bioihbjkbjnl/mcl2 huggingface dataset:
Effects on Balance of Suspension Exercise vs. Exercise on Unstable Surfaces
Condition: Balance Training; Instability
Study type: Interventional

Summary: 
      Most human movements are executed while in a state of postural instability. For this reason,
      instability training is a highly-specific method that is intended to improve balance and
      postural control. This research aimed to determine the effect of instability training on the
      balance of individuals with similar baseline abilities, who initiated training within
      different stability conditions. Research question: Does different type of instability
      training determine improvements in balance?
    


Intervention name(s): Suspension training; Instability training
Intervention type(s): Other; Other
Intervention description(s): Training with suspension devices. 12 sessions of 40-45 min in four weeks.; Training on unstable surfaces. 12 sessions of 40-45 min in four weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Suspension training; Instability training; Balance
Two-site Intradermal Influenza Vaccination in Elderly
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      One-site dose sparing intradermal influenza vaccination in elderly had been studied but
      resulted in unsatisfactory outcomes. The investigators evaluate the safety and immunogenicity
      of the two-site intradermal injection of influenza vaccine containing all 6 and 12 micrograms
      of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram
      HA/strain intramuscular vaccine respectively) in elderly over 60 years of age. An influenza
      vaccine administered intramuscularly at the standard dose is used as the reference vaccine.
    

Detailed description: 
      The subjects would be randomly divided into three groups of 60 subjects each. Group1 receives
      a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15
      microgram of hemagglutinin antigen per strain, Group II receives two-site intradermal dose of
      0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and
      group III receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram
      of hemagglutinin antigen per strain per site. Check for HA Antibody
    

Intervention name(s): seasonal influenza vaccine; seasonal influenza vaccine; seasonal influenza vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain; receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group; receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site
Other intervention name(s): influenza vaccine 2010 southern hemisphere; lot no 0700302A; influenza vaccine 2010 southern hemisphere; lot no 0700302A; influenza vaccine 2010 southern hemisphere; lot no 0700302A
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: influenza; aged; intradermal injection
Reliability and Validity of Turkish Version of PEM-CY
Condition: Child
Study type: Observational

Summary: 
      The Participation and Environment Measure for Children and Youth (PEM-CY) is the first
      instrument that combines parental assessment of children's participation in home, school, and
      community activities with qualities of each environment that are perceived to support or
      hinder participation. This combined format may help to clarify the relative impact of
      environmental factors (including the natural and built environment), compared to personal
      factors, on children's participation in specific settings. The aim of this study was to
      examine reliability and validity of Turkish version of the Participation and Environment
      Measure for Children and Youth (PEM-CY).
    

Detailed description: 
      The International Classification of Functioning, Disability and Health-Child and Youth
      Version (ICF-CY; WHO 2007) is designed to guide assessment and intervention efforts to
      minimize disparities in children's participation. Participation is defined in the ICF-CY as
      ''involvement in life situations'' and is further conceptualized as a multidimensional
      construct with both objective (e.g., frequency) and subjective (e.g., satisfaction)
      dimensions. Participation is linked to contextual factors, including: 1) personal factors
      (child personal factors such as child's age, gender, and functional abilities; family
      demographic factors); and 2) features of environments (physical (natural and built), social,
      attitudinal, and institutional factors, and availability and adequacy of resources). Since
      its adoption in the ICF-CY, an increasing number of participation measures have been
      developed. Among these measures, the Participation and Environment Measure for Children and
      Youth (PEM-CY) is the first instrument that combines parental assessment of children's
      participation in home, school, and community activities with qualities of each environment
      that are perceived to support or hinder participation. This combined format may help to
      clarify the relative impact of environmental factors (including the natural and built
      environment), compared to personal factors, on children's participation in specific settings.
    

Intervention name(s): Participation
Intervention type(s): Other
Intervention description(s): The PEM-CY will be field-tested with a sample of 650 caregivers of children with and without disabilities residing in the Turkey.
Other intervention name(s): PEM-CY
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Caregivers of children with and without disabilities
      
Keywords: children; disability; family; participation
Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients
Condition: Parkinson's Disease; Tolerability
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the safety and tolerability of ACR325 in Parkinson disease patients
      and evaluate the effect on levodopa induced dyskinesias.
    


Intervention name(s): ACR325; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks; Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Levodopa; Dyskinesia; ACR325
TeleRehabilitation Following Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Injuries
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed
      at patients' home utilizing video telecommunication services with real-time synchronous
      exchange of information. The advantages of telerehabilitation include reducing unnecessary
      travel to the hospital and person to person contact while maintaining social distancing.
      While some of the patients are truly staying at remote areas, others are unable to manage
      travel in the lockdown period. Telemedicine offers the opportunity to deliver rehabilitative
      services in the patients' home, closing geographic, physical, and motivational gaps.
      Punctuality on either side is also assured since the travel times are saved on both the ends.

      The purpose of the research study is to compare two standard of care rehabilitation methods
      (telerehabilitation vs in-person rehabilitation) following routine rotator cuff repair.
      Objectives include assessing range of motion and patient reported functional outcomes.
    


Intervention name(s): Telerehabilitation Therapy; In-person Rehabilitation Therapy
Intervention type(s): Other; Other
Intervention description(s): Rehabilitation services will be dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information - range of motion exercises and stretching.; Range of motion exercises and stretching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Lenalidomide may stop the growth of kidney cancer by blocking blood flow to the
      tumor.

      PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients
      with advanced or unresectable kidney cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the best response in patients with advanced or unresectable renal cell
           carcinoma (RCC) treated with lenalidomide.

        -  Evaluate the response duration, time to tumor progression, and survival of patients with
           advanced RCC treated with lenalidomide.

        -  Evaluate the safety of this drug in these patients.

      OUTLINE: This is an open-label study.

      Patients receive oral lenalidomide daily on days 1-21. Courses repeat every 28 days in the
      absence of unacceptable toxicity or disease progression.

      After completion of study treatment, patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
    

Intervention name(s): lenalidomide
Intervention type(s): Drug
Intervention description(s): drug
Other intervention name(s): CC-5013
Intervention MeSH terms: Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III renal cell cancer; stage IV renal cell cancer; recurrent renal cell cancer
The Role of Hydration on Exercise Performance - ODIN
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      During exercise in the heat, there is a need to replenish fluids in order to avoid
      dehydration and decrease the risk for heat illness. What drives this urge to drink is the
      thirst mechanism. Following ingestion of fluids, there is an inhibition of thirst before
      there is a replenishing of fluids. However, there is little scientific evidence of where
      thirst is inhibited, if this thirst inhibition is augmented by exercise and how thirst itself
      influence exercise performance. Further, during rehydration studies, it is very difficult to
      successfully blind a subject to their drinking/hydration protocol. Previous studies that have
      blinded a subject to their drinking have used various methods such as intravenous fluid
      administration and/or nasogastric tubes. Therefore, the purpose of this research is to
      examine the mechanistic roles thirst inhibition plays while exercising in the heat while
      undergoing intravenous fluid administration. Specific attention will be directed to the
      cardiovascular and thermoregulatory function of the individuals. All blood, cardiovascular,
      thermoregulatory, and perceptual measures are shown in the diagram below.
    


Intervention name(s): iv fluid infusion
Intervention type(s): Other
Intervention description(s): Intravenous isotonic saline infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Phase I Trial of an Investigational Small Pox Medication
Condition: Orthopoxviral Disease; Smallpox; Monkey Pox
MeSH terms: Smallpox; Monkeypox
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a
      single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy
      volunteers.
    

Detailed description: 
      This was a Phase I, double-blind, cross-over, single-dose study of the orally administered
      anti-orthopoxvirus compound, ST-246, to 12 healthy, fed volunteers between the ages of 18 and
      50 years. Subjects were randomized such that 6 subjects received either ST-246 Form I
      (monohydrate) followed 10 days later after a wash-out period by Form V (hemihydrate), and 6
      subjects received ST-246 Form V followed by Form I, as for the previous group.

      Both forms of ST-246 were similar in the way they were manufactured. The only difference
      between Form I and Form V may be related to how it dissolves, and this may affect the way
      that it is absorbed in the human body. Information about any side-effects that may occur will
      also be collected in this study.
    

Intervention name(s): ST-246 Days 1 - 3; ST-246 Days 11 - 13
Intervention type(s): Drug; Drug
Intervention description(s): First Intervention is on Days 1 - 3, and includes 6 patients dosed once orally with ST-246 Form I (Arm 1), and 6 patients dosed once orally with ST-246 Form V (Arm 2).; Second Intervention is on Days 11 - 13 (after a 3 day post-treatment monitoring and 7 day wash-out period) where the 6 patients previously given ST-246 Form I (Arm 1) are now dosed once orally with ST-246 Form V, and the 6 patients previously given ST-246 Form V (Arm 2) are now dosed once orally with ST-246 Form I.
Other intervention name(s): Tecovirimat; Tecovirimat
Intervention MeSH terms: Tecovirimat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Orthopoxviral; Smallpox; Monkey pox
Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare efficacy of quetiapine fumarate combined with
      Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social
      outcome in patients with schizophrenia.
    


Intervention name(s): Quetiapine fumarate; conventional treatment for schizophrenia
Intervention type(s): Drug; Drug
Intervention description(s): oral; various standard therapies
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Time of Intravenous Acetaminophen Administration
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to examine the effects of timing of administration of intravenous
      (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative
      pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled
      total hip replacement under general anesthesia will be randomized into one of two arms: 1)
      the pre-closure group will receive the first dose administered upon onset of skin closure, 2)
      the preemptive group will receive the first dose administered within 60 minutes prior to
      incision. Both groups will receive subsequent doses every 6 hours x 24 hours.
    

Detailed description: 
      The purpose of the study is to examine the effects of timing of administration of intravenous
      (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative
      pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled
      total hip replacement under general anesthesia will be randomized into one of two arms: 1)
      the closure group will receive the first dose of one gram of intravenous acetaminophen
      administered upon onset of skin closure, 2) the preemptive group will receive the first dose
      of one gram of intravenous acetaminophen administered within 60 minutes prior to incision.
      Both groups will receive subsequent doses of one gram of intravenous acetaminophen every 6
      hours x 24 hours. The maximum dose in a 24 hour period will not exceed 4 grams according to
      FDA recommendations.
    

Intervention name(s): Acetaminophen
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: acetaminophen; timing; arthroplasty
Performance-based Reinforcement to Enhance Cognitive Remediation Therapy
Condition: Substance-Related Disorders; Mental Disorders
MeSH terms: Substance-Related Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether monetary reinforcement for performance
      will enhance the effects of cognitive remediation therapy for substance users seeking
      treatment at an outpatient facility.
    

Detailed description: 
      Forty individuals seeking treatment for an alcohol or cocaine use disorder at the Substance
      Abuse Treatment Unit (SATU) will be randomized to receive cognitive remediation therapy with
      or without additional compensation based on performance. Participants will use the
      computerized cognitive remediation program (PSSCogRehab 2012) three times per week for four
      weeks. The primary outcome measure will be an improved performance on the computerized tasks,
      with secondary outcomes of changes in cognitive functioning (e.g., attention, concentration,
      memory) as measured by neuropsychological tests between baseline and post-treatment.
    

Intervention name(s): Cognitive Remediation Therapy - Standard; Cognitive Remediation Therapy plus Contingency Management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Computerized cognitive remediation therapy provided three times per week for four weeks; Standard cognitive remediation therapy plus monetary incentives based on performance provided three times per week for four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive remediation therapy; substance abuse treatment
Effects of Crestor on Inflammation of Atherosclerotic Plaques
Condition: Atherosclerosis; Inflammatory Activity in Carotid Arteries
MeSH terms: Atherosclerosis; Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary aim of this study is to investigate the effect of 40 mg dose of rosuvastatin on
      carotid plaque inflammation measured with MRI and PET scanning, to evaluate whether these
      techniques are promising for future proof of principle studies. A number of patients will
      receive placebo as a control.
    


Intervention name(s): rosuvastatin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg, tablet, once daily for 3 months.; 40 mg, tablet, once daily for 3 months
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: imaging biomarkers; MRI; FDG-PET/CT scanning; Crestor
Mechanisms of Diabetes Control After Weight Loss Surgery
Condition: Gastric Bypass Surgery; Obesity
MeSH terms: Weight Loss
Study type: Observational

Summary: 
      Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking
      bariatric surgery have T2DM. Although all surgeries result in significant weight loss and
      often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass
      (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the
      improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by
      weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance
      insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific
      anatomical changes after this surgery. While some determinants of impaired insulin secretion,
      such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in
      the incretin effect after GBP might be specific to this surgery. The aim of this study is to
      determine whether the magnitude of the incretin effect on insulin secretion is greater after
      GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients
      with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent
      weight loss on the incretin effect (difference in insulin secretion after comparable oral and
      intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding
      the mechanisms that produce improvement in their diabetes is increasingly important.
    


Intervention name(s): gastric bypass surgery; Diet induced weight loss
Intervention type(s): Procedure; Other
Intervention description(s): weight loss bariatric surgery; low calorie diet with meal replacements. weekly outpatient visits with nutritionist.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Morbidly obese patients with type 2 diabetes of less than 5 years duration
      
Biospecimen description: 
      blood samples
    
Keywords: gastric bypass; diabetes; obesity; diet-induced weight loss; incretin levels (GLP-1,GIP); incretin effect