louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05720286: Performance and Safety of the FIXIT® Anchor in Arthroscopic Rotator Cuff Repair
Official title: Verification of the Performance and Safety of the First Row Resorbable Threaded Anchor FIXIT® in Arthroscopic Rotator Cuff Repair as Part of the Post-marketing Follow-up of Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Injuries
Lead sponsor: Science and biomaterials
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 30 patients, aged between 45 to 78 and operated for a rotator cuff repair were selected in this study. Initially, 31 patients were included but 1 withdrew from the study.

Brief summary: Verification of the performance and safety of the first row resorbable threaded anchor FIXIT® in arthroscopic rotator cuff repair Non-interventional, prospective, non-comparative, multi-center study as part of the post-marketing follow-up of devices

Detailed description: the main objective of this study was to verify the safety of the resorbable threaded anchor FIXIT®, used in arthroscopic rotator cuff repair. This objective was to be imaging assessed (echography, MRI) for the presence or absence of a rotator cuff re-tear and its degree of retractation. The second objective was to verify the performance of the FIXIT® anchor with 4 scoring criteria : Constant score, pain score EVA, Quick DASH score and Bernageau classification

Eligibility criteria: Inclusion Criteria:

* Patient with broken tendinopathy of the rotator cuff
* Patient over 18 years old
* Patient who has received complete medical information and not objecting to participate in research
* Social insured patient

Exclusion Criteria:

* Pregnant or likely to be pregnant, or breastfeeding
* Patient under guardianship
* Non-cooperative patient, who does not want or is unable to follow the post-operative instructions (drug addict or alcoholic patient in particular)

Primary outcomes:
measure: Sugaya classification
timeFrame: 1 year postoperative
Secondary outcomes:
measure: Constant score
timeFrame: 45 days, 5months and 1 year postoperative
measure: Pain score
timeFrame: 45 days, 5months and 1 year postoperative
measure: Quick DASH score
timeFrame: 45 days, 5months and 1 year postoperative
measure: Fatty degeneration
timeFrame: preoperative
Other outcomes:
Locations:
city: Tarbes
country: France
facility: Polyclinique de l'Ormeau
city: Toulouse
country: France
facility: CH Purpan
Study officials:
name: Nicolas BONNEVIALLE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00988663: The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems?
Official title: Memantine Augmentation of Electroconvulsive Therapy in Patients With Major Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: electroconvulsive therapy
memantine
cognitive function
memory
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2009-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether memantine will enhance the therapeutic of effect on depression and prevent memory and other cognitive problems caused by ECT.

Detailed description: Patients will be assigned randomly either to a treatment group or a placebo groups. All patients in both groups will be receiving standard ECT. The treatment group will receive memantine. All patients will be given a battery of cognitive tests and test of depression before ECT treatments start, after the 6th ECT treatment and after the completions of ECT. An analysis will be performed to see if memantine causes any impact on the response to ECT and prevents memory and cognitive impairment.

Eligibility criteria: Inclusion Criteria:

* Meets criteria for Major Depressive disorder

Exclusion Criteria:

* Neurological disease
* Mental retardation
* Seizure disorder

Primary outcomes:
measure: Assessment of whether Memantine protects memory and cognitive impairment caused by ECT.
timeFrame: 6 to 8 weeks
Secondary outcomes:
measure: Whether memantine will improve response of Depression to Electroconvulsive therapy.
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa hosptitals and clinic
state: Iowa
Study officials:
affiliation: University of Iowa Hospitals and Clinic
name: Jerry L Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00185263: Safety and Efficacy of Intracoronary Ad5FGF-4 in Patients With Stable Angina
Official title: A Multinational Multicenter, Randomized , Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Stable Angina
Keywords: angina
FGF-4
angiogenesis
adenovector
growth factor
myocardial ischemia
revascularization
Lead sponsor: Cardium Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 116
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
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 determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing, angina functional class, patient symptoms, quality of life, and cardiovascular outcomes. To doses are to be studied, 2.87x10(8) and 2.87x10(9) viral particles, to evaluate the dose-response of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* CCS class II - IV, technically unsuitable for revascularization by CABG or PTCA able to exercise between 3 and 10 minutes on treadmill

Exclusion Criteria:

* Unstable angina, CCS class 1 angina optimal candidates for revascularization

Primary outcomes:
measure: Treadmill exercise duration
timeFrame: Week 12
Secondary outcomes:
measure: Time to coronary events
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
affiliation: Cardium Therapeutics, 12255 El Camino Real, Suite 250, San Diego, CA 92130, USA, +1-858-436-1000
name: Paul Foster, MD
role: STUDY_DIRECTOR
References:
citation: Henry TD, Grines CL, Watkins MW, Dib N, Barbeau G, Moreadith R, Andrasfay T, Engler RL. Effects of Ad5FGF-4 in patients with angina: an analysis of pooled data from the AGENT-3 and AGENT-4 trials. J Am Coll Cardiol. 2007 Sep 11;50(11):1038-46. doi: 10.1016/j.jacc.2007.06.010. Epub 2007 Aug 24.
Clinical trial NCT04808063: Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.
Official title: Prevention of Incisional Hernia in Emergent Laparotomy Using a Prophylactic Mesh Augmentation Protocol Algorithm.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incisional Hernia of Midline of Abdomen
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with emergency surgery using midline laparotomy
Primary purpose: PREVENTION

Brief summary: Use of informed algorithm for patients selection of prophylactic mesh aplication after midline laparotomy in emergency surgery.

Detailed description: Midline laparotomy complications have a high rate. When midline laparotomy is performed complications rate is even higher. One of the commons complications is incisional hernia, reaching up to 40%- 50% of cases in High risk groups.

Prophylactic mesh use has been proved to be useful preventing midline laparotomy in elective surgery. Despite this, there is not enough data to recommend its use in emergency surgery.

Aim of the study is to investigate if use of an algorithm of informed decision for use of prophylactic mesh in emergency midline laparotomy reduces incisional hernia incidence.

Prospective cohort study of all consecutive midline laparotomy performed at our emergency surgery department. Compare correct application of algorithm outcomes versus non correct application.

Eligibility criteria: Inclusion Criteria:

* Emergency midline laparotomy.

Exclusion Criteria:

* Surgical infection present at the moment of surgery.
* Ventrla or incisional hernia present at the moment of laparotomy .
* Open abdomen.
* Preoperative American Society of Anesthesiologist score (ASA) of V.

Primary outcomes:
measure: Incisional hernia
timeFrame: Durign first and second year of follow up
Secondary outcomes:
measure: Incidence os surgical site ocurrence complications
timeFrame: During first postoperative month.
measure: Long term mesh related complications: chronic pain and mesh infection.
timeFrame: During first year of follow-up.
Other outcomes:
measure: Global rate of complication.
timeFrame: Durign first month of postoperative follow up.
measure: Reintervention
timeFrame: During first postoperative month follow up.
measure: Hospital readmission
timeFrame: During first postoperative month follow up.
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalonia
Study officials:
References:
Clinical trial NCT02005263: Hysteroscopic Assessment of Fallopian Tubal Patency
Official title: Hysteroscopic Assessment of Fallopian Tubal Patency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Menorrhagia
Keywords: Hysteroscopy
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 621
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Disease of the fallopian tubes is one of the most common reasons for infertility. The most common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses concurrent uterine disease. We propose using a less painful technique (through modified office hysteroscopy) for tubal assessment that can be performed in the office rather than hospital radiology and that uses gold standard technology for identifying coexisting uterine conditions.


Eligibility criteria: Inclusion Criteria:

1. 18 - 50 years old
2. Able to give consent
3. Must have a uterus
4. Must have documented negative testing for gonorrhea and chlamydia within the past year or previously negative when tested with a current partner in a monogamous relationship
5. Negative test prior to procedure

Exclusion Criteria:

1. Pregnancy
2. Active lower and upper genital tract infection
3. Patients with allergies to hysterosalpingogram contrast will not be exposed to a contrast material to which they are allergic
4. Premenarchal or postmenopausal
5. Unable to read English at a 6th grade level or above
6. History of endometrial Ablation
7. Asherman's syndrome \> Stage 1

Primary outcomes:
measure: Hysteroscopic assessment of tubal patency
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: John P. Parry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parry JP, Riche D, Rushing J, Linton B, Butler V, Lindheim SR. Performing the Parryscope technique gently for office tubal patency assessment. Fertil Steril. 2017 Oct;108(4):718. doi: 10.1016/j.fertnstert.2017.07.1159. Epub 2017 Aug 31.
Clinical trial NCT05018663: Artificial Intelligence (AI) Cytopathology Trial
Official title: Artificial Intelligence for Rapid On-site Evaluation (AI-ROSE) for Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) Biopsy of Pancreatic Solid Lesions: A Prospective Double Blinded Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Solid Lesions
Keywords: Endoscopic Ultrasound guided fine needle aspiration (FNA)
Endoscopic Ultrasound guided fine needle biopsy (FNB)
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from the inpatients and outpatients departments of the participating hospital and will be included in the study. A consent will be obtained for the EUS FNA/FNB per standard of care.

Brief summary: Purpose The primary objective of the study is to compare interpretation of EUS FNA/FNB samples for adequacy between ROSE and AI at bedside. To compare accuracy of preliminary diagnosis results between ROSE and AI at bedside versus final pathology report.

Research design This is a prospective single center study to compare performance characteristics in the interpretation of EUS FNA/FNB samples between AI and ROSE.

Procedures to be used Eligible patients will undergo EUS guided FNA/FNA of PSLs using standard of care. Sample slides are prepared by a cytopathologist at bedside and observed under a microscope. At the same time, the slides are scanned using a slide scanner and those images are saved for interpretation by AI at a later time.


Eligibility criteria: Inclusion Criteria:

* Have EUS finding of a PSL;
* Do not have contraindications for FNA/FNB.

Exclusion Criteria:

* Inability to provide informed consent for the procedure;
* Contraindication for FNA/FNB eg coagulopathy, lack of avascular window for FNA.

Primary outcomes:
measure: Detection the adequacy for diagnosis
timeFrame: During procedure
Secondary outcomes:
measure: Comparing the accuracy between preliminary diagnosis
timeFrame: During procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nirav Thosani, MD, MHA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05946863: Caudal Block & Hip Fracture Surgery in Anticoagulated Patient
Official title: Caudal Anesthesia for Surgical Repair of Fractured Hip or Femoral-neck in Anticoagulated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Anticoagulants and Bleeding Disorders
Keywords: Caudal anesthesia
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult or elderly patients with fractured hip or femoral neck who undergo emergency surgical repair

Brief summary: Hip fractures are common in elderly patients, and require surgery. Many elderly patients take anticoagulants for vasculopathy treatment. Anticoagulation precludes the use of neuraxial anesthesia because of the risk of epidural bleeding. Caudal anesthesia may be a safe and effective technique in anticoagulated emergency surgical patients.

Quantitative analysis of prospective clinical data. Evaluation of caudal anesthesia efficacy for hip fracture surgery. Analysis of perioperative outcome, and postoperative course.

Detailed description: Hip or femoral neck fractures are common in elderly patients. These fractures require surgical repair. Many elderly patients take regular anticoagulant therapy for vasculopathy. Anticoagulation precludes the use of spinal or epidural anesthesia because of the risk of epidural bleeding. Caudal anesthesia is another form of neuraxial anesthesia that may be safe and effective for hip fracture surgery in anticoagulated elderly patients.

Quantitative analysis of prospective clinical data. It is an evaluation of caudal anesthesia efficacy for hip fracture surgery. This is an analysis of intraoperative analgesia, perioperative outcome, postoperative course, and complications.

Eligibility criteria: Inclusion Criteria:

* Patients with fractured hip or femoral neck who undergo surgical repair

Exclusion Criteria:

* Patients who refuse surgical repair

Primary outcomes:
measure: Pain score, objective measurement using the validated Numeric Pain Rating scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Salem Anaesthesia Pain Clinic
state: British Columbia
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olu Bamgbade, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandby-Thomas M, Sullivan G, Hall JE. A national survey into the peri-operative anaesthetic management of patients presenting for surgical correction of a fractured neck of femur. Anaesthesia. 2008 Mar;63(3):250-8. doi: 10.1111/j.1365-2044.2007.05328.x.
Clinical trial NCT00815763: Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke
Official title: Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Stroke
Keywords: randomized trial
ischemic stroke
Ginsenoside-Rd
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2008-12-30
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this phase 3 study is to validate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.

Detailed description: A phase Ⅲ randomized, double-blind, placebo-controlled, multicenter study was conducted to examine the efficacy and safety of ginsenoside-Rd in patients with acute ischemic stroke. Stroke patients were randomized equally to receive a 14-day infusion of placebo or ginsenoside-Rd 20mg. Primary end points were NIHSS scores at 15 days. Secondary end points were NIHSS scores and the Barthel index at 8 days, the Barthel index and the modified Rankin scale at 15 days and 90 days. The safety end points included serious and nonserious adverse events, laboratory values and vital signs. Analysis was by intention to treat.

Eligibility criteria: Inclusion Criteria:

* between 18 to 75 years
* the first episode
* from onset to admission within 72 hours
* NIHSS scores:5\~22

Exclusion Criteria:

* had other intracranial pathologies (e.g., tumor, infection)
* had a neurologic or psychiatric disease
* had a coexisting condition that limited their life expectancy
* had significant drug or alcohol misuse
* had high-grade carotid artery stenosis for which surgery was planned
* were pregnant or nursing
* participated in a clinical trial with an investigational drug or device within the past 3 months
* were unlikely to be available for follow-up

Primary outcomes:
measure: the modified Rankin scale
timeFrame: 90 days
Secondary outcomes:
measure: NIHSS scores
timeFrame: 8 days
measure: NIHSS scores
timeFrame: 15 days
measure: the Barthel index
timeFrame: 8 days
measure: the Barthel index
timeFrame: 15 days
measure: the modified Rankin scale
timeFrame: 15 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the Department of Neurology , Xijing Hospital
state: Shaanxi
Study officials:
affiliation: the Department of Neurology , Xijing Hospital
name: Gang Zhao, MD
role: STUDY_DIRECTOR
affiliation: the Department of Neurology, Xijing Hospital
name: Xuedong Liu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00440063: A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.
Official title: A Randomized Study to Compare the Safety and Effectiveness of Two Monitoring Schedules to Maintain Hemoglobin Levels and Iron Parameters in Patients With Renal Anemia Receiving NeoRecormon
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-02-26
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: This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-80 years of age;
* stage 3-4 chronic kidney disease (eGFR 15-60mL/min);
* Hb \<100g/L, TSAT\>=20%, and ferritin \>=100 mcg/L at screening.

Exclusion Criteria:

* anticipating to go on renal replacement therapy;
* anticipating a living related-donor kidney transplant, or a prior recipient of a kidney transplant;
* uncontrolled hypertension;
* congestive heart failure;
* active bleeding or red blood cell transfusions in 8 weeks prior to screening; systematic hematological disease.

Primary outcomes:
measure: Percentage of patients achieving target Hb within 20 weeks.
Secondary outcomes:
measure: Efficacy: % of patients exceeding upper Hb target; % who fail to reach target Hb; median time to achieve Hb target; dose of NeoRecormon required to meet target Hb concentration; % who maintain target iron parameters. Safety: AEs, SAEs.
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Gosford
country: Australia
city: Herston
country: Australia
city: Liverpool
country: Australia
city: Parkville
country: Australia
city: Perth
country: Australia
city: Sydney
country: Australia
city: Tasmania
country: Australia
city: Woolloongabba
country: Australia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: