louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03028272: Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft vs. Fascia for Tympanoplasty
Official title: Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft Versus Fascia for Tympanoplasty: A Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tympanic Membrane Perforation
Keywords: tympanic membrane perforation
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and functional outcomes as fascia when used for tympanoplasties while offering benefits including reduced operative time, better patient satisfaction, and fewer complications.

Detailed description: A prospective randomized controlled trial will be conducted. Eligible patients will be identified, recruited and randomized to receive either repair using the standard fascia graft or repair using the Skye ActiveBarrier. Subjects will undergo a preoperative evaluation followed by TM repair and subsequent regular office visits to assess functional outcomes, complications, and satisfaction. Patients will be blinded to the substrate used for their repair. As there are two different approaches for a tympanoplasty (through the ear canal or incision behind the ear) based on the subject's ear anatomy and location of the perforation, a sham surgery will not be necessary to disguise which graft is received. At follow up visits, photos may be taken of patients' TMs and these photos will be evaluated for healing by an otologist who did not conduct the surgery in a blinded fashion. At the 1 year follow up appointment, subjects will be told which substrate they received and at the study's conclusion subjects will notified about the study's findings.

Eligibility criteria: Inclusion Criteria:

1. Presence of a tympanic membrane perforation
2. Patient at PI's clinic

Exclusion Criteria:

1. Presence of cholesteatoma
2. Prior surgery on the same-sided TM or middle ear
3. Ossicular chain abnormalities
4. Congenital deformities involving the middle ear or eustachian tube
5. Refusal to undergo surgery

Primary outcomes:
measure: Comparable or improved performance of Skye ActiveBarrier
timeFrame: 12-18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Missouri-Columbia
name: Arnaldo Rivera, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04388072: An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit
Official title: An Diagnostic Cohort on Applicability and Accuracy of AQP4-Immunoglobulin G Detection Kit in the Diagnosis of Neuromyelitis Optica Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromyelitis Optica Spectrum Disorders
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
Collaborators: name: MyBiotech Co. Ltd, China
name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2020-05-14
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with NMOSD who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy by two neurolgists

Brief summary: The diagnostic cohort study could will be use to verify the clinical performance of the AQP4 -immunoglobulin G detection kit and whether it has a good correlation with the clinical diagnosis results. The applicability and accuracy of the kit in clinical diagnosis will be verified according to the measured data.


Eligibility criteria: Inclusion Criteria:

1. The patients who were diagnosed with NMOSD , and the cell-based assay was used to determine the AQP4-IgG-seropositive patients;
2. AQP4-IgG is negative in health people with age and sex matching and determined by cell-based assay;
3. Female or male, age 14-80;
4. Patients or authorized family members volunteered to participate in this study and signed informed consent.

Exclusion Criteria:

1. Patients with coagulation disorders;
2. Infection-related encephalitis;
3. Immune-related encephalitis;
4. A patient with severe mental illness who cannot cooperate clinically;
5. A patient with severe jaundice.

Primary outcomes:
measure: results of AQP4 -immunoglobulin G detection kit
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology,First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
Study officials:
References:
Clinical trial NCT02789072: Effects of Microgravity on Central Aortic Pressure During Parabolic Flights
Official title: Effects of Microgravity on Central Aortic Pressure During Parabolic Flights
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Novespace
First posted: 2016-06-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Cardiovascular events remain the main cause of death of the industrialized world (Global status report on noncommunicable diseases 2010. Geneva, World Health Organization, 2011). Arterial hypertension, hyperlipoproteinemia, smoking, diabetes and family history represent the main cardiovascular risk factors. Arteriosclerosis leads to coronary heart disease, cerebrovascular insufficiency and peripheral vascular diseases that reflect in myocardial infarction and stroke.

The main objective of this experiment is to investigate the differential effect of microgravity on central aortic blood pressure.

The main criterion is the central aortic pressure (measured in mmHg). The hypothesis is that microgravity leads to an increased central aortic pressure.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Treated or non-treated arterial hypertension
* History of cardiovascular disease
* Pregnant women

Primary outcomes:
measure: central aortic pressure
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen CHU
Study officials:
affiliation: CHU CAEN
name: Pierre DP Denise, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03110172: Short-term Efficacy of Antidepressant in Patients Underwent TKA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis Of Knee
Keywords: Osteoarthritis
Depression
Pain
Lead sponsor: Dalian Municipal Central Hospital
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 32
Sex: ALL
Minimum age (years): 51
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients will be randomly divided into two groups. The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation. On the basis of the above scheme, the The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation.
Primary purpose: TREATMENT

Brief summary: By taking certain antidepressant in early postoperative period，which is supposed to improve the psychological status of patients with osteoarthritis, explore the effect of certain antidepressant on the recovery of the early stage after the operation of knee joint replacement.

Detailed description: In this study, the investigators are going to investigate the efficacy of Duloxetine on pain, physical function, mental health and quality of life in patients underwent TKAs.

The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation.On the basis of the above scheme, the treatment group is going to receiving duloxetine 60mg/24h to 8 weeks after operation.HAMD-17 scale, KSS scale, SF-36 scale and WOMAC scale will be used to evaluate the two groups before and after operation for 4 and 8 weeks.

Eligibility criteria: Inclusion Criteria:

1. No extra articular malformations are diagnosed and accord with Kellgren-Lawrence criteria
2. Primary TKA surgery,Varus is smaller than 20°
3. Always there is no history of mental illness, no history of relevant medicine
4. Be able to read and understand Chinese, with good communication skills
5. Voluntary participation in this clinical study

Exclusion Criteria:

1. Previous history of mental and psychological illness
2. With severe diseases in respiratory system, circulatory system or digestive system
3. Allergic to duloxetine and celecoxib

Primary outcomes:
measure: Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 4 weeks of treatment.
timeFrame: up to 6 months
measure: Function score of participants with Duloxetine as assessed by Knee Society Score after 4 weeks of treatment.
timeFrame: up to 6 months
Secondary outcomes:
measure: Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 8 weeks of treatment.
timeFrame: up to 6 months
measure: Function score of participants with Duloxetine as assessed by Knee Society Score after 8 weeks of treatment.
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Dalian
country: China
facility: Dalian municipal central hospital
state: Liaoning
Study officials:
affiliation: Dalian Municipal Central Hospital
name: QI Zhiming, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02943772: Does Local Cooling of Testis in Patients With Epididymitis Relieve Pain and Reduce Quantity of Analgetics Intake?
Official title: Effect of Local Cooling of Testis in Patient With Epididymitis on Analgetics Consumption and Pain Level
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators propose to examine the effect of local cooling of testis in participants with acute epididymitis or orchiepididymitis on participants reported pain level and analgetics consumption.

Detailed description: Epididymitis or orchiepididymitis is an acute disease causing pain and discomfort.

our hypothesis is that local cooling of the affected testis or epididymis may relieve the pain and reduce the analgetics consumption In order to examine this hypothesis we will recruit adult patients with epididymitis or orchiepididymitis and will randomize these patients to two arms.

One arm will receive every 8 hours a brick cooled for at least 2 hours in -20(celsius) for local use on the affected hemiscrotum, while the second arm will receive a brick in room temperature.

Pain level will be estimated one hour following the application of the brick using visual analogue pain score. Patient will receive analgetics according to a predefined escalating protocol.

Pain level and analgetics consumption will be compared between the two arms.

Eligibility criteria: Inclusion Criteria:

* Male patients 18-99 years
* Acute epididymitis or acute orchiepididymitis

Exclusion Criteria:

* Patient unable to informed consent
* Suspicion of testicular malignancy

Primary outcomes:
measure: change in pain level
timeFrame: pain level change from baseline three times a day following the intervention of brick/cooled brick from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks
Secondary outcomes:
measure: Total consumption in grams of protocol analgetics
timeFrame: analgetics consumption will be recorded from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Kaplan Medical Center
Study officials:
affiliation: Kapaln medical center
name: Dan Leibovici, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01846572: Clopidogrel Response in Acute Ischemic Stroke
Official title: Prevalence of Low Response to Clopidogrel in Patients After Acute Ischemic Stroke. The Bochumer CRISP Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: Stroke
Clopidogrel
Aggregometry
Antiplatelet therapy
Platelet function tests
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 159
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: Patients with an acute ischemic stroke admitted to our hospital and treated with clopidogrel

Brief summary: The aim of this study was to determine the prevalence rate and risk factors for chemical laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* acute ischemic stroke
* admittance to stroke unit
* clopidogrel medication

Exclusion Criteria:

* no consent
* prior bleeding disorders
* severe liver disorders
* current gastrointestinal disorders
* congestive heart failure
* life-threatening malignancies

Primary outcomes:
measure: Result of platelet function test
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ruhr University Bochum, Department of Neurology
name: Saskia H Meves, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04537572: A Comparison of Sample Collection Methods for SARS-COV-2 Antibody Testing
Official title: A Comparison of Sample Collection Methods for SARS-COV-2 Antibody Testing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Salveo Diagnostics
Sponsor class: INDUSTRY
First posted: 2020-09-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The negative global consequences of the COVID-19 pandemic has prompted efforts to develop efficient laboratory testing protocols that can be quickly scaled in a practical way. Traditional phlebotomy requirements for antibody testing (venipuncture) often serve as a barrier to widespread population testing since they typically require dedicated facilities and personnel training. Conversely, antibodies are typically very stable in blood and require very little testing volume, which make antibody tests well suited to be run on samples collected via finger-stick, saliva, or other self-administered collection devices. Salveo Diagnostics is a CLIA/CAP certified clinical laboratory that routinely performs testing for anti-SARS-Cov-2 antibodies. The purposes of this protocol are to 1) assess the feasibility of streamlined sample collection procedures for assessing COVID-related immune status, and 2) to provide a mechanism for securing sequential samples in COVID positive and negative patients to support additional studies (e.g. investigating timing of anti-SARS-CoV-2 antibody class switching and antibody persistence).


Eligibility criteria: Inclusion Criteria:

* Confirmed presence (N = 200) or absence (N = 100) of anti-SARS-COV2 antibodies
* \>17 years old

Exclusion Criteria:

* Refusal or inability to provide informed consent

Primary outcomes:
measure: Laboratory determination of presence of anti-SARS-COV2 antibodies (IgM, IgA, and IgG)
timeFrame: testing will be performed within 2 days of collection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Salveo Diagnostics
name: Stephen A Varvel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02152072: Using Simulation-Based Training to Incorporate Lung Ultrasound Into Physical Examination
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Medical Students,Lung Ultrasound,Simulation Training
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 0
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: Medical Students

Brief summary: Dyspnea is a common symptom encountered frequently by medical practitioners. The differential diagnosis for a patient with such a symptom is broad and time consuming, while immediate management for distressed patients is what is desired. Lung ultrasound (LUS) is a relatively new technique that will help physicians more accurately diagnose and manage patients who present with dyspnea.

Focused medical ultrasonography education is becoming integrated into many physician residency training programs. Recent studies indicate a possible relationship between focused ultrasonography training in medical school curricula and improved physical examination accuracy. Thus, a short-term training program in LUS during medical school will have a major impact on physicians to be comfortable in using this skill when dealing with distressed patients in their prospective residency training. It will reduce educational burdens for physician residency programs and improve overall physician competency.

Simulation-based medical education (SBME) is ideally suited for offering effective training in a zero-risk environment. It enables trainees to gain knowledge and confidence in dealing with stressful clinical scenarios without exposing patients to any additional risk. SBME has also been shown to be a reliable tool for assessing learners' procedural skills and for teaching topics such as teamwork and communication.

The investigators hypothesize that simulation-based training of medical students will enable them to more effectively evaluate patients with shortness of breath using LUS.


Eligibility criteria: Inclusion Criteria:

* Third year medical students who signed the consent

Exclusion Criteria:

* a medical student who is not a third year and/or didn't signed the consent

Primary outcomes:
measure: Assess the pre and post-performance of medical students in using lung ultrasound (LUS) for patients with shortness of breath.
timeFrame: 8 weeks
Secondary outcomes:
measure: Measure diagnostic agreement between trainees and experienced physicians in LUS following simulation-based medical education..
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Tulane University
name: Fayez Kheir, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00185172: Olmesartan in Essential Hypertension
Official title: Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 2333
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the efficacy and safety of olmesartan in patients with essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Age: 18 (19 if required by local authorities) to 75 years
* Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized
* Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg
* Written Informed Consent
* Mentally competent
* Negative pregnancy test in women at a childbearing age at the beginning of the study

Exclusion Criteria:

* Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension
* Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months
* Patients with a history or current evidence of congestive heart failure
* Bilateral renal artery stenosis
* Severe renal insufficiency (serum creatinine greater than 200 micro mol/l)
* Severe hepatic impairment or biliary obstruction

Primary outcomes:
measure: To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan.
timeFrame: From week 8 to week 12
Secondary outcomes:
measure: To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12.
timeFrame: 12 weeks
measure: To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Result Cro
city: Aachen
country: Germany
facility: INPUT GmbG
city: Bologna
country: Italy
facility: Biokos Farma s.r.l.
city: Berghem
country: Netherlands
facility: IMRO TRAMARKO International bv
city: Lisboa
country: Portugal
facility: EUROTRIALS Lda
city: Madrid
country: Spain
facility: Phidea S.L.
city: Zurich
country: Switzerland
facility: PFC Pharma Focus Consultants AG
state: Volketswil
city: Edinburgh
country: United Kingdom
facility: Inveresk Ltd.
Study officials:
affiliation: Universitatskliniken des Saarlandes, Homburg, Germany
name: Prof. Michael Bohm, MD
role: PRINCIPAL_INVESTIGATOR
References: