bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Hypnotherapy and Educational Intervention in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Aim: Gut directed hypnotherapy can reduce IBS symptoms but the mechanisms underlying this
      therapeutic effect remain unknown. We determined the effect of hypnotherapy and educational
      intervention on brain responses to cued rectal distensions in IBS patients. Methods: 44 women
      with moderate to severe IBS and 20 healthy controls (HCs) were included.. Blood oxygen level
      dependent (BOLD) signals were measured by functional Magnetic Resonance Imaging (fMRI) during
      expectation and delivery of high (45 mmHg) and low (15 mmHg) intensity rectal distensions.
      Twenty-five patients were assigned to hypnotherapy (HYP) and 16 to educational intervention
      (EDU). 31 patients completed the treatments and the post treatment fMRI. Results: Similar
      symptom reduction was achieved in both groups. HYP responders demonstrated a pre-post
      treatment BOLD attenuation in both anterior and posterior insula during high intensity
      distension, while EDU responders had a BOLD attenuation in prefrontal cortex. Pre-post
      differences for the low distension and for the two expectation conditions were almost
      exclusively seen in the HYP group. For all responders there was a significant correlation
      between treatment induced reduction of GI related anxiety and BOLD decrease in the anterior
      insula. Following treatment, the brain response to distension was similar to that observed in
      HCs, suggesting that the treatment had a normalizing effect on the central processing
      abnormality of visceral signals in IBS. Conclusions: The abnormal processing and enhanced
      perception of visceral stimuli in IBS can be normalized by psychological interventions.
      Symptom improvement in the treatment groups may be mediated by different brain mechanisms.
    


Intervention name(s): Hypnotherapy; Educational intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Gut-directed hypnotherapy administered by an experienced hypnotherapist.; Educational intervention vith education regarding Irritabel bowel Syndrome.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized Placebo Controlled Trial of the Effectiveness of Metformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall objective of the EMERGE trial is to determine whether metformin + usual care,
      compared to placebo + usual care (introduced at the time of initial diagnosis of GDM),
      reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive
      maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for
      women with Gestational Diabetes Mellitus.
    


Intervention name(s): Metformin Hydrochloride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Women randomised to the metformin group will receive metformin 500mg once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of 2500mg Metformin daily (5 tablets) or maximum tolerated dose, in addition to usual care (exercise and MNT), and taken until delivery.; Women randomised to the placebo group will receive 1 placebo tablet once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of five placebo tablets daily, in addition to usual care (exercise and MNT), and taken until delivery.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gestational Diabetes; Diabetes; Pregnancy
Lung Screening Study
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: New imaging procedures such as spiral CT may improve the ability to detect lung
      cancer in patients who are at high risk for the disease.

      PURPOSE: Randomized clinical trial to compare the effectiveness of a spiral CT scan with that
      of a chest x-ray in detecting lung cancer in patients who are at high risk for the disease.
    

Detailed description: 
      OBJECTIVES: I. Compare the efficacy of screening spiral CT scan and screening chest x-ray in
      detecting lung cancer in current or former smokers at high risk for lung cancer.

      OUTLINE: This is a randomized, multicenter study of lung cancer screening. Patients are
      randomized to one of two screening arms. Arm I: Patients undergo one spiral CT scan. Arm II:
      Patients undergo one chest x-ray. Patients and their primary care physicians are notified of
      test results within 3 weeks of the exam.

      PROJECTED ACCRUAL: A total of 3,000 participants (1,500 per screening arm) will be accrued
      for this study at six screening centers (500 per center) by October 31, 2000.
    

Intervention name(s): bronchoscopic and lung imaging studies; comparison of screening methods; computed tomography; radiography; study of high risk factors
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Primary purpose: Screening
Keywords: non-small cell lung cancer; small cell lung cancer
To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328
      in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule)
      during two treatment periods, after food intake or during fasting condition.
    


Intervention name(s): AZD0328
Intervention type(s): Drug
Intervention description(s): Oral capsule, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: AZD0328; Food Effect
BlueWind Medical Reprieve System for the Treatment of PNP
Condition: Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      The current study will evaluate the safety and performance of the BlueWind Medical Reprieve
      System for the treatment of Chronic Painful Peripheral Neuropathy.
    

Detailed description: 
      The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external
      components.

      The system is intended for home care use. The chronic pain treatment is achieved by an
      electrical stimulation of peripheral nerve fibers. The stimulation is set so that it
      generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and
      improving the quality of life for the patient.
    

Intervention name(s): The Reprieve System
Intervention type(s): Device
Intervention description(s): BlueWind Medical neurostimulator for the treatment of neuropathic pain
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PNP; Stimulation; Peripheral neurostimulation
The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Diseases; Obesity
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Obesity
Study type: Observational

Summary: 
      Unlike the general population, a higher body mass index (BMI) is associated with greater
      survival among patients with chronic kidney disease (CKD). However, obesity is defined as
      excess body fat that associated with clearly elevated health risks according to the World
      Health Organization. In addition, muscle wasting is prevalent among CKD subjects. Thus, we
      hypothesized that different definition of obesity, based on BMI or body fat percentage, might
      have different impact on clinical outcomes among CKD population.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with nondialysis CKD with eGFR < 60ml/min/1.73m2
      
Keywords: Diagnostic discordance of obesity; all-cause mortality
Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant
Condition: Hematopoietic Stem Cell Transplantation; Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Observational

Summary: 
      The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while
      minimizing the complications of graft-versus-host disease.
    

Detailed description: 
      The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while
      minimizing the complications of graft-versus-host disease (GVHD) by determining the
      qualitative and quantitative changes in T regulatory cells throughout the transplant process.
      Their understanding of this can lead to new treatment strategies and improved clinical
      therapeutic implications.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant
        for various hematologic conditions
      
Keywords: T-Lymphocyte Subsets
A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers
Condition: Pulmonary Disease; Lung Disease; Moxifloxacin
MeSH terms: Lung Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.
    


Intervention name(s): PF-00610355; PF-00610355; moxifloxacin; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): An orally inhaled dose of PF-00610355 450 µg on days 1 to 4; An orally inhaled dose of PF-00610355 1200 µg on days 1 to 4; A single oral dose of moxifloxacin 400 mg on Day 4.; A single oral dose of non-matched placebo on Day 4.
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: QTC
A UK Multicentre, Health-Related Quality of Life Study for Children and Adolescents With XLH
Condition: X-Linked Hypophosphataemia
MeSH terms: Familial Hypophosphatemic Rickets; Hypophosphatemia
Study type: Observational [Patient Registry]

Summary: 
      This study aims to provide Health-related Quality of Life (HRQoL) data from children and
      adolescents with growing skeletons in the United Kingdom (UK), including those treated with
      burosumab or alternative XLH treatment, as part of an updated submission to the SMC in early
      2023. This study will utilise data from a subset of UK sites already within the XLH Registry
      (including participating Scottish sites) and collect additional HRQoL data within these sites
      (that are otherwise not included in the wider XLH Registry protocol). The HRQoL data will
      enable the calculation of HRQoL to derive the HRQoL utility estimates in children and
      adolescents with growing skeletons for the RSS health states, hence addressing an area of
      uncertainty.
    

Detailed description: 
      This is a multicentre, non-interventional HRQoL study of children and adolescents with
      growing skeletons using routinely collected XLH Registry data and prospectively collected
      HRQoL data. This study will aim to enrol approximately 50 patients from approximately 5 UK
      centres (currently participating in the XLH Registry) over a 6-month period. Each patient
      will be followed for up to 12 months after enrolment. As stipulated, the data collection
      should not require additional patient visits or data collection within the health service.

      Three types of data will be used in this study:

        1. Routinely collected data from the XLH Registry on patient demographics and clinical
           data, as well as PedsQL HRQoL data.

        2. HRQoL data prospectively collected at enrolment, 6-month and 12-month follow-up by the
           patient and/or their parent / legal guardian.

        3. RSS scores within the XLH Registry will be used where available, or RSS will be
           centrally calculated retrospectively from radiographs of the affected wrist and/or knee.
           All RSS calculations will be centrally reviewed.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The study will aim to enrol approximately 50 patients from at least 5 UK centres (currently
        participating in the XLH Registry).

        Subjects will be receiving any XLH treatment (burosumab, oral phosphate and active vitamin
        D or another XLH treatment) within 30 days or prior to informed consent.
      
Keywords: Crysvita; Burosumab; X-linked Hypophosphataemia (XLH); PHEX Gene Mutation
Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study is a retrospective cohort study of patients diagnosed with asthma based on the
      data extracted from the MDV database. The study period is from 1st Jun 2016 to 29th February
      2020 .
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All individuals who meet followed inclusion / exclusion criteria will be identified between
        study period in the MDV database, and will be included in Full Analysis Set.
Pilot Clinical Study of CT1812 in Mild to Moderate Alzheimer's Disease Using EEG
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-site, randomized, double-blind, placebo-controlled, 29-day, 2-period
      crossover Phase 2 study of 1 dose level of CT1812 (active) or placebo in adults with mild to
      moderate AD.
    

Detailed description: 
      This is a single-site, randomized, double-blind, placebo-controlled, 29-day, 2-period
      crossover Phase 2 study of 1 dose level of CT1812 (active) or placebo in adults with mild to
      moderate AD.

      16 participants (8 randomized to 300 mg CT1812, 8 randomly assigned to placebo during each
      treatment period): the 8 participants randomly assigned to CT1812 in Treatment Period 1 will
      receive placebo in Treatment Period 2; the 8 participants randomly assigned to placebo in
      Treatment Period 1 will receive CT1812 in Treatment Period 2.
    

Intervention name(s): CT1812; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Active Treatment- CT1812 at a dose of 300mg; Placebo Comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-site, randomized, double-blind, placebo-controlled, 29-day, 2-period crossover Phase 2 study of 1 dose level of CT1812 (active) or placebo in adults with mild to moderate AD.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Metformin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety and tolerablility of AZD1656 after multiple
      repeated oral doses in patients with type 2 diabetes on top of metformin.
    


Intervention name(s): AZD1656; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.; Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Administered to Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 44847
      in Japanese healthy volunteers
    


Intervention name(s): BI 44847; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Prognostic Value of Tertiary Lymphatic Structure in Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Observational

Summary: 
      Retrospective analysis of the presence and maturity of tertiary lymphoid structures in
      pathological sections of patients with esophageal squamous cell carcinoma after surgical
      treatment. Pay attention to the overall survival and disease free survival of these
      esophageal squamous cell carcinoma patients.
    


Intervention name(s): no-Intervention
Intervention type(s): Other
Intervention description(s): no-Intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients pathologically confirmed esophageal squamous cell carcinoma(ESCC) who underwent
        complete surgical resection at Tianjin Medical University Cancer Hospital between 2014 and
        2021
Feasibility Study of the Hemolung Respiratory Assist System
Condition: Hypercapnic Respiratory Failure, COPD
MeSH terms: Respiratory Insufficiency; Hypercapnia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the Hemolung Respiratory
      Assist System in patients with hypercapnic respiratory failure associated with acute
      exacerbation of chronic obstructive pulmonary disease (COPD) and a 50% likelihood of failure
      of noninvasive positive pressure ventilation leading to intubation and mechanical
      ventilation.
    


Intervention name(s): Hemolung Respiratory Assist System
Intervention type(s): Device
Intervention description(s): Patients meeting the inclusion criteria will be placed on the Hemolung Respiratory Assist System. Patients will be weaned from non-invasive ventilation and then the Hemolung. Hemolung support will be provided for up to 7 days. Follow-up exams will be performed every 15 days until hospital discharge or 30 days from completion of Hemolung therapy, whichever is later.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypercapnic respiratory failure, COPD
Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, vehicle-controlled Phase 3 study to evaluate the efficacy
      and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in
      adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to
      receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.
    

Detailed description: 
      This study is a 12-week double-blind, vehicle-controlled treatment study in which subjects
      will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 12 weeks.
      At the end of the 12-week study treatment, qualified subjects completing the study will have
      the option to enter a separate open-label, long-term safety and efficacy study for an
      additional 40 weeks of treatment with tapinarof cream, 1%. Subjects who do not enroll in the
      open-label long-term study will complete a follow-up visit approximately 4 weeks after end of
      treatment in this study (at Week 16).
    

Intervention name(s): Tapinarof; Vehicle Cream
Intervention type(s): Drug; Drug
Intervention description(s): Tapinarof cream, 1%, applied once daily; Vehicle cream applied once daily
Other intervention name(s): DMVT-505
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Following a 34-day screening period, eligible subjects will be randomized at a 2:1 ratio to receive once daily treatment with tapinarof cream, 1% or vehicle cream.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tapinarof; plaque psoriasis; adult; phase 3; topical; double-blind; efficacy; safety; psoriasis
Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
Condition: Pyoderma Gangrenosum; Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases; Pyoderma; Pyoderma Gangrenosum
Study type: Interventional

Summary: 
      Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease
      (Crohn's or ulcerative colitis) and pyoderma gangrenosum.

      This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2
      weeks initially, then every 1-2 months later in the study.
    


Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention description(s): IV drug given at weeks 1,2,14,22
Other intervention name(s): Remicade
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count
Condition: Antral Follicle Deficit; Fertility
Study type: Observational

Summary: 
      The deficit in the total number of antral follicles is associated with a reduction of the
      ovarian fertility potential in young women.

      The principal objective of this study is to evaluate the relationship between FSH receptor
      polymorphism and antral follicle count.

      The investigators have designed a study of FSH receptor polymorphisms P1 and P2 as an
      association with a low antral follicle count in the ovary.
    

Detailed description: 
      The present study will compare the prevalence of FSH receptor polymorphisms P1 and P2 in
      women having reduced follicle count (1 to 9 antral follicles) or normal follicle count (13 to
      20 antral follicles) determined by ultrasound scans.
    

Intervention name(s): Blood samples
Intervention type(s): Procedure
Intervention description(s): Blood samples
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        YOUNG WOMAN
      
Biospecimen description: 
      DNA
    
Keywords: Polymorphism P1; Polymorphism P2; FSH Receptor; Antral follicle count; FSH receptor polymorphism