bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Vitamin D on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      This is a double blind randomised placebo-controlled study involving women with polycystic
      ovary syndrome (PCOS). The patients will be randomised either to Vitamin D 3200 IU or placebo
      for three months. The main hypothesis of this study is "Vitamin D improves hormonal,
      metabolic and cardiovascular risk markers in women with PCOS".
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is a very common condition in women which could present with
      irregular periods, excessive hair growth on body, acne and cysts in the ovaries. PCOS is also
      associated with increased risk of problems later in life like diabetes, high cholesterol
      levels and heart disease. One of the risk factors for having increased incidence of such
      problems in PCOS patients could be low vitamin D levels as many women with polycystic ovary
      syndrome (PCOS) are vitamin D deficient. Vitamin D supplementation may have a beneficial
      effect on insulin levels and fat around the abdomen. It has been seen in previous research
      studies that low level of vitamin D is related to a greater risk of diabetes and heart
      disease. Low vitamin D levels are also associated with fat in the liver. The amount of fat in
      the liver is a sign of early liver disease. So, in this study the investigators want to
      supplement women having PCOS and vitamin D deficiency with vitamin D (3,200 IU) and examine
      the effects on hormones related to PCOS and risk factors for diabetes and heart disease in
      them.
    

Intervention name(s): Vitamin D3, 3200IU; Placebo
Intervention type(s): Other; Other
Intervention description(s): Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.; Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Assessing Fertility Potential in Female Cancer Survivors
Condition: Effects of Chemotherapy
Study type: Observational

Summary: 
      Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience
      endocrine changes more similar to women in their late reproductive years than to same-age
      peers. These changes will be more dramatic in women who receive high dose therapy compared to
      women who receive low dose therapy.

      At annual visits over 3-5 years, a combination of physical exam, medical history, menstrual
      diary keeping, pelvic ultrasound and blood hormones tests will be used to measure "ovarian
      reserve" , that is the number and quality of the eggs that remain in the ovaries. The study
      will also try to learn if those who received higher doses of certain chemotherapies are more
      likely to have changes in these tests sooner than those women who received smaller doses of
      these same drugs. Additionally a DNA (deoxyribonucleic acid) sample will be collected to look
      for gene variations that may predict susceptibility to ovarian damage from cancer treatments.
      Information learned from this study may help researchers to develop guidelines to identify
      problems with a female cancer survivor's ovaries before irregular menses or other symptoms of
      ovarian failure occur.
    

Detailed description: 
      Up to 400 females will participate in this study in one of three cohorts:

        -  150 females ages 11-35, with history of exposure to alkylating agent chemotherapy and/or
           radiation therapy

        -  150 Unexposed peers, ages 11-35, never exposed to chemotherapy or radiation therapy

        -  100 Unexposed females, ages 40-50 never exposed to chemotherapy or radiation therapy
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with a history of cancer, or other conditions treated by chemotherapy, will be
        identified through local survivorship programs or self-referral. In addition, two groups of
        regularly menstruating unexposed subjects will be recruited through local advertising: a
        group of similar-age subjects and another group in the late reproductive years. Exposed and
        unexposed controls will be frequency matched with respect to age (within 2 years) at
        enrollment. In addition,subjects will be balanced with respect to self reported
        race/ethnicity. Enrollment is purposefully targeted and stratified for this study to
        reflect the population in the pediatric and adult oncology practices.
      
Biospecimen description: 
      Serum
    
Keywords: Oncofertility; Fertility; Late effects; cancer; chemotherapy; radiation therapy; survivor; ovarian reserve; premature ovarian failure; early menopause; healthy volunteers; perimenopause; middle age; pediatric survivors; healthy women
Extracorporeal Shock Wave Lithotripsy for Treatment of Large Pediatric Renal Pelvic Stone Burden More Than 2 cm
Condition: Determine the Efficacy and Safety of SWL in Renal Stones Larger Than 2 cm in Pediatric Age Group
MeSH terms: Kidney Calculi; Nephrolithiasis
Study type: Interventional

Summary: 
      Extracorporeal shock wave lithotripsy (SWL) was first described for pediatric nephrolithiasis
      in 1986; SWL has been a mainstay of treatment for both renal and ureteral calculi in children
      . SWL is currently regarded as first-line therapy for most renal and upper ureteral calculi
      <2.0 cm according to the EAU/ESPU guidelines . Meanwhile, the American Urological Association
      (AUA) considers SWL to be a first-line option along with URS for renal or ureteral calculi
      <2.0 cm, and a first-line option along with PNL for renal calculi >2.0 cm . The shock waves
      are better transmitted and spontaneous clearance of fragmented stones in pediatric kidneys is
      higher than adults' kidneys; thus, SWL treatment seems likely to be more successful in the
      pediatric population compared to the adult population .Younger age is associated with better
      stone clearance in children treated with SWL, and this is related mostly to increased
      ureteral compliance (shorter, more elastic and distensible) and shorter skin-to-stone
      distance .
    


Intervention name(s): extracorporeal shock wave lithotripsy
Intervention type(s): Device
Intervention description(s): shock wave transmited from the device through patient body towards the stone to disintegrate it
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of the study is to learn how differences in learning under mildly-stressful
      circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the
      body. The investigators will also examine the impact of any anxiety, depression, and stress
      related symptoms on learning processes.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liquid metered-dose nasal spray, 30 IUs, administered once.; Matched nasal spray placebo
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Effect of oxytocin on learning
Effects of N-3 Polyunsaturated Fatty Acids On Chylomicron Secretion And Expression Of Genes That Regulate Intestinal Lipid Metabolism In Men With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The overaccumulation of apoB-48-containing lipoproteins of intestinal origin seen in patients
      with type 2 diabetes are now thought to be attributable to elevated intestinal production and
      reduced clearance. Substantial evidence exists indicating that elevated plasma levels of
      these lipoproteins are associated with increased cardiovascular disease risk. Therefore,
      reduction of atherogenic plasma triglyceride-rich lipoproteins (TRL) levels of intestinal
      origin appears to be crucial to improve CVD risk associated with type 2 diabetes. In this
      regard, n-3 PUFAs have been shown to exert beneficial effects on diabetic dyslipidemia.
      However, the investigators understanding of the physiological changes that occur with n-3
      PUFA supplementation is suboptimal, thereby limiting the investigators appreciation of its
      impact on CVD risk associated with type 2 diabetes. The effects of n-3 PUFAs on the
      intestinal production of TRLs and the expression of genes regulating intestinal lipid
      absorption and chylomicron synthesis have not yet been examined in humans. The general
      objective of the proposed research is to investigate the mechanisms by which n-3 PUFAs
      beneficially modify intestinal lipoprotein metabolism in patients with type 2 diabetes. The
      investigators hypothesize that n-3 PUFA supplementation in men with type 2 diabetes will:

        -  reduce TRL apoB-48 production rate and increase fractional catabolic rate of these
           lipoproteins,

        -  decrease the expression of genes that regulate intestinal lipid absorption and synthesis
           as well as synthesis of apoB-48-containing lipoproteins,

        -  decrease both plasma surrogates of cholesterol absorption and cholesterol synthesis.
    


Intervention name(s): n-3 PUFAs; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5 capsules/day in order to provide 3 g/day of n-3 PUFAs.; 5 capsules/day containing corn and soybean oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Bifocals in Children With Down Syndrome
Condition: Visual Acuity at Near; Accuracy of Accommodation; Prevention of Strabismus; Task Readiness
MeSH terms: Down Syndrome; Strabismus
Study type: Interventional

Summary: 
      Visual acuity at near improves in children with Down syndrome using bifocals
    

Detailed description: 
      The accommodation is consistently reduced in 50 to 100% of children with Down syndrome and
      does not improve with age.
    

Intervention name(s): bifocals; single vision glasses
Intervention type(s): Device; Device
Intervention description(s): bifocal glasses with an addition of 2.5 Dioptres; single vision glasses
Other intervention name(s): bifocal glasses; reading glasses
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Down syndrome; visual functions; bifocals; children; visual acuity at near
Treatment of Calcium Deficiency in Young Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study looks at the effects of calcium supplementation on bone density in women in their
      third decade of life. We placed women aged 19-27 who take in low amounts of calcium in their
      diets in one of two groups. We will give women in one group a placebo (inactive pill) and
      women in the other group 1500 milligrams of calcium per day (as calcium carbonate). We will
      monitor the results by looking at the change in bone mineral density measured at the hip,
      total body, forearm, and spine. Treatment will last 3 years.
    

Detailed description: 
      This is a randomized, controlled trial of calcium carbonate supplementation (1500 milligrams
      per day) in third-decade women with low calcium-to-protein intakes. We accept women aged
      19-27 on the basis of good health and the 7-day food diary demonstrating a dietary
      calcium-to-protein ratio (in milligrams:grams) that does not exceed 13. The outcome variable
      is the change in BMD at hip, total body, forearm, and spine. Treatment lasts for 3 years. We
      expect that bone mass will increase in both groups but will increase to a greater extent in
      the calcium-supplemented group than in the nonsupplemented group.
    

Intervention name(s): Calcium supplement
Intervention type(s): Drug
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Calcium deficiency; Dietary calcium; Dietary protein; Osteoporosis; Calcium supplement; Bone density; Bone mass; Bone mass accumulation
Study of Sleep-maintenance Activity of 3 Doses of SKP-1041
Condition: Sleep Disorder; Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is
      currently available as Sonata as well as several generic formulations. Sonata and its
      generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is
      designed to become active 2-3 hours after ingestion. It is intended for use in people who
      have no trouble falling to sleep but who often awaken in the middle of the night. This trial
      will determine the best dose to prevent those awakenings.
    

Detailed description: 
      Patients will participate in the study for approximately 44 to 56 days, including a 14- to
      21-day Screening Period, 4 Treatment Periods each followed by washout periods, and a final
      Follow-up Visit. Patients will receive their randomly assigned study medication and spend 2
      nights in a sleep laboratory, subsequently returning home for a 4- to 7-day washout period
      between each treatment period. The fourth and final treatment period will include a third
      night at the site during which all patients will continue to receive the same study
      medication as on the first 2 nights of this treatment period. Blood will be drawn from all
      patients for pharmacokinetic analyses at specific time intervals. Patients will undergo final
      safety assessments 2 to 5 days after the last dose of study medication.
    

Intervention name(s): placebo; SKP-1041 (experimental formulation of zaleplon)
Intervention type(s): Drug; Drug
Intervention description(s): tablet at bedtime; tablet at bedtime
Other intervention name(s): sugar pill; zaleplon
Intervention MeSH terms: Zaleplon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: insomnia; middle of the night; sleep maintenance
Metabolic Syndrome of Occupational Drivers
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to discover the health status of occupational drivers. The
      health status includes data collection of body mass index, blood pressure, central obesity,
      anxiety scale scores, smoking habit and related cessation therapy, etc.
    

Detailed description: 
      Occupational drivers' health is essential for passengers' safety. However, occupational
      drivers' health is damaged by long-term sitting and driving, lack of exercise, stress from
      traffic, and irregular diet. The objectives of this study were to assess the health status of
      occupational drivers in Taiwan. The measures included blood pressure, central obesity,
      fasting blood sugar, triglyceride, body mass index (BMI), anxiety scale scores, and metabolic
      syndrome, etc.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This study is to understand the health status of occupational status. Occupational drivers
        work in a sitting position for long durations, facing traffic stress, irregular mealtimes
        and lack of exercise etc, and may impede their health. For passengers, their safety is
        related to the occupational drivers' health status and should pay attention to the health
        condition of the occupational drivers.
      
Keywords: occupational drivers; health status
Mind-body Awareness Training and Brain-computer Interface
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices,
      has become increasingly prevalent due to an increase in awareness of the potential health
      benefits, and improvements in concentration that this training can provide to practitioners.
      In the present study, the role of Mind-Body Awareness Training (MBAT) in the initial learning
      of a sensorimotor (SMR) based Brain-Computer Interface (BCI) is being investigated. The
      hypothesis is that MBAT will improve performance in SMR based BCI.
    

Detailed description: 
      In this protocol, the following hypothesis will be tested; namely that MBAT including the
      verified mindfulness based stress reduction (MBSR) course will improve the ability for
      subjects to concentrate on the control of the SMR thus improving the performance of BCI.
      Subjects will be recruited for short term MBAT and then undergo BCI training. The performance
      of subjects with MBAT will be compared with those without MBAT to test the hypothesis.
      Procedures involved include a standard 8-week MBSR course, and an EEG brain noninvasive brain
      computer interface study.
    

Intervention name(s): Mindfulness Based Stress Reduction
Intervention type(s): Behavioral
Intervention description(s): 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sirolimus-eluting Stent CALYPSO vs Everolimus-eluting Stent XIENCE
Condition: Ischemic Heart Disease; Coronary Atherosclerosis; Coronary Artery Disease; Coronary Artery Stenosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases; Atherosclerosis; Coronary Stenosis
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the efficacy and safety of sirolimus-eluting coronary
      stent "Calypso" (Angioline, Russia) in comparison with everolimus-eluting coronary stent
      "Xience" (Abbott Vascular, USA)
    


Intervention name(s): DES "Calypso"; DES "Xience Prime"; Coronary angioplasty
Intervention type(s): Device; Device; Procedure
Intervention description(s): A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Stenosis of coronary artery is passed by the hydrophilic coronary wire. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.; A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Stenosis of coronary artery is passed by the hydrophilic coronary wire. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Calypso; Xience; Coronary stenosis; Drug-eluting stent; Coronary angioplasty with stenting; Ischemic Heart Disease
Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation.
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Virus Diseases; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate the efficacy (and safety) of antiviral therapy in
      patients with chronic hepatitis C after liver transplantation. The only approved drugs for
      treatment of hepatitis C are pegylated interferon and ribavirin.
    

Detailed description: 
      Hepatitis C recurrence after liver transplantation remains the main cause of graft loss after
      liver transplantation. Several strategies can be used to prevent or treat hepatitis C in the
      setting of liver transplantation. There are no controlled studies evaluating the efficacy and
      safety of antiviral treatment (using pegylated interferon and ribavirin) in liver transplant
      recipients. The main endpoint of this study was: 1) histological outcomes (effect of
      antiviral treatment on disease progression, i.e. liver fibrosis). The secondary endpoint were
      1) Sustained virological response (persistent HCV-RNA clearance) and 2) Safety of pegylated
      interferon and ribavirin
    

Intervention name(s): Pegylated interferon and ribavirin
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liver fibrosis; portal pressure; antiviral therapy
Experiential Avoidance in Combat Veterans With and Without Posttraumatic Stress Disorder
Condition: PTSD; Suicidal Ideation
MeSH terms: Stress Disorders, Post-Traumatic; Suicidal Ideation
Study type: Observational

Summary: 
      This study plans to examine if symptoms of PTSD affect how Veterans who have served in combat
      think and react to certain information, and whether or not this has an influence on suicidal
      thoughts.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The sample for the current project will be recruited from the group of veterans receiving
        or eligible to receive outpatient mental health services at the Denver VA Medical Center
        who have served in combat who may or may not have a diagnosis of PTSD.
      
Keywords: PTSD; Suicidal ideation; Cognitive processes