bioihbjkbjnl/mcl2 huggingface dataset:
Saccharomyces Boulardii as Pretreatment Before Rescue Therapy of Helicobacter Pylori
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      The increasing rate of drug resistance in often leads to eradication failure and the need for
      rescue therapy, and it is of great significance to explore new rescue therapeutic regimens.
      In this study, we observed the efficacy of rescue treatment of Helicobacter pylori (H.pylori)
      with Saccharomyces boulardii (S.boulardii) alone. the primary outcome of the trial was the
      eradication rate, and the secondary outcome was the incidence of adverse events.
    

Detailed description: 
      Background: Helicobacter pylori(H.pylori)infection is a common bacterial infection that
      causes chronic gastritis, peptic ulcer, MALT lymphoma, gastric cancer, and other
      gastrointestinal diseases. and has been classified as a group 1 biologic carcinogen with a
      prevalence of about 50% population in china. In recent years, with the massive use of
      antibiotics, poor patient compliance, and irregular drug use, the side effects associated
      with drugs have increased and have led to the development of antibiotic-resistant bacteria
      and a gradual increase in refractory H.pylori infections, researchers have been searching for
      a safe, effective and simple treatment for H. pylori.

      Methods: The patient come from the department of Gastroenterology, Xiangya Third Hospital,
      Central South University. After obtaining informed consent, patients is randomly divided into
      a study group and a control group. The study group (n=100) is divided into two stages of
      treatment, starting with Saccharomyces boulardii monnotherapy for 14 days, Patients who are
      still positive on reexamination after 4 weeks of stopping the drug continue with bismuth
      quadruple therapy. As for the control group (n=100), patients is observed for 4 weeks without
      any gastric drugs as well as antibiotics, and those who were still positive on retest after 4
      weeks continued with bismuth quadruple therapy. We observe the eradication rate of patients
      and the occurrence of adverse effects during the treatment.
    

Intervention name(s): Saccharomyces Boulardii 250 MG; Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate
Intervention type(s): Drug; Drug
Intervention description(s): Saccharomyces Boulardii:
0.25 g * 6, Produced by The French encyclopedia pharmaceutical Factory; Ilaprazole:
5mg*6, produced by Livzon Pharmaceutical Group Inc
Doxycycline:
0.1 g * 10, produced by Jiangsu Yongxin Ltd.
Furazolidone:
0.1g*100 produced by Tianjin Lisheng Pharmaceutical Co., LTD
Colloidal Bismuth Tartrate:
55 mg * 36,produced by Shanxi Xinbaoyuan Pharmaceutical Co., LTD
Other intervention name(s): treatment drugs of stage I; treatment drugs of stage II
Intervention MeSH terms: Doxycycline; Furazolidone; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Saccharomyces boulardii Helicobacter pylori rescue
Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the trial is to check if inhaled glucocorticosteroids (iGCS) have influence on
      bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with
      asthma.
    

Detailed description: 
      Asthma is the most prevalent chronic disease of respiratory tract, the largest frequency is
      noticed in children. iGCS are the basic group of drugs in asthma, because of inflammatory
      character of disease. All iGCS are absorbed to the systemic circulation (small amounts)
      despite of local exposition in lungs and possess systemic effects. The purpose of trial is to
      check if iGCS have influence on bone condition (if iGCS increases risk of osteoporosis and
      bone fraction) in children with asthma.
    

Intervention name(s): budesonide; D3 vitamin; montelukast sodium; salbutamol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): budesonide; D3 vitamin; montelukast sodium; salbutamol
Intervention MeSH terms: Cholecalciferol; Budesonide; Albuterol; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: asthma; children; inhaled glucocorticosteroids; bone metabolism
Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first in human study of PF-06651600. PF-06651600 is being developed for
      treatment of inflammatory bowel disease. This study will test single and multiple doses of
      PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics
      and pharmacodynamics of PF-06651600 in healthy volunteers.
    


Intervention name(s): PF-06651600 or Placebo
Intervention type(s): Drug
Intervention description(s): PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inflammatory bowel disease
Obesity and Metabolic Surgery in Patients With Type I Diabetes
Condition: Type I Diabetes
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Obesity is the indication for bariatric surgery in type I diabetes. Interestingly postsurgery
      the patients improve remarkable in their need for insulin, not only in the daily total
      insulin dosage but also in the dosage of IU per kg.
    

Detailed description: 
      The investigators performed a retrospective analysis on 16 patients undergoing weight loss
      surgery in obesity with concomitant type I diabetes. All patients were evaluated during
      Follow - Up to analyze insulin dosage and metabolic changes.
    

Intervention name(s): Obese patients with type I diabetes
Intervention type(s): Other
Intervention description(s): Postsurgical follow - up in obese patients with type I diabetes
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All obeses patients with type I diabetes who underwent weight loss surgery in our
        department.
      
Keywords: obesity surgery; type I diabetes; weight loss; insulin dosage; postsurgery metabolic changes
Does Oxytocin Modulate Rewarding Effects in Women and Fluctuating Across the Menstrual Cycle
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of the study is to explore how the rewarding effect of men's verbal compliment is
      modulated by oxytocin and gonadal hormone in a romantic context.
    

Detailed description: 
      To investigate whether oxytocin (24IU) might interact with female sex hormone in modulating
      the rewarding effect of compliment to women in a romantic context.

      The study employs a double-blind, within-subject, placebo-control design. Women will be
      administered with the same drug twice (oxytocin or placebo) respectively the fertile and
      luteal phase followed by a MRI scanning. During fMRI participants will rate men's attraction
      based on their facial pictures of average attractiveness associated with compliments of
      different combination of form and topic. Each male face will be paired with two sentences of
      the same kind. After the fMRI participants will recall the judgment followed by a memory test
      during which they have to indicate whether the they have seen the face during scanning (old)
      or whether it is an unknown face (new).
    

Intervention name(s): Oxytocin; Placebos
Intervention type(s): Drug; Drug
Other intervention name(s): oxytocin treatment; placebo control
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: oxytocin; sex hormone; verbal reward; mate selection; metaphorical language
Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese
      cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in
      healthy volunteers
    

Detailed description: 
      This is a first time in human, phase 1, randomized, blinded, placebo-controlled study to
      evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending subcutaneous
      doses of MEDI5884 in healthy volunteers (age 18-55). The study consists of 4 cohorts of
      increasing doses (8 subjects each) and an optional Japanese American cohort (24 subjects) for
      a total of 56 healthy subjects. The decision whether or not to dose escalate will be based
      upon data review by the Dose Escalation Committee. Subjects will be randomized 3:1 to
      MEDI5884 or placebo. Following screening, the study consists of a 3 day inpatient stay and
      follow up visits. The number of follow up visits depend on the cohort assigned.
    

Intervention name(s): Placebo; MEDI5884 Dose 1; MEDI5884 Dose 2; MEDI5884 Dose 3; MEDI5884 Dose 4
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Participants will receive single dose of placebo matched MEDI5884 injection SC on Day 1; Participants will receive single dose MEDI5884 Dose 1 injection SC on Day 1.; Participants will receive single dose MEDI5884 Dose 2 injection SC on Day 1; Participants will receive single dose MEDI5884 Dose 3 injection SC on Day 1; Participants will receive single dose MEDI5884 Dose 4 injection SC on Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: atherosclerosis; acute coronary syndrome; MEDI5884
Marker for FAI Diagnosis
Condition: Femoroacetabular Impingement
MeSH terms: Femoracetabular Impingement
Study type: Observational

Summary: 
      The diagnostic gold standard to differentiate FAI (femural acetabular impingement) from other
      muscular-tendinous pathologies is, actually, the injection of intra-articular anesthetic
      (lidocaine), with a pre- and post- evaluation of pain scale.

      If, after injection, the pain disappears, the pain is probably due to an articular problem
      (FAI). This kind of differential diagnosis test has a sensibility of 100% and a specificity
      of 81%.

      C-terminal telopeptide of type II collagen (CTXII) as cartilage degradation index, could be a
      marker, simply detectable, to assess the healthy of the cartilage status and could be
      measured in serum and urine.
    

Detailed description: 
      This study is observational-analytical and cross-sectional, because the same patient will
      receive both the diagnostic iter.

      For the rules of Evidence-based Medicine (Brown et al., 2006), the definition of this study
      PICO is:

      P (population)= all the patients with suspected FAI afferent to Orthopaedic-Traumatology and
      Prosthetic surgery and revisions of hip and knee implants

      I (intervention)= enzyme-linked immunosorbent assay (ELISA) for C-terminal telopeptide of
      type II collagen (CTXII) in serum and urine

      C (comparison)= intra-articular lidocaine injection

      O (outcome)= sensibility/specificity of ELISA test

      From a literature analysis the C-terminal telopeptide of type II collagen (CTXII) seem to be
      the best candidate for this kind of comparison. Some previous studies (Scarpellini et al,
      2008) demonstrated that this marker could be used in this way, and, for this reason, the aim
      of this study is to investigate the sensibility and specificity of this marker in serum and
      urine, vs the actual diagnostic gold standard (anesthetic intra-articular injection).

      If the marker will be equal or better than the actual gold standard, the clinical practice
      will have an improvement, because this kind of analysis is simply performing and less
      invasive for the patient.

      The study will enroll 20 patients with suspected FAI between 18-45 years and of both the
      gender.
    

Intervention name(s): Local anesthetic
Intervention type(s): Drug
Intervention description(s): local injection
Other intervention name(s): Lidocaine
Intervention MeSH terms: Lidocaine; Anesthetics, Local; Anesthetics
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        20 male and female, age range 18-45 recovered for suspicious FAI
      
Biospecimen description: 
      serum and urine samples
Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      The purpose of this study is to investigate the effect of weight loss rate on liver
      steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and
      after bariatric surgery. The investigators also aim to study the short-term effect of
      bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric
      surgery.
    


Intervention name(s): Sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): An intra-operative liver biopsy was performed in 20 patients
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        26 diabetic patients with NAFLD (diagnosed by ultra sound) undergoing sleeve gastrectomy
        (SG) at Surgery C department at Sheba Medical Center, Israel.
      
Biospecimen description: 
      Whole blood, Liver tissue
    
Keywords: Nonalcoholic fatty liver disease; Nonalcoholic steatohepatitis; Obesity; Bariatric surgery; Weight loss
A Two-Part Phase 1 Study to Investigate the Safety and Tolerability of Supratherapeutic Dose of Zanubrutinib and Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Two-Part Phase 1 Study to Investigate A) Safety and Tolerability of Supratherapeutic dose
      of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization in Healthy
      Subjects
    

Detailed description: 
      This is a Two-Part Phase 1 Study.

      Part A: This is a randomized, placebo-controlled, double blind, single dose study to evaluate
      the safety and tolerability of a single oral supratherapeutic dose of zanubrutinib in eight
      (8) subjects.

      Part B: This is a randomized, placebo and positive-controlled, double-blind, 4-way crossover
      study being conducted in about 28 subjects to investigate the effect of a single therapeutic
      dose of zanubrutinib, a supratherapeutic dose of zanubrutinib and placebo on cardiac
      repolarization. Open-label Moxifloxacin (400 mg), a fluoroquinolone broad spectrum antibiotic
      will be used as a positive control.
    

Intervention name(s): BGB-3111; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive BGB-3111; Subjects will receive Placebo; Subjects will receive Moxifloxicin
Other intervention name(s): Avelox
Intervention MeSH terms: Moxifloxacin; Zanubrutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part A: Single Group Part B: Crossover
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; pharmacokinetics; safety
Quantitative Ultrasonography (US) Evaluation on Femoral Condyle Cartilage
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      The purpose of this study is to investigate the feasibility of using quantitative
      ultrasonography (US) evaluation to determine the severity of osteoarthritic femoral condyle
      cartilage erosion.
    


Sampling method: Probability Sample
Study population: 
        patients with knee OA who were going to receive total knee arthroplasty
      
Keywords: ultrasonography; knee; early degeneration; cartilage
Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to
      evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect
      of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.
    

Detailed description: 
      This study is a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and
      efficacy of intermittent chronic dosing with AXS-07 in subjects with migraine attacks.
      Eligible subjects will take AXS-07 following the onset of a migraine. Subjects will be
      treated for up to 12 months.
    

Intervention name(s): AXS-07
Intervention type(s): Drug
Intervention description(s): AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Axsome; AXS-07; MoSEIC™ meloxicam; rizatriptan
A Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a single-center, single dose, randomized, double-blind, placebo-controlled
      study in healthy Japanese male subjects. The study will consist of 2 parts: Part A (young
      subjects) and Part B (elderly subjects). In Part A sequential cohorts of subjects will be
      treated with single ascending doses of E2307. The maximum tolerated dose (MTD) will be
      determined in Part A. Part B will be initiated after Part A is completed. In Part B one
      cohort of healthy elderly subjects will be treated with a single dose of E2307 at one dose
      level below the MTD. In part A, a total of 56 subjects will be enrolled into 7 cohorts
      sequentially and randomized 3:1 to receive either E2307 (1 mg, 3 mg, 10 mg, 30 mg, 100 mg,
      200 mg, or 300 mg) or placebo. In part B, a total of 8 subjects will be randomized, 6
      subjects to a single dose of E2307 and 2 subjects to placebo.
    


Intervention name(s): E2307; E2307 Matching Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Japanese Subjects; E2307; Pharmacokinetics
Deep Brain Stimulation of the Superolateral Branch of the Medial Forebrain Bundle (slMFB) for the Treatment of Refractory Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators will investigate in a sham controlled staggered onset design antidepressant
      effects and safety of deep brain stimulation (DBS) to the superolateral branch of the main
      medial forebrain bundle (slMFB).
    

Detailed description: 
      The target point for DBS in major depression disorder is located lateral to the ventral
      tegmental area (VTA) in the midbrain at the branching point of the superolateral branch
      (slMFB) from the main medial forebrain bundle (MFB).

      The exact stimulation coordinates are:

      Montreal Neurologic Institute brain 152 coordinates (MNI152 coordinates):

      left: x(lat.)=-5, y(ap)=-14, z(vert.)=-8 right: x(lat.)=5, y(ap)=-14, z(vert.)=-9

      Mid-commissural point coordinates (MCP coordinates):

      eft: x(lat.)=-6, y(ap)=-1, z(vert.)=-6 right: x(lat.)=4, y(ap)=-1, z(vert.)=-7

      All coordinates refer to the MNI152 brain.

      Legend:

      slMFB = superolateral branch of medial forebrain bundle lat. = lateral, ap= anteroposterior,
      vert. = vertical.

      More information can be found at: http://goo.gl/n9sWV
    

Intervention name(s): Deep Brain Stimulation with Activa PC Multi-program Neurostimulator
Intervention type(s): Device
Intervention description(s): Device: DBS 130 Hertz (Hz) frequency, 90us pulsewidth, 4 Volt (V) currency Amplitude
Device: DBS - No Stimulation (Sham) 130 Hertz (Hz)frequency, 90us pulsewidth, 0 Volt (V) currency Amplitude
Intervention model description: Deep Brain Stimulation
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Viral Biofilms: Hijacking T Cell Extracellular Matrix to Regulate HIV-1 Spread?
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This project aims at characterizing HIV-1 viral biofilms structural and functional properties
      and at deciphering its role as a new viral reservoir and as a new mode of viral spread. The
      prospective national study will be conducted on cells isolated from blood samples from 20
      patients infected with HIV.
    

Detailed description: 
      The investigators' preliminary data indicate that besides " free " infectious viral
      particles, HIV-1 infected cluster of differentiation 4 (CD4+) lymphocytes also produce
      extracellular viral assemblies wrapped in an extracellular matrix cocoon and tightly bound to
      the surface of the cell. Importantly, these structures are infectious, transferred to target
      cells upon intercellular contacts and they are key role in HIV-1 spread between T
      lymphocytes. HIV-1 viral biofilm could be important not only for direct transmission of the
      virions but also for " trans-infection ", a process our objectives are:

        -  to better characterize the molecular composition and the architecture of this biofilm
           (using proteomics, glycomic superresolution cell imaging approaches) with regard to its
           properties (infectivity, adhesiveness, protection of virions) and to determine whether
           cells from infected patients produce such structures.

        -  to delineate the viral factors regulating the formation of these new infectious
           structures (with a particular attention on Tat, Vpu and Nef HIV-1 encoded using mutant
           viruses or expression vectors).

        -  to investigate the lymphocyte pathways regulating the viral biofilms formation and
           composition in extracellular matrix (ECM) proteins (using quantitative polymerase chain
           reaction (qPCR) and siRNA).

        -  to determine whether those viral biofilms are involved in HIV-1 transmission by
           transinfection

        -  to study the contribution of those infectious structures and the dynamics of their
           transmission in lymph nodes.

      This project may contribute to decipher the role of viral biofilms in HIV-1 transmission.
      Ultimately, we intend to determine how the interference of retroviral infections with T cell
      activation pathways modulates the pattern of ECM production by T cells, tuning viral biofilm
      composition and regulating viral dissemination.
    

Intervention name(s): Blood sample
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV; Biofilm; Transmission