bioihbjkbjnl/mcl2 huggingface dataset:
Peanut Oral Immunotherapy in Children
Condition: Peanut Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut
      oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in
      peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned
      to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26
      weeks.
    

Detailed description: 
      An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be
      conducted. Participants must have a clinical reaction during this OFC to initiate study
      dosing. After the initial OFC, the study design includes four phases:

        -  Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally
           and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein)
           or placebo flour is given.

        -  Build-up (30 weeks): Initial observed dose administration of highest tolerated dose,
           followed by daily OIT at home with return visit every 2 weeks for dose escalation.

        -  Maintenance (104 weeks):The participant will continue on daily OIT with return visits
           every 13 weeks. At the end of this phase the participant will undergo a blinded OFC to
           10 g peanut flour (5 g peanut protein).

        -  Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks. At
           the completion of this phase participants will have a final blinded OFC to 10g peanut
           flour (5 g peanut protein).
    

Intervention name(s): Peanut Oral Immunotherapy - Liquid Extract; Placebo for Peanut Oral Immunotherapy - Liquid Extract form; Peanut Oral Immunotherapy - Peanut Flour; Placebo for Peanut Oral Immunotherapy - Peanut Flour
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Used during initial dose escalation for doses 0.1 to 0.8 mg.; Similar in appearance, texture, and taste to peanut liquid extract.; This will be used for the remainder of dose escalation, build-up, and maintenance.; Similar in appearance, texture, and taste to peanut flour.
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Allergy, Peanut; Peanut allergy; Hypersensitivity; Immunotherapy; Desensitization, Immunologic
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III, multicentre, randomized, double-blind, parallel group, long-term study
      investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment
      of uterine myoma.
    

Detailed description: 
      The target population is composed of pre-menopausal women with symptomatic uterine myoma(s)
      characterised by heavy bleeding.The main objective of this study is to assess the sustained
      efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine
      bleeding, myoma size, pain and quality of life.
    

Intervention name(s): PGL4001 5 mg; PGL4001 10 mg
Intervention type(s): Drug; Drug
Intervention description(s): PGL4001 5 mg daily administration; PGL4001 10mg daily administration
Other intervention name(s): Ulipristal Acetate, Esmya; Ulipristal Acetate
Intervention MeSH terms: Ulipristal acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Comparison of Methods to Detect Polyps During Colonoscopy
Condition: Colorectal Cancer
MeSH terms: Polyps
Study type: Interventional

Summary: 
      Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer
      deaths in western countries. Colonoscopy is a preferred colorectal screening modality since
      it has both diagnostic and therapeutic capability. Detection and removal of polyps at
      colonoscopy decreases the incidence and mortality from colorectal cancer.

      Typical practice is to insert the colonoscope rapidly until it reaches the cecum (a
      pouch-like portion of the intestines, where the large bowel and the small bowel meet). The
      physician then withdraws the colonoscope slowly and looks for any polyps or abnormalities
      within the large bowel. The purpose of this study is to compare this standard practice to the
      approach whereby the physician examines the bowel as the scope is initially inserted AND as
      the colonoscope is withdrawn from patients' colons.
    


Intervention name(s): Standard Inspection Colonoscopy; Dual Inspection Colonoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): The large bowel will be inspected for polyps during the withdrawal of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.; The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: colonoscopy; adenoma detection; polyps
Intra-dermal Injections of DLX105 Into Lesional Skin in Patients With Mild-to-moderate Psoriasis Vulgaris
Condition: Mild-to-moderate Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The overall purpose of this study is to support the development of a DLX105 topical
      formulation for the indication mild to moderate psoriasis vulgaris.
    


Intervention name(s): DLX105
Intervention type(s): Drug
Intervention description(s): intradermal injections (volume: 0.1 mL) of 0.02 mg (low dose cohort), 1 mg (high dose cohort) DLX105, days: Day 1, Day 4, Day 7 and Day 10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: safety tolerability and immunogenicity of two different doses of DLX105 applied intra-dermally into psoriatic lesion of mild-to-moderate psoriatic patients
Effect of Virtual Reality on Functional Fitness and Quality of Life of Older Population
Condition: Aging; Happiness; Quality of Life
Study type: Interventional

Summary: 
      The purpose of this study is to assess the influence of virtual reality (VR) on the different
      parameters, happiness, quality of life and functional fitness, among older population. The
      study aims to conduct a randomized controlled trial, where the participants in intervention
      group will use VR and those in control group do not use VR.
    

Detailed description: 
      This study aims to conduct a randomized control trial, on 60 older age group participants,
      and perform the functional fitness test based on the protocol developed by Rikli and Jones,
      before and after the VR intervention. The functional fitness tests include evaluation of
      upper body strength, lower body strength, cardiorespiratory endurance, upper body flexibility
      test, lower body flexibility test, balance, agility test. They will be randomly assigned to
      the intervention group, receiving the VR program, and the control group who will not receive
      the VR program. The participants in the intervention group will be asked to use the VR device
      for 15 minutes, twice a week for 6 weeks, along with their daily routine activities. Control
      group will carry out the daily routine activities, without the intervention. The change in
      the quality of life (QOL) and happiness, for both control and intervention groups, will be
      assessed through EuroQol 5 dimensions 3 level questionnaire (EQ-5D-3L), mini version of
      Chinese happiness Inventory questionnaire, respectively, to filled at recruitment and
      follow-up after 6 weeks. The effect of the VR programs will be determined by the comparison
      of performance, for the functional fitness tests before and after the intervention and also,
      for the differences between the control and intervention groups
    

Intervention name(s): Virtual Reality experience
Intervention type(s): Other
Intervention description(s): Participants will receive virtual reality based experience and will be assessed for its influence on happiness, functional fitness components and quality of life of older age groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention study with 2 parallel arms
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: virtual reality; older population; functional fitness; quality of life; happiness
Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to identify a safe dose of MK-2248 in participants with
      Hepatitis C Virus (HCV) that mediates at least a 3 log10 reduction in viral load (VL) from
      baseline. It is anticipated that once-daily administration of a safe and well tolerated dose
      of MK-2248 will reduce VL by at least 3 log10 IU/mL.
    

Detailed description: 
      In this Phase 1b study, the pharmacokinetic (PK), pharmacodynamic (PD), and safety profile of
      MK-2248 in HCV-infected participants will be evaluated as follows: Part I will assess
      sequentially ascending MK-2248 doses from 200 mg to ≤800 mg over 4 panels (A, B, C, and D).
      Part II will assess sequentially ascending MK-2248 doses from 200 mg to ≤800 mg over 4 panels
      (E, F, G, and H). Part III will assess sequentially ascending MK-2248 doses ranging up to
      ≤800 mg in 2 panels (I and J). The potential relationship between plasma MK-2248 levels and
      VL reduction will be determined.
    

Intervention name(s): MK-2248
Intervention type(s): Drug
Intervention description(s): MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Color Flow Doppler Ultrasound in Subclinical Thyroid Dysfunction
Condition: Subclinical Hypothyroidism; Hyperthyroidism; Thyroid Dysfunction
MeSH terms: Thyroid Diseases; Hypothyroidism; Hyperthyroidism
Study type: Observational

Summary: 
      Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic
      changes.Regional blood flow disturbances (including intrathyroidal) were also reported in
      these thyroid disorders. The purpose of this study is to investigate the thyroid vascularity
      and blood flow by Color Flow Doppler Sonography in patients with subclinical thyroid
      dysfunction
    

Detailed description: 
      Color Flow Doppler Sonography (CFDS) has become in the last years an increasing procedure to
      assess the thyroid blood flow. Previous studies showed specific changes of thyroid blood flow
      in hyperthyroidism, Hashimoto's thyroiditis and thyroid nodules when investigated by CFDS.
      Subclinical hyperthyroidism and hypothyroidism are common laboratory findings, defined by
      normal thyroid hormones concentrations along with ,respectively,decreased or increase Thyroid
      stimulating hormone (TSH) level. We purpose to investigate thyroid vascularity by CFDS in
      patients with subclinical hyperthyroidism or hypothyroidism and compared them with euthyroid
      patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with subclinical hypothyroidism and hyperthyroidism
      
Keywords: hypothyroidism; hyperthyroidism; thyroid dysfunction; ultrasound; doppler
Effectiveness of an Integrated Care Program on Asthma Control and Inhaled Corticosteroids Adherence
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The investigators propose to implement and evaluate an integrated care program for enhancing
      the care of patients with asthma in a region of Quebec province, Canada. The investigators
      will implement our intervention in a family medicine group practice setting and plan to
      deliver it to 150 experimental group subjects. The investigators will simultaneously study
      300 control subjects who are receiving usual care in other regions of the province of Quebec.
      Our hypothesis is that the program will improve the quality of life of patients with asthma
      exposed to the program, asthma control, inhaled corticosteroid adherence, knowledge of
      asthma, and a number of variables that relate to the conceptual model selected as a framework
      for this study (the PRECEDE-PROCEED model of Green and Kreuter).
    


Intervention name(s): Integrated care program
Intervention type(s): Other
Intervention description(s): Integrated care program meant in effect, calling on the family medicine group (FMG) nurses to evaluate and support asthmatic patients. The FMG and asthma education centre (AEC) nurses received special training and followed a protocol based on the theoretical model and the Canadian asthma management recommendations then in force. The protocol had five main aspects: 1) asthma assessment, 2) self-management, 3) environment and lifestyle, 4) collaborative care plan, and 5) information sharing and follow-up.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: asthma; intervention; medication adherence; inhaled corticosteroids; asthma control; integrated care
Bioavailability of BIBR 953 ZW After BIBR 1048 (Oral Pro-drug of BIBR 953 ZW) Administered as Hydroxypropyl Methylcellulose (HPMC) Polymorph II Capsule Relative to HPMC Polymorph I Capsule in Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of the relative bioavailability of BIBR 953 ZW after administration of 150 mg
      BIBR 1048 polymorph II versus BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph
      I in HPMC capsules
    


Intervention name(s): BIBR 1048 MS polymorph II; BIBR 1048 MS polymorph I
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus
Condition: Erosive Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional

Summary: 
      this study evaluates the effect of diode laser in treatment of oral lichen planus.
    

Detailed description: 
      44 patients with erosive oral lichen planus were included in the study and divided into 2
      equal groups. Group I received topical steroid therapy three times daily for 4 weeks and
      antifungal oral gel once daily for 1 week. Group II received 980nm Diode Laser 300 mW, up to
      10 sessions.
    

Intervention name(s): 980nm Diode Laser; 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"
Intervention type(s): Device; Drug
Intervention description(s): 300 mW, 4 J/cm2, 2mm non-contact mode up to 10 sessions; three times daily for 4 weeks
Other intervention name(s): Kenacourt-A Orabase
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Benzocaine; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients
Condition: Acute and Chronic Inflammation; Dyspepsia
MeSH terms: Inflammation; Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety of an association with one
      anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and
      one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.
    

Detailed description: 
      -  Double-blind,randomized, multicenter

        -  Experiment duration: 14 days

        -  03 visits

        -  Evaluate the safety of an association with one anti-inflammatory and one
           gastroprotective compared to association with one anti-inflammatory and one
           gastroprotective agent in patients with acute or chronic osteoarticular inflammation

        -  Adverse events evaluation
    

Intervention name(s): Nimesulide + Pantoprazole; Naproxen + Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo.; 1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Nimesulide + Pantoprazole placebo.
Other intervention name(s): VIMOVO
Intervention MeSH terms: Naproxen; Nimesulide; Esomeprazole; Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ibuprofen and Biomarkers of Acute Kidney Injury After Running in the Heat
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to determine if ibuprofen prior to exercise in the heat worsens
      biomarkers of acute kidney injury. Participants were given 600mg of ibuprofen or placebo
      (corn starch) 12- and 1-hour prior to running for 1-hour in a hot environment (35°C) at
      moderate intensity. Urine, plasma, and serum samples were collected pre-, post-, and 1hour
      post-exercise to assess biomarkers of acute kidney injury. This was a double blind,
      randomized crossover design, so that participants completed the alternate trial (ibuprofen or
      placebo) at least seven days later.
    


Intervention name(s): Ibuprofen 600 mg; Placebo Corn Starch
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg of ibuprofen was ingested 12- and 1-hours prior to exercise.; 600 mg of corn starch (placebo) was ingested 12- and 1-hours prior to exercise.
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block
Condition: Rib Fractures; Serratus Anterior Plane Block; Erector Spinae Plane Block; Acute Pain
MeSH terms: Acute Pain; Fractures, Bone; Rib Fractures
Study type: Interventional

Summary: 
      More than 50% of patients presenting with chest trauma experience rib fractures and these rib
      fractures are associated with significant morbidity, mortality, and long-term disability.
      Many of these adverse outcomes result from poorly controlled pain that interferes with
      breathing, leading to atelectasis, pneumonia, and respiratory failure. Therefore, early
      provision of adequate analgesia is crucial in the management of these patients. The basic
      stones of analgesic therapy are oral and intravenous drugs such as paracetamol, nonsteroidal
      anti-inflammatory drugs (NSAIDs), and opioids. However, patients with more significant
      injuries or comorbidities often require interventional procedures to provide adequate
      analgesia and avoid opioid-related side effects. Thoracic epidural analgesia and thoracic
      paravertebral blocks have traditionally been used, but these techniques are associated with
      side effects and may cause hemodynamic instability. Today, the use of ultrasonography (USG)
      guided block techniques such as erector spinae plane block (ESPB), serratus anterior plane
      block (SAPB) and intercostal block (ICB) has increased. These techniques are considered to be
      simpler and theoretically safer. Although ICB is frequently mentioned in the literature, the
      publications of new plane blocks such as ESPB and SAPB are new and few in number. In this
      study, SAPB and ICP to be performed with USG will be evaluated in terms of analgesic effect.
    


Intervention name(s): Serratus Anterior Plane Block; Intercostal Block
Intervention type(s): Procedure; Procedure
Intervention description(s): Serratus anterior plane block will be performed unilaterally, under US guidance.; Intercostal Block will be performed unilaterally, under US guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rib Fractures; Serratus Anterior Plane Block; Erector Spinae Plane Block
Impact of Non-intentional Leaks on Noninvasive Ventilation
Condition: Intermittent Positive-pressure Ventilation; Respiratory Physiological Phenomena
Study type: Observational

Summary: 
      The investigators hypothesized that increasing non intentional leaks could increase work of
      breathing and could lead to patient/non-invasive ventilation (NIV) asynchrony.

      The main objective is to compare ventilatory pattern (work of breathing, flow, pressure)
      under NIV with and without non-intentional leaks in 10 awakened healthy subjects and 10
      awakened and asleep obese hypoventilation syndrome (OHS) patients.

      Methods: While the subjects will be under NIV, several levels of leaks will be simulated in a
      random order with an automatically opening valve. Breathing pattern (work of breathing,flow,
      pressure, thorax and abdominal movements) will be recorded by Polygraphy. Healthy subjects
      will be recorded only during awakened state. OHS patients will be recorded both during awake
      and sleep sates.

      Analysis: A repeated measures analysis of variance (ANOVA) will compare work of breathing
      according to the different levels of leaks.
    


Intervention name(s): Non intentional leaks during non invasive ventilation
Intervention type(s): Other
Intervention description(s): During NIV sessions (in awake state for both the 10 healthy and the 10 OHS subjects and during sleep only for the OHS subjects), the investigators will create several levels of non intentional leaks in a random order
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        10 healthy subjects recruited in professionnal area 10 patients with Obesity
        hypoventilation syndrome addressed to the sleep laboratory for clinical assessment
      
Keywords: non-invasive intermittent positive-pressure ventilation; work of breathing; Pulse transit time