bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Betahistine on Body Weight in Obese Subjects
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effect that betahistine has on body weight in
      obese subjects.
    


Intervention name(s): Betahistine; Dietary counseling
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Betahistine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
Condition: Dysentery; Dysentery, Bacillary
MeSH terms: Dysentery, Bacillary; Dysentery
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei
      Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.
    


Intervention name(s): S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine; S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine; S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine; Haemophilus b Conjugate Vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.; Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.; Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.; Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Neuropathic Pain in Patients With Combat-related Extremity Injury
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Observational

Summary: 
      It has been suggested that veterans with chronic pain might be at increased risk for the
      development of depression, anxiety and post-traumatic stress disorder. To date, most of the
      published studies have focused on chronic pain as a whole, and there are limited studies
      examining association of neuropathic pain with psychological comorbidity and quality of
      life.Combat related extremity injury significantly influences the patients' quality of life
      and psychological state. In this context, the purpose of this study is to illustrate to what
      extent neuropathic pain influences the quality of life, depression level and sleep quality of
      patients with combat-related extremity injury.
    

Detailed description: 
      A total of 120 patients with combat-related extremity injury and 60 age and BMI-matched
      healthy controls will be participated in this cross-sectional study. The presence of
      neuropathic pain will be evaluated using Leeds assessment of neuropathic symptoms and signs
      (LANSS) questionnaire. The impact of pain on health-related quality of life will be assessed
      using the 36-Item Short Form Survey (SF-36). Beck Depression Scale (BDS) will be used to
      evaluate depression status of the patients. Quality of sleep will be assessed using the
      Pittsburgh Sleep Quality Index (PSQI).
    

Intervention name(s): The effect of neuropathic pain on quality of life, depression and sleep quality
Intervention type(s): Other
Intervention description(s): The effect of neuropathic pain on quality of life, depression and sleep quality
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        A total of 98 patients with combat-related extremity injury
Midwifery Students' Performance Before and After Teaching Fundamentals of Documentation
Condition: Documentation Skill
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Midwives are responsible for documenting and keeping care facts in midwifery departments.
      Inaccurate documentation or even minute error in reporting may lead to burdensome
      responsibility for midwives. This study has been conducted aimed to compare midwifery
      students' performance before and after teaching fundamentals of documentation. In this
      quasi-experimental study, 28 midwifery students were participated. Data were collected by a
      questionnaire including a. demographic data and b. Scenarios (1) and (2) of an imaginary
      patient with physician order and a checklist contain 11 elements of documentation
    


Intervention name(s): lecture
Intervention type(s): Other
Intervention description(s): Teaching documentation skill using lecture method
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Students practice, Lecture; Nursing records; Nursing education; Midwifery
Lumenato Nutritional Supplement on Skin Appearance
Condition: Skin
Study type: Interventional

Summary: 
      This 12-week study is an open-label study assessing the perceived effectiveness of the
      Lycored Lumenato supplement on skin health and appearance.
    

Detailed description: 
      The purpose of this study is to evaluate perceived changes in skin health and appearance
      after taking the study product daily for 12 weeks. The study product is a soft gel supplement
      containing tomato oil. This an open-label study, meaning there is no placebo control arm for
      the study, and everyone enrolled in the study will receive the active study product.
    

Intervention name(s): Lumenato
Intervention type(s): Dietary Supplement
Intervention description(s): tomato oleoresin obtained from yellow dry tomato pulp
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nutritional Supplement
The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Purpose/Goal: To determine if a remote computerized cognitive remediation program (CRT) can
      stabilize or improve cognitive functioning in a group of patients from the New York Institute
      of Technology Academic Health Care Center with Parkinson's disease (PD) after three months of
      intervention.

      Hypothesis: Patients with PD who present with current cognitive deficits will show
      improvement in such deficits after three months of participation in a remotely supervised
      structured Cognitive Remediation Therapy Program (CRT) compared to control subjects with PD
      who receive treatment as usual.

      Research design: Pilot study. Prospective randomized treatment and control comparison
      pre-post study.
    


Intervention name(s): Cognitive Remediation Therapy Program (BrainHQ)
Intervention type(s): Other
Intervention description(s): Brain HQ games involving training cognitive abilities like memory and attention, made up of adapting tasks or creating our own.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
EoE(Eosinophilic Esophagitis)
Condition: Eosinophilic Esophagitis; Dysphagia
MeSH terms: Deglutition Disorders; Esophagitis; Eosinophilic Esophagitis
Study type: Interventional

Summary: 
      To evaluate quantitative magnetic resonance imaging(MRI) as a potential non-invasive,
      radiation-free diagnostic tool for evaluating esophageal wall remodeling (thickness and
      stiffness) and response to treatment in children and adolescents with newly diagnosed
      eosinophilic esophagitis (EoE) presenting with dysphagia (difficulty swallowing) and food
      impaction.
    

Detailed description: 
      Eosinophilic esophagitis(EoE) is a form of chronic inflammation affecting the esophagus which
      often results in wall thickening and esophageal stiffening and is associated with
      complications, such as esophageal tears and strictures (narrowings). Chronic dysphagia and
      acute food impaction (swallowed food stuck in the esophagus) are common symptoms of EoE and
      are associated with esophageal wall thickening and stiffness.

      Current diagnostic techniques such as endoscopy with biopsy give only limited information
      about changes in the esophageal wall in eosinophilic esophagitis(EoE). In routine clinical
      practice, repeat endoscopic evaluation with biopsy is commonly performed about 3-6 months
      after initial therapy for eosinophilic esophagitis(EoE). However, follow-up endoscopy with
      biopsy has drawbacks as it is invasive, costly and typically requires deep sedation or
      general anesthesia.

      We propose to evaluate quantitative MRI as a potential non-invasive diagnostic option for
      evaluating esophageal wall remodeling in patients with eosinophilic esophagitis(EoE).
    

Intervention name(s): Eosinophilic Esophagitis with Dysphagia; Eosinophilic Esophagitis with Dysphagia
Intervention type(s): Procedure; Procedure
Intervention description(s): An upper endoscopy with biopsy at the time of diagnosis(which is a standard procedure to diagnose eosinophilic esophagitis. This will be done with sedation or general anesthesia, also a standard procedure. At the time of the anesthesia a small amount of blood will be drawn to measure markers of inflammation and fibrosis. This procedure will take approximately 45 minutes to complete. This endoscopy with biopsy will be repeated in 6 months.
Subjects will also complete a magnetic resonance imaging(MRI)scan with 2 weeks of the initial clinical endoscopy with biopsy, prior to the initiation of your medical treatment. This MRI will be repeated in 6 months. Each magnetic resonance imaging(MRI)scan will take approximately 2 hours to complete.; Subjects will also complete a magnetic resonance imaging(MRI)scan with 2 weeks of the initial clinical endoscopy with biopsy, prior to the initiation of your medical treatment. This MRI will be repeated in 6 months. Each magnetic resonance imaging(MRI)scan will take approximately 2 hours to complete.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Accuracy of the Drager Dual-sensor Temperature Measurement System
Condition: Hypothermia; Anesthesia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at
      the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal
      temperature and oral temperature for routine clinical use during hypothermic conditions, as
      well as during fever.
    

Detailed description: 
      We will include patients undergoing general anesthesia or regional anesthesia. The
      temperature recorded by Draeger dual-sensor monitoring system will be obtained at 5-minute
      interval.
    

Intervention name(s): Draeger double-sensor; Esophageal stethoscope temperature sensor; Foley catheter temperature sensor
Intervention type(s): Device; Device; Device
Intervention description(s): The sensor will be attached to the patient's forehead with adhesive tape, and a small amount of contact gel will be applied between sensor and skin.; Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery.; Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: surgery; thermometer; non-invasive; interoperative core temperature; anesthesia
Retardation of Myopia in Orthokeratology
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The primary aim of this study is to evaluate and compare the eyeball elongation in children
      wearing orthokeratology lenses and single-vision spectacles.
    

Detailed description: 
      Prevalence of myopia is high in Asian countries like Hong Kong. Orthokeratology has shown
      potential in slowing myopic progression but the efficacy is yet to be confirmed by a
      randomized clinical trial (RCT). The current RCT aims at studying the efficacy of
      orthokeratology in retardation of myopic progression by comparing the eye growth in terms of
      axial length elongation in children wearing orthokeratology lenses (study group) and those
      wearing single-vision spectacles (control group).
    

Intervention name(s): orthokeratology lenses; single-vision spectacle lenses
Intervention type(s): Device; Device
Intervention description(s): Nightly use of orthokeratology to correct the refractive error for a period of two years; Daily use of spectacles to correct the refractive error for a period of two years
Other intervention name(s): Corneal reshaping therapy; Menicon Z Night Lens; CR-39 lenses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: children; corneal reshaping; myopia; myopia control; orthokeratology
The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study
Condition: Symptomatic Carotid Stenosis; Hypercholesterolemia; Indication for Carotid Endarterectomy
MeSH terms: Carotid Stenosis; Hypercholesterolemia
Study type: Interventional

Summary: 
      The impact on cardiovascular events achieved by statin therapy seems to be mostly
      attributable to the cholesterol-lowering effect with a highly debated contribution of the
      lipid-independent pleiotropic effects. However, a short-term benefit has been documented for
      patients treated with statins in acute coronary syndromes and other clinical settings. These
      observations strengthened the hypothesis of additional, so-called pleiotropic actions of
      statins.

      The investigators therefore sought to investigate how different lipid-lowering strategies
      (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of
      carotid plaque over a short-term period of three months. Specifically the investigators tried
      and dissect the LDL-C lowering impact on plaque cellular composition as compared to the
      lipid-independent contribution on plaque macrophage and smooth muscle cells.
    

Detailed description: 
      Patients (with Total Cholesterol (TC) ranging between 5.83-7.64 mmol/l), never treated with
      lipid lowering drugs, with symptomatic carotid stenosis >70% (NASCET criteria), and therefore
      eligible for carotid endarterectomy, were recruited. All patients were enrolled within 30
      days from the clinical event, and randomized to one of three treatment groups. Each group,
      composed of 20 patients, received atorvastatin 10 mg/day (AT-10 group), or atorvastatin 80
      mg/day (AT-80 group), or cholestyramine (Questran, Bristol Myer Squibb) 8 g/day plus
      sitosterol (Unilever) 2.5 g/day (C-S group) for three months prior to the vascular procedure.
      A placebo group was not included for ethical reasons due to the high cardiovascular risk
      profile in this population.
    

Intervention name(s): Atorvastatin - Cholestyramine - Sitosterol
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin; Cholestyramine Resin; Gamma-sitosterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Atherosclerosis; Macrophages; Carotid arteries; Statin
Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of
      two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an
      allergen challenge chamber in male subjects with seasonal allergic
    


Intervention name(s): GSK1004723 (200mg); Placebo; GSK1004723 (1000mg)
Intervention type(s): Drug; Other; Drug
Intervention description(s): Intranasal antihistamine.; Equivalent to GSK1004723 in presentation etc.; Intranasal antihistamine.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Allergic Rhinitis; Proof-of-Concept
CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study
Condition: Recurrent Upper-Respiratory Tract Infections
MeSH terms: Infections; Respiratory Tract Infections; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of
      Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of
      younger age who develop infectious diseases more frequently than other children of this age
      in general.
    


Intervention name(s): J022X ST; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration - During 6 months and according to the approved summary of product characteristics : 1 sachet per day in the morning on an empty stomach
First month: 4 consecutive days per week during 3 consecutive weeks
5 next months: 4 consecutive days per month at monthly intervals; Oral administration - During 6 months : 1 sachet per day in the morning on an empty stomach
First month: 4 consecutive days per week during 3 consecutive weeks
5 next months: 4 consecutive days per month at monthly intervals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Recurrent common cold; laryngitis; pharyngitis/tonsillitis; acute rhinitis; acute rhinosinusitis; acute otitis media
Effects of Cognitive Intervention on Cognition, Mobility and Brain Electrocortical Activity
Condition: Cognitive Decline; Cognitive Impairment; Aging; Motor Coordination or Function
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Within this project the investigators tested the effectiveness of 2-month of computerized
      cognitive training (CCT) on CogniFit online platform on 77 older adults, which were randomly
      divided into intervention and control group. The investigators tested close (battery of
      cognitive functions) and far transfer (postural and mobility control, EEG, blood samples) of
      the CCT. Additionally, the investigators were interested into seeing a long-lasting effect,
      therefore participants were brought back to the laboratory 1 year post CCT.
    


Intervention name(s): Computerized cognitive training
Intervention type(s): Other
Intervention description(s): Intervention used CogniFit platform with Personalized brain training sub-option
Other intervention name(s): cognitive remediation; cognitive training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants in the intervention group followed a computerized cognitive training program for 2-months, 3x/week, 40min/session
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cognition; mobility; cognitive reserve; EEG/ERP
Exercise Preconditioning and Breast Cancer Cardiotoxicity
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a supervised exercise-training program,
      initiated prior to chemotherapy induction (pre-conditioning) and continued throughout
      chemotherapy treatment, can preserve short- and long-term cardiovascular performance,
      skeletal muscle function, cognitive ability and quality of life better than current standard
      or care recommendations for exercise during chemotherapy.
    

Detailed description: 
      The primary aim of this study is to determine the efficacy of a novel, high-intensity aerobic
      interval exercise preconditioning protocol to ameliorate anthracycline-mediated cardiac and
      skeletal muscle toxicity in women with breast cancer undergoing de novo chemotherapy.

      Research Design:

      Women with breast cancer scheduled to undergo de novo chemotherapy with anthracyclines will
      be enrolled. Qualified patients will be randomized to either 1) a high-intensity interval
      exercise group, or 2) an attention-control group.

      Supervised exercise training will be carried out at the Mayo Clinic Cardiac rehabilitation
      center in Arizona on cycle ergometers using Electrocardiogram (EKG) telemetry. Patients in
      the high-intensity interval exercise group will perform four, 4-min intervals at 85-90% peak
      heart rate (PHR), separated by 3 min at 50% PHR. Each training session will begin with a
      10-minute warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR.

      The attention-controls will receive counseling consistent with standard of care regarding
      physical activity during chemotherapy. Attention-control group will receive a weekly phone
      call to maintain physical activity during chemotherapy and compliance will be verified using
      physical activity diaries and pedometers.

      Treatment for each group will commence 1-week prior to chemotherapy induction. The first dose
      of chemotherapy will be given within 16-18 hours of the last bout of exercise. High-intensity
      intermittent exercise (HIIE) training will be continued throughout four, 2-week cycles of
      chemotherapy (total training time = 9 weeks, 3 days/week).
    

Intervention name(s): A high-intensity interval exercise group; An Attention-Control Group
Intervention type(s): Other; Other
Intervention description(s): To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested; Patients will be contacted weekly to access physical activity. To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Chemotherapy; Exercise