bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the non-inferiority of a heterologous prime-boost
      regimen using Ad26.ZEBOV as prime and MVA-BN-Filo as boost administered at different doses at
      a 56-day interval versus the same regimen with the recently released batches of Ad26.ZEBOV
      and MVA-BN-Filo in terms of humoral immune response against the Ebola virus (EBOV) GP
      (glycoprotein) as measured by enzyme-linked immunosorbent assay (ELISA) at 21 days post
      boost.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to
      evaluate safety and immunogenicity of Ad26.ZEBOV and MVA-BN-Filo at different dose levels,
      administered to healthy adults participants. The study consists of a Screening period of up
      to 6 weeks, vaccinations on Day 1 and Day 57, and a post-vaccination phase until the 6 months
      post-boost visit (Day 237). The participants will be randomized at baseline (on Day 1) in a
      2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.
    

Intervention name(s): Ad26.ZEBOV 5*10^10 viral particles (vp); Ad26.ZEBOV 2*10^10 (vp); Ad26.ZEBOV 0.8*10^10 (vp); MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]; MVA-BN-Filo 5*10^7 Inf. U.; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5*10^10 viral particles on Day 1; Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 2*10^10 viral particles on Day 1; Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.8*10^10 viral particles on Day 1; MVA-BN-Filo- live replication incompetent vaccine, IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57; MVA-BN-Filo- live replication incompetent vaccine, IM injection of 5*10^7 Inf. U. once on Day 57; One 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Ebola viruses; Ebola virus disease (EVD); Filoviruses; Monovalent vaccine; Safety; Immunogenicity; Ebola vaccine; Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo); Healthy participants
A Pilot Study of the Effects of BCG Immunization on CSF and Blood-based Biomarkers in Older Adults.
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      A pilot study of the effects of Bacillus Calmette-Guérin (BCG) immunization on cerebrospinal
      fluid and blood-based biomarkers in older adults.
    

Detailed description: 
      This single-site, open-label clinical trial will investigate the immune and neurobiological
      effects of BCG vaccination in cognitively unimpaired older adults and older adults with
      memory and thinking problems by measuring target engagement, pharmacodynamic response, and
      effect on Alzheimer's disease (AD) pathology and immune response markers. This study will
      also gather data on study feasibility, tolerability, and safety.
    

Intervention name(s): Bacillus Calmette-Guerin (BCG)
Intervention type(s): Biological
Intervention description(s): Vaccine
Intervention MeSH terms: BCG Vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cognition; Alzheimer's disease; Memory; BCG; Immunization
Intraoperative Flow Cytometry In Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      This study was designed to investigate the efficacy of flow cytometry to accurately identify
      between normal and cancer cells in colon epithelium in humans diagnosed with colorectal
      cancer.
    

Detailed description: 
      Tissue samples from normal and cancerous colon epithelium are collected intraoperatively
      following standard colectomy and analyzed blindly by flow cytometry, which reports, in less
      than 10 min, on the origin of the sample based in the estimation of DNA and tumor index.
    

Intervention name(s): flow cytometry
Intervention type(s): Diagnostic Test
Intervention description(s): evaluation of intraoperative flow cytometry in detecting cancer cells in colorectal epithelium
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients diagnosed with colorectal cancer and being treated by standard colectomy or/and
        neoadjuvant theraphy according to current guidelines.
      
Biospecimen description: 
      tissue samples from normal and cancer epithelium collected following colectomy
The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
Condition: Coronary Artery Disease; Chronic Total Occlusion; Native Coronary Artery
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting
      PTCA-balloon in combination with bare-metal stenting for treatment of chronic total
      occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.
    


Intervention name(s): paclitaxel eluting PTCA balloon catheter (SeQuent Please); paclitaxel eluting Taxus stent (Boston Scientific)
Intervention type(s): Device; Device
Intervention description(s): paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery; paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries
Other intervention name(s): SeQuent Please; paclitaxel eluting balloon
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The planned study is to determine the safety and pharmacokinetic properties of CPL500036
      compound after single and multiple (two weeks) administration in healthy volunteers.
    

Detailed description: 
      This is to be one-centre, single ascending dose and double-blind multiple ascending dose two
      part study of CPL500036 compound in healthy volunteers.

      PART A is a single dose, open-label part with CPL500036 compound administered with dose
      escalation between cohorts.

      PART B is a multiple, double-blind part with CPL500036 compound administered for 14 days with
      dose escalation between cohorts. Participants in this part are to be randomized to receive
      Investigational Medicinal Product (IMP) or placebo in 3:1 ratio.

      Safety and pharmacokinetic properties of CPL500036 compound is to be determined following
      different doses in single oral IMP administration in PART A and different doses of IMP
      administered orally for two weeks in PART B.
    

Intervention name(s): CPL500036 compound; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IMP is a capsule with CPL500036 as an Active Pharmaceutical Ingredient (API).; matching placebo capsules
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to
      explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative
      colitis.
    


Intervention name(s): BBT-401-1S or Placebo
Intervention type(s): Drug
Intervention description(s): Administered by 200mg capsules of BBT-401-1S or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study in Unsettled Infants Experiencing Feeding Intolerance
Condition: Feeding Disorder
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula
      on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding
      intolerance
    

Detailed description: 
      The purpose of the present study is therefore to evaluate the effect of an experimental
      formula in an unsettled formula-fed infant population whose parents are considering switching
      formulas due to perceived feeding intolerance.
    

Intervention name(s): Experimental Formula; Standard control formula
Intervention type(s): Other; Other
Intervention description(s): Experimental formula; Standard Infant formula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
Condition: Growth Hormone Disorder; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the
      safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male
      Japanese subjects.
    


Intervention name(s): NNC126-0083; NNC126-0083; NNC126-0083; NNC126-0083; placebo; placebo; placebo; placebo; NNC126-0083; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks; Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks; Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks; Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks; Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks; Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks; Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks; Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks; Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks; Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the protocol is to assess the initial pharmacokinetic (PK) profile of a single
      oral dose of GSI-953 to healthy male Japanese subjects and healthy elderly male Japanese
      subjects.
    


Intervention name(s): GSI-953
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Japanese; Healthy; Alzheimers Disease
Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Bid on Nutritional Status in Subjects With IBS-D
Condition: Diarrhea-predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      To evaluate the safety and effectiveness of oral nutritional therapy Serum-Derived Bovine
      Immunoglobulin (SBI) on nutritional status, epithelial barrier function, and mucosal
      expression of pivotal genes including tight junction, secretory mechanisms, tissue repair
      proteins and chemokines in subjects with IBS-D.
    

Detailed description: 
      This is an open label study evaluating the impact of SBI 5.0 g twice daily on

        1. nutritional status (plasma amino acid profile and kynurenine to tryptophan ratio),

        2. intestinal permeability (in vivo) and

        3. mucosal expression of pivotal genes including tight junction, secretory mechanisms,
           tissue repair proteins and chemokines status in patients with IBS-D.

      Plasma, duodenal and stool samples will be collected. Fifteen eligible subjects will be
      enrolled to receive SBI for 8 weeks (SBI 5.0g BID for 8 weeks).

      Intestinal permeability will be measured in vivo by two sugar urine excretion(s) after oral
      ingestion.

      Biopsies from the distal second or third portion of the duodenum will be obtained
      endoscopically, to measure mRNA expression of tight junction proteins and markers of immune
      function,
    

Intervention name(s): Serum-derived bovine immunoglobulin protein isolate (SBI)
Intervention type(s): Other
Intervention description(s): Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g bid on Nutritional Status and intestinal functions in Subjects with IBS-D
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: diarrhea; irritable bowel syndrome
Role of Social Incentives in PRO Collection
Condition: Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      Value-based healthcare is heavily dependent on the accurate measurement of patient outcomes,
      both immediately after treatment and at long-term intervals. Patient reported outcomes (PROs)
      are often the central component of any quality improvement process as they are patient
      centered, reflect the ultimate objective of the intervention and are endorsed by many
      professional societies as the preferred physician performance metric. Although high response
      rates are critical to producing reliable data to support value-based payment models, quality
      improvement, and stakeholder transparency - especially in arthroscopy in which patients often
      fare well over time and may be less likely to continue with follow-up - response rates to
      outcome surveys after initial recovery from treatment are consistently below 50%. Monetary
      incentives offer only minor improvements in response rates against large increases in already
      rising costs. Individually tailored social incentives - as grounded in current behavioral
      economic practice - offer a potential cost-effective solution to this problem in Sports
      Medicine and arthroscopy.

      The investigators predict that well-constructed, personal social incentives will increase
      response rates for long-term follow-up of episodic care compared to control. The
      investigators predict these rates will vary depending on the patient demographics and other
      characteristics.
    


Intervention name(s): Interview
Intervention type(s): Other
Intervention description(s): Interviews will be conducted with orthopedic patients to review the construction and phrasing of various social incentives aimed at promoting patient reported outcome collection amongst post-operative patients.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include post-operative orthopedic patients.
      
Keywords: Patient Reported Outcomes (PRO); Social Incentives
Early Screening for Gestational Diabetes Mellitus
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      The working hypothesis of this proposal is that screening for gestational diabetes mellitus
      as early as the 1st trimester is efficient for detecting the forthcoming presence or absence
      of gestational diabetes mellitus. The investigators long-term goal is the prevention of
      gestational diabetes mellitus onset i.e. the prevention of progression to gestational
      diabetes mellitus, in order to enable delivery of appropriate counselling, diagnostics and
      treatment for pregnant women, as well as to improve pregnancy outcomes. Therefore, robust 1st
      trimester screening criteria is needed.

      The overall objective of this proposal is to determine an accurate and valid 1st trimester 1h
      post 50g oral glucose challenge test plasma glucose cut-off value that is predictive of
      gestational diabetes mellitus onset.
    


Intervention name(s): 50 g oral glucose challenge test - 75 g oral glucose tolerance test
Intervention type(s): Procedure
Intervention description(s): 50 g oral glucose challenge test at 6-13 weeks of gestation and 75 g oral glucose tolerance test at 24-28 weeks of gestation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant Women
Effect of Omega-3 and Probiotic Dietary Supplements on Elevated High Sensitivity C-reactive Protein (Hs-CRP) as a Marker of Low-grade Inflammation
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Study objectives:

      Immunity, Inflammation, and Brain Function To determine the effect of supplements with
      probiotics, Omega-3 and Vitamin D on the inflammatory marker highly sensitive CRP (primary
      outcome), markers of inflammation (secondary outcome), and gastrointestinal barrier function
      (secondary outcome) in elderly and obese cohorts that exhibit elevated inflammation at
      baseline.

      Mobility To determine the effect of supplements with probiotics, Omega-3 and Vitamin D on
      joints, bones, and muscles by means of the WOMAC questionnaire, sit/stand test (muscle
      function) and CTX-I (cartilage degradation) as secondary endpoints in elderly and obese
      cohorts that exhibit elevated inflammation at baseline.
    


Intervention name(s): Probiotic, Omega-3, Vitamin D supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The first supplement we would like to assess is named VNP and is composed by Omega-3 Active and vitamin D. It contains a total of 1100 mg fish oils: 640 mg Omega-3 and with 300 mg eicosapentaenoic acid (EPA), 220 mg docosahexaenoic acid (DHA) plus 200 IU Vitamin D per daily dose (2 capsules).
The second supplement we investigate is four-strain probiotics combination based on the commercially available formulation HOWARU® by DuPont; two capsules containing 10 billion CFU total (supplied by Pfizer but manufactured by Danisco, DuPont). The probiotic specific composition, contains equal amounts of each strain per capsule (1.25 x 109 CFU each): Bifidobacterium lactis Bi-07, Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus NCFM, Bifidobacterium lactis Bl-04. One capsule contains 5 billion CFU (Swedish milliards).; Placebo generated for probiotic and omega-3/vitamin D supplements
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: proof-of-concept, randomized double-blinded placebo-controlled parallel study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Duodenal, Ileal or Combined Infusion of Tastants on Food Intake
Condition: Obesity
Study type: Interventional

Summary: 
      Rationale: The appearance of tastants in the small intestine can result in the activation of
      a negative feedback mechanism from different parts of the intestine to the stomach, the small
      intestine and to the central nervous system. These processes inhibit food processing,
      appetite sensations and food intake, and furthermore they increase feelings of satiety and
      satiation. The effects of intraduodenal and/or intraileal infusion of a combination of
      tastants (sweet (rebaudioside A), bitter (quinine) en umami (monosodium glutamate(MSG))) and
      placebo on ad libitum food intake, satiation and gastrointestinal symptoms will be
      investigated.

      Objective: To investigate the effect of intraduodenal, intraileal and combined infusion of a
      combination of tastants versus infusion of placebo on food intake.

      Secondary objectives:

        1. To compare the effect of intraduodenal versus intraileal versus combined intraduodenal
           and intraileal delivery of a combination of tastants on satiation.

        2. To assess the effect of intraduodenal and/or intraileal delivery of a combination of
           tastants on gastrointestinal symptoms/complaints.
    


Intervention name(s): Tastants duodenal; Tastants ileal; Placebo duodenal; Placebo ileal
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Duodenal infusion of combination of tastants (sweet, bitter and umami); Ileal infusion of combination of tastants (sweet, bitter and umami); Duodenal infusion of placebo (tap water); Ileal infusion of placebo (tap water)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention