louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04535843: Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China
Official title: Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myasthenia Gravis
Keywords: myasthenia gravis
precision diagnosis
antibody detection
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the outpatient clinics and inpatient wards are planned to be enrolled, as long as meeting the inclusion criteria.

Brief summary: The present study is a prospective cohort study aiming to improve the clinical capacity in the diagnosis and natural history of Chinese patients with myasthenia gravis (MG). 300 MG patients are planned to recruit, document and prospectively follow up. Management of screening test and cohort manifestation are studied.


Eligibility criteria: Inclusion Criteria:

* fluctuating muscle weakness and fatigability, along with one of the below:
* more than 10% amplitude decrement in low frequency repetitive nerve stimulation,less than 10% amplitude increment in high frequency repetitive nerve stimulation;
* anti-AChR or MuSK antibody positivity;
* positive to the neostigmine test;
* understanding and assigning the informed consent form, and having a good compliance with the follow up.

Exclusion Criteria:

* excluding the possible diagnosis of Lambert-Eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc;
* poor compliance to the follow up.

Primary outcomes:
measure: Myasthenia gravis foundation of America post intervention status
timeFrame: 3 years
Secondary outcomes:
measure: Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scores at the follow up
timeFrame: Baseline, 1 year, 2 year, and 3 year
measure: Change From Baseline in Activities of Daily Living (ADL) Scores at the follow up
timeFrame: Baseline, 1 year, 2 year, and 3 year
measure: Change From Baseline in Myasthenia Gravis-Quality of Life Questionnaire-15 item (MG-QOL15) Scores at the follow up
timeFrame: Baseline, 1 year, 2 year, and 3 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Obsterics and Gynecology Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital, Shanghai,China
name: Chongbo Zhao, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05783843: Comparison of Text and Pictorial Waterpipe Tobacco Warnings Among Young Adults
Official title: Comparison of Text and Pictorial Waterpipe Tobacco Warnings Among Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Waterpipe Tobacco Smoking
Keywords: Waterpipe Tobacco Smoking
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-24
Enrollment: 1215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized to the text-only condition will see six packages with different text warnings. Participants randomized to the pictorial condition will see six packages with different pictorial warnings. Participants in the control condition will see a single package without a warning.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to whether exposure to waterpipe tobacco warnings reduce young adults' intentions to smoke waterpipe in the future.

Detailed description: Young adults, defined as those 18-29 years old, have the highest rates of waterpipe tobacco smoking, which increases their risk of a variety of pulmonary, neurological, and oncological health conditions, among many others. This trial will randomly assign young adult waterpipe users or those susceptible to use to view waterpipe tobacco packages with text warning, pictorial warnings, or no warnings in a one-time online study. Participants will answer a series of questions regarding each package.

Eligibility criteria: Inclusion Criteria:

* United States (US) Resident
* Has used waterpipe tobacco within the past year (self-report) OR
* Has not used waterpipe tobacco within the past year but is susceptible to use (self-report)

Exclusion Criteria:

* Younger than 18 or older than 29
* Not a US Resident
* Has not used waterpipe tobacco within the past year and is not susceptible to use (self-report)

Primary outcomes:
measure: Behavioral Intentions
timeFrame: Minute 2
Secondary outcomes:
Other outcomes:
measure: Product Appeal
timeFrame: Minute 2
measure: Perceived Message Effectiveness
timeFrame: Minute 2
measure: Attention
timeFrame: Minute 1
measure: Emotional Reactions
timeFrame: Minute 2
measure: Cognitive Elaboration
timeFrame: Minute 1
measure: Self-reported Learning
timeFrame: Minute 1
measure: Social Interactions
timeFrame: Minute 1
measure: Knowledge
timeFrame: Minute 3
measure: Beliefs
timeFrame: Minute 3
measure: Worry
timeFrame: Minute 3
measure: Quit Motivation
timeFrame: Minute 1
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Erin Sutfin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06587243: "Facts Tell… and With Stories Sell?" Combining Viewer-tailored Personal Human Papillomavirus (HPV) Narrative Video With HPV Vaccine Information Video to Improve HPV Vaccine Uptake
Official title: "Facts Tell… and With Stories Sell?" Combining Viewer-tailored Personal HPV Narrative Video With HPV Vaccine Information Video to Improve HPV Vaccine Uptake
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaccination
Keywords: HPV
Vaccine
Narrative
Communication
Videos
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2024-09-19
Enrollment: 1100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare the use of informational videos only, personal story videos only, and the combination of both, to see which is most effective in increasing HPV vaccination.


Eligibility criteria: Inclusion Criteria:

* Parents of 11-17 year olds not yet vaccinated against HPV

Exclusion Criteria:

* Parents whose adolescent children are already vaccinated against HPV
* Participants who do not complete the survey
* Participants who are unable or refuse to view and listen to videos on the participant's device

Primary outcomes:
measure: Number of participants who receive HPV vaccination
timeFrame: 9-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Daniel Salmon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05691543: Modified Technique in Sacrospinous Fixation for Treatment of Apical Genital Prolapse
Official title: A Modified Technique in Sacrospinous Fixation Using Posterior Vaginal Wall Flap for Treatment of Apical Genital Prolapse
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Genital Prolapse
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 15
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test)

Brief summary: Pelvic organ prolapse is one of the most common benign gynecological disorders and affects approximately 40% of women over 50 years of age. The causes of utero vaginal prolapse are pregnancy, labor, obesity, increased intra-abdominal pressure, and weak pelvic floor structures


Eligibility criteria: Inclusion Criteria:

1- Symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test ) .

Exclusion Criteria:

1. Patients with medical disorders that may interfere with surgical interventions ( Like severe chest and heart diseases , renal and liver cell failure , bleeding tendency ) .
2. Patients with urinary incontinence ( excluded by history , examination \& Urodynamics)

Primary outcomes:
measure: The difference of quality life score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04386343: CH1701 for Prevention and Treatment of Radiation Burns
Official title: A Combined Phase I&II, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety for Prevention and Treatment of Radiation Therapy Burn of CH1701
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cancer
Lead sponsor: Vietlife Healthcare Corporation
Sponsor class: OTHER_GOV
Collaborators: name: Vietnam National Cancer Hospital
First posted: 2020-05-13
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase I: Three dose level - 50%, 100% and 167% of the expected dose level Phase II: Four dose level - 0% (Placebo), 50%, 100% and 167% of the expected dose level
Primary purpose: PREVENTION

Brief summary: A combined Phase I\&II, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety for prevention and treatment of radiation therapy burn of CH1701


Eligibility criteria: \*Phase I:

Inclusion Criteria:

* Healthy volunteers, aged 18 and older at the time of enrollment
* Voluntarily participate in the study by signing a consent form to participate in the study
* Ability to adhere to treatment according to researchers' assessment

Exclusion Criteria:

* Subjects with other acute or chronic diseases need to be treated
* It is not possible to comply with the research or studied drug treatment process in the opinion of the researcher

  * Phase II:

Inclusion Criteria:

* Female patient, aged 18 to 60 years old
* Having been diagnosed with breast cancer with axillary lymph node metastasis, having radiation therapy for radiation therapy in the range of 45-50 Gy for a period of 5-6 weeks
* Treatment can be started within 3 days of signing the consent to participate in the study
* Agree to voluntarily sign the consent form to participate in the study

Exclusion Criteria:

* The available skin lesions in the breast and chest and according to the researchers' judgment will affect the assessment of inflammation caused by radiation
* The patient had radiation therapy before the breast area
* History of connective tissue disorders
* The patient is incapable of complying with the research procedures or is unable to ensure compliance with the study medication as assessed by the researcher
* Participate in other clinical trial studies within 1 month before joining this study

Primary outcomes:
measure: Side effects by skin biopsy
timeFrame: 14 days
measure: Degree of burns according to CTCAE 4.03 atlas
timeFrame: 63 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietlife Healthcare Corporation
Study officials:
References:
Clinical trial NCT03221543: Resting Metabolic Rate Testing in Bariatric Surgery Patients
Official title: The Role of Pre-Surgical Metabolic Testing for Procedure Selection in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Weight Loss
Bariatric Surgery Candidate
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates if measuring resting metabolic rate (the number of calories the body burns at rest) before surgery can help predict successful weight loss after surgery.

Detailed description: This is a prospective study enrolling patients from the Baylor Weight Loss Surgery Center who have met all of the requirements to proceed with primary bariatric surgery. Patients will undergo pre-operative and post-operative metabolic testing (6 months, and 1 year after surgery) using a portable calorimeter with eventual follow up of medical record at 5 years. Data from up to 50 patients will be collected. The main objectives are to examine if the pre-operative resting metabolic rate can accurately predict successful weight loss after bariatric surgery and if it can be used to guide the selection of the type of bariatric surgery that would be most successful for the patient.

Eligibility criteria: Inclusion Criteria:

* All patients scheduled for a primary bariatric surgery
* 18 years of age to no upper limit

Primary outcomes:
measure: Examine percent total weight loss
timeFrame: 1 year
Secondary outcomes:
measure: Change in resting metabolic rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Weight Loss Surgery Center
state: Texas
Study officials:
References:
Clinical trial NCT05903443: Research on the Brain Death Determination in China
Official title: Research on the Brain Death Determination and Quality Controlin Chinese Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Death
Electroencephalogram
Evoked Potential
TCD
Quality Control
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 1974
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Coma cases registered by the National Brain Death Determination Quality Control Demonstration Hospital (BDQCH) in the BQCC/NHC from 2013 to 2019 were retrieved.

Brief summary: Purpose China has a population of 1.4 billion and an enormous medical expenditure burden, and Chinese traditional culture has a long history. It takes time to recognize and accept the concept of brain death (BD) as death. Promoting brain death determination (BDD) and rationally allocating medical resources have become major national policy issues. To identify the safest and most reliable ancillary tests needed if the clinical examination is incomplete.

Method The technical group of the Brain Injury Evaluation Quality Control Center of the National Health Commission retrieved coma cases registered from 2013 to 2019. According to clinical criteria for Brain Death Determination (BDD), the patients were divided into two groups: a brain-death (BD) group and a non-BD group. The BD group was divided into a complete brain death with no doubt group (BD1 group) and an incomplete brain death with doubt group (BD2 group). Depending on the site of the brain injury, the accuracy of BDD was evaluated using the independent ancillary test or combined ancillary tests. Data from the BQCC/NHC database and yearbook were obtained, and data analysis and status comparison were conducted on six practical activities: organizational system construction, standard and specification formulation, case quality control, professional skills training, scientific research publicity and education, and international communication.


Eligibility criteria: Inclusion Criteria:

* All cases met the clinical criteria for BD, involving deep coma (Glasgow Coma Scale (GCS)=2T), the absence of brainstem reflexes (pupillary light reflex, corneal reflex, oculocephalogyric reflex, oculovestibular reflex, and cough reflex), and spontaneous respiration. Ancillary tests were completed for all patients.

Exclusion Criteria:

* Does not meet BD clinical evaluation criteria. Ancillary tests were not implemented.

Primary outcomes:
measure: sensitivity
timeFrame: 1 month
measure: specificity
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05516043: Safety and Performance of POLYTHESE® Vascular Prosthesis
Official title: A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data of POLYTHESE® Vascular Prostheses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm Arterial
Peripheral Arterial Disease
Marfan Syndrome
Arterial Dissections
Ehlers-Danlos Syndrome
Lead sponsor: Perouse Medical
Sponsor class: INDUSTRY
Collaborators: name: Eclevar Medtech
First posted: 2022-08-25
Enrollment: 256
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all potential subjects who are appropriate for study inclusion, i.e. subjects implanted with POLYTHESE® for at least one year, or with complete data to death. As the study explores real world data, there is no exclusion criteria for subjects and all subjects with POLYTHESE® implanted for at least one year and have not objected to the collect of their data will be included in the study.

Brief summary: POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®. This study will be done on Real World Data to describe the safety and performance of the device.

PMCF Study.


Eligibility criteria: Inclusion Criteria:

Patients must meet the following inclusion criteria in order to be eligible for inclusion in the study:

- Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death

Exclusion Criteria:

- none

Primary outcomes:
measure: Performance: Primary patency rate
timeFrame: 1 year
measure: Safety : Mortality rate
timeFrame: 30 days
Secondary outcomes:
measure: Procedural success rate
timeFrame: 5 years
measure: Primary patency rate
timeFrame: 5 years
measure: Primary assisted patency rate
timeFrame: 5 years
measure: Secondary patency
timeFrame: 5 years
measure: Device Failure
timeFrame: 5 years
measure: Mortality rate
timeFrame: 5 years
measure: Limb salvage rate
timeFrame: 5 years
measure: Adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU CAEN
city: Nantes
country: France
facility: CHU de NANTES
city: PAris
country: France
facility: CHU La Pitié Salpétrière
Study officials:
References:
Clinical trial NCT03996343: Airway Management and Weight in Children
Official title: Laryngeal Mask Airway Versus Endotracheal Intubation for Airway Management During General Anesthesia in Obese Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Perioperative Respiratory Adverse Events
Airway Management
Keywords: Laryngeal mask airway
Endotracheal intubation
Obese
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators in this study want to see how overweight/obese children who undergo elective surgery requiring airway management react to general anesthesia. They believe that the incidence of perioperative respiratory adverse events (PRAE) associated with Laryngeal mask airway (LMA) use during general anesthesia in overweight/obese children is lower than that associated with endotracheal intubation (ETT).


Eligibility criteria: Inclusion Criteria:

* sex-specific body mass index (BMI) is ≥85th percentile
* elective surgical outpatient peripheral or lower abdominal procedures
* Surgery length estimated to last between 30 and 120 minutes

Exclusion Criteria:

* Active gastro-esophageal reflux, possible difficult intubation or planned asleep fiber optic intubation, cardiac disease, thoracic deformities, upper abdominal, and thoracic or airway surgeries.
* Children with active asthmatic attack or those considered to be "full stomach" will also be excluded.
* Laparoscopic surgical procedures and those requiring extreme head-down tilt will also be excluded.
* Children with a physiology or other condition requiring a certain type of airway for the procedure will also be excluded
* Children whose anesthesiologist is not agreeable to randomization of airway management choice will also be excluded.

Primary outcomes:
measure: Severe respiratory adverse events
timeFrame: perioperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Olubukola Nafiu, MD
role: PRINCIPAL_INVESTIGATOR
References: