bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with
      pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised
      to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po
      daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The
      anticipated time on study treatment is 3 months and the target sample size is 100-500
      individuals.
    


Intervention name(s): Placebo; Pravastatin; Dalcetrapib; Dalcetrapib; Dalcetrapib
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): po daily for 12 weeks; 40mg po daily for 12 weeks; 300mg po daily for 12 weeks; 600mg po daily for 12 weeks; 900mg po daily for 12 weeks
Intervention MeSH terms: Pravastatin; Dalcetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The main aim of this study is to compare thoracic paravertebral block and rhomboid block for
      postoperative analgesia and analgesic usage in thoracic surgeries.
    

Detailed description: 
      Patients with scheduled thoracic surgery are going to be enrolled for this study. Patients
      will be randomized and separated in two groups. Group I will receive thoracic paravertebral
      block, group II will receive rhomboid block. Each group will receive patient controlled
      analgesia with intravenous fentanyl. Patients will be monitored at postoperative 1st, 3rd,
      6th, 12th, 24th hours and their VAS scores, adverse reactions like nausea and vomiting, total
      analgesic usage, additional analgesic need and time of the first report of pain will be
      filed. Then the two groups will be compared and evaluated.
    

Intervention name(s): Thoracic Paravertebral Block; Rhomboid Block
Intervention type(s): Procedure; Procedure
Intervention description(s): Paravertebral block for postoperative analgesia in thoracic surgery; Rhomboid block for postoperative analgesia in thoracic surgery
Other intervention name(s): TPVB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thoracic surgery; Postoperative pain; Rhomboid block; Paravertebral block
ORWH:SCOR on Sex and Gender Factors Affecting Women's Incontinence
Condition: Urinary Incontinence; Diabetes
MeSH terms: Urinary Incontinence
Study type: Observational

Summary: 
      This study consists of two studies with overlapping cohorts. One is a follow up
      epidemiological study of urinary incontinence, the other is a case control study of lower
      urinary tract dysfunction in women with diabetes.

      Study One:

      Subjects for the study will be a retrospective cohort of 2100 middle-aged and older women
      from a large health maintenance organization who have participated in the Reproductive Risk
      Factor for Incontinence Study at Kaiser (RRISK). The RRISK I study assembled a retrospective
      cohort of long-term female Kaiser Permanente members to determine the association between
      specific childbirth events, hysterectomy, hormone use and urinary incontinence later in life.
      The study also provides descriptive information on urinary incontinence by type, age,
      ethnicity, severity and age of onset.

      Study Two:

      Women with diabetes have a 30-70% increased risk of lower urinary tract dysfunction,
      including lower urinary tract symptoms, urinary incontinence, and ultimately bladder
      cystopathy. This sudy investigates the natural history, risk factors, and possible mechanisms
      of lower urinary tract dysfunction and infection among women with type 2 diabetes as compared
      to women without diabetes.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women aged 40-69 on 1/1/99 who have been Kaiser Permanente members since age 18 and have
        had half or more of their deliveries at Kaiser Permanente or are nulliparous and have
        diabetes.
      
Keywords: Healthy
Morphofunctional Imaging and Developmental Dyslexia
Condition: Developmental Dyslexia
MeSH terms: Dyslexia
Study type: Observational

Summary: 
      Developmental dyslexia is a frequent learning disability. The aim of this study is to analyze
      cortical thickness and phonological treatment in right handed adults with developmental
      dyslexia. They are compared to control adults paired with age and laterality. To study
      phonological treatment, the researchers used functional magnetic resonance imaging (fMRI)
      with a rime judgement task and silent word generation.
    


Intervention name(s): Morphological and functional MRI
Intervention type(s): Procedure
Intervention description(s): one time
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This is a prospective study including 15 right-handed male subjects, aged 18 to 35 years,
        carrying a developmental dyslexia and 15 control subjects handed the same sex. We chose to
        include only male subjects to obtain a homogeneous population and to avoid the problem of a
        functional organization differs according to gender.
      
Keywords: phonological treatment; language; fMRI
Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes
Condition: Healthy
Study type: Observational

Summary: 
      The main objective of this study is to investigate the effect of genetic and environmental
      parameters on racial/ethnic differences in aspects of insulin secretion and action. The
      genetic component will be modeled by estimating the degree of European genetic admixture
      (ADM) obtained from approximately 50 ancestry informative markers (AIMs). The environmental
      components will be modeled by measuring energy intake (food intake), energy expenditure
      (physical activity) and socioeconomic status.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        120 African Americans, 120 European Americans and 120 Hispanic Americans (60 males and 60
        females per group). To minimize the influence of puberty on SI and AIRg, recruitment will
        be limited to individuals between ages 7-12, a range that based on previous observations
        from our team, categorize children from Tanner stage 1 and 2.
      
Biospecimen description: 
      Three 5-ml blood samples will be obtained from each subject and sent to the Laboratory Core
      of the General Clinical Research Center to establish EBV lymphoblastoid cell lines and for
      DNA extraction. EBV lines will be kept at UAB for future genetic analysis. Extracted DNA will
      be sent to Dr. Mark Shriver at the Pennsylvania State University for genotyping of the
      ancestry informative markers (AIMs).
    
Keywords: race/ethnicity; insulin senistivity; genetic admixture; type 2 diabetes; obesity; body composition; Insulin dynamics; Racial/ethnic differences
Frequency of Fibromyalgia in Behcet Disease
Condition: Fibromyalgia; Behcet Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Behcet Syndrome
Study type: Observational [Patient Registry]

Summary: 
      In various studies, the incidence of fibromyalgia in Behçet's patients is widely distributed.
      It was aimed to investigate the frequency and severity of fibromyalgia in Behcet disease in
      province Bursa.
    

Detailed description: 
      There are few studies in the literature investigating the frequency of fibromyalgia in
      Behçet's disease. In various studies, the incidence of fibromyalgia in Behçet's disease was
      5.7% -37.1%, which is widely distributed. There are no studies in literature comparing
      disease severity and pain thresholds at trigger points in fibromyalgia with and without
      Behcet's disease. In this study, it was aimed to investigate the frequency of fibromyalgia in
      Behcet's disease according to the criteria defined by the American Colloge of Rheuatology in
      2010 and updated in 2013. It was also aimed to compare the severity of disease in
      fibromyalgia with and without Behcet's disease.
    

Intervention name(s): group 1:Patients diagnosed with Behcet disease; group 2: Patient diagnosed with fibromyalgia without Behcet disease
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Frequency and severity of fibromyalgia will be investigated in patient diagnosed with Behcet disease; Severity of fibromyalgia will be investigated in patient diagnosed with fibromyalgia
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population consists of participants who are between age 18-75, not pregnant and who
        were not diagnosed previously with diabetes mellitus or chronic renal failure
      
Keywords: Fibromyalgia; Behcet Disease; Trigger points
Evaluation of Sperm Selection Technique Using Hyaluronic Acid Binding in Intra-cytoplasmic Sperm Injection (ICSI)
Condition: Infertility, Male
MeSH terms: Infertility; Infertility, Male
Study type: Interventional
Phase: Phase 4

Summary: 
      In vitro sperm selection for ICSI is important as it has a direct influence on the paternal
      contribution of preimplantation embryogenesis. Various laboratory tests were developed to
      assess the functions of the spermatozoa. Among them, only the tests for sperm DNA
      fragmentation, hyperactivation of the spermatozoa and the hyaluronan-binding ability are
      simple and fast.
    

Detailed description: 
      In vitro sperm selection for ICSI is important as it has a direct influence on the paternal
      contribution of preimplantation embryogenesis. Men with oligozoospermia who require ICSI
      often demonstrate compromised DNA integrity and increased chromosomal aberrations of the
      sperms in their semen. Studies have shown that embryos resulting from ICSI in those men have
      higher risk of sex chromosome disomies, chromosomal aneuploidies, de novo numerical
      chromosomal aberrations and cytogenetically detectable structural chromosomal aberrations.
      Although the main candidates for ICSI are oligozoospermic men, there is an increase in the
      use of ICSI, therefore, more couples are potentially exposed to those potential risks.

      Various laboratory tests were developed to assess the functions of the spermatozoa. Among
      them, only the tests for sperm DNA fragmentation (Halosperm), hyperactivation of the
      spermatozoa and the hyaluronan-binding ability (HBA) are simple and fast enough to allow the
      same semen sample tested to be used for oocytes' insemination. Spermatozoa that are fail to
      bind to hyaluronan have many aspects of immaturity. They retain histones in the sperm
      nucleus, cytoplasm on the sperm neck, and have higher aberrant sperm head morphology, in
      addition to, lower genomic integrity. It has also been shown that sperm DNA fragmentation is
      associated with male factor of infertility, correlating with the morphology and motility of
      spermatozoa.

      The aim of the present study is to carry out a comparative analysis between two groups:
      Hyaluronan binding system for sperm selection for ICSI procedures and another group of
      conventional morphology sperm selection (ICSI-PVP), both in cycles with only male infertility
      factor. The evaluated parameters were semen quality, fertilization and cleavage rates,
      chemical and clinical pregnancy, and miscarriage rates.
    

Intervention name(s): Hyaluronan binding system; ICSI
Intervention type(s): Biological; Other
Intervention description(s): Hyaluronan binding system for sperm selection for ICSI procedures (PICSI); Normal ICSI procedure
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Flaxseed Intervention Study to Assess Sex Hormone Levels Among Post-Menopausal Women
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to understand whether consuming flaxseed for approximately 50
      days may beneficially affect the level of certain hormones in the blood thought to be
      involved in the development of breast cancer. This study will address the first steps toward
      the development of possible breast cancer prevention strategies. Differences in hormone
      levels (from blood samples) will be compared between two groups of women - those in the group
      assigned to eating ground flaxseed daily and those in the control group (with no change in
      diet).
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Evaluate whether a dietary flaxseed intervention among post-menopausal women influences
      circulating levels of sex steroid hormones and estrogen metabolites (including estradiol,
      estrone, 2-hydroxy(OH)-/16-OH-estrone ratio, SHBG, testosterone, 2-MeOH-E1&-E2,
      4-MeOH-E1&-E2) thought to be involved in the development of breast cancer.

      SECONDARY OBJECTIVES:

      II. Assess a) the effect of flaxseed intake on serum enterolignan levels (lignan biomarker),
      b) the relationship between serum enterolignan and sex hormone levels.

      III. Describe adherence to the flaxseed intervention.

      OUTLINE: Participants are randomized to 1 of 2 arms.

      ARM 1: Participants take 2 tablespoons of ground flaxseed daily for approximately 50 days.

      ARM 2: Participants maintain their usual diet for approximately 50 days.

      All participants will complete a questionnaire and have their blood drawn at the beginning of
      the study (Day 0) and at the end of the study period (approximately Day 50).
    

Intervention name(s): Ground flaxseed
Intervention type(s): Dietary Supplement
Intervention description(s): 2 tablespoons of ground flaxseed taken daily for approximately 50 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Flaxseed; Postmenopause; Hormones; Lignans; No Evidence of Disease
Exploratory Propofol Dose Finding Study In Neonates
Condition: Adverse Reaction to Drug; Neonatal Disorder
MeSH terms: Infant, Newborn, Diseases; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to explore the optimal propofol dose in neonates receiving a single
      intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE
      (intubation-surfactant-extubation) procedure (preterm neonates) and (semi-)elective
      non-INSURE procedures (term-preterm neonates).
    

Detailed description: 
      The aim of the study is to evaluate the pharmacokinetics and pharmacodynamics of propofol
      (short acting anesthetic) in 50 neonates to whom the drug is administered as a intravenous
      bolus. This is part of routine clinical care in patients receiving (semi-) elective
      intubation. It's the aim to explore the most effective IV propofol dose for a successful
      INSURE (intubation, surfactant, extubation) procedure and for successful (semi-) elective
      intubation in non-INSURE procedures. We hereby aim to define the most optimal dose regimen
      for propofol in neonates.

      we will hereby use

        -  predefined scoring systems to evaluate sedation, relaxation and intubation conditions

        -  vital parameter monitoring

        -  pharmacokinetic analysis with blood samples

        -  brain monitoring with NIRS (Near infrared spectroscopy) derived cerebral oxygenation and
           aEEG (amplitude integrated EEG).
    

Intervention name(s): propofol administration
Intervention type(s): Drug
Intervention description(s): Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.
Other intervention name(s): Diprivan
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neonatology; intratracheal intubation; propofol
Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The safety, tolerability, pharmacokinetics and pharmacodynamics/efficacy profiles of two
      different doses of GSK233705 will be compared with 2 active comparators and placebo, all
      medication delivered via dry powder inhaler.
    

Detailed description: 
      A multi-centre, randomised, partially blinded, placebo-controlled, three-way crossover,
      incomplete block design study to investigate the, safety, tolerability,
      pharmacodynamics/efficacy and pharmacokinetics of dual bronchodilator therapy with salmeterol
      50 mcg twice daily plus two different doses of GSK233705 (20 and 50 mcg twice daily),
      compared with placebo, salmeterol 50 mcg twice daily alone, and tiotropium 18 mcg once daily
      alone, in subjects with chronic obstructive pulmonary disease
    

Intervention name(s): salmeterol; tiotropium; GSK233705
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): salmeterol; tiotropium
Intervention MeSH terms: Tiotropium Bromide; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COPD; plethysmography.; muscarinic receptor antagonist; anticholinergic
GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to
      15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation
      disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other
      metabolic abnormalities. Visceral fat dysfunction is an important factor in the onset of
      PCOS. GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to
      improving blood sugar control, weight loss and appetite suppression, and reducing
      cardiovascular risk. The purpose of this study was to compare whether the combined treatment
      of GLP-1 receptor agonists and calorie restrict diet reduced more visceral fat of
      overweight/obese patients with PCOS at the same weight loss (7%) compared with calorie
      restrict diet alone.
    


Intervention name(s): GLP-1 RAs; calorie restricted diet
Intervention type(s): Drug; Other
Intervention description(s): GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk.; Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.
Other intervention name(s): Dulaglutide
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pilot Study: Snacking, Willpower and Glucose Availability
Condition: Willpower
Study type: Interventional

Summary: 
      To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a
      non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test
      whether there is a threshold of glucose that will result in improved ease of resistance to
      problem foods (tested by comparing three different levels of glucose).
    

Detailed description: 
      Ingestion of 100 calories of glucose during individually pre-determined times of waning
      dietary self-control will result in improved ease of resistance to problem foods when
      compared to ingestion of lower calories of glucose or placebo (0 calorie beverage)
    

Intervention name(s): Sequence 1; Sequence 2; Sequence 3; Sequence 4
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.; Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.; 50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.; 10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Patients with bipolar disorder are at increased risk of weight gain, which in turn, increases
      the risk for somatic disease and non-adherence to maintenance therapy. Therefore,
      interventions addressing weight gain are expedient for the management of this disorder. The
      investigators set out to evaluate the effects of a lifestyle intervention on body mass index,
      cardiovascular, glycemic and metabolic parameters in patients with bipolar disorder under
      mood stabilizing pharmacological treatment. 50 outpatients with bipolar disorder under mood
      stabilizing treatment participated in a randomized controlled trial (waiting control group
      N=24 and multimodal lifestyle intervention N=26). Each experimental group consisted of two
      cohorts. The intervention lasted five months and consisted of eleven group sessions and
      weekly fitness training. Body Mass Index (BMI), body weight as well as cardiovascular,
      glycemic and metabolic parameters were determined as baseline (March and September 2005) and
      after five (July 2005 and January 2006) and eleven months (January and July 2006).
    


Intervention name(s): lifestyle intervention to increase physical activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment