louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01835951: Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?
Official title: Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Pregnancy
Keywords: Simulation
Debriefing
Anaesthesia Crisis Management
Cardiac Arrest
Pregnancy
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Simulation-based training is essential in learning or maintaining skills in high risk industry such as aviation and railway and in the medical field like anaesthesia. Debriefing following simulation is fundamental in order to reduce the emotional impact of the session and to asses the technical and non-technical skills (behavior). Even if the ideal debriefing method is still to be found, individual debriefing is considered as the gold standard but time consuming. The DEBRIEF-SIM study is a prospective, single blinded, multicentric and randomized study that will compare the individual (defined by learning couple resident and nurse) approach to a grouped (several couples) debriefing. The primary end point is to define the noninferiority of this approach compared to the individual one on the educational impact.

The learners will be debriefed according to their randomization after the first session, but will all undergo individual debriefing following the second session.

Detailed description: Individual debriefing consists in a individual meeting between each subject of the study and the investigator to analyze the management of the anaesthesia crisis simulated.

Grouped debriefing consists in the analysis by the investigator of the management of the anaesthesia crisis simulated in the presence of all the subjects included in the Grouped Debriefing group.

Eligibility criteria: Inclusion Criteria:

* Doctor:

  * resident in anesthesia and intensive care CHU Besançon and Dijon

Student nurse anesthetist:

* Student nurse anesthesist 1st or 2nd year of school Besançon and Dijon

Exclusion Criteria:

* Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (\< 18 years)
* Refusal to participate in the study
* Refusal to sign the confidentiality clause

Primary outcomes:
measure: Score of technical competence
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Faculté de Franche-Comte des études de medecine et pharmaceutiques
Study officials:
affiliation: Faculté de Franche-Comté des Etudes de Médecine et Pharmaceutiques
name: Sébastien Pili-Floury
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06800651: Trial of JMKX003142 in Participants with Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: ADPKD (autosomal Dominant Polycystic Kidney Disease)
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2025-01-30
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Detailed description: Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive ADPKD

Eligibility criteria: Inclusion Criteria:

* Able to understand the procedures of this trial and provide written informed consent voluntarily;
* Age between 18 to 55 years, male or female;
* ADPKD diagnostic criteria were met before randomization;
* Rapidly progressive ADPKD criteria were met.

Exclusion Criteria:

* 12 weeks prior to screening, patients had taken tolvaptan or another ADPKD improvers, or patients who were assessed by the investigator to be likely to use diuretic during the trial period;
* Praticipants who are unable to feel thirst, or have difficulty with fluid/food intake;
* Patients who have previously received decompression surgery for renal cysts; or who received major surgery within 12 weeks before signing the ICF;
* The investigator think that the praticipant is unable to comply with the requirements of the trial or cannot be evaluated by the trial.

Primary outcomes:
measure: Percentage Change of TKV from baseline to Week 52
timeFrame: 52 weeks
Secondary outcomes:
measure: Annual rate of change in eGFR from baseline to Week 52
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01481051: A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
Official title: PPL GLAU 12: A Phase 2 Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension (OH)
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 57
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: The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.


Eligibility criteria: Inclusion Criteria:

* Male or female at least 18 years old
* Diagnosis of bilateral open angle glaucoma or ocular hypertension
* Unmedicated IOP must be ≥22mm Hg

Exclusion Criteria:

* Any significant vision loss in the last year
* No contact lens use for the length of the study
* Abnormal eye lids, eye infection, or diseases to the eye
* Recent eye surgery
* Uncontrolled medication conditions

Primary outcomes:
measure: IOP change from baseline
timeFrame: 12 weeks to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center, Inc
state: California
city: Los Angeles
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: San Diego
country: United States
facility: West Coast Eye Care Associates
state: California
city: Roswell
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: San Antonio
country: United States
facility: R and R Eye Associates
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Eye Care Associates
state: Utah
Study officials:
affiliation: QLT Inc.
name: Suzanne Cadden
role: STUDY_DIRECTOR
References:
Clinical trial NCT03098251: Effect of 3D Typing on Surgical Treatment of Hepatolithiasis
Official title: Efficacy of 3D Typing and Routine Typing on Surgical Treatment of Hepatolithiasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatolithiasis
Surgery
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Chinese PLA General Hospital
First posted: 2017-03-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis.

Detailed description: According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis. In this cohort study, two group will be enrolled to compare the outcomes.

Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 65 years old
* Without gender restriction
* With a favorable liver function of Child-Pugh A to B
* No contraindications to surgery and anesthesia
* Diagnosed with Hepatolithiasis and Signed informed consent.

Exclusion Criteria:

* Diffused type of Hepatolithiasis
* Impairment in liver function
* Severe disorders in vital organ
* Accompanied with tumors.

Primary outcomes:
measure: residual ratio of biliary stone
timeFrame: 3 months
Secondary outcomes:
measure: postoperative complications
timeFrame: 6 months
measure: residual lesions
timeFrame: 6 months
measure: Health economics index
timeFrame: 3 months
measure: mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT04568551: COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor
Official title: COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor - CAASPtrial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety State
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women between 33 until 37 weeks of Gestations with planned Labor in University Hospital of Halle or St.Elisabeth and St.Barbara Hospital Halle, Germany

Brief summary: Capture of anxiety for anomalies, stillbirth and preterm Labor of pregnant women during COVID-19 pandemia


Eligibility criteria: Inclusion Criteria:

* consenting ability

Exclusion Criteria:

* language barrier
* uncompleted questionary

Primary outcomes:
measure: anxiety for anomalies during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)
timeFrame: 6 months
measure: anxiety for stillbirths during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)
timeFrame: 6 months
measure: anxiety for preterm labour during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Halle
country: Germany
facility: University Hospital of Halle
state: Saxony Anhalt
Study officials:
References:
Clinical trial NCT04840251: Investigating a Well-being Review in Pulmonary Hypertension
Official title: Investigating the Feasibility of a Randomised Controlled Trial of a Physiotherapy Well-being Review in Patients With Pulmonary Hypertension.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmnary Hypertension
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 0
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: Pulmonary Hypertension (PH) is a rare disease that makes patients easily become breathless. There is evidence that people with PH can benefit from exercise; we want to look at how they can access rehabilitation in their local community.

Aim: To see if it is feasible to study physiotherapy well-being reviews in PH. Step 1: We will interview some patients with PH who have had rehabilitation and ask questions about their experiences. We will also ask what they think we should measure to show any difference their rehabilitation has made to them. The findings from Step 1 will help us to shape the details of Step 2, where we will conduct a small study to see if it is feasible to run a full study. Participants will be divided randomly into a treatment group and a control group. The treatment group will have a physiotherapy well-being review, leading to referral to their most suitable local rehabilitation service and follow-up after 6 months. The control group will receive brief exercise advice and follow-up after 6 months. The findings will help to design a full study and be shared with patients and health professionals.


Eligibility criteria: Inclusion Criteria:

* in World Health Organisation (WHO) Functional Class II or III
* have a diagnosis of PH
* have started on PH drug therapy in the preceding 18 months
* showing no signs of worsening breathlessness or heart failure
* on an unchanged PH therapeutic regime for at least 6 months prior to inclusion.

Exclusion Criteria:

* have an active infection or acute exacerbation of lung disease
* have participated in a clinical study involving another investigation of drug, device or exercise within the previous 6 months
* are on a surgical or other pathway of care that has pre-determined physiotherapy or activity regimes or restrictions
* have any additional medical conditions that may adversely affect the safety of the subject or severely limit the lifespan of the subject
* have participated in rehabilitation in the last 12 months.

Primary outcomes:
measure: 6MWD
timeFrame: Follow up at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Sospitals NHS Foundation Trust
Study officials:
References:
Clinical trial NCT04676451: Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism
Official title: Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Cataract
Keywords: Astigmatism
Cataract
Femtosecond laser
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, single-center, single-arm, interventional clinical trial. Subjects that meet inclusion and exclusion criteria are invited to participate.
Primary purpose: TREATMENT

Brief summary: A cataract is a clouding of the lens that occurs naturally with age. Cataract surgery involves removal of the cloudy lens and replacement with an artificial one. A special laser (femtosecond laser) is now being used to help make cataract surgery safer and more accurate . The femtosecond laser can also be used to correct astigmatism, an irregular curvature of the cornea, at the time of cataract surgery through a procedure called astigmatic keratotomy (AK). This study is gathering information about the specific laser settings that are used to perform astigmatic keratotomies (AK) during cataract surgery. This information will be used to improve the outcomes of patients that receive cataract surgery with astigmatic keratotomies in the future.


Eligibility criteria: Inclusion Criteria:

* Age: ≥18 years of age
* Sex: male or female
* Patients who are planned to undergo femtosecond laser-assisted cataract surgery with astigmatic keratotomy at the Schein Ernst Mishra Eye clinic within the next 60 days of their cataract consultation visit. Subjects with planned single or bilateral cataract eye surgeries are eligible. Planned opposite eye surgery must be within 2-4 weeks of first cataract surgery.
* Fluent in written and spoken English

Exclusion Criteria:

* Patients with corneal dystrophies, including anterior basement membrane dystrophy, keratoconus, and Fuch's endothelial corneal dystrophy.
* Age \< 18 years
* Pregnant women
* Cognitive impairment
* Prisoners

Primary outcomes:
measure: Keratometric Correction Index
timeFrame: 1 month
measure: Refractive Correction Index
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Eye Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00296751: Epidural Analgesia Versus IV Meperidine for Labor Pain Control
Official title: Epidural Analgesia Versus IV Meperidine for Labor Pain Control. Objective Evaluation of the Pain Intensity Influence on the Autonomic Nervous System.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-02-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 60 female that care for pain control during second stage of delivery, will choose between epidural or systemic analgesia. Continuous ECG (3 lead)monitoring will be recorded during the second stage for 10 minutes. 30 minutes after administration of either pain relief, a second recording of maternal ECG will take place for 10 minutes.

Detailed description: Population 60 female during second stage of delivery

* Inclusion criteria : all parturients requiring pain relief will choose between systemic or epidural analgesia.
* Exclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular autonomic system.
* Method: A 10 minute recording of a 3 lead ECG will be performed during the second stage of the delivery (3-7 CM opening).

the parturient will be lying on her left side for that period.

* 30 minutes after administration of either epidural or systemic Meperidine for pain relief, a second recording of maternal ECG will take place for 10 minutes.
* estimated duration of the procedure about one hour per woman.

Eligibility criteria: Inclusion Criteria: all parturients requiring pain relief will choose between systemic or epidural analgesia.

Exclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular or autonomic system.

-

Primary outcomes:
measure: Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam - health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Amir Weissman, MD
role: STUDY_DIRECTOR
affiliation: Rambam Health Care Campus
name: Olga Torchov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03453151: Abdominal Nerve Blockade in Chronic Heart Failure.
Official title: Splanchnic Nerve Blockade in Chronic Heart Failure. Splanchnic CHF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 19
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: Patients with chronic heart failure and undergoing right heart catheterization will be enrolled in this study. Subjects will undergo catheterization of the heart to obtain central cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will undergo a regional nerve block of the splanchnic nerves.

This study will be a prospective, uncontrolled clinical trial. The study will not be controlled as invasive monitoring of hemodynamics will be performed, allowing clear demonstration of a cause-effect relationship. The goal of the study is to provide proof of concept.

Patients will undergo detailed physiological testing.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of heart failure (HF)
* Symptomatic with dyspnea
* On a stable HF drug regimen

Exclusion Criteria:

* Ongoing treatment with oral anticoagulation other than aspirin
* Immunosuppressive medications for solid organ transplant
* Acute MI (STEMI or Type I NSTEMI) within 7 days
* Systolic blood pressure \< 90 mmHg or \>180 mmHg
* Infiltrative cardiomyopathy or constrictive cardiomyopathy
* Chronic kidney disease stage 5
* Pregnancy

Primary outcomes:
measure: Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2)
timeFrame: baseline, up to 1 hour
measure: Mean Pulmonary Arterial Pressure (mPAP)
timeFrame: baseline, up to 1 hour
measure: Pulmonary Capillary Wedge Pressure (PCWP)
timeFrame: baseline, up to 1 hour
Secondary outcomes:
measure: Cardiac Index (CI)
timeFrame: baseline, up to 1 hour
measure: Urine Output
timeFrame: 2 hours pre-SNB, 2 hours post-SNB
measure: Renal Biomarker Levels
timeFrame: 2 hours pre-SNB, 2 hours post-SNB
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke
state: North Carolina
Study officials:
affiliation: Duke University
name: Manesh Patel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fudim M, Patel MR, Boortz-Marx R, Borlaug BA, DeVore AD, Ganesh A, Green CL, Lopes RD, Mentz RJ, Patel CB, Rogers JG, Felker GM, Hernandez AF, Sunagawa K, Burkhoff D. Splanchnic Nerve Block Mediated Changes in Stressed Blood Volume in Heart Failure. JACC Heart Fail. 2021 Apr;9(4):293-300. doi: 10.1016/j.jchf.2020.12.006. Epub 2021 Mar 10.
citation: Fudim M, Boortz-Marx RL, Ganesh A, DeVore AD, Patel CB, Rogers JG, Coburn A, Johnson I, Paul A, Coyne BJ, Rao SV, Gutierrez JA, Kiefer TL, Kong DF, Green CL, Jones WS, Felker GM, Hernandez AF, Patel MR. Splanchnic Nerve Block for Chronic Heart Failure. JACC Heart Fail. 2020 Sep;8(9):742-752. doi: 10.1016/j.jchf.2020.04.010. Epub 2020 Jun 10.