bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Oligofructose and Barley on Satiety and Energy Intake
Condition: Appetite Regulation
Study type: Interventional

Summary: 
      The effect of beta-glucan or fructo-oligosaccharide or their combination in bars on satiety
      and food intake was tested by supplying these bars on two consecutive days.
    

Detailed description: 
      Background: Increasing gastro-intestinal viscosity or colonic fermentation is suggested to
      help improve appetite control and reduce food intake. Beta-glucan (BG) and
      fructo-oligosaccharide (FOS) are food ingredients proposed to act this way, but results so
      far remain inconclusive.

      Objective: To test the effect of FOS, BG, or their combination in bars on appetite ratings
      and food intake during 2 consecutive days.

      Design: In a 4-way balanced order cross-over double-blind design, 21 healthy volunteers (mean
      BMI 25.9 kg/m2) received a meal replacement bar at 09.00h and an ad libitum lunch at 13.00h
      on 2 consecutive days. On day 1 only, subjects consumed a second (identical) bar at 17.00h
      and a fixed snack at 19.00h. The control bar contained 0.3g BG (control, from 6.8 g oats), vs
      equi-caloric bar formulations containing an additional: 1) 0.9 g BG (from 8.0g barley), 2) 8g
      FOS, or 3) 0.9 g BG + 8g FOS. Appetite scores and subsequent ad libitum test meal intakes
      were measured. Bar viscosities were determined under simulated gastric conditions. Results
      were analyzed using ANCOVA.

      Results: Addition of BG, FOS or their combination did not affect appetite ratings or food
      intake, although addition of BG to the bar doubled apparent gastric viscosity (841 vs 351
      mPa.s).

      Conclusions: BG, FOS or their combination in bars at these levels do not improve appetite
      control when consumed on 2 consecutive days. Efficacy might be increased by a longer exposure
      period, increasing the BG content, or a form of BG that generates even higher gastric
      viscosity.
    

Intervention name(s): beta-glucan and fructooligosaccharide
Intervention type(s): Dietary Supplement
Intervention description(s): 1g beta-glucan or 8 g fructooligosaccharide or combination per meal replacement bar given twice on day 1 and once on day 2
Other intervention name(s): oats; barley; oligofructose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: satiety; food intake
Misoprostol for Secondary Prevention of Postpartum Hemorrhage at the Community Level in India
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      This study compares two community-level strategies: selective administration of 800 mcg
      sublingual misoprostol to women at 350 mL blood loss for secondary prevention of postpartum
      hemorrhage (PPH) with universal use of 600 mcg oral misoprostol at the time of delivery for
      primary prevention of PPH. The study hypothesizes that at community-level births, secondary
      prevention for women is non-inferior (based on clinical parameters) to universal prophylaxis
      provided to women for primary prevention of PPH. This cluster-design non-inferiority trial
      has the potential to inform service delivery programs on clinical outcomes, program
      feasibility, cost and acceptability of two different community models of PPH care using
      misoprostol.
    

Detailed description: 
      Rationale for Research: There is an absence of concrete data on the programmatic and
      cost-effectiveness of different service delivery models for prevention and treatment of
      postpartum hemorrhage with misoprostol, prompting a discussion of whether resources are best
      spent on misoprostol for primary prevention at lower levels (with treatment carried out at
      higher levels via referral) or whether immediate proactive treatment strategies should be
      considered. As the training and policy implications of universal prevention versus selective
      treatment approaches vary, simple and effective service delivery models are urgently needed
      to help governments and organizations decide how to best focus their limited resources. This
      study proposes to study the efficacy of a hybrid strategy (i.e., secondary prevention) that
      combines elements of prevention and treatment. Results of this study could provide a new
      model of care that will medicate fewer women, save costs and address the clinical conundrum
      of guessing at the safety of administering a prevention dose of misoprostol followed quickly
      by a larger treatment dose.

      Study design: This randomized cluster trial will recruit women with deliveries attended by
      auxiliary nurse midwives (ANMs) that occur at homes or at health sub-centers. ANMs will be
      randomized to administer the intervention as described in the primary or secondary prevention
      arm.
    

Intervention name(s): Misoprostol; Misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): Selective administration of 800 mcg sublingual misoprostol to women with at least 350 mL blood loss within 1 hour following delivery; Universal administration of 600 mcg oral misoprostol given to all women within 5 minutes of delivery of the baby
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Postpartum hemorrhage; Prevention; Misoprostol; Developing countries; Nurse midwife
Use of Essure® Micro-inserts in Women With Hydrosalpinx Prior to In Vitro Fertilization: A Prospective, Multicenter, International Feasibility Study
Condition: Women Who Suffer From Hydrosalpinx That is Causing Infertility and Whom Want a Safer Way of Treamtent
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to gather safety data related to the use of Essure®
      micro-inserts in women with hydrosalpinx prior to in vitro fertilization and during pregnancy
      and to collect data with regard to implantation rates, clinical pregnancy rates, and
      pregnancy outcomes.
    


Intervention name(s): Essure Micro Insert
Intervention type(s): Device
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Hydrosalpinx or infertility
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      The study objective is to investigate the efficacy of levocetirizine in reducing symptoms
      associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life.
    


Intervention name(s): levocetirizine dihydrochloride; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg daily (oral tablet) for 14 days; 0 mg daily (matching oral tablet) for 14 days
Other intervention name(s): Xyzal
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: levocetirizine; Xyzal; Seasonal Allergic Rhinitis; total symptom score; quality of life
Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Immunogenicity is reduced in immunocompromised patients. The aim of this prospective
      randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of
      anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3,
      co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will
      be evaluate.
    

Detailed description: 
      RECOMMANDATIONS for hepatitis A vaccination is the same for HIV-infected patients than for
      general population. However, immunogenicity induced with 2 doses of anti-HAV vaccine is lower
      in HIV-infected patients. The primary objective of the study is to compare the immunogenicity
      (percentage of patients with anti-HAV antibodies > 20 mUI/ml at month 7) of 2 strategies (2
      doses at months 1 and 6, versus 3 doses at months 1, 2 and 6)of anti-HAV vaccine in HIV-1
      infected patients co-infected with HBV and/or HCV with CD4 cell count between 200 and
      500/mm3. The second objectives are to compare mean anti-HAV antibodies titers obtained with
      the 2 strategies, the durability of the seroprotection 12 months after the end of
      vaccination, and the safety. The PARAMATERS than may have an effect on the immune response
      will be evaluated.

      This open, prospective, study have included 99 patients, aged from 18 to 55 years old.
      Patients were randomized to receive 2 or 3 doses of HAVRIX 1440 UI intramuscularly at week O,
      4, and 24 or week 0, and 24. Clinical and biological safety is evaluated after each
      immunisation and blood samples for serological evaluation taken at week -4, 4, 8, 24 and 28
      for immunogenicity and week 72 for long term analysis
    

Intervention name(s): group1; group2
Intervention type(s): Drug; Drug
Intervention description(s): Havrix at 1440IU was administrated à weeks S0, S4 and S24; Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; hepatitis A; vaccine; HBV and/or HCV co-infection
Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing,
      2-treament, 2-sequence, 3-period crossover study to evalulate overall vision and comfort..
    


Intervention name(s): soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore; ACUVUE OASYS 1-Day for Astigmatism
Intervention type(s): Device; Device
Intervention description(s): TEST Lens; CONTROL Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      A randomized pilot study will be conducted, the goal of which is to determine which format
      represents the most viable approach to behavioral weight loss treatment with 18-25 year olds.
      Specifically, participants will be randomized to one of three arms; all arms will receive a
      12-week behavioral weight loss intervention, including identical dietary, physical activity,
      and weight loss prescriptions.
    

Detailed description: 
      A randomized pilot study will be conducted, the goal of which is to determine which format
      represents the most viable approach to behavioral weight loss treatment with 18-25 year olds.
      Specifically, participants will be randomized to one of three arms; all arms will receive a
      12-week behavioral weight loss intervention, including identical dietary, physical activity,
      and weight loss prescriptions. Behavioral goals / prescriptions will be the same, and basic
      content delivered will also be the same; only the format by which the intervention is
      delivered will differ among the treatment arms. A total of 45-55 participants, 18-25 years of
      age, with a BMI between 25 and 45 kg/m2 will be randomized to one of three groups: 1)
      Face-to-face brief behavioral weight loss (FBWL), 2) Web-based brief behavioral weight loss
      (WBWL), or 3) Web-based brief behavioral weight loss PLUS optional group sessions (WBWL
      Plus). Assessments will take place at 0 (baseline), 3 (post-treatment), and 6 months
      (follow-up).
    

Intervention name(s): Behavioral Weight Loss Intervention for Young Adults
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; weight loss; young adults
Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 2 of 7)
Condition: Exposure to Man-made Visible Light
Study type: Interventional

Summary: 
      NOTE: This is the second of in total 7 sub-studies related to the Ethics Committee of the
      Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 6
      arms, in total 350 participants will be assessed in all 7 sub-studies.

      General study information: This is a randomized, cross-over, quantitative study, which
      investigates physiological variables, mood, and affect of healthy participants in response to
      colored light exposure. The Participants take part in 5-8 arms and are exposed to colored
      light only, or are additionally asked to solve cognitive tasks during the colored light
      exposure. Primary aim is to measure the change in several physiological variables, mood, and
      affect during colored light exposure of 15 or 45 minutes. The risk for the participants is
      negligible and comparable to the risk during daily life.
    


Intervention name(s): Visible light exposure
Intervention type(s): Other
Intervention description(s): Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cerebral oxygen metabolism; functional near-infrared spectroscopy; partial pressure of carbon dioxide; heart rate variability; blood pressure; affect; mood; respiration; systematic randomized cross-over study; systemic physiology; electro-dermal activity; pulse-respiratory quotient
Determination of the Bioavailability of Short Chain Fatty Acids in Healthy Humans
Condition: Short Chain Fatty Acids Bioavailability
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the bioavailability of acetate, propionate and
      butyrate in healthy humans using a stable isotope technology.

      In addition the level of acetate, propionate and butyrate production from inulin will be
      determined using the principle of isotope dilution.
    


Intervention name(s): 13C-labeled Acetate; 13C-labeled propionate; 13C-labeled butyrate; Inulin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 400 mg of sodium acetate 1-13C (2 colon delivery capsules with 200 mg); 340 mg of sodium propionate 1-13C (2 colon delivery capsules with 170 mg); 990 mg sodium butyrate 1-13C (2 colon delivery capsules with 495 mg); 15 g of inulin dissolved in 200 ml of water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Short chain fatty acids; Acetate; Propionate; Butyrate; Bioavailability
Effects of Collagen Protein on the Amino Acid Profile of the Blood
Condition: Collagen Protein
Study type: Interventional

Summary: 
      This project aims to investigate the absorption of enzymatically hydrolysed and
      non-enzymatically hydrolysed collagen on the Amino acid profile of the blood
    


Intervention name(s): Collagen protein
Intervention type(s): Dietary Supplement
Intervention description(s): Collagen protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Vitamin D in Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease; Vitamin D Deficiency
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the influence of vitamin D in reducing laboratory, elastographic
      (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive vitamin D
      (Plivit D3) while the other half will receive placebo
    

Detailed description: 
      In this study will participate patients who come to the regular ambulatory examinations
      (referred by gastroenterologists, or family physicians in the Department of Gastroenterology
      CHC Rijeka) and have one or more components of the metabolic syndrome (hypertension,
      diabetes, obesity, dyslipidemia).Nonalcoholic fatty liver disease will be defined by
      transient elastography (FibroScan, Echosens, Paris); Controlled Attenuation Parameter (CAP)
      for assesment of liver steatosis and Liver Stiffness Measurements (LSM) for liver fibrosis.
      In all patients other causes of chronic liver disease will be excluded; chronic viral
      hepatitis, autoimmune diseases and other metabolic liver diseases as well as use of drugs
      than can cause liver steatosis and fibrosis and alcoholic liver disease.

      This study will include 450 patients. Taking into account the possible drop-out rate around
      15% of the patients during the study period, a total of 400 patients will be randomized.
      Patients will be randomized into two groups. The first group will be consisted of the
      patients with NAFLD who will be receiving original medication during the 12 month period. The
      second group will be consisted of the patients with NAFLD who will be receiving placebo
      during the 12 months period, which will be identical to the original medication in its
      packaging and form.

      After the 6 and 12 months of therapy in all patients will be evaluated: liver enzymes and
      metabolic laboratory parameters of NAFLD (insulin resistance, lipidogram and serum glucose),
      as well as the TE-CAP in order to evaluate the efficiency of Plivit D3 for the treatment of
      NAFLD.
    

Intervention name(s): 1,25-Dihydroxyvitamin D; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1,25-dihydroxy-vitamin D3 1000 IU orally daily for 12 months; Placebo identical to the study intervention drug
Other intervention name(s): 1,25-Dihydroxy-Cholecalciferol, Cholecalciferol, Vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol; Dihydroxycholecalciferols; Calcitriol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Influence of Thoracolumbar Proprioceptive Support in the Segmental Stabilization Training
Condition: Transversus Abdominis Activation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Proprioceptive training has been shown to be effective in increasing the efficiency of
      motor-sensory tissues that stabilize the trunk. The investigators hypothesis is that
      proprioceptive support do influence in the activation of the transversus abdominis muscle
      (TrA) during segmental stabilization training.
    


Intervention name(s): Segmental trunk exercise associated with proprioception; Segmental trunk exercise
Intervention type(s): Other; Other
Intervention description(s): Proprioceptive exercise; Segmental trunk exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Human Phototoxicity Test
Condition: Sunscreening Agents
MeSH terms: Dermatitis, Phototoxic
Study type: Interventional

Summary: 
      To determine the phototoxic potential of a topically applied article in human subjects
    


Intervention name(s): Sunscreen Sport Lotion (BAY987516); Untreated Skin
Intervention type(s): Drug; Other
Intervention description(s): 50 μl/cm*2 or 0.05 gm/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB# Y65-110); This site is patched without treatment as irradiated control
Intervention MeSH terms: Sunscreening Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given
      to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein
      conjugate vaccine.
    


Intervention name(s): MenACWY-CRM; MenACWY-CRM; Licensed meningococcal ACWY vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly; 2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age; 1 injection of the licensed meningococcal ACWY was administered intramuscularly
Other intervention name(s): Menveo; Menveo; Menactra
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: vaccine; children; healthy; meningitis; meningococcal; prevention of meningococcal disease serogroups ACWY; Menveo
Youth Partners in Care: Depression and Quality Improvement
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This randomized effectiveness trial evaluates a quality improvement intervention aimed at
      providing access to evidence-based depression treatments (particularly cognitive-behavior
      therapy for depression and or pharmacotherapy) through primary care for youth ages 13-21, as
      compared to enhanced usual care. The major hypothesis is that the quality improvement
      intervention will be associated with improved outcomes, relative to enhanced usual care.
    


Intervention name(s): Quality Improvement (QI) for depression; Usual Care
Intervention type(s): Other; Other
Intervention description(s): Major intervention components included a) expert leader teams who planned and implemented the intervention at each clinic, b) care managers who supported primary care clinicians with depression evaluation and management, c) access to cognitive-behavior therapy for depression within each primary care clinic, and d) patient and provider choice regarding treatment modality.; Usual care enhanced by provider education regarding depression evaluation and management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: depression; quality improvement; treatment; adolescents