louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02821429: Respiratory Weaning Following Cardiac Surgery.
Official title: Respiratory Weaning Following Cardiac Surgery. Potential Interest of Combined Thoracic Echography in the Characterization of the Failure Causes.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Respiratory Insufficiency
Keywords: Respiratory weaning
Pulmonary ventilation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 0
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: Patients will be recruited during the pre anesthetic visit

Brief summary: Respiratory weaning failure worsens prognostic of patients following on-pump cardiac surgery. There are increasing evidences that pulmonary, diaphragmatic or cardiologic echographies are useful in order to improve this critical medical status.

Based both on a previous study conducted in the critical care unit of Purpan and on literature we hypothesize that a combined thoracic echography score could be of interest. We make the hypothesis that the use of a score based on thoracic combined echography (ETC = cardiac, pulmonary and diaphragmatic) allows to predict the failure of respiratory weaning in cardiac surgery and allows to improve the characterization of the causes of this failure


Eligibility criteria: Inclusion Criteria:

* Adult (\> 18 years old) beneficiating of mechanical ventilation following cardiac surgery
* Weaning test period
* Patient insured under the French social security system

Exclusion Criteria:

* Tracheostomy
* Neurological disorders
* Need for prophylactic non invasive ventilation.
* Global obstructive lung disease with a forced expiratory volume \< 50%.
* Judicial protection
* Patient already included in a trial still running.
* Pregnancy

Primary outcomes:
measure: Evaluation of predictive value of combined Thoracic Echography (ETC) as assessed by difference in the ETC score before and after extubation
timeFrame: 1 hour after the weaning test and 48h after
Secondary outcomes:
measure: Evaluation of predictive value of combined Thoracic Echography (ETC) as assessed T tube Test score difference between patient who succeed or failed the weaning test
timeFrame: H0 and 48h after the weaning test
measure: Evaluation of diagnostic value of combined Thoracic Echography (ETC) after failure to weaning test as assessed be ECT scores collected
timeFrame: H0, H1 and H48
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Nicolas MAYEUR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03073629: Assessing Outcomes in ED Patients With RV Failure
Official title: Implementation of a Clinical Pathway to Improve Outcomes in Emergency Department Patients With Right Ventricular Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Right Heart Failure
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 2
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: Millions of Americans seek emergency care for acute shortness of breath, and many undergo computerized tomographic pulmonary angiography (CTPA) testing that is negative for acute disease. Management of patients with persistent shortness of breath despite normal testing continues to pose a challenge for clinicians. Right ventricular (RV) failure is a common cause of dyspnea that brings patients to the emergency department (ED), however, it is often not considered in the differential diagnosis, remains unrecognized, or patients are not properly followed up once diagnosed. Delays in diagnosis and management of RV failure are associated with poor outcomes. The investigators propose a novel clinical pathway, which entails identifying and enrolling patients with RV failure in the ED, then referring them to a specialized cardiovascular clinic where they will receive a standardized evaluation and management plan. Our hypothesis is that management of RV failure, through this pathway, will improve patient outcomes when compared to standard care. The primary outcome will assess 1-year unscheduled healthcare visits.


Eligibility criteria: Inclusion Criteria:

* adult patients \> 18 years old,
* with a non-significant CTPA scan (i.e. no acute disease), dyspnea PLUS an emergency physician performed echocardiogram with isolated RV failure OR CTPA scan with evidence of pulmonary hypertension OR comprehensive echocardiogram within 3 months of index hospital visit showing isolated RV dysfunction

Exclusion Criteria:

* Currently being evaluated and/or treated for RV failure or PH,
* those unable to have a comprehensive echocardiography performed,
* those with indeterminate RV function OR LV dysfunction on comprehensive echocardiography, and
* those patients with circumstances where they may be lost to follow-up (homeless, prisoner, severe psychiatric disorder, no reliable contact information).

Primary outcomes:
measure: Unscheduled healthcare visits
timeFrame: 1 year
Secondary outcomes:
measure: Mortality
timeFrame: 1 year
measure: Hospital re-admissions
timeFrame: 1 year
measure: Change in quality of life via the SF-36
timeFrame: 1 year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT02245529: Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia
Official title: Secotex ®: Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 982
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) who require medical treatment to improve their quality of life

Brief summary: The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving patients treated with Secotex® (Tamsulosin) in "real life" settings. The aim of a PEM is to monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic Hyperplasia as used in general practice


Eligibility criteria: Inclusion Criteria:

* Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) and/or that, according to the Physician, their symptoms require medical treatment to improve their quality of life. The patients could be naïve to treatment or could be on treatment with other drugs but have not responded adequately to treatment. This study is non-interventional, so the decision to treat must be based on the best standard accepted clinical practice, and according to Secotex® prescribing information

Exclusion Criteria:

* Patients with known hypersensitivity to Tamsulosin, or any other component of the product
* Patients with a history of orthostatic hypotension or severe liver failure

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06564129: Prediction of Anterior Circulation Large Vessel Occlusion Stroke With EEG
Official title: Characteristics and Prehospital Triage of Anterior Large Vessel Occlusion Stroke Based on EEG
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anterior Large Vessel Occlusion Stroke
Keywords: anterior large vessel occlusion stroke
electroencephalography
prehospital triage
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 1194
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: All patients with suspected stroke or known stroke were included in the study

Brief summary: This study is designed to evaluate the accuracy of saline electrode EEG in the prehospital diagnosis of LVO-a stroke.

Detailed description: This is a multicenter, prospective, observational study,which will screen a total of 1194 patients in the participating centers during the period of June 1, 2024-December 31, 2025, and record single scalp EEG signals with eyes open at rest in the lying position of the patients using a non-invasive EEG acquisition device, and collect clinical data.

Eligibility criteria: Inclusion Criteria:

* Phase I.1.Acute ischemic stroke caused by occlusion of the anterior circulation (intracranial origin of the internal carotid artery or proximal middle cerebral artery (M1/M2)) confirmed by CTA, MRA or DSA (diagnosis in accordance with the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023")；2. Patient age ≥18 years；3: Last normal time to EEG acquisition time ≤ 72 hours；4: Signed informed consent.

Phase II-III

1. Diagnosed by a healthcare professional as a suspected acute stroke patient or a known acute stroke patient
2. Patient age ≥18 years
3. Last normal time to EEG acquisition time ≤ 24 hours
4. Signed informed consent

Exclusion Criteria:

1. Wounds in the area of electrode cap placement or active infection in the scalp;
2. Patients who do not cooperate with the EEG examination.

Primary outcomes:
measure: Saline electrode EEG characteristics: area under the ROC curve for theta/alpha ratio;
timeFrame: 24 hours
Secondary outcomes:
measure: Other EEG features including relative δ, θ, α power, δ/α ratio, δ+θ/α+β ratio, pdBSI, and WPLI diagnostic accuracy for LVO-a;
timeFrame: 24 hours
measure: Logic and technical feasibility of saline electrode EEG in ambulance for suspected stroke patients by paramedics;
timeFrame: 24 hours
measure: Development of one or more new algorithms for optimal diagnosis of LVO-a based on EEG data
timeFrame: 24 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Beijing
state: Beijing
Study officials:
References:
Clinical trial NCT06661629: Characterizing Bilateral Hypoglossal Nerve Stimulation During Drug-Induced Sleep Endoscopy
Official title: Characterizing Bilateral Hypoglossal Nerve Stimulation During Drug-Induced Sleep Endoscopy (BLISS - BiLateral Inspire Sedated Stimulation)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: OSA - Obstructive Sleep Apnea
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will investigate the treatment effect of bilateral genioglossus muscle stimulation on upper airway collapsibility during drug-induced sleep endoscopy in patients implanted with the Inspire hypoglossal nerve stimulator.


Eligibility criteria: Inclusion Criteria:

* Adults (≥ 22yrs) willing and capable of providing informed consent
* Implanted with the Inspire hypoglossal nerve stimulator

Exclusion Criteria:

* • Pregnant women\*

Primary outcomes:
measure: Upper Airway Collapsability Measures
timeFrame: During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs.
measure: Upper Airway Collapsability Measures
timeFrame: During DISE - during the 20 minutes that the Drug Induced Sleep Endoscopy Occurs
Secondary outcomes:
measure: Difference in Voltage Requirements
timeFrame: During DISE - During the 20 minutes during which the Drug Induced Sleep Endoscopy occurs
Other outcomes:
Locations:
Study officials:
affiliation: Penn Medicine
name: Raj C Dedhia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03519529: Sex Hormone Binding Globulin, Testosterone and Glycemic Control in Patients With Type 2 Diabetes
Official title: The Relationship Between Sex Hormone Binding Globulin, Testosterone and Glycemic Control in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Keywords: sex hormone-binding globulin
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 250
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to April 2018 were enrolled in this study.

Brief summary: Sex hormone-binding globulin(SHBG) is a surrogate marker of insulin resistance. This study aims at the characteristic and clinical significance of SHBG and testosterone in patients with type 2 diabetes(T2D).

Detailed description: The investigators recorded clinical factors, biochemical criterion such as serum levels of glucose and lipids, HbA1c, SHBG, testosterone, insulin, EPO, C-peptide, glucagon, microalbuminuria, glycemic variation via CGM, carotid plaque, ECG and ultrasonic cardiogram in patients with T2D who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to Aprol 2018. The relationship between levels of SHBG, testosterone and glycemic variation/diabetic complications are analysed.

Eligibility criteria: Inclusion Criteria:

● Patients with T2D and the diagnostic criteria of T2D is according to the World Health Organization in 1999.

Exclusion Criteria:

* Patients use systemic steroidal anti-inflammatory drugs.
* Patients with an acute infection.
* Patients with acute complication of diabetes.

Primary outcomes:
measure: sex hormone-binding globulin
timeFrame: Day 1
Secondary outcomes:
measure: Testosterone
timeFrame: Day 1
measure: EPO
timeFrame: Day 1
measure: HbA1c
timeFrame: Day 1
measure: MBG
timeFrame: Day 1-4
measure: MAGE
timeFrame: Day 1-4
measure: SD
timeFrame: Day 1-4
Other outcomes:
Locations:
Study officials:
References:
citation: Ding B, Sun R, Zhai XF, Lu TT, Cheng L, Li FF, Hu Y, Ma JH. Association of high circulating testosterone with increased glycaemic variability in type 2 diabetes: A cross-sectional study in China. Diabetes Metab Res Rev. 2019 May;35(4):e3126. doi: 10.1002/dmrr.3126. Epub 2019 Jan 23.
Clinical trial NCT00548080: Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia (0991-055)
Official title: A Non-Comparative, Multicenter, Open-Label, Study to Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fungal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-23
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Registration study


Eligibility criteria: Inclusion Criteria:

* Patient has had an absolute neutrophil count \< 500/mm3 for at least 96 hours (the patient must not be expected to recover from neutropenia in the next 48 hours), and has received at least 96 hours of parenteral broad spectrum systemic antibacterial therapy preceding study entry, and patient has fever \>38.0 Degrees Centigrade within the last 24 hours prior to study entry

  * Appropriate antibiotics are those that provide broad spectrum gram-positive and gram-negative coverage

Exclusion Criteria:

* Patient has an inadequately managed bacterial infection at the time of enrollment

Primary outcomes:
measure: The proportion of caspofungin-treated patients with SAE
Secondary outcomes:
measure: The proportion of caspofungin-treated patients with a favorable efficacy response at the end of caspofungin study therapy
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02511080: Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
Official title: Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothermia
Keywords: Spot-on; perioperative hypothermia.
Lead sponsor: Osakidetza
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 70
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: PREVENTION

Brief summary: Using the spot-on device for monitoring core body temperature during colon laparoscopic surgery and prevent non-therapeutic hypothermia.

Detailed description: Take active measures to prevent non-therapeutic hypothermia during the laparoscopic colon surgery. We improve these measures using heat conductive air warm blankets placed under and o over the patient.

Perform monitoring core body temperature every 15 minutes by spot-on device compared with standard nasopharyngeal probe.

Eligibility criteria: Inclusion Criteria:

* All patients that need a colorrectal laparoscopic surgery

Exclusion Criteria:

* Use of antagonist of Calcium
* Alergy to medications
* History of Malignant Hipertemia
* Laparosocopy surgery ≥ 120 min
* Temperature previous surgery over 38ºC
* Taking chronic steroids

Primary outcomes:
measure: change in the Body Core Temperature
timeFrame: measure every 15 minutes since the patient arrive to operating room until is derivated to recovery room, an average of 3 hours
Secondary outcomes:
measure: incidence of blood transfusion
timeFrame: In the first two weeks after being operated.
measure: surgical wound infection
timeFrame: while the patient stay in the hospital, an average of two weeks
Other outcomes:
Locations:
city: Galdakao
country: Spain
facility: Hospital de Galdakao
state: Vizcaya
Study officials:
affiliation: Osakidetza
name: unai ortega
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
citation: Eshraghi Y, Nasr V, Parra-Sanchez I, Van Duren A, Botham M, Santoscoy T, Sessler DI. An evaluation of a zero-heat-flux cutaneous thermometer in cardiac surgical patients. Anesth Analg. 2014 Sep;119(3):543-549. doi: 10.1213/ANE.0000000000000319.
Clinical trial NCT05339880: Relation Between Oculocardiac Reflex and Laryngospasm
Official title: Evaluation of Correlation Between Laryngospasm, Emergence Agitation and Oculocardiac Reflex in Strabismus Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eye Abnormalities
Arrythmia
Keywords: strabismus surgery
laryngospasm
oculocardiac reflex
emergence agitation
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and adult patients whose ages ranged between 2-18 and 18-65 and from the group of American Society of Anesthesiology (ASA) I-II who will have elective strabismus surgery

Brief summary: The aim of this study is to evaluate whether there is a significant relation between various arrhythmias during the surgeon's stretching the eye muscles and laryngospasm and emergence agitation in strabismus surgeries

Detailed description: Background: Laryngospasm is one of the serious complications that can be seen in perioperative period, especially during anesthesia induction and extubation. The aim of this study is to evaluate whether there is a significant relation between various arrhythmias during the surgeon's stretching the eye muscles and laryngospasm and emergence agitation in strabismus surgeries

Eligibility criteria: Inclusion Criteria:

* Scheduled for the strabismus surgery
* ASA 1-2 patients
* 2-65 yo patients

Exclusion Criteria:

* Patients with kidney, cardiac diseases
* Being treated with sedative or anticonvulsant drugs
* ASA 3-4 patients
* Patients with upper respiratory tract disease in the last 2 weeks
* Patients who do not want to participate in the study
* Patients with behavioral disorders

Primary outcomes:
measure: Laryngospasm ratio
timeFrame: an average of 20 minutes during emergence
Secondary outcomes:
measure: Emergence agitation in children
timeFrame: an average of 30 minutes
measure: Emergence agitation in adults
timeFrame: an average of 30 minutes
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
state: Melikgazi
Study officials:
affiliation: TC Erciyes University
name: Adnan Bayram, Professor
role: STUDY_DIRECTOR
affiliation: TC Erciyes University
name: Ahmet Cakir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01304680: Evaluation of Fluid Resuscitation in Children With Cancer With Severe Sepsis / Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Septic Shock
Other Fluid Overload
Lead sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients admitted to intensive care unit with septic chock

Brief summary: Retrospective study to evaluate the characteristics of patients and of fluid resuscitation during intensive care unit hospitalization of patients under septic chock.


Eligibility criteria: Inclusion Criteria:

* patients admitted between Jan/2009 and Dec/2010
* patients with septic chock diagnosis

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Grupo de Apoio ao Adolescente e a Criança com Cancer
Study officials:
References: