bioihbjkbjnl/mcl2 huggingface dataset:
Enhanced Broccoli Consumption After a Liking Norm and Vegetable Variety Message: Effects After a 24 Hour Delay.
Condition: Eating Behaviour
Study type: Interventional

Summary: 
      Encouraging individuals to eat vegetables is difficult. However, recent evidence suggests
      that using social-based information might help. For instance, it has been shown that if
      people think that others are eating lots of fruit and vegetables, that they will consume more
      of these foods to match the 'norm'. The purpose of this study was to determine whether a
      liking social norm (information about how much others like vegetables) would be effective at
      encouraging people to eat more vegetables and to examine whether these effects are sustained
      beyond initial exposure (i.e. whether the effect of the norm persists on food selection 24
      hours alter).
    

Detailed description: 
      Using a 2 x 5 x 2 experimental design we investigated the effects of exposure to various
      messages on later food intake and whether any effects were sustained 24 hours after exposure
      in both low and high consumers of vegetables. There were three factors of delay (immediate
      food selection versus food selection 24 hours after exposure), message type (liking norm,
      descriptive norm, health message, food-based control, and neutral control message) and
      habitual consumption (low versus high). The buffet consisted of three raw vegetables, three
      energy-dense foods and two dips.

      In this study the investigators hypothesised that a liking norm would increase the
      consumption of vegetables (compared to a neutral control condition) and that the effect would
      persist on vegetable consumption 24 hours after intital exposure to the liking norm.
    

Intervention name(s): Neutral Control Condition; Food-based Control Condition; Health Condition; Descriptive Social Norm; Liking Social Norm
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Message about age of University of Birmingham; Message about variety of vegetables in the world; Message about the health benefits of eating vegetables; Message suggesting most people eat plenty of vegetables; Message suggesting most people like eating vegetables
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the
      treatment of major depressive disorder (MDD) compared to placebo plus an ADT.
    

Detailed description: 
      This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the
      trial was transferred to Biogen.
    

Intervention name(s): SAGE-217; Matching Placebo; Sertraline; Escitalopram; Citalopram; Duloxetine; Desvenlafaxine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral capsules; Oral capsules; Oral tablets; Oral tablets; Oral tablets; Oral capsules; Oral tablets
Intervention MeSH terms: Duloxetine Hydrochloride; Citalopram; Sertraline; Desvenlafaxine Succinate; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD; SAGE-217
The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults
Condition: Hypertension; Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the source of dietary protein (pork or
      chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high
      blood pressure.
    

Detailed description: 
      High blood pressure is a major risk factor for heart disease and stroke and affects 50
      million people in the United States. Making healthy food choices, such as those in the DASH
      (Dietary Approaches to Stop Hypertension) Diet, has been shown to improve blood pressure
      control in people with high blood pressure. The purpose of this study is to determine if the
      source of dietary protein (pork or chicken/fish) as a part of the DASH diet affects blood
      pressure control in adults with high blood pressure.
    

Intervention name(s): DASH diet counseling
Intervention type(s): Behavioral
Intervention description(s): Comparison of protein source (chicken and fish vs. pork) as part of DASH diet on blood pressure regulation and blood lipids.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic and Functional Impact of Various Breakfast Models
Condition: Metabolism and Nutrition Disorder
MeSH terms: Nutrition Disorders
Study type: Interventional

Summary: 
      In the present study the investigators compared the hormonal and metabolic effects of three
      meal loads very popular among Italian eating habits, both in the resting- and exercising
      state. Given the lack of time is considered a common barrier to exercise adherence, we wanted
      to identify a low dose of exercise capable to produce health benefits in the post-absorptive
      status elicited by three commonly consumed meal-models in Mediterranean countries. To this
      end, healthy young volunteers firstly underwent an oral glucose tolerance test (OGTT) and
      three meal tolerance tests. Secondly, in an extra set of experiments, subjects cycled at low
      intensity for the last 20 minutes of the same glucose/meal tolerance test. Glycemia,
      insulinemia, ghrelinemia, lipidemia, and satiety were measured throughout OGTT and each
      test-meal load.
    

Detailed description: 
      The investigators evaluated postprandial responses (glucose, insulin, ghrelin, free fatty
      acids (FFA)) elicited by three diverse test-meal loads followed by a 20-min bout of
      low-intensity aerobic exercise were investigated. All subjects underwent a 50-g OGTT (A) and
      3 test-meal loads: milk and cereals (B1); milk, apple and chocolate cream-filled sponge cake
      (B2); milk, bread, apple and hazelnut chocolate cream (B3). In the exercise trial,
      participants cycled for 20 minutes at 40% VO2max, 100 minutes after load ingestion.
    

Intervention name(s): Breakfast; exercise
Intervention type(s): Dietary Supplement; Other
Intervention description(s): All subjects received a standard 75-g OGTT to assess eligibility for the study. The 19 subjects matching the inclusion criteria completed 2 experimental trials: resting and exercise. During the resting trial, all subjects underwent an OGTT (50-g: A) and 3 meal tolerance tests [one for each breakfast tested: B1 = milk (125ml) and cereals (30g); B2 = milk (220ml), apple (200g) and chocolate cream-filled sponge cake (30g); B3 = milk (125ml), apple (150g), bread (50g) and hazelnut chocolate cream (15g)]. In the exercise trial, 100 minutes after the glucose/meal ingestion, participants cycled for 20 min at 40% of maximum oxygen uptake.; aerobic exercise at 40% of VO2max, for 20 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized-crossover in healthy subjects
Masking: None (Open Label)
Primary purpose: Other
Keywords: meal absorption; exercise; energy balance; lipolysis
Depression Prevention Program for American Indian Adolescents During and After Pregnancy
Condition: Depression; Pregnancy
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will determine the effectiveness of the "Living in Harmony" depression prevention
      program in preventing depressive symptoms among pregnant American Indian adolescents during
      pregnancy and after giving birth.
    

Detailed description: 
      Pregnancy among reservation-based American Indian adolescents has become increasingly common.
      Numerous psychosocial and environmental factors have put this population at high risk for
      pregnancy-related depression. Depression during pregnancy and after giving birth is
      associated with reduced quality of life for both young mothers and their children. Many
      reservations lack mental health services; therefore, an inexpensive intervention is needed to
      prevent depressive symptoms among pregnant adolescents who live on reservations.

      The duration of this study will vary for each participant, depending on the time of study
      entry. Participants will be randomly assigned to receive weekly sessions of either the
      "Living in Harmony" program, consisting of cognitive behavioral therapy (CBT),
      culturally-relevant education, and support; or general depression-prevention education and
      support. Participants' depressive symptoms will be assessed at study entry, at 4, 12, and 24
      weeks after giving birth, and study completion. Interviews and self-report scales will be
      used to assess participants.
    

Intervention name(s): "Living in Harmony" depression prevention program; Depression-prevention education and support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly therapy sessions consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support; Weekly therapy sessions offering general depression-prevention education and support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Postpartum Depression; Postpartum Period; Indians, North American; Adolescent; Female; CBT
Comparison of Low and High Phytosterol Diets With Respect to Cholesterol Metabolism
Condition: Hypercholesterolemia; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Interventional

Summary: 
      The objective of this study is to compare cholesterol absorption and metabolism after feeding
      diets naturally low or high in phytosterols. All meals will be prepared in a metabolic
      kitchen and analyzed for phytosterols. In a randomized crossover design a group of up to 25
      healthy subjects will consume diets containing either 100 mg/day or 600 mg/day phytosterols
      for 4 weeks. At the end of each dietary period percent cholesterol absorption, fecal
      cholesterol excretion and LDL cholesterol level will be measured. The hypothesis is that LDL
      cholesterol and cholesterol excretion will be improved on the high phytosterol diet even
      though macronutrient composition, mineral intake and fiber consumption are similar.
    


Intervention name(s): Low Phytosterol and High Phytosterol Diets
Intervention type(s): Other
Intervention description(s): Diets with 600 or 100 mg of daily phytosterols for 4 weeks were given to each subject, in random order
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: phytosterols; cholesterol excretion; cholesterol absorption; diet; mass spectrometry; deuterium
Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for Treatment of High Risk Hematologic Malignancies
Condition: Leukemia; Multiple Myeloma
MeSH terms: Multiple Myeloma; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to conduct a phase I study of adoptive immunotherapy with
      autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate
      in autologous stem cell transplant patients with high-risk hematologic malignancies.
    

Detailed description: 
      Disease relapse remains the major cause of treatment failure in autologous stem cell
      transplantation for patients with high-risk disease. Relapse after autologous transplant is
      in part due to the persistence of residual cancer cells. Cellular immunotherapy using
      activated autologous effector cells to recognize and kill tumor targets in a minimal disease
      state after transplant is a strategy being explored to reduce relapse and improve survival.
      We hypothesize that cytokine-induced killer (CIK) cell-based immunotherapy can reduce the
      relapse rate after high-risk autologous stem cell transplantation by treating post-transplant
      minimal residual disease.
    

Intervention name(s): CIK cells; etoposide; bcnu; cyclophosphamide; gemcitabine; vinorelbine; melphalan
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2x10e8 cells/kg; 60 mg/kg; 15 mg/kg; 100 mg/kg; 1250 mg/m2; 30 mg/m2; 200 mg/m2
Other intervention name(s): autologous cytokine-induced killer cells; Eposin; Etopophos; Vepesid; VP-16; Carmustine; Endoxan; Cytoxan; Neosar; Procytox; Revimmune; cytophosphane; Gemzar; Navelbine; Alkeran; Melphalan hydrochloride
Intervention MeSH terms: Cyclophosphamide; Melphalan; Carmustine; Gemcitabine; Etoposide; Vinorelbine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides
Condition: Iron Absorption
Study type: Interventional

Summary: 
      The co-primary objectives of this study are: 1) to investigate the effect adding a synbiotic
      (combination of a pre-and probiotic) to iron-fortified follow-up formula (FUF) on iron
      bioavailability, and 2) to investigate the effect adding Human Milk Oligosaccharides (HMOs)
      to iron-fortified FUF on iron bioavailability in 10-14 month-old Thai children.
    

Detailed description: 
      Iron stores of healthy, full-term neonates are supposed to cover iron needs for the first 4-6
      months of life. After 6 months of age, requirements for absorbed iron are high, as infants
      need to build body iron stores and triple their body weight before the first year of life.
      Iron concentrations in mature breastmilk are low (~0.3 mg/L) and cannot adequately cover the
      high iron requirements of children between 6 and 24 months of age. Follow-up formulas (FUF)
      are fortified milk-based products intended for infants above 6 months of age and young
      children aged 1-3 years, and are widely used as a liquid part of the weaning diet to
      supplement the diet of young children with macro- and micronutrients. Prebiotics and
      probiotics are increasingly added to foods for infants and young children due to emerging
      evidence on possible health benefits. We recently showed that the addition of prebiotic
      galacto-oligosaccharides (GOS) to an iron-containing micronutrient powder increased iron
      absorption in Kenyan infants. To our knowledge, the effect of the combination of pre- and
      probiotics (synbiotic) or human milk oligosaccharides (HMOs) on iron absorption from an
      iron-fortified FUF has not been investigated.

      Thai children (10-14 months old) will be assigned to receive FUF fortified with isotopically
      labelled iron as FeSO4 1) with synbiotic, 2) HMO, and 3) without added prebiotics as a
      reference, in random order. Besides the iron source and synbiotic or HMO, the test FUF will
      be identical in terms of macro- and micronutrient composition. For the secondary objectives
      of this study, which will have a single-group, before-after design, each infant will receive
      the test FUF with added synbiotic for 25 days on gut comfort and quality of life outcomes.
    

Intervention name(s): Test formula A without added pre- and pro-biotic; Test formula B with synbiotic; Test formula C with HMOs
Intervention type(s): Other; Other; Other
Intervention description(s): An identical formula as test formulas fortified with 2.20 mg iron as FeSO4-58 and 0.05 mg native iron per serving (235 ml), but without added pre- or probiotic.; Test formula fortified with 2.20 mg iron as FeSO4-57 and 0.05 mg native iron per serving (235 ml) and added synbiotic.; Test formula fortified with 2.20 mg iron as FeSO4-54 and 0.05 mg native iron per serving (235 ml) and added HMOs.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Embryoscope and Reproductive Outcome
Condition: Invitro Fertilization
Study type: Observational

Summary: 
      cases with embyos cultured in the standard incubator and evaluated only by morphology are
      compared to cases with embryos continuously monitored by the embryoscope followed by embryo
      selection based on a multivariable model
    

Detailed description: 
      cases with embyos cultured in the standard incubator and evaluated only by morphology
      (control group) are compared to cases with embryos continuously monitored by the embryoscope
      followed by embryo selection based on a multivariable model(study group)
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        770 women undergoing ICSI cycles
Safety Study of Viaskin Peanut to Treat Peanut Allergy
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy
      in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg or
      a placebo for a period of 6 months, after which all subjects will be receiving the active
      treatment up to a period of 3 years under active treatment.
    


Intervention name(s): Viaskin Peanut 250 mcg; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures
Condition: Post-ERCP Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      For 40 years, the post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis has
      been the most frequent adverse effect of endoscopic transpapillary interventions. We sought
      to determine the efficacy of thoracic epidural analgesia for the prevention of post-ERCP
      pancreatitis.

      Between 2008 and 2013, a randomized study of the results of endoscopic treatment of 491
      patients was conducted. The first group of patients (N=247) received thoracic epidural
      analgesia (TEA) during ERCP procedures, the patients of the second group (N=244) received a
      narcotic analgesic. To detect statistically significant differences between research groups
      adjusted odds ratios (OR) and their 95% confidence interval (CI) were calculated.
    

Detailed description: 
      Preoperatively the subjects were randomly assigned (by using sealed envelopes - blind
      randomization) into two groups, 250 patients each.

      The patients of the first group had TEA applied during the ERCP procedure; other methods of
      pain relief were applied to the patients of the second (control) group.

      The first group (TEA group) of patients received the following premedication: atropine
      sulfate 0.5-1 mg, midazolan 5 mg. The puncture and catheterization of the epidural space was
      carried out according to standard procedure between thoracic vertebrae VII-VIII. Half an hour
      before performing ERCP ropivacaine 0.5% -10 ml. was injected into the epidural space.

      The second group (control group) of patients received the following premedication: atropine
      sulfate 0.5 -1 mg, midazolan 5 mg, trimeperidine 2% -1 ml.
    

Intervention name(s): ERCP; Thoracic epidural analgesia; Premedication
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Endoscopic retrograde cholangiopancreatography balloon dilatation; Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml); For premedication used trimeperidine 2%-1ml intravenously.
Other intervention name(s): endoscopic transpapillary intervention; Epidural analgesia; Epidural anaesthesia; anociassociation; anocithesia; prenarcosis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: therapeutic ERCP; prevention of post-ERCP pancreatitis; thoracic epidural analgesia
Clinical Study to Evaluate Tolerability and Safety of ARK-E021 Foam and to Monitor Clinical Effect in Acne Vulgaris Patients
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group,
      ambulatory safety and efficacy study of ARK-E021 topical foam of 5% and 10% in subjects with
      mild to moderate acne vulgaris.
    

Detailed description: 
      This is a phase I/II prospective, multicenter, randomized, double blind, placebo controlled,
      parallel group, dose range finding clinical study to evaluate the safety, tolerability and
      preliminary efficacy of ARK-E021 foam for treatment of acne vulgaris.

      It is anticipated that the study will be conducted at the listed Medical Centers as well as
      out-patient clinics at the community.

      Approximately 144 male and female subjects with mild to moderate facial acne vulgaris will be
      enrolled in this study. Following satisfaction of the entry criteria and screening
      procedures, subjects will be randomized to either 5% or 10% topical foam (ARK-E021) or
      placebo foam. Subjects will apply the study medication once daily on the face at bedtime for
      12 weeks followed by a post-treatment follow up visit 4 weeks after end of treatment. The
      first dose will be applied in the presence of the study investigator or his assignee.
      Subsequent applications will be made by the patient.

      Safety will be monitored throughout the study duration. Efficacy will be assessed by facial
      lesion counts and by the investigator global evaluation of acne severity at baseline and at
      weeks 3, 6, 9, 12 and 16.
    

Intervention name(s): ARK-E021 5%; ARK-E021 10%; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topically applied once daily at bedtime; Topically applied once daily at bedtime; Topically applied once daily at bedtime
Other intervention name(s): Not yet marketed; Not yet marketed; Not marketed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne Vulgaris; Topical; Foam