bioihbjkbjnl/mcl2 huggingface dataset:
Weight Loss and Exercise in Physically Limited Obese Elderly Subjects
Condition: Obesity; Frailty; Elderly
MeSH terms: Weight Loss; Frailty
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall purpose of this research is to determine the effect of weight loss and physical
      training on quality of life, physical function, metabolism, bone strength, body fat and
      muscle mass.
    

Detailed description: 
      Obesity causes serious medical complications and impairs quality of life. Moreover, in
      elderly persons, obesity can lead to frailty because of decreased strength, joint function,
      balance and mobility associated with aging. The primary objective of this study is to
      evaluate the effect of weight loss and physical training on physical function, body
      composition, metabolism and quality of life in frail, obese elderly men and women. Subjects
      are randomized to either control or 10% weight loss plus physical training.
    

Intervention name(s): diet, exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Obesity, Aging, Frailty, exercise, weight loss
Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a standardized education and exercise
      program proposed before a total knee replacement for knee osteoarthritis is effective in
      functional recovery after surgery.
    

Detailed description: 
      Knee osteoarthritis leads to deficiencies in muscle strength, knee range of motion and
      balance, and cardio respiratory deconditioning that contribute to alter abilities to perform
      activities of daily living. It is the principal indication for total knee arthroplasty (TKA).
      Patients' functional state and pain level are generally improved after TKA and the physical
      and functional status pre-TKA are predictive of recovery after surgery. Decreasing length of
      stay at surgery departments and promoting return at home after TKA are recommended. The
      recommendations of the Health Authority in France (HAS) and the new law of finance for French
      clinics contribute to shorter hospital stays and to restrain the conditions of admission to
      Physical Medicine and Rehabilitation department after TKA.Exercise and education programs
      conducted before TKA could help better prepare patients for surgery, improve functional
      outcome and accelerate functional recovery after surgery thus reducing the length of stay in
      orthopedic departments and facilitate return to home (directly or after a stay in PMR
      departments). The type of program necessary to achieve those goals remains to be defined.A
      systematic review of the literature associated with an analysis of practices about the
      relevance of rehabilitation programs before TKA, concluded that the implementation of such
      programs before TKA was likely to reduce the length of stay in surgery departments and
      improve the rate of direct return to home after surgery but that high quality trials were
      lacking. It also suggested that association of exercise programs with educational ones could
      be more effective than exercise or education alone, particularly for fragile patients with
      impaired functional capacity, co-morbidities and/or social problems.
    

Intervention name(s): Educational and exercise program; Usual care
Intervention type(s): Other; Other
Intervention description(s): 4 (twice a week) group education sessions lasting 30 minutes plus an education booklet about knee replacement
4 (twice a week) sessions of an exercise programme lasting 1 hour; Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total knee arthroplasty; Total knee replacement; Knee osteoarthritis; Education; Exercise; Handicap; Function; Cost-effectiveness; Cost-utility; Quality of life
A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study in healthy people is to evaluate safety, toleration and time course
      of plasma concentration of single oral doses of PF-06372865. The pharmacodynamic activity of
      PF-06372865 will also be assessed. The effect of food on PK and the PK of PF-06372865
      administered as a tablet formulation may also be investigated. Pharmacodynamic interaction
      between PF-06372865 and lorazepam will be evaluated.
    


Intervention name(s): PF-06372865 or Placebo; PF-06372865 or Placebo; PF-06372865 or Placebo; PF-06372865 or Placebo or Lorazepam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.; PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.; PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.; Lorazepam 2 mg dose, PF-06372865 Dose 1, PF-06372865 Dose 2, PF-06372865 Dose 1 and Dose 2 in combination with lorazepam, placebo administered as tablet formulation
Intervention MeSH terms: Lorazepam; PF-06372865
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Single Dose; Pharmacokinetics; Safety; Toleration; Pharmacodynamics
Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 2
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      Objective is to examine the physical activity and screen-time behaviors of children enrolled
      in licensed childcare centers before and after the enactment of new state regulations.
    

Detailed description: 
      Pause and Play aims to enroll 266 children. Each child will participate in the study for
      approximately 1 year. Surveys, anthropometric measures, and screen-time observations will
      take approximately 1 day each to complete, and the child will be given an accelerometer to
      wear at home for 7 days at both baseline and 1 year follow-up. Fundamental motor skill
      assessments will take place at baseline and 1 year follow-up after the 7 days of
      accelerometer wear. Staff members will spend approximately 2 weeks at each childcare center
      at baseline and 1 year follow-up to complete study procedures with each child.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ten licensed DOE Class A or B childcare centers will be randomly selected from a list of
        all DOE licensed childcare centers in East Baton Rouge Parish (EBR). From the ten centers,
        266 children and their parent(s) will be recruited to complete additional measures of
        physical activity and screen-time behaviors.
      
Keywords: Childcare Center Regulations; Physical Activity; Sedentary Behavior; Screen-time Behavior
Sleep Loss and Mechanisms of Impaired Glucose Metabolism
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps
      people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S.
      Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in
      the United States as LUNESTA.

      Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that
      can be reversed by two months of eszopiclone for the primary insomnia
    

Detailed description: 
      Insomnia is the most common sleep disorder, affecting nearly one-third of all adults in any
      given year, and chronically affecting 10-15% of the adult population. Reduced sleep time,
      independent of insomnia, has been associated with a variety of deleterious long term effects,
      including an increased risk of incident myocardial infarction and symptomatic diabetes.
      Chronic partial sleep loss or insomnia may impair glucose metabolism in the short term and
      are associated with the development of diabetes in the long term. Although the extent of
      sleep loss is more acute in the laboratory-based 'sleep debt' studies of healthy volunteers,
      chronic primary insomnia patients exhibit 'hyperarousal' (hypercortisolemia in the afternoon
      and evening, accelerated metabolism) similar to that seen with acute sleep deprivation. In
      addition, degradations of sleep quantity and quality in primary insomnia have been attributed
      to cognitive and somatic hyperarousal in the sleep setting. study examines and quantifies in
      adult men and women the link between primary insomnia and impaired glucose tolerance. This
      study examines the extent which adequate treatment of primary insomnia reverses impairments
      of glucose metabolism. If abnormalities of glucose metabolism are reversible, this study will
      demonstrate the importance of treatment of chronic primary insomnia.
    

Intervention name(s): eszopiclone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3mg tablet, by mouth nightly 30 min before bed, for two months; inactive placebo tablet, by mouth nightly 30 minutes before bed, for two months
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: sleep; metabolism; insulin; glucose; actigraphy; diary; volumetry; GABA
CP-481,715 Nickel Allergy Study.
Condition: Dermatitis, Allergic Contact
MeSH terms: Dermatitis; Dermatitis, Allergic Contact
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the suitability of contact allergy as a method for the evaluation of c-chemokine
      receptor-1 antagonist.
    


Intervention name(s): CP-481,715
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Phendimetrazine and Cocaine
Condition: Cocaine Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will determine the safety and tolerability of phendimetrazine (Bontril®) as a
      pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will
      be conducted in which the subjective and physiological effects of cocaine are evaluated
      during maintenance on placebo and phendimetrazine.
    


Intervention name(s): Cocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and phendimetrazine.; The pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine.
Intervention MeSH terms: Cocaine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cocaine; phendimetrazine; pharmacotherapy
The Use of a New Core Needle in the Endoscopic Ultrasound Assisted Tissue Sampling for Pancreatic Solid Masses
Condition: Pancreatic Masses
Study type: Observational

Summary: 
      Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and
      effective technique for obtaining samples from pancreatic masses. A new core biopsy needle
      has been developed by Beacon bnx® (Medtronic, Newton, MA) that allows the possibility to
      achieve a core for histology evaluation and the interchangibility of needle size using the
      same needle shelter and different needle sizes.
    

Detailed description: 
      At every pass, the material will be fixed in formalin. Three passes will be done. Details of
      the aspirated material will be described at macroscopic evaluation by the endoscopist and
      then by the pathologist at macroscopic and microscopic evaluation, in order to find an
      interobserved agreement on the definition of the core.
    

Intervention name(s): FNA with 25 G Beacon needle
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All consecutive patients referred for EUS examination and FNA of solid pancreatic masses,
        will undergo EUS-FNA with the 25G Shark core needle.
Study Evaluating Bifeprunox in Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate whether eight weeks of treatment with flexible
      doses of bifeprunox is superior to treatment with placebo in depressed patients with bipolar
      disorder.
    


Intervention name(s): Bifeprunox; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Depression; Bipolar Disorder
Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions
Condition: Hypertension, Essential
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence
      of a new fixed dose combination tablet of nifedipine GITS and candesartan with the
      corresponding loose combination and to compare it with the individual drugs
    


Intervention name(s): Nifedipine-candesartan FDC (BAY 98-7106); Nifedipine GITS (Adalat LA, BAYA1040); Candesartan (Atacand)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan; Single oral dose of 1 tablet of nifedipine GITS 60 mg; Single oral dose of 32 mg (2 x 16 mg tablet) candesartan
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Nifedipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Nifedipine; Candesartan; FDC
Efficacy of Ethnodyne Visio in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      ETHNODYNE VISIO is a food supplement composed of an innovative plant-based active ingredient
      acting alongside vitamin B2. It is proposed in patients with visual problems. Based on
      clinical and experimental data, the investigators propose a pilot open study in order to test
      the efficacy of "Ethnodyne visio" in patients with Parkinson 's disease (PD). The hypothesis
      is that Ethnodyne visio may improve motor and non motor signs of PD. 24 patients with PD will
      be evaluated before and after 3 months of add on treatment by Ethnodyne visio.
    


Intervention name(s): ETHNODYNE VISIO
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Treatment; Motor signs; Non motor signs; Fluctuations; Open labelled
Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study evaluates the efficacy isolated and combinaded of photobiomodulation therapy with
      low level laser therapy and the transcutaneous electrical nerve stimulation.
    

Detailed description: 
      Non-specific chronic neck pain patients will be treated with low-level laser therapy and/or
      trancutaneous electricam nerve stimulation. They will receive 10 sessions of treatment.
      Before and after the treatment physical measures and psychosocial factors will be evaluted to
      verificy the efficay these electrophysical agents.
    

Intervention name(s): Active PBM; Active TENS; Placebo PBM; Placebo TENS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): To active photobiomodulation therapy (PBMT) the patient will be oriented to lie preferably in prone. The treatment area will be defined according to painful area. In the active group will be used the followings parameters: low-level laser therapy, 808 nm, 4 infrared diodes, 180 mW, 9 J. In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.; To active transcutaneous electrical nerve stimulation (TENS) the patient will be oriented to lie preferably in prone. Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. It will be used the following parameters: frequency of 100 Hz, pulse duration of 125 µs (positive phase), 30 minutes of current stimulation and the pulse amplitude will be increased until the patient reports a strong but comfortable paresthesia (including motor level stimulation but no painful TENS). The amplitude will be adjusted (if necessary) each 5 minutes to keep a strong but comfortable paresthesia.; In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.; To placebo transcutaneous electrical nerve stimulation (TENS) Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. This device was customized to deliver a current for 30 seconds (both channels) and then ramp off over the next 15 seconds so that it will be active for a total of 45 seconds. This will permit the patient to fell the TENS sensation while applying the settings.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electrophysical agents; Low-level laser therapy; TENS; Neck pain; Chronic pain
Effects of Red Blood Cells Transfusion on Renal Blood Flow
Condition: Acute Kidney Injury; Transfusion-Associated Circulatory Overload; Anemia; Fluid Overload
MeSH terms: Acute Kidney Injury; Transfusion Reaction
Study type: Observational

Summary: 
      The renal Doppler resistive index (RRI) is a noninvasive tool that has been used to assess
      renal perfusion in the intensive care unit (ICU) setting. It is associated with the
      occurrence of acute kidney injury (AKI). Many parameters have been described as influential
      on the values of renal RI. Red blood cell (RBC) transfusion were shown to be able to increase
      renal oxygenation in animal model, whereas crystalloid resuscitation did not. We sought to
      describe the different effect of crystalloids infusion and RBC transfusion on renal blood
      flow, as evaluated with doppler ultrasound
    


Intervention name(s): Transfusion; Crystalloids infusion
Intervention type(s): Other; Other
Intervention description(s): RBC transfusion (1 unit); Infusion of 500 ml of balanced crystalloids
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cohort of critically ill patients
Effect of Glutamine and Vitamin C on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients
Condition: Critical Care
Study type: Interventional

Summary: 
      Background & Aims. Glutamine is a conditional essential amino acid that was found in reduced
      plasma amount in Intensive Care Unit (ICU) patients. The supplementations of glutamine and
      vitamin C potentially have beneficial effects on wound healing and a reduction in infection
      rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient,
      and the associated changes in proinflammatory cytokines and clinical outcomes were
      investigated.
    

Detailed description: 
      Background & Aims. Glutamine is a conditional essential amino acid that was found in reduced
      plasma amount in Intensive Care Unit (ICU) patients. The supplementation of glutamine in ICU
      patients has been under much debate. Another nutritional supplement, vitamin C, had a
      beneficial effect on wound healing and a reduction in infection rate. In this investigation,
      enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in
      proinflammatory cytokines and clinical outcomes were investigated.

      Methods. This is a prospective double-blind randomized study for surgical ICU patients whom
      can sustain enteral feeding. The test group was provided with glutamine and vitamin C (the GA
      group); the control (C) group was provided with maltodextrin of equivalent calories as that
      provided in the GA group. Plasma glutamine, interleukin-6 (IL-6), and clinical data were
      collected and analyzed with biostatistical methods.
    

Intervention name(s): Glutamine and vitamin C enteral supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects in the GA group received enteral supplement of 10 g L-glutamine and 90 mg vitamin C per serving provided by Nutritec-Enjoy Nutrition Inc. (Taipei, Taiwan). Subjects in the C group received isocaloric maltodextrin as placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Vitamin C; Glutamine; Interleukin-6; Clinical outcomes