bioihbjkbjnl/mcl2 huggingface dataset:
Walnuts and Healthy Aging
Condition: Age Related Cognitive Decline; Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This will be a systematic investigation of the role of walnuts in preventing or slowing age
      related cognitive decline and age related macular degeneration. 700 subjects will be
      recruited between 2 sites, Loma Linda University in California, USA and Hospital Clinic in
      Barcelona, Spain. Participants will be randomly assigned to either the walnut group or the
      control group for a 2 year intervention. Baseline and annual data will be collected and
      analyzed.
    

Detailed description: 
      Epidemiological studies suggest that nutrients such as n-3 polyunsaturated fatty acid,
      antioxidants and B-vitamins may protect against age related cognitive decline. Small human
      studies have shown beneficial effects of polyphenol rich foods on cognition and age related
      macular degeneration. Walnuts are a rich source of n-3 polyunsaturated fatty acid,
      alpha-linolenic acid, antioxidants, polyphenols and other bioactive compounds. A 2-year
      intervention will be conducted with healthy, elderly subjects to investigate the role of
      walnuts in preventing or slowing age related cognitive decline and age related macular
      degeneration.

      350 subjects, age 63 to 79 years, will be recruited at each of 2 sites, Loma Linda University
      in California and Hospital Clinic in Barcelona. Participants will be randomly assigned to one
      of two groups: walnut group (habitual diet with 1 or 2 oz/d walnut supplement) or control
      group (habitual diet only). At baseline and yearly, cardiometabolic risk factors, red blood
      cell membrane fatty acids, urinary polyphenols and biomarkers of inflammation and oxidation
      will be measured. Eye exam, blood pressure and cognitive function tests will be measured at
      the beginning and end of 2 years. At the Barcelona site only, participants will be given a
      brain MRI and carotid ultrasound.

      Descriptive results will be reported as mean plus/minus standard deviation. Primary analysis
      will be carried out on the basis of groups as randomly assigned. Results will be presented as
      appropriate effect sizes with a measure of precision (95% CI). Analysis of covariates gender,
      age, educational status will be conducted.
    

Intervention name(s): Walnuts; habitual diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 30 to 60g (1 to 2 oz) per day of walnuts; Dietary information will be provided
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: walnuts; age related cognitive decline; age related macular degeneration; healthy elderly subjects
A Comparison of the I-gel and Self-pressurised Air-Q Intubating Laryngeal Airway (Air-Q sp) in the Elderly Patients
Condition: Supraglottic Airway Device
Study type: Interventional

Summary: 
      Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these
      devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating
      laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. It is a new
      single-use device that may optimise the airway sealing while reducing the potential for
      postoperative complications such as sore throat. The overall structure of the air-Q sp is
      similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial
      was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients
    


Intervention name(s): Insertion of the i-gel; Insertion of the air-Q sp
Intervention type(s): Device; Device
Intervention description(s): After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: elective surgery; undergoing general anesthesia; elderly adult patients
The Effects of an NR2B NMDA Antagonist, CP-101,606, in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the effects of the NMDA antagonist, CP-101,606, in subjects with Parkinson's
      Disease
    


Intervention name(s): NR2B NMDA Antagonist CP-101,606 (traxoprodil)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
RCT Mesenchymal Stem Cells Versus Hyaluronic Acid in OA Knee):
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to evaluate the therapeutic effect of adult autologous
      mesenchymal stem cells (abbreviated as MSCs) in patients with osteoarthritic knee and compare
      to intra articular injection of Synvisc-One.
    

Detailed description: 
      Study Participants:

      This study will involve patients affected by osteoarthritis who comply with the inclusion and
      exclusion criteria. 30 patients, between the age of 18 and <65, will be enrolled in the study
      and randomized into three groups to receive either an injection of MSCs, hyaluronic acid (HA)
      or no injection.

      Type of Study: This is a randomized control study.

      Treatment method: Each patient will randomly be assigned to one of the following treatment
      groups:

      Group A) Mesenchymal stem cells (MSCs) Group B) Hyaluronic acid (HA) Group C) No injection

      Treatment:

      Group A) Autologous Mesenchymal Stem Cells Treatment (MSCs) The MSCs treatment group patients
      will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the
      affected knee.

      The treatment will be carried out after the patient has received a blood test and clinically
      evaluated at T0.

      T0: Beginning of the study, blood test and bone marrow aspiration. T30: Intra-articular
      injection of MSCs T44: Adverse events follow up 2 weeks after intra-articular injection (by
      phone)

      Group B) Hyaluronic acid (HA) The patient will be given a single intra-articular injection of
      hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.) The hyaluronic acid will be
      purchased for the patient from the manufacturer or from the pharmacy of the hospital.

      The intra-articular injection will be carried out after the patient has received a clinical
      evaluation at T0.

      T0: Beginning of the study T30: Intra-articular injection of Synvisc-One (HA) T44: Adverse
      events follow up 2 weeks after intra-articular injection (by phone)
    

Intervention name(s): Autologous Mesenchymal Stem Cells Treatment (MSCs); Hyaluronic acid (HA)
Intervention type(s): Biological; Drug
Intervention description(s): The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.; The HA group patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.)
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The overall goal of this project is to determine the feasibility of conducting a cognitive
      intervention for children with sickle cell disease.
    

Detailed description: 
      The primary aims of this clinical trial are:

        1. Determine the effectiveness of targeted learning and memory strategy remediation in
           students with sickle cell disease and cognitive deficits.

        2. Determine if there is improvement in academic achievement after targeted memory strategy
           remediation.
    

Intervention name(s): General Tutoring; Memory Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be tutored for approximately 8-10 hours per month during the school year.; Participants will receive memory training for approximately 8-10 hours per month during the school year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sickle Cell Disease; Sickle Cell; Memory; Learning; Achievement
Exercise Duration Models, in Middle-aged Men
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Duration of exercise is an important factor among the medical guides for weight loss.
      However, there is still little knowledge about other its models in middle-aged and older men.
      The present study aimed to determine the effects of the interval training on weight loss and
      lipid profile, and to compare its efficiency with the continuous training.
    

Detailed description: 
      Participants included sedentary men (age 45-75 years) with overweight or obesity (n= 82).
      They were randomly divided into two groups including continuous exercise, and interval
      exercise. The weight assessment parameters including change in weight and body composition,
      blood sample tests were performed pre- and three month post-intervention.
    

Intervention name(s): Continuous training; The interval training
Intervention type(s): Other; Other
Intervention description(s): Study group I (42 participants) received the continuous training.; Study group II (40 participants) received the interval training.
Other intervention name(s): group I; group II
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Caloric Restriction; Dietary Formulations; Exercise; Men
Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the primary phase of the study is to demonstrate the non-inferiority of a
      single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC)
      conjugate vaccine when given in the second year of life to subjects primed in infancy with a
      Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available
      Hib and MenC vaccines.

      In the extension phase, at Years 1, 2, 3, 4 & 5, one blood sample is taken at each year to
      follow the antibody persistence up to 5 years after vaccination. No additional vaccine is
      administered during the extension phase. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      This multicenter study is open and has 2 treatment groups with Hiberix™ + a commercially
      available MenC vaccine as active controls. Priorix™ is given concomitantly in both groups. In
      the primary phase, two blood samples are taken from all subjects for immunogenicity analyses:
      before and one month after vaccination. In the extension phase, at Year 1, 2, 3, 4 & 5, one
      blood sample is taken at each year to follow the antibody persistence up to 5 years after
      vaccination. No additional vaccine is administered during the extension phase.
    

Intervention name(s): Haemophilus influenzae type b and meningococcal serogroup C (vaccine); Priorix™; Hiberix™; Meningitec™
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One intramuscular dose at 12-18 months of age; One subcutaneous dose at 12-18 months of age; One intramuscular dose at 12-18 months of age.; One intramuscular dose at 12-18 months of age
Other intervention name(s): Hib-MenC; Menitorix™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal serogroup C diseases; H.influenzae type b diseases
Interprofessional Rehabilitation for Adults With Chronic Non-specific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The primary aim of the study is to analyse the long-term effectiveness of an
      interprofessional and interdisciplinary rehabilitation program named "PASTOR", with a
      biopsychosocial approach for participants with chronic non-specific low back pain (CLBP)
      compared to the standard inpatient multidisciplinary orthopaedic rehabilitation (MOR) in
      Germany. The investigators hypothesize that in adults with CLBP the rehabilitation program
      PASTOR would result in a significantly higher increase in functional ability 12 months after
      completion of the program in comparison to the standard inpatient MOR. The investigators
      further hypothesize that PASTOR would lead to significantly larger improvements regarding
      pain-related cognitions, pain coping strategies, physical activity, health-related quality of
      life, and back pain episodes compared to the standard inpatient MOR.
    


Intervention name(s): Multidisciplinary rehabilitation; Interprofessional rehabilitation
Intervention type(s): Procedure; Procedure
Intervention description(s): Multidisciplinary rehabilitation includes interventions from the physical and psychological dimensions:
health education
exercise therapy
back school
physical treatments
psychological interventions in groups and individual counselling
rehabilitation/social counselling.; Interprofessional rehabilitation includes also interventions from the physical and psychological dimensions:
education about low back pain
behavioural exercise therapy
coping with pain
relaxation
work related informations
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rehabilitation; Treatment Outcome; Interprofessional Relations; Interdisciplinary Communication; Behavioural Exercise Therapy; Cognitive Therapy; Health Education; Workplace related information; Multicenter Study
Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
Condition: Drug-Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Drug interaction and safety of
      Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.
    


Intervention name(s): Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Intervention type(s): Drug
Intervention description(s): Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other intervention name(s): FAH
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Once-Daily KRP-104 in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and effectiveness of KRP-104 on glycemic
      control in patients with type 2 diabetes inadequately controlled on metformin alone.
    


Intervention name(s): KRP-104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Metformin
Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987518)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-76_V27-006)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Complementary Medicine Approaches to TMD Pain Management
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine whether selected complementary approaches to temporomandibular
      joint (TMJ) pain management-acupuncture are as effective as usual care.
    

Detailed description: 
      Temporomandibular disorders are characterized by pain and tenderness in the muscles of
      mastication and/or the (TMJ), limitations of jaw opening often accompanied by deviations in
      mandibular path, and clicking, popping or grating TMJ sounds. This study will compare the
      effectiveness of the complementary therapies chiropractic therapy and bodywork therapy to the
      standard of care for TMJ pain. If these complementary interventions are shown to be
      effective, the goal is to design and implement a Phase III clinical trial to further evaluate
      the health consequences and cost of these therapies.

      Participants will be evaluated at baseline, and 6 and 12 months post-intervention. Clinical
      examinations, saliva samples to assess salivary cortisol levels, and a series of
      questionnaires to assess pain and grade of dysfunctional pain, psychological functioning, and
      other physical symptoms will be used to assess outcomes. The investigators will passively
      monitor health care utilization within KPNW using clinical, research, and administrative
      databases.
    

Intervention name(s): Acupuncture; chiropractic therapy; bodywork therapy
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Determination of Protein Requirement in Elderly Female Subjects 65-75 Yrs Old
Condition: Healthy
Study type: Interventional

Summary: 
      Minimal data are available on protein requirements throughout the lifespan. Currently
      available recommendations are based on nitrogen balance data. The limitations of the nitrogen
      balance method have been well described. Importantly, nitrogen balanced underestimates
      requirements.

      The current DRI requirement for healthy adult males is based on the reanalysis of the
      nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by
      Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83
      (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group
      estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2
      g/kg/day (mean and RDA).

      Currently there are no studies on protein requirement in the elderly. In a recent nutrition
      survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70
      years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents
      about 15 % of calories. Depending on the calculations used for ideal body weight some older
      adults could be getting higher or lower than requirement. There is no scientifically derived
      protein estimate for older adults. Therefore there is a need to measurer protein requirement
      in that population.

      The goal of this study therefore is to measure the protein requirement of female elderly
      subjects between the ages of 65 - 70 years using the IAAO technique.
    


Intervention name(s): protein intake.
Intervention type(s): Dietary Supplement
Intervention description(s): •Protein intakes will be varied at 0.2, 0.5, 0.7, 0.9,1.0, 1.2, 1.5, 1.8g, 2.0g/kg/day
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: protein requirement; female elderly; healthy female subject's protein requirements
A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is randomized, placebo controlled study to determine safety and efficacy of VGX-3100 DNA
      Vaccine delivered by Electroporation to adult women with biopsy-proven HPV 16 or 18
      associated Cervical intraepithelial neoplasia grade 2/3 or 3.
    


Intervention name(s): VGX 3100; Placebo; CELLECTRA™-5P
Intervention type(s): Biological; Biological; Device
Intervention description(s): 1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12.; 1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12.; CELLECTRA™-5P is used for electroporation following IM delivery of VGX 3100 or placebo on Day 0, Week 4 and Week 12.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CIN 2/3 or CIN 3; Cervical cancer; Papillomavirus
Efficacy and Safety of Biocellulose Sheet Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment
Condition: Skin Pigmentation; Skin Irritation
MeSH terms: Hyperpigmentation
Study type: Interventional

Summary: 
      The laser areas treated with biocellulose sheet from coconut juice containing
      anti-hyperpigmentation agent ("biocellulose mask", "Farhorm®") heal faster than vaseline
      ointment which is a standard treatment.
    

Detailed description: 
      Volar surface at upper arm (2X2 cm) on both sides were treated with semi ablative, 1,550 nm
      Erbium: glass fractional laser. Biocellulose sheet from coconut juice containing
      anti-hyperpigmentation agent ("biocellulose mask","Farhorm®")was applied for 20 min on one
      side and the other side was treated with vaseline ointment. The redness, skin hydration and
      skin pigmentation were evaluated at that area before laser, immediately after laser and after
      applying the treatment. These parameters were compared between treatment (area treated with
      Biocellulose sheet from coconut juice containing anti-hyperpigmentation agent, "biocellulose
      mask", "Farhorm®") and control (vaseline ointment).
    

Intervention name(s): "Biocellulose Mask", Farhorm®"
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment