bioihbjkbjnl/mcl2 huggingface dataset:
Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 4

Summary: 
      Gastric bypass surgery is the gold standard in bariatric surgery and is a successful method
      to reduce weight in morbidly obese subjects. Patients qualified for gastric bypass surgery
      are routinely pre-treated with a low calorie diet in order to reduce liver volume and to
      facilitate the approach of the gastro-oesophageal junction. Pre-treatment with omega-3 fatty
      acids has similar effects on liver volume, but a prospective comparison of both treatments
      has not been performed yet. Morbidly obese patients respond differently to surgical stress,
      due to a number of factors. First, obesity is associated with a low-grade inflammatory state
      induced by an increased amount of macrophages in adipose tissue. This state is associated
      with higher levels of pro-inflammatory cytokines in serum and with a less adequate immune
      response to infections. Second, obesity is associated with an altered cortisol metabolism
      possibly related to adrenal insufficiency. This could play an important role in the altered
      response to surgical stress and postoperative complications in obese subjects. Third, obesity
      is associated with altered erythrocyte function, including decreased erythrocyte
      deformability and increased aggregation, factors contributing to an impaired
      microcirculation.

      This study has a number of different aims. First, we will compare pre-treatment with the
      standard low calorie diet with omega-3 fatty acids on liver volume in patients qualified for
      gastric bypass surgery because of morbid obesity. Second, we will investigate the effect of
      omega-3 fatty acids on immune function, the low-inflammatory state of adipose tissue, the
      stress response of obese subjects before and erythrocyte function. Third, we will investigate
      the effect of gastric bypass surgery by comparing values before surgery with values on the
      first postoperative day and 6 months after surgery regarding to immunological parameters,
      stress response and erythrocyte function.
    


Intervention name(s): Omega-3 fatty acid capsules; Low calorie diet
Intervention type(s): Drug; Behavioral
Intervention description(s): 2 times a day 1 capsule for 4 weeks before gastric bypass surgery; A low calorie diet of 600 kcal/day during 2 weeks, using Modifast or an adjusted normal diet.
Other intervention name(s): purified fish oil; omega-3 fatty acids; eicosapentoenoic acid (EPA); docosahexaenoic acid (DHA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      study the effect of mefanamic acid or valproate on ciprofol
    


Intervention name(s): Mefanamic Acid; Valproate
Intervention type(s): Drug; Drug
Intervention description(s): mefanamic acid once every 6 hours on Day 4 and Day 5, Ciprofol on Day 1 and Day 5; valproate once daily on Day 4 to Day 8, Ciprofol on Day 1 and Day 8
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does Dairy Benefit Bone & Body Composition in Overweight Girls Undergoing a Weight Management Program?
Condition: Overweight; Obesity; Children
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether increased dairy intake, at the level
      recommended by Canada's Food Guide, combined with healthy eating and exercise, will improve
      body composition and bone turnover over 12 weeks in overweight and obese girls.
    

Detailed description: 
      Three groups will participate in this study. Participants must be low dairy consumers (0-1
      svgs/d) and do little to no structured physical activity at study entry. Each participant
      will be assigned to a group; one of two experimental groups or a control group. The two
      intervention groups will differ only in the amount of dairy consumed (4 svgs vs. 0-1 svg/d).
      Both will undergo the same exercise program (3x/wk) and will be counseled on healthy eating
      by a trained nutritionist-dietitian every month. The control group will be tested at the
      beginning and end of the study to help account for any growth-related changes during the
      study but will not receive any formal intervention. In each group, the investigators will
      assess body composition (muscle mass, fat mass, % body fat and regional fat mass) and bone
      (bone turnover markers). The investigators will also measure various metabolic and
      inflammatory markers, hormones as well as dietary intake, strength and fitness.

      This study will determine whether increased intake of dairy products improve bone and body
      composition during a 12-week weight management intervention. The investigators expect the two
      groups participating in the intervention to show significant changes in body weight and body
      composition and greater gains in fitness compared to the control group. The investigators
      expect those consuming dairy to show greater improvements in body composition and bone health
      compared to those not consuming added dairy. The investigators also anticipate better vitamin
      D status and less whole-body inflammation in those consuming dairy. Both intervention groups
      should show improvements in fasting insulin, glucose and cholesterol.
    

Intervention name(s): I.D.E.A.L. for Adolescents Study - Higher Dairy; I.D.E.A.L. for Adolescents Study - Lower Dairy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 weeks diet and exercise intervention characterized by higher dairy consumption (4 servings per day) and exercise 3 times per week; 12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bone health; Body composition; Dairy foods; Exercise; inflammation; nutrition intervention; weight management
18F-FES PET/CT's Additional Clinical Value in ER+ BC
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      To figure out whethetr 18F-FES PET/CT could influence the staging and management of newly
      diagnosed Oestrogen Receptor-positive Breast Cancer Patients.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis,
        regardless of being de novo diagnosed or progressed from a non-metastatic stage
EVALUATION OF DIFFERENT PROPHYLACTIC INTERVENTIONS TOWARD COVID-19 IN SOLID ORGAN TRANSPLANT PATIENTS
Condition: COVID-19 Pandemic; Transplant-Related Disorder
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The goal of this observational study is to evaluate the immune response after COVID-19
      vaccination in Liver(LT) and Kidney(KT) transplant recipient. The main question it aims to
      answer are:

        -  the evaluation of the antibody response after complete vaccination

        -  the efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB)

      All LT and KT patients during follow-up have been enrolled. anti-COVID-19 title was obtained
      by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche). In the case of antibody
      level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442,
      AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection. At
      Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT
      who undergo to LAAB.
    

Detailed description: 
      Liver(LT) and kidney(KT) transplant patients are at high risk of mortality from
      COVID-19(16-29%, 28%; respectively). Although transplant patients undergo a full vaccination
      course(3 doses), they are frequently low-responders and long-acting-antibody prophylaxis
      (LAAB) has been proposed. However, the efficacy of these strategies has not yet been
      demonstrated in LT and KT.

      The goal of this observational study is to evaluate the immune response after COVID-19
      vaccination in Liver(LT) and Kidney(KT) transplant recipient. The main question it aims to
      answer are:

        -  the evaluation of the antibody response after complete vaccination

        -  the efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB)

      All LT and KT patients during follow-up have been enrolled. anti-COVID-19 title was obtained
      by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche). In the case of antibody
      level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442,
      AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection. At
      Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT
      who undergo to LAAB.
    

Intervention name(s): tixagevimab-cilgavimab(AZD7442, AstraZeneca)
Intervention type(s): Drug
Intervention description(s): In the case of antibody level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca).
Intervention MeSH terms: Cilgavimab and tixagevimab drug combination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who underwent KT and LT transplant currently in follow up in Tor Vergata
        University hospital
      
Keywords: transplant; Vaccination; COVID-19 pandemic
Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term
Condition: Respiratory Aspiration; Pregnancy
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Solid food or fluid residue in the stomach is always a major concern when patients need
      medical procedures under sedation or general anesthesia, due to the high risk of pulmonary
      aspiration of the stomach contents. This is especially important in emergency procedures,
      when a fasting period is not observed. The aspiration of the stomach contents into one's
      lungs can lead to serious complications (such as severe respiratory failure). Information
      from a bedside ultrasound assessment of the stomach may be a very useful tool to decide
      whether or not it's safe to proceed, cancel or delay a surgical procedure.

      The investigotrs hypothesize that a mathematical model can be constructed to predict clear
      fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in
      healthy adult volunteers.
    

Detailed description: 
      Food residue in the stomach of patients scheduled to have surgery is considered a major risk
      factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise
      after aspiration is associated with significant morbidity and mortality. The risk of
      pulmonary aspiration is especially important in pregnant women, as they may often require
      surgery without having observed appropriate fasting. A bedside ultrasound assessment of the
      status of the gastric content would be of great value for the clinician. This technique has
      recently been shown very promising in non-pregnant patients and it is important to study its
      feasibility in the pregnant population.

      In this study, patients fast overnight and are randomized to the following groups: empty, or
      various volumes of fluid (50, 100, 200, 300 or 400mL of apple juice before scanning). Their
      gastric contents are then assessed by an anesthesiologist, using ultrasound. The
      investigators aim to evaluate a standardized quantitative ultrasound assessment of gastric
      volume in non-labouring pregnant women.
    

Intervention name(s): water
Intervention type(s): Other
Intervention description(s): water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Pregnancy; Respiratory Aspiration; Gastric Contents; Ultrasound
Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants
Condition: Malaria; Anemia
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment
      in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks,
      episodes of anemia, and the overall morbidity and mortality
    

Detailed description: 
      In order to define the effectiveness of Intermittent Preventive Treatment in Infants (IPTi)
      with Sulfadoxine-Pyrimethamine, a novel principle of malaria intervention, the following
      parameters are evaluated: i) the level of protection from malaria attacks and episodes of
      anemia during the treatment period, ii) the level of protection from severe malaria during
      the treatment period, iii) the effect on malaria morbidity after sustaining treatment, iv)
      the decrease of overall morbidity and mortality, including the number of hospital admissions
      and visits of hospital outpatient departments v) the influence of the intervention on the
      development of drug resistances, vi) the impact of the intervention on the development of
      immunity, vii) the possible influence of the intervention on sub-clinical organ dysfunction
      due to chronic Plasmodium falciparum infection. Parts of the study are performed in
      collaboration with the Laboratory of Research, Hospital Albert Schweitzer, Lambaréné, Gabon
      and the School of Medicine and Health Sciences, University of Development Studies, Tamale,
      Ghana
    

Intervention name(s): Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)
Intervention type(s): Drug
Intervention MeSH terms: Pyrimethamine; Sulfadoxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malaria; Anemia; IPTi; Intermittent Preventive Treatment in Infants; Sulfadoxine-Pyrimethamine; Chemoprophylaxis; Ghana
Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study
Condition: Gender Dysphoria, Adolescent
MeSH terms: Gender Dysphoria
Study type: Observational

Summary: 
      The number of adolescents engaging in a transidentity journey has been increasing rapidly
      over the last decade. However, the knowledge of the medical world concerning the
      specificities of these adolescents is still too little in France. The objective of this study
      is to refine the knowledge of the different health care providers who are brought to meet
      these adolescents. This research proposes to study more specifically the register of
      psychological vulnerabilities: to cite only a few examplesThese include disorders such as
      depression, anxiety disorders and eating disorders, all of which cause suffering and
      difficulties in everyday life. A better understanding of the presence or absence and the
      distribution of these different types of vulnerabilities among transgender adolescents would
      allow, among other things, to promote their their screening by health care providers. This
      better screening would allow doctors to physicians to offer targeted treatment for these
      disorders in parallel with the transition process. transition process.
    


Intervention name(s): KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia)
Intervention type(s): Diagnostic Test
Intervention description(s): completion of the semi-structured questionnaire: the KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia). The duration is 1h30 to 2h
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adolescents receiving follow-up in a specialized consultation on gender dysphoria
      
Keywords: mental disorders
A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of this study is to evaluate the safety and effectiveness of memantine
      (Namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism
      spectrum disorders (ASD). This is an exploratory, 12-week, pilot study, seeking to determine
      whether Namenda is efficacious and well tolerated in the treatment of adults with ASD. The
      study results will be used to generate hypotheses for a larger randomized controlled clinical
      trial with explicit hypotheses and sufficient statistical power.
    


Intervention name(s): Memantine
Intervention type(s): Drug
Intervention description(s): Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer's disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.
During the 12 weeks of study duration, subjects will be evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine will be administered in divided dose twice a day in the morning and evening. Titration of study medication will be guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects will be evaluated.
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Memantine; Namenda; Autism Spectrum Disorders; Pervasive Developmental Disorders; Adults
Eplerenone and Extracellular Adenosine Formation
Condition: Pharmacodynamics
Study type: Interventional
Phase: Phase 4

Summary: 
      Various studies have reported cardioprotective effects of mineralocorticoid receptor (MR)
      antagonists in the setting of an acute myocardial infarction. In a recent animal study, the
      protective effect of MR antagonists on infarct size was completely abolished in CD73
      knock-out and adenosine A2b receptor knock-out mice, and by co-administration of adenosine
      receptor antagonists in rats. These findings suggest that extracellular formation of
      adenosine is crucial for this protective effect and that MR antagonists stimulate
      extracellular adenosine formation by the enzyme CD73.

      To investigate whether eplerenone promotes adenosine receptor stimulation by activating CD73,
      the investigators will measure forearm blood flow in response to various dosages of
      dipyridamole with the use of plethysmography. Dipyridamole increases the extracellular
      endogenous adenosine concentration by inhibition of the ENT transporter and induces local
      vasodilation. Therefore, the vasodilator effect of dipyridamole accurately reflects
      extracellular adenosine formation by the CD73 enzyme.
    


Intervention name(s): Eplerenone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 tabs of eplerenone 25 mg will be over-encapsulated and a fully mimicking placebo will be provided by the department of clinical pharmacy of the Radboud University Medical Centre Nijmegen
Other intervention name(s): Inspra, RVG 29963
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: healthy
Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1
      month dispensing study (2 weeks each lens pair)
    

Detailed description: 
      The aim of this study is to determine the clinical performance of fanfilcon A in comparison
      to senofilcon A sphere contact lenses.
    

Intervention name(s): fanfilcon A; senofilcon A
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Food Effect on Pharmacokinetics and Safety of Fixed-dose Combination of CJ-30056 in Healthy Male Subjects
Condition: Food Effect Study of CJ-30056 20mg/500mg
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluate the food effect on pharmacokinetics and safety of fixed-dose combination
      of "CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)" in healthy male subjects
    


Intervention name(s): CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Metformin; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)
Condition: Obesity, Morbid; Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Morbid
Study type: Observational

Summary: 
      This study will examine changes in various gut-derived hormones in obese type 2 diabetic
      patients before and after elective bariatric surgery.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Morbidly obese type 2 diabetic patients