bioihbjkbjnl/mcl2 huggingface dataset:
Study To Evaluate The Immunogenicity And Safety Of r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of the study are:

      - comparison of the incidence and time course of the development of neutralizing antibodies
      (NAbs) to Rebif after 48 weeks of therapy, to historical data from Serono clinical trial
      databases to assess the safety and tolerability of Rebif®
    


Intervention name(s): Rebif® (clone 484-39)
Intervention type(s): Biological
Intervention description(s): s.c. administered Rebif®
Other intervention name(s): Recombinant-human interferon beta-1a; r-hIFN Beta-1a
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lymphedema Prevention in Breast Cancer
Condition: Breast Cancer; Lymphedema
MeSH terms: Breast Neoplasms; Lymphedema
Study type: Interventional

Summary: 
      OBJECTIVE: To find out the effectiveness of early application of Manual Lymph Drainage in the
      prevention of upper limb lymphedema after breast surgery and axillary lymphadenectomy in
      women with breast cancer.

      DESIGN: Randomized, controlled and single blinded clinical trial. Five years duration.
      Patients were randomly assigned to one of these groups: Experimental group: Manual Lymph
      Drainage + training in means of prevention; Control group: just training in means of
      prevention. In both groups several physical therapy assessments were undertaken: 1st before
      surgery; 2nd 3 month after surgery; 4th, 5th, 6th, 7th, 8th and 9th after 6, 12, 24, 36, 48
      and 60 months.

      SUBJECTS: Women with breast cancer treated with breast surgery including axillary
      lymphadenectomy in Provincial Hospital of Toledo, provided that there is no contraindication
      for manual lymph drainage, and after reading, understanding and freely signing an informed
      consent form.

      SAMPLE SIZE: A total of 150 subjects were included in the study (57 subjects in experimental
      group and 93 in control group), assuming a 20% of drop-outs and at least 25% reduction, with
      a statistical power of 75%.

      DATA ANALYSIS: To find out the effectiveness of intervention the investigators will compare
      the rate of lymphedema in both groups by means of a logistic regression analysis, in which
      the main factor is the intervention group. Other factors aimed to control the effect of the
      intervention will also be included. In order to compare the rate of appearance of lymphedema
      in both groups, a survival analysis will also be included.
    


Intervention name(s): 14 sessions of manual lymphatic drainage technique; the health education
Intervention type(s): Procedure; Other
Intervention description(s): Early manual lymph drainage including 14 sessions of manual lymphatic drainage technique in the three months following surgery and health education for lymphedema prevention including verbal instructions and written materials.; The health education for lymphedema prevention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lymphedema; Prevention
Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With Schizophrenia
Condition: Cognitive Deficits in Schizophrenia
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an efficacy and safety study evaluating an experimental treatment for cognitive
      deficits in adults with schizophrenia.
    

Detailed description: 
      This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-288 in
      approximately 210 adults with schizophrenia. Subjects will be randomized to one of three
      treatment groups (ABT-288 Dose 1, ABT-288 Dose 2 or placebo) for a 12-week Treatment Period.
      The purpose of this research study is to find out whether ABT-288 compared to placebo can
      improve cognition and what side effects ABT 288 may cause. Cognition is the way a person
      thinks, and it includes abilities like paying attention, focusing, remembering things, and
      solving problems. Acronyms listed in the Outcomes and/or Eligibility sections for this study
      are defined below:

        -  MCCB: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
           Consensus Cognitive Battery

        -  UPSA-2: University of California at San Diego (UCSD) Performance-Based Skills
           Assessment-2

        -  CANTAB: Cambridge Neuropsychological Test Automated Battery

        -  PANSS: Positive and Negative Syndrome Scale

        -  NSA-16: Negative Symptom Assessment-16

        -  CGI-S: Clinical Global Impression - Severity
    

Intervention name(s): ABT-288 Low Dose; Placebo; ABT-288 High Dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): inactive substance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Pre-Exercise Nutrition Strategies on Body Temperature and Thermoregulatory Responses
Condition: Impaired Thermoregulation
Study type: Interventional

Summary: 
      Carbohydrate ingestion, in particular fructose, has been shown in a handful of previous
      studies to elicit a thermic effect and increase core body temperature after ingestion.
      Carbohydrate foods and supplements are commonly consumed prior to endurance running
      competition, including situations where an athlete's ability to dissipate body heat is
      compromised. Thus, there is some potential for pre-exercise carbohydrate ingestion to have a
      deleterious effect on body heat regulation in hot and humid environments. Thus, this projects
      aims to study the effects of pre-exercise carbohydrate ingestion on core body temperature,
      perceived thermal stress, and perceived exertion during high-intensity running.
    


Intervention name(s): Carbohydrate Beverage; Placebo Beverage
Intervention type(s): Other; Other
Intervention description(s): 750 ml of a 13.5% carbohydrate (sucrose) beverage; 750 ml of an artificially-sweetened beverage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Exercise
An Exploratory Phase 1 Microdose Study of PRX-105
Condition: Organophosphate Exposure
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Exploratory phase 1, first in human, open label, non-randomized, single-dose study of
      PRX-105, administered intravenously by slow bolus injection to 10 healthy volunteers. The
      objective is to evaluate the pharmacokinetic profile of PRX-105 without any significant
      physiological effect in healthy volunteers after a single, intravenous microdose
      administration.
    


Intervention name(s): PRX-105
Intervention type(s): Drug
Intervention description(s): Sterile solution for intravenous injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: acetylcholinesterase
Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis
Condition: Peritoneal Dialysis Associated Peritonitis
MeSH terms: Peritonitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in
      Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent
      peritonitis remains the major cause of peritoneal failure. A reliable predictor of relapsing
      peritonitis is invaluable in the management of PD peritonitis. Recent studies showed that
      bacterial-derived lipopolysaccharide (LPS) fragments are present in clinically used fluids
      such as dialysis fluid. LPS are thought to be derived from microorganisms inhabiting body
      fluid. The investigators hypothesize that the presence of LPS in PD effluent is a predictor
      of relapsing peritonitis in PD patients. The investigators plan to study 300 patients with PD
      peritonitis. After inform consent, specimens of PD effluent will be collected on the day of
      initiating antibiotic treatment, every 5 days until the day of completing antibiotic
      treatment, and then 28 days later for the test of LPS level. All patients will be followed
      for one year after completion of antibiotic therapy for the development of relapsing,
      recurrent, or repeat peritonitis episodes. Our study would explore the use of detecting LPS
      in PD effluent as a non-invasive tests for the prediction of relapsing peritonitis.
    


Intervention name(s): endotoxin assay in peritoneal dialysis effluent
Intervention type(s): Other
Intervention description(s): endotoxin level by Limulus Amebocyte Lysate (LAL) assay
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: renal failure; survival; peritoneal failure
A Study to Investigate the Receptor Occupancy of SK-1405 in Healthy, Caucasian, Male Subjects
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to confirm the target receptor occupancy of SK-1405 and to correlate
      receptor occupancy with SK-1405 dose and plasma concentration.

      The secondary objective is to assess the safety and tolerability of SK-1405 in healthy,
      Caucasian, male subjects.
    


Intervention name(s): SK-1405
Intervention type(s): Drug
Primary purpose: Treatment
Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.
Condition: Sexual Dysfunction
Study type: Interventional

Summary: 
      Patients with a primary complaint of vaginal looseness and sexual dysfunction, visiting a
      sexual dysfunction clinic at a tertiary medical center will undergo randomization to either a
      series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be
      measured by several validated questionaires and by means of gynecological examination.
    

Detailed description: 
      Patients suffering from vaginal looseness and sexual dysfunction, as a primary sexual
      dysfunction complaint will be recruited, sign an informed consent and will receive a thorough
      explanation regarding the side effects and possible beneficial affects the laser treatments
      may bestow.

      Patients will undergo randomization to either a series of 3 laser treatments or 3 sham
      treatments, and the effect of these treatments will be measured by several validated
      questionaires and by means of gynecological examination.

      Follow up after treatment cessation will be for 12 months post-treatment.
    

Intervention name(s): Erbium laser; Sham Laser
Intervention type(s): Device; Device
Intervention description(s): Erbium laser device; Sham laser device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Exercise During Pregnancy and Perinatal Outcome
Condition: Pregnancy; Healthy
Study type: Interventional

Summary: 
      Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.
    

Detailed description: 
      The aim of this study is to examine the effect of a supervised physical exercise program
      during pregnancy on fetoplacental circulation, fetal heart echocardiogram parameters and
      perinatal outcome.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training.
Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: fetal heart; cesarean section; exercise; pregnancy
HPI in Older Patients Undergoing Major Gastrointestinal Surgery
Condition: the Severity and Duration of Intraoperative Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The incidence of intraoperative hypotension was 91%. The increasing incidence of
      intraoperative hypotension would increase the risk of postoperative complications, such as
      postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a
      major surgery. Older patients usually have many comorbidity, such as hypertension or
      cardiovascular disease. Prevention intraoperative hypotension is an important issue.
      Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean
      arterial pressure (MAP)<65mmHg). In this study, we aimed to investigate whether HPI could
      prevent the intraoperative hypotension happened in patients receive elective major
      gastrointestinal surgery with older than 65 years old.
    

Detailed description: 
      Background: the incidence of intraoperative hypotension was 91%. The increasing incidence of
      intraoperative hypotension would increase the risk of postoperative complications, such as
      postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a
      major surgery. Older patients usually have many comorbidity, such as hypertension or
      cardiovascular disease. Prevention intraoperative hypotension is an important issue.
      Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean
      arterial pressure (MAP)<65mmHg).

      Objectives: to investigate whether HPI could prevent the intraoperative hypotension happened.

      Patients and methods: The patients receive elective major gastrointestinal surgery with older
      than 65 years old. These patients have divided into two groups, including with/without HPI
      guided. The intraoperative hypotension incidence has been measured.

      Expected result: The HPI would significantly decrease the intraoperative hypotension
      incidence.
    

Intervention name(s): hypotension prediction index guided; without hypotesion prediction index guided
Intervention type(s): Device; Other
Intervention description(s): patients receiving hypotension prediction index monitoring and let the anesthesiologist' alerted the coming intraoperatiobe hypotension; patients receiving usual care without hypotension prediction index monitoring but with usual arterial line care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured.
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Effect of Symbicort on GR Localisation in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      To investigate a possible interaction between formoterol and budesonide on GR-translocation
      and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 mcg) with the
      effect of budesonide (200 mcg and 800 mcg) on GR translocation, and to investigate the effect
      of the study drugs on exhaled NO (bronchial and alveolar fraction.
    

Detailed description: 
      Combination therapy with inhaled corticosteroids (ICS) and long-acting β(2)-adrenergic
      agonists (LABA) is reported to have superior effects on controlling asthma symptoms to ICS
      alone; however, there is no molecular-based evidence to explain the clinical effects. Here,
      the effect of the ICS/LABA combination was compared with ICS on glucocorticoid receptor (GR)
      activation in sputum macrophage.

      In a randomised, double-blind cross-over placebo-controlled 6-visit study, 10 patients with
      mild asthma were given placebo, formoterol (Oxis(®) 12 μg), budesonide (Pulmicort(®) 200 μg
      :BUD200, or 800 μg :BUD800), or budesonide/formoterol combination (Symbicort(®)) as a single
      100/6 μg (SYM100) or double 200/12 μg (SYM200) dose. Sputum macrophages were separated by
      plate adhesion from induced sputum. GR binding to the glucocorticoid-response elements on
      oligonucleotides (GR-GRE binding) was evaluated by ELISA. mRNA expression of MAP-kinase
      phosphatase (MKP)-1 and IL-8 were measured by quantitative RT-PCR.
    

Intervention name(s): Placebos; Formoterol Inhalant Powder; Budesonide Powder; Budesonide and Formoterol Product
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dry powder inhaler; 12ug; Inhaler; Combination Inhaler, Symbicort
Other intervention name(s): Oxis; Pulmicort; Combination Inhaler, Symbicort
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Asthma; Glucocorticoid; Long-acting beta2-adrenoceptor; Inhaled corticosteroids
RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein
      nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess
      the impact of maternal immunization on infant safety through one year of life.
    


Intervention name(s): Saline Placebo (0.5mL injection); RSV F vaccine (0.5mL injection)
Intervention type(s): Drug; Drug
Other intervention name(s): 0.9% Sodium Choloride; RSV F Protein with Aluminum adjuvant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: RSV; Third Trimester; Maternal Immunization
Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Cardiovascular Diseases; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to develop and field-test new tools for diagnosis and hazard
      assessment of cardiometabolic risk (CMR) in people with chronic spinal cord injury (SCI) and
      to advance the evidence base with much needed information on CMR and cardiovascular disease
      (CVD) burden in people with SCI. These data can be used to develop screening guidelines for
      early identification and prevention of CMR in SCI, as well as targeted approaches to primary
      disease management.
    

Detailed description: 
      Unlike current assessments utilizing lipid scores, the new system will be anchored in more
      reliable measurements of cardiovascular disease (CVD) burden using contemporary surrogate end
      points of coronary artery calcium (CAC) score, coronary CT angiography and carotid intima
      media thickness (CIMT). By the end of the 5-year funding cycle we will develop an updatable
      web-based cardiometabolic risk assessment tool (RISK) that will allow clinicians and SCI
      consumers to quantify risk for a cardiovascular sentinel event (stroke, non-fatal heart
      attack, or death) and will also provide a body mass index (BMI) table adjusted for SCI.

      Specific Aims:

        1. Examine the relationships among surrogates of cardiovascular disease burden in persons
           with SCI and established cardiometabolic risks.

        2. Identify significant predictors of cardiometabolic risk (CMR) that are unique to persons
           with specific levels of SCI.

        3. Develop and validate SCI CMR assessment tool (RISK) based on cardiometabolic risk
           scores.

        4. Develop and validate an adjusted BMI table for SCI.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample of healthy persons with spinal cord injury
Effect of Coffeeberry on Mood, Motivation and Cognitive Performance
Condition: Fatigue, Mental; Alertness; Mood; Motivation; Cognitive Performance
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      The primary purpose is to test the short-term effects of the acute consumption of two novel
      beverages made from coffeeberries, the fruit of the coffee plant (Coffea arabica) benchmarked
      against caffeine on several aspects of cognitive performance.

      Preliminary studies suggest that flavanols and chlorogenic acids can enhance cognitive
      performance. It is unknown if drinks formulated with flavanols and chlorogenic acids (without
      high sugar or caffeine) improve cognition or mood to a similar extent as caffeine.
      Coffeeberry beverage comparisons will be made to a flavored positive control beverage
      containing caffeine and a flavored placebo beverage.
    


Intervention name(s): Cherry-flavored still beverage; Placebo cherry-flavored still beverage
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 10 oz bottle; 10 oz bottle
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: alertness; mental fatigue; coffeeberry; coffee fruit
Relationship Between Cognitive Function and Pain
Condition: Cognitive Ability, General
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with chronic pain can experience considerable changes in their cognitive function
      such as forgetfulness, increased absentmindedness, confusion etc. Opioids (e.g. morphine and
      morphine-like analgesics) are often used in treatment of acute and chronic pain and can lead
      to worsening of the cognitive function. The interaction between pain, treatment and cognitive
      function is very complex and is far from understood.

      The hypothesis of the present study is that by use of experimental pain in healthy volunteers
      it will be possible to elucidate the interaction between pain, treatment and cognitive
      function.
    


Intervention name(s): Ultiva (remifentanil) or placebo
Intervention type(s): Drug
Intervention description(s): 0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min
Other intervention name(s): Ultiva (remifentanil)
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Cognitive function; Experimental pain