louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03281213: Acute Postthoracotomy Pain - Impact of Gender
Official title: No Impact of Gender on Acute Postthoracotomy Pain - a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gender
Postoperative Pain
Thoracotomy
Analgesia
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: Adequate analgesia in thoracic surgery is essential to prevent severe postoperative complications, especially respiratory problems. Current knowledge about gender-related differences in pain states generally more frequent and intense pain and more demand for analgesics in women. Results about postsurgical pain in particular are very inconclusive.

The investigators tried to find out if gender has an influence on postthoracotomy pain and analgesics requirement.


Eligibility criteria: Inclusion Criteria:

* open lung surgery between July 2010 and December 2014

Exclusion Criteria:

* redo-thoracotomy
* chest wall or rib resection
* other approach than lateral thoracotomy
* additional incision at other site (e.g. laparotomy)
* chest trauma
* mesothelioma
* hemofiltration or haemodialysis
* longer than one day stay at intensive care unit
* pre-existent chronic pain and/or chronic opioid intake
* short stay in hospital

Primary outcomes:
measure: Visual Analogue Scores
timeFrame: first 5 postoperative days
measure: Analgesics requirement
timeFrame: first 5 postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Division of Thoracic and Hyperbaric Surgery
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Daniel Auinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Graz
name: Freyja-Maria Smolle-Jüttner
role: STUDY_DIRECTOR
References:
citation: Auinger D, Sandner-Kiesling A, Striessnig A, Lindenmann J, Smolle J, Friedl H, Smolle-Juttner FM. Is There an Impact of Sex on Acute Postthoracotomy Pain? A Retrospective Analysis. Ann Thorac Surg. 2020 Apr;109(4):1104-1111. doi: 10.1016/j.athoracsur.2019.11.016. Epub 2019 Dec 28.
Clinical trial NCT03772613: The Randomized OPTIMAL-ACT Trial
Official title: Optimal Target of Activated Clotting Time During Percutaneous Coronary Intervention and Outcomes: The Randomized OPTIMAL-ACT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Anticoagulant-induced Bleeding
Coronary Syndrome
Keywords: activated clotting time
outcomes
bleeding
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 180
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: The purpose of this study is to find the ideal range of the activated clotting time (ACT) during percutaneous coronary intervention (PCI) that is associated with lowering the rate of undesirable medical outcomes


Eligibility criteria: Inclusion Criteria:

* Age\>18
* Referred for coronary angiography with possible coronary revascularization or adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)

Exclusion Criteria:

* Receipt of LMWH at treatment dose (not DVT prophylaxis dose) within 6 hours of coronary angiography
* Prior GP IIb/IIIa use within the previous 72 hours
* Use of warfarin (vitamin K antagonist) or direct oral anticoagulant
* Patients on LMWH bridging strategy
* PCI within prior 30 days
* Planned use of bivalirudin as the procedural anticoagulant
* Rotational atherectomy
* Excimer laser coronary angioplasty
* Chronic total occlusions
* Patients with active bleeding disorders or bleeding diathesis
* Patients with ST-segment elevation myocardial infarction
* Patient with clinical evidence of cardiogenic shock (defined as SBP\<90 mmHg for ≥30 min OR support to maintain SBP ≥90 mmHg AND evidence of end-organ hypoperfusion (urine output \<30 mL/h or cool extremities)
* Chronic kidney disease stage 4/5 (GFR 30 mL/min)

Primary outcomes:
measure: Bleeding
timeFrame: From date of randomization until the date of first documented bleeding event up to 24 hours
measure: Adverse Clinical Events
timeFrame: 30 days
Secondary outcomes:
measure: Stent Thrombosis
timeFrame: 30 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Shahyar M Gharacholou, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05249413: Early Vitrectomy for Endophthalmitis After Cataract Surgery
Official title: Outcomes of Early Vitrectomy for Endophthalmitis After Cataract Surgery in Delta Population, Egypt, 2015-2020.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endophthalmitis
Cataract
Vitreous Detachment
Retinal Detachment
Keywords: endophthalmitis
cataract
vitrectomy
retinal detachment
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 11
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that were diagnosed as acute post-operative endophthalmitis at ophthalmology department, Benha University Hospital, EGYPT.

Brief summary: Post-operative infectious endophthalmitis is devastating condition that causes a diffuse intraocular inflammation and may lead to blindness. Acute post-operative endophthalmitis usually presented within 6 weeks of intraocular procedure and diagnosis is confirmed by clinical examination and by the aid of B-scan ultrasonography.

Detailed description: There is no consensus regarding the timing of vitrectomy in cases with endophthalmitis after cataract surgery. The Endophthalmitis Vitrectomy Study concluded that vitrectomy should be preserved for cases with only light perception. The advances in posterior segment machines and small gauge cannulas decrease the incidence of intra-operative complications and encourage for early intervention in cases with endophthalmitis after primary cataract surgery.

Eligibility criteria: Inclusion Criteria:

* Acute onset endophthalmitis within 6 weeks after primary cataract surgeries.
* Patients had undergone early pars-plana vitrectomy within 48 hours of their confirmed diagnosis.

Exclusion Criteria:

* Patients were diagnosed as endogenous or chronic endophthalmitis.
* Patients with a previous history of rupture globe surgery or trauma.
* Patients who didn't complete the follow up period.

Primary outcomes:
measure: Best-corrected visual acuity
timeFrame: Baseline and 3 months after intervention.
Secondary outcomes:
measure: Other prognostic factors
timeFrame: Baseline and 3 months after intervention.
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Ophthalmology department, Benha University, EGYPT
Study officials:
affiliation: Benha University
name: Ahmed A Abdelshafy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05783713: Evaluation of the Effectiveness of a Flu Vaccination Campaign for Healthcare Workers of a Teaching Hospital: a Pre-post Study
Official title: Evaluation of the Effectiveness of a Flu Vaccination Campaign for Healthcare Workers of the Fondazione Policlinico Universitario "A. Gemelli" IRCCS and the Catholic University of the Sacred Heart (UCSC): a Pre-post Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Vaccination
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 10737
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health personnel employed by the Fondazione Policlinico Universitario "A. Gemelli" IRRCS

Brief summary: The goal of this observational study is to evaluate the effectiveness of the vaccination strategy implemented during the 2019/2020 flu vaccination campaign compared with the previous one. The main question it aims to answer is whether there are differences in the total coverage of influenza vaccination, in different categories of professionals and in different operating units.


Eligibility criteria: Inclusion Criteria:

* Health personnel employed by the Fondazione Policlinico Universitario "A. Gemelli" IRRCS

Exclusion Criteria:

-

Primary outcomes:
measure: influenza vaccination coverage
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario "A. Gemelli" IRCCS
state: RM
Study officials:
References:
Clinical trial NCT01963013: Non-returning Catheter Valve for Reducing CAUTI
Official title: A Pilot Study of Non-returning Catheter Valve for Reducing Catheter-associated Urinary Tract Infection in Critically-ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Associated Urinary Tract Infection
Critically Ill Patients
Keywords: Non-returning catheter valve
Catheter associated urinary tract infection
Critically ill patients
Prevention
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was to determine efficacy of the non-returning catheter valve for reducing catheter associated urinary tract infection compared with conventional urine bag in critically ill patients.

Detailed description: Non-returning catheter valve (generic name) used UnometerTM SafetiTM Plus (trade name)

Eligibility criteria: Inclusion Criteria:

* The participants who age more than 18 year and admitted to the medical intensive care unit or intermediate care unit
* All participants must be retained the urinary catheter.

Exclusion Criteria:

* The participants were diagnosed urinary tract infection before retention of the urinary catheter.

Primary outcomes:
measure: Incidence density of the catheter associated urinary tract infection (CAUTI)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Srinagarind hospital
state: Khon Kaen
Study officials:
References:
citation: Panitchote A, Charoensri S, Chetchotisakd P, Hurst C. Pilot study of a non-return catheter valve for reducing catheter-associated urinary tract infections in critically ill patients. J Med Assoc Thai. 2015 Feb;98(2):150-5.
Clinical trial NCT01092013: Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopy
Clinical Competence
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This prospective randomized study aims for determination whether focused simulator based laparoscopic camera training in novices can improve camera performance in an actual clinical situations in the same manner as traditional training in the OR does, especially considering efficient use of training time.

Detailed description: Medical students in their final years without any significant experience in handling an angled laparoscopic camera participate in the study and perform a camera guidance test in surgery. The participants are then randomized in two groups to receive either a simulator based or traditional in theatre training during three weeks. The camera test will be repeated, while both tests are going to be recorded. Videos of 14 camera tests carried out by laparoscopic experts are taped as well.

Eligibility criteria: Inclusion Criteria:

* Medical students on a surgical clerkship rotation at the department of visceral and transplantation surgery of the university hospital of Zurich, Switzerland

Exclusion Criteria:

* Any experience in laparoscopic camera handling in the OR and/or simulator based laparoscopic training

Primary outcomes:
measure: Progress of skills shown in test regarding target centring as assessed by rating scale
timeFrame: After 3 weeks of individual training
Secondary outcomes:
measure: Total time effort spend for respective training time
timeFrame: During 3 weeks of individual training
measure: Progress of time to completion of test
timeFrame: After 3 weeks of individual training
measure: Progress of skills shown in test regarding horizon alignment as assessed by rating scale
timeFrame: After 3 weeks of individual training
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: University of Zurich, Faculty of Medicine
name: Florian M Franzeck, cand. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Zurich, Departement of Visceral and Transplantation Surgery
name: Dieter Hahnloser, MD
role: STUDY_DIRECTOR
References:
citation: Franzeck FM, Rosenthal R, Muller MK, Nocito A, Wittich F, Maurus C, Dindo D, Clavien PA, Hahnloser D. Prospective randomized controlled trial of simulator-based versus traditional in-surgery laparoscopic camera navigation training. Surg Endosc. 2012 Jan;26(1):235-41. doi: 10.1007/s00464-011-1860-5. Epub 2011 Aug 19.
Clinical trial NCT06099613: Study to Safety, Tolerability and Immunogenicity of EG-COVII in Healthy Adult
Official title: A Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: EyeGene Inc.
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This is a Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers

Detailed description: Subjects will undergo a Screening period beginning up to 2 weeks prior to enrollment, the vaccinations will be administered on week 0 and week 3, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable).

Eligibility criteria: Inclusion Criteria:

* Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure;
* Healthy volunteers aged above 18 years at the time of screening;
* Have had at least authorised primary COVID-19 vaccination(s) regardless of numbers of booster;
* The last authorised COVID-19 vaccination, the participants received, should be more than 16 weeks prior to the first IP vaccination;

Exclusion Criteria:

* Participant with the evidence of COVID-19 infection at screening (Positive for COVID-19 with RT-PCR test with nasal mid-turbinate specimen);
* Participant who has the history of COVID-19 infection within 6 months from the first IP vaccination;
* Close contact with a person infected with COVID-19 within 2 weeks prior to the first IP vaccination;

Primary outcomes:
measure: Safety and tolerability of EG-COVII in healthy adult volunteers
timeFrame: 7 weeks follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd- Melbourne
state: Victoria
Study officials:
affiliation: Nucleus Network Pty Ltd- Melbourne
name: Christina Chang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04423536: Predictive Value of a SNP Signature and Liquid Biopsy in Natural Killer T-cell Lymphoma
Official title: Predictive Value of a SNP Signature and Liquid Biopsy in Natural Killer T-cell Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Natural Killer T-cell Lymphoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 800
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: adults

Brief summary: The purpose of this study is to determine the Predictive value of a SNP signature and liquid biopsy in patients with natural killer T-cell lymphoma.


Eligibility criteria: Inclusion Criteria:

* biopsy proved Natural Killer T-cell Lymphoma
* newly diagnosed patients

Exclusion Criteria:

* patients with biopsy samples unavailable

Primary outcomes:
measure: Overall survival
timeFrame: 5-years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
Study officials:
References:
Clinical trial NCT00026936: A Pilot Study to Investigate the Clinical Utility of the Peregrine Monte Carlo Dose Calculation System for Radiation Therapy Treatment Planning
Official title: A Pilot Study to Investigate the Clinical Utility of the Peregrine Monte Carlo Dose Calculation System for Radiation Therapy Treatment Planning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasm
Keywords: External Beam Radiotherapy
TCP
DVH
NTCP
3-D Programming
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-11-15
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The utility of PEREGRINE Monte Carlo calculations for radiation treatment planning in a clinical setting will be assessed by comparing results with other fully three-dimensional programs. ROB will investigate PEREGRINE for clinical use at NCI in collaboration with Lawrence Livermore National Laboratory (LLNL).

Detailed description: The utility of PEREGRINE Monte Carlo calculations for radiation treatment planning in a clinical setting will be assessed by comparing results with other fully three-dimensional programs. ROB will investigate PEREGRINE for clinical use at NCI.

Eligibility criteria: INCLUSION CRITERIA:

Patients with documented malignancy requiring standard radiotherapy OR patients with a benign condition for whom radiotherapy is indicated.

EXCLUSION CRITERIA:

Documented connective tissue disease or Ataxia Telangiectasia.

Cognitively impaired patients who cannot give informed consent.

Other medical conditions deemed by the PI to make the patient ineligible.

Patients requiring emergent radiotherapy.

Patients who are not able to undergo a CT scan.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
citation: Perez CA, Purdy JA, Harms W, Gerber R, Graham MV, Matthews JW, Bosch W, Drzymala R, Emami B, Fox S, et al. Three-dimensional treatment planning and conformal radiation therapy: preliminary evaluation. Radiother Oncol. 1995 Jul;36(1):32-43. doi: 10.1016/0167-8140(95)01566-y.
citation: Lawrence TS, Ten Haken RK, Kessler ML, Robertson JM, Lyman JT, Lavigne ML, Brown MB, DuRoss DJ, Andrews JC, Ensminger WD, et al. The use of 3-D dose volume analysis to predict radiation hepatitis. Int J Radiat Oncol Biol Phys. 1992;23(4):781-8. doi: 10.1016/0360-3016(92)90651-w.
citation: Yorke ED, Kutcher GJ, Jackson A, Ling CC. Probability of radiation-induced complications in normal tissues with parallel architecture under conditions of uniform whole or partial organ irradiation. Radiother Oncol. 1993 Mar;26(3):226-37. doi: 10.1016/0167-8140(93)90264-9.
Clinical trial NCT04575636: MRL in the Upper Extremity
Official title: Magnetic Resonance Lymphography in Upper Extremity Lymphedema and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Upper Limb
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Objective: The aim of this study is to examine the feasibility and applicability of the MRL protocol for the upper extremity in Maastricht University Medical Center, and to examine the differences of the lymphatic system between lymphedema patients and healthy volunteers.

Study design: An explorative study of an MRL protocol for the upper extremity in Maastricht University Medical Center+.

Study population: There are two study groups. The first group (n=10) consists of patients with secondary lymphedema in the upper extremity. The second group (n=10) consists of healthy volunteers.

Intervention (if applicable):

All participants will undergo an MRL examination with the same protocol, developed in a previous 'proof of principle' study, in the Maastricht University Medical Center+.

After localizer scans, a T2-weighted sequence is used. Then a T1-weighted sequence will be made before the injection of contrast. After the injection of the contrast agent a T1-weighted sequences of the upper and lower arm are performed alternately.

Main study parameters/endpoints:

The primary outcome is to determine the feasibility and applicability of the MRL protocol by evaluating the images of the upper extremity in patients with secondary lymphedema and healthy subjects.

The secondary outcome is to assess the value of MRL in staging lymphedema.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* informed consent
* BMI \< 30 kg/m2

Group A:

- Secondary lymphedema in the upper extremity

Group B:

- Healthy volunteers

Exclusion Criteria:

* Active skin infection/erysipelas in the arm.
* Known allergy for a contrast agent
* History of surgical intervention in the arm.
* Contraindications for MRI with contrast; pregnancy, metals, prostheses, renal insufficiency, claustrophobia
* Active cancer
* Distant metastases

Primary outcomes:
measure: feasiblity of Magentic Resonance Lymphography (MRL) of the arm by evaluating the MRL output images
timeFrame: 0.5 hours per participant
Secondary outcomes:
measure: lymphedema staging by evaluating the MRL output images
timeFrame: 0.5 hours per participant
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Scannexus
Study officials:
References: