bioihbjkbjnl/mcl2 huggingface dataset:
The Adrenal Contribution to Androgen Production in Girls During Puberty
Condition: Development
Study type: Interventional
Phase: Phase 3

Summary: 
      In girls with elevated androgens the precise source of androgen excess throughout puberty and
      early adolescence has not been carefully examined. The investigators propose to examine
      whether the adrenal gland produces the majority of androgens during puberty by studying the
      differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in
      normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare
      steroid changes before and 60 min after ACTH administration in NW and OB girls.
    

Detailed description: 
      Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each
      subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following
      day, subjects will have a blood sample drawn for hormone measurements. After this blood
      sample, 0.25 mg adrenocorticotropin hormone (ACTH) will be administered as an iv bolus. At 30
      and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone
      measurements.
    

Intervention name(s): Adrenocorticotropin; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.; Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
Other intervention name(s): Cosyntropin; ACTH; dex
Intervention MeSH terms: Dexamethasone; Cosyntropin; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: adolescents; puberty; androgens; hyperandrogenemia
Lifestyle, Adiposity and Cardiovascular Health in Youths
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To determine the influences of diet and physical activity (PA) on total body fatness and
      regional fat distribution and the relationship of these to risk factors of cardiovascular
      disease during adolescence.
    

Detailed description: 
      BACKGROUND:

      Adult studies have shown that adiposity, especially visceral adipose tissue, and
      cardiovascular (CV) fitness are key links between lifestyle factors like diet and exercise on
      one hand, and CV disease on the other. However, very little is known about these links during
      the juvenile years, when the processes leading to CV disease are at an early stage of
      development.

      The study is in response to a Program Announcement issued in March 1998 on Diet and
      Cardiovascular Disease Risk in Children and Adolescents. The Program Announcement, jointly
      issued by the National Institute of Nursing Research and the NHLBI, sought to encourage
      research relevant to the development and/or testing of dietary interventions to improve the
      cardiovascular disease (CVD) risk profiles in children and adolescents, especially those at
      increased risk for CVD or for development of CVD risk factors because of genetics, family
      history, socioeconomic status (SES), race/ethnicity, levels of blood cholesterol or blood
      pressure, or other factors.

      DESIGN NARRATIVE:

      The study determines the relations of free-living diet and exercise to total body percent fat
      ( percent BF), visceral adipose tissue and CV fitness in black and white boys and girls of
      varying socioeconomic status (SES). The study also determines the relations of fatness and
      fitness to different CVD risk factors. A total of 800 15 to 18 year olds, 200 in each ethnic
      and gender subgroup will be recruited. Diet will be assessed with seven 24-hour recalls, and
      exercise with two seven-day recalls and heart rate monitoring. Percent body fat will be
      measured with dual-energy x-ray absorptiometry, visceral adipose tissue with magnetic
      resonance imaging and CV fitness with a multi-stage treadmill test. Measurements will be made
      of major fatness- and fitness-related CV disease risk factors (e.g., total cholesterol:HDL
      cholesterol ratio, insulin, systolic blood pressure, left ventricular mass indexed to height,
      fibrinogen). Multivariate and univariate analyses will be conducted to determine
      relationships.
Reproductive Hormonal Alterations in Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine why obese women have lower hormone levels and less
      fertility than women of normal body weight. The proposal will examine the reproductive system
      at the level of the brain and the ovary to define the changes that happen leading to lowered
      hormone production. Women will be studied throughout a menstrual cycle and given medications
      that will test how well their pituitary gland can make hormones that stimulate the ovary
      (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a
      medication to abolish estrogen production in the body and their response to this medication
      will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will
      be examined.

      --Hypotheses:

        1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing
           hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese
           compared to normal weight women)

        2. Obese women have abnormally increased sensitivity to estradiol negative feedback which
           will be reversed by an aromatase inhibitor. (comparative study of obese compared to
           normal weight women)
    

Detailed description: 
      AIM 1: test the hypothesis that reduced pituitary sensitivity to GnRH-induced LH and FSH
      secretion causes the relative hypogonadotropic hypogonadism of obesity AIM 2: test the
      hypothesis that the hypothalamic-pituitary axis is abnormally sensitive to estradiol negative
      feedback in obesity
    

Intervention name(s): Cetrorelix; Gonadorelin-GnRH; Recombinant LH; Letrozole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Abolishes pituitary sensitivity to GnRH.; GnRH is used to stimulate the pituitary gland to produce LH and FSH.; Used to stimulate ovarian function in women.; An aromatase inhibitor.
Other intervention name(s): Cetrotide; Lutrepulse; Luveris; Femara
Intervention MeSH terms: Letrozole; Cetrorelix; Prolactin Release-Inhibiting Factors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: LH pulsatility; Obesity; Reproduction
Effect of Kefir on Appetite
Condition: Appetitive Behavior
Study type: Interventional

Summary: 
      This study aimed to determine the effect of kefir on appetite in healthy subjects. A
      randomized, single-blind, and 3-intervention crossover trial included 22 healthy and
      normal-weight (BMI 18.5-25 kg/m2) females aged 21-24 years. Participants were recruited to
      three test meals: an LGI-Milk, an LGI-Kefir, and an HGI-Kefir, with a one-week washout
      period. Appetite ratings were measured at 0, 15, 30, 60, 90, 120, 150, and 180 minutes. At
      the end of three hours, participants were served an ad libitum lunch meal. Then, the foods
      eaten at lunch were recorded and their energy and nutrient analysis was calculated.
    


Intervention name(s): LGI-Milk Breakfast; LGI-Kefir Breakfast; HGI-Kefir Breakfast
Intervention type(s): Other; Other; Other
Intervention description(s): This test meal with low glycemic index and milk were served as a breakfast after 12-hours fasting and participants were asked to consume the meal in full, within 15 min.; In crossover design, this test meal with low glycemic index and kefir was served as a breakfast to compare the LGI-Milk Breakfast.; In crossover design, this test meal with high glycemic index and kefir was served as a breakfast to compare the LGI-Milk Breakfast and the LGI-Kefir Breakfast.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Appetite; Probiotic; Glycemic index
PDMS Outcome After Intensive Care, Organdysfunction and Monitoring
Condition: Pleural Effusion; Blood Pressure
MeSH terms: Pleural Effusion
Study type: Observational

Summary: 
      The objective of the explorative registry study is to investigate outcome parameters in the
      routine treatment of patients who are monitored after heart surgery for either short or
      long-term treatment in the intensive care unit for close monitoring of blood pressure.
    

Detailed description: 
      The close monitoring of patients after cardiac surgery is regarded as standard. However,
      little is currently known about the influence on patient-related outcome parameters. Recently
      it has already been shown that intraoperative variability of blood pressure during heart
      surgery has a postoperative effect on 30-day mortality.

      The aim of this retrospective study is to investigate the effects of different hemodynamic
      measurements and management after cardiac surgery on patient-specific outcome parameters.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All adult male and female patients who have undergone cardiac surgery in the period
        01/06-12/13 at Campus Mitte in the Charité, approx. 7000 patients.
Cystic Fibrosis (CF) Flow Rates Study
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      We wish to measure the inspiratory flow and volumes generated by the subjects inhaling from a
      spirometer with a high resistance dry powder inhaler in series in subjects with cystic
      fibrosis.
    


Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        CF 6yrs and above
      
Keywords: device characteristics
Effect of Milk Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine the tolerability of dietary supplements and if
      these supplements can promote a healthy bacterial environment in the intestines of children
      with autism spectrum disorders and gastrointestinal complaints.
    

Detailed description: 
      This study investigates the feasibility, tolerability, and effects of a dietary supplement on
      the intestinal flora of children with autism spectrum disorders. This study is divided into
      two parts, each five weeks long, with a two week break in between. During one part of the
      study, a prebiotic (milk oligosaccharides from bovine colostrum) will be given. During the
      other part of the study, the synbiotic composed of the prebiotic and probiotic
      (bifidobacterium infantis) will be given. Stool will be analyzed at the end of each study arm
      to determine content of bifidobacteria.

      On May 8, 2018, we updated the study start and completion dates to the actual (instead of
      anticipated) dates.

      On May 30-31, 2019, we updated the study results section.
    

Intervention name(s): Synbiotic; Prebiotic
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Bifidobacterium infantis SC268; bovine colostrum, bovine oligosaccharides; bovine colostrum, bovine oligosaccharides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: probiotic; prebiotic; autism; oligosaccharides; Bifidobacterium infantis
Levemir-Body Composition and Energy Metabolism
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives is to compare the changes in body composition (primary objective), diabetes
      parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin®
      4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and
      insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type
      2 diabetic patients failing on oral diabetic agents .
    


Intervention name(s): Detemir or Glargine
Intervention type(s): Drug
Intervention description(s): Initial dose of 10 units of insulin at bedtime. The insulin dose will be increase by 1 unit per day until fasting plasma glucose (FPG) levels are 5.0 mmol/L.
Other intervention name(s): Detemir; Levemir; Long acting insulin; Bed time insulin; Lantus; basal insulin analogue
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin initiation; oral therapy failure
The Predictive Value of Complement C3 in Patients With Advanced Gastric Cancer
Condition: Gastric Cancer; Complement Component Deficiency; Surgery
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      This study is designed to investigate whether complement C3 depletion is associated with poor
      short-term outcomes in postoperative patients with gastric cancer.
    

Detailed description: 
      The complement system plays an important role in the development of digestive malignancies.
      The complement C3 is the point of convergence for the three complement activation pathways.
      However, the concrete effect of C3 in the development of gastric cancer is still obscured.
      This study is designed to explore whether complement C3 can be regarded as a predictive
      factor of postoperative outcomes for postoperative patients with gastric cancer.

      This study is designed as a prospective cohort study and included consecutively treated
      patients. The perioperative plasma value of complement components, such as C3, C4, and CH50,
      are detected to explore the incidence rate of complement depletion. All enrolled patients are
      divided into two groups mainly according to the levels of preoperative C3 levels (C3
      depletion and Non-C3 depletion groups). The primary endpoints are the 1-year overall survival
      and disease-free survival, while the secondary endpoints are postoperative complications,
      length of hospital stay, and hospital charges.

      This study would be helpful to confirm the role of complement depletion in anticipated
      outcomes of postoperative patients with gastric cancer.
    

Intervention name(s): gastrectomy plus D2 lymphadenectomy; S-1+Oxaliplatin
Intervention type(s): Procedure; Drug
Intervention description(s): A classic total or subtotal gastrectomy plus D2 lymph nodes dissection would be performed for all enrolled patients. Patients in both groups would undergo the identical therapeutic approach for gastric cancer, mainly decided by a multidisciplinary treatment group in our center.; A postoperative systemic chemotherapy would be performed for some subjects who have advanced gastric cancer. The concrete chemo regimen for adjuvant chemotherapy is also determined by a MDT group. Generally, SOX chemo regimen is the first-line treatment in our center, as following described:
S-1: 40~60mg bid，po, Day1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid）
Oxaliplatin: 130mg/m2，iv drip for 2h，Day1
Other intervention name(s): D2 surgery; SOX regimen
Intervention MeSH terms: Oxaliplatin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have a confirmed pathological diagnosis of gastric adenocarcinoma would be
        selected for further observation. Those patients who subsequently underwent a radical tumor
        resection can be included for final analysis.
      
Keywords: gastric cancer; complement system; overal survival
Association Between Dental Implants Properties and Malodor Production
Condition: Halitosis
MeSH terms: Halitosis
Study type: Observational

Summary: 
      Malodor production is bacterial in origin. The bacterial activity of anaerobic bacteria
      results in the breakdown of proteins and the production of foul smelling compounds. The aim
      of the study is to test the hypothesis that bacterial growth on dental implants contributes
      to malodor production and to see whether this contribution is associated with various
      properties of the dental implant such as: maker, type, depth ext.
    


Time perspective: Other
Keywords: Oral malodor; Dental implants
Project Prepared: Risks, Roles and Relationships
Condition: F01.145.802.845; F01.145.802.987
Study type: Interventional

Summary: 
      Project Prepared is a theoretically based, comprehensive, intensive group intervention that
      is designed to prepare early adolescents for middle adolescence and its challenges. It
      emphasizes skills in avoiding risky sexual situations, and provides medically accurate
      information about sexual development, sexually transmitted infections and pregnancy.
      Effectiveness is measured by using a randomized control trial design and tracking differences
      in cognitive factors (HIV/STI (Sexually Transmitted Infections) knowledge, sexual
      self-efficacy; intention to use a condom); relationship factors (immature romantic beliefs,
      relationship self-efficacy), gender norms (macho man, powerless female), and resilience.
    


Intervention name(s): Project Prepared; TEEN
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral intervention to reduce sexual risk and promote healthy relationships; Control condition the promote communication, decision-making skills etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Obesity is an independent risk factor for cardiovascular disease, which may be mediated by
      increased secretion of proinflammatory cytokines by adipose tissue.

      To determine the effect of a program of changes in lifestyle designed to obtain a sustained
      reduction of body weight on markers of systemic vascular inflammation and insulin resistance.

      Randomized single-blind trial conducted from February 1999 to February 2002 at a university
      hospital in Italy.

      One hundred twenty premenopausal obese women (body mass index 30) aged 20 to 46 years without
      diabetes, hypertension, or hyperlipidemia.

      The 60 women randomly assigned to the intervention group received detailed advice about how
      to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet
      and increased physical activity. The control group (n = 60) was given general information
      about healthy food choices and exercise.
    


Intervention name(s): lifestyle changes; Control - general information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Detailed advice about how to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet and increased physical activity.; General information about healthy food choices and exercise
Other intervention name(s): lifestyle; control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity, lifestyle, vascular inflammation
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Healthy Postmenopausal Women
Condition: Menopause
Study type: Interventional
Phase: Phase 1

Summary: 
      Bazedoxifene/Conjugated Estrogens (BZA/CE) is an investigational drug that is being developed
      for treatment of menopause. The purpose of this trial is to compare a new manufacturing
      process for making BZA/CE to the current process by assessing the way it is absorbed into the
      blood.
    


Intervention name(s): Bazedoxifene/Conjugated Estrogens 20 mg/0.625 mg tablet
Intervention type(s): Drug
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postmenopausal