bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D Effect in Rheumatoid Arthritis.
Condition: Active Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      Regulatory T (Tregs) cells play an important role in the maintenance of immunological
      tolerance. It decrease in the peripheral blood of rheumatoid arthritis patients. Vitamin D
      has an immunomodulatory and anti-inflammatory effect in rheumatoid arthritis.

      Vitamin D supplementation significantly enhances Tregs percentage in the peripheral blood of
      RA patients. So supplementation of Vit D improves rheumatoid arthritis disease activity.
    

Detailed description: 
      Background: Regulatory T cells (Tregs) play an important role in the maintenance of
      immunological tolerance, so Tregs deficiency or decrease suppressor functions may be
      associated with development of autoimmune diseases.

      Vitamin D is essential for normal bone mineralization and growth, prevention of osteopenia,
      osteoporosis, and nonspecific painful musculoskeletal conditions . Vitamin D is thought to
      have an immunomodulatory and anti-inflammatory actions, as its receptors are widely expressed
      in peripheral mononuclear blood cells, also its deficiency associated with several autoimmune
      disorders, including rheumatoid arthritis

      Methods: 40 patients with active RA were randomly assigned into two groups. Group I received
      MTX plus hydroxychloroquine, group II received MTX and hydroxychloroquine plus vitamin D
      supplementation for 3 months, in addition to 30 healthy volunteers as control group.
      Peripheral blood Tregs were measured by Flow Cytometry.

      Statistical Analysis. The collected data analyzed by SPSS software (version 16). The range,
      mean and standard deviation were calculated for quantitative variables. Categorical variables
      were expressed as number and percentages; Chi square was used as a test of their
      significance. Skewness, kurtosis; Shapiro-Wilk, and The Kolmogorov-Smirnov tests were used to
      test the normality for the data. The difference between two means was analyzed using the
      students (t) test (paired and unpaired samples- T tests). Significance was considered at
      p<0.05.
    

Intervention name(s): Ergocalciferol 1.25 mg tablet
Intervention type(s): Drug
Intervention description(s): weekly 50000 IU of Vitamin D2 (Ergocalciferol 1.25 mg tablet) given orally group II
Intervention MeSH terms: Ergocalciferols; Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Regulatory T cell; Foxp3+; vitamin D supplementation; Rheumatoid arthritis; DMARD
Parent Mentor Interventions for Early Childhood Obesity
Condition: Obesity, Childhood
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to identify the most effective strategy for
      intervention to change behaviors and affect weight status in obese children 2-5 years of age
      within the context of early childhood education centers.
    

Detailed description: 
      The primary aim is to test an intervention to disseminate and promote the adoption of
      positive deviance behaviors among parents of obese Hispanic children using peer mentors. This
      trial will evaluate the efficacy and feasibility of this approach in reducing adiposity among
      a high-risk population of children.

      Our central hypothesis is that children randomized to the intervention with a parent mentor
      using positive deviance methods with have a greater reduction in adiposity as measured by
      body mass index (BMI) compared with a parent mentor using traditional education or a control
      receiving usual education.
    

Intervention name(s): Parent Mentor with Standard Education; Parent Mentor with Positive Deviance
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parent mentors will provide coaching based on the current guidelines around diet and physical activity; Parent mentors will provide coaching based on findings from the positive deviance study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers
Condition: Nicotine Dependence; Nicotine Dependence, Cigarettes; Tobacco Use; Tobacco Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of
      JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.
    

Detailed description: 
      E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing
      vaporization rather than combustion, the generation and inhalation of smoke and carbon
      monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid
      blends for use in e-cigarettes. This study will provide an understanding of the levels of
      nicotine obtained with use of the company's 1.7% and 5% ENDS products.
    

Intervention name(s): Tobacco flavored JUUL 1.7% ENDS; Tobacco flavored JUUL 5% ENDS; Mint flavored JUUL 1.7% ENDS; Mint flavored JUUL 5% ENDS; Fruit Medley flavored JUUL 1.7% ENDS; Fruit Medley flavored JUUL 5% ENDS; Crème brulee flavored JUUL 1.7% ENDS; Crème brulee flavored JUUL 5% ENDS; JUUL 1.7% ENDS 10 puffs vs. ad lib puffs; JUUL 5% ENDS 10 puffs vs. ad lib puffs
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs); Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs); Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs); Treatment with Mint flavored JUUL 5% ENDS(10 puffs); Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs); Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs); Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs); Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs); Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs; Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electronic Nicotine Delivery System; Combustible Cigarettes; Nicotine
The Ajyal Salima Longitudinal Study to Prevent Childhood Obesity
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The study was carried out to determine the long-term effectiveness of a school-based
      intervention programme when implemented over 2 years and its sustained effect one year later.
    


Intervention name(s): Ajyal Salima
Intervention type(s): Other
Intervention description(s): It comprises in class-activities, meetings with parents and improvement of school foodservice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: BMI; Health policies; School health promotion; Intervention
Effect of Rosiglitazone
Condition: Healthy
Study type: Interventional

Summary: 
      To evaluate :

        -  acute effects of a single dose of 8 mg rosiglitazone (therapeutic dose)

        -  on insulin secretion and

        -  insulin sensitivity in 12 healthy male subjects.
    


Intervention name(s): rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: rosiglitazone; insulin secretion; clinical trial; healthy; persons
TDCS Effects on Motor Learning and Motor Control in Healthy Subjetcs
Condition: Healthy
Study type: Interventional

Summary: 
      Clinical Trial with two groups, transcranial direct current stimulation aplication and sham;
      triple blinded. The protocol is applied 5 consecutive days during the training of a manual
      dexterity task. Manual dexterity and somatosensory variables are measured pre intervention,
      post one day of intervention, post 5 days of intervention, and 5 days after finish the
      intervention.
    

Detailed description: 
      Clinical Trial with two groups, transcranial direct current stimulation aplication (1 mA )
      and sham (ramp up and down of 30 seconds in total) . Bouth interventions will last 20
      minutes; at the same time of the aplication bouth are going to train the manual dexterity
      with Purdue Pegboard Test.

      This protocol is applied 5 consecutive days, also it have a follow up of 5 days more.

      It is triple blinded. Manual dexterity and somatosensory variables are measured pre
      intervention, post one day of intervention, post 5 days of intervention, and 5 days after
      finish the intervention.
    

Intervention name(s): transcranial direct current stimularion
Intervention type(s): Device
Intervention description(s): aplication of direct current stimulation on the scalp wiht sponge electrodes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial direct current stimulation; motor learning
Neurology Inpatient Clinical Education Trial
Condition: Myasthenia Gravis; Guillain-Barre Syndrome; Multiple Sclerosis; Seizures; Parkinsonism; Meningitis; Encephalitis; Headache; Vestibular Disorder; Spondylosis; Normal Pressure Hydrocephalus
MeSH terms: Myasthenia Gravis; Spondylosis; Vestibular Diseases; Multiple Sclerosis; Seizures; Meningitis; Encephalitis; Hydrocephalus; Parkinsonian Disorders; Hydrocephalus, Normal Pressure; Guillain-Barre Syndrome
Study type: Interventional

Summary: 
      The objective of this study is to compare the effectiveness of a personalized patient
      education program to the current hospital education and evaluate its impact using patient
      satisfaction scores.

      The investigators hypothesize that a personalized patient education intervention will
      increase patient's understanding of their diagnosis and satisfaction with the care as
      reflected in the survey results.
    


Intervention name(s): Current standard discharge educational intervention; Personalized discharge educational intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The patients will receive the current hospital standard discharge educational material which explains the diagnosis, new medications, follow up and any activity/diet restrictions. A member of the study team will explain this material to the patient and answer any questions.; The patients will receive a new personalized discharge educational material which will explain the specifics of their disorder, the treatment, and prognosis. The materials will contain simple, organized explanations and graphics. A member of the study team will explain this material to the patient and answer any questions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study team members will randomize patients to receive either the current standard hospital education material or the new personalized education material. Investigators will use a stratified randomization process to allocate the patients from different categories including age range, gender, and discharge diagnosis into each group. Thereby the investigators will achieve equal distribution of diagnoses and other demographics among groups in real time. They will review the two groups when performing statistical analysis near the end of the study to ensure heterogeneity of distribution.
A study team member who has also been a member of the care team will use the either the current hospital standard or the new personalized education materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: clinical education
Impact of a Novel Immune Modulating Dietary Supplement on House Dust Mite Induced Allergic Rhinoconjunctivitis
Condition: Dust Mite Allergy; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Dust Mite Allergy
Study type: Observational

Summary: 
      A validated mobile Allergen exposure chamber (AEC) is used to expose qualified study
      participants suffering from house dust mite (HDM) induced allergic rhinoconjunctivitis. A
      maximum of four individuals are exposed at a time under standardized conditions with a
      mixture of allergens from Dermatophagoides pteronyssinus and Dermatophagoides farinae (each
      50%, faeces and body allergens; doses of 250 μg/m3 air; 21°C, and 55% relative air moisture).
      After the first exposure, a dietary supplement lozenge, containing beta-lactoglobulin (BLG),
      iron, retinoic acid, zinc and polyphenols, is taken twice daily for a period of 12 weeks,
      followed by the second exposure. A minimum of thirty persons are challenged with HDM
      allergen. After entering the chamber there is an acclimatization phase of 20 minutes with no
      exposure. Exposure time starts after acclimatization in the chamber and is 120 minutes at
      each visit. Objective parameters are recorded every 30 minutes, and subjective parameters are
      recorded every 10 minutes over a period of 120 minutes. During the exposure a plateau
      (steady-state) of total nasal symptom score with a difference from baseline is measured in
      all participants for each of the two exposures with HDM.
    


Intervention name(s): holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, is loaded with ligands such as retinoic acid, zinc and polyphenol-iron complexes.
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects suffering from house dust mite (HDM) allergic rhinoconjunctivitis who are reacting positively to chamber exposure with HDM are reevaluated in the exposure chamber 3 months after taking food supplements.
Intervention MeSH terms: Tretinoin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study group recruitment is based on an existing data base of subjects suffering from
        HDM-induced allergic rhinoconjunctivitis reacting positively to chamber exposure with HDM
        and by advertising for volunteers.
Sexual Functions and Marital Adjustment for Spouses in Menopause
Condition: Menopause
Study type: Observational [Patient Registry]

Summary: 
      Objective: This study was conducted as a cross-sectional descriptive study in order to
      determine the effect of menopause on the SFs and marital adjustment of the spouses.
    

Detailed description: 
      Objective: This study was conducted as a cross-sectional descriptive study in order to
      determine the effect of menopause on the SFs and marital adjustment of the spouses.

      Materials and Methods: The sample of the study consisted of a total of 254 people, 127 of
      whom were postmenopausal women and their spouses. The data were collected with The
      Descriptive Information Form (DIF), The Female Sexual Function Scale (FSFS) and the Arizona
      Sexual Experiences Scale (ASES), The Marital Adjustment Scale (MAS). T test was used for
      two-group comparison of parametric data, Mann Whitney U test was used for two-group
      comparison of non-parametric data, and Kruskal Wallis Test was used for non-parametric data
      comparison of more than two groups. In addition, the relationship between the mean scores of
      FSFS, ASES and MAS was evaluated with Spearman's rho Correlation analysis.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population of this study, which was planned as a cross-sectional descriptive study,
        consisted of women who applied to the menopause polyclinic of a university hospital between
        08.11.2017 and 29.12.2017. The sample of the study consisted of women aged between 45-65
        years. Accordingly, the number of couples to be taken into the sample was determined as
        125, and a total of 254 individuals, 127 of whom were menopausal women and their spouses,
        were included in the study.
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely,
      human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the
      natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural
      cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To
      induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing
      hormone (GnRH) agonist can be given.

      The purpose of this study is to find out which approach may work better in IVF patients who
      experienced 4 IVF failures.
    


Intervention name(s): GnRH agonist trigger; hCG trigger
Intervention type(s): Drug; Drug
Other intervention name(s): Oovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.; Ovulation trigger with Ovitrelle 250 microgram.; Luteal support with daily progesterone gel = Crinone 8%
Intervention MeSH terms: Triptorelin Pamoate; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients
Condition: Kidney Failure; Secondary Hyperparathyroidism; Vascular Diseases
MeSH terms: Neoplasm Metastasis; Renal Insufficiency; Vascular Diseases; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot, prospective randomized controlled study with the primary objective to
      evaluate and compare medical treatment of severe SHPT, namely oral cinacalcet versus surgical
      treatment, that is, parathyroidectomy with forearm autografting, on the progression of
      coronary artery and valvular calcification and left ventricular mass index in endstage renal
      disease patients receiving peritoneal dialysis over 12 months. The change in arterial
      stiffening, left ventricular volume, aortic valve calcium score and bone mineral density,
      nutritional status and biochemical parameters, quality of life measures will be evaluated as
      secondary objectives of this study.
    

Detailed description: 
      Patients with severe secondary hyperparathyroidism (SHPT) are frequently complicated with
      vascular calcification. There is some suggestion that subtotal parathyroidectomy may reduce
      or stabilize vascular calcium scores in dialysis patients. Experimental data suggests that
      SHPT plays an important role in mediating uraemic arterial disease and that parathyroidectomy
      largely prevented the development of calcification. Cinacalcet has emerged as a novel therapy
      for the treatment of SHPT and has been shown to reduce the need for surgical
      parathyroidectomy. However, their effects on vascular, cardiac, bone and nutrition status
      have not been evaluated and compared with parathyroidectomy.
    

Intervention name(s): Cinacalcet; Surgical total parathyroidectomy with forearm autografting
Intervention type(s): Drug; Procedure
Intervention description(s): oral cinacalcet 25mg once daily as a start and up titrated by 25mg daily according to response in lowering PTH and maximum oral dose allowed is 100mg daily; Surgical total parathyroidectomy with forearm autografting will be performed
Other intervention name(s): Regpara
Intervention MeSH terms: Cinacalcet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cinacalcet medical treatment versus total parathyroidectomy with forearm autografting surgical treatment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic kidney disease; peritoneal dialysis; secondary hyperparathyroidism; parathyroidectomy; vascular calcification; cinacalcet
A Study of Safety and Tolerability of Fipamezole in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this clinical trial is to determine the maximum tolerated dose of Fipamezole
      in adult patients with Parkinson's disease who are receiving levodopa.
    

Detailed description: 
      Parkinson's Disease is the second most common neurodegenerative disorder worldwide. While
      treatment with dopaminergic agents like levodopa, the mainstay of treatment, is effective in
      the early phases of the disease, their benefits decrease with disease progression, and
      problems such as dyskinesia and on-off phenomenon begin to manifest. In this study,
      fipamezole, a new antagonist of an adrenergic receptor, is being investigated to better
      understand the safety and side-effect profile in patients with Parkinson's Disease.

      The sampling method used was simple random sampling.
    

Intervention name(s): Fipamezole ODT; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects take three daily doses of Fipamezole ODT, with each dose escalating from 30 to 60, 90, 120, 150 and up to 180 mg over 8 weeks.; 1 to 2 tablets three times per day to be taken according to the same schedule as the active study drug.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Parkinson's Disease on stable regimen of levodopa
      
Keywords: Dyskinesia
Myocardial Injury is Not Related to Training Levels Among Recreational Participants in the Silicon Valley Marathon
Condition: Troponin; Natriuretic Peptide, Brain; Exercise; Echocardiography
Study type: Observational

Summary: 
      To determine if pre-race training effects heart damage induced by marathon running.
    

Detailed description: 
      Investigations have shown increases in cardiac markers consistent with myocardial injury and
      left ventricular dysfunction in both recreational and elite athletes after endurance
      exercise. Pre-race training is an important component of endurance events, yet its effect on
      cardiovascular injury is unclear. The present study aimed to evaluate the correlation between
      myocardial injury and training level in recreational marathon runners utilizing both
      objective and subjective measures.
    

Time perspective: Prospective
Keywords: Troponin; Natriuretic Peptide, Brain; Exercise; Echocardiography
A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Study AG120-C-012 is a Phase 1, open-label, single-dose study designed to evaluate the PK,
      safety, and tolerability of a single 500 mg AG-120 (Ivosidenib) dose in subjects with mild or
      moderate hepatic impairment (HI) compared to subjects with normal hepatic function. The study
      will be conducted at 2 US centers.
    


Intervention name(s): AG-120 (Ivosidenib)
Intervention type(s): Drug
Intervention description(s): Single 500 mg dose of AG-120 (Ivosidenib).
Intervention MeSH terms: Ivosidenib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AG-120; Healthy Volunteer; Clinical Pharmacology; Hepatic Impairment