louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00815048: Remifentanil and Atropine for Intubation in Neonates
Official title: Remifentanil and Atropine for Intubation in Neonates; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endotracheal Intubation
Keywords: Remifentanil
Endotracheal intubation
Premedication
Sedation
Endotracheal Intubation in Neonates
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2008-12-29
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that the use of a combination of Atropine and Remifentanil will safely facilitate non emergent intubation procedure as effectively as the protocol of Atropine, Fentanyl, and Succinylcholine.


Eligibility criteria: Inclusion Criteria:

* Hemodynamically stable neonates of any gestational age admitted to the Neonatal Intensive Care Unit at McMaster Children's Hospital requiring an elective endotracheal intubation was anticipated.

Exclusion Criteria:

* Urgent intubations
* Cyanotic congenital heart lesions
* Anticipated difficult airway
* Concurrent or recently administered (within 3 hours of the procedure) intravenous opioid infusions
* Pre-existing hyperkalemia
* Family history of malignant hyperthermia
* Prior enrollment

Primary outcomes:
measure: Time to Successful intubation
timeFrame: 15 minutes
Secondary outcomes:
measure: Time to return of spontaneous respirations
timeFrame: 15 minutes
measure: Oxygen saturation
timeFrame: During the procedure up to 15 minutes
measure: Heart Rate
timeFrame: During the procedure up to 15 minutes
measure: Blood Pressure
timeFrame: During the procedure up to 15 minutes
measure: Intubation Condition
timeFrame: 15 minutes post procedure
measure: Evidence of Trauma
timeFrame: 15 minutes post procedure
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University NICU
state: Ontario
Study officials:
affiliation: King Saud University
name: Khalid M Alfaleh, MBBS, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Karen Choong, FRCPC
role: STUDY_DIRECTOR
References:
Clinical trial NCT05092048: A Study for PRO of CML in Real Word
Official title: Validation Value of the Questionnaire to Assess Health-related Quality of Life in Patients With CML
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CML (Chronic Myelogenous Leukemia)
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Above 18 years of age. Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).

Brief summary: Successful outcomes in CML require both prolonged adherence to oral TKI therapy by patients and careful monitoring of treatment responses by their physicians. Patient Reported Outcomes(PRO) assessment is important to facilitate decisions in the current treatment landscape of CML.

Detailed description: 1. Above 18 years of age.
2. Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
3. Written informed consent.
4. Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.


Primary outcomes:
measure: Assess health-related Quality of Life and Symptom Burden in patients with chronic myeloid leukemia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Department of Hematology, Nanfang Hospital, Southern Medical University,
Study officials:
References:
Clinical trial NCT06850948: Experiences of Healthcare for Autistic TGD Adults
Official title: Exploring the Experiences of Gender Identity Healthcare for Autistic Transgender/ Gender Diverse Adults
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autism Spectrum Disorder (ASD
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present study will be promoted via the NHS at the Nottingham Centre for Transgender Health, for which advertisements of the study (see attached document) will be displayed within the clinic

Brief summary: To explore the experiences of autistic gender diverse adults that have attempted or are attempting to access, have accessed or are currently accessing gender identity healthcare in the United Kingdom


Eligibility criteria: Inclusion Criteria:

* Participants must be 18 years or older, they must have first-hand experiences of currently accessing, previously having accessed, or having attempted to access NHS Gender identity clinics in the United Kingdom. The participant must identify as TGD in some capacity (e.g. transgender, nonbinary) and have a formal diagnosis of autism. (Proof of formal diagnosis will not be sought, but participants will be asked about information on this. Diagnosis of autism be asked on the demographic questionnaire, along with question on the diagnosis procedure (e.g. service diagnosis, age of diagnosis). The participant must be able to communicate (verbal or written) in the English Language and be able to provide informed consent.

Exclusion Criteria:

* People who do not meet the inclusion criteria will be excluded from the research.

Primary outcomes:
measure: Interview
timeFrame: From March 2025 to September 2026
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00418548: Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis
Official title: A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly Compared With 25 mg Twice Weekly in Subjects With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare efficacy, pharmacokinetics, and safety of investigational formulations of etanercept administered as 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis (AS).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
* Active AS, defined by average of visual analog scale (VAS) of ≥ 30 for duration and intensity of morning stiffness and at least 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100).

Exclusion Criteria:

* Complete ankylosis (fusion) of spine.
* Previous treatment with etanercept, antibody to Tumor Necrosis Factor α (TNFα), or other TNFα inhibitors or other biologic agents.
* Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Subjects treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
* Receipt of multiple nonsteroidal anti-inflammatory drugs (NSAIDs) at baseline.
* Dose of NSAID changed within 2 weeks of baseline evaluation.
* Dose of prednisone \>10 mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.

Primary outcomes:
measure: The primary objective is to assess the efficacy (measured by % of subjects achieving ASAS 20 (Assessments in Ankylosing Spondylitis 20%) at week 12) and safety of etanercept 50 mg once weekly.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Baraliakos X, Szumski A, Koenig AS, Jones H. The role of C-reactive protein as a predictor of treatment response in patients with ankylosing spondylitis. Semin Arthritis Rheum. 2019 Jun;48(6):997-1004. doi: 10.1016/j.semarthrit.2018.10.019. Epub 2018 Nov 2.
Clinical trial NCT03611348: Microneedling and Latanoprost in Acrofacial Vitiligo
Official title: Effectiveness of Microneedling and Topical Latanoprost in Treatment of Acrofacial Vitiligo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Vitiligo
Keywords: acrofacal vitiligo, latanoprost, microneedling
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: To compare efficacy of topical latanoprost preceded by microneedling versus topical latanoprost alone in treatment of acrofacial vitiligo.

Detailed description: patients meeting inclusion and exclusion criteria presented to Dermatology Outpatient Clinic, Sohag University Hospital will be enrolled in the study after obtaining a written consent from them. Full history will be obtained and meticulous examination will be carried out. Patients will be randomly divided into 2 groups, one group will receive topical latanoprost with microneedling, and the other one will receive topical latabnoprost alone.

Eligibility criteria: Inclusion Criteria:

- Acrofacial stable vitiligo for 6 months duration (without new lesions appearance or change in size of the existing lesions).

Exclusion Criteria:

* History of scar formation.
* Patients with systemic diseases (diabetes, bleeding disorders, chronic renal diseases, chronic liver diseases, asthma and hypertension).
* Patients who are receiving chemotherapy or radiotherapy.
* Pregnant and lactating females.

Primary outcomes:
measure: Improvement in VASI score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: Ramadan Saleh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02183948: Effect of Oxytocin on Masked Facial Expressions: an fMRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Facial Expressions
Keywords: treatment
mask face exoressions
genier
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose is to test whether oxytocin has an effect on masked facial expressions

Detailed description: The neuropeptide oxytocin (OXT) has been shown to modulate several aspects of human social cognition. Although the exact mechanisms behind these effects remain unclear, recent research suggests that OXT modulates the perception of cues that are important for interpersonal processing, particularly emotional facial expressions. Using a backward masking procedure and functional magnetic resonance imaging, we investigated the modulatory effects of intranasal OXT on the processing of sub-liminally presented emotional faces. In a double-blind placebo-controlled between-subject pharmaco-fMRI experiment healthy volunteers received either 24IU of intranasal oxytocin or placebo 45mins before they were presented emotional (happy, angry, fearful, sad, disgusting) faces and mirror-reversed neutral faces masked by neutral faces of the same individual. To ensure attentional processing of the faces subjects were required to perform a simple gender decision task in the scanner and a recognition memory task afterwards. All subjects were additionally assessed for their state and trait anxiety and depression as well as empathy. For the analysis, we will use matlab, SPM and SPSS to conduct structural ROI analysis and two Sample t test.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects, no smoke or drink alcohol, coffee or other stimulants during the day before Experiment.

Exclusion Criteria:

* history of head injury; pregnancy; uterine cavity operations were took within one year; medical or psychiatric illness; rhinitis in case they may not fully absorb the spray.

Primary outcomes:
measure: Number of participants with neuro activity to facial expressions
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05619848: Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery
Official title: Effect of Paravertebral Muscle Fat Infiltration on Rocuronium Use in Lumbar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Spinal Stenosis Lumbar
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To investigate the effect of different degrees of fat infiltration on rocuronium use in lumbar surgery was monitored by trapezius muscle relaxation.

Detailed description: Select the patients who will receive posterior lumbar surgery in the Second Hospital of Shanxi Medical University. According to the classification criteria of fat infiltration, it will be divided into three groups: mild, moderate and severe. This study will pump and titrate rocuronium bromide under the monitoring of muscle relaxation during the operation, record the dosage of rocuronium bromide and the duration of pump injection, and evaluate its clinical effect. Postoperative results include the use and clinical effect of rocuronium, which will be counted after the trial.

Eligibility criteria: Inclusion Criteria:

Age: 18-65; ASA grade I-II; no significant cardiopulmonary disease; no history of surgery in the corresponding surgical area; no coagulopathy.

Exclusion Criteria:

refusal to participate by the present experimenter; those with severe cardio-cerebrovascular disease, severe hepatic and renal dysfunction; taking medications affecting the neuromuscular junction; area of monitoring site for skin breakers; patients with intraoperative bleeding, anaphylactic shock, or other serious complications; patients requiring intraoperative neurophysiological monitoring (including sensory, motor evoked potentials).

Primary outcomes:
measure: use of rocuronium bromide
timeFrame: Perioperative period
Secondary outcomes:
measure: The general condition of the paraspinal muscle
timeFrame: Perioperative period
Other outcomes:
measure: Muscle relaxation satisfaction score
timeFrame: Perioperative period
Locations:
city: Taiyuan
country: China
facility: Second of Shanxi Medical University
state: Shanxi
Study officials:
affiliation: Second of Shanxi Medical University
name: Guo Zheng, Ph. D
role: STUDY_CHAIR
References:
Clinical trial NCT00031148: Keratinocyte Growth Factor to Prevent Acute GVHD
Official title: Phase I/II Trial of Keratinocyte Growth Factor (rHuKGF) to Prevent Acute GVHD in 6/6 HLA=BMT Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Graft-vs-Host Disease
Keywords: Keratinocyte growth factor
Bone Marrow Transplantation
Hematopoietic Stem Cell Transplantation
HLA Antigens
Transplantation, Homologous
Recombinant Proteins
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2002-02-27
Enrollment: 72
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: This is a study to determine the safety and efficacy of keratinocyte growth factor (KGF) to prevent acute graft-versus-host disease (GVHD) in patients undergoing allogeneic bone marrow (BM) or peripheral blood progenitor cell (PBPC) transplantation.

Detailed description: GVHD remains the major complication of allogeneic BM transplantation and is initiated during the conditioning of the recipient for transplant when the host tissues are damaged. Research has demonstrated that the gastrointestinal (GI) tract is a critical organ in GVHD pathophysiology. Agents that protect the GI tract may provide prophylaxis against the cytokine cascade and can lead to a reduced incidence and severity of GVHD. KGF is a protein that stimulates the growth of epithelial cells including those of the GI tract. KGF can protect the GI tract, prevent GVHD, and preserve donor T-cell function.

Patients will receive standard GVHD prophylaxis in addition to the study drug. Overall GVHD will be graded weekly during the first 2 months after transplant, then every other week to Day 100. Response to therapy will be measured through the use of severity indices, physical exam, and laboratory serum values.

Eligibility criteria: Inclusion criteria:

* Diagnosis of a hematological malignancy, including myelodysplastic syndromes.
* Eligible for cyclophosphamide and total body irradiation conditioning therapy or busulphan and cyclophosphamide conditioning therapy.
* Must have a 6/6 human leukocyte antigens (HLA)-matched family member donor.
* Women must be post-menopausal, sterile, or using effective contraception for 1 month before, during, and for 2 months after study.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion criteria:

* T-cell depletion for GVHD prophylaxis.
* Active hepatitis.
* Pre-existent inflammatory bowel disease requiring active therapy.
* Active uncontrolled infection.
* Prior bone marrow or peripheral blood stem cell (PBSC) transplantation.
* Documented hypersensitivity to rHuKGF.
* Prior enrollment to a study of rHuKGF.
* HIV-positive.
* Pregnant or nursing.
* Active chronic skin disease requiring therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
References:
Clinical trial NCT00285948: Primary Birmingham Hip Resurfacing Arthroplasty Using a Metal-on-Metal Couple in the Young Active Patient
Official title: Primary Birmingham Hip Resurfacing Arthroplasty Using a Metal-on-Metal Couple in the Young Active Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indications for a Total Hip Prosthesis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-02-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To prospectively obtain data about the clinical and radiological results of the resurfacing technique as primary hip prosthesis in young active patients


Eligibility criteria: Inclusion Criteria:

* Total hip prosthesis

Exclusion Criteria:

-

Primary outcomes:
measure: Clinical and radiological results
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Rene Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04274348: Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum
Official title: Role of Staphylococci on Cytokine and T Cell Profiles in the Pathogenesis of Atopic Dermatitis and Eczema Herpeticum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Staphylococcus Aureus
Bacterial Toxins
Immune Response
Cytokines
T Cells Subsets
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. Clinical studies have demonstrated a link between staphylococcal skin colonization and the pathogenesis of AD, but the implication of bacterial virulence factors remains largely uncharacterized. Finally, AD is often associated with herpes simplex skin infections. The aim of this project is to investigate the role of staphylococcal toxins in the exacerbation and maintenance of atopic skin inflammation and in the occurrence of infectious complications such as eczema herpeticum.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate AD (SCORAD between 25 and 50) or severe AD (SCORAD\> 50)
* Skin lesions in the forearms
* Free subject, without neither guardianship, wardship nor subordination
* Patient with Social Security
* Informed and signed consent by the patient after clear and loyal information on the study

Exclusion Criteria:

* Age \< 18 year-old
* Patients with mild AD (SCORAD \< 25)
* Patients without skin lesions in the forearms
* Patients treated with dermocorticoid or calcineurin inhibitor for less than two weeks
* Patients under systemic treatment : Methotrexate, Ciclosporin, Mycophenolate Mofetil, Azathioprine, general corticosteroids for less than 4 weeks
* Patients under biological treatment : Dupilumab for less than 5 half-lives
* Patient without Social Security
* Pregnant and nursing women

Primary outcomes:
measure: Quantification of S. aureus colonization level and characterization of bacterial virulence profile in AD lesions.
timeFrame: 2 hours (with consultation and sample)
Secondary outcomes:
measure: Determination of the inflammatory profile of skin and blood during AD. Definition of the seric cytokine signature characteristic of AD. Characterization of the phenotype and function of the lymphocytic infiltrate T during AD.
timeFrame: 2 hours (with consultation and sample)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References: