bioihbjkbjnl/mcl2 huggingface dataset:
Oxidative Stress and Nutritional Supplementation Intervention Study
Condition: Oxidative Stress; Inflammation; Aging; Dementia; Pain
MeSH terms: Dementia; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      A major means whereby oxidative stress promotes aging-related disease is by activating
      inflammatory pathways. Decreasing oxidative stress and inflammation should ameliorate many of
      the problems associated with aging, including vascular dementia, Alzheimer's disease,
      osteoporosis, muscle wasting, insulin resistance, type 2 diabetes, and metabolic syndrome.
      Animal and human studies have demonstrated that consumption of vitamin D and phase 2 protein
      inducers decrease oxidative stress and associated inflammation. The flax lignan
      secoisolariciresinol diglucoside (SDG) is metabolized to enterolactone, a potent phase 2
      protein inducer. Animal and human studies have shown that consumption of flax seed or its
      component SDG decreases hypertension, serum cholesterol, atherosclerosis, the growth of
      experimentally-induced cancers as well as metastases of human breast tumours implanted into
      nude mice, and delays the development of type 2 diabetes. Vitamin D plays a role in
      modulating inflammation, enhancing immunity (while suppressing autoimmune injury) and
      exerting control over cell differentiation. Adequate levels of vitamin D also appear to
      promote better glycemic control. The investigators predict that consumption of SDG in persons
      with adequate vitamin D status will decrease oxidative stress and associated inflammation. If
      this hypothesis is upheld, this research has the potential to greatly decrease healthcare
      costs while allowing healthier aging.
    


Intervention name(s): secoisolariciresinol diglucoside
Intervention type(s): Dietary Supplement
Intervention description(s): SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks
Other intervention name(s): Beneflax Flax Lignan Extract Archer Daniels Midland,#080001.; Natural Factors Whey Factors whey protein (unflavored).; Vitamin D NPN 80003663 WN Pharmaceuticals
Intervention MeSH terms: Vitamin D; Secoisolariciresinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: long term care; lignans; oxidative stress; inflammation; aging; dementia; postural balance; depression; muscle weakness; quality of life; pain
Evaluation of Surfactant Protein B in the Differential Diagnostics of Dyspnea
Condition: Dyspnea; Cardiac Disease; Pulmonary Disease
MeSH terms: Dyspnea; Heart Diseases
Study type: Observational

Summary: 
      Establishing new biochemical markers in the differential diagnostics and risk stratification
      in heterogeneous patient collectives is becoming more and more important. The markers should
      be objective, reliable, reproducible, quick and cost effective as well as specific and
      sensitive. Concerning the differential diagnostics of "dyspnea", NT-pro-BNP plays the most
      important role for the evaluation of a cardiac origin. However, a corresponding biochemical
      marker for pulmonary stress is lacking. The aim of the study at hand therefore was the
      evaluation of surfactant protein B in the differential diagnostics of pulmonary and cardiac
      diseases.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients presenting with the symptom "dyspnea" in a university hospital emergency room
      
Keywords: surfactant protein B; differential diagnostics
MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years (0633-028)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety, tolerability and pharmacokinetics (PK) of MK0633 in
      adolescent mild-to-moderate Japanese asthma patients to permit further clinical investigation
    


Intervention name(s): MK0633
Intervention type(s): Drug
Intervention description(s): MK0633 (50 mg) Oral, single dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)
Condition: Endometriosis-related Pain
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of gefapixant
      (MK-7264) in premenopausal female participants with moderate to severe endometriosis-related
      pain. The primary hypothesis: gefapixant is superior to placebo in reducing the average daily
      pelvic pain score (cyclic and non-cyclic, combined) during Treatment Cycle 2.
    


Intervention name(s): Gefapixant; Placebo; Naproxen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Gefapixant tablet 45 mg taken orally; Placebo matching gefapixant tablet taken orally; Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator
Other intervention name(s): MK-7264
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pediatric Switch Study for Children and Adolescent Patients With Epilepsy
Condition: Pediatric Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets
      to Depakote ER tablets in the pediatric population.
    


Intervention name(s): Depakote Delayed-Release/Depakote Sprinkle; Depakote ER
Intervention type(s): Drug; Drug
Intervention description(s): Administered according to the subject's usual regimen.; Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.
Other intervention name(s): ABT-711; Depakote DR; Depakote Sprinkle; divalproex sodium; ABT-711; Depakote Extended Release; divalproex sodium
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Docetaxel and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By Surgery
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after
      surgery.

      PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin
      works in treating patients with stage I, stage II, or stage III non-small cell lung cancer
      that has been completely removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel
           and cisplatin with the chemotherapy regimens used in the International Adjuvant Lung
           Cancer Trial (IALT) in patients with completely resected stage IA-IIIB non-small cell
           lung cancer.

      Secondary

        -  Explore the relationship of time to recurrence, disease-free survival, and overall
           survival of these patients with levels of circulating DNA and proteomic analysis of
           serum.

      OUTLINE: This is an open-label study.

      Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 8
      hours on day 15. Treatment repeats every 28 days for up to 4 courses in the absence of
      disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
    

Intervention name(s): cisplatin; docetaxel; adjuvant therapy
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Docetaxel
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer
The Cork and Kerry Diabetes and Heart Disease Study (Phase II) Mitchelstown Cohort
Condition: Cardiovascular Diseases; Diabetes; Obesity; Hypertension; Dyslipidemia; Metabolic Syndrome; Diet Habit; Life Style; Physical Activity; Smoking
MeSH terms: Cardiovascular Diseases; Heart Diseases; Diabetes Mellitus; Metabolic Syndrome; Dyslipidemias
Study type: Observational [Patient Registry]

Summary: 
      The aim of the Cork and Kerry Study Phase II (Mitchelstown cohort recruited 2010-11) is to
      provide an updated profile of glucose tolerance status, cardiovascular health and their
      related factors in an Irish adult general population sample and to compare the findings with
      those obtained during baseline assessment of Phase I of the Cork and Kerry study (1998) and
      the rescreen (2008).
    

Detailed description: 
      Additional objectives include determining the prevalence of proximal risk factors, such as
      hypertension, dyslipidaemia, body mass index (BMI) and insulin resistance as well as of more
      distal risk factors of diet, smoking, alcohol consumption and physical activity, and the
      association between cardiovascular health and its risk factors with general measures of
      well-being and mental health. The new cohort includes collection of qualitative and
      quantitative data in an effort not only to describe the current health status of the cohort
      and assess individual level determinants but also to provide the appropriate context to
      interpret the role of behavioural factors and social circumstances on health.

      Recruitment was completed on a new cohort of 2047 men and women aged 50-69 years from
      patients attending a single large primary care centre, the Living Health Clinic in
      Mitchelstown, a town with a population of 43000 in county Cork. The Living Health clinic
      includes eight GPs, and the practice serves a catchment area of 20 000, with a mix of urban
      and rural residents. Participants were randomly selected from all registered attending
      patients in the 50-69-year age group.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Recruitment was completed on a new cohort of 2047 men and women aged 50-69 years from
        patients attending a single large primary care centre, the Living Health Clinic in
        Mitchelstown, a town with a population of 43000 in county Cork. The Living Health clinic
        includes eight GPs, and the practice serves a catchment area of 20 000, with a mix of urban
        and rural residents. Participants were randomly selected from all registered attending
        patients in the 50-69-year age group (response rate: 67%).
      
Biospecimen description: 
      Plasma
Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      This is a pilot study evaluating the efficacy of acupuncture on quality of life in gastric
      cancer patients undergoing postoperative adjuvant chemotherapy. Enrolled participates will
      randomly receive high-dose acupuncture, low-dose acupuncture or none-acupuncture during the
      first 3 cycles of adjuvant chemotherapy after resection.
    


Intervention name(s): acupuncture
Intervention type(s): Procedure
Intervention description(s): Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric cancer; Acupuncture; Quality of life; Adjuvant chemotherapy
Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the investigators intend to compare the efficacy and safety of two fixed doses
      of once weekly oral methotrexate in a prospective randomized double blind manner in patients
      with severe plaque type psoriasis.
    


Intervention name(s): Methotrexate
Intervention type(s): Drug
Intervention description(s): once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Tea Extract on Post Prandial Blood Glucose
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed as a randomized, single blind (data evaluation), placebo controlled,
      full cross-over study and conducted in 166 (including 10% drop out) males and females, aged ≥
      18 and ≤ 65 and waist circumference of >80 cm for women and >94 cm for men (indicating
      increased risk of metabolic complications (WHO)) and having a sedentary lifestyle. Subjects
      will receive rice with a tea extract and rice without a tea extract.

      There will be three visits to the test facility: one screening visit and two intervention
      visits. During the intervention visits venous blood samples will be collected for the
      analysis of plasma glucose (t = -30m, -5m, 15m, 30m, 45m, 1h, 1h 30m, 2h and 3h, relative to
      the start of rice consumption ) and serum insulin (t = -5m, 30m, 1h, 2h and 3h).

      Between the two intervention visits subjects have an interval of one week. This interval is
      required to minimize subject discomfort from repeated blood sampling.
    


Intervention name(s): Rice with tea extract; Rice without tea extract
Intervention type(s): Other; Other
Intervention description(s): Rice with tea extract; Rice without tea extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Blood glucose
The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Condition: Infertility, Female; IVF
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      The objective of the study is to gain a better understanding of the gene expression changes
      in the endometrial biopsy especially whether the endometrium has reached a receptive status,
      i.e. the implantation window, or not.
    

Detailed description: 
      The endometrium goes through huge gene expression changes during a cycle, the cells are
      transformed, the mucous membrane thickens, then loosens, and finally sheds. In this process,
      the expression of the genes also goes through significant changes, which can be determined
      from a small tissue sample.

      Endometrium biopsy samples can be used for endometrium phasing. A question of the study is
      the feasibility of using for endometrium phasing beside endometrium tissue biopsy also
      samples generated by endometrium lavage. The advantage of this latter method is that it is
      minimally invasive, it does not cause haemorrhage and has minimal side effects. In some
      selected cases endometrial lavage will be performed on the same day with endometrial tissue
      sampling together with the drawing of a peripheral blood sample.

      A list of potential biomarkers was proposed from the meta-analysis of published gene
      expression datasets. From the endometrium derived samples, RNA will be isolated and gene
      expression biomarkers will be measured. Expression profiles will be compared to published
      reference samples.
    

Intervention name(s): endometrium biopsy; endometrium lavage; repeated endometrium lavage
Intervention type(s): Other; Other; Other
Intervention description(s): All patients will have endometrium biopsy.; In some selected cases biopsy is preceded by endometrium lavage.; Endometrium lavage is repeated during the same cycle.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Infertile women participating in the diagnostic evaluation of infertility. The patients are
        contacted for participation in the study during the diagnostic evaluation of their
        infertility at specialized infertility or gynaecological clinic.
      
Keywords: gene expression; biomarkers; implantation window; embryo transfer; endometrium; biopsy; lavage; liquid biopsy
Development of an Adaptive Treatment for Weight Loss in People With Prediabetes
Condition: PreDiabetes; Obesity
MeSH terms: Prediabetic State; Glucose Intolerance; Weight Loss
Study type: Interventional

Summary: 
      This 16-week study will use an experimental approach called the Sequential Multiple
      Assignment Randomized Trial to help determine which combination and sequence of weight loss
      program features are most effective in people who are at risk for type 2 diabetes.
      Participants in the study will be initially randomized to consume either a high or reduced
      carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than
      or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will
      continue with their initial randomized group for the remainder of the trial. Non-responders
      will be re-randomized to 2nd stage interventions of either including additional exercise
      counseling and training or beginning a time restricted eating protocol for the remainder of
      the trial.
    


Intervention name(s): High Carbohydrate Diet; Reduced Carbohydrate Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomized to this group will participate in a group-based weight behavioral management program and consume a high carbohydrate (HC) diet. Because this protocol uses a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed at week 4. Responders will continue with their 1st stage assignment for the remainder of the study. Non-responders will be randomized to 2nd stage intervention of either combine HC diet with time-restricted eating (TRE) or HC diet with additional exercise counseling and support.; Participants randomized to this group will participate in a group-based behavioral weight management program and consume a reduced carbohydrate (RC) diet. Because this is a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed at week 4. Responders will continue with their 1st stage assignment for the remainder of the study. Non-responders will be randomized to 2nd stage intervention of either combine RC diet with time-restricted eating (TRE) or RC diet with additional exercise counseling and support.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: weight loss; reduced carbohydrate diet; exercise training; time restricted eating
GLS-5700 in Dengue Virus Seropositive Adults
Condition: Healthy; Zika
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700.
      GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. This is a Phase 1
      clinical trial of this vaccine which encodes for the premembrane-membrane and envelope
      regions of Zika virus.

      Zika virus, first discovered in the Zika forest in 1947, has caused a large epidemic in South
      America, Central America, and the Caribbean islands commencing in late 2014 or early 2015.
      Zika virus can cause significant neurologic disease to include Guillain Barre Syndrome in
      adults and microcephaly and other birth defects among children born to mothers who are
      infected during pregnancy. At present no vaccines or treatments have been approved for Zika
      virus infection.
    

Detailed description: 
      GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope
      (prME) proteins of the Zika virus.
    

Intervention name(s): GLS-5700; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): GLS 5700 at 2 mg DNA/dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: DNA; Vaccine
Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate
Condition: Magnesium Sulfate; Labetalol
MeSH terms: Pre-Eclampsia
Study type: Interventional

Summary: 
      the purpose of this study is to compare Intravenous infusion of Labetalol versus Magnesium
      Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients using Transcranial Doppler
    

Detailed description: 
      after being informed about the study and potential risks. All patients giving written consent
      will be randomized by double blind manner into 2 groups each one containing 30 patients ,
      (Group M) : will be given intravenous infusion of magnesium sulfate at a dose of 4 gm
      intravenously over 20 min as a loading dose then MgSO4 intravenous infusion is continued at a
      rate of 1 gm/h for 24 h or until obtain and stabilize the targeted blood pressure..

      (Group L) : The patients will be given intravenous infusion of labetalol (Trandate™,)
      available in 20 ml ampoules containing 100mg labetalol (5mg/ml). Starting the infusion with
      20mg/h and then titrate to obtain and stabilize the targeted blood pressure by adjusting the
      infusion as required every 15 - 30min to a maximum dose of 160mg/hr.
    

Intervention name(s): Magnesium sulfate; Labetolol
Intervention type(s): Drug; Drug
Intervention description(s): intravenous infusion; intravenous infusion
Other intervention name(s): (Trandate™,)
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: magnesium sulfate, labetalol, severe preeclampsia