louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04202796: Catheter Ablation in Congenital Heart Disease: French National Prospective Registry
Official title: Catheter Ablation in Congenital Heart Disease: French National Prospective Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Arrhythmia
Keywords: catheter ablation
Lead sponsor: Paris Cardiovascular Research Center (Inserm U970)
Sponsor class: OTHER_GOV
Collaborators: name: European Georges Pompidou Hospital
name: Centre Chirurgical Marie Lannelongue
name: Clinique Pasteur Toulouse
First posted: 2019-12-18
Enrollment: 300
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: All patients with congenital heart disease referred for catheter ablation

Brief summary: Arrhythmias represent one of the main late complications in patients with congenital heart disease. Atrial arrhythmias are associated with a significant morbidity and are the first cause of urgent hospitalization, and sudden death from ventricular arrhythmias is a leading cause of death in this population.

The exponential increase of the number of patients with congenital heart disease and the improvement of ablative technologies are associated with a significant increase of the number of catheter ablation procedures.

Most of available studies are retrospective or include a limited number of patients.

The aim of this study is to assess the efficacy of catheter ablation in patients with congenital heart disease through a national prospective registry. Secondary objectives are i) to identify factors associated with catheter ablation efficacy in different cardiac defects, ii) to describe complications associated with catheter ablation in this specific population, and iii) to assess the impact of catheter ablation on quality of life of patients with congenital heart disease.


Eligibility criteria: Inclusion Criteria:

* All patients with congenital heart disease referred for catheter ablation

Exclusion Criteria:

* Absence of patient's consent
* Patient under guardianship or curatorship
* Pregnant woman

Primary outcomes:
measure: Recurrence of targeted arrhythmia
timeFrame: 12 months
Secondary outcomes:
measure: Recurrence of any arrhythmia
timeFrame: 12 months
measure: Long-term recurrence of targeted and any arrhythmia
timeFrame: 24 months
measure: Complications
timeFrame: 1 month
measure: Quality of life assessed by SF36 score
timeFrame: 6 months
measure: Quality of life assessed by EQ5D3L score
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Georges Pompidou European Hospital
Study officials:
affiliation: Paris Cardiovascular Research Center (Inserm U970)
name: Victor Waldmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03417596: Vestibular Rehabilitation in Patients With Vestibular Migraine
Official title: Efficacy of Vestibular Rehabilitation in Patients With Vestibular Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Migraine
Vestibular Disorder
Migraine Variant
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Abstract: Introduction:

Vestibular migraine(VM) is a disease that manifests with episodic vertigo attacks in patients with or without migraine type headaches, when present accompanying the headaches. Its prevalence was found out as %1 in a study in Germany. It usually involves middle aged women. VM can make a huge impact on quality of life, therefore advances in its diagnosis and management are valuable. While pharmacotherapy that is being used in migraine can be beneficial, vestibular rehabilitation(VR) programmes are predicted to be one of the most important types of treatment in management of VM. This study compares the results of pharmacological management options and vestibular rehabilitation programmes in the context of dizziness, balance problems and headache.

Material and methods:

77 patients with VM were included in study, and 60 of them completed it. While one group took only VR programme, and another took only pharmacological prophylaxis. The third group took a combined therapy, and the groups were consisted of 20 patients. Patients were assessed with caloric tests, audiometric studies, static posturography, Dizziness Handicap Inventory(DHI), and Activities Specific Balance Confidence(ABC) scales. All of the assessments were applied 3 times throughout the study, and the results were compared with relevant statistical tests.


Eligibility criteria: Inclusion Criteria:

* 1-Vestibular Migraine diagnosis according to International Classification of Headache Disorders (3 rd edition-Beta version) 2- No history of vestibular rehabilitation or exercises

Exclusion Criteria:

* History of psychiatric disorder which might interfere with compliance to study
* Other diagnosis that might possibly cause vestibular disorder(cerebellar disorders, Meniere disease etc)
* Anatomical defects of the inner ear or vestibular system
* Patients who are unable to stand up straight or walk

Primary outcomes:
measure: Dizziness Handicap Inventory
timeFrame: 6 months
measure: Activities-specific balance confidence scale
timeFrame: 6 months
measure: Static Posturography
timeFrame: 6 months
Secondary outcomes:
measure: Vertigo attack severity
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01155596: Negative Pressure Ventilation Imapcts Weaning Ventilator In Medical Intensive Care Units (ICUs)
Official title: Phase 2 Study of Negative Pressure Ventilation That Imapcts Weaning Ventilator in Medical Intensive Care Units
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Respiratory Failure
Keywords: Acute respiratory failure patients in medical ICUs.
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a Quasi-experimental research design. The subjects are limited in intensive care unit within north medical center hospital. All subjects depend on ventilator and receive weaning plans. Experimental group is weaning with the support of negative pressure ventilator .The investigators collect basic personal variables in the questionnaire, APACHE Ⅱ scale, Dyspnea scale and arterial blood gas analysis and ventilator weaning index. Compare experimental group and control group data. Data will be Statistical analyzed by: descriptive statistics (such as: mean, standard deviation, median, frequency, percentage) and inferential statistics (such as: Independent T-test, Pair T-test, Mann-Whitney U test), P-value \<0.05 will consider to be statistically significant.


Eligibility criteria: Inclusion Criteria:

* Acute respiratory failure patients in medical ICUs

Exclusion Criteria:

* Age\<20 years old
* Malignancy
* Pregnancy

Primary outcomes:
measure: Ventilator weaning rate
timeFrame: 28 days
Secondary outcomes:
measure: ICU stay
timeFrame: 28 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Gung Memorial Hospital, Chang Gung University, College of Medicine.
Study officials:
References:
Clinical trial NCT04872296: Weight Bearing for Fibular Fractures
Official title: Early Weight Bearing for Isolated Fibular Fractures: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibula Fracture
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is common practice to restrict weight bearing after ankle fracture open reduction and internal fixation (ORIF) until week 6 postoperatively. However, controversy exists surrounding the optimal postoperative protocol. At our institution, all ankle fractures are made non-weight bearing for 6 weeks across the board. Isolated lateral malleolar fractures after ORIF may benefit from earlier weight bearing in terms of patient satisfaction, short-term functionality, and return to work. The purpose of this study is to determine if early weight bearing at 2 weeks postoperatively for isolated lateral malleolar fractures leads to a higher satisfaction with surgery as compared to standard protocol for postoperative ankle fractures and better functional outcomes


Eligibility criteria: Inclusion Criteria:

* Adult patients (age\>18) undergoing surgical treatment for isolated lateral malleolar fracture with foot and ankle surgeons at the Rothman Orthopaedic Institute

Exclusion Criteria:

* Patients requiring other fracture fixation, deltoid ligament repair, or syndesmosis fixation
* Revision ankle fracture cases
* Pre-existing impaired mobility,
* Pre-existing cognitive disability,
* Open fractures,
* BMI \>40,
* Diabetes mellitus (DM)

Primary outcomes:
measure: Participant Satisfaction with treatment #1
timeFrame: 24 weeks
measure: Participant Satisfaction with treatment #2
timeFrame: 24 weeks
measure: Participant Pain after surgery
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00829296: Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries
Official title: The Effects of Nebivolol on Aortic Impedance Parameters in Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypertension
Diabetes
Keywords: diabetes
hypertension
aortic impedance
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2009-01-27
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.

Detailed description: To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.

Eligibility criteria: Inclusion Criteria:

* Established Type 2 diabetic not treated with insulin
* Stage 1 hypertensives blood pressure \> 130/80 mmHg and \< 160/100 mmHg
* BMI \< 35
* Hemoglobin A1C \< 8.5
* Must be postmenopausal or taking some form of birth control of surgically sterile

Exclusion Criteria:

* Acute myocardial infarction, unstable angina, stroke or TIA within the past year.
* Active angina in the last three months
* Diabetes requiring treatment with insulin
* Severe asthma
* Female who are pregnant, planning to be pregnant during the study period, lactating or women of childbearing potential who are not using a medically approved method of contraception
* Recent history of substance or alcohol abuse .
* Uncontrolled hypertension systolic blood pressure \>160mmHg or diastolic blood pressure \> 100 mmHg

Primary outcomes:
measure: Change in Central Systolic Blood Pressure (SBP)
timeFrame: Baseline and 26 Weeks
Secondary outcomes:
measure: Change in Pulse Wave Velocity (PWV)
timeFrame: Baseline and 26 Weeks
measure: Change in Augmentation Index
timeFrame: Baseline and 26 Weeks
measure: Change in Pulse Pressure Amplification
timeFrame: Baseline and 26 Weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: George Bakris, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04453696: Dentist-Patient Communication on Dental Anxiety Using the Social Media and Timing in Communication
Official title: Dentist-Patient Communication on Dental Anxiety Using the Social Media and Timing in Communication: A Double-blinded Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Anxiety
Timing in Dentist-Patient Communication
Keywords: Communication
Dental anxiety
Social Media
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
Collaborators: name: Onur Yilmaz
name: Pinar Sivrikaya
First posted: 2020-07-01
Enrollment: 143
Sex: ALL
Minimum age (years): 22
Maximum age (years): 36
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients scheduled to undergo impacted lower third molar removal at the oral and maxillofacial surgery clinic at Karadeniz Teknik University were selected by randomly between 2018 and 2020

Brief summary: Scales application one week before and one week after impacted tooth extraction.

Detailed description: The purpose of the present study was to assess the effects of dentist-patient communication via social media on dental anxiety, and second, to evaluate the appropriate timing of such communications.

Instagram's quick replies system was used to answer patients' questions to alleviate dental anxiety for patients undergoing impacted mandibular third-molar extraction under local anesthesia. Patients were assigned randomly into four groups according to timing of such communications: Communication before operation (n=36), Communication after operation (n=35), Communication before and after operation (n=36), and a control group who received no communication on social media (n=36). Dental anxiety was evaluated one week before and after the surgical operation using recognized assessment scales-the Spielberger's State-Trait Anxiety Inventory, Modified Dental Anxiety Scale and a visual analog scale.

Eligibility criteria: Inclusion Criteria:

* Must be able to use the Instagram platform. I
* Clinicial diagnosis of mesioangular impacted lower third molar according to the classification of Winter and the Pell and Gregory classification (2 or 3/B).

Exclusion Criteria:

* Patients who previously obtained information from social media
* Bad dental history
* Systemic disease
* Pregnant

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
measure: State-Trait Anxiety Inventory (STAI-T and STAI-S)
timeFrame: 2 weeks
measure: Modified Dental Anxiety Scale (MDAS)
timeFrame: 2 weeks
Locations:
city: Trabzon
country: Turkey
facility: Efe Can Sivrikaya
Study officials:
References:
Clinical trial NCT03079596: ERAS (Early Recovery After Surgery) Protocol After Laparoscopic Total Gastrectomy and Proximal Gastrectomy
Official title: Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Total Gastrectomy and Proximal Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: gastric cancer
ERAS (early recovery after surgery)
laparoscopic total gastrectomy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.

Detailed description: There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.

However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.

The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic total gastrectomy and proximal gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.

Eligibility criteria: Inclusion Criteria:

* Elective surgery
* American Society of Anesthesiologists (ASA) scores \< 3
* Gastric cancer, adenocarcinoma, possible to perform laparoscopic total gastrectomy and proximal gastrectomy
* Informed consent
* No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.
* No systemic inflammatory disease

Exclusion Criteria:

* conversion to open

Primary outcomes:
measure: Tolerance of diet for 24 hours
timeFrame: 4 days after surgery
measure: Analgesic-free
timeFrame: 4 days after surgery
measure: Safe ambulation
timeFrame: 4 days after surgery
measure: Afebrile status without major complications
timeFrame: 4 days after surgery
Secondary outcomes:
measure: Postoperative length of hospital stay
timeFrame: up to 4 weeks after surgery
measure: Time to tolerance of a full diet
timeFrame: up to 1 month after surgery
measure: Time to first bowel motion
timeFrame: up to 7 days after surgery
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT06261996: Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation.
Official title: Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation in Anesthesiology Intensive Care Unit: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Invasive Mechanical Ventilation
Keywords: Fospropofol
Propofol
Invasive mechanical ventilation
sedation
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 200
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: The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following:

* Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS).
* Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications.
* Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications.

Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-65 years old
2. Intubation and mechanical ventilation \<12h before enrollment
3. Expected to require continuous invasive ventilation and sedation less than 6h after admission to anesthesia intensive care unit (AICU).
4. Signed informed consent

Exclusion Criteria:

1. parturient, childbirth or lactating mothers
2. acute severe neurological disease or coma
3. chronic renal failure
4. previous mechanical ventilation \>12h
5. severe liver dysfunction (Child-Pugh score C)
6. BMI \>30kg/m2 (\>90kg)
7. dying

Primary outcomes:
measure: The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions
timeFrame: Admission to the intensive care unit to 2 hours after weaning off the ventilator.
Secondary outcomes:
measure: Incidence of adverse reactions during the follow-up period
timeFrame: 2 hours after weaning off the ventilator to 24 hours after leaving the intensive care unit.
measure: Extubation time
timeFrame: From admission to the intensive care unit to removal of the endotracheal tube
Other outcomes:
Locations:
Study officials:
affiliation: Henan Provincial People's Hospital
name: Jiaqiang Q Zhang, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT00375596: A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis
Official title: Study Withdrawn Prior to Determining Official Title
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2006-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL

Brief summary: This study will evaluate the safety and efficacy of a new allergy medication

Detailed description: Study withdrawn prior to determining study details

Eligibility criteria: Inclusion Criteria:

* Be at least 6 years of age, of any race, or either gender.
* Have a positive allergic history of ocular allergies and a positive skin test reaction to cat hair/dander, ragweed, tree and/or grass pollen within the past 24 months.
* Have a calculated best-corrected visual acuity of 0.6 logMar or better in each eye as measured using an ETDRS chart.
* Positive bilateral CAC reaction at Visit 1 \& 2.

Exclusion Criteria:

* Have any known contraindications, allergies, or sensitivities to the use of any of the study medications, or their components.
* Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
* Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the baseline slit-lamp exam of any visit

Primary outcomes:
measure: Safety and efficacy of a new allergy medication
timeFrame: 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03898596: Umbilical Vessel Catheterization Under ECG Monitoring and Guidance
Official title: Umbilical Vessel Catheterization Under ECG Monitoring and Guidance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric ALL
Keywords: Neonates
Electrocardiogram
Umbilical Vein Catheterization
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Umbilical venous catheters (UVC) are typically places with poor guidance and some radiological confirmation. Misplacement of the catheter could lead to its placement in other unintended anatomical areas such as the liver or the spleen, which could be detrimental in critically-ill infants. Our study aims at using a more non-invasive means of placing and continuously monitoring catheter placement using superficial electrocardiogram (ECG) tracings.


Eligibility criteria: Inclusion Criteria:

* Neonate pediatric patient
* 2 - 6kg
* Require or currently have UVC

Exclusion Criteria:

* Participants who do not consent or have parental consent
* Patients who are clinically unstable

Primary outcomes:
measure: Electrocardiogram Readings
timeFrame: Duration of ECG placement and reading (typically 15 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
References: