bioihbjkbjnl/mcl2 huggingface dataset:
Properties of Dietary Fibre and Energy Intake
Condition: Healthy Male Subjects
Study type: Interventional

Summary: 
      Dietary fibers likely have a role in body weight management. They may increase satiety and,
      as a consequence, reduce energy intake during the next meal. There are, however, many
      different types of dietary fiber, which have diverse physical properties and can therefore
      impact these outcomes differently. It is, however, unclear whether dietary fibers with
      different properties lead to differences in energy intake during the next meal. The objective
      of this study is to study the effect of pectin in 4 different physicochemical states on ad
      libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones,
      gastric emptying rate, feelings of satiety and the method of fiber supplementation. We
      hypothesize that viscous and gelling fibers will reduce ad libitum energy intake compared to
      low viscous and low gelling fibers.
    


Intervention name(s): control: no fiber addition; breakfast with low viscous, low gelling pectin; high viscous, low gelling pectin; low viscous, high gelling pectin; high viscous, high gelling pectin; pectin supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): liquid breakfast without addition of fiber; 10g of low viscous, low gelling pectin dissolved in a liquid breakfast; 10g of high viscous, low gelling pectin dissolved in a liquid breakfast; 10g of low viscous, high gelling pectin dissolved in a liquid breakfast; 10g of high viscous, high gelling pectin dissolved in a liquid breakfast; 10g of high viscous, high gelling pectin provided as a dietary supplement, a liquid breakfast is served seperately
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: dietary fiber; energy intake; appetite; satiety hormones; glucose; gastric emptying
Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in
      children 2 to 10 years of age
    


Intervention name(s): Meningococcal ACWY-CRM conjugate vaccine; Meningococcal ACWY-PS polysaccharide vaccine
Intervention type(s): Biological; Biological
Intervention description(s): MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.; MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Meningitis; children; vaccine; safety; efficacy
Follicular Activation in Poor Responders
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      This study aims to assess whether activation of primordial follicles through ovarian cortex
      fragmentation may increase the number of antral follicles present in the ovary of patients
      with diminished ovarian reserve. Secondary outcomes include number of oocytes retrieved and
      pregnancy rates after IVF.

      Hypothesis; Evaluate whether the proposed intervention increases the pool of antral follicles
      (potentially stimulable ones).
    

Detailed description: 
      Controlled, randomized, assessor-blind clinical trial.

      Thirty-six patients of La Fe University Hospital (Valencia), previously confirmed as poor
      responders according to the European Society of Human Reproduction and Embryology (ESHRE)
      criteria, will be randomized to two treatment arms:

        -  Arm 1 (control): no intervention.

        -  Arm 2 (intervention): ovarian cortex extraction by unilateral laparoscopic biopsy and
           ovarian tissue fragmentation in aliquots of 1 mm2. These fragments will be grafted under
           the ovarian cortex and meso-ovarium ipsilateraly.

      Subsequently the number of antral follicles in both intervention groups will be compared and
      also will be the number of antral follicles in the native ovary and the grafted one in each
      of the patients.

      Patients will receive a standard IVF treatment for poor responders according to the protocols
      of the assisted reproduction unit of La Fe University Hospital.

      The final aim is to assess the pregnancy rate in both groups, as well as parameters related
      to the reproduction technique when required.
    

Intervention name(s): In vitro fragmentation of the ovarian tissue
Intervention type(s): Procedure
Intervention description(s): Unilateral ovarian cortex extraction, in vitro fragmentation and reimplantation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Poor ovarian response; Salvador/Warts/Hippo pathway; Follicular activation; Poor ovarian reserve
Video Game Playing on Lunch-time Food Intake in Children
Condition: Exogenous Obesity
Study type: Interventional

Summary: 
      The purpose of this experiment is to investigate the effect of video game playing for 30
      minutes on food intake and subjective appetite. The investigators hypothesize that video game
      playing will affect food intake in children. Food intake will be measured at 30 minutes
      following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg
      Sucralose® in 250ml of water) beverage with or without video game playing. Subjective
      appetite will be measured at 0, 20, 35 and 65 minutes.
    


Intervention name(s): Glucose Beverage; Video Game Playing; Control Beverage
Intervention type(s): Dietary Supplement; Behavioral; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208)
Condition: Chemotherapy Induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the safety and efficacy of a three-day oral aprepitant regimen
      (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced
      nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in
      pediatric participants. Those who complete this first cycle of treatment and meet certain
      eligibility criteria will have the option of continuing for 5 additional cycles of open-label
      aprepitant.
    


Intervention name(s): Aprepitant 125 mg; Aprepitant 80 mg; Aprepitant powder for suspension (PFS); Ondansetron; Placebo for Aprepitant 125 mg; Placebo for Aprepitant 80 mg; Placebo for Aprepitant PFS; Emetogenic chemotherapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age; On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age; On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age; Day 1: Administered according to product label for pediatric usage or local standard of care; On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age; On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age; On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age; Any moderately or highly emetic chemotherapeutic agent such as cyclophosphamide, doxorubicin, methotrexate, carboplatin, cisplatin, irinotecan, carmustine, ifosfamide, and streptozocin, or chemotherapeutics of a lower emetogenicity that were not previously tolerated. No chemotherapeutic agents were specified by the protocol, and many could potentially have been used."
Other intervention name(s): MK-0869, Emend®; MK-0869, Emend®; MK-0869, Emend®; Zofran™
Intervention MeSH terms: Ondansetron; Aprepitant; Fosaprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Investigation of Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single-Dose of PF-06823859 in Japanese Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose of the study is to evaluate the safety, tolerability, immunogenicity and
      pharmacokinetics (PK) of PF-06823859 following a single intravenous dose of PF-06823859 300
      and 900 mg in Japanese healthy adult participants.
    

Detailed description: 
      Approximately 12 participants are planned to be enrolled into the study. The study consists
      of 2 cohorts, and approximately 5 participants will be randomized to PF-06823859 and
      approximately 1 participant will be randomized to placebo in each cohort.
    

Intervention name(s): PF-06823859; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): low dose or high dose intravenous infusion; Intravenous infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Aminolaevulinic Acid Photodynamic Therapy for HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)
Condition: Cervical Intraepithelial Neoplasia; Low-Grade Squamous Intraepithelial Lesions; Papillomavirus Infections
MeSH terms: Papillomavirus Infections; Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid for
      the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia (LSIL;CIN1).
    


Intervention name(s): Aminolaevulinic acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aminolaevulinic acid with illumination; Placebo with illumination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an
      assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an
      incomplete response to a prospective eight week trial of the same assigned open-label
      marketed ADT.
    

Detailed description: 
      A comparison of the Fixed dose arm (OPC-31712, 0.15 mg) verses placebo was included as a
      general secondary efficacy variable and results for this dose group comparison are included
      under each of the Outcome Measures.
    

Intervention name(s): OPC-34712; Placebo; ADT
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks; Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks; Tablets, 10 - 225 mgs, dose once daily, 14 weeks
Other intervention name(s): Generic Name: Brexpiprazole; Each individual will receive one of the following 6 ADTs:; Escitalopram (Lexapro); Fluoxetine (Prozac); Paroxetine CR (Paxil CR); Sertraline (Zoloft); Desvenlafaxine (Pristiq); Venalfaxine XR (Effexor XR)
Intervention MeSH terms: Fluoxetine; Paroxetine; Sertraline; Desvenlafaxine Succinate; Escitalopram; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OPC-34712, Major Depressive Disorder, Adjunctive Treatment
Clinical Evaluation of Daily Disposable Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of the study is to compare the overall subjective preference of filcon II 3
      daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A
      daily disposable conventional hydrogel contact lenses.
    

Detailed description: 
      Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one
      or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses.
      The first randomly assigned lens type was worn for 3 days, with daily replacement, followed
      by 3 days of wear of the other lens type, with daily replacement.
    

Intervention name(s): filcon II 3; etafilcon A; nelfilcon A
Intervention type(s): Device; Device; Device
Intervention description(s): Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.; Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.; Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
Other intervention name(s): Silicone Hydrogel Daily Disposable Contact Lens; Hydrogel Daily Disposable Contact Lens; Hydrogel Daily Disposable Contact Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion
Condition: Ovarian Cyst; Ultrasonography Prenatal
MeSH terms: Cysts; Ovarian Cysts
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether prenatal ovarian cyst aspiration is
      effective and safe to prevent perinatal ovarian torsion.
    

Detailed description: 
      With the widespread use of routine sonography during pregnancy, the incidence of fetal
      ovarian cysts detected in utero has increased in the past decades. However
    

Intervention name(s): Fetal ovarian cyst aspiration
Intervention type(s): Procedure
Intervention description(s): Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aspiration; Fetal ovarian cyst; Ovarian torsion
Colorectal Cancer Screening in Familiar-Risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is aimed: 1) to compare the accuracy of colonoscopy vs immunochemical faecal
      occult blood test (iFOBT) and colonoscopy when positive for colorectal cancer (CRC) screening
      in familiar-risk population and; 2) to determine the complications associated with both
      strategies.
    

Detailed description: 
      This is an observational, controlled, randomized phase III study to evaluate the
      effectiveness of the iFOBT for detecting advanced neoplasia (polyps > 1cm in size, high grade
      dysplasia or with villous component, or CRC) in first degree relatives of patients with CRC.

      Index cases will be interviewed to obtain the family tree and their first-degree relatives
      will be contacted to invite them to participate in the study. Index-cases, will be randomized
      into one of the following two groups in order that their relatives receive the same screening
      strategy: A) colonoscopy; or B) annual iFOBT test (OC-Sensor®, cut off ≥50 ng/ml) and
      colonoscopy if positive. To determine the sensitivity and specificity of the iFOBT strategy,
      individuals randomized to group B will be invited to undergo a complete colonoscopy following
      two years follow-up. In addition, epidemiological data, personal history of disease, family
      history of neoplasm, characteristics of lesions at colonoscopy and histological diagnosis
      will be recorded.

      To test the hypothesis of equivalence between the iFOBT test and colonoscopy for detecting
      advanced colorectal neoplasm, it was considered a probability of participation, detection
      capability and prevalence of advanced adenomas for iFOBT of 0.750, 0.565 and 0.077,
      respectively, being the product of them 0.033. In the case of colonoscopy, the likelihood of
      participation, detection capability and prevalence of advanced adenomas in this population at
      risk are 0,500, 0.965 and 0.077, respectively, and their product 0.037. Accordingly, for a
      Type I error (alpha) of 5%, a power of 80% and a maximum deviation between the probabilities
      of the two tests of 0.03 the number of subjects to be included per arm is 744
    

Intervention name(s): Immunochemical fecal occult blood test And colonoscopy if test is positive; Colonoscopy with sedation
Intervention type(s): Procedure; Procedure
Intervention description(s): Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.; Colonoscopy with sedation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: FOBT; colonoscopy; familiar risk; colorectal cancer; advanced adenoma
Poly-L-lactic Acid for Skin Quality
Condition: Skin Aging
Study type: Interventional
Phase: Phase 4

Summary: 
      Anecdotal evidence suggests that patients' skin quality may improve as a result of
      poly-L-lactic acid injection. While this is not the primary goal of such treatments it is
      often seen and described as so called "Sculptra glow".

      The aim of this study is to evaluate the effect of repeated subcutaneous injections of
      poly-L-lactic acid (Sculptra Aesthetic) on skin quality.

      Participating subjects will be part of the study for about 15 months. There will be an
      initial treatment period of up to 12 weeks, followed by a 12-month follow-up period. There
      will be a total of 7 scheduled visits.

      This study is a double-blind, randomized study. "Double-blind" means that neither the
      subjects nor the study doctor will know who is receiving Sculptra Aesthetic or placebo.
      "Randomized" means that the group subjects will be placed in is decided by chance, similar to
      drawing numbers out of a hat or flipping a coin. Subjects will have a 1 out of 2 chance of
      receiving the active study drug. After the completion of the study, if subjects are assigned
      to the control (placebo) group they will receive free injections with Sculptra Aesthetic same
      as the treatment group.
    


Intervention name(s): Poly-L-lactic acid; Placebo comparator
Intervention type(s): Device; Device
Intervention description(s): Sculptra injections; saline injections
Other intervention name(s): Sculptra Aesthetic; P030050/S002; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Poly-L-lactic acid; Sculptra Aesthetic; Skin Quality; Wrinkles; Filler
Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
Condition: Polymyositis; Dermatomyositis
MeSH terms: Dermatomyositis; Polymyositis
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy
      of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based
      on the changes in manual muscle strength (MMT) scores as primary endpoint, and in addition,
      to assess the safety of GB-0998.
    


Intervention name(s): GB-0998; Placebo of GB-0998
Intervention type(s): Drug; Drug
Intervention description(s): 8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days; 8 mL/kg per day is intravenously administered for five successive days
Other intervention name(s): High-dose intravenous immunoglobulin; Venoglobulin-IH
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: polymyositis, dermatomyositis; High-dose intravenous immunoglobulin; Venoglobulin-IH; Steroid-resistant polymyositis(PM) and dermatomyositis(DM)
The Effect and Safety of Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
Condition: Hyperparathyroidism; Refractory Pruritus; Ostalgia; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Pruritus; Hyperparathyroidism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of
      combination of conventional hemodialysis(HD) and hemoperfusion(HP) on middle molecules
      removal and complications improvement in long-term maintenance hemodialysis (MHD) patients.

      There are two phases of study for each subject. Phase 1 (screening phase). During this phase,
      each potential subject will be evaluated to determine if he/she is eligible for the study.

      Phase 2 (intervention phase). Each subject will be randomly allocated to HD+HP(HA130 once per
      week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3
      months.
    

Detailed description: 
      All patients recruited from these centers who met the inclusion criteria were randomly
      allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group.
      The follow-up duration was 3 months.

      Hemoperfusion is performed by HA130 or HA330 resin adsorbents. Blood flow is
      200ml/min，dialysate flow is 500ml/min， hemodialysis and hemoperfusion last for 2.5h，continue
      HD after removing the adsorbent to complete 4 hours'treatment.Heparin for anticoagulation
      ：first pulse 0.5-1mg/kg ，appending 8-10mg/h. Primary endpoint is the improvement of the
      clinic symptoms, meanwhile secondary endpoint is serum β2MG、iPTH、CRP、ADMA、BMP2 decrease
      compared with the baseline, life quality, nutrition condition, and cardiovascular (CVD)
      incidence.
    

Intervention name(s): hemodialysis only; hemodialysis plus hemoperfusion(HA330); hemodialysis plus hemoperfusion(HA130)
Intervention type(s): Other; Other; Other
Intervention description(s): hemodialysis treatment only; combination of hemodialysis and hemoperfusion (HA330) treatment; combination of hemodialysis and hemoperfusion (HA130) treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemodialysis; hyperparathyroidism; refractory pruritus; ostalgia; insomnia; CVD incidence; life quality