louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04598568: Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique
Official title: Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Arthropathy
Lead sponsor: Mathys Ltd Bettlach
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: according to Eligibility Criteria

Brief summary: The purpose of the study is the evaluation of the clinical and radiological long-term performance of the balanSys UNI fix in a multicenter routine clinical setting.

Detailed description: Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the balanSys UNI fix knee prosthesis.

In total at least 100 participants in 3 clinics are included in this multicenter study.

The primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery.

The following parameters will be collected during the regular clinical and radiological follow-up: Knee Society Score, Knee and Osteoarthritis Outcome Score (KOOS), radiographic evaluation and detection of adverse events.

Eligibility criteria: Inclusion Criteria:

* Informed consent form (signed by participant and investigator)
* Primary implantation
* Age at inclusion: Between 18 and 90 years old
* Willing to participate in the follow-up

Exclusion Criteria:

* Missing Informed consent form
* Known or suspected non-compliance (e.g. drug or alcohol abuse)
* Enrollment of the investigator, his/her family, employees and other dependent persons
* Patient younger than 18 years old
* Revision surgery
* Does have a known allergy to metal in medical devices
* Suffers from ACL rupture
* Pregnancy or in the breast feeding period

Primary outcomes:
measure: Knee Society Score
timeFrame: 2 years
Secondary outcomes:
measure: Radiographic evaluation of lucent lines
timeFrame: 6-12 weeks - 10 years
measure: Adverse Events and Complications
timeFrame: 6-12 weeks - 10 years
Other outcomes:
Locations:
Study officials:
References:
citation: Tille E, Beyer F, Auerbach K, Tinius M, Lutzner J. Better short-term function after unicompartmental compared to total knee arthroplasty. BMC Musculoskelet Disord. 2021 Apr 2;22(1):326. doi: 10.1186/s12891-021-04185-w.
Clinical trial NCT06675968: Evaluating the Need for Transosseous Anchoring in Anterolateral Hip Prosthetic Surgery
Official title: A Randomized, Prospective, Single-blind Controlled Clinical Trial to Systematically Assess the Need for Transosseous Anchoring in the Anterolateral Approach to Primary Hip Prosthetic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suture, Complication
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to discuss the challenges associated with breakage or failure of the abductor mechanism after total hip arthroplasty, which can lead to gait issues, instability, and the need for revision surgery. Sutures play a crucial role in preventing these failures, with two main types: transosseous and tendon sutures. Transosseous suturing involves using non-absorbable threads anchored in the bone, while tendon suturing uses absorbable threads for layered closure.

Both techniques are commonly used, but there is a lack of evidence to determine which is more beneficial for patients. Current studies are limited and often focus on cases requiring revision surgery due to complications, with transosseous sutures generally being the preferred method.

A meta-analysis indicated that transosseous repair may result in lower dislocation rates and less postoperative pain, but further randomized clinical trials with long-term follow-up are necessary for definitive conclusions. The text proposes a prospective study to compare transosseous suturing with the common absorbable tendon suturing in primary hip surgeries.


Eligibility criteria: Inclusion Criteria:

* Adult population
* Patients diagnosed with coxarthrosis (stages 2 and 3), confirmed by X-ray, according to D. Tonnis's classification of 1972
* Willingness to follow up for up to 12 months
* Patients capable of understanding the study and giving their informed consent

Exclusion Criteria:

* Difficulty understanding and following the study procedure
* Patients with previous surgery on the same hip
* Patients with a diagnosis other than the inclusion criteria (e.g. acute femoral fracture requiring total hip arthroplasty

Primary outcomes:
measure: Trendelenburg Test
timeFrame: preoperative and 3 months
Secondary outcomes:
measure: Pain Level
timeFrame: Preoperative at 24 and 48 hours and postoperative at 3, 6 and 12 months
measure: Quality of life
timeFrame: Preoperative, 3, 6 and 12 months.
measure: Surgeons sensation
timeFrame: 3 and 12 months
measure: Patient Satisfaction
timeFrame: 3 and 12 months
measure: Complications
timeFrame: Up to 1 year
measure: Complementary tests
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
Study officials:
References:
Clinical trial NCT05197868: Applied Forces During Neonatal Intubation
Official title: Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Training
Neonate
Manikin
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be to compare the forces applied to mannequin airways (at epiglottis and at palate) during direct laryngoscopy and indirect video laryngoscopy with two kinds of blades (straight blade and hyper-angulated blade)

Detailed description: This is a randomized controlled crossover trial of intubation with three laryngoscope devices in a neonatal manikin model. Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study. Participants in the ABC arm will be assigned to perform the intubation with a traditional laryngoscope (A), followed by the intubation with a straight blade video laryngoscope (B) and by the intubation with hyper-angulated video laryngoscope (C). Participants in different arms will be assigned to perform the intubations in different sequences (BCA/CAB/ACB/BAC/CBA). The primary outcome measure will be the forces applied to mannequin oro-tracheal tissues during intubation with the three kinds of tools. The secondary outcome measures will be the perceived workload during intubation and intubation time with the traditional laryngoscope and the video laryngoscope.

Eligibility criteria: Inclusion Criteria:

* Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study.

Exclusion Criteria:

* Refusal to participate.

Primary outcomes:
measure: Forces applied to the epiglottis
timeFrame: 5 minutes
Secondary outcomes:
measure: Forces applied to the palate
timeFrame: 5 minutes
measure: Perceived workload during intubation
timeFrame: 20 minutes
measure: Time of intubation
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University Hospital of Padova
Study officials:
References:
citation: Balaban O, Tobias JD. Videolaryngoscopy in Neonates, Infants, and Children. Pediatr Crit Care Med. 2017 May;18(5):477-485. doi: 10.1097/PCC.0000000000001128.
citation: Gordon JK, Bertram VE, Cavallin F, Parotto M, Cooper RM. Direct versus indirect laryngoscopy using a Macintosh video laryngoscope: a mannequin study comparing applied forces. Can J Anaesth. 2020 May;67(5):515-520. doi: 10.1007/s12630-020-01583-x. Epub 2020 Mar 9.
citation: Pouppirt NR, Nassar R, Napolitano N, Nawab U, Nishisaki A, Nadkarni V, Ades A, Foglia EE. Association Between Video Laryngoscopy and Adverse Tracheal Intubation-Associated Events in the Neonatal Intensive Care Unit. J Pediatr. 2018 Oct;201:281-284.e1. doi: 10.1016/j.jpeds.2018.05.046. Epub 2018 Jul 3.
Clinical trial NCT00721968: Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract
Official title: A Prospective, Randomized, Controlled, Parallel Groups, Multicenter Clinical Investigation Of The Trabecular Micro-Bypass Stent Model GTS400 In Conjunction With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-angle Glaucoma
Keywords: Open angle
Glaucoma
Cataract
Surgery
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 62
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: To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate open angle glaucoma.

Detailed description: The objective of this trial is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 (hereinafter referred to as GTS400) in combination with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma. This is a prospective, randomized, concurrently controlled, parallel groups, multicenter clinical investigation of the GTS400. Treatment will consist of either implantation of GTS400 stents in the study eye in conjunction with cataract surgery (Group 1, Investigational Group), or cataract surgery only (Group 2, Control Group). Clinical data through 12 months postoperative will form the basis of a pre-market approval (PMA) submission. Subjects will be followed for two years postoperatively.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate Open-Angle Glaucoma with specific criteria, in need of cataract surgery
* Subject willing to attend scheduled follow-up exams for two years postoperatively, Subject willing to provide written informed consent on the Institutional Review Board approved Informed Consent Form

Exclusion Criteria:

Not meeting inclusion criteria

Primary outcomes:
measure: Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Number of Ocular Hypotensive Medications by Visit
timeFrame: 12 months
Locations:
Study officials:
affiliation: Glaukos Corporation
name: Head of Clinical Affairs
role: STUDY_DIRECTOR
References:
Clinical trial NCT01958268: Dysphagia Handicap Index: A Structured Translation From English to German
Official title: Dysphagia Handicap Index: A Structured Translation From English to German of a Quality of Life Questionnaire Relating to Swallowing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from dysphagia

Brief summary: Establishment of a questionnaire in German to determine in a structured and quantifiable manner the quality of life of patients with dysphagia.


Eligibility criteria: Inclusion criteria: All patients with dysphagia

Exclusion criteria: Inability to fill in the questionnaire

Primary outcomes:
measure: Percentage of patients able to fully understand and fill out the german translation of the questionnaire.
timeFrame: Patients suffering from dysphagia for at least half a year will be asked to answer the questionnaire at the time of enrolment.
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Otorhinolaryngology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Otorhinolaryngology
name: Joerg E Bohlender, KD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01206868: Prophylactic Fenestration of the Peritoneum in Kidney Transplantation
Official title: Prospective Open Randomized Study to Evaluate the Efficiency of Prophylactic Fenestration of the Peritoneum in Kidney Transplantation in Preventing the Occurrence of Postoperative Lymphoceles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incidence of Symptomatic Lymphocele After Kidney Transplantation
Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks
Keywords: kidney, transplantation, surgery, complications, lymphocele, fluid collections.
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 130
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: A single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation.

Adult (\>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. From March 2007 to May 2009 130 patients were included. The patients were randomized either to peroperative peritoneal fenestration, or to serve as controls. Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes from each group. Patients who previously had undergone extensive abdominal surgery, or were included in other studies were excluded.


Eligibility criteria: Inclusion Criteria:

* Adult recipients of kidney transplants from deceased donors

Exclusion Criteria:

* Former extensive abdominal surgery
* Participation in other studies

Primary outcomes:
measure: Incidence of symptomatic lymphoceles
timeFrame: 1 - 3 years
Secondary outcomes:
measure: Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks
timeFrame: 1 -10 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Syversveen T, Midtvedt K, Brabrand K, Oyen O, Foss A, Scholz T. Prophylactic peritoneal fenestration to prevent morbidity after kidney transplantation: a randomized study. Transplantation. 2011 Jul 27;92(2):196-202. doi: 10.1097/TP.0b013e318220f57b.
Clinical trial NCT04779268: Large Scale ICU Data Sharing for 1000 Critically Ill Patients With Severe Acute Respiratory Distress Syndrome Coronavirus (SARS.COV19) in Three Distinct Isolation Centers
Official title: Large Scale ICU Data Sharing for 1000 Critically Ill Patients With Severe Respiratory Distress Syndrome Coronavirus in Three Distinct Isolation Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Median Nerve Entrapement
Keywords: neuropathy
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID positive patients

Brief summary: Cohort study of patients with severe respiratory distress syndrome coronavirus2 in three different isolation hospitals recording data about outcome.


Eligibility criteria: Inclusion Criteria:

* All COVID positive candidates

Exclusion Criteria:

* patient refusal

Primary outcomes:
measure: follow up
timeFrame: 3 months
Secondary outcomes:
measure: prediction
timeFrame: 3 months
Other outcomes:
Locations:
city: Minia
country: Egypt
facility: Mina Raouf
Study officials:
References:
Clinical trial NCT02571868: Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm-QuickSept Study
Official title: Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm (QuickOpt™) Compared With Echocardiographic Method for Cardiac Resincronization Therapy in CRT Implants With Right Interventricular Basal-Mid Septum Placement of Leads (QuickSept Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Maria Vittoria Hospital
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 53
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 with CRT-D

Brief summary: AtrioVentricular (AV) and InterVentricular (VV) delay optimization can improve ventricular function in Cardiac Resynchronization Therapy (CRT) and is usually performed by means of echocardiography. St Jude Medical has developed an automated algorhythm which calculates the optimal AV and VV delays (QuickOptTM) based on Intracardiac ElectroGrams, (IEGM), within 2 minutes. So far, the efficacy of the algorhythm has been tested acutely with standard lead position at right ventricular (RV) apex. Aim of this project is to evaluate the algorhythm performance in the mid- and long-term with RV lead located in mid-septum.

Detailed description: Primary end-point was to evaluate the relationship between the series of aortic flow Velocity Time Integral (aVTI) values calculated by the two methods at the PV, AV, and VV interval settings recommended by both the QuickOptTM and the standard ECHO optimization in CRT-D patients, at three index times: pre-discharge, at 6-month and at 12-month follow-ups.

Secondary end-point was to define the correlation between the optimal AV, PV and VV intervals defined by ECHO, using aVTI measurements and by the QuickOptTM algorithm, IEGM-based.

Eligibility criteria: Inclusion Criteria:

* Patients with CRT-D
* stable and safe placement of an active-fixation RV lead on mid-interventricular septum;
* achievement of an efficacious LV intravenous pacing from a Coronary Sinus (CS) branch.

Exclusion Criteria:

* AF
* Patients without spontaneous rhythm

Primary outcomes:
measure: Correlation between QuickOptTM and standard ECHO optimization
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Ospedale Maria Vittoria
Study officials:
References:
Clinical trial NCT06492668: Risk of Exposure and Prevention of Ticks and Tick-borne Diseases Among Foresters in Alsace
Official title: Risk of Exposure and Prevention of Ticks and Tick-borne Diseases Among Foresters in Alsace (France)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lyme Borreliosis
Keywords: Tick-Borne Diseases
Lyme borreliosis
Febrile syndromes
Ixodes ricinus tick
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 20
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: Major forester (≥18 years old), ONF (National Forestry Office) staff regularly exposed to ticks in Alsace.

Brief summary: Ticks are blood-sucking arthropods that feed on vertebrate hosts. Although wild and domestic animals are the primary source of tick blood meals, humans can be an accidental host. During a blood meal, a microorganism can be transmitted to the host who can develop a disease. All infectious diseases transmitted by ticks are referred to as tick-borne diseases (TBDs). They are the most prevalent vector-borne diseases in the Northern Hemisphere. Among these diseases, Lyme borreliosis is the most common.

In Europe, Lyme borreliosis does not cause high fevers (\> 38°C). Therefore, when a patient presents with a high fever with the notion of exposure to ticks, another etiology must be suspected. Anaplasma phagocytophilum and the tick-borne encephalitis virus are classically described as causing febrile syndromes.

In France, ticks and tick-borne diseases are increasing, particularly those associated with the Ixodes ricinus tick. This tick is mainly present in forest ecosystems with a peak of activity in May. Foresters represent a population with biting ticks and tick-borne diseases, notably Lyme borreliosis.


Eligibility criteria: Inclusion Criteria:

* Major forester (≥18 years old)
* Male or female gender
* ONF (National Forestry Office) staff
* Regularly exposed to ticks in Alsace (exclusively)
* Practicing regular forestry activities in a group
* Agreeing to participate in the study.

Exclusion criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Number of ticks found on clothing during activities in forest ecosystems, and if tick bites, their number.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre National de Référence Borrelia - CHU de Strasbourg - France
state: Les Hôpitaux Universitaires De Strasbourg
Study officials:
References:
Clinical trial NCT02430168: Comparison of RIRS Versus PCNL Methods, According to Postoperative Pain and Analgesic Demand in 2 to 4 cm Renal Stones
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Stones
Keywords: Stone
RIRs
PCNL
Pain
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: to investigate the postoperative outcomes of Retrograde intrarenal surgery versus percutaneous nephrolithotomy in 2 to 4 cm kidney stones.


Eligibility criteria: Inclusion Criteria:

* The patients who have 2 to 4 cm kidney stones
* ASA score within 1 to 3

Exclusion Criteria:

* Previous surgical treatment including SWL
* Congenital abnormalities

Primary outcomes:
measure: Analgesic demand
timeFrame: Postoperative 24 hours
measure: Stone clearance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi TRH
Study officials:
References:
citation: Akman T, Binbay M, Ozgor F, Ugurlu M, Tekinarslan E, Kezer C, Aslan R, Muslumanoglu AY. Comparison of percutaneous nephrolithotomy and retrograde flexible nephrolithotripsy for the management of 2-4 cm stones: a matched-pair analysis. BJU Int. 2012 May;109(9):1384-9. doi: 10.1111/j.1464-410X.2011.10691.x. Epub 2011 Oct 28.