louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00886418: Influence of Muscle Relaxation on a Closed-loop Anesthesia System
Official title: Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, General
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 140
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: Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for a surgical procedure which not require a myorelaxation

Exclusion Criteria:

* age less than 18 years,
* ASA III and above,
* pregnant woman
* combined general and regional anesthesia,
* history of prolonged myorelaxation due to a decrease in cholinesterase,
* patient with a known lack in cholinesterase,
* history of cerebral or psychiatric central,
* allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
* known hypersensitivity to remifentanil or to an other derivative of fentanyl,
* presence of a pacemaker,
* psychotropic or agonist-antagonist morphine treatment,
* planned post-operative sedation.

Primary outcomes:
measure: propofol dose
timeFrame: one hour anesthesia
Secondary outcomes:
measure: remifentanil dose
timeFrame: one hour anesthesia
measure: number of automatic modifications of the propofol and remifentanil concentrations
timeFrame: one hour anesthesia
measure: number of patients' movements
timeFrame: one hour anesthesia
measure: number of hemodynamic abnormalities requiring treatment
timeFrame: one hour anesthesia
measure: time to wake up
timeFrame: end of anesthesia
measure: intraoperative awareness
timeFrame: postoperative day 1 or 2
measure: performance of the closed-loop system
timeFrame: one hour anesthesia
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
city: Marseille
country: France
facility: Institut Paoli-Calmette
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05076318: Dysregulated Urea-synthesis at Terminal Uremia
Official title: Dysregulated Urea-synthesis at Terminal Uremia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urea Cycle Disorder
Uremia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project will examine the dysregulation of the urea cycle in patients with terminal uremia using a validated method named "Functional Hepatic Nitrogen Clearance"


Eligibility criteria: Inclusion Criteria:

* Age \> or equal to 18 years
* Chronic hemodialysis during 3 months
* Patients with functioning arteriovenous-fistula assigned to "Center-Hemodialysis" at "Nyresygdomme, AUH Skejby"

Exclusion Criteria:

* Active infection
* Conditions with vomiting or diarrhea
* Diabetes
* Active disease being treated with chemotherapy, radiationtherapy, biologic- or similar treatments. Disease under observation can be included.
* Liver disease
* Vessels on the upper extremities not suited for cannulation
* Prednisolone treatment during the last 8 weeks
* Pregnancy
* BMI \> or equal to 30 or \< or equal to 18
* Physically or mentally condition that does not allow the project to be completed
* Language-difficulties that does not allow the project to be completed

Primary outcomes:
measure: Urea synthesis rate during alanine infusion
timeFrame: 4 hours. 1 hour of blood sample measuring of baseline urea-synthesis rate and 3 hours of urea-synthesis rate during alanine-infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: University Hospital Aarhus
Study officials:
References:
Clinical trial NCT02797418: "Cognitus & Moi": a New Cognitive Remediation Tool
Official title: "Cognitus & Moi": a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mental Retardation
Keywords: Attentional disorders, intellectual deficiency
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 18
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Holders children with intellectual disabilities have great difficulty in adapting to social situations and relationships.Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved.Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are children with intellectual disabilities manner in their daily functioning.

Detailed description: Cognitus \& ME is a remediation program focused on attentional functions and visuospatial, to limit the presence of behavioral disorders among children with intellectual disabilities.The main objective is to validate the effectiveness of Cognitus \& ME program on behavioral disorders in children with intellectual disabilities (with or without autism spectrum disorder associated).

Eligibility criteria: Inclusion Criteria:

* Children with intellectual deficiency (5-13 years) (40 \< total IQ \< 75) with or without autism spectrum disorders
* Native French speaker
* Clinically stable
* Parental consent

Exclusion Criteria:

* visual or auditory disorder
* history of neurological illness or trauma
* Absence of language

Primary outcomes:
measure: Aberrant Behavior Checklist scale
timeFrame: 6 months
Secondary outcomes:
measure: MDI-C scale ( Multiscore Depression Inventory for Children scale)
timeFrame: 6 months
measure: KIDSCREEN-27 scale
timeFrame: 6 months
measure: Vineland 2 scale (Vineland Adaptive Behavior Scale)
timeFrame: 6 months
measure: ABC scale (Irritability and social withdrawal)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Demily Caroline
state: Lyon
Study officials:
affiliation: Le Vinatier Hospital
name: DEMILY DR CAROLINE, MD PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Favre E, Peyroux E, Babinet MN, Poisson A, Demily C. Computer-based cognitive remediation program for the treatment of behavioral problems in children with intellectual disability: the <<COGNITUS & MOI>> study protocol for a randomized controlled trial. BMC Psychiatry. 2018 Jul 20;18(1):235. doi: 10.1186/s12888-018-1810-z.
Clinical trial NCT03775018: TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass
Official title: Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 140
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: Patients will be randomized into 2 groups:

* TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia
* IV: Patients receiving only intravenous Acetaminophen analgesia

Postoperative pain 24 hours after surgery will be evaluated.

Detailed description: Patients will be randomized into 2 groups:

* TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia (1g/6h)
* IV: Patients receiving only intravenous Acetaminophen analgesia (1g/6h)

Postoperative pain 24 hours after surgery will be evaluated, by a Visual Analogic Scale (VAS), ranging from 0 to 100mm.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing One-anastomosis gastric bypass (OAGB) as primary bariatric procedure

Exclusion Criteria:

* Patients undergoing OAGB as revisional procedure
* Patients undergoing other bariatric procedures
* Patients undergoing additional surgical procedures during the same surgical act (band removal, cholecystectomy, hernioplasty, or hiatal hernia treatment)
* Patients with history of allegy to local anesthetic drugs

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Rey Juan Carlos
name: Damian Garcia, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05341518: Subscapularis Repair During Reverse Total Shoulder Arthroplasty
Official title: Subscapularis Repair During Reverse Total Shoulder Arthroplasty: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Shoulder Osteoarthritis
Arthropathy Shoulder
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multi-site study involving Northwestern Medicine, Beaumont Health, and Loyola Medicine seeks to answer the following question: do patients who undergo subscapularis (SSc) repair during reverse total shoulder arthroplasty (RSA) have better post-operative outcomes than patients who do not undergo SSc repair during RSA? The investigators hypothesize that patients who do not undergo SSc repair during RSA have better post-operative outcomes than patients who undergo SSc repair during RSA. This study will address the controversy surrounding SSc repair during RSA via a multi-institutional randomized controlled trial that will compare clinical outcomes of patients who receive SSc repair during RSA to those who do not.


Eligibility criteria: Inclusion Criteria:

1. Primary RSA procedure with repairable (intact) SSc
2. Operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant
3. Diagnosis with imaging of arthropathy with rotator cuff insufficiency
4. Surgical approach: Deltopectoral
5. Fluent English speakers/readers

Exclusion Criteria:

1. Minor (\<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)
2. Revision surgery
3. Oncologic surgery
4. non-ZB CRSS implants
5. Unrepairable SSc

Primary outcomes:
measure: The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: up to 12 months post-surgery
Secondary outcomes:
measure: Internal Rotator (IR) Strength
timeFrame: up to 12 months post-surgery
measure: PROMIS Bank v1.1 - Pain Interference
timeFrame: up to 12 months post-surgery
measure: Shoulder Range of Motion
timeFrame: up to 12 months post-surgery
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola Medicine
state: Illinois
city: Royal Oak
country: United States
facility: Beaumont Health
state: Michigan
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Guido Marra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914718: Dose-adjusted EPOCH-R in MYC Positive DLBCL
Official title: Dose-adjusted EPOCH-R in Patients With Diffuse Large B-cell Lymphoma: a Phase II Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Keywords: DLBCL
DA-EPOCH-R
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.

Detailed description: The prognosis of MYC positive diffuse large B-cell lymphoma (DLBCL) is very poor even treated with R-CHOP regimen. Recently, dose-adjusted EPOCH-R was shown to be effective in patients with DLBCL and relapsed/refractory Burkitt lymphoma. The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.

Eligibility criteria: Inclusion Criteria:

* Previously untreated MYC positive diffuse large B-cell lymphoma
* Age range 18-70 years old
* Eastern Cooperative Oncology Group performance status 0-2
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria:

* Primary or secondary central nervous system involvement
* Previous serious cardiac disease
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection

Primary outcomes:
measure: 3-year progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Objective response rate
timeFrame: 4 months
measure: 3-year overall survival
timeFrame: 3 years
measure: Toxicity
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06601413: Modified Thoracoabdominal Nerve Block(M-TAPA) in Total Laparoscopic Hysterectomies
Official title: Modified Thoracoabdominal Nerves Block Through Perichondrial Approach (M-TAPA) Versus Incisional Local Anesthetic Administration for Total Laparoscopic Hysterectomy : a Prospective, Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pain,Postoperative
Keywords: M-TAPA, post-operative pain,
Total laparoscopyc histerectomy
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is comparing the postoperative effects of ultrasound-guided Modified Perichondrial Approach to Thoracoabdominal Nerves (M-TAPA) block for postoperative pain control after total laparoscopic hysterectomy.

Detailed description: Pain is one of the most common problems seen in the postoperative period in patients who underwent total laparoscopic hysterectomy.

Multimodal analgesia methods are used in postoperative pain management. Nerve blocks, which are an important component of multimodal analgesia, have an important place in postoperative analgesia management today.

Local Anesthetic Infiltration at the Trocar Site is the most classical nerve block method that has been used for a long time as a part of multimodal analgesia in laparoscopic surgeries.

Modified TAPA block applied with ultrasound guidance; It is a regional block affecting both the anterior and lateral branches of the thoracoabdominal nerves with a perichondrial approach. It is used in total laparoscopic hysterectomies.

Eligibility criteria: Inclusion Criteria:

* Ages 18-65
* Elective cases
* ASA I-III functional status
* Body mass index (BMI)\<35
* Total laparoscopic hysterectomy planned with general anesthesia
* No contraindications for M-TAPA block to be applied
* Cases that give written and verbal consent for participation in the study will be included.

Exclusion Criteria:

* Conversion to open surgery
* Development of perioperative complications (due to surgery and/or anesthesia)
* Coagulation disorder
* Infection at the injection site
* Allergy to local anesthesia
* Those who used any painkillers in the preoperative 24 hours
* Those who did not agree to participate in the study

Primary outcomes:
measure: Postoperative total tramadol consumption for first 24 hours
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: at postoperative 0 (PACU), 1, 2, 4, 8, 12 and 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Health Sciences University
Study officials:
References:
Clinical trial NCT04448613: Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema
Official title: Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Optic Disk
Magnetic Resonance Imaging
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-06-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the radiology service of the A. de Rothschild foundation and presenting a papillary edema detected clinically at the back of the eye sent by the emergency department for an MRI

Brief summary: The presence of optic disc swelling at the fundus is a non-specific clinical sign that can occur in many ophthalmologic, neuro-ophthalmologic or encephalic pathologies. The diagnostic range is vast, including inflammatory pathologies of the optic nerve, infiltrative or compressive orbital pathologies, idiopathic or secondary intracranial hypertensions, not to mention the pseudo optic disc swelling found in drüsens.

MRI is increasingly being used as a first-line examination to obtain an etiologic diagnosis in a patient with optic disc swelling. It allows a rapid diagnosis to be made in cases of inflammatory pathology or compressive or infiltrative pathology. It can provide very suggestive elements in the case of intracranial hypertension. It appears to be potentially useful in diagnosing ischemic optic neuropathy or in directing towards an etiological diagnosis of Giant Cell Arteritis.

The development of new high-resolution MRI sequences has made it possible to obtain extremely fine resolutions of a few hundred microns in the plane. Apart from a few clinical cases and small series, there is no precise evaluation of the interest of these new sequences in the positive and etiological diagnosis of ophthalmological, neuro-ophthalmological and encephalic pathologies responsible for the presence of optic disc swelling.

The objective of our study is therefore to evaluate the diagnostic contribution and the gain in diagnostic confidence provided by these new sequences in the context of pathologies manifesting as optic disc swelling.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* presenting a papillary edema detected clinically at the back of the eye
* Express consent to participate in the study
* Affiliate or beneficiary of a Social Security scheme

Exclusion Criteria:

* MRI contraindication (electrical device, metallic foreign body, claustrophobia)
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman

Primary outcomes:
measure: FLAIR hypersignal size: larger diameters and area
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Study officials:
References:
Clinical trial NCT00353613: Prevention of Surgical Site Infections
Official title: Prevention of Surgical Site Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: Antibiotic prophylaxis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2006-07-18
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary research question is whether interventions to prevent caregiver and system errors will increase the proportion of laparotomy patients who receive recommended measures to prevent surgical site infections.

Detailed description: Background: Surgical site infections (SSIs) cause significant and largely preventable morbidity, mortality, and resource use due to failure to comply with evidence-based guidelines. Quality improvement programs report increased compliance with these guidelines, but are subject to a variety of biases.

Hypothesis: The primary hypothesis is that a targeted intervention program will increase the proportion of patients in a county hospital who receive recommended interventions to prevent SSIs, when assessed in the most rigorous feasible clinical trial. The specific aims of the trial are to establish practical surveillance measures to determine the percentage of patients whose care complies with 5 major guidelines to prevent SSIs; to use chart review, direct observation, attitude surveys, and focus groups to identify, quantify, and address latent and active errors linked to non-compliance, and to develop, implement, and assess the effectiveness of an intervention program to increase guideline compliance.

Study Design: An innovative trial design will be performed with 3 staggered phases in the two major county hospitals in Houston, TX. This design allows for adjustment for temporal trends and hospital differences in assessing the intervention program in a large, high-risk, disadvantaged urban population. Based on a compliance goal of 95%, this design has adequate power to detect even a small absolute increase ( \>= 5%) above baseline in the percentage of patients receiving all 5 recommended preventive measures.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing laparotomy at either Ben Taub Hospital or Lyndon Baines Johnson Hospital in Houston, Texas

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections
timeFrame: 1 year
Secondary outcomes:
measure: Surgical site infections
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon Baines Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lillian S Kao, MD
role: PRINCIPAL_INVESTIGATOR
References: