louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05724836: Prospective Carotid Artery Stenosis Trial
Official title: Prospective Carotid Artery Stenosis Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients With Any Degree of Carotid Artery Stenosis and Vulnerable Features in the Carotid Artery Plaque
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 200
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: Subjects undergoing carotid artery intervention

Brief summary: Researchers are collecting information and blood from subjects undergoing carotid artery interventions.


Eligibility criteria: Inclusion Criteria:

* All subjects undergoing carotid artery intervention that presents to our clinic

Exclusion Criteria:

* None

Primary outcomes:
measure: Biospecimen Acquisition
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Young M Erben
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04155736: Testing a Self-Management App for Symptoms of Posttraumatic Stress
Official title: A Randomized Controlled Trial of a Self-Management App for Symptoms of Posttraumatic Stress: The Role of Coaching Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 100
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 this study is to evaluate the acceptability and efficacy of a self-guided behavioral health tool delivered by mobile app (called "Renew") for people who are experiencing symptoms of posttraumatic stress. This study also aims to determine the necessity of coaching support over and above support from peers, shedding light on the critical question of level of support resources needed to maintain mHealth app engagement.


Eligibility criteria: Inclusion Criteria:

* Veterans 18 years or older
* own an Android smart phone (as the app is only available for Android)
* self-report having experiencing symptoms of posttraumatic stress (defined as a PCL-5 score of 31 or higher).

Exclusion Criteria:

* None

Primary outcomes:
measure: Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)
timeFrame: Approximately 10-weeks after participant enrollment
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
timeFrame: Approximately 10-weeks after participant enrollment
measure: A PTSD coping self-efficacy measure, developed following Bandura's (2006) guidelines
timeFrame: Approximately 10-weeks after participant enrollment
measure: Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, (1988)
timeFrame: Approximately 10-weeks after participant enrollment
measure: Perceived helpfulness of Renew
timeFrame: Approximately 6-weeks after participant enrollment
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: VA Palo Alto Healthcare System
state: California
Study officials:
affiliation: Palo Alto Veterans Institute for Research
name: Carmen McLean, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McLean C, Davis CA, Miller M, Ruzek J, Neri E. The Effects of an Exposure-Based Mobile App on Symptoms of Posttraumatic Stress Disorder in Veterans: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Nov 4;10(11):e38951. doi: 10.2196/38951.
Clinical trial NCT00315536: Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children
Official title: Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urological Surgery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-04-18
Enrollment: 63
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to investigate the influence of remifentanil and glycopyrrolate on cardiac index and blood pressure in children.To differentiate between contractility and the effect of the circulating volume, some of the subjects will receive additional fluid.This will be evaluated using two transthoracic echocardiac exams within the first 30 min of anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA I and II children
* 1-6 years
* urological surgery

Exclusion Criteria:

* Cardiac disease
* Diabetes

Primary outcomes:
measure: Cardiac index
timeFrame: Twice in 16 minutes.
measure: Blood pressure
timeFrame: Twice in 16 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Koen Reyntjens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04652336: Study Comparing the Effect of Ligamentum Teres Cardiopexy on de Novo GERD Post LSG
Official title: Randomized Controlled Trial Comparing the Effect of Ligamentum Teres Cardiopexy on de Novo GERD Post LSG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: GERD
Keywords: de Novo GERD
Lead sponsor: GEM Hospital & Research Center
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of ligamentum teres cardiopexy on incidence of de Novo GERD.

Detailed description: Laparoscopic Sleeve Gastrectomy (LSG) is now the most commonly performed bariatric surgery world wide. The results of LSG on outcomes of GERD are conflicting. It has been reported to increase the severity of pre existing GERD and also to cause new onset GERD in considerable number of patients.

In this study the effect of adding a novel procedure i.e. ligamentum teres cardiopexy,(LTC) to regular LSG on occurence of de Novo GERD will be investigated. de Novo GERD has been found to occur in 20% of cases post LSG.

This study is a randomized, prospective, parallel group, controlled trial to compare the effect of LSG versus LSG with LTC on occurence of de Novo GERD.

This is a single center based trial, being conducted in GEM hospital and research center, Coimbatore, Tamil Nadu, India. The trial has been approved by GEM research ethics committee.

Investigators are planning to enroll patients who are not having any objective or subjective evidence of GERD. The participants will be optimized as per institutional bariatric surgery protocol. After complete evaluation and optimization, participants will be randomized by computer generated random numbers into either LSG or LSG with LTC group.

The demographic data, preoperative GERD - Q scores, 24 hour pH study, intra operative details will be recorded. Post operative details during each follow up will be recorded, which will include excess weight loss, GERD - Q scores. At 6 months follow up repeat 24 hour pH study will be done to assess the status of GERD objectively.

The trial duration is expected to be of 1 year where in investigators will be recruiting patients for 6 months.

Eligibility criteria: Inclusion Criteria:

* candidate for bariatric surgery according to IFSO - APC guidelines
* No evidence (objective and subjective) of GERD

Exclusion Criteria:

* Presence of GERD either by history or by 24 hr pH study

Primary outcomes:
measure: GERD
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04764136: Reliability and Validity of a New Device Measuring Spinal Rotation on the Transverse Plane
Official title: Reliability and Validity of a New Device Measuring Spinal Rotation on the Transverse Plane
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anyone with thoracic and/or lumbar scoliosis

Brief summary: The purpose of this research is to investigate the reliability and validity of a new device similar to a scoliometer. The intended name of the device will be Scolioscope

Detailed description: Οne cohort of participants will be used and the reliability of the equipment will be used to test/retest the repeatability of the measurements

The validity will be measured against a gold standard for measuring angles

Eligibility criteria: Inclusion Criteria: lumbar and thoracic scoliosis -

Exclusion Criteria: recent spinal surgery, cancer, spinal fixation

-

Primary outcomes:
measure: Reliability
timeFrame: 2021-2022
measure: Validity
timeFrame: 2021-2022
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Motus Liberi Physiotherapy Centre
state: Attica
Study officials:
affiliation: Attikon University Hospital, Athens, Greece
name: Konstantinos Soultanis, MD
role: STUDY_CHAIR
affiliation: PT, PhD
name: GEORGIOS KREKOUKIAS, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01189136: Treatment for Acute Postoperative Voiding Dysfunction
Official title: Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Acute Postoperative Voiding Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Keywords: Voiding dysfunction
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2010-08-26
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: If patients are unable to have their foley catheter removed because their bladder is not emptying well, they may be eligible for study participation. This study is designed to evaluate whether Posterior Tibial Nerve Stimulation is effective in improving bladdder function after surgery. Study participation is limited to one day.

Detailed description: If patients fail a voiding trial (the test done to see if a foley catheter is ready to be removed after surgery), they may be offered participation in this trial. Patients are randomized to receive active treatment or a sham treatment. A small, accupuncture-type needle is inserted through the skin just above the ankle. A small, battery-powered generator will be attached to the needle. The generator will give a low-voltabe stimulation which is adjusted for comfort level and applied for 30 minutes. After treatemnt, the voiding trial will be repeated.

Eligibility criteria: Inclusion Criteria:

* First voiding trial after Urogynecological surgery shows that bladder is not emptying well.

Exclusion Criteria:

* Patient declines participation.

Primary outcomes:
measure: Persistent Retention
timeFrame: 30 minutes
Secondary outcomes:
measure: Amount of Improvement in Voiding Efficiency
timeFrame: 30 minutes
Other outcomes:
measure: Questionnaire Data - Impression of Allocation
timeFrame: 30 minutes
measure: Pain From Treatment
timeFrame: 30 minutes
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital
name: Charles R Rardin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03406936: Sedation and Ease of Weaning From Mechanical Ventilation
Official title: Daily Interruption of Sedation Versus Non Sedation in Mechanically Ventilated Respiratory Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Midazolam Overdose
Chronic Obstructive Pulmonary Disease
Weaning Failure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Daily interruption of sedation is one of the modalities which is known to enhance early weaning and separation from mechanical ventilation . Daily sedation interruption is also known to help decreasing incidence of ventilator associated pneumonia. The new modality is no sedation.

Detailed description: there is an increase of incidence of chronic obstructive lung disease associated respiratory failure which necessitates invasive mechanical ventilation. It is well known that one of the bundles for enhanced recovery of such cases is the daily interruption of sedation . Recently studies have demonstrated the feasibility of just using sedation for initiation of mechanical ventilation, then utilization of no sedation technique as a more this offers less side effects .

Eligibility criteria: Inclusion Criteria:

* Obstructive lung disease
* Respiratory failure
* Invasive mechanical ventilation

Exclusion Criteria:

* Neurological deficit
* Cognitive dysfunction
* Extensive malignancy
* septic Shock

Primary outcomes:
measure: duration of mechanical ventilation
timeFrame: first 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT01562236: Gender-specific aEEGs and Outcome in Preterms
Official title: Gender-related Differences in Early Amplitude-integrated Electroencephalography in Newborns < 30 Weeks' Gestational Age and Their Correlation With Neurodevelopment Outcome at Three Years Corrected Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gender Role Disorder, Male to Female Type
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 148
Sex: ALL
Minimum age (years): 24
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: preterms born \< 30 weeks gestational age who had aEEG measurements within the first 2 weeks of life who had assessment of outcome at 3 years corrected age

Brief summary: Background and objectives: Male sex is a risk factor for poor neurodevelopmental outcome following preterm birth. The investigators aimed to investigate gender-related differences in amplitude-integrated electroencephalography (aEEG) and to correlate these findings with neurodevelopmental outcome.

Methods: Preterm infants born \<30 weeks' gestational age between 2000 and 2002 were prospectively included. aEEGs obtained within the first two weeks of life were evaluated and classified according to background activity, sleep-wake cycling (SWC) and seizure activity. Outcome was assessed at three years.


Eligibility criteria: Inclusion Criteria:

* born\<30 weeks gestational age
* who had aEEGs in first 2 weeks of life
* who were assessed for outcome at 3 years of age

Exclusion Criteria:

* born\>30 weeks gestational age
* had no aEEGs in first 2 weeks of life
* lost for follow-up at 3 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Neonatology
name: Monika Olischar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06433336: Effect of Blood Pressure on Cardiovascular Outcomes and Recurrence After Catheter Ablation in Patients With Atrial Fibrillation
Official title: Effect of Blood Pressure on Cardiovascular Outcomes and Recurrence After Catheter Ablation in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation, Persistent
Blood Pressure
Lead sponsor: Lanzhou University Second Hospital
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between February 2019 and December 2024, 800 consecutive patients who had been referred to lanzhou University second Hospital for treatment of AF and underwent successful ablation were assessed

Brief summary: Effect of blood pressure on cardiovascular outcomes and recurrence after catheter ablation in patients with atrial fibrillation


Eligibility criteria: Inclusion Criteria:

The inclusion criteria were age \&gt;18 years and a diagnosis of AF by electrocardiogram during the preceding six months or on admission

Exclusion Criteria:

No follow-up

Primary outcomes:
measure: cardiovascular events
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
Study officials:
affiliation: Lanzhou University Second Hospital
name: xiao wei xiaowei zhang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06601036: Sevoflurane Sedation as an Alternative for Awake Fiberoptic Intubation in Difficult Airway Patients
Official title: Sevoflurane Sedation as an Alternative for Awake Fiberoptic Intubation in Difficult Airway Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sevoflurane
Sedation
Awake Fiberoptic Intubation
Difficult Airway
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare patient satisfaction and intubating conditions with fiber optic intubation under sevoflurane sedation versus airway blocks in difficult airway patients

Detailed description: Awake fiberoptic intubation (AFOI) is a suitable option for anticipated difficult intubation. The ideal condition for AFOI requires a calm, cooperative patient with blunted airway reflexes to facilitate easy intubation, especially if there is difficulty with laryngeal anatomy and/or pathology.

For this purpose, sedative and anxiolytic agents such as benzodiazepines, sevoflurane, remifentanil, ketamine, propofol, and dexmedetomidine are almost always required to relieve the patients from comfort without impairing ventilation. Patient responsiveness and cooperation are almost always required.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 50 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Patients with difficult airway (Mallampati grade 3 and 4 with mouth opening less than 5 cm).

Exclusion Criteria:

* Patient refusal.
* Patients with bleeding disorders and nasal mass.
* Allergy or intolerance to one of the study medications.
* Patients with uncontrolled systemic diseases.
* patients with gastro-esophageal reflex.
* history of nasopharyngeal surgery or drug abuse.

Primary outcomes:
measure: Degree of patient satisfaction
timeFrame: Immediately after intubation
Secondary outcomes:
measure: Intubation time
timeFrame: Intraoperatively
measure: Heart rate
timeFrame: 5 minutes after intubation
measure: Mean arterial pressure
timeFrame: 5 minutes after intubation
measure: Patient's tolerance to endoscopy
timeFrame: Intraoperatively
measure: Patient's tolerance to intubation
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT02906436: Ex-Vivo Lung Reconditioning
Official title: Pilot Study of Lung Transplantation After Ex-Vivo Lung Reconditioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplantation
Keywords: Lung transplantation
ExVivo reconditionning
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 45
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: Only about 15% of the potential candidates for lung donation are considered suitable for transplantation. Thus, a strategy that could improve the quality and precision of assessment of nonacceptable donor lungs could have a major impact on reducing waiting time and mortality while on the list.

A new method for ex vivo lung perfusion (EVLP) has been developed recently by Steen and colleagues to assess the quality of lungs from a non-heart-beating donor. The method can also be used to recondition "marginal" and nonacceptable donor lungs.

After harvesting, the lungs were perfused ex vivo with Steen Solution, an extracellular matrix with high colloid osmotic pressure. A membrane oxygenator connected to the circuit received gas from a mixture of nitrogen and carbon dioxide, maintaining a normal mixed venous blood gas level in the perfusate. The lungs were gradually rewarmed, reperfused, and ventilated for evaluation through analyses of oxygenation capacity, pulmonary vascular resistance (PVR), lung compliance (LC), and biopsy.


Eligibility criteria: Inclusion Criteria:

* Patients on the waiting list for lung transplantation and for which the Biomedicine -Agency has awarded a lung transplantation after Ex-Vivo lung reconditioning
* Patients affiliated to a social security system;
* Patients who consented to participate in writing

Exclusion Criteria:

-Patients under tutorship or unable to consent or institutionalized

Primary outcomes:
measure: number of "transplantable" grafts and Reduced waiting time before transplantation
timeFrame: 12 months
Secondary outcomes:
measure: Difference of data obtained 2 hours after Ex-Vivo lung reconditioning with those obtained 4 hours after Ex-Vivo lung reconditioning
timeFrame: 4 hours after Ex-Vivo lung reconditioning
measure: Number of deaths of patients on waiting list
timeFrame: 5 years
measure: survival time after lung transplantation with ExVivo lung reconditioning
timeFrame: 1 year after end of study
measure: Quality of life scale score after lung transplantation with ExVivo lung reconditioning
timeFrame: 1 year after end of study
Other outcomes:
Locations:
city: Le Plessis Robinson
country: France
facility: Centre chirugical Marie Lannelongue
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Alain Chapelier, PhD
role: PRINCIPAL_INVESTIGATOR
References: