bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Need to Void on Parkinsonian Gait
Condition: Lower Urinary Tract Symptoms; Parkinsonism; Gait Disorders, Neurologic
MeSH terms: Parkinsonian Disorders; Nervous System Diseases; Gait Disorders, Neurologic; Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      This study evaluates the effect of the need to void on parkinsonian gait
    

Detailed description: 
      Parkinsonian syndromes are common causes of gait disorders, associated with hypometria,
      bradykinesia or rigidity. If motor disorders are the most visible part, lower urinary tract
      dysfunction is one of the most prevalent dysautonomic disorder (27-80%), especially over
      active bladder syndrome (OAB). If it seems evident that gait and urinary disorders are
      linked, because of similar anatomic pathways and control processes, no studies have
      investigated their association in extrapyramidal patients.

      The aim of this study is to assess the effect of the need to void on the walking speed in
      this particular population.

      This prospective study inclues all parkinsonian syndromes who had a follow-up for OAB. They
      must have a security delay over five minutes, no severe cognitive, motor or psychiatric
      disorders. We invite them to drink until a need to void (or equivalent). Bladder filling is
      measured by bladder scan, then they performe gait tests in a specific place, with calm and no
      passage : Patient can use their habitual walking device. Speed walk asking is comfortable for
      the two test. Three ten-meter tests, one double-task ten-meter test, one timed-up-and-go
      test, one timed raise of the floor (GMT). We repeat the same tests after voiding or
      self-catheterization. Toilets are just next to the hall where they realize the tests. A
      clinical examination assesses urinary dysfunction (USP, IPSS), motor score (UPDRS-III, Hoehn
      and Yahr scale, daily equivalent of levodopa), history of falls and comorbidities.
    

Intervention name(s): Gait speed
Intervention type(s): Other
Intervention description(s): No intervention, only propose water and wait for need to void
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients consulting in a tertiary center in neuro-urology
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety tolerability, and PK profile of K-312
      and its metabolites in healthy Japanese and non-Japanese adults.
    


Intervention name(s): K-312 10 mg QD; K-312 25 mg QD; K-312 50 mg QD; K-312 100 mg QD; K-312 200 mg QD; K-312 400 mg QD; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Cognitive Rehabilitation in Sickle Cell Disease
Condition: Sickle Cell Disease; Cognitive Impairment
MeSH terms: Anemia, Sickle Cell; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The majority of school-age children with sickle cell disease (SCD) experience neurocognitive
      deficits, even in the absence of stroke. In particular, deficits in attention and working
      memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal
      of the present proposal is to address feasibility and compliance of a novel computerized
      cognitive training program, Cogmed. Pilot data will also be collected to establish
      preliminary efficacy. Twenty-four children meeting initial age and diagnostic criteria will
      be identified and approached about participation by their attending physician during
      regularly-scheduled SCD clinic visits. Baseline assessments will include a brief measure of
      intellectual functioning, a brief cognitive testing battery evaluating processing speed and
      working memory, in addition to questionnaires regarding behavior and quality of life.
      Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist
      control (n=12). Participants enrolled in the computerized CT program will be asked to
      complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week).
      Following completion of the program, children and their parents will be asked to return to
      clinic for a follow-up visit. After a five to eight-week waiting period, children in the
      waitlist condition will also be asked to return to clinic for a second visit. Following this
      assessment, participants initially enrolled in the waitlist will be offered an opportunity to
      participant in the intervention. If interested, they will follow the same intervention
      protocol described above. These children will return to clinic for a third visit following
      completion of the intervention. Compliance rate and its confidence interval will be
      calculated for the overall study population. A t-test for binomial proportion with continuity
      correction will be used to examine whether the compliance rate is lower than the target.
      Participants' change in criterion outcomes will be evaluated (i.e., those neurocognitive
      measures such as attention, executive functioning and working memory, that are most closely
      related to the trained tasks).
    


Intervention name(s): Cogmed
Intervention type(s): Behavioral
Intervention description(s): Computer based program that aims to improve children's memory, attention, and processing speed.
Other intervention name(s): Cogmed computerized cognitive training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sickle cell disease; pediatric; learning disability; cognitive impairment; memory; attention; Children with sickle cell disease
MyoStrain CMR for the Detection of Cardiotoxicity
Condition: Cardiotoxicity; Heart Failure; Chemotherapeutic Toxicity
MeSH terms: Cardiotoxicity
Study type: Observational

Summary: 
      The Prefect Pilot Study evaluates the use of the EC approved MyoStrain SENC CMR Imaging
      System to detect cardiotoxicity from drugs used to treat cancer (e.g. Breast Cancer and
      Lymphomas).
    

Detailed description: 
      The study is a prospective, observational, single center, observational clinical study that
      will enroll up to 50 patients undergoing chemotherapy and/or targeted therapy with or without
      concomitant radiotherapy for the treatment of breast cancer or lymphoma. Enrolled subjects
      will be evaluated with the MyoStrain SENC CMR Imaging System that measures myocardial strain
      during standard Cardiac Magnetic Resonance imaging at baseline through 6 month follow-up.

      The MyoStrain SENC CMR Imaging System has been approved with an EC Certificate according to
      Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 (CE 657862) in respect
      of: Design, development and manufacture of software for the quantification of cardiac MRI
      images. MyoStrain measures the contraction of heart muscle in one heartbeat per image plane.
      With 6 image planes (3 short axis & 3 long axis), a complete measure of the health of the
      myocardium, both regionally and globally, can be obtained within a minute without requiring
      contrast injection or a breath-hold.

      Heart health will be monitored throughout cancer therapy to quantify the toxic effects of
      chemotherapy with or without a reduction in traditional measures such as ejection fraction,
      and the ability to reverse observed cardiotoxicity with standard heart failure therapy.

      The goal of the study is to determine the ability to detect subclinical cardiotoxicity before
      extensive damage causes the reduction in traditional measures, which are currently used to
      categorize heart failure and serve as the basis of treatment guidelines.
    

Intervention name(s): MyoStrain
Intervention type(s): Diagnostic Test
Intervention description(s): MyoStrain quantifies myocardial contraction to detect changes in heart function during chemotherapy.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be carefully selected from the pool of patients currently undergoing or
        scheduled to undergo chemotherapy for cancer treatment including breast cancer and lymphoma
        patients.
      
Keywords: Strain
Desensitization in Kidney Transplantation
Condition: HLA Sensitization
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine if deletional strategies will provide effective desensitization.
    

Detailed description: 
      A prospective iterative trial of proteasome inhibitor (PI)-based therapy for reducing
      HLAantibody (Ab) levels was conducted in five phases differing in bortezomib dosing density
      and plasmapheresis timing. Phases included 1 or 2 bortezomib cycles (1.3mg/m2,6-8 doses), one
      rituximab dose and plasmapheresis. HLA Abs were measured by solid phase and flow cytometry
      (FCM) assays. Immunodominant Ab (iAb) was defined as highest HLA Ab level. Forty-four
      patients received 52 desensitization courses (7 patients enrolled in multiple phases): Phase
      1 (n=20), Phase 2 (n=12), Phase 3 (n=10), Phase 4 (n=5), Phase 5 (n=5).
    

Intervention name(s): plasmapheresis; Bortezomib; Rituximab; Methylprednisolone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients will receive plasmapheresis 1.5 x plasma volume prior to each Bortezomib dose. Plasma volume replacement will be per physician discretion.; Patients will receive bortezomib as described in protocol; Patients will receive rituximab as described in protocol; Each bortezomib dose will be preceded by intravenous methylprednisolone (100mg for first two doses and 50mg for following doses).
Other intervention name(s): Velcade; Rituxan; Medrol
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Rituximab; Bortezomib; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alloantibody; Desensitization; Kidney Transplantation; Nephrology; Plasma Cells; Translational Research/Science
Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo Via Devices Administered Twice Daily for 5 Days
Condition: Influenza A Virus, H1N1 Subtype
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and tolerability of Zanamivir using a
      Rotahaler device presentation to placebo within the Rotahaler presentation and to the
      Diskhaler device.
    

Detailed description: 
      The purpose of this study is to compare the safety and tolerability of Zanamivir using a
      Rotahaler to placebo within the Rotahaler presentation and to the Diskhaler. Eighteen
      subjects will receive each of three treatments for 5 days in a 3-way crossover design.
    

Intervention name(s): Zanamivir; Zanamivir; Zanamivir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rotahaler placebo 10mg BID 5 days; Rotahaler Zanamivir 10mg BID 5 days; Diskhaler Zanamivir 10mg BID 5 days
Intervention MeSH terms: Zanamivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: pk; healthy subjects; influenza virus; Safety; pandemic
Apoptotic Changes in Gingiva Caused by Smoking
Condition: Smoking; Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Observational

Summary: 
      Smoking is a major environmental risk factor associated with common forms of human chronic
      periodontitis. The aim of the present study was to evaluate apoptotic tissue alterations and
      tissue destruction in smoker and non-smoker chronic periodontitis patients and healthy
      individuals. The investigators of the study suggest that smoking decrease tissue quality and
      increase inflammation level in gingival tissues in both healthy individuals and periodontitis
      patients. One possible mechanism for this is suggested to be increased apoptosis.
    

Detailed description: 
      Periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the
      production of collagen, the quality, and quantity of the connective tissue. The etiology and
      pathogenesis of chronic periodontitis are mostly revealed, however, the mechanism of
      environmental factors such as smoking yet to be clarified. Major consequences of smoking in
      gingival tissues are suggested to be the reduction in neutrophil and fibroblast function,
      decreased immunoglobulin G production, increased periodontal pathogen bacteria prevalence,
      difficulty in eliminating pathogens with mechanical therapy, and reduction in growth factor
      production. In the present study, markers of tissue destruction, matrix metalloproteinase-8
      and tissue inhibitor of matrix metalloproteinase-1, hypoxia markers, vascular endothelial
      growth factor and hypoxia-inducible factor and apoptotic markers, bax, bcl-2, and caspase-3
      were evaluated.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy individuals who were either smokers or non-smokers, chronic periodontitis patients
        who were either smokers or non-smokers older than 30 years old and younger than 50 years
        old were enrolled. The age was specifically chosen because aging changes periodontal and
        gingival tissues independently of other variables. Any possible factor which might alter
        connective tissue metabolism were excluded.
      
Biospecimen description: 
      Gingival tissue biopsy samples
    
Keywords: smoking; hypoxia; apoptosis; chronic periodontitis
Long Sleep Duration and Vascular Function
Condition: Sleep
Study type: Interventional

Summary: 
      Sleep duration has received much attention in recent years due to strong evidence that not
      enough sleep can increase risk for a number of diseases and disorders. Research is emerging
      that too much sleep also has a negative impact on health, particularly higher risk for
      myocardial infarction and stroke. The investigators hypothesize that long duration sleep has
      the ability to impair peripheral and cerebral vascular function in middle-aged to older
      adults.
    

Detailed description: 
      The aim of this study is to compare the effect of long duration sleep (>9 hours) to
      recommended levels of sleep (7-8 hours) in a crossover designed study requiring adults to
      maintain each prescribed sleep duration for one week. Ambulatory brachial and central aortic
      blood pressure will be measured during sleep, while cerebrovascular reactivity, carotid
      artery hemodynamics (e.g., flow pulsatility), aortic pulse wave reflections, cognitive
      function, and peripheral vasodilatory function will be measured before and after each sleep
      protocol. A secondary objective of this study is to understand whether aerobic exercise can
      improve vascular function under conditions of different sleep durations. This information
      will shed light upon the impact of sleep parameters on exercise-induced improvements in
      vascular function.
    

Intervention name(s): Sleep duration
Intervention type(s): Behavioral
Intervention description(s): Participants will be asked to alter time in bed to achieve specified sleep durations.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This project will be a randomized crossover study. Each week will consist of a different time in bed schedule of either 8 or 11 hours time in bed (TIB). The investigators estimated that about 11 hours in bed will result in at least 9 hours of total sleep time (i.e., long duration sleep). Laboratory testing will occur after five consecutive nights of either 8h or 11h TIB to assess the effect of sleep duration on vascular function, and after the sixth consecutive night of TIB to assess the effect of exercise on vascular function under different sleep conditions.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sleep duration; blood pressure; vasodilation; cognitive function
Our Lifestyles Our Lives
Condition: Pediatric Obesity; Weight Loss
MeSH terms: Obesity; Pediatric Obesity; Weight Loss
Study type: Interventional

Summary: 
      The purpose of the study was to examine the influence of step goals with pedometers to
      improve children's weight loss, physical activity, and psychosocial health during behavioral
      treatment. Children with overweight or obesity were assigned to receive the behavioral
      treatment alone, plus pedometers, or plus pedometers with step goals.
    

Detailed description: 
      A total of 105 overweight and obese children ages 8 to 17 years participated in a 10-week
      family-based weight management intervention focusing on physical activity, nutrition, and
      behavioral modification. A quasi-experimental design was used to group cohorts into three
      conditions: two cohorts had no pedometer (n=24); two cohorts had pedometer only (n=25); and
      four cohorts had pedometer with step goals (i.e. 500 steps/day weekly increase above
      baseline; n=56). Height and weight were measured at baseline and week 10 and used to
      calculate body mass index (BMI). Analysis of covariance was performed to examine difference
      by condition for change in weight, BMI, and BMI z-score, controlling for age and baseline
      value. Differences in steps/day and psychosocial health were compared between the two
      pedometer conditions.
    

Intervention name(s): Family-based weight management; Pedometer; Individualized step goals
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The "Our Lifestyles, Our Lives" family-based weight management intervention consisted of 10 weekly 90-minute group sessions focused on physical activity, nutrition, and behavioral modification. Parents and siblings were encouraged to join the participant in these sessions. Sessions were interactive and included cooking demonstrations, light to moderate intensity physical activity that engaged all family members, and behavioral counseling sessions in both mixed (parent and child) and parent-only format.; In addition to participating in the family-based weight management intervention, participants were given a pedometer (Omron HJ-324U, Omron Healthcare, Lake Forest, IL) and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10.; In addition to participating in the family-based weight management intervention, participants were given a step goal to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
Other intervention name(s): Activity monitor
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: behavior goals; self-monitoring; pedometer; physical activity
IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer
Condition: Stage IV Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to improve the duration of control disease for PS 0-1 patients
      who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is
      for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a
      second-line chemotherapy when progression of disease is occurring. Two approaches will be
      experimented in this trial in attempt to prolong progression free survival :

        -  Maintenance chemotherapy with single-agent gemcitabine continued till disease
           progression or toxicity.

        -  Sequential treatment with erlotinib immediately given after the end of first-line
           chemotherapy.
    


Intervention name(s): observation; gemcitabine; erlotinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): observation, second line chemotherapy if progression; 1250 mg/m² D1, D8 q21 days; 150 mg daily
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-small cell lung cancer ;; metastatic ;; chemotherapy ;; erlotinib
Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This is a 3-arm randomized trial aimed at increasing rates of participation in colorectal
      cancer (CRC) screening by outreach to patients' homes using choice architecture informed by
      behavioral science principles.
    

Detailed description: 
      The investigators will evaluate the effectiveness of mailed outreach with choice between
      colonoscopy and FIT, and FIT alone, as compared to colonoscopy alone in increasing CRC
      screening rates.
    

Intervention name(s): Colonoscopy Only; Choice; FIT Only
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Mailed letter asking participants to complete CRC screening by colonoscopy; Mailed letter and FIT test asking participants to complete CRC screening by their choice of either colonoscopy or mailed FIT; Mailed letter and FIT test asking participants to complete CRC screening by mailed FIT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: screening; prevention; colonoscopy; stool testing
Pilot Clinical Trial of Computer-based Motivational Intervention - 1
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Pilot trial of computer-based motivational intervention. Hypothesis: The brief
      computer-delivered intervention would result in higher motivation to change at follow-up.
    

Detailed description: 
      Participants were randomized into brief intervention vs. assessment-only conditions, with
      follow-up to measure overall motivation to change.
    

Intervention name(s): Brief computer-delivered intervention
Intervention type(s): Behavioral
Intervention description(s): 20-minute interaction with voice-enabled software that could provide reflections, images, text, etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment