louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02422602: Better Adherence With New Oral Anticoagulant in Atrial Fibrillation : Effectiveness of a Personalized Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-valvular Atrial Fibrillation
Keywords: Patients
treated by Rivaroxaban
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is multicentric, single-blind, and interventional with a randomization into two parallel arm, between a standard of care information and an additional information of the patient, with a 12 month follow up.

The aim of this study is to evaluate the effectiveness of a personalized information program versus information provided from standard of care in patients taking Xarelto for Stroke Prevention in Atrial Fibrillation.


Eligibility criteria: Inclusion Criteria:

* All patients treated with rivaroxaban chronically, (atrial fibrillation non-valvular under current AMM) for less than one year whatever anti vitamin K treatment history
* Affiliate or beneficiary of a social security system.
* Patient who formulated its "does not oppose" to participate in this research
* Age higher than or equal to 18 years

Exclusion Criteria:

* Opposition to participation
* Patient don't understand french language
* Patient does not have responsibility for the management of treatment (treatment administered by a nurse at home, or by caregivers)
* Tutorship or curatoship
* Law-protected patient
* Pregnant women or breast-feeding

Primary outcomes:
measure: The occurence of serious adverse event
timeFrame: 12 months
Secondary outcomes:
measure: The number ok hospitalization
timeFrame: 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Heart and vascular diseases service
Study officials:
References:
Clinical trial NCT03189602: Pulmonary Artery Involvement in Takayasu's Arteritis
Official title: Pulmonary Artery Involvement in Takayasu's Arteritis: a Retrospective Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Takayasu Arteritis
Pulmonary Artery Hypertension
Keywords: Takayasu Arteritis
Pulmonary artery hypertension
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 51
Sex: ALL
Minimum age (years): 14
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Takayasu's arteritis patients with pulmonary artery involvement

Brief summary: The purpose of this study is to analyze the clinical manifestations, imaging features, and prognosis-related factors of pulmonary artery (PA) involvement in Takayasu's arteritis (TA), and to explore the early clinical features of PA involvement in TA patients.

Detailed description: Takayasu's arteritis patients with pulmonary artery involvement were enrolled into this study. The demographic information of the patients (age, sex, course of disease), symptoms at their admissions (cough, hemoptysis, dyspnea, palpitations, fever), laboratory examinations (blood lab routines, erythrocyte sedimentation rate, C-reactive protein), and imaging examinations (vascular ultrasonography, computed tomographic angiography, echocardiography, chest CT, CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT) were collected by reviewing the cases. The prognostic information was collected by telephone follow-up. The follow-up end point was December 2015.

Eligibility criteria: Inclusion Criteria:

* 1.Meet the diagnostic criteria of TA as defined by the American College of Rheumatology (ACR).
* 2.PA involvement: meet at least one of three items: (1) at least one of computed tomographic pulmonary angiography (CTPA), pulmonary perfusion imaging, or pulmonary arteriography suggests thickening of vessel wall, stenosis, aneurysm, or occlusion; (2) 18F-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) suggests high intake of local radioactive material in pulmonary artery wall; (3) pulmonary artery systolic blood pressure is higher than 50 mmHg assessed by transthoracic echocardiography (defined as PAH), without left ventricular disease.

Exclusion Criteria:

-

Primary outcomes:
measure: Pulmonary Artery Systolic Blood Pressure
timeFrame: 1day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Juhong Shi, M.D
role: STUDY_CHAIR
References:
citation: Yang J, Peng M, Shi J, Zheng W, Yu X. Pulmonary artery involvement in Takayasu's arteritis: diagnosis before pulmonary hypertension. BMC Pulm Med. 2019 Nov 27;19(1):225. doi: 10.1186/s12890-019-0983-7.
Clinical trial NCT02087202: Hyperalgesia and NMDA Receptor Antagonist
Official title: Hyperalgesia and NMDA Receptor Antagonist
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: pain
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: NMDA receptor is administered and postoperative remote hyperalgesia is investigated.

Detailed description: NMDA receptor is adminstered and postoperative tertiary hyperalgesia is investigated.

QST and pain measures for remote hyperalgesia are compared between control and magnesium or ketamine group.

Eligibility criteria: Inclusion Criteria:

* ASA1-2

Exclusion Criteria:

* contraindication to the study drugs

Primary outcomes:
measure: pain
timeFrame: until 1 month from the end of the operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01378702: Safety and Immunological Effects of Two Mistletoe Preparations in Healthy Volunteers
Official title: Safety and Immunological Effects of Iscucin Populi and Viscum Mali e Planta Tota in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Mistletoe
Anthroposophical medicine
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this clinical trial is to describe safety, tolerability and the course of parameters of the immune system during administration of different doses of two subcutaneously administered mistletoe preparations (Iscucin populi and Viscum Mali e planta tota) in healthy volunteers, compared to placebo.


Eligibility criteria: Inclusion Criteria:

* 18-45 years. Healthy volunteers

Exclusion Criteria:

* Any disease except hay fever.
* Smoking.
* Drug abuse.
* Pregnancy

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: After 4 weeks treatment with each dose
Secondary outcomes:
measure: Interleukin-6
timeFrame: After 4 weeks treatment with each dose
measure: Eosinophil counts
timeFrame: After 4 weeks treatment with each dose
measure: Granulocyte counts
timeFrame: After 4 weeks treatment with each dose
measure: Lymphocyte counts
timeFrame: After 4 weeks treatment with each dose
measure: T-cell counts
timeFrame: After 4 weeks treatment with each dose
measure: General tolerability of the treatment(excellent, good, moderate or bad)
timeFrame: After 4 weeks treatment with each dose
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Univerity Medical Center Freiburg
Study officials:
affiliation: University Hospital Freiburg
name: Roman Huber, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huber R, Ludtke H, Wieber J, Beckmann C. Safety and effects of two mistletoe preparations on production of Interleukin-6 and other immune parameters - a placebo controlled clinical trial in healthy subjects. BMC Complement Altern Med. 2011 Nov 24;11:116. doi: 10.1186/1472-6882-11-116.
Clinical trial NCT05767502: Assignment of the Verbal Component Score and Addition of Pupil Reaction to the Glasgow Coma Scale
Official title: Investigation of the Effect of Assigning Verbal Component Score to Glasgow Coma Scale in Patients With Traumatic Brain Injury and Adding Pupil Reaction to Determining Mortality/Morbidity in Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injuries, Traumatic
Keywords: GCS
GCS-Pupil score
Brain trauma
Consciousness
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 199
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: When α: 0.05 β: 0.20 and the acceptable difference between models were selected as 10% using the G-Power program, the number of patients to be included in the study was determined as 199.

Brief summary: In this study, it is aimed to determine the prognostic value of GCS-P and the GCS-P score, which is formed by assigning a verbal score, in patients with traumatic brain injury, where all parameters can be evaluated. In the model to be created, a new total score will be obtained with Motor score + Eye Response + assigned verbal Score-Pupil score and this score will be compared with GCS and GCS-Pupil score.


Eligibility criteria: Inclusion Criteria:

* Admitted to hospital due to traumatic brain injury,
* 18 years and older,
* who were alive at the time of admission,
* Patients whose GCS and pupil reactivity can be evaluated completely.

Exclusion Criteria:

* Younger than 18,
* Not alive at the time of admission,
* Patients whose GCS score and pupil reactivity are not correctly evaluated (facial trauma, past eye diseases or eye defects, etc.).

Primary outcomes:
measure: MORTALITY
timeFrame: From admission to discharge, an average of 1 weeks
measure: MORBIDTIY
timeFrame: From admission to discharge, an average of 1 weeks
Secondary outcomes:
measure: MORTALITY
timeFrame: 3 months after hospital discharge
measure: MORBIDITY
timeFrame: 3 months after hospital discharge
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa City Hospital
Study officials:
References:
Clinical trial NCT00594802: Systemic Reactions to Allergen Immunotherapy Amd Skin Testing
Official title: Systemic Reactions to Allergen Immunotherapy Amd Skin Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SYSTEMIC REACTION
Keywords: ALLERGIC REACTION
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice.

Brief summary: Allergy skin tests and allergen immunotherapy are common procedures for both the diagnosis and treatment of atopic diseases. Allergen immunotherapy has proved to be effective in reducing the symptoms of allergic rhinitis and asthma1-2. Despite its clinical benefit, there is risk of systemic reactions associated with these procedures.

The systemic reaction rate to skin testing for aeroallergens is significant lower than the rate of reactions to immunotherapy, but it is not negligible. Lin et al reported only 2 patients who had systemic allergic reactions to skin testing for respiratory allergies in 10,400 patients tested.3 They determined the overall risk of inducing anaphylactic reactions by skin testing to be less than 0.02% and other studies have produced similar results.4-5 The rate of systemic reactions to skin testing is likely underscored. Thompson et. al reported a systemic reaction rate of 6% of patients receiving skin testing.6 It is important to recognize the risk of systemic reactions seeing skin testing is commonly done. It is also imperative to recognize the treatments for these reactions to prevent progression.

Hypothesis The systemic reaction rate to allergen immunotherapy and skin testing to aeroallergens is higher than previously reported. Biphasic anaphylactic reactions rarely occur with allergen immunotherapy and skin testing.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice.

Exclusion Criteria:

* NON Male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice.

Primary outcomes:
measure: This is a prospective observational study of patients who are having either skin testing or allergen immunotherapy for the diagnosis or treatment of allergic rhinitis, conjunctivitis, and/or asthma.
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF
state: Florida
Study officials:
affiliation: USF DIRECTOR OF ALLERGY AND IMMUNOLOGY
name: RICHARD F LOCKEY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bagg A, Chacko T, Lockey R. Reactions to prick and intradermal skin tests. Ann Allergy Asthma Immunol. 2009 May;102(5):400-2. doi: 10.1016/S1081-1206(10)60511-X.
Clinical trial NCT00139802: DANish Multicenter STENT Trial
Official title: Low Restenosis Rate of the NIR Coronary Stent: Results of the Danish Multicenter Stent Study (DANSTENT) - a Randomized Study Comparing a First-Generation With a Second-Generation Stent.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Heart Disease
Stable Angina
Unstable Angina
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate procedural and late outcome of coronary artery stenting using 2 different unmounted stents


Eligibility criteria: Inclusion Criteria:

* Stable, unstable or silent angina,
* De novo lesion

Exclusion Criteria:

* Allergy to ticlopidine
* Recent myocardial infarction
* Expected survival \> 1 year

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Henning Kelbaek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jorgensen E, Kelbaek H, Helqvist S, Jensen GV, Saunamaki K, Kastrup J, Madsen JK, Klovgaard L, Thuesen L, Villadsen A, van Weert AW, Reiber JH; Danish multicenter stent study (DANSTENT). Low restenosis rate of the NIR coronary stent: results of the Danish multicenter stent study (DANSTENT)--a randomized trial comparing a first-generation stent with a second-generation stent. Am Heart J. 2003 Feb;145(2):e5. doi: 10.1067/mhj.2003.32.
Clinical trial NCT03622502: The Effect of Dexmedetomidine for Emergence Cough
Official title: The Effect of Dexmedetomidine on the Remifentanil Concentration for Preventing Cough During Emergence After Propofol Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cough
Keywords: dexmedetomidine
remifentanil
extubation
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dexmedetomidine or remifentanil are effective in attenuating cough during peri-extubation period after general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence.

Detailed description: Administration of dexmedetomidine before end of surgery could reduce airway reflexes and hemodynamic changes during tracheal extubation. Compared with remifentanil alone, administration of dexmedetomidine in combination with remifentanil is effective in relieving cough and hemodynamic changes without inhibition of respiration. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence using the modified up-and-down method.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II undergoing endoscopic sinus surgery or septoplasty under general anesthesia

Exclusion Criteria:

* predicted difficult airway
* body mass index \> 35 kg/m2,
* recent upper respiratory infection
* asthma
* current smoker
* patients using angiotensin converting enzyme-inhibitors
* uncontrolled hypertension

Primary outcomes:
measure: Number of cough
timeFrame: from end of surgery to 5 min after tracheal extubation]
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeongki-do
Study officials:
affiliation: Ajou University Hospital, Suwon, Gyeongki-do, Korea
name: Jong Yeop Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HY, Kwak HJ, Lee D, Lee JH, Min SK, Kim JY. Comparison of remifentanil concentrations with and without dexmedetomidine for the prevention of emergence cough after nasal surgery: a randomized double-blinded trial. BMC Anesthesiol. 2021 May 4;21(1):136. doi: 10.1186/s12871-021-01358-x.
Clinical trial NCT00596102: Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51
Official title: Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Japanese Encephalitis
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 3258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 3,300 subjects having completed IC51, JE-VAX or placebo treatment in studies IC51-301 or IC51-302 will take part in the safety follow up, up to month 6 after 1st vaccination in the study IC51-301 (NCT00604708) or IC51-302 (NCT00605085).

Only \~160 subjects, who have been treated with IC51 will take part in the immunogenicity and long-term analysis up to month 60.

Brief summary: The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects at least 18 years of age
* Written informed consent obtained prior to study entry
* Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination

Exclusion Criteria:

* Inability or unwillingness to provide informed consent and to abide the requirements of the study

Primary outcomes:
measure: Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)
timeFrame: 24 months after the first vaccination
Secondary outcomes:
measure: Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)
timeFrame: 6, 12, 36, 48 and 60 months after 1st vaccination
measure: Geometric Mean Titers
timeFrame: 6, 12, 36, 48 and 60 months
measure: Adverse Events
timeFrame: 6, 12, 24, 36, 48 and 60 months after 1st vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Valneva Austria GmbH
name: Evelyn Hatzenbichler, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Taucher C, Kollaritsch H, Dubischar KL. Persistence of the immune response after vaccination with the Japanese encephalitis vaccine, IXIARO(R) in healthy adults: A five year follow-up study. Vaccine. 2019 May 1;37(19):2529-2531. doi: 10.1016/j.vaccine.2019.03.030. Epub 2019 Apr 5.
Clinical trial NCT05932602: AVEIR DR Coverage With Evidence Development (CED) Study
Official title: The AVEIR DR Coverage With Evidence Development (DRIVE) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Pacemaker
Arrythmia
Bradycardia
Keywords: dual chamber
sick sinus rhythm
pacemaker
AV Block
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 2812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir DR leadless pacemaker or a full-system dual-chamber transvenous pacemaker (from any manufacturer) in any US location

Brief summary: The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).

Detailed description: This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir DR LP health outcomes among Medicare beneficiaries.

The study will enroll all Medicare patients with continuous claims data implanted with the Aveir DR LP system or a dual-chamber transvenous pacemaker system from any manufacturer.

Due to the RWE data collection methods used in this study, a central institutional review board (IRB) approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.

Eligibility criteria: Inclusion Criteria:

* Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study.

OR

Medicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date

Exclusion Criteria:

None

Primary outcomes:
measure: Acute device related complication rate
timeFrame: 30 days
measure: Two-year survival rate
timeFrame: 2 years
Secondary outcomes:
measure: Chronic complication rate
timeFrame: 6 months
measure: Device-related re-intervention rates
timeFrame: 2 years
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Abbott
state: California
Study officials:
affiliation: Abbott
name: Nicole Harbert
role: STUDY_DIRECTOR
References: