bioihbjkbjnl/mcl2 huggingface dataset:
Real-time Computer Aided Detection of Barrett's Neoplasia
Condition: Barrett Esophagus; Barrett Adenocarcinoma
MeSH terms: Barrett Esophagus
Study type: Observational [Patient Registry]

Summary: 
      In the real-time pilot study, the performance of a recently developed Computer Aided
      Detection (CADe) system will be investigated in 30 patients during real-time live endoscopic
      examination. Three expert endoscopists in the field of Barrett's esophagus and endoscopic
      resection techniques will perform the inclusions following a standardized data acquisition
      protocol. In total, 15 patients with a visible neoplastic lesion in their Barrett's esophagus
      and 15 patients without any visible abnormalities in their Barrett's esophagus will be
      included in this study. Outcomes: to investigate feasibility of the use of the CADe system in
      the endoscopy suite, to investigate the performance of the CADe system when used by
      endoscopists.
    

Detailed description: 
      Patients in this study will undergo a scheduled surveillance endoscopy (according to current
      guidelines; n = 15) or are referred to a tertiary referral center for endoscopic resection of
      a possible neoplastic area in their known Barrett's esophagus (n = 15).

      Patients will be consciously sedated (standard care) before start of the procedure. During
      the endoscopic procedure, the endoscopist follows the standard protocol after extensive
      cleaning of the Barrett's segment: first, a standardized pullback video will be recorded,
      followed by a careful inspection of the Barrett segment every 2 centimeters. Per 2cm, a video
      of 10 seconds and 3 overview images are being recorded.

      During the imaging protocol, the CADe system presents its prediction on a second screen, next
      to the main endoscopy monitor. After the imaging protocol, standard clinical care is being
      resumed.
    

Intervention name(s): Computer Aided Detection system for Barrett's neoplasia
Intervention type(s): Other
Intervention description(s): CADe system running in the back, not directly interfering with patient care
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with Barrett's esophagus, either receiving a surveillance endoscopy
        according to protocol or referred for endoscopic treatment for proven neoplasia in their
        Barrett's esophagus
      
Keywords: Barrett's Esophagus; Computer Aided Detection
Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
Condition: Diphtheria; Pertussis; Haemophilus Infection; Tetanus; Polio
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections
Study type: Observational

Summary: 
      The purpose of this survey is to collect selected safety data.

      Primary Objective:

      To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.
    

Detailed description: 
      This is a retrospective survey to collect selected safety data at 6 months following the 4th
      dose of Pentacel® in children residing in the Canadian Province of British Columbia who have
      received the 4th dose of the Pentacel® series before their 2nd birthday.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children residing in the Canadian Province of British Columbia who have received the 4th
        dose of the Pentacel® series before their 2nd birthday
      
Keywords: Pertussis; Whooping cough; Diphtheria; Tetanus; Haemophilus influenzae; Poliovirus Types 1, 2, and 3.
GVHD Prophylaxis With Post-transplantation Bendamustine in Refractory Leukemia
Condition: Leukemia, Acute Lymphoblastic; Acute Myeloid Leukemia; Mixed-Lineage Acute Leukemias
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Biphenotypic, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Several groups have demonstrated very low incidence of acute and chronic graft-versus-host
      disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in haploidentical, unrelated
      and related allogeneic stem cell transplantation (SCT). Nonetheless for majority of the
      grafts, except for 10/10 HLA-matched bone marrow, with this type of prophylaxis require
      concomitant administration of calcineurin inhibitors±MMF, which delays immune reconstitution
      and development of graft-versus-leukemia (GVL) effect. So, despite reduction of
      transplant-related mortality, use of PTCy doesn't lead to the reduction of relapse incidence.
      This is particularly important for relapsed or refractory acute leukemia patients, where,
      despite all efforts to intensify conditioning regimens, relapses after SCT occur in more than
      50% of patients, and long-term survival rarely exceeds 10-20%. In preclinical model of
      haploidentical SCT the substitution of post-transplantation cyclophosphamide with
      bendamustine, led to comparable GVHD control, but significantly augmented GVL effect. To test
      this hypothesis and improve the outcome of allogeneic SCT in refractory acute leukemia
      patients we initiated a pilot trial with high-dose post-transplantation bendamustine for GVHD
      prophylaxis. The selection of doses is based on the previous dose-escalation studies.
      Additional immunosuppression could be added for mismatched grafts.
    


Intervention name(s): Allogeneic stem cell transplantation; Fludarabine monophosphate; Busulfan; Bendamustine
Intervention type(s): Procedure; Drug; Drug; Drug
Other intervention name(s): HSCT
Intervention MeSH terms: Fludarabine; Fludarabine phosphate; Busulfan; Bendamustine Hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allogeneic Transplantation; Hematopoietic Stem Cell Transplantation; Leukemia, Acute Lymphoblastic; Acute Myeloid Leukemia; Mixed-Lineage Acute Leukemias; Immune System Diseases; Immunosuppressive Agents; Myeloablative Agonists; Busulfan; Fludarabine; Antineoplastic Agents, Alkylating; Bendamustine Hydrochloride
Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional

Summary: 
      Aim: To evaluate the efficacy of iron supplements given at intervals corresponding to the
      mean life of red blood cells compared to weekly supplementation, in reducing the prevalence
      of preschool anemia.

      Method: Ninety-nine children from public day care centers with ages from 24 to 59 months old
      were randomly divided into two groups. All the children received 40 doses of 30 mg of ferrous
      sulfate during a 10-month intervention period. Group 1 received once weekly supplementation
      and Group 2 received supplementation in two 5-month cycles, each cycle consisting of one
      month of supplementation (20 workdays) and four months without supplementation.
    

Detailed description: 
      The prevalence of anemia after the supplementation regimens reduced from 20.20% to 5.05% (P <
      0.0005); the reduction was not significantly different between the two groups (P = 0.35). The
      mean hemoglobin concentration increased in both groups (Group 1: 0.27 g/dL; P < 0.016 and
      Group 2: 0.47 g/dL; P < 0.0005) without significant differences between the groups (P =
      0.17).
    

Intervention name(s): iron supplementation; iron supplementation
Intervention type(s): Drug; Biological
Intervention description(s): 40 doses of 30 mg of ferrous sulfate during a 10-month intervention period; supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iron; anemia; supplementation; preschoolers; prevalence; preschoolers children from public day care centers
Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Malnutrition is a frequent complication in patients with liver cirrhosis. Most patients have
      decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory
      cytokines.

      We hypothesized that branched chain aminoacids can improve nutritional status and delay
      episodes of hepatic encephalopathy
    


Intervention name(s): Branched-chain aminoacids; High-fiber high protein diet
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Branched chain aminoacids; Nutritional status; Hepatic encephalopathy
Helicobacter Pylori and Proton Pump Inhibitor
Condition: Helicobacter Infections
MeSH terms: Helicobacter Infections
Study type: Observational

Summary: 
      The purpose of this study is to know the distribution of HP in stomach before use of PPI,
      during use of PPI, and after stop of PPI.
    

Detailed description: 
      Endoscopy and biopsy will be performed to investigate the distrubition of HP before, during,
      and after using PPI.
    

Intervention name(s): PPI (proton pump inhibitor)
Intervention type(s): Drug
Intervention description(s): Pre ESD (endoscopic submucosal dissection)
Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori
Use of PPI for 2 months
Post ESD 1 (After 2 months)
Assess the distribution of helicobacter pylori after using PPI.
Stop of PPI
Post ESD 2 (After 4 months)
Assess the distribution of helicobacter pylori after stop of PPI.
Other intervention name(s): pantoprazole, lansoprazole, dexlansoprazole, rabeprazole
Intervention MeSH terms: Rabeprazole; Pantoprazole; Lansoprazole; Dexlansoprazole; Proton Pump Inhibitors
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sample size will be determined based on the analysis the distribution rate of HP at first
        30 patients.
      
Biospecimen description: 
      endoscopic biopsy
    
Keywords: Stomach Neoplasms; proton pump inhibitor; endoscopic submucosal dissection; Helicobacter pylori; Gastritis, Atrophic
Autologous Mesenchymal Stromal Cell Therapy in Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      It is a single centre, randomised controlled study of the effect of NOGA-guided direct
      intramyocardial injection of mesenchymal stromal cells on the development of new myocardium
      and blood vessels in patients with heart failure.

      Stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before
      injected into the myocardium.

      The patients will be followed with safety, clinical, MRI and CT endpoints for 1 year.
    

Detailed description: 
      The primary objective is to investigate the regenerative capacity of direct intra-myocardial
      injection of mesenchymal stromal cells in patients with reduced left ventricular EF (≤45%)
      and heart failure NYHA 2-3.

      A total of 60 patients with will be enrolled in the study and randomised 2: 1 to cells or
      placebo (saline).

      The patients will be followed for 12 months. The primary endpoint is changes in left
      ventricle end-systolic volume (LVESV) at 6 months follow-up.

      The secondary endpoints are changes in left ventricular ejection fraction (LVEF),
      end-diastolic volume and end-systolic mass at 6 months follow-up.

      Other secondary endpoints are NYHA, CCS, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6
      min walking test, and major adverse events endpoints: all-causes death, cardiovascular death,
      and hospitalization for worsening heart failure and MI at 12 months follow-up.
    

Intervention name(s): Mesenchymal stromal cell; Saline
Intervention type(s): Biological; Biological
Intervention description(s): Mesenchymal stromal cells 20 - 40 mill.; 12 injection with 0.2 ml saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart failure; stem cell; mesenchymal stromal cell; mesenchymal stem cell
Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients
Condition: Non-alcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine whether LCQ908 effectively lowers liver fat, as
      assessed by MRI and to assess its safety and tolerability profile in subjects with
      non-alcoholic fatty liver disease (NAFLD).
    


Intervention name(s): LCQ908; placebo
Intervention type(s): Drug; Drug
Intervention description(s): LCQ908 5 mg, 10 mg, 20 mg tablets; Matching placebo of LCQ908 5 mg, 10 mg, 20 mg tablets.
Other intervention name(s): pradigastat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multi-center,; randomized,; double-blind,; NAFLD,; elevated triglycerides
Encapsulated Calcium Absorption in Pregnancy
Condition: Pregnancy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will enroll at least 60 pregnant women in a randomized cross-over study in Dhaka,
      Bangladesh. Each participant will be randomized to one of 3 calcium doses: 500 mg, 1000 mg,
      1500 mg elemental Ca per day. Each participant will undergo two calcium absorption tests, one
      with a micronutrient supplement powder containing non-encapsulated (non-coated) calcium and
      the other with a micronutrient supplement powder containing encapsulated calcium at the same
      dose. The absorption tests will be separated by a 2-week washout period. Fractional calcium
      absorption will be measured using the dual stable isotope method. For each test, the
      formulation will be administered orally for 9 days; on the 10th day, a 44Ca- labeled stable
      isotope will be given orally and a 42Ca-labeled stable isotope dose will be given
      intravenously. Urine will be collected for 48 hours to measure calcium absorption.
    


Intervention name(s): Encapsulated Calcium; Non-capsulated Calcium
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The intervention is a multi-micronutrient powder containing enteric-coated calcium carbonate, in addition to ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg).; The comparator/control intervention is a micronutrient powder containing non-coated calcium (500, 1000 or 1500 mg elemental calcium from calcium carbonate), ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg). This product will be similar in Ca dose, appearance, taste and texture to the experimental formulation but will not include the enteric-coating.
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pregnancy; Micronutrient Powder; Calcium; Iron; Bangladesh
Valsartan Optimal Therapy Against Elevated Home Blood Pressure Research（VOYAGER）Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare improvement percentage of urinary albumin excretion
      between valsartan 80 mg- and valsartan 160 mg-based therapy in patient with morning
      hypertension.
    

Detailed description: 
      The cardiovascular diseases such as stroke and myocardial infarction consist 50% of the cause
      of death in Japanese population. Numerous mega trials have shown that strict
      anti-hypertensive therapy could reduce cardiovascular morbidity and mortality in hypertensive
      patients.

      It is reported, however, over 50% hypertensive patients have not been controlled below
      therapeutic target blood pressure that the JSH2004 guideline recommends.

      Recently use of Angiotensin II receptor blockers (ARBs) is increasing progressively for their
      pharmacological action on organ protection as well as potent reduction in blood pressure.
      However, usual dosage of ARB in Japan is almost half of that in the mega trials executed in
      Europe and America. Lower dosage compared to western countries might be a reason why
      cardiovascular events are not fully reduced in Japan.

      Valsartan optimal therapy against elevated home blood pressure research (VOYAGER) study will
      be a multi-center, open-label, randomized, active-controlled study to evaluate the following;
      improvement percentage of urinary albumin exception, home blood pressure, hospital blood
      pressure, incidence of stroke, cardiovascular disease, and microangiopathy with valsartan 80
      mg- or valsartan 160 mg based therapy in patients with elevated morning home blood pressure.
    

Intervention name(s): Valsartan 80mg daily; Valsartan 160mg daily
Intervention type(s): Drug; Drug
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: home blood pressure
Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.
Condition: Pneumonia, Viral
MeSH terms: COVID-19; Pneumonia; Pneumonia, Viral
Study type: Interventional
Phase: Phase 3

Summary: 
      The study objective is to assess Efficacy and safety of Reparixin treatment as compared to
      placebo (both on top of standard treatment) in adult patients with severe COVID-19 pneumonia.
    

Detailed description: 
      This is a phase 3 clinical trial designed as a randomized, double-blind, placebo-controlled,
      multicentre study to evaluate the efficacy and safety of Reparixin in hospitalized adult
      patients with severe COVID-19 pneumonia.

      Patients will be screened for the participation in the study and eventually randomized based
      on an unbalanced randomization scheme (2:1) to Reparixin oral tablets (2 x 600 mg TID) for up
      to 21 days or to placebo.

      An unequal randomization is justified by the need to gain experience and more safety data
      with the investigated treatment and by an expected better acceptability of the trial by
      patients.

      The placebo control arm is justified by the unavailability of a well-defined standard of care
      for subjects with COVID-19 pneumonia who are candidates for this study.

      All patient will receive the standard supportive care based on the patient's clinical need.
      Follow-up information on the patient's clinical condition will be collected until day 90.
    

Intervention name(s): Reparixin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 2 tablets of Reparixin (600 mg each), for the total of three daily administrations (6 tablets daily).; Matched placebo, i.e. 2 tablets for the total of three daily administrations (6 tablets daily).
Other intervention name(s): DF 1681Y
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: subjects will be randomized with a 2:1 randomization ratio
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Covid-19; SARS-CoV-2; Pneumonia; Severe pneumonia
The Purpose of This Study is to Look at Pelvic Support Problems, Also Commonly Known as Pelvic Organ Prolapse
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      FemmeJock is a pelvic floor support system developed by pelvic floor physiotherapists for
      patients with pelvic organ prolapse in order to ameliorate symptoms of pelvic floor pressure
      and discomfort. The device is a girdle to be worn on the outside of underwear. The device is
      machine washable and there are no documented risks with wearing it. This product is currently
      being used by pelvic floor physiotherapists and has been subjectively reported by individual
      accounts as being successful in improving pelvic floor symptoms. The efficacy of this product
      has not been previously studied in women with pelvic organ prolapse. The investigators are
      proposing a pilot study with the following specific aims:

        1. to assess patient satisfaction and continuation of use of the FemmeJock support system
           after 3 months of treatment.

        2. to describe, if any, the reasons for discontinuation associated with the use of this
           product, and

        3. to assess whether women experience improvement of pelvic floor symptoms after using this
           product.
    

Detailed description: 
      This will be a prospective pilot study in order to determine the efficacy and tolerability of
      FemmeJock in patients with pelvic organ prolapse. We plan to enroll 30 patients who will be
      recruited from the OU Health Science Center. We will offer study participation to patients
      who meet the inclusion criteria listed below, and who are: (1) awaiting surgical management
      and desire a temporary nonsurgical option, (2) seeking permanent nonsurgical treatment, or
      (3) who have a contraindication to surgical management.
    

Intervention name(s): FemmeJock
Intervention type(s): Device
Intervention description(s): The participant will be fitted with the girdle. The participant will use the girdle for the next 3 months. The girdle is only to be worn during the daytime during times of physical activity. The length of time you choose to wear it during the day is the patients choice. In two weeks the participant will be asked to fill out a 5 question survey in a follow up visit. The participant will be asked to return 3 months after wearing the FemmeJock girdle and to fill out a 5 question survey, as well as to complete a 20 question survey.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: FemmeJock; Pelvic Organ Prolapse
Study to Assess the Safety and Tolerability of Single Doses of REGN1500
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, first-in-human, randomized, ascending single-dose, placebo-controlled, double-blind
      study of the safety, tolerability, and bioeffect of REGN1500
    


Intervention name(s): REGN1500; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment