bioihbjkbjnl/mcl2 huggingface dataset:
Differences in Fat Mass Estimation Formulas in Physically Active Adult Population and Relation With Skinfold Sums.
Condition: Body Weight Changes; Body Weight
MeSH terms: Body Weight; Body Weight Changes
Study type: Observational

Summary: 
      The objective of the present study was to analyze the differences between the formulas used
      to estimate fat mass and to establish the existing relationship with the skinfold sum in
      anthropometry. A total of 2,458 active subjects participated in the study (mean age:
      27.98±7.43 years-old). Basic measurements and skinfolds variables were measured following the
      guidelines of the International Society for the Advancement in Kinanthropometry (ISAK), and
      Kerr, Durnin-Womersley, Faulkner and Carter equations were used to assess fat mass.
      Significative differences were found between all the formulas for the percentage of fat mass
      and the fat mass in kilograms. The correlations among the skinfolds sums and the different
      equations were high and significative in all the cases. There were differences between all
      the formulas used to estimate the fat mass. The six or eight skinfold sums could be a valid
      and better alternative than the fat mass equations or the BMI to assess the subcutaneous fat
      mass in physically active adults.
    


Intervention name(s): Anthropometry
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The present study was conducted with a sample of 2,458 active subjects (mean age:
        27,98±7,43 year-old), 1775 men (mean age: 27,99±7,46 years) and 681 women (mean age:
        27,94±7,37 years) from Región de Murcia (Spain)
      
Keywords: Fat mass; Body composition assessement; Health; Antropometry
Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      Total hip replacement (THR) is one of the most common interventions in orthopedic surgery.

      Rehabilitation is essential for maximizing the effectiveness of the surgery.
      Tele-rehabilitation programs after orthopedic surgery have proven their effectiveness,
      validity and cost-efficacy.

      It seems of interest to test the potential advantages of early virtual reality based
      rehabilitation programs after total hip arthroplasty compared to standard care. The aim of
      the study is to evaluate the functional recovery following total hip arthroplasty and home
      telerehabilitation programs with a virtual reality based system.
    


Intervention name(s): virtual reality rehabilitation system (VRRS); standard care
Intervention type(s): Procedure; Procedure
Intervention description(s): experimental group is equipped with a telerehabilitation system which comprises a tablet (VRRS tablet) and a set of inertial magnetic sensors. participants are invited to follow a daily rehabilitation exercise program provided via VRRS tablet; participants in the control group are invited to follow a daily rehabilitation exercise program and indications for the recovery as illustrated in the dimission booklets drawn up by the rehabilitation unit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil
Condition: Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Interventional

Summary: 
      The purpose of this study was to follow a person's response to experimental pain after
      multiple consecutive exposures to alfentanil or diphenhydramine to see if the person can
      tolerate the pain more, less, or the same at the end of the study.
    

Detailed description: 
      This project investigates the phenomenon of opioid-induced hyperalgesia (OIH). Opioid
      analgesics, in addition to their therapeutic anti-nociceptive effects, under some conditions
      produce pro-nociceptive effects. This phenomenon of pain or pain sensitivity being increased
      by prior opioid administration is called opioid-induced hyperalgesia. It is thought to be
      relevant both to pain management complications and to complications of opioid dependence and
      its treatment. This study investigated the time-course of opioid-induced hyperalgesia
      development in healthy normal volunteers (N=12 completers), using a series of acute
      alfentanil administrations (15 mg/kg mg intramuscular (IM) per day) spaced at 3-4 day
      intervals, with testing for pain tolerance using the cold pressor test (CPT), and mechanical
      quantitative sensory testing (MQST) each administered repeatedly over time within each
      testing day. The goal was to determine the time course of OIH development following acute
      opioid administration, and to assess whether this changes over repeated acute opioid
      administrations.
    

Intervention name(s): Alfentanil; Diphenhydramine
Intervention type(s): Drug; Drug
Intervention description(s): 15 mcg/kg IM; 25 mg IM
Other intervention name(s): Benadryl
Intervention MeSH terms: Diphenhydramine; Promethazine; Alfentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: opioid induced hyperalgesia
Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of
      patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical
      Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care
      setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.
    


Intervention name(s): Aripiprazole and aripiprazole once-monthly; Paliperidone and paliperidone palmitate
Intervention type(s): Drug; Drug
Intervention description(s): Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.; Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
Other intervention name(s): Aripiprazole: Abilify®; Aripiprazole (extended-release injectable suspension): Abilify Maintena®; Paliperidone: Invega®; Paliperidone palmitate: Xeplion® or Invega® Sustenna®
Intervention MeSH terms: Aripiprazole; Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Colchicine for Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study evaluates the effects of two different Colchicine doses (0.01mg/kg/day or 0.005
      mg/kg/day) compared to placebo in Amyotrophic Lateral Sclerosis (ALS) patients. Disease
      progression as defined by changes in ALSFRS-r is the primary outcome measure. Other measures
      of clinical progression and survival, together with safety and tolerability of Colchicine in
      ALS patients will be assessed.
    

Detailed description: 
      Recent evidence supports the disruption of the ubiquitin-proteasome-system and autophagy as
      central events in ALS. ALS is characterized by the presence of misfolded proteins prone to
      oligomerize into aggregates, which exert a toxic effect by affecting several intracellular
      functions. Heat shock protein B8 (HSPB8) recognizes and promotes the autophagy-mediated
      removal of misfolded mutant SOD1 and TDP-43 fragments from ALS motor neurons (MNs). Moreover,
      HSPB8-BAG3-HSP70 maintains the so called "granulostasis", a surveillance mechanism that
      avoids the conversion of dynamic stress granules (SGs) into aggregation-prone assemblies,
      which are a hallmark of ALS.

      Colchicine enhances the expression of HSPB8 and of several autophagy players while blocking
      TDP-43 accumulation in neurons. Moreover, given the cross-talk between infalmmation and
      autophagy, the well-known antinflammatory action of Cochicine may contribute to cell
      homeostasis.

      Based on these premises, this is a phase II randomized, double-blind, placebo-controlled,
      multicenter (9 MND Centres in Italy: 2 centres in Milan, Pavia, Turin, Modena, Padua, Rome,
      Naples, Bari), clinical trial to test efficacy of Colchicine in ALS.
    

Intervention name(s): Colchicine 1 MG Oral Tablet; Colchicine 1 MG Oral Tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Colchicine tablets depending on arm (0.01 mg/kg/day, 0.005 mg/kg/day, placebo) and on weight (>70 kg or <71 kg) for 30 weeks of duration.; Colchicine tablets depending on arm (0.01 mg/kg/day, 0.005 mg/kg/day, placebo) and on weight (>70 kg or <71 kg) for 30 weeks of duration.; Corresponding tablets for 30 weeks
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three arms of 18 patients each; in two arms two colchicine dosages will be tested compared to placebo in the control arm. The three arms will undergo treatment vs placebo in parallel
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: amyotrophic lateral sclerosis; stress granules; HSPB8; protein quality control; colchicine; ALSFRS-r; survival; safety
Effects of Different Omeprazole Dosing on Gastric pH in Non-variceal Upper Gastrointestinal Bleeding
Condition: Non-variceal Upper Gastrointestinal Bleeding
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to identify the best method of omeprazole (OME) application with
      respect to intragastric pH, cytochrome P450 2C19 (CYP2C19) genotype and phenotype.
    

Detailed description: 
      The patients with non-variceal upper gastrointestinal bleeding (NVUGIB) are prospectively
      enrolled. After the achievement of endoscopic hemostasis, the patients are randomized to
      40-mg intravenous (i.v.) OME bolus injection every 12 h or 8-mg/h continuous i.v. infusion
      for 72 h after an 80-mg i.v. OME bolus administration. The intragastric pH is recorded for 72
      h. The CYP2C19 variant alleles (*2, *3, *17) are analyzed and the serum concentrations of OME
      and 5-hydroxyomeprazole (5-OH OME) are determined. The diagnosis of Helicobacter pylori
      infection was based on the results of the rapid urease test performed on stomach mucosa
      biopsies (antrum and angle) and on the results of the stool antigen test.
    

Intervention name(s): Omeprazole
Intervention type(s): Drug
Other intervention name(s): endoscopic treatment of non-variceal upper gastrointestinal bleeding
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CYP2C19; Helicobacter pylori; non-variceal upper gastrointestinal bleeding; intragastric pH; proton pump inhibitor
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once
      per day for up to 12 weeks to patients with mild cognitive impairment.
    


Intervention name(s): CHF 5074 1x; CHF 5074 2x; CHF 5074 3x; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral tablet, 1x, once a day in the morning for 12 weeks; oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks; oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks; oral tablet, once a day in the morning for 12 weeks
Intervention MeSH terms: 1-(3',4'-dichloro-2-fluoro(1,1'-biphenyl)-4-yl)cyclopropanecarboxylic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin
      oral antibiotic suspension medications in pediatric subjects. It is designed to determine if
      Omnicef or amoxicillin is preferred to the other with regard to taste or smell.
    

Detailed description: 
      The Primary Purpose for the study is "Other". Per ClinicalTrials.gov, more information
      regarding the primary purpose is described here; the primary purpose for the study is to
      determine whether cefdinir possesses preferred taste and smell characteristics when compared
      to amoxicillin, a pediatric taste test.
    

Intervention name(s): cefdinir (Omnicef); amoxicillin
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 ml of strawberry cream flavored oral suspension 125 mg/5 mL; 2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 mL
Other intervention name(s): ABT-198; Omnicef; cefdinir
Intervention MeSH terms: Amoxicillin; Cefdinir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: pediatric taste test; antibiotic taste test; cefdinir; amoxicillin
Fenretinide in Treating Patients With Recurrent Malignant Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System 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.

      PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who
      have recurrent malignant glioma.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of fenretinide as assessed by 6-month progression- free
      survival in patients with recurrent malignant glioma. II. Determine the rate of measurable
      clinical response, time to progression, and overall survival of patients treated with this
      drug. III. Determine the unexpected toxicity of this drug in these patients.

      OUTLINE: This is a multicenter study. Patients are stratified according to disease type
      (glioblastoma multiforme (closed to accrual as of 05/31/2001) and gliosarcoma (closed to
      accrual as of 05/31/2001) vs anaplastic astrocytoma, anaplastic oligodendroglioma, and mixed
      malignant glioma). Patients receive oral fenretinide twice daily during weeks 1 and 4.
      Treatment repeats every 6 weeks in the absence of disease progression or unacceptable
      toxicity. Quality of life is assessed at baseline and then before each course of
      chemotherapy. Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 41-85 patients (21-45 with anaplastic astrocytoma, anaplastic
      oligodendroglioma, and mixed malignant glioma and 20-40 with glioblastoma multiforme (closed
      to accrual as of 05/31/2001) and gliosarcoma (closed to accrual as of 05/31/2001)) will be
      accrued for this study.
    

Intervention name(s): fenretinide
Intervention type(s): Drug
Intervention MeSH terms: Fenretinide
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma
Efficacy and Safety of Gosogliptin as Monotherapy and in Combination With Metformin vs. Vildagliptin as Monotherapy and in Combination With Metformin in Drug-naive Type 2 Diabetic Patients.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that efficacy of Gosogliptin as Monotherapy and in Combination with Metformin
      is non-inferior to efficacy of Vildagliptin as Monotherapy and in combination with Metformin
      in the effects on glycosilated hemoglobin (HbA1c) at Week 12 and Week 36 compared to baseline
      (Week 0).
    

Detailed description: 
      -  Screening of patients at Week -2

        -  Training for all complying patients in Diabetes Program School at Week -1 with
           glucometer and patient diary distribution for SMBG

        -  Randomization in one of two groups in the ratio 1:1.

        -  The 1st stage includes 12 weeks of monotherapy with Gosogliptin or Vildagliptin.

        -  The 2nd stage includes 24 weeks of combination therapy with Gosogliptin and Metformin or
           Vildagliptin and Metformin.

        -  Follow-up period of 4 weeks.
    

Intervention name(s): Gosogliptin; Vildagliptin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg per day, dose titration to 30 mg per day at Week 4 as required Administration: orally; 50 mg per day, dose titration to 100 mg per day at Week 4 as required (50 mg twice a day) Administration: orally; 1000 mg per day starting Week 12 (500 mg twice a day), dose titration to 2000 mg per day at Week 16 as required (1000 mg twice a day).
Administration: orally
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nasogastric Tube in Premature Babies - Pain and Treatment
Condition: Infant, Premature
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is
      inserted?
    

Detailed description: 
      A total of 24 premature babies are randomised to receive either placebo (sterile water), 30 %
      sucrose, or pacifier in a complete factorial, cross-over design. Pain is rated on the PIPP
      scale by observers blinded to the procedure other than use of pacifier.
    

Intervention name(s): Sucrose; Pacifier; sterile water
Intervention type(s): Drug; Device; Other
Intervention description(s): 30 % sucrose
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Care Provider)
Keywords: pain; infant, premature; intubation, gastrointestinal; Neonatal nursing
Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics
Condition: Opioid Overdose
MeSH terms: Drug Overdose; Opiate Overdose
Study type: Observational

Summary: 
      Retrospective study to assess incidence and predictors of opioid abuse overdose and death
      associated with opioid overdose among patients prescribed opioid products in long-term use.
    

Detailed description: 
      The purpose of this study is to quantify risk, and predictors of risks for opioid overdose
      and for death associated with opioid overdose in persons who are or have been long-term
      recipients of prescriptions for Schedule II opioids. The study uses coded terms in large
      heath databases maintained by healthcare providers and health insurers, supplemented by
      overdose deaths identified from the National Death Index. The terms for overdose are combined
      following validated rules as developed in companion studies. The study is being conducted in
      parallel with a prospective questionnaire-based cohort study of the same risks.
    

Intervention name(s): Observation only
Intervention type(s): Other
Intervention description(s): No intervention.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The source populations will be those members of the selected health plans and insurance
        programs identified for which full demographic, provider, facility and pharmacy data are
        available, and in which protected health information (PHI) can be linked to death
        certificate information.

        The four large healthcare systems that have established electronic databases for studying
        coded terminology outcomes selected for this study are: Kaiser Permanente Northwest;
        HealthCore, Inc. with access to commercial insurance data; Optum with access to commercial
        insurance data; and Vanderbilt University with access to Medicaid data for the State of
        Tennessee.
Safety, Tolerability, PK of Oral NYX-2925 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in human study of NYX-2925. It will evaluate single and multiple ascending
      doses of NYX-2925 in healthy volunteers.
    

Detailed description: 
      This is a first in human study of NYX-2925. This is a randomized, double-blind, sponsor-open,
      placebo-controlled, single and multiple ascending dose, parallel safety, tolerability, and PK
      study of oral NYX-2925 in healthy volunteers. The single ascending dose phase will comprise
      up to five dose groups. There will be up to 3 dose groups in the multiple ascending dose
      phase. One open-label dose group will be repeated in the multiple ascending dose phase to
      collect cerebrospinal fluid (CSF) samples, in order to explore central nervous system
      penetration. One elderly cohort (single dose) will be completed after all single and multiple
      dose escalation groups have completed. One open-label dose group will be repeated in the
      single ascending dose phase to collect CSF samples, in order to establish a more complete
      cerebral spinal fluid pharmacokinetic profile.

      The influence of food ("food effect") on the bioavailability and pharmacokinetics of NYX-2925
      will be explored in one dose group in the single ascending dose phase.

      A data review committee will review safety and tolerability (adverse events and other
      relevant data), plus preliminary pharmacokinetic data, prior to proceeding to the next higher
      dose group, cohort, and/or phase of the study, as well as administration of the fed dose in
      the food effect group.

      Stopping rules for individual study participants and dose groups or cohorts are established
      in order to evaluate the dose escalation scheme, the need to stop or terminate dosing, or to
      establish the maximum tolerated dose. If a cohort is stopped due to safety or tolerability
      concerns, the previous cohort may be repeated to determine the highest tolerated dose.
    

Intervention name(s): NYX-2925
Intervention type(s): Drug
Intervention description(s): NYX-2925 is a small molecule that acts as an N-methyl-D-aspartate receptor (NMDAR) functional glycine-site partial agonist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment