bioihbjkbjnl/mcl2 huggingface dataset:
Apolipoprotein (APO)E Genotype, Meal Fatty Acids, Postprandial Lipaemia
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD) is the greatest cause of morbidity and mortality in the UK.
      Abnormalities in the concentration and/or composition of lipoproteins (the lipid carrying
      particles), in particular low density lipoproteins (LDL) in circulation, is one of the most
      important physiological defects contributing to the development of CVD.

      The LDL cholesterol (LDLC) response to fatty acid change is in part mediated by the APOE
      genotype, with E4 individuals (25% of the UK population) being most responsive to changes in
      dietary fats, showing greater reductions when low levels of saturated fats or fish oils are
      consumed and greater increases when high levels of these fats are consumed. Therefore the
      aims of the present study is to understand the mechanism that regulates the higher LDLC
      response associated with saturated fatty acids and fish oil consumption in healthy men
      prospectively recruited based on their APOE genotype.
    


Intervention name(s): High saturated fat meal; Saturated fatty acids and fish oil meal; High unsaturated fat meal
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats.; Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats and fish oil.
The dose of fish oils was equivalent to two portions of oily fish.; Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for unsaturated fats. It provided a fatty acid profile representative of a typical UK diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: fatty acids; cardiovascular disease; genotype; apoE
Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The immediate objective of this proposal is to assess the effectiveness of a multi-faceted
      intervention to improve patient-provider communication about colorectal cancer screening in
      improving patient adherence with colorectal cancer screening recommendations. This
      intervention consists of: (1) guiding the communication process through patient activation to
      initiate a colorectal cancer screening discussion; (2) optimizing communication content
      through the use of a prompt sheet; and (3) cueing the provider to assess patient perception
      of the communication. The long-term objective of our research program is to maximize
      colorectal cancer screening rates throughout the VA through widespread adoption of clinically
      feasible approaches to enhance patient-provider communication.
    

Detailed description: 
      In the United States, colorectal cancer is the third most common cancer and the second
      leading cause of cancer mortality with over 56,000 deaths in 2004). Early detection through
      screening decreases the mortality associated with the disease. However, adherence with
      current screening recommendations is low. A survey of the general population indicates that
      only 53.1% of Americans, age 50 years and older for whom colorectal cancer screening is
      recommended, are up-to-date with this preventive service. While colorectal cancer screening
      rates with the VA Healthcare System (VHA) are better than in the general population (75% in
      Fiscal Year (FY) 2005), they are lower than performance rates for other types of cancer
      screening (e.g., mammography) in VHA. Further, numerous VA medical centers report colorectal
      cancer screening rates below the level considered satisfactory.
    

Intervention name(s): Communication; Standard of care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Communication sheet; Standard of care brochures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: cancer; screening; communication; prevention
Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial
Condition: Pregnancy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized placebo-controlled trial of oral weekly vitamin D3
      (cholecalciferol) supplementation during the third trimester of pregnancy among women in
      Dhaka, Bangladesh. The overall goal of the study is to establish whether there is evidence
      that improving vitamin D status among pregnant women in Bangladesh will enhance the
      resistance of the infant offspring to infection.

      The aims of the study are to assess the effect of supplementation on 1) maternal and infant
      vitamin D status (based on blood concentrations of a vitamin D metabolite) and, 2) markers of
      neonatal immune function.
    

Detailed description: 
      The primary aims of this study are:

      AIM #1 - To assess the effect of weekly antenatal administration of oral vitamin D3 (875
      mcg/week = 35,000 IU week ≈ 5,000 IU per day) started in the third trimester (26-29 weeks
      gestation) on maternal vitamin D status and fetal-neonatal vitamin D status (cord blood), in
      comparison to a placebo control supplement.

      AIM #2 - To demonstrate the maternal and fetal safety of weekly maternal antenatal (second
      and third-trimester) vitamin D supplementation at a dose of 875 mcg/week by monitoring
      maternal serum calcium, urinary calcium excretion, cord blood calcium concentration, and
      newborn clinical parameters.

      AIM #3 - To measure the effect of antenatal vitamin D supplementation on selected biomarkers
      of fetal-neonatal immune function in cord blood: in vitro stimulated cord blood mononuclear
      cell (CBMC) LL-37 expression, gene expression related to inflammatory and immunoregulatory
      pathways, Th1/Th2 cytokine secretion, and bactericidal properties.
    

Intervention name(s): Vitamin D3; Placebo control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 35,000 IU per week, started at 26-29 weeks gestation, until delivery.; Miglyol 812, administered weekly from 26-29 weeks gestation until delivery.
Other intervention name(s): Cholecalciferol; Vigantol Oil
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D; cholecalciferol; Micronutrients; Developing countries; Bangladesh; Infant, Newborn; Reproductive Health; Infant, Newborn, Diseases; Perinatology; Immunology; cathelicidin; Maternal Nutrition Physiology
The Reflex Mechanism Underlying Neuromuscular Effects Of The Whole Body Vibration
Condition: Reflex, Ankle, Decreased
MeSH terms: Reflex, Abnormal
Study type: Interventional

Summary: 
      This study was conducted to determine whether the spinal reflex mechanism underlying the
      neuromuscular effects of whole body vibration (WBV) is tonic vibration reflex. Local and
      whole body vibration reflex latencies were measured in young adult healthy volunteers.
    

Detailed description: 
      A total of eight volunteers were included according to the inclusion and exclusion criteria.
      The subjects were vibrated while standing upright with the WBV device (PowerPlate® Pro5). The
      30, 35 and 40 Hz WBVs were applied for thirty seconds for each frequency with an amplitude of
      2 mm. In the same session, 100, 135 and 150 Hz local vibrations were applied to the right
      Achilles tendon for thirty seconds for each frequency. 100, 135 and 150 Hz local vibrations
      were then applied to the right heel for thirty seconds for each frequency with an interval of
      five seconds. Vibration stimuli were recorded accelerometers. Reflex muscle responses were
      recorded from the right soleus muscle at a sampling rate of 40 KHz. Recording electrodes were
      placed on the belly of the right soleus muscle and the ground electrode was placed on the
      right medial malleolus.

      The data were recorded with the PowerLab device, the records were processed and analyzed
      offline from the LabChart program. After the EMG records are filtered and rectified, reflex
      latencies were measured by cumulative averaging method using the accelerometer records as
      triggers (Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Türker KS.A new method to
      determine reflex latency induced by high rate stimulation of the nervous system.Front Hum
      Neurosci.2014 Jul 18; 8: 536.doi: 10.3389 / fnhum.2014.00536). After determining the Achilles
      tendon vibration reflex latency and the reflex latency induced by WBV, it was compared with
      statistical methods.
    

Intervention name(s): vibration
Intervention type(s): Other
Intervention description(s): local and whole-body vibration were applied
Intervention model: Single Group Assignment
Intervention model description: Self controlled experimental study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: whole body vibration; tonic vibration reflex; muscle spindle
Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance
Condition: Hand; Wrist; Wounds and Injuries
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The scaphoid is the most common fractured carpal bone in active adults, accounting for up to
      80% of all carpal fractures. The optimum treatment approach of the acute scaphoid fractures
      is under discussion. Cast immobilization is the main treatment for non-displaced scaphoid
      fractures, however, about 20% of scaphoid fractures fail to heal with conservative treatment.
      Long periods of cast immobilization may result in wrist stiffness, loss of grip strength,
      muscle atrophy and disuse osteopenia. Operative treatment for displaced and unstable scaphoid
      fractures was mostly adopted, however, open fixation for scaphoid fractures have the inherent
      disadvantages of ligament and capsular dissection, blood vessels damage. This study
      introduces a novel measures of percutaneous screw fixation for acute scaphoid fractures. We
      used one K-wire maintaining the reduction of the scaphoid fractures throughout the entire
      process of drilling and screw insertion and screw fixation for acute scaphoid fractures.
    


Intervention name(s): Percutaneous screw fixation through K-wire-assisted reduction and maintenance
Intervention type(s): Procedure
Intervention description(s): Percutaneous screw fixation for acute scaphoid fractures through K-wire-assisted reduction and maintenance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms
      of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who
      still suffer symptoms of RA. The purpose is also to ensure that the combination of
      methotrexate is safe for patients to take and that any side effects are acceptable to
      patients with RA.
    

Detailed description: 
      The study is a double-blind, placebo-controlled study of BG00012 plus methotrexate, versus
      methotrexate alone, in patients with active RA, who have had an incomplete response to other
      conventional disease modifying anti-rheumatic (DMARD) therapy.
    

Intervention name(s): BG00012; BG00012; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; Oral; oral placebo
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia
Condition: Eosinophilic Pneumonia; Chronic Disease
MeSH terms: Pneumonia; Pulmonary Eosinophilia; Chronic Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in
      the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may
      be as effective as 6 months-therapy.
    


Intervention name(s): prednisolone 0.5 mg/kg/day for three months; prednisolone 0.5 mg/kg/day for six months
Intervention type(s): Drug; Drug
Intervention description(s): period of treatment; period of therapy
Other intervention name(s): prednisolone; prednisolone
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination
      (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c).

      Secondary Objectives:

        -  To assess the effects of the FRC in comparison with insulin glargine on:

        -  Percentage of patients reaching HbA1c targets (<7% );

        -  Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma
           Glucose; (PPG);

        -  Body weight

        -  Fasting Plasma Glucose (FPG);

        -  Percentage of patients reaching HbA1c targets of <7% with no body weight gain and no
           hypoglycemia (as defined in the evaluation criteria);

        -  7-point Self-Monitoring Plasma Glucose (SMPG) profile;

        -  Insulin glargine dose.

        -  To assess the safety and tolerability in each treatment group.
    

Detailed description: 
      The maximum study duration per patient is 33 weeks.
    

Intervention name(s): INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010); INSULIN GLARGINE (HOE901); Metformin; Insulin Glulisine (HMR1964)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: Injection
Route of administration: Subcutaneous; Pharmaceutical form: Injection
Route of administration: Subcutaneous; Pharmaceutical form: Tablet
Route of administration: Oral; Pharmaceutical form: Injection
Route of administration: Subcutaneous
Other intervention name(s): Soliqua, Insulin Glargine/Lixisenatide Fixed Ratio Combination; Lantus®; Apidra
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin glulisine; Lixisenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase II, Randomized, Double-blind, Placebo-controlled, in Parallel Groups Clinical Trial to Assess the Safety and Efficacy of Dietary Supplementation With Tryptophan to Achieve Weight Loss, and Its Neuropsychological Effects in Adolescents With Obesity
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase II, randomized, double-blind, placebo-controlled, in parallel groups clinical trial
      to assess the safety and efficacy of dietary supplementation with tryptophan to achieve
      weight loss, and its neuropsychological effects in adolescents with obesity.
    


Intervention name(s): TRYPTOPHAN; PLACEBO
Intervention type(s): Dietary Supplement; Other
Intervention description(s): at the dose of 3,5 m/kg/ day divided in two capsules; at the dose of 3,5 m/kg/ day divided in two capsules
Other intervention name(s): lactose capsules
Intervention MeSH terms: Tryptophan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Mechanisms Of Change in Adolescent Pain Self-management
Condition: Chronic Pain; Central Sensitisation; Headache
MeSH terms: Chronic Pain; Headache
Study type: Interventional

Summary: 
      The MOCAS Study aims to describe the mechanisms through which sleep deficiency affects youth
      responses to an online pain self-management intervention over a 6-month period. The study is
      a single arm trial with repeated measurements using surveys, daily diaries, and actigraphic
      monitoring.
    

Detailed description: 
      The study objective is to characterize how sleep deficiency influences youth's ability to
      engage with, implement, and benefit from pain self-management intervention. The investigators
      will recruit a cohort of 80 youth, ages 12 to 17 years, with chronic musculoskeletal, head,
      or abdominal pain into a single arm trial conducted at one site. Assessments will occur at
      baseline, immediately after intervention, and repeated at 3 months post-intervention.
      Mediators will be assessed at mid-treatment (4 weeks). All youth will receive an 8-week
      internet-delivered pain self-management intervention (WebMAP). Following the recommended
      Common Data Elements for self-management three self-management processes are measured
      including patient activation, pain self-efficacy, and self-management skills, and
      patient-reported outcomes of health (global health, fatigue) and pain (pain symptoms,
      pain-related disability). Positive and negative affect and executive function are assessed as
      potential mediators. Sleep deficiency is comprehensively assessed with subjective measures,
      daily sleep logs, and ambulatory actigraphy monitoring to measure disrupted sleep, amount of
      sleep, sleep quality, and insomnia symptoms.
    

Intervention name(s): Web-based CBT (Web-MAP)
Intervention type(s): Behavioral
Intervention description(s): see arm description
Intervention model: Single Group Assignment
Intervention model description: All participants will receive internet-delivered CBT for pain self-management (Web-MAP).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pain; internet intervention; pain management; CBT; adolescent; sleep
Study Analyzing the Effect of Rifampicin Administration on the Pharmacokinetics of Neramexane Mesylate
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objectives:

      • Assess the effects of poly-specific cytochrome P450 and drug-transporter induction by
      repeated dose Rifampicin (600 mg/day) co-administration on the single-dose pharmacokinetics
      of Neramexane.

      Secondary Objectives:

      • To assess safety and tolerability of Neramexane single dose treatment alone and
      co-administration of a Neramexane single dose with a Rifampicin repeated dose treatment.
    


Intervention name(s): Neramexane
Intervention type(s): Drug
Intervention description(s): Drug-Drug Interaction Study
Masking: None (Open Label)
Keywords: Healthy subjects
Feasibility Study of Exenatide by Continuous Subcutaneous Infusion
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study to investigate the feasibility of administering exenatide by
      continuous subcutaneous infusion to healthy subjects. Study will consist of two parts i.e.
      Part A and B. In Part A 2 healthy subjects will receive exenatide infusion over 24 hours
      followed by a follow-up visit 10 to 14 days after discharge from clinic. In Part B
      approximately 6 healthy subjects will receive subcutaneous infusions of exenatide for maximum
      of 7 days followed by a follow-up visit 10 to 14 days after discharge from clinic.
    


Intervention name(s): Exenatide
Intervention type(s): Drug
Intervention description(s): Prefilled pen containing 2.4 mL of drug will be transferred into MiniMed Paradigm Real-Time Revel device for subcutaneous infusion.
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nausea; subcutaneous infusion; exenatide
Camel Whey Protein Gel for the Treatment of Aphthous Ulcer
Condition: Aphthous Stomatitis, Recurrent; Antioxidative Stress
MeSH terms: Stomatitis; Stomatitis, Aphthous
Study type: Interventional

Summary: 
      Higher prevalence of recurrent aphthous ulcer in young adults and the severity decreased with
      increasing age. The etiology of aphthous ulcer remains unclear. Other possible factors
      include trauma, drug use, deficiency in vitamin B12, folic acid, iron, stress, hormonal
      changes and metabolic diseases. Many topical agents such as local and systemic an- tibiotics,
      local antiseptics, topical NSAIDs, and topical corticosteroids are generally prescribed for
      symptomatic relief. Several approved drug for- mulations such as pills, mouthwash, sprays and
      paste such as vitamin B12, chlorhexidine mouthwash, steroid lozenges and local anesthetics
      are primarily suggested for the treatment of aphthous ulcer.

      Camel whey protein gel was fabricated to get benefits of its antiinflammatory,
      immunomodulator, Antibacterial and antioxidant effects.
    

Detailed description: 
      40 cases of recurrent aphthous ulcer patients as the research object,were randomly divide
      into the study group and the control group, each with 20 cases of both sexes with age ranging
      from 18 years to 50 years.

      Inclusion criteria consisted of the following: (a) clinical examination and confirmed history
      of recurrent oral ulcer, (b) recurrence of the oral ulceration, and (c) patients in good
      condition with no serious systemic disease. Eligible persons were excluded if they were
      administered antibiotics or glucocorticoids or accepted periodontal or dental treat- ments
      that interfered with the results of our experimental drugs.

      the control group will be subjected to placebo gel consisting of methyl cellulose gel whereas
      the study group will use camel whey protein dissolved in methyl cellulose gel base. the gel
      will be applied 1 day after ulcer appearance and will be stopped after ulcer disappearance
    

Intervention name(s): placebo gel; camel whey protein gel
Intervention type(s): Combination Product; Combination Product
Intervention description(s): just methyl cellulose gel was applied to the ulcer; camel whey protein gel was prepared and dissolved in methyl cellulose gel base and applied to the ulcer
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Methylcellulose gel
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment