louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05352737: Exploring the Role of Serum Methylmalonic Acid (MMA) in Breast Cancer
Official title: A Retrospective Study Exploring the Role of Serum Methylmalonic Acid (MMA) in Breast Cancer---focusing on Metastasis, Chemotherapy Resistance, and Ageing Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with breast cancer admitted into University of Hospital, Leuven, from 2003 to 2015.

Brief summary: This project aims to investigate the role of MMA in breast cancer. To this end, we will measure MMA on serum samples collected at the time of breast cancer diagnosis, to investigate the role of MMA in predicting long-term recurrence risk, response to neoadjuvant chemotherapy, and its association with age and clinical frailty.

Detailed description: This project aims to investigate the role of MMA in breast cancer. To this end, we will measure MMA on serum samples collected at the time of breast cancer diagnosis, to investigate the role of MMA in predicting long-term recurrence risk, response to neoadjuvant chemotherapy, and its association with age and clinical frailty. If the role of baseline serum MMA in therapy resistance and/or metastasis is confirmed, our study could be further extended by evaluating SOX4 expression in the tumor tissues (SOX4 is activated by MMA, and SOX4 induces EMT (epithelial to mesenchymal transition) and the metastasis process.

Eligibility criteria: Inclusion Criteria:

1. Female patients older than 18 years at diagnosis.
2. First diagnosis of invasive breast cancer.
3. All pathological parameters are available to identify histological subtype according to standard procedures.
4. Availability of frozen serum samples at diagnosis.
5. Voluntarily signed Informed Consent obtained before blood drawing for biobanking was performed.

Exclusion Criteria:

1. Pregnant at diagnosis.
2. stage 0 disease (in situ).
3. Bilateral BC at diagnosis or multifocal unilateral BC with different histology.
4. Other subtypes than Invasive ductal carcinoma.
5. Prior breast cancer.

Primary outcomes:
measure: MMA levels
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Lab of Experimental Oncology
state: State Or Province:
Study officials:
affiliation: UZ Leuven
name: Hans Wildiers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01811537: Safety and Efficacy Study of a New Device for Making Neochordae in Mitral Valve Repair
Official title: Phase II Study of Using a New Device (Neochordameter) in Making Artificial Chordae for Mitral Valve Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Mitral Valve Repair
Keywords: Artificial Chordae
Mitral Valve Repair
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mitral prolapse is a common cardiac disease whose patients are at higher risk for serious complications. Mitral valve (MV) repair offers several important advantages compared with valve replacement and it achieves excellent midterm and long-term results. Two major problems of using pre-measured expanded polytetrafluoroethylene(ePTFE) neochordae (the loop technique) are deciding the length of the neochordae and tying the knot at the intended length. Therefore, a great need still exists to find new method to simplify and precise the length of neochordae. 20 patients with mitral valve prolapse who undergo mitral valve repair using neochorda will be recruited in this study. Trans thoracic echocardiography (TTE) will be done preoperatively for all patients. Two, three, and four chamber view of each patient will be pre-operatively recorded. The device will be set with extracted measurements. Artificial corda loops are made using CV-4 ePTFE sutures. After artificial chordae replacement, the ring annuloplasty will be done. Follow up: A leakage test after attaching the 1st loop; Post operative trans esophageal echocardiography (TEE) and determining the severity of mitral regurgitation \[Wall motion Score Index (WMSI), Mitral Annulus Area (MAA), LVEF, End Systolic Volume (ESV), End Diastolic Volume (EDV), Iso-Volemic Relaxation Time (IVRT), (IVRT/(QE-QE\^') ,Chamber Relaxation velocity)/(Myocard relaxation velocity(E/E\^' ), HR\]; TEE 3 months after discharge; Cross clamp time; Intubation period in ICU.


Eligibility criteria: Inclusion Criteria:

* Patients with Mitral valve prolapse who undergo mitral valve repair using neochorda

Exclusion Criteria:

* Nothing

Primary outcomes:
measure: Mortality
timeFrame: Early (within 30 days after surgery), Late (After 12 months)
Secondary outcomes:
measure: Mitral Valve prolapse measurement after using neochordae
timeFrame: Intra-operation, 3, 6, and 12 months after surgery
Other outcomes:
measure: Cardiopulmonary bypass time
timeFrame: During Surgery
Locations:
Study officials:
References:
Clinical trial NCT00480337: In Vitro Maturation of Immature Oocytes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Ovarian Hyperstimulation Syndrome
Keywords: PCOS
Fertility Preservation
Repeated IVF Failure
S/P Hyperstimulation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-05-30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to aspirate immature oocytes from antral follicles and mature the oocytes in vitro. These mature oocytes will serve for fertilization and the creation of embryos which will be replace in the uterus as performed during normal IVF.We will record the efficacy and safety of this procedure.


Eligibility criteria: Inclusion Criteria:

* Women with PCOS
* Women with previous Hyperstimulation or with risk of developing hyperstimulation during IVF Treatment
* Women diagnosed with cancer who are interested in fertility preservation
* Women with repeated IVF failure

Exclusion Criteria:

* Severe cases of endometriosis
* Large myomas
* Hydrosalpinxs Technical problem with previous oocytes pick-up

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: IVF Unit, Shea Medical Center, Tel-Hashomer
Study officials:
affiliation: IVF Unit, Sheba Medical Center
name: Ariel Hourvitz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00446537: Procedural Learning in Participants With ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Skill Acquisition and the Evolution of Long Term Procedural Memory in participants with ADHD: The Effect of Methylphenidate
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2007-03-13
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Skill acquisition refers to the process of improvement of performance following practice experience. This process is the basis for generation of a long-lasting memory. Individuals with Attention Deficit Hyperactivity Disorder (ADHD) have been shown to be impaired on some performance aspects of previously learned skills, an impairment that is often ameliorated, at least temporarily, by psychostimulant medication (the standard therapy in ADHD). The proposed study aims to define the course of learning and of generation of long-term memory consolidation in individuals with ADHD, and to essay the effectiveness of psychostimulant medication on both the learning and retention of the skills.

Detailed description: Skill Acquisition and the Evolution of Long Term Procedural Memory in participants with ADHD: The Effect of Methylphenidate

Eligibility criteria: Inclusion Criteria:

* Full scale IQ score of 85 or above

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Neuropediatric Unit
Study officials:
affiliation: Bar-Ilan University, Israel
name: Esther Adi-Japha, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek Medial Center
name: Ruth Shalev, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01434537: Evaluation of a Touchless Vein Scanner for Venepuncture and Cannulation in Pediatric Patients
Official title: Venepuncture and Vein Cannulation With Support of the AccuVein AV300 Vein Scanner in Paediatric Patients in a Pre-operation Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venepuncture
Keywords: pediatric anesthesia
venepuncture
peripheral venous access
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-09-15
Enrollment: 238
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from 0 to 17 years in a peripoerative setting in the pediatric operation room with need for peripheral venous access.

Brief summary: Evaluation of the AccuVein ® AV 300 vein scanner in clinical routine in a pediatric operation room setting for a 4 weeks period. Assessment of usability, anonymous clinical register of every venepuncture(age, gender, size, weight, punction site, number of attempts, time until successful cannulation, local anaesthesia, general anaesthesia, pain scales: faces pain scale und BPS/BPOS).

Detailed description: For application of drugs and liquids a peripheral venous access is necessary in anaesthesiological procedures.The peripheral venepuncture is a painful procedure and induces a higher level of perioperative stress in children.

The punction of peripheral veins in children can be made difficult by the often distinctive amount of subcutaneous fat or other medical conditions.

The AccuVein ® AV300 vein scanner is a contactless, laser-driven device made for facilitate the search for peripheral veins up to a depth of 7mm. This could lead to a minimization of time until successful puncture and smaller number of failures.

Eligibility criteria: Inclusion Criteria:

* age from 0 to 17 years
* perioperative indication for peripheral venous access
* regular work time of the operation room from 7 am to 4 pm

Exclusion Criteria:

* age more than 17 years
* no indication for or already established venous access

Primary outcomes:
measure: time until completion of procedure
timeFrame: Day 1
Secondary outcomes:
measure: number of attempts until completion of procedure
timeFrame: Day 1
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: Rothbart A, Yu P, Muller-Lobeck L, Spies CD, Wernecke KD, Nachtigall I. Peripheral intravenous cannulation with support of infrared laser vein viewing system in a pre-operation setting in pediatric patients. BMC Res Notes. 2015 Sep 21;8:463. doi: 10.1186/s13104-015-1431-2.
Clinical trial NCT04528537: Validation of the Quality of Recovery Questionnaire for the Postanesthesia Care Unit (QoR-PACU)
Official title: Adaptation and Validation of the Quality of Recovery 15-questionnaire for the Postanesthesia Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Quality of Recovery in the Postanesthesia Care Unit
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 375
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 scheduled for non-cardiac surgery under general anesthesia in a postanesthesia care unit at a tertiary care hospital

Brief summary: Quality of recovery after surgery and anesthesia is an important endpoint in perioperative medicine. Several questionnaires have been developed that assess the patient's perception on postoperative recovery at 24 h after surgery. This study aims to adapt validate the Quality of Recovery 15-questionnaire for application in the postanesthesia care unit.


Eligibility criteria: Inclusion Criteria:

* elective non-cardiac surgery
* general anesthesia
* fluency in German

Exclusion Criteria:

* postoperative intensive care unit stay

Primary outcomes:
measure: 16-item quality of recovery questionnaire for the postanesthesia care unit (QoR-PACU)
timeFrame: up to 4 hours following extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT02071537: Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors
Official title: A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Neoplasm
Solid Tumors
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the safety of chloroquine in combination with carboplatin and gemcitabine and see what effects (good and bad) it has on advanced solid tumors.

Also, the research study will be increasing the dose of chloroquine to find the highest dose of chloroquine that can be given in combination with carboplatin and gemcitabine without causing severe side effects.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of a malignancy that is metastatic or unresectable and for which either standard curative measures do not exist or are no longer effective and carboplatin/gemcitabine is considered a reasonable treatment option whether first line or acceptable and approved combination therapy.
* Age \>18 years of age.
* Performance status less than or equal 2 (Karnofsky \>60%)
* Life expectancy of greater than 3 months.
* Adequate labs
* Measurable disease

Exclusion Criteria:

* Current treatment with any other investigational agents.
* Patients with untreated brain metastases
* History of allergic reaction attributed to compounds of similar chemical or biologic composition to chloroquine or other agents used in study.

Primary outcomes:
measure: Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine
timeFrame: Up to 12 months
Secondary outcomes:
measure: Time to Disease Progression
timeFrame: Up to 24 months
measure: Time of Overall Survival
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Institute
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Nagla Abdel-Karim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01368237: Dynamic Myocardial Perfusion Imaging by 320 Multidetector Computed Tomography
Official title: Dynamic Myocardial Perfusion Imaging by 320 Multidetector Computed Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Computed tomography
Myocardial perfusion
Coronary heart disease
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2011-06-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients awaiting invasive coronary angiography

Brief summary: Recent advances in technology have resulted in the development of scanners that can image the heart blood vessels within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters. Further advances in technology allow the visualisation of both the blood vessels and the supply of blood to the heart muscle. Here we propose to assess the latest and most powerful computed tomography scanner and compare it to magnetic resonance and conventional coronary angiography.


Eligibility criteria: Inclusion Criteria:

* referred for invasive coronary angiography because of suspected coronary heart disease

Exclusion Criteria:

* inability or unwillingness to undergo computed tomography or magnetic resonance imaging
* renal failure (serum creatinine \>200 micromol/L or estimated glomerular filtration rate \<30 mL/min)
* hepatic failure
* allergy to iodinated contrast or gadolinium
* pregnancy
* contraindication to adenosine infusion
* inability to give informed consent
* inability to perform fractional flow reserve during invasive coronary angiography

Primary outcomes:
measure: Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software
timeFrame: 1 month
Secondary outcomes:
measure: Identification of regional wall motion abnormalities qualitatively by trained observers
timeFrame: 1 month
measure: Identification of infarction qualitatively by trained observers
timeFrame: 1 month
measure: Identification of regional wall motion abnormalities quantitatively by computer software
timeFrame: 1 month
measure: Identification of infarction qualitatively by computer software
timeFrame: 1 month
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Scotland
Study officials:
affiliation: University of Edinburgh
name: David E Newby
role: PRINCIPAL_INVESTIGATOR
References:
citation: Papanastasiou G, Williams MC, Dweck MR, Alam S, Cooper A, Mirsadraee S, Newby DE, Semple SI. Quantitative assessment of myocardial blood flow in coronary artery disease by cardiovascular magnetic resonance: comparison of Fermi and distributed parameter modeling against invasive methods. J Cardiovasc Magn Reson. 2016 Sep 13;18(1):57. doi: 10.1186/s12968-016-0270-1.
Clinical trial NCT05105737: Degenerative Scoliosis
Official title: Retrospective Analysis of Degenerative Scoliosis Corrections by Posterior Instrumentation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Scoliosis
Keywords: Degenerative Scoliosis
Degenerative lumbar scoliosis
Scoliosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject with a surgical indication for arthrodesis and surgical correction of degenerative scoliosis

Brief summary: Several deformities of the spine exist such as degenerative lumbar scoliosis. These deformities can generate functional discomfort and limit the patient's quality of life.

In the event of severe trunk imbalance and progression of the deformity, operative correction of the spinal deformity by instrumentation and posterior arthrodesis may be indicated.

Surgical techniques and instrumentation have evolved over the past 5 years. These changes in surgical strategies have a potential impact on the patient's quality of life and the correction results in the medium and long term.

The aim of the study is the analysis of surgical corrections obtained and radiological changes over time with classic 2-rod techniques versus modern 4-rod instrumentation techniques


Eligibility criteria: Inclusion criteria:

* Major subjects\> 18 years old
* Subject with a surgical indication for arthrodesis and surgical correction of degenerative scoliosis
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: Retrospective analysis of degenerative scoliosis corrections by posterior instrumentation
timeFrame: Files analysed retrospectively from January 01, 2010 to December 31, 2010 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT05836415: Effectiveness and Durability Long-term Results of Tricuspid Annuloplasty With 3D Shaped Rings.
Official title: Effectiveness and Durability Long-term Results of Tricuspid Annuloplasty With 3D Shaped Rings.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Tricuspid Regurgitation
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent tricuspid surgery due to functional tricuspid regurgitation, treated with implant of a 3D ring

Brief summary: Interest in tricuspid valve disease has grown exponentially over the past few years, in response to increased interest in the poor prognosis of patients with functional tricuspid regurgitation (TR). Tricuspid valve repair (TVR) using a prosthetic ring represents the first option in many centers worldwide, due to the low incidence of residual and recurrent TR and improved survival compared to suture techniques. The goal of ring annuloplasty is to restore the normal geometry of the annulus, thereby improving the coaptation of the leaflets and preventing further dilatation of the annulus. Recently, the three-dimensional geometry of the tricuspid valve has been shown and analyzed by means of data obtained from echocardiography, CT scan and magnetic resonance imaging. Normal tricuspid annulus is characterized by a more prominent part in the anteroseptal commissure area near the aortic valve and right ventricular outflow tract and a deeper part in the posteroseptal commissure area near the coronary sinus ostium . Based on these characteristics, new three-dimensional rings have been developed for tricuspid annuloplasty, such as the MC3 (Edwards Lifescience, Irvine, CA) and the Contour 3D (Medtronic, Minneapolis, MN).

There are few studies concerning the short-term results of tricuspid rings implantation and almost none on the long-term, therefore this study aims to analyze the long-term results of TVR by implantation of the two new prosthetic ring models mentioned above.

The aim of this study is the long-term analysis of the results of tricuspid annuloplasty with three-dimensional rings in patients with functional IT.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Operated for functional TR
* Implantation of three-dimensional tricuspid prosthetic ring MC3 or Contour 3D, isolated or concomitant to surgery on the left heart sections
* Surgical access in median sternotomy or minithoracotomy

Exclusion Criteria:

- emergency/urgency intervention

Primary outcomes:
measure: Mortality
timeFrame: through study completion, an average of 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References: