louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02852447: The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve
Official title: The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve : A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antimullerian Hormone
Ovarian Cysts
Antral Follicle Count
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bening ovarian cyst and requiring surgical removal

Brief summary: The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy.

The secondary objective is the analysis of predictors of change in the ovarian reserve after surgery


Eligibility criteria: Inclusion Criteria:

* Patients with non endometriosis ovarian cysts
* Age between 15-40 years
* Regulars menses
* Signed informed consent

Exclusion Criteria:

* Patients with Previous surgery,
* Patients with infertility,
* Patients with endometriosis or
* Patients with suspicious of malignance

Primary outcomes:
measure: differences in the ovarian reserve before and after surgery by Antimullerian Hormone
timeFrame: 3 months
measure: differences in the ovarian reserve before and after surgery by Antral Follicle Count
timeFrame: 3 months
Secondary outcomes:
measure: Ovarian Size (mm)
timeFrame: 3 months
measure: Time of surgery (minutes)
timeFrame: 3 months
measure: Age (years)
timeFrame: 3 months
measure: BMI in kg/m2
timeFrame: 3 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Tauli
state: Barcelona
Study officials:
References:
Clinical trial NCT02966847: Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery
Official title: Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracoscopy
Keywords: Video assisted thoracoscopy
Cone beam computed tomography
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In the coming years, an increase in lung nodule resection is expected, particularly in Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a tool whose use is constantly spreading.

Detailed description: The aim of this study is to evaluate the feasibility of using intraoperative CBCT to develop a new procedure for intraoperative localization of pulmonary nodules in video-assisted thoracoscopic surgery.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18;
* patient with unique or multiple pulmonary lesions of a size ranging from 5 to 20 mm;
* Complete preoperative assessment;
* Patient receiving information about the protocol who did not indicate his/her opposition to participate;
* Patient covered by a social insurance system

Exclusion Criteria:

* Reoperation (history of ipsilateral thoracic surgery);
* Inability to achieve or obtain a single-lung ventilation during surgery;
* Adult subject to legal protection (trusteeship, guardianship);
* Person deprived of liberty.

Primary outcomes:
measure: Assessment of CBCT
timeFrame: the day following the acquisition
Secondary outcomes:
measure: Feasibility of CBCT
timeFrame: At the end of the surgery
measure: Assessment of global image quality
timeFrame: the day following the acquisition
measure: Assessment of image quality of lesions
timeFrame: the day following the acquisition
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de RENNES
Study officials:
affiliation: CHU Rennes
name: Simon ROUZE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alvarez P, Rouze S, Miga MI, Payan Y, Dillenseger JL, Chabanas M. A hybrid, image-based and biomechanics-based registration approach to markerless intraoperative nodule localization during video-assisted thoracoscopic surgery. Med Image Anal. 2021 Apr;69:101983. doi: 10.1016/j.media.2021.101983. Epub 2021 Jan 30.
Clinical trial NCT05763147: Study of BD Pre-filled Flush Syringes in China
Official title: A Prospective, Multi-center, Randomized, Open Label, Controlled Trial of BD Pre-filled Flush Syringes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effectiveness and Safety of Pre-filled Flush Syringe
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is to compare the BD PosiFlush™ Pre-filled Flush Syringes (manufactured by BD, USA) and evaluate the effectiveness and safety of the pre-filled flush syringes (manufactured by Suzhou Becton Dickinson Medical Devices Co., Ltd.) for locking and flushing the end of catheter line in Chinese popluation.


Eligibility criteria: Inclusion Criteria:

* 1. Age \>or equal to 18, no limitation on gender; 2. Hospitalized patients; 3. Patients who are anticipated to need or have in situ vascular access catheter devices (This may include: Peripheral Intravenous Catheter (PIVC), Central Venous Catheter (such as peripherally inserted central catheter (PICC)); 4. Patients who are expected to require flushing the vascular access catheter with saline at the beginning, during, or end of infusion therapy, or who require to flush and/or lock vascular access catheters at the beginning, during, the end of drug therapy; 5. Patients who can understand the purpose of the trial, agree to participate in this clinical trial and voluntarily sign the informed consent form.

Exclusion Criteria:

* 1. Patient reports pregnancy or lactation (self-report); 2. Subjects who are known to have blockage or recanalization of vascular access prior to this trial.

  3. Subjects who are known to have uncomfortable symptoms such as redness and pain, or common complication associated with indwelling catheter such as phlebitis and infection at the localized insertion site prior to this trial.

  4. Patient participating in another drug or medical device clinical trial at the time of consent or has participated in a drug or medical device clinical trial within three months before enrollment; 5. Any other situation that, in the option of the Investigator would make the patient considered unfit for this study.

Primary outcomes:
measure: the Overall Performance for Flushing and / or Locking the Catheters.
timeFrame: one hour after treatment
Secondary outcomes:
measure: Device Ease of Use
timeFrame: one hour after treatment
Other outcomes:
measure: Number of Adverse Events and Serious Adverse Events
timeFrame: 1 hour after treatment
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
Study officials:
affiliation: Beijing Hospital
name: Chao Chao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02262247: A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures
Official title: A Multicenter OUS Post-Market Clinical Follow-Up of the Medrobotics Flex® Robotic System Used for Accessing and Visualizing the Oropharynx, Hypopharynx, and Larynx During Transoral Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: OSA
Oral Disease
Oropharyngeal Neoplasms
Hypopharyngeal Neoplasms
Keywords: Transoral
Oropharynx
Hypopharynx
Endoscopic
TORS
Endoscopic Transoral
Larynx
Lead sponsor: Medrobotics Corporation
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 80
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects ≥ 22 years of age requiring transoral procedures

Brief summary: The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic System to visualize and access specific anatomical locations along with evaluation of the safety of the device.


Eligibility criteria: Inclusion Criteria:

* ≥ 22 years of age
* Candidate for transoral surgery in the oropharynx, hypopharynx and larynx

Exclusion Criteria:

* Less than 22 years of age
* Not a candidate for transoral surgery in the oropharynx, hypopharynx and larynx

Primary outcomes:
measure: Access and Visualizaton in Oropharynx, Hypopharynx and Larynx
timeFrame: Intra-Operative
Secondary outcomes:
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: University Hospital of Louvain at Mont-Godinne
city: Ulm
country: Germany
facility: University Hospital Ulm
state: Baden-Württemberg
city: Marburg
country: Germany
facility: University Hosptial Giessen and Marburg
state: Baldingerstraße
city: Essen
country: Germany
facility: University Hospital of Essen
state: Hufelandstraße
Study officials:
affiliation: Medrobotics Corp
name: Michael D Tricoli, BS, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT01354847: Influence of Extracorporeal Circulation on Platelet Function of Patients Undergoing Cardiac Surgery
Official title: Influence of Extracorporeal Circulation on Platelet Function of Patients Undergoing Cardiac Surgery - a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Platelet Function Disorder
Keywords: extracorporeal circulation
platelet dysfunction
Multiplate electrode aggregometry analyses
Multiplate
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2011-05-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiac surgery patients undergoing complex cardiac surgery (double valve, aortic surgery, combined - or redo procedures)

Brief summary: This study is planned to investigate the relationship between duration of extracorporeal circulation and the extent of (acquired) platelet dysfunctions in patients undergoing cardiac surgery.

Detailed description: Patients undergoing complex cardiac surgery are planned to be included. At several intra- and postoperative measuring point, blood is drawn for multiple electrode aggregometry to investigate ex-vivo platelet aggregation as a surrogate for platelet function.

Transfusion rate of allogenic blood products as well as postoperative blood loss is planned to be recorded.

Eligibility criteria: Inclusion Criteria:

* duration of extracorporeal circulation \> 120 min

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Changes in arachidonic acid induced platelet aggregation as compared to baseline (before extracorporeal circulation)
timeFrame: Baseline (before extracorporeal circulation) and 60, 90, 120, 150 and 180 minutes after extracorporal circulation as well as ad admission to ICU
Secondary outcomes:
measure: Changes in Adenosin Diphosphate (ADP) and Thrombin induced platelet aggregation as compared to baseline (before extracorporeal circulation)
timeFrame: Baseline (before extracorporeal circulation) and 60, 90, 120, 150 and 180 minutes after extracorporal circulation as well as ad admission to ICU
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe - University
state: Hessen
Study officials:
affiliation: Goethe University Frankfurt, Theodor Stern Kai 7, 60590 Frankfurt, Germany
name: Christian F Weber, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Goethe University Frankfurt, Clinic for Anesthesiology, Theodor Stern Kai 7, 60590 Frankfurt, Germany
name: Christian Reyher, M.D.
role: STUDY_CHAIR
References:
citation: Velik-Salchner C, Maier S, Innerhofer P, Kolbitsch C, Streif W, Mittermayr M, Praxmarer M, Fries D. An assessment of cardiopulmonary bypass-induced changes in platelet function using whole blood and classical light transmission aggregometry: the results of a pilot study. Anesth Analg. 2009 Jun;108(6):1747-54. doi: 10.1213/ane.0b013e3181a198ac.
Clinical trial NCT00816647: A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction
Official title: A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patella-Dislocation
Patellofemoral Osteoarthritis
Patellar Instability
Keywords: Patella
Dislocation
Knee
Medial Patellofemoral Ligament
Lead sponsor: Finnish Defense Forces
Sponsor class: OTHER_GOV
Collaborators: name: Tampere University Hospital
First posted: 2009-01-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The operative management of chronic patellar instability has been controversial. Medial patellofemoral ligament reconstruction has gained success recently and might be superior to other soft-tissue procedures. The objective of this prospective study was to compare the clinical outcome after medial patellofemoral ligament reconstruction compared with medial reefing for chronic patellar instability.

Detailed description: Many of the previous studies on medial patellofemoral ligament (MPFL) reconstruction for patellar instability have been difficult to interpret, either because the study setting has included both first-time and recurrent dislocations, or because a lack of control group. Moreover, several studies have enrolled patients with a wide age range, and the majority of the studies have employed retrospective and nonrandomized study designs. Therefore the investigators designed a prospective, randomized study with the primary goal to compare the outcome after MPFL reconstruction with medial reefing for chronic patellar instability. The distance between tibial tubercle and trochlear groove is measured on MRI and corrected if it exceeds 17mm. Primary outcome measure is the occurrence of recurrent objective and subjective patellar instability. The second goal is to evaluate the development of articular cartilage lesions within the patellofemoral joint, and assess clinical scores.

Eligibility criteria: Inclusion Criteria:

* Chronic patellar instability (more than 2 dislocations)
* Minimum 6 months nonoperative treatment

Exclusion Criteria:

* Severe PF OA
* Acute patellar dislocation

Primary outcomes:
measure: Recurrent patellar instability
timeFrame: 2 years
Secondary outcomes:
measure: Patellofemoral osteoarthrosis progression.
timeFrame: 2 years
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Petri J Sillanpaa, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03547947: Clinical and Radiological Outcomes of Medacta Shoulder System
Official title: Clinical and Radiological Outcomes of Medacta Shoulder System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Osteoarthritis
Secondary Osteoarthritis
Rotator Cuff Tear Arthropathy
Rheumatoid Arthritis Shoulder
Avascular Necrosis
Fracture
Revision of Shoulder Arthroplasty
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2018-06-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring TSA and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.

Brief summary: This is a post-marketing surveillance on Medacta Shoulder System


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Patient with one of the following diagnosis:

Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (\<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty

Exclusion Criteria:

* Patients with malignant diseases (at the time of surgery)
* Patients with proven or suspect infections (at the time of surgery)
* Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)
* Patients with known incompatibility or allergy to products materials (at the time of surgery)

Primary outcomes:
measure: Survival rate
timeFrame: 10 years
Secondary outcomes:
measure: Clinical outcome
timeFrame: 1, 2, 5 and 10 years
measure: Functional outcome
timeFrame: 1, 2, 5 and 10 years
measure: Radiographic performance of the implants
timeFrame: 3 months, 1, 2, 5 and 10 years
measure: Quality of life
timeFrame: 1, 2, 5 and 10 years
measure: Adverse events
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Marcq-en-Barœul
country: France
facility: Clinique du Sport et de Chirurgie Orthopédique
city: München
country: Germany
facility: Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation
city: Bern
country: Switzerland
facility: Orthopädie Sonnenhof
city: Bern
country: Switzerland
facility: Inselspital
city: Bern
country: Switzerland
facility: Lindenhofspital
city: Saint Gallen
country: Switzerland
facility: Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen,
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Matthias Zumstein, Prof Dr. Med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01415947: V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
Official title: V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mitral Leaflet Prolapse
Keywords: Heart disease
Device
Mitral valve
leaflet prolapse
Heart valve disease
Cardiovascular disease
Neochordae
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines.
* Patient able and willing to return to the implant center for follow-up visits
* Able and willing to give informed consent and follow protocol procedures.

Exclusion Criteria:

* Inadequate echocardiographic window for transthoracic imaging
* Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
* Evolving endocarditis or active endocarditis in the last 3 months.
* Heavily calcified annulus or leaflets.
* Congenital malformation with limited valvular tissue
* Patient requires mitral valve replacement.
* Previously implanted annuloplasty ring/band.
* Patient requires aortic or pulmonic valve replacement or repair.
* Patient is pregnant (urine HCG test result positive) or lactating.
* Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
* Life expectancy of less than twelve months.
* Patient is participating in concomitant research studies of investigational products.

Primary outcomes:
measure: Technical success rate
timeFrame: 6 months
measure: Efficacy
timeFrame: 30 days and 6 months
Secondary outcomes:
measure: Incidence of Major Adverse Events (MAE).
timeFrame: 30 days, and 6 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: HSR
Study officials:
affiliation: Hospital San Raffaele
name: Ottavio Alfiieri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00329147: Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Official title: A Randomized, Open-Label, Cross-Over Drug Interaction Study to Evaluate the Effects of Desvenlafaxine (DVS SR) and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Healthy Subjects
Major Depressive Disorder
Depression
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women between 18 to 55 years of age
* Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
* History of being a nonsmoker for at least 1 year Other inclusions apply.

Exclusion Criteria:

* Presence or history of any disorder or significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic condition, and any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure) or psychiatric disease
* Known or suspected alcohol abuse or consumption of more than 2 standard units per day within the past 6 months
* Use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day-1 until the end of the study Other exclusions apply.

Primary outcomes:
measure: The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
Secondary outcomes:
Other outcomes:
Locations:
city: Neptune
country: United States
state: New Jersey
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: