bioihbjkbjnl/mcl2 huggingface dataset:
Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases
Condition: Inflammatory Bowel Disease (IBD)
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder
      affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2
      different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut
      Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a
      treatment option for Clostridium difficile colitis and UC. The literature supports strong
      evidence for the plausibility of using GMT for patients with IBD associated colitis,
      especially for patients with UC.

      This research will be conducted in the Helen DeVos Children's Hospital (HDVCH) Pediatric
      gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to
      evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis
      (UC and CD with colonic involvement only) will be approached for GMT as a treatment option
      for their disease. Each subject will undergo 5 sessions (1 session/day, and not necessarily
      on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be
      done at their regularly scheduled clinic follow up.

      Healthy donors >18 years of age will be chosen by the family, inclusive of immediate family
      members and friends. Donors will be required to complete a screening questionnaire, provide
      medical history, and undergo blood and stool tests.
    


Intervention name(s): Gut Microbial Transplantation
Intervention type(s): Drug
Intervention description(s): Each participant received Gut Microbial Transplantation (GMT) as retention enema over a period of 1 hour (60mL enema every 15 minutes) daily for 5 days. Although 240mL of GMT solution was prepared for each participant, the final administered dose was dependent on the subject's comfort and willingness to proceed with the next enema, which was assessed after each enema infusion. Subjects were monitored for 30 minutes after GMT for any immediate adverse events and discharged.
Other intervention name(s): GMT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ulcerative colitis, gut microbial transplantation
The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound
Condition: Obstetric; Injury Pelvic Floor
Study type: Observational

Summary: 
      Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to
      urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%),
      sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries
      are not easy to diagnose as they are not visible when looking at surface anatomy during a
      standard gynaecological examination. The investigators are therefore in urgent need of better
      tools to diagnose these injuries. Having a reliable and easily accessible tool enables
      studies of the consequences of such pelvic floor muscle injuries. It also makes it possible
      for us to explore the effect of interventions such as pelvic floor muscle training and
      surgery in patients with and without pelvic floor muscle injuries. The investigators have
      previously presented data to support the reliability and the validity of the three and four
      dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in
      healthy volunteers and have now a tool to study women before and after delivery. At the
      Department of Obstetrics and Gynaecology, Akershus University Hospital there are
      approximately 4500 deliveries annually and 1500 women are giving birth for the first time.

      Challenges: The invitation to participate in the study will be given to all women expecting
      their first child fulfilling inclusion criteria. The biggest challenges in the project will
      be logistical. To be able to inform, recruit and follow women having their first child is a
      challenge in it self.

      Applications: If it is possible to identify a risk group for pelvic floor injuries before
      delivery, it might be ethical to recommend a prophylactic caesarean section to avoid
      disabling incontinence and prolapse later in life.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women giving birth to their first child at Akershus University Hospital, Norway
      
Keywords: Pelvic organ prolapse; Levator hiatus; 3 and 4 dimensional ultrasound
Kefir Cholesterol Lowering Pilot Study
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      High cholesterol (a type of fat in humans blood) may be one factor that can lead to heart
      disease. If people have higher cholesterol, it is possible that kefir (a food similar to
      yogurt) may help to control blood cholesterol levels.
    

Detailed description: 
      New research shows that kefir (which contains bacteria also known as microbes), similar to
      yogurt, may improve health by lowering cholesterol levels. Much of this research however,
      focuses on traditional types of kefir, which differ significantly from commercially prepared
      kefir with regards to the types of microbes in each kefir. Additionally, there is a lack of
      research looking at how commercial kefir compares to traditional kefir in its ability to
      improve health. This has led to the consumer being confused about the health benefits they
      believe they are receiving, such as reduced weight gain, and improved cholesterol levels,
      when they purchase and consume commercial kefir. The researchers have produced a commercially
      usable kefir that has the health benefits of traditional grain fermented kefir. This was
      accomplished with only a small subset of microbes present in the traditional kefir, leading
      to a much easier product to commercialize and produce. Thus, this study aims to look at
      whether kefir, produced in the researchers laboratory and commercially available kefir, given
      to males for in two separate months, results in any cholesterol lowering effects. Successful
      completion of this project could potentially result in the development of a new commercial
      kefir with health benefits that are supported by scientific research and testing. In
      addition, if positive results are seen, a larger study will be carried out to ensure that
      results of the current study are consistent for the Canadian population.
    

Intervention name(s): Kefir
Intervention type(s): Other
Intervention description(s): commercial versus traditional kefir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: high cholesterol, kefir
Effect of Concept Mapping Teaching Method on Critical Thinking Skills of Medical Students
Condition: Education
Study type: Interventional

Summary: 
      effect of concept map in teaching critical thinking was done with randomized study
    

Detailed description: 
      This quasi-experimental study with two groups design and pre-posttest method was conducted at
      Ahvaz University of Medical Sciences in 2014. About 100 Medical Students of in their third
      semester were recruited for the study based on census. Participants were divided into two
      intervention and control groups by using random sampling and Random Number Table List.
      Students in the control group were lectured in Anatomy using traditional lecture method.
      Whereas, students in the experimental group were taught Anatomy using concept map teaching
      method. Student's critical thinking was evaluated by examining" Standard California Critical
      Thinking Skills Questionnaire"
    

Intervention name(s): concept map teaching; traditional teaching
Intervention type(s): Other; Other
Intervention description(s): teaching anatomy using concept map to improve critical thinking; teaching anatomy using lecture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Concept Map; critical thinking; medical student teaching
Randomized Controlled Trial Between Auto-titration and Manual Titration of Non-invasive Ventilation in Obesity Hypoventilation Syndrome
Condition: Chronic Hypercapnic Respiratory Failure; Obesity Hypoventilation Syndrome
MeSH terms: Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Syndrome
Study type: Interventional

Summary: 
      Primary Objectives: To evaluate the effectiveness in the obesity hypoventilation syndrome
      (OHS) treatment with non-invasive ventilation (NIV) set manually by polysomnography compared
      to the same treatment with a respirator with automatic NIV adjustment, analyzing as primary
      variable PaCO2 and as operational variables dropout rate for medical reasons and mortality.
      Secondary objectives: cost-effectiveness, clinical and functional improvement in wakefulness
      and during sleep, quality of life, blood pressure monitoring for 24 hours, incidence and
      evolution of cardiovascular events and use of health resources. Other objectives: 1)
      effectiveness of treatments in the following subgroups of patients: gender, age,
      socioeconomic status, severity of sleep apnea, VNI compliance, quality of life and
      comorbidities; 2) To evaluate the profile of patients with poor adherence to NIV based on
      clinical severity, gender, age and socioeconomic status in the whole sample and in both
      intervention groups.
    

Detailed description: 
      Method: Prospective, blind researchers, randomized, controlled non-inferiority and
      cost-effectiveness relationship, with two parallel open groups. 200 OHS patients will be
      divided into two groups by simple randomization 1:1 and followed for one year. The premise of
      non-inferiority is -2 at the lower limit of the confidence interval 95% for the change in
      PCO2 between the arms being assessed by analysis of covariance, adjusted for 2-sided, age,
      sex, body mass index in intention-to-treat and per-protocol analysis. The cost-effectiveness
      will be performed by Bayesian techniques with sensitivity analysis.
    

Intervention name(s): Manual Non invasive ventilation titration; Automatic Non invasive ventilation titration
Intervention type(s): Device; Device
Intervention description(s): Manual Group: during a complete polysomnography, adding transcutaneous capnography and the basic ventilators curves, the ventilators setting will be adjusted in order to correct respiratory events and patient-ventilator asyncrony. A 10 hours face-to-face investigator training meeting is programmed before opening the inclusion period.; Automatic Group: the A40 ventilator in the automatic AVAPS mode will be adjusted in order to achieve 8-10 ml/kg of ideal weight.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, double arm, double blind controlled trial.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic respiratory failure; Obesity; Non invasive mechanical ventilation
Biopsy Protocol of Upper Gastrointestinal Subepithelial Tumors:Diagnostic Accuracy of EUS-FNB Versus Unroofing Biopsy
Condition: Upper Gastrointestinal Subepithelial Tumors
Study type: Interventional

Summary: 
      To increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are
      required. It is difficult to obtain adequate tissue samples. There were several biopsy
      methods to obtain tissue samples. Pathological examination would include mitosis counts,
      particularly in hypoechoic subepithelial tumors located in the 4th layer of the gastric wall,
      where differentiation between leiomyoma of benign nature and gastrointestinal stromal tumor
      (GIST) of malignant potential is essential.

      So We hypothesize that unroofing biopsy is an more appropriate method than EUS-FNB(endoscopic
      ultrasonography guided fine needle biopsy). We will compare diagnostic accuracy and
      complications between EUS-FNB & unroofing biopsy.
    


Intervention name(s): unroofing biopsy; EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)
Intervention type(s): Procedure; Procedure
Intervention description(s): Unroofing biopsy menas that the mucosa is resected with endoscopic mucosal resection and biopsies are done repeatedly for the exposed tumor with a conventional forcep. It will be performed for the patients with a suspected upper gastrointestinal subepithelial tumor after EUS-FNB. After unroofing biopsy, the final histopathological result will be used to determine diagnostic accuracy.; EUS-FNB will be performed for the same patients who have a gastrointestinal subepithelail tumor before unroofing biopsy. EUS-FNB is called when the tissue is obtained by puncutre of a tumor, the tissue whithin the lumen of the fine needle being detached by rotatin, and the needle withdrawn. The pathological result will be also used to compare diagnostic accuracy between EUS-FNB & unroofing biopsy.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: stomach neoplasm; biopsy
A Study to Evaluate the Pharmacokinetics of Tezepelumab After Being Delivered by an Accessorized Pre Filled Syringe or Autoinjector Compared With Vial and Syringe in Healthy Adult Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to compare PK of tezepelumab exposure in healthy subjects by using vial and
      syringe, APFS, and AI.
    

Detailed description: 
      This study will be a single center, randomized, open label, parallel group study designed to
      compare tezepelumab PK exposure in healthy subjects following single subcutaneous (SC)
      administration of a fixed dose of tezepelumab by using vial and syringe, APFS, or AI. A total
      of 315 subjects will be randomized to receive a single, fixed dose of tezepelumab
      administered SC using vial-and-syringe, APFS, or AI at 1 of 3 injection sites: abdomen, thigh
      or upper arm. Separate randomization lists will be produced for each weight group (50 to < 70
      kg, 70 to < 80 kg, 80 to 90 kg), and within each of the 3 weight groups, subjects will be
      randomized 1:1:1:1:1:1:1:1:1 to 1 of the 9 combinations of treatment (vial-and-syringe, APFS,
      or AI) with injection site (abdomen, thigh, upper arm). Within each weight group, at least 36
      subjects will be randomized resulting in at least 12 subjects per treatment group (device)
      within each weight group.
    

Intervention name(s): Tezepelumab
Intervention type(s): Biological
Intervention description(s): Tezepelumab subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Human monoclonal antibody; Tezepelumab; Accessorized Pre-filled Syringe; Autoinjector
GIOTRIF rPMS in Korean Patients With NSCLC
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean
      patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
    


Intervention name(s): GIOTRIF 20mg; GIOTRIF 40mg; GIOTRIF 30mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NSCLC with GIOTRIF 20mg; NSCLC with GIOTRIF 40mg; NSCLC with GIOTRIF 30mg
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        NSCLC in Korea
Community Based Study on Occupational Asthma
Condition: Asthma; Lung Diseases
MeSH terms: Asthma; Lung Diseases
Study type: Observational

Summary: 
      To examine the occupations, industries and exposures in the work-place which were associated
      with a high risk for asthma and other adverse respiratory health effects, with particular
      emphasis on specific exposures of predominantly female occupations (irritants, detergents and
      other asthmagens), and of other high risk major occupations which had not been adequately
      examined.
    

Detailed description: 
      BACKGROUND:

      Respiratory diseases are strongly related with exposure in the workplace. A considerable
      proportion of adult onset asthma is associated with these exposures. The importance of
      occupational risk factors for asthma has been underestimated, particularly among women. The
      occupational asthma study (ECRHS-OA) forms part of a wider international multicentre survey
      on respiratory health (European Community Respiratory Health Survey-ECRHS). The first phase
      of the ECRHS was conducted in 1991/92 and examined risk factors for asthma and atopy in
      subjects aged 20-44 years. The study updated (ECRHS-II), following-up approximately 17,000
      young adults from 12 countries (Australia, Belgium, France, Germany, Iceland, Italy, Norway,
      Spain, Sweden, Switzerland, UK and USA).

      The study provided valid and precise estimates on the importance of specific occupations,
      industries and exposures in relation to asthma incidence and prevalence, similar estimates
      for other respiratory symptoms and diseases and also for declines in pulmonary function.

      DESIGN NARRATIVE:

      Longitudinal, community-based, multicenter study. Those subjects who took part in the first
      occupational asthma study survey were re-contacted in 1999, to determine risk factors for
      incidence and remission of asthma, other respiratory symptoms, atopy, changes in bronchial
      responsiveness and lung function. Subjects were asked to perform a forced spirometry,
      methacholine challenge and to provide blood samples for IgE testing. A questionnaire
      administrated by trained interviewers was delivered requesting information on respiratory
      symptoms and diseases, socio-demographic factors, tobacco smoking, complete occupational
      history since the last survey, environmental exposures, family history, diet, treatment and
      use of health services. Modular occupational questionnaires were developed for subjects
      employed as cleaners, homemakers, welders, metal workers, nurses, and subjects exposed to
      organic dusts in the paper and textile industries.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Study of Na-ASP-2 Human Hookworm Vaccine in Healthy Adults Without Evidence of Hookworm Infection
Condition: Hookworm Infection
MeSH terms: Infections; Communicable Diseases; Hookworm Infections; Ancylostomiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this clinical trial is to determine the safety and tolerability of
      the Na-ASP-2 Hookworm Vaccine in healthy subjects following the administration of 3
      intramuscular (IM) injections of the vaccine over 16 weeks using 3 different doses. The
      secondary objective is to make a preliminary evaluation of the immunogenicity of each of the
      3 doses of the vaccine in healthy volunteers.
    

Detailed description: 
      There is an urgent need for new tools to control human hookworm infection and to reduce its
      burden of disease in developing countries. This is especially true for children and women of
      reproductive age who represent populations that are highly vulnerable to the effects of
      hookworm disease. Up to 65,000 deaths annually have been attributed to human hookworm
      infection. However, the mortality estimates of hookworm pale in comparison to global disease
      burden estimates.

      The primary approach to hookworm control worldwide has been the frequent and periodic use of
      benzimidazole anthelminthics for school-age children. However, school-based anthelminthic
      chemotherapy programs miss populations highly vulnerable to hookworm, including adolescent
      and adult women. In addition, high rates of hookworm re-infection occur within 4-12 months
      following anthelminthic chemotherapy, and there is evidence for diminished efficacy of
      benzimidazoles with frequent and periodic use, possibly because of emerging drug resistance.
      These concerns have prompted interest in developing alternative tools for hookworm control.
      Vaccination to prevent high intensity hookworm infection would alleviate the public health
      deficiencies of drug treatment alone.
    

Intervention name(s): Na-ASP-2/Alhydrogel Hookworm Vaccine; Saline placebo
Intervention type(s): Biological; Biological
Intervention description(s): The recombinant hookworm protein Na-ASP-2 formulated on aluminum hydroxide adjuvant (Alhydrogel), in one of three dose concentrations, compared to a saline placebo control.; Inactive saline placebo control
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Hookworm; Phase 1; Human Hookworm Infection; Na-ASP-2
Targeting the Right Ventricle in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is looking to see if giving ranolazine to subjects on stable pulmonary
      hypertension specific therapies but with right ventricular dysfunction (RVEF <45%) would
      improve their outcome. This study is accompanied by a baseline comparison of the metabolic
      profiling/microRNA/iPS cells of subjects with and without right ventricular dysfunction.
    


Intervention name(s): Ranolazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks.; Placebo by mouth twice per day for a total of 26 weeks.
Other intervention name(s): Ranexa
Intervention MeSH terms: Ranolazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulmonary hypertension; right ventricular function; ranolazine
A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine the safety and side effects of LY3000328, to
      determine how well the body will tolerate LY3000328, and to determine how long LY3000328
      remains in the body.
    


Intervention name(s): Placebo; LY3000328
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment