin in participants with high cholesterol.
    


Intervention name(s): ezetimibe (+) simvastatin; Comparator : rosuvastatin calcium; Comparator: Placebo (unspecified); Comparator: Placebo (unspecified)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.; rosuvastatin 10mg. The treatment duration will be 6 weeks.; rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.; ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.
Other intervention name(s): MK0653A; Vytorin®
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin; Ezetimibe; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: High Cholesterol
Evaluation of Triathlon - A New Total Knee Prosthesis System - Triathlon PA vs. Triathlon Pressfit
Condition: Arthroplasty, Replacement, Knee
Study type: Interventional

Summary: 
      The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric
      behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective
      randomized clinical trial.
    

Detailed description: 
      The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric
      behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective
      randomized clinical trial.

      The evaluation is carried out by a prospective randomised RSA-study with Triathlon PA vs.
      Triathlon Pressfit
    

Intervention name(s): Triathlon PA; Triathlon Pressfit
Intervention type(s): Device; Device
Intervention description(s): Implantation of Knee Prosthesis; Implantation of Knee Prosthesis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee; Arthrosis; Implant
The Effects of Dietary Fiber on the Gut Microbiome and HDL Particles of Human Subjects
Condition: Gut Microbiota
Study type: Interventional

Summary: 
      The objective of this project is to conduct a randomized-order, double-blinded cross-over
      trial in 20 participants to test the effects of a dietary fiber formulation on gut microbiota
      composition and short chain fatty acid production, lipid profiles, glucose sensitivity,
      intestinal permeability, overall gut health, and markers of inflammation.
    


Intervention name(s): Dietary Fiber; Placebo
Intervention type(s): Other; Other
Intervention description(s): Dietary fiber will be given in a powder form to mix with a beverage of one's choice.; Placebo will be given in a powder form to mix with a beverage of one's choice.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The aim of this randomized controlled trial is to evaluate the feasibility and effectiveness
      of providing an e-Health rehabilitation program through a web platform performing
      electroanalgesia and an exercise program following the McKenzie Method for patients with
      chronic low back pain in primary care, compared with the same home rehabilitation program but
      without the support of an electronic program.
    

Detailed description: 
      A double blind clinical trial will be developed in a sample of 80 subjects with chronic low
      back pain. Patients will receive 3 weekly sessions of electroanalgesia and an exercise
      program for 8 weeks, for a total of 24 sessions. The aim is to analyze the effectiveness of a
      home rehabilitation program vs a web platform program on disability, pain, fear of movement,
      quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular
      electrical activity.
    

Intervention name(s): Home Rehabilitation Program; e-Health program
Intervention type(s): Other; Other
Intervention description(s): It consists in a home rehabilitation program performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.; It consists in an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; electroanalgesia; exercise program; e-health; Randomized Controlled Trial