bioihbjkbjnl/mcl2 huggingface dataset:
Community-based Adolescent Diabetes Prevention Program
Condition: Pre-Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional

Summary: 
      The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a
      disproportionate increase among minority youth. The research proposed in this Career
      Development Award will use community-based participatory research methodology as well as
      novel strategies (peer education and mobile health technologies) to design, implement and
      evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban
      community with high disease burden.
    

Detailed description: 
      Approach: The proposed research addresses diabetes risk and prevention among racial/ethnic
      minority adolescents in East Harlem (EH), NY. Aim 1 will use qualitative methods to explore
      the best strategies for using peer education for diabetes risk reduction in youth and the
      potential role of mobile health technologies in improving adherence to behavioral
      modification plans. Aim 2 will utilize findings from preliminary studies and Aim 1 to design
      and evaluate a pilot community-based intervention to 1) maintain/reduce BMI (primary
      outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and
      3) improve other measures of diabetes risk. Data will be collected at baseline, immediately
      after the intervention (3 months) and at one year in the intervention and wait list control
      groups. Aim 3 involves refining the pilot intervention based on an examination of
      intervention feasibility, acceptability, and sustainability and planning for a future R01.
    

Intervention name(s): TEEN HEED
Intervention type(s): Behavioral
Intervention description(s): Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: community-based participatory research; adolescents
Comparison of Volume Controlled Ventilation With 1:1 Inspiratory to Expiratory Ratio and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
Condition: Robot Assisted Laparoscopic Prostatectomy
MeSH terms: Pneumoperitoneum
Study type: Interventional

Summary: 
      The purpose of this study is to compare the 1: 1 I: E ratio VCV and the autoflow VCV in
      patients undergoing robot assisted laparoscopic prostatectomy
    


Intervention name(s): ventilation strategy 1; ventilation strategy 2
Intervention type(s): Procedure; Procedure
Intervention description(s): In Group I, after trendelenburg position, patients will be applied 1:1 ratio VCV.
Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:1, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.; In group A, after trendelenburg position, patients will be applied autoflow VCV.
- Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:2, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 I:E ratio VCV group
autoflow VCV group
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Portion Size Strategies for Management of Body Weight
Condition: Obesity
Study type: Interventional

Summary: 
      The primary aim of this research is to determine the efficacy of two portion-control
      strategies to achieve sustainable dietary and behavior changes and to promote weight loss and
      maintenance. A randomized controlled trial will test two approaches to managing portion
      sizes: one that gives individuals skills and tools to help them make appropriate portion
      choices, and another that focuses on consumption of pre-portioned foods in order to limit
      exposure to large portions in the personal food environment. A third group will receive a
      basic nutritional program to promote weight loss.

      The second aim of the research is to determine the effects of the programs on knowledge and
      consumption of appropriate portions, as assessed by innovative assessment methods and
      multiple-pass dietary recalls. The third aim is to conduct exploratory analyses of individual
      factors that may influence the response to the portion-control interventions, such as
      psychosocial indicators, blood biomarkers, and measures of adherence to the interventions.
      The expected outcome of the project is that it will lead to the development of specific,
      evidence-based strategies to help control portion sizes in order to manage weight.
    


Intervention name(s): Advice on diet, physical activity, and behavior change; Instruction in food portion size; Provision of pre-portioned foods; Advice on healthy eating for weight loss
Intervention type(s): Behavioral; Behavioral; Other; Behavioral
Intervention description(s): Individuals will participate in individual sessions with Registered Dietitians providing basic instruction in principles of weight loss. The program will instruct individuals on the principles of healthy eating and nutrition during calorie restriction. These materials include one module with general information on the importance of limiting portion sizes. The program will also include instruction on physical activity and behavioral strategies for weight loss.; Individuals assigned to this program will participate in individual instructional sessions with specialized materials and tools that address food selection and choosing appropriate portion sizes of various foods.; Individuals assigned to this program will be provided with commercially available pre-portioned foods and will be taught effective ways to incorporate them into their daily diet.; Individuals assigned to this program will participate in individual instructional sessions that address principles of healthy eating while on a calorie-restricted diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Oligodendroglioma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining chemotherapy and radiation therapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation
      therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed
      anaplastic oligoastrocytomas.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the rate of progression in patients with newly diagnosed anaplastic
           oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and
           concurrent temozolomide with radiotherapy.

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the survival of patients treated with this regimen.

      OUTLINE: This is a multicenter study. Patients are stratified according to response to
      neoadjuvant temozolomide (stable disease or partial response (PR) vs complete response (CR)).

      Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for
      up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with
      CR or PR receive 2 courses beyond CR or PR.

      Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or
      PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide
      daily for 42 days concurrently with radiotherapy.

      Patients with CR after completion of neoadjuvant temozolomide undergo observation.

      Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3
      years, and then annually thereafter.

      PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.
    

Intervention name(s): temozolomide; neoadjuvant therapy; radiation therapy
Intervention type(s): Drug; Procedure; Radiation
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult anaplastic oligodendroglioma; adult mixed glioma
Comparative Effects of Two Conservative Treatments in Teres Major in Handball Athletes With Shoulder Pain
Condition: Shoulder Pain; Dry Needling; Diacutaneous Fibrolysis; Athletic Injuries
MeSH terms: Shoulder Pain; Athletic Injuries
Study type: Interventional

Summary: 
      The aim of the study is to investigate the effects of the dry needling technique and
      diacutaneous fibrolysis technique in teres major muscles on pain, range of motion, strength
      extensibility and muscular properties of the soft tissues of the shoulder in athletes with
      shoulder pain.
    


Intervention name(s): Diacutaneous Fibrolysis; Dry needling
Intervention type(s): Other; Other
Intervention description(s): Application of diacutaneous fibrolysis in teres major; Dry needling based on fast-in fast-out technique in the teresa major muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Niacin will improve postprandial hyperlipidaemia and cardiovascular risks indices via its
      lipid lowering as well as via pleiotropic effects in patients with polycystic ovary syndrome
      (PCOS).
    

Detailed description: 
      Polycystic ovary syndrome is a common hormone problem in young women and, as a result of it,
      they can experience irregular periods, reduced fertility, acne and increased body hair.
      Frequently, increased weight is a feature. Research suggests that they could have a higher
      risk of diabetes, high cholesterol and cardiovascular disease such as high blood pressure,
      angina, heart attack and stroke.

      The fat from the diet is transported from the stomach into the blood and then taken up by the
      liver, muscles and fat tissues to store or use as an energy source. Delayed removal of fat
      from the circulation resulting rise of fat after a meal has been known to happen in PCOS.
      High fats after a meal are a strong risk factor for cardiovascular disease.

      Niacin has been in clinical use to lower bad cholesterol and to increase good cholesterol for
      many years. It has been proved to be effective in reducing risks of heart disease in patients
      with diabetes. However the effect of niacin on reducing cardiovascular risks and reducing fat
      level after a meal in PCOS has not been studied and this is why we plan to do this research.
    

Intervention name(s): tredaptive (nicotinic acid/ laropiprant); placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks; placebo tablet one a day for first 4 weeks followed by two a day for 8 weeks
Other intervention name(s): tredaptive
Intervention MeSH terms: Nicotinic Acids; Niacin; Niacinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PCOS
Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
Condition: Breast Cancer
Study type: Observational

Summary: 
      It has been shown that women who have dense breasts have an increased risk of breast cancer
      compared with women whose breasts are less dense. However, while breast density may be a risk
      factor, the etiology of the relationship between breast cancer and breast density is not
      understood. Furthermore, it is well recognized that breast cancer can still develop in women
      whose breasts are not dense.

      At menopause, the amount of breast glandular tissue and stroma naturally decreases due to a
      lack of hormonal stimulation. This is characterized as a decrease in the mammographic
      density. Although certain medications, including hormone therapy (HT) and dopamine
      antagonists can increase breast density, these effects are reversible upon discontinuation of
      the specific agent. Other medications such as the selective estrogen receptor modulators
      (SERM), raloxifene (RAL) and tamoxifen, have been shown to not affect breast density and
      allow the normal age-related changes to occur. The effects of bazedoxifene (BZA), a new SERM,
      on breast density are not known. The purpose of this study is to examine the effect of BZA on
      breast density changes over 24 months in postmenopausal women. The results may be useful for
      clinicians to understand the effect of BZA on breast density and its mammographic effects.

      This is an observational, multicenter, double-blind, randomized, placebo- and active
      comparator-controlled study. It is also an ancillary that will use women who are already
      participants in a phase 3 trial for fracture reduction (protocol 3068A1-301-WW; primary
      study). In the primary study, subjects received BZA 20 mg, BZA 40 mg, RAL 60 mg, or placebo.
      This ancillary study will request a subset of participants to use their mammograms taken in
      this study. Their mammogram will be digitized by a central imaging center. A single
      radiologist will perform the quantifications of breast density from the digitized mammograms.
    


Time perspective: Retrospective
Blue Light for Treating Eczema
Condition: Eczema
MeSH terms: Eczema
Study type: Interventional

Summary: 
      Monocenter, randomized, intraindividual, open label, exploratory study comparing 4 weeks of
      treatment with 453nm blue light with no treatment in patients with Eczema. Patients will be
      screened up to 28 days before start of treatment. During the screening visit, the purpose and
      procedures of the study will be explained to potential patients and informed consent will be
      obtained. In addition, fungal superinfection of the target area will be examined using direct
      preparations and mycology cultures. At the baseline visit, patients with Eczema will be
      determined and all inclusion and exclusion criteria will be assessed. For eligible patients,
      two comparable treatment areas will be randomized to treatment with blue light (target area)
      or to serve as untreated control area. After randomization, patients will receive treatment
      of the target area with 3 applications per week at the investigational site for a total
      treatment period of 4 weeks. During those 4 weeks, safety and effectiveness assessments will
      be performed at weekly intervals. After end of treatment, the patients will be followed-up
      for another 2 weeks. In case no full resolution of adverse events occurred at the 2 week
      follow-up visit, a follow-up call will be performed after another 2 weeks. Treatment
      responses will be photo documented
    


Intervention name(s): PSO-CT02 device
Intervention type(s): Device
Intervention description(s): The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Oats on Lipid Profile
Condition: Mildly Hypercholesterolemic Subjects
Study type: Interventional

Summary: 
      A randomized control trial to assess the effect of oats on lipid profile of mildly
      hypercholesterolemic subjects. Subjects consumed 35g of oats twice daily (total of 70g / day)
      in place of carbohydrates as part of their usual diet. 70 grams of oats provide 3 grams of
      soluble fiber. Control group consumed the usual diet. Subjects followed up for 4 weeks. In
      total 3 assessment visits of the subjects planned for the study period.
    


Intervention name(s): Oats
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first-in-human study is to evaluate the safety, tolerability and
      pharmacokinetics of single intravitreous injections,single ascending doses, of RC28-E(a
      chimeric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in subjects
      with wet age-related macular degeneration (wAMD).
    

Detailed description: 
      This is an open-label, non-randomized,double-center phase 1 study evaluating
      pharmacokinetics, safety and tolerability of single intravitreal injections of RC28-E in the
      patients with AMD.RC28-E is recombinant dual decoy receptor IgG1 Fc-fusion protein,can block
      VEGF-A and FGF-2. In preclinical studies suggested that RC28-E might be more effective in
      inhibiting pathological angiogenesis than other VEGF antagonists on CNV. Every subject will
      only accept one dose. In addition to safety and preliminary efficacy, pharmacokinetics and
      immunogenicity of RC28-E will be evaluated as well.
    

Intervention name(s): RC28-E
Intervention type(s): Biological
Intervention description(s): RC28-E intravitreous injection 50ul
Other intervention name(s): RC28-E is a chimeric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2.
Intervention MeSH terms: RC28-E protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Geko™ Plaster Cast Study, Deep Vein Thrombosis (DVT) Prophylaxis
Condition: Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary objective of this study is to examine the flow characteristics of deep venous
      flow in the leg veins using Doppler ultrasound imaging and how this flow is modified by the
      application of a plaster and with a geko™ device in healthy volunteers
    


Intervention name(s): geko; Plaster cast
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Deep Vein Thrombosis
Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      At present, there is no agreement on the effect of vitamin D level in serum and follicular
      fluid on the outcome of IVF-ET pregnancy. Most of these studies were based on the research of
      total 25 (OH) D, which have ignored that the biological activity of vitamin D molecule is not
      total 25 (OH) D, but free vitamin D or vitamin D bioavailable, and have flaws in methodology.
      This project intends to make a prospective cohort study with large sample, based on a
      complete methodology of total vitamin D and free vitamin D to measure maternal vitamin D
      levels in blood,to systematically study the effect of maternal vitamin D status on IVF - ET
      pregnancy outcome. This study is also the first to study the relationship between maternal
      vitamin D status and the outcome of IVF-ET pregnancy using a complete methodology.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        the study population will be selected from patients of Reproductive and Genetic Hospital of
        CITIC-Xiangya
Dose-dependent Effects of VAC BNO 1095 on Cyclic Mastodynia and Premenstrual Syndrome
Condition: Cyclic Mastodynia; Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome; Mastodynia
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180
      patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to
      achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150 are
      expected to complete the study per protocol.

      Study objectives:

      Identification of the optimal dosage of VAC BNO 1095 (product name) film coated tablets for
      treatment of cyclic mastodynia and premenstrual syndrome.

      To prove the efficacy of VAC BNO 1095 film coated tablets in the treatment of cyclic
      mastodynia.

      Dose regimen:

      Group 1: VAC BNO 1095 1x10 mg:

      1 tablet of verum in the morning, 1 placebo tablet in the evening

      Group 2: VAC BNO 1095 2x10 mg:

      1 tablet of verum in the morning, 1 tablet of verum in the evening

      Group 3: Placebo:

      1 tablet placebo in the morning, 1 tablet placebo in the evening

      The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first
      screening further visits are scheduled after the end of each of the first and second run-in
      cycle, and after the first, second and third treatment cycle, respectively.

      Visits will be performed during the menses at day 3 (-1+3 days), i.e. 2 days after day 1 of
      menstruation number n, with exception of the first screening visit which can be performed at
      any time prior to the first run-in cycle. Subsequently the time between the first study visit
      and the onset of the first run-in cycle menses T shall be added to the overall study
      duration.

      In case that the next menstruation does not commence as expected, the patient should contact
      her investigator immediately in order to schedule a new appointment, approximately on the
      actual day 3 of the menses.
    


Intervention name(s): VAC BNO 1095 film coated tablets
Intervention type(s): Drug
Intervention description(s): 3 dosages: Placebo, 10 mg of VAC BNO 1095 once daily in the morning, 10 mg of VAC BNO 1095 twice daily in the morning and in the evening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment