bioihbjkbjnl/mcl2 huggingface dataset:
FMT in Ulcerative Colitis-Associated Pouchitis
Condition: Ulcerative Colitis Associated Pouchitis
MeSH terms: Colitis; Colitis, Ulcerative; Pouchitis; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test whether Fecal Microbiota Transplant (FMT) is a safe and
      effective treatment for people who have Ulcerative Colitis and have had an ileal pouch
      anastomosis.

      Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that may be caused by a
      person's immune system responding in an unusual way to bacteria normally found in the gut.
      Studies have shown that the gut bacteria in people with ulcerative colitis (UC) are different
      from the gut bacteria in people without ulcerative colitis (UC). Often, people with
      ulcerative colitis (UC) have fewer types of bacteria in their gut which can change the way
      that person's immune system works.

      This study is for people who have had a proctocolectomy with an ileal pouch anastomosis
      (IPAA) to treat ulcerative colitis (UC). More than 50% of people who have had an IPAA will
      develop a condition called pouchitis. Pouchitis is short or long-term inflammation of the
      ileal pouch that was created in order to store waste from your intestines. Patients with
      pouchitis are being asked to take part in this study.

      Currently, antibiotics, probiotics and prebiotics are used to treat pouchitis. However, it
      has been shown that probiotics are not very helpful once the patient stops taking them. In
      addition, antibiotics may cause unfavorable side effects. Fecal microbiota transplantation
      (FMT) is being studied as another form of treatment for patients with active pouchitis. Fecal
      microbiota transplantation (FMT) or "stool transplant" involves receiving a single fecal
      enema from someone who has volunteered to donate their stool.

      There are two purposes of this research study:

        1. To see whether or not fecal microbiota transplantation (FMT) is a useful treatment for
           patients with ulcerative colitis (UC) associated pouchitis

        2. To study the changes within the bacteria in the gut in patients with pouchitis (before
           and after study treatment) using stool, blood and urine samples
    


Intervention name(s): biologically active human fecal microbiota; sigmoidoscopy
Intervention type(s): Biological; Procedure
Intervention description(s): instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ulcerative colitis; fecal microbiota transplantation
Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could
      improve the progression disease, in patients with Parkinson's Disease (PD).
    

Detailed description: 
      Periodical measures of the clinical features with UPDRS will be done at the beginning, each
      three months until two years. Each group will be compare to evaluate.
    

Intervention name(s): VIUSID/ALZER; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): VIUSID/ALZER, 3 per day, oral, one year; Placebo Viusid and Placebo Alzer, 3 per day, oral, one year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Distinct Metastatic Phenotypes Between Early-onset and Late-onset Colorectal Cancer
Condition: Early-onset Colorectal Cancer; Late-onset Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The clinical and pathological features of early-onset colorectal cancer (EOCRC) differ from
      those of late-onset colorectal cancer (LOCRC). Our research aims to thoroughly elucidate the
      distinctions between them by analyzing clinical prognosis, metastatic patterns, gene
      expression, and genomic mutation profiles. Our deliberation will uncover latent strategies
      for personalized therapeutic of both EOCRC and LOCRC.
    


Intervention name(s): standardized treatment
Intervention type(s): Other
Intervention description(s): Patients enrolled in these 2 cohorts all received standardized treatment of colorectal cancer.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with colorectal cancer hospitalized in Fudan university Shanghai cancer center.
Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of roflumilast plus alogliptin on
      glucagon-like peptide-1 (GLP-1) and glucose levels in patients with type 2 diabetes.
    

Detailed description: 
      This is a study to evaluate the antiglycemic efficacy and safety of roflumilast + alogliptin
      compared to alogliptin alone and roflumilast alone; it will also include an open-label
      exenatide treatment arm as a control. The antiglycemic efficacy of the combination will be
      evaluated through the measurement of postprandial active GLP-1 level, ß cell secretion
      activity (via the measurement of C-peptide and insulin levels), appetite sensations (as
      assessed by VAS) and glycemic control as assessed by a continuous glucose monitoring system
      (CGMS).
    

Intervention name(s): Roflumilast; Alogliptin; Exenatide; Placebo to roflumilast; Placebo to alogliptin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Roflumilast tablets; Alogliptin tablets; Exenatide solution; Placebo-matching roflumilast tablets; Placebo-matching alogliptin tablets
Other intervention name(s): Daxas, Daliresp; Nesina; Byetta; Bydureon
Intervention MeSH terms: Exenatide; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy
Changes in Elastic Properties of Descending Thoracic Aorta After Ascending Aorta Replacement
Condition: Aortic Surgery
Study type: Observational

Summary: 
      The aim of our study was to evaluate the impact of aortic root replacement by a graft on the
      elastic properties of the descending thoracic aorta using cardiac Magnetic Resonance Imaging
      (MRI) and automatic post-processing.

      Nineteen patients were operated on an aortic root aneurysm and a cardiac MRI allowing aortic
      compliance measurement was performed before and after surgery. Images were acquired with a
      1.5 T MRI with only one additional sequence to a conventional aortic MRI protocol.
    

Detailed description: 
      Observational and retrospective trial on medical data only. The patients are operated of
      planned aortic root aneurysm without additional intervention.

      The pre and postoperative cardiac MRI are planned in standard of care.
    

Intervention name(s): Ascending aorta replacement with graft
Intervention type(s): Procedure
Intervention description(s): Patient with planned Ascending aorta replacement with graft
Other intervention name(s): cardiac MRI
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        19 patients operated in Cardiac Surgery unit of DIJON Hospital between September 2014 and
        December 2017.
EVENDOL Scale Validation for at Term New-born
Condition: Analgesia
Study type: Observational

Summary: 
      Maternity and neonatology, caregivers are regularly confronted with the pain of the newborn,
      especially after a birth injury, but it is sometimes difficult ti define.

      There is not, to our knowledge, any prevalence study of pain in newborn motherhood. The data
      available are those of the perinatal survey 2010, with the number of operative vaginal
      deliveries (5.3% of suction, forceps 3.9%, 2.9% spatulas) and the number of extractions the
      seat (4.7%). These delivery modes can be purveyors of pain.

      At St. Joseph's Hospital, there were in 2013: 259 instrumental deliveries and 90 extractions
      by headquarters. Fifty five paracetamol bottles were consumed in the layer sequence in 2013,
      and 15 in the delivery room. But this consumption is a poor reflection of the pain because
      treatment could be given pain-authenticated (measured with the EDIN scale), and because a
      bottle is discarded one month after opening.

      The scales measuring pain used in the new-born at term based on the assessment of change in
      behavior; two specific scores of the newborn are used in France: Pain and Discomfort Scale
      Newborn (EDIN) for prolonged pain and Acute Pain scale Newborn (DAN) for acute pain related
      to health care.

      The EVENDOL scale (Child Pain Evaluation) has been validated for pediatric emergencies in
      children 0-7 years, as well as pre-hospital, to measure the intensity of pain whether acute
      or prolonged (8 ). It is easy and fast to use. validation cohorts included a significant
      proportion of newborns. This scale appears suitable for evaluation of the newborn to term
      maternity
    

Detailed description: 
      Objectives:

      Principal: validation of the instrument "EVENDOL" in the new-born at term.

      Secondary:

        -  EVENDOL is equivalent to EDIN to diagnose the pain of the newborn at term.

        -  While being faster and easier to dimension.

        -  EVENDOL preferred by caregivers

      Methodology and conduct of the study:

      DESIGN: Study of practical evaluation of observational, prospective, multicenter.

      Places of study: maternity of Saint Joseph Hospital, and Kremlin Bicetre. A feasibility study
      is underway, it was started in neonatology Antoine Béclère. Time study: 12 to 18 months
      Required subjects: 100 patients (1/3 painless children, 2/3 of painful children).
    

Intervention name(s): pain scale
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This scale appears suitable for evaluation of the newborn at term pregnancy.
Tissue Characterisation by Endoscopic GI-elastography
Condition: Disorder of Upper Gastrointestinal Tract; Pancreatic Nodule; Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes; Secondary Malignant Neoplasm of Lymph Node
MeSH terms: Neoplasms; Neoplasm Metastasis
Study type: Observational

Summary: 
      In this single centre study we study the use of endoscopic ultrasonography (EUS) combined
      with elastography in order to separate malignant tissue from benign tissue in and adjacent to
      the upper gastrointestinal tract.
    

Detailed description: 
      The purpose of this study is to use endoscopic ultrasonography (EUS) with strain based
      elastography to identify strain traits separating malignant from benign lesions. We are
      registering feasibility of endoscopic strain imaging and compare diagnostic accuracy of EUS +
      elastography with previous data on EUS alone.

      Inclusion criteria:

        -  Group 1: Focal subepithelial lesions in esophageal, ventricular or duodenal wall
           discovered by endoscopy or other imaging modality.

        -  Group 2: Pancreatic lesion discovered by other imaging modality.

        -  Group 3: Mediastinal or retroperitoneal lymph node or tumor discovered by other imaging
           modality.

      Histology of lesions should not be known at the time of examination. EUS elastography
      findings are evaluated shortly after the examination and categorised by different methods;
      categorical score, VAS, Strain Ratio. The result is then compared to histology or cytology
      results. Patients who do not undergo tissue sampling are followed up to discover disease
      progress.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients referred to EUS examination or relevant surgery at Haukeland University
        Hospital, bergen, Norway within the inclusion period (2007- January 2011).
      
Biospecimen description: 
      Tissue samples are stored as pathological slides in the diognostic biobank of Dep. of
      Pathology, Helse Bergen.
    
Keywords: elastography; strain ratio; pancreas; GI wall lesions; lymph nodes
Femoral or Radial Approach in Coronary Chronic Total Occlusion
Condition: Chronic Coronary Occlusion
MeSH terms: Coronary Occlusion
Study type: Interventional

Summary: 
      Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly
      performed using bilateral transfemoral access and 8 French guiding catheters. However,
      transfemoral approach (TFA) is associated with higher risk of vascular access complications.5
      It has been reported that using transradial approach (TRA) reduces vascular complications and
      may be associated with a better clinical outcome. Transradial access is also used in complex
      PCI interventions.There is a growing body of evidence regarding the use of this approach also
      in CTO procedures. In available literature, all studies comparing TRA vs. TFA in CTO
      consisted of single center and single operator experience. Besides, none of them is
      randomized. To fill in the gap, we sought to examine the technique and outcomes of
      transradial vs. transfemoral CTO PCI in a contemporary multicenter randomized study.
    

Detailed description: 
      All consecutive patients referred for CTO PCI between August 2017 and July 2021 at Acibadem
      University Kocaeli Acibadem Hospital, Kocaeli; Erciyes University Medical Faculty, Kayseri;
      Istanbul University Cerrahpasa Medical Faculty, Haseki Cardiology Institute; Istanbul;
      Memorial Bahcelievler Hospital, Istanbul were screened for enrollment in the study. The
      exclusion criteria included: (a) any acute coronary syndrome within 3 months; (b) severe
      heart failure issues; (c)severe renal failure (d) failure to provide written informed
      consent.The radial access group consisted of patients with single or bi-radial approach. Any
      femoral artery puncture was considered a femoral case. For example, a crossover from any
      radial to femoral access was considered a femoral case. Procedures were performed by 4
      interventional cardiologists, who are dedicated radial operators, at 4 different centers. The
      protocol was approved by the institutional review board and all patients provided written
      informed consent.
    

Intervention name(s): radial access site; femoral access site
Intervention type(s): Other; Other
Intervention description(s): radial route; femoral route
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Femoral approach; Radial approach; Chronic total occlusion
A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache Disorders, Secondary; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled
      study to evaluate the efficacy and safety of erenumab against placebo in participants with
      chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are
      diagnosed with medication overuse headache (MOH).
    

Detailed description: 
      Study 20170703 is a phase 4, randomized, double-blind, double-dummy, parallel-group,
      placebo-controlled study to evaluate the safety and efficacy of erenumab against placebo in a
      CM population with MOH and prior history of treatment failure. Participants will be enrolled
      based on fulfilment of the International Classification of Headache Disorders, 3rd Edition
      (ICHD-3) CM and MOH criteria and will not be advised to early discontinue acute medication.

      Participants who successfully complete the 24-week double-blind treatment period (DBTP) of
      the study will be offered an opportunity to continue in an open-label treatment period (OLTP)
      of 28-weeks duration. Participants who received erenumab treatment during the DBTP will
      continue to receive the same erenumab dose during the OLTP. Participants who received placebo
      during the DBTP will be allocated in a 1:1 ratio to receive either erenumab 70 mg or 140 mg
      SC QM during the OLTP. All participants will remain blinded to their original DBTP treatment
      assignment.
    

Intervention name(s): Erenumab 70 mg; Erenumab 140 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Erenumab once every 4 weeks. Subcutaneous injection.; Erenumab once every 4 weeks. Subcutaneous injection.; Placebo once every 4 weeks. Subcutaneous injection.
Other intervention name(s): Aimovig; Aimovig
Intervention MeSH terms: Erenumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Migraine; Medication Overuse Headache
Effects of XOMA 052 on Insulin Production in Type 1 Diabetes
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the effects of treatment with XOMA 052 on beta-cell function and insulin production
      in subjects with well-controlled Type 1 diabetes. The safety, tolerability, and
      pharmacokinetics (PK) of XOMA 052 will also be assessed.
    


Intervention name(s): XOMA 052; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.3 mg/kg XOMA 052. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections; 0.3 mg/kg Placebo. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effect of Hesperidin on Glucose / Insulin Metabolism
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Metabolic Syndrome (MS) is a well-known group of obesity-related metabolic disorders
      including insulin resistance (IR), dyslipidemia and hypertension (HTN). In addition,
      overweight has a causal relationship with a chronic low grade systemic inflammatory condition
      and increased intestinal permeability. Over the last decade, this multiplex disorder has
      progressively become a major worldwide public health problem, because of its association with
      increased risk of type 2 diabetes mellitus (DM2), atherosclerotic cardiovascular disease and
      all-cause mortality. Scientific evidence for measures to improve cardiometabolic and
      intestinal health by non-pharmaceutical means are of urgent need. Administration of the
      flavonoid hesperidin to those at risk may have beneficial effects on glucose / insulin
      metabolism, lipid metabolism, blood pressure, heart rate, pro-inflammatory and oxidative
      stress biomarkers and gut barrier function.

      Objective: To determine the 12-week effect of daily administration of hesperidin on the main
      cardiometabolic disorders related to MS as assessed by investigation of glucose/insulin
      metabolism, blood lipid profile, blood pressure, heart rate, body composition and gut barrier
      function in subjects at risk for MS.

      Study design: This is a randomized, double-blind, placebo-controlled study with parallel
      design.

      Study population: Healthy (male/female) volunteers, age 18-65, at risk for metabolic syndrome
      (presenting with 2 out of 5 of the components from NCEP-ATP-III criteria).

      Intervention: Participants will be randomly assigned to one of the intervention groups. One
      group will receive one daily dose of hesperidin capsules while the other group receives
      identical looking placebo capsules for a period of 12 weeks. The capsules will have to be
      ingested with a glass of water every morning just before breakfast.

      Main study parameters/endpoints: The primary efficacy parameter of this study is the oral
      glucose tolerance test (OGTT), a validated surrogate endpoint to study the β-cell function
      and insulin sensitivity. Secondary endpoints entail the evaluation of effects of daily
      administration of hesperidin on lipid profile (blood measurements), blood pressure and heart
      rate, body composition, low-grade inflammation biomarkers (blood measurements) and gut
      barrier function (blood measurements, fecal samples, urine collection).
    


Intervention name(s): Hesperidin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Citrus peel extract; Cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin
Condition: Healthy; Japanese; Non-Asian
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase I, single-dose, open-label trial is to evaluate the
      pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and
      Non-Asian subjects. The study plans to evaluate 3 cohorts of a single oral dose of AG-348 in
      Japanese and Non-Asian subjects. Pharmacokinetic sampling will take place serially at
      specified times during conduct of the study.
    


Intervention name(s): AG-348; AG-348; AG-348
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg single-dose; 5 mg single-dose; 200 mg single-dose
Intervention MeSH terms: Mitapivat
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy; Japanese