bioihbjkbjnl/mcl2 huggingface dataset:
Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease
Condition: Metabolic Syndrome
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      There is some evidence that dietary supplementation with fish oil has health benefits,
      especially in respect of some of the known risk factors for cardiovascular (heart) disease
      such as cardiac arrhythmia. However, supplies of fish oil are limited, and it is desirable to
      validate alternative sustainable sources of the important omega-3 fatty acid components. It
      has been suggested that oil from krill, which are small marine crustaceans, may be as
      effective or possibly more beneficial than fish oil, and may provide a more effective and
      beneficial supplement. Dietary management of cardiovascular health parameters (such as blood
      lipids)is becoming more and more important as the rising trends in obesity nationally and
      worldwide are leading to escalating incidence of diabetes and heart disease. The
      investigators propose to use some specific novel lipid measurements of cardiovascular risk to
      test this possibility in a group of men who, although generally healthy, show some risk
      factors in terms of their weight and metabolic profile.This pilot study will provide
      preliminary data to show whether krill oil has similar or different effects from fish oil on
      the cardiovascular health of overweight but otherwise healthy men, and in particular will
      provide detailed information on alterations in novel lipid markers of cardiovascular disease,
      which may be a better diagnostic tool than classical lipid measurements (e.g. serum
      cholesterol). The investigators have been developing and validating new techniques to measure
      emerging lipid markers of cardiovascular risk accurately and will continue to develop and
      investigate these techniques during the course of this project. The investigators hypothesise
      that krill oil will be more efficacious in reducing markers of risk relating to
      cardiovascular disease.
    


Intervention name(s): Krill oil; Fish oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Krill oil 300 mg DHA/EPA daily for 6 weeks; Fish oil 500 mg DHA/EPA daily for 6 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Males; Metabolic syndrome; Otherwise healthy
The Evaluation of the Summer EBT for Children Demonstration
Condition: Food Insecurity Among Children; Dietary Modification
Study type: Interventional

Summary: 
      The Summer Electronic Benefit for Children (SEBTC) demonstration provided food assistance to
      households with school-aged children during the summer through electronic benefit transfer
      (EBT) procedures used by the Supplemental Nutrition Assistance Program (SNAP) and Special
      Supplemental Nutrition Program for Women, Infants and Children (WIC) programs. The evaluation
      design included two components: an impact study and an implementation study. The evaluation
      assessed the impact of SEBTC on children's food security and nutritional status, household
      food expenditures and purchasing behaviors, parental perceptions, and participation in
      nutrition assistance programs. The implementation study analyzed SEBTC use patterns using
      administrative data, and described demonstration implementation and costs.
    

Detailed description: 
      The SEBTC evaluation took place in the summers of 2011 through 2014. Ten grantees implemented
      the demonstration in a total of 16 sites; the number of participating sites and/or the
      evaluation components differed by year. In 2011, 5 grantees with five sites participated and
      the evaluation included implementation and cost analysis, EBT analysis, and an impact study.
      In 2012, 10 grantees implemented SEBTC in 14 sites and the evaluation included the same study
      components. In 2013, four grantees with six sites participated and the study components
      included EBT analysis and an impact study (no implementation or cost data collection).
      Finally, in 2014, three grantees participated in three sites and only implementation data
      were collected. Information on human subjects was collected for the evaluation's impact
      evaluation.
    

Intervention name(s): SEBTC
Intervention type(s): Other
Intervention description(s): SEBTC benefits were issued on EBT cards using either the existing EBT delivery systems for the Supplemental Nutrition Assistance Program (SNAP) or Supplemental Nutrition Assistance Program for Women Infants and Children (WIC). Sites selected only one of the two EBT systems to be used to implement SEBTC prior to random assignment; households were not randomized to a specific delivery system.
Other intervention name(s): food assistance; electronic benefit transfer payments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Euminz® for Tension-Type Headache
Condition: Episodic Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use)
      compared to placebo in patients with episodic tension-type headache (ETTH).

      Prospective, double-blind, placebo-controlled, phase IV clinical trial; Parallel-groups
      design; Randomisation 1:1; First attack per patient will be evaluated for primary objectives,
      following attacks during study duration will be observed and documented.

      Study duration per patient: 10 weeks
    

Detailed description: 
      To demonstrate the efficacy of Euminz® to reduce the intensity of headache symptoms
      experienced by patients with episodic tension-type headache. The two primary objectives will
      be tested hierarchically (a-priory ordered) to avoid alpha-adjustment:

      First primary objective of the first headache episode is "pain-free" (0 or 1) after 2 hours
      measured on a six-step verbal pain rating scale (VPRS). Acute treatment (3 to 5 time topical
      use of Euminz®) will start immediately after assessment of a baseline pain intensity of at
      least moderate pain (3 on VPRS).

      Second primary objective of the first headache episode will be the decrease of intensity of
      pain measured by a visual analogue scale (VAS). The difference from measure point 0 (before
      first application of Euminz®) on the VAS in comparison to 15, 30, 45, 60, 90 and 120 minutes
      after start of treatment will be shown as area under the curve representing the pain
      intensity difference (PID).
    

Intervention name(s): Euminz®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 to 5 time topical use of study drug.; 3 to 5 time topical use of study drug.
Other intervention name(s): Peppermint oil (10% ethanolic solution).; Peppermint oil (0,5% ethanolic solution).
Intervention MeSH terms: Peppermint oil; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
IL8 Monitoring and Its Correlation With 251-gene Polymorphism
Condition: Sepsis; Systemic Inflammatory Response Syndrome
MeSH terms: Systemic Inflammatory Response Syndrome
Study type: Observational

Summary: 
      One hundred eighty critically ill African adult intensive care patients divided into two
      groups, eighty septic critically ill patients (sepsis group) while, eighty non-septic
      critically ill patients (SIRS) group. Admission serum IL-8 was measured in both sepsis and
      SIRS groups. IL-8 (-251A/T) polymorphism was detected in sepsis and SIRS groups.
    

Detailed description: 
      A total of one hundred eighty African patients (97men and 83 women) were included in the
      study. Eighty patients developed septic complication during ICU stay (sepsis group). Eighty
      patients were critically ill without evidence of infectious organism (SIRS group). Patients
      received anti-inflammatory drugs or corticosteroids before admission, who had
      immunosuppressive illness, who had chronic organ failure; who had received massive blood
      transfusion; those with radiation therapy, previous organ transplantation were excluded from
      the study. At admission, the patient's age, sex, height and weight were recorded. These data
      include the following: clinical status; sequential organ failure assessment (SOFA) score;
      temperature; heart rate; respiratory rate; blood pressure; central venous pressure;
      laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium,
      potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time,
      albumin and CRP) and arterial blood gas analysis. Routine cultures of blood, urine and
      suspected sites were obtained to determine the presence of infection. We attempted to
      maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o.
      If needed, blood products, intravascular fluid replacement and inotropic and/or vasopressor
      agents were administered. Each day the attending physician in the ICU evaluated all the study
      patients for sepsis, severe sepsis, or septic shock.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of eighty African patients (47men and 33 women) were included in the study. Forty
        patients developed septic complication during ICU stay (sepsis group). Forty patients were
        critically ill without evidence of infectious organism (SIRS group).
      
Keywords: Serum Il-8; IL8 polymorphism; critically ill patients
Mazindol Controlled Release in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a controlled release formulation of
      mazindol is more effective than a placebo in the treatment of Attention Hyperactivity
      Disorder (ADHD) in adults.
    

Detailed description: 
      This study is an outpatient, randomized, double-blind, placebo-controlled trial in which
      adult subjects with ADHD will be randomized to either oral mazindol controlled release or
      placebo once daily. Subjects will be treated with study medication or placebo for 6 weeks
      with visits occurring weekly to measure efficacy and any adverse events with adjustment of
      medication dosing as necessary.
    

Intervention name(s): mazindol
Intervention type(s): Drug
Intervention MeSH terms: Mazindol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Electro-acupuncture and Flumazenil's Effect on Sedation
Condition: Acupuncture; General Anaesthesia; Sedation
Study type: Interventional

Summary: 
      Object: To explore the mechanism of the electro-acupuncture (EA) induced sedation effect in
      general anaesthesia through investigating the role of the Benzodiazepines-GABA system.

      Method: 80 patients undergoing abdominal surgery were randomly divided into four groups
      (n=20): C group (propofol only group), F group (propofol + flumazenil group), EA group
      (propofol + electro-acupuncture group), and EA+F group (propofol + electro-acupuncture +
      flumazenil group). Before induction, acupuncture needles were inserted at the points of
      Zusanli (ST 36) and Neiguan (PC 6) bilaterally to elicit"DeQi". Target-controlled infusion
      (TCI) of propofol was used for the induction and maintenance of anaesthesia. After 15minutes,
      equilibrium of Narcotrend Index (NT index) was achieved, patients were then assigned to
      receive different interventions. In EA group and EA+F group, patients received EA for 30
      minutes under general anaesthesia, and flumazenil with the dosage of 0.1mg/kg was added in
      the latter at the end of EA. In C group and F group, patients didn't receive EA, and
      flumazenil with the dosage of 0.1mg/kg was administered in F Group at the same time point
      with EA+F group. HR, MAP and NT index were recorded at different time points up to 30 minutes
      after the end of EA.
    


Intervention name(s): Flumazenil; Acupuncture
Intervention type(s): Drug; Procedure
Intervention description(s): used alone or with acupuncture; used alone or with flumazenil
Intervention MeSH terms: Flumazenil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Acupuncture; Flumazenil; Narcotrend; General Anaesthesia; Sedation
Iron Absorption From Infant Formula and Iron Drops in Infants (MJAU-studien)
Condition: Infant; Dietary Supplements; Food, Fortified
Study type: Interventional

Summary: 
      Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with
      cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant
      foods are recommended for infants. However, the optimal iron dose and mode of delivery have
      not yet been established. This is a concern as excessive iron intake may impair growth and
      increase morbidity in iron-sufficient infants. Previous studies have suggested that
      iron-fortified foods may have different effects than iron supplements. In this study, the
      investigators will investigate whether the mode of iron administration (supplementation vs.
      fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption,
      iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.
    


Intervention name(s): ferrous sulfate; iron-fortified infant formula (12.4 mg iron/L); iron-fortified infant formula (2.3 mg iron/L)
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): 6.3 mg iron from iron drops and 0.3 mg iron from infant formula with no added iron (0.5 mg iron/L) for 45 days; 6.6 mg iron from iron-fortified infant formula (12.4 mg iron/L) for 45 days; 1.2 mg iron from iron-fortified infant formula (2.3 mg iron/L) for 45 days
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Infant; Dietary Supplements; Food, Fortified; Iron Absorption
Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up
Condition: Disturbance of Growth
Study type: Interventional

Summary: 
      The study is conducted to examine the suitability of partially respectively extensively
      hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term
      infants.

      Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with
      modified protein content is non inferior compared to a standard infant formula based on a
      Protein hyrolysate in respect to proper growth of healthy, term infants within the first four
      month of life.

      4-year follow-up (without further Intervention) will focus on body composition and allergic
      predisposition.
    

Detailed description: 
      View Section Brief Summary
    

Intervention name(s): control formula; intervention formula 1; intervention formula 2; intervention formula 3
Intervention type(s): Other; Other; Other; Other
Intervention description(s): infants are fed a commercial hydrolyzed formula; formula has hydrolysed protein and a different protein content; formula has hydrolysed protein, different protein content and pro- and prebiotics; formula has hydrolysed protein, different protein content and pro- and prebiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      This study aims to assess the impact of preoperative oral carbohydrate drink on gastric
      emptying and PH of gastric fluid in gastric cancer patients directly. Furthermore,
      investigators aim to evaluate the safety and effectiveness of preoperative oral carbohydrate
      in elective gastric cancer surgery, providing direct evidence for clinical practice.
    

Detailed description: 
      In clinic, administration of oral carbohydrate 2-3 hours before surgery has been widely
      applied in elective colorectal surgery. However, no direct evidence has been showed that
      whether it is safe to do so in gastric cancer patients who are fit for elective radical
      gastric resection.

      This study aims to discuss the impact and safety of oral administration of 5% glucose
      solution 250ml 2-3 hours before elective gastric cancer surgery. It is an equivalence study,
      which refers to a single-center, prospective, single blind, and randomized controlled study
      design. Eighty-eight patients with gastric adenocarcinoma are going to be enrolled in the
      study, who will be allocated into control or treatment group. Patients in control group
      follow the traditional routine of 6-8 hours preoperative fasting, while those in the
      treatment group will orally intake 250ml 5% glucose solution 2-3 hours before surgery. The
      primary end-point is the preoperative gastric residual volume. The secondary end-points
      include preoperative PH of gastric fluid, assessment of perioperative psychosomatic
      conditions, rate of perioperative complications, level of insulin sensitivity, recovery of
      bowel function, and the length of hospital stay, etc.
    

Intervention name(s): preoperative oral carbohydrate drink
Intervention type(s): Dietary Supplement
Intervention description(s): 5% glucose solution 250ml 2-3 hours before surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity
Condition: Obesity; Binge-Eating Disorder
MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of topiramate compared
      to placebo in reducing the number of binge days in patients with moderate to severe
      binge-eating disorder associated with obesity.
    

Detailed description: 
      Binge-Eating Disorder (BED) is characterized by recurrent binge eating without extreme
      behaviors to lose weight (e.g., self-induced vomiting, misuse of laxatives) resulting in
      marked distress, feelings of loss of control, and association with overweight or obesity.
      Treatment goals for binge-eating therapies include reducing the urge to binge, weight loss,
      and management of co-existing medical and psychological conditions. Currently, there are no
      approved medication treatments available for BED, however, studies have shown that treatment
      for BED (psychotherapy or the use of medications) may be effective at reducing the number of
      binges, while effects on weight have been variable. Topiramate has been approved for epilepsy
      in adults and children aged 2 years and above, and for the prevention of migraine in adults.
      This is a randomized, double-blind, flexible dose, parallel group study to determine if
      topiramate, a prescription medication approved by the Food & Drug Administration for the
      treatment of epilepsy and the prevention of migraine, administered at a dose of 400 mg per
      day or the subject's maximum tolerated dose, is safe and effective compared with placebo in
      patients with moderate to severe binge-eating disorder associated with obesity. Subjects will
      have an equal chance of receiving topiramate or placebo. The study hypothesis is that
      topiramate will be more effective than placebo in reducing the number of binge days per week
      in patients with moderate to severe binge-eating disorder associated with obesity and is
      generally well tolerated. Patients completing the 16-week double-blind phase of the trial are
      eligible to participate in the 12-week open-label phase of the study.

      Topiramate tablets (25 and/or 100 mg) or placebo in increasing doses starting at 25 mg/day up
      to 400 mg/ day (or MTD) during first 8 wks, achieved dose maintained for additional 8 wks. If
      entering OL reduce DB medication while increasing dose of active topiramate to 400mg/day or
      MTD for addn 12 wks.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Binge-Eating Disorder; medication treatment; obesity; bingeing
Safety and Tolerability Study With Multiple Ascending Doses of ORM-12741
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of escalating multiple
      doses of ORM-12741 in healthy volunteers
    


Intervention name(s): ORM-12741
Intervention type(s): Drug
Intervention description(s): Alternating panel multiple dose escalation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteer study
A Clinical Study Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with
      acne vulgaris.
    


Intervention name(s): IDP-110; Clindamycin; Benzoyl peroxide; Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical application for 12 weeks; Topical application for 12 weeks; Topical application for 12 weeks; Topical application for 12 weeks
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
QUILT-1.004: A Single Center, Open-label, Pharmacokinetic Study of Subcutaneous ALT-803
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label, pharmacokinetic study of ALT-803 administered as a subQ
      injection to healthy volunteers.
    


Intervention name(s): ALT-803
Intervention type(s): Drug
Intervention description(s): Subjects randomized to Group A (n=8) will receive ALT-803 at a concentration of 1.0 mg/mL and subjects randomized to Group B (n=8) will receive ALT-803 at a concentration of 2.0 mg/mL. Subjects will receive a single 10 µg/kg subQ dose of ALT-803 on Day 1 of study period 1. After a rest period, subjects will receive a single 20 µg/kg subQ dose of ALT-803 on Day 1 of study period 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ALT-803; PK