bioihbjkbjnl/mcl2 huggingface dataset:
Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The aim of this study is to investigate the potential effect of a marine protein hydrolysate
      (MPH) supplement before a meal on postprandial glucose tolerance in healthy subjects, to
      achieve more knowledge on this presumed beneficial, blood glucose lowering effect
    

Detailed description: 
      To further investigate the effects of MPH in a single dose of 20 mg/kg of body weight on
      postprandial blood glucose, insulin and GLP-1 (as markers of glucose metabolism) in healthy,
      active middle-aged to elderly subjects - age 40-65 years.
    

Intervention name(s): Marine protein hydrolysate (mph); Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Marine (Cod) protein hydrolysate; Maltodextrin/Casein
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A double-blind crossover trial, including two different study days, with 4-7 days wash-out (WO) period in between. The intervention implemented 20 mg of MPH per kg body weight (test material) or control (casein).
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Dietary Supplements; Fish Proteins; Protein Hydrolysates; Aged
Brazil Nut Consumed on the Metabolic Profile, Oxidative Stress and Nutritive Microcirculatory Patterns
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose this research is to check if Brazil Nuts consumed improvement the metabolic
      profile, state redox and endothelial function in obese adolescents.
    

Detailed description: 
      The purpose this research is to check if Brazil Nuts consumed improvement the metabolic
      profile (lipid profile, glucose, insulin), state redox (about glutathione peroxidase,
      isoprostane and LDL-ox) and endothelial function (by videocapillaroscopy) in obese
      adolescents (12-18 years).
    

Intervention name(s): Brazil Nut
Intervention type(s): Dietary Supplement
Intervention description(s): During 16 weeks the adolescents consumed 3-5 nuts/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obese; brazil nuts; oxidative stress; microcirculatory; metabolic profile
Mortality After Endoscopic Retrograde Cholangiopancreatography
Condition: Cholangiopancreatography, Endoscopic Retrograde; Mortality; Deep Sedation
Study type: Observational

Summary: 
      In this study, the investigators aimed to overview patients with specific and non-specific
      complications who admitted to intensive care unit following endoscopic retrograde
      cholangiopancreatography and had fatal course in the facility
    

Detailed description: 
      The investigators retrospectively reviewed patients who underwent elective or emergent
      endoscopic retrograde cholangiopancreatography at semi-prone position under pharyngeal
      anesthesia (lidocaine spray) with routine monitoring (including electrocardiography,
      non-invasive blood pressure, peripheral capillary oxygen saturation) and standard sedation
      protocol (midazolam 0.02 mgkg-1; fentanyl, 1 mgkg-1; propofol 1 mgkg-1) between 2011 and 2016
      after approval of local ethics committee of Umraniye Training Hospital.
    

Intervention name(s): complications during procedure
Intervention type(s): Procedure
Intervention description(s): patients may have anesthesia related complications during procedure
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We retrospectively reviewed 1471 patients who underwent elective or emergent ERCP at
        semi-prone position under pharyngeal anesthesia (lidocaine spray) with routine monitoring
        (including electrocardiography, non-invasive blood pressure, peripheral capillary oxygen
        saturation) and standard sedation protocol
The Effect of Growth Hormone in Very Young Girls With Turner Syndrome
Condition: Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This study investigated the effect of growth hormone on the growth of infants and toddlers
      with Turner syndrome during 2 years of treatment with growth hormone. This was compared with
      the growth of infants and toddlers with Turner syndrome who did not receive any growth
      hormone treatment. The overall aim was to prevent the growth failure usually seen during this
      period. The study also looked at middle ear disease, hearing problems, and cognitive and
      behavioral development.
    


Intervention name(s): Somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Seresis® in the Skin in Healthy Young Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid
      reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs)
      and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment
      of individual antioxidant compounds contained in the product and to investigate whether or
      not some of them accumulate in target tissues such as skin, BMCs and plasma
    


Intervention name(s): Seresis®
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy
Condition: Hyperopia
MeSH terms: Hyperopia
Study type: Interventional

Summary: 
      To assess the efficacy, predictability, stability and safety of corneal wavefront-guided
      photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial
      keratotomy (RK).
    


Intervention name(s): Photorefractive keratectomy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: photorefractive keratectomy; hyperopia; radial keratotomy; refractive surgery
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and
      pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants
      with type 2 diabetes. The study duration is approximately 60 weeks.
    


Intervention name(s): Dulaglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY2189265
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pediatrics
Membrane Shedding During Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Observational

Summary: 
      Microparticles (MPs) result from plasma cell membrane remodeling and shedding after cell
      stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with
      emerging role in pathophysiology of immune and cardiovascular diseases. MPs have been
      characterized during septic shock and may contribute to dissemination of pro-inflammatory and
      procoagulant mediators. This is a prospective observational study of circulating MPs and
      blood coagulation in 100 septic shock patients admitted in 3 tertiary hospitals medical ICU
      at baseline (D1), D2, D3, D4 and D7.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with septic shock
Comparison of Covered and Bare Stent in TIPS
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional

Summary: 
      Investigators aim to compare the efficacy of 8 mm Fluency covered stent and bare stent in
      transjugular intrahepatic portosystemic shunt (TIPS) for the treatment of cirrhotic portal
      hypertension.
    

Detailed description: 
      From January 2006 to December 2010, the covered (experimental group) or bare stent (control
      group) was used in 131 and 127 patients, respectively. The recurrence rates of
      gastrointestinal bleeding and refractory hydrothorax/ascites, the cumulative restenosis rates
      in 1, 2, 3, 4, and 5-years, the incidence rate of hepatic encephalopathy, the rate of
      secondary interventional therapy, the 1, 2, 3, 4 and 5-year survival rates were compared
      between the experimental group and the control group.
    

Intervention name(s): covered stent; bare stent
Intervention type(s): Device; Device
Intervention description(s): A broad range of implant diameters and lengths for the treatment of in-stent restenotic peripheral and central lesions* in patients with AV grafts and AV fistulae Small incremental stent graft lengths to help maintain venous real estate and cannulation area Minimal shortening and radiopaque markers aid in excellent placement accuracy; A one piece laser cut, self-expanding nitinol stent combining a micromesh design with a multi segmental construction.
The 36 strut, 6 bridge construction of the Stent provides an unmatched balance of radial force, scaffolding, and longitudinal stability.
The design offers crush recoverable flexibility in the most challenging vasculature, with optimal wall apposition, conformability and minimal foreshortening.
It offers a broad portfolio of sizes for the treatment of routine and challenging Iliofemoral lesions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TIPS; Hepatocellular Carcinoma; Portasystemic Shunt
Dressing Wear Time After Breast Augmentation With Prosthesis
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection
Study type: Interventional

Summary: 
      This study was designed to determine whether the duration of dressing wear following
      augmentation mammaplasty influence skin colonization and eventually surgical site infections
      rates.
    

Detailed description: 
      Augmentation mammaplasty is currently one of the most performed plastic surgery procedures.
      It is a clean operation, and surgical site infection (SSI) rates are low. However, a SSI,
      since a minor one, leads to the failure of the procedure. Thus, minimizing SSI risks is
      imperative.

      The Centers for Disease Control and Prevention (CDC) provides recommendations concerning
      prevention of SSI.No recommendation is offered for some practices, either because there is a
      lack of consensus regarding their efficacy or because of the available scientific evidence is
      insufficient to support their adoption.

      CDC´s "Guideline for Prevention of Surgical Site Infection" recommends protecting with a
      sterile dressing for 24 to 48 hours an incision that has been closed primarily. There is no
      recommendation to cover the incision beyond 48 hours. One major risk factor for SSI is the
      presence of bacteria at surgical site.Thus, this trial was designed to verify the influence
      of dressing wear time on skin colonization.
    

Intervention name(s): augmentation mammaplasty; augmentation mammaplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Dressing is removed on the first postoperative day; Dressing is removed on the 6th postoperative day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: breast prosthesis implantation; bandages; skin colonization; surgical site infection; augmentation mammaplasty; dressing wear time
A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)
Condition: Paget's Disease of Bone
MeSH terms: Bone Diseases; Osteitis Deformans
Study type: Interventional
Phase: Phase 3

Summary: 
      To test the safety, effectiveness of MK0217 when taken once a week for six months in treating
      patients with Paget's bone disease.
    


Intervention name(s): alendronate
Intervention type(s): Drug
Intervention description(s): Duration of Treatment : 6 Months
Other intervention name(s): MK0217
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Paget's bone disease
Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Acute-On-Chronic Liver Failure.
Condition: Acute on Chronic Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure
Study type: Interventional

Summary: 
      All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016.ACLF (Acute on
      chronic Liver Failure). ACLF will be randomize into

      Group 1: MVP (Modest Volume Paracentesis) OF Less than 5 liters with IV albumin at a dose 8
      gms/L of ascitic fluid

      Group 2: MVP (Modest Volume Paracentesis) of Less than 5 liters without albumin
    


Intervention name(s): Albumin; Ascitic fluid
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous albumin 8 gms/L of ascitic fluid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early DVC Ligation and Urinary Continence Recovery After RARP
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the impact of early deep venous complex ligation (eDVCL)
      in patients affected by clinically localized prostate cancer (PCa) undergoing robot-assisted
      radical prostatectomy with or without pelvic lymph node dissection. Overall, 312 patients
      will be randomized to the standard technique vs. eDVCL. The primary endpoint is represented
      by early urinary continence recovery. The secondary endpoints are perioperative outcomes,
      erectile function recovery and positive surgical margins.
    


Intervention name(s): Early DVC ligation
Intervention type(s): Procedure
Intervention description(s): After the posterior isolation of seminal vesicles, the Retzius space will be accessed and the endopelvic fascia will be incised. The DVC will be identified and incised. The DVC will be then selectively ligated using a V-lok 3/0 barbed suture. This approach would allow for the preservation of the external urethral sphincter and for the identification and preservation of the neurovascular bundles that are located in the anterolateral aspect of the prostate. After the early DVC isolation, incision and ligation, the bladder neck will be incised and preserved when possible. A posterior nerve sparing approach will be then performed. During apical dissection, the urethral sphincter will be identified and carefully preserved. Posterior reconstruction and anastomosis will be then performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: prostate cancer; radical prostatectomy; deep venous complex ligation
APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism
Condition: Presbyopia; Myopia; Hyperopia; Astigmatism
MeSH terms: Astigmatism; Presbyopia; Hyperopia
Study type: Interventional

Summary: 
      Vision and comfort, both objective and subjective, will be assessed for single vision contact
      lens wearers for either the APIOC™ for Presbyopia or the APIOC™ for Presbyopia Astigmatism
      contact lenses.
    


Intervention name(s): APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism
Intervention type(s): Device
Intervention description(s): Contact Lenses for Presbyopia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of ColdZyme® on Experimentally Induced Common Cold.
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional

Summary: 
      This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold
      symptoms on experimentally induced rhinovirus upper respiratory tract infection in healthy
      volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will
      receive placebo.
    

Detailed description: 
      88 subjects will be inoculated with rhinovirus 16 via the nasal route. The subjects will be
      randomized 1:1 to ColdZyme® or placebo. Treatment (6 doses per day) will be applied for 11
      days from the day of inoculation. The subjects will visit the investigational clinic on 6
      occasions. During these visits the subjects will leave nasal (lavage) and pharyngeal (swab)
      samples for quantification of virus replication. All subjects will have a diary for scoring
      of cold symptoms.
    

Intervention name(s): ColdZyme® mouth spray; Placebo
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to a Calorie-Restricted Diet in Women
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of the South Beach Diet™ and South
      Beach Diet™ products compared to a traditional calorie restricted diet.
    


Intervention name(s): South Beach Diet™ with South Beach Diet™ Products; South Beach Diet™; Calorie restricted diet with South Beach Diet™ Products; Calorie Restricted Diet
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: South Beach Diet™; overweight; obesity; satiety; weight loss
A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography
Condition: Pregnancy
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The goal of this project is to compare the efficiency of pelvic ultrasounds performed by
      emergency medicine residents and attending physicians to the efficiency of pelvic ultrasounds
      performed by the department of radiology.
    

Detailed description: 
      This study is a randomized, prospective interventional study of pregnant patients presenting
      to the emergency department with complaints of pelvic pain and/or vaginal bleeding. This
      study will be conducted at 4 sites across the United States. Patients who are eligible and
      consent to participate will be randomized to one of two conditions; 1) a pelvic ultrasound
      that is performed by a certified emergency department attending or physician, or 2) a pelvic
      ultrasound that is performed by a certified radiology technician (standard-of-care). The time
      to diagnosis and emergency department length of stay between the two groups will be compared.
    

Intervention name(s): Emergency Medicine Physician Ultrasound; Ultrasound
Intervention type(s): Other; Device
Intervention description(s): An ultrasound will be performed by an emergency medicine resident or attending physician; An ultrasound will be performed by a radiology department technician
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: ultrasonography; emergency department
Diet, Obesity and Genes (DiOGenes)
Condition: Obesity; Metabolic Syndrome; Type 2 Diabetes; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Obesity; Metabolic Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat
      diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on
      bodyweight in overweight and obese subjects after an initial weight loss.
    

Detailed description: 
      DiOGenes is a randomised controlled dietary intervention study in obese/overweight families
      (adults and children) in 8 different European countries, testing the efficacy and safety of
      diets differing in Glycaemic Index (GI) and protein content.

      The 8 centres are divided into "shop centers" and "instruction centers", that provide
      different kind of dietary intervention and for a different length(see below):

      The 2 Shop Centers (Denmark & The Netherlands):

      Dietary periods and clinical examinations:

        1. Clinical examination 1 with anthropometry, blood etc.

        2. 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day)(Adults only)

        3. Clinical examination 2 with anthropometry, blood etc.

        4. 6 months dietary intervention period 1 (SUPERMARKET period)(Family)

        5. Clinical examination 3 with anthropometry, blood etc.

        6. 6 months dietary intervention period 2 (DIETARY INSTRUCTION period)(Family).

        7. Clinical examination 4 with anthropometry, blood ect.

        8. 12 months free-living period with no dietary intervention. (Family)

        9. Follow up (only body weight registration)

      The 6 Instruction Centers (UK, Crete, Germany, Spain, Bulgaria, Czech Republic)

      Dietary periods and clinical examinations:

        1. Clinical examination 1 with anthropometry, blood etc.

        2. 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day). (Adults only)

        3. Clinical examination 2 with anthropometry, blood etc.

        4. 6 months dietary intervention period (DIETARY INSTRUCTION period). (Family)

        5. Clinical examination 3 with anthropometry, blood etc.

        6. 6 months free-living period with no dietary intervention. (Family)

        7. Follow up (only body weight registration)

      Note that, during the first 6 month intervention all families from the shop centers are
      provided all foods free of charge "SUPERMARKET PERIOD", whereas in the "Instruction Centers",
      the families receive dietary instruction only "Instruction Only".
    

Intervention name(s): High or low Glycemic Index and high or low Protein Diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diogenes; Diet Intervention; Family; Glycemic Index; Protein
Study of Metformin Pharmacogenetics in Twins
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The trough concentration of metformin will be examined in monozygotic and dizygotic twins.
      Current twin study will determine the total weight of genetics on the trough concentration of
      metformin.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): 6 days treatment with metformin to steady-state
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science