louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04548141: Quick Questionnaire to Evaluate Physical Activity
Official title: Simplification de l'évaluation de l'Activité PHysique Par Interrogatoire Rapide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Keywords: Physical activity
Questionnaire
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-09-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Self completion of questionnaire in the waiting room
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test and validate a new questionnaire (SAPHIR) in order to get an evaluation of patients physical activity.

Detailed description: Two questionnaires the SAPHIR and the "International Physical Activity Questionnaire" (IPAQ) are submitted (self completion) to patients referred for consultation.

Retrival of physical activity data on podometer if available

Eligibility criteria: Inclusion Criteria:

* French Native language
* Covered by the French social care system
* Be referred for a consultation to the Sports Medicine Service of Angers Hospital or to the CRSS of Angers

Exclusion Criteria:

* Person opposed to participating in the research
* Person unable to understand the objectives of the study

Primary outcomes:
measure: Proportion of questionnaires with errors after self completion
timeFrame: 1 day
Secondary outcomes:
measure: Facility of the filling of the questionnaires
timeFrame: 1 day
measure: Correlation of the SAPHIR questionnaire to the IPAQ questionnaire
timeFrame: 1 day
measure: Correlation of the SAPHIR questionnaire to the number of weekly steps for patients who have a pedometer available
timeFrame: 1 day
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre hospitalier universitaire
Study officials:
affiliation: University and Hospital in Angers
name: Pierre ABRAHAM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402141: A Human Trial to Evaluate the Effects of Chungkookjang on Histamine-induced Wheal Size in Healthy Subjects
Official title: Efficacy and Safety of Chungkookjang, a Fermented Soy Paste, on Histamine-induced Wheal Size
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy Subjects
Keywords: Chungkookjang
histamine
skin reaction
wheal
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators investigate the effect of Chungkookjang on histamine-induced skin reaction in a double-blind, randomized, placebo-controlled, human trial

Detailed description: Sixty volunteers (aged 20-80) who gave a written consent before entering the study, were randomized in two groups of thirty subjects each. The skin prick test with histamine was performed on the ventral forearm, 10 cm from the elbow, before and after supplement administration, as well as three times daily for 12 weeks of chungkookjang(35g/day) or placebo(35g/day)intake.

Eligibility criteria: Inclusion Criteria:

* Histamine skin prick test: above 3mm

Exclusion Criteria:

* No medication or cosmetic creams were allowed during Substances the previous week and no drugs containing corticosteroids or ACTH within 3 months.
* Patients on systemic or topical treatment with immunosuppressive agents on the nondominant arm were excluded

Primary outcomes:
measure: Changes in Histamine-induced Wheal Size
timeFrame: 12weeks
measure: Number of Participants With Greater Than 40% Decrease in Histamine-induced Wheal Size (Wheal Size by More Than 40% Decrease in the Number of Subjects Compared With Placebo)
timeFrame: 12weeks
Secondary outcomes:
measure: Changes in Immunoglobulin E
timeFrame: 12weeks
measure: Changes in Serum Histamine
timeFrame: 12weeks
measure: Changes in Interferon-gamma
timeFrame: 12weeks
measure: Changes in Interleukin-4
timeFrame: 12weeks
measure: Changes in Eosinophil
timeFrame: 12weeks
measure: Changes in Eosinophil Cationic Protein(ECP)
timeFrame: 12weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Baek-Hwan Cho, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwon DY, Yang HJ, Kim MJ, Kang HJ, Kim HJ, Ha KC, Back HI, Kim SY, Park EO, Kim MG, Yun SK, Chae SW, Cho BH. Influence of the Chungkookjang on histamine-induced wheal and flare skin response: a randomized, double-blind, placebo controlled trial. BMC Complement Altern Med. 2011 Dec 5;11:125. doi: 10.1186/1472-6882-11-125.
Clinical trial NCT00918541: Natural History of Atherosclerosis
Official title: Natural 1-year History of Atherosclerosis in Asymptomatic Patients With Mild to Moderate Carotid Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: atherosclerotic disease
progression
natural progression of atherosclerotic disease
natural history of atherosclerosis at the level of the carotid artery as evaluated by MRI
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Districthospital of Bellinzona
First posted: 2009-06-11
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the districthospital Bellinzona

Brief summary: 20 patients will be recruited. The aim of the study is to determine the natural progression of atherosclerotic disease.


Eligibility criteria: Inclusion Criteria:

* stable carotid artery disease not requiring revascularization
* asymptomatic carotid artery stenosis \< 80% or symptomatic patients with stenosis \< 60 %
* prophylactic therapy with aspirin (\> 100mg/day, statin, blood pressure therapy if indicated (goal \< 130/80 mmHg))
* informed consent

Exclusion Criteria:

* non atherosclerotic occlusive disease (Bürgers disease)
* uncontrolled BP (DBP \> 110 mmHg and/or SBP \> 200 mmHg)
* hemorrhagic disease or platelet count \< 100'000 mm\^3
* Known active liver disease (elevations of GPT GOT or increased ammonia)
* impaired renal function (crea \> 180 mmol/l)
* pregnancy
* severe claustrophobic reactions
* short - term life - threatening pathology
* physically unable to participate in the study
* compliance not guaranteed

Primary outcomes:
measure: Progression of atherosclerotic plaque
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni Bellinzona
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni
city: Zürich
country: Switzerland
facility: Cardiovascular Center Cardiology University Hospital Zürich
Study officials:
affiliation: Cardiovascular Center Cardiology, University Hospital Zürich, Zürich Switzerland
name: Roberto Corti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale San Giovanni Bellinzona, Switzerland
name: Augusto Gallino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03044041: Comparison Between Low Dose and High Dose Intra-articular Tranexamic Acid in Total Knee Arthroplasty
Official title: Topical Intra-Articular High Doses Compared With Low Doses of Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss, Surgical
Keywords: Blood loss
Tranexamic acid
Total knee arthroplasty
Topical administration
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
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 blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT


Eligibility criteria: Inclusion Criteria:

* Osteoarthritic knee who underwent primary total knee arthroplasty

Exclusion Criteria:

* Abnormal coagulation or bleeding disorder
* Allergy to tranexamic acid
* History of thromboembolism or ischemic heart disease or cerebrovascular accident
* chronic kidney disease stage 3-4

Primary outcomes:
measure: Total blood loss
timeFrame: 72 hours after TKA
Secondary outcomes:
measure: Blood transfusion
timeFrame: 0-72 hours after surgery
measure: Rate of participants with thromboembolism
timeFrame: At 72 hours and 2 weeks after surgery
measure: Rate of participants with infection
timeFrame: 0-3 months after surgery
measure: Knee ROM
timeFrame: At 2, 6 weeks after surgery
measure: Functional score
timeFrame: At 6 weeks after surgery
Other outcomes:
Locations:
city: Klong Luang
country: Thailand
facility: Thammasat University
state: Pathum Thani
Study officials:
References:
Clinical trial NCT05155241: A Randomized Controlled Trial Evaluating an Online Intervention in Increasing Seasonal Influenza Vaccination Among Community Dwelling People Aged ≥65 Years
Official title: A Randomized Controlled Trial Evaluating an Online Intervention Based on the Trans-Theoretical Model in Increasing Seasonal Influenza Vaccination Among Community Dwelling People Aged ≥65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination Refusal
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 396
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A non-blinded two-arm parallel randomized controlled trial will be conducted. Inclusion criteria are: 1) aged ≥65 years, 2) having Hong Kong ID, 3) Chinese speaking, 4) willing to be followed up by telephone, 5) having a smartphone, and 6) have not received SIV for the incoming flu season. Exclusion criteria include: 1) cognitive impairment, blindness or deafness, 2) not able to communicate with others effectively, and 3) with known contradictions of SIV (allergic to previous SIV, diagnosed/suspected egg allergy, with bleeding disorder or on warfarin). A total of 396 participants will be randomly assigned to either the intervention group (n=198) or the control group (n=198). Intervention group will watch an online health promotion video tailored to their current stage of change related to SIV uptake once every two weeks for four times (at week 0, 2, 4, and 6).

Participants in the control group will watch a same online video providing general advices related to SIV at week 0, 2, 4, and 6. All participants will be followed up by telephone 3 and 6 months after the baseline survey.


Eligibility criteria: Inclusion Criteria:

* Aged ≥65 years,
* Having Hong Kong ID
* Chinese speaking
* Willing to be followed up by telephone
* Having a smartphone
* Have not received seasonal influenza vaccination for the incoming flu season

Exclusion Criteria:

* Cognitive impairment, blindness or deafness,
* Not able to communicate with others effectively
* With known contradictions of seasonal influenza vaccination listed by the Centre for Health Protection (allergic to previous SIV, diagnosed/suspected egg allergy, with bleeding disorder or on warfarin)

Primary outcomes:
measure: Seasonal influenza vaccination uptake
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre for Health Behaviours Research, the Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT06078241: Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
Official title: Intravenous Lidocaine Infusion Versus Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Analgesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure to remove stones from the kidney by a small puncture wound through the skin. Patients receiving lidocaine infusion had lower pain scores, reduced postoperative analgesic requirements and decreased intraoperative anesthetic requirements. Erector spinae plane block (ESPB) seems to be effective when compared with no block or a placebo block.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score I-II..
* Body mass index \< 35 kg/m2.

Exclusion Criteria:

* Patient's refusal.
* Known coagulopathy.
* Known peripheral neuropathy or neurological deficits.
* Chronic pain disorders.
* Known allergy to study drugs

Primary outcomes:
measure: Time to first rescue analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References:
Clinical trial NCT01393041: St. Jude Medical Angio-Seal VIP Vascular Closure Device
Official title: Clinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Requiring a Diagnostic and/or Interventional Diagnostic Procedure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to assess device deployment characteristics and performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6 French device utilizing the SJM collagen.


Eligibility criteria: Inclusion Criteria:

1. Patient is undergoing a diagnostic and/or interventional endovascular procedure via a retrograde femoral arterial access.
2. Patient is of legal age.
3. Patient has given written informed consent for participation prior to the procedure.
4. Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.

Exclusion Criteria:

1. Patient is unable to provide written informed consent.
2. Patient has an inability or is unwilling to adhere to data collection and follow-up requirements.
3. Patients who are pregnant or lactating.
4. Patient may not participate in another clinical trial which has the potential to impact hemostasis (pharmaceutical/ device/ homeopathic).

Primary outcomes:
measure: Device deployment characteristics and performance
timeFrame: At procedure
measure: Adverse events (vascular complications)
timeFrame: Ongoing
Secondary outcomes:
measure: Time to hemostasis
timeFrame: The time elapsed from device deployment (cutting of the suture) to complete cessation of arterial bleeding, stratified as hemostasis in less than 1 minute, 1-5 minutes, or greater than 5 minutes.
measure: Rate of minor vascular complications
timeFrame: Ongoing
Other outcomes:
Locations:
city: Luedenscheid
country: Germany
facility: Klinikum Luedenscheid
Study officials:
References:
Clinical trial NCT06234241: Normal Values of Cardiac Measurements by Echocardiography in Chinese Based on Artificial Intelligence
Official title: Normal Reference Values of Cardiac Measurements by Echocardiography in Chinese Han Adults Based on Artificial Intelligence: A Multi-center Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Chambers
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese Han healthy adults

Brief summary: Establish echocardiographic normal reference values of Chinese Han adults based on artificial intelligence.

Detailed description: We will establish normal reference values for the volume, function and strain of various heart chambers of Chinese people based on the recruitment of healthy Chinese subjects.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years; No history or clinical evidence of cardiac, cardiovascular, lung, or kidney disease; No abnormal findings on physical examination, biochemical examination, electrocardiography, or echocardiography.

Exclusion Criteria:

* Hypertension (blood pressure \[BP\] \> 140/80 mmHg) or receiving medication for hypertension; body mass index \> 30 kg/m2; total cholesterol ≥ 6.2 mmol/L, triglyceride ≥ 2.3 mmol/L, or high-density lipoprotein cholesterol \< 1.0 mmol/L; endocrine diseases, such as diabetes mellitus (fasting blood glucose ≥ 7.0 mmol/L), thyroid disease, pheochromocytoma, adrenal insufficiency, and hyperaldosteronism; anemia; abnormal liver function; connective tissue diseases, such as rheumatoid arthritis, vasculitis, systemic lupus erythematosus, dermatomyositis, and scleroderma; malignancy; current pregnancy or lactation; professional sport activity; and a history of alcoholism.

Primary outcomes:
measure: Cardiac volumes
timeFrame: 2024-10-31
measure: Cardiac Function
timeFrame: 2024-10-31
measure: Cardiac strain
timeFrame: 2024-10-31
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT06617741: Myasthenia Gravis Foundation of America Global MG Patient Registry
Official title: Myasthenia Gravis Foundation of America Global MG Patient Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myasthaenia Gravis
Myasthenia
Myasthenia Gravis Associated with Thymoma
Myasthenia Gravis Crisis
Myasthenia Gravis Exacerbations
Myasthenia Gravis Generalised
Myasthenia Gravis with Exacerbation (Disorder)
Myasthenia Gravis, Adult Form
Myasthenia Gravis, Generalized
Myasthenia Gravis, Ocular
Myasthenia Gravis, Thymectomy
Myasthenia Gravis
Myasthenia Gravis, MuSK
Keywords: myasthenia
patient registry
MGFA
Myasthenia Gravis Foundation of America
myasthenia gravis
Lead sponsor: Myasthenia Gravis Foundation of America
Sponsor class: OTHER
Collaborators: name: Alira Health
First posted: 2024-09-27
Enrollment: 3800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with access to a mobile device or desktop computer with internet connection are eligible to participate in this study

Brief summary: The goal of this observational study is to learn about the experiences of people living with Myasthenia Gravis (MG) in the United States. The main questions it aims to answer are:

* How and when are people with MG diagnosed?
* What are the most common symptoms associated with MG?
* What treatments are being used to treat MG?
* What are the impacts of MG on activities of daily living, employment and quality of life?
* What are the experiences with exacerbation, hospitalization and healthcare access for people with MG? Participants will answer a survey to enroll in the study, and be invited to fill out an update survey twice a year.

Detailed description: This is a longitudinal, observational, patient reported registry.

Eligibility criteria: Inclusion Criteria:

* age over 18
* positive MG diagnosis

Exclusion Criteria:

* age under 18
* misdiagnosed with MG

Primary outcomes:
measure: Diagnosis of MG
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Westborough
country: United States
facility: Myasthenia Gravis Foundation of America
state: Massachusetts
Study officials:
affiliation: Yale University
name: Patient Registry PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02348541: Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis
Official title: A Post-Market Clinical Follow-up Study to Investigate the Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysteroscopic Adhesiolysis
Lead sponsor: Innocoll
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.

Detailed description: Intrauterine adhesions following gynaecological surgery is a major complication which may cause a range of severe clinical symptoms in women. IUA's can result in menstrual abnormalities, dysmenorrhea and infertility. In pregnancy, adhesions are related to miscarriage, ectopic pregnancy, abnormal placentation, premature labor and delivery and possibly birth defects.

CollaGUARD adhesion barrier is a transparent bioresorbable film approved in Europe for the prevention of postoperative adhesions in patients undergoing abdomino-pelvic laparotomy or laparoscopy.

This study will assess the feasibility of using CollaGUARD adhesion device in hysteroscopic surgery.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis
* Willing to use additional contraception throughout study

Exclusion Criteria:

* Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study
* Has suffered or currently suffers from a gynaecological malignancy
* Has undergone a previous hysteroscopic surgery (such as removal of fibroids)

Primary outcomes:
measure: Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire
timeFrame: following initial hysteroscopy
Secondary outcomes:
measure: Number of de novo adhesion and adhesion reformation
timeFrame: 9 weeks post initial hysteroscopy
measure: Change in severity of adhesions
timeFrame: 9 weeks post initial hysteroscopy
measure: Degradation of CollaGUARD
timeFrame: 2 weeks post initial hysteroscopy
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Sint Lucas Andreas Ziekenhuis
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis
Study officials:
affiliation: Sponsor GmbH
name: David Prior, PhD
role: STUDY_DIRECTOR
References: