louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03192865: Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery
Official title: Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery: Consequences and Causes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Hypoxia
Analgesia
Lead sponsor: Clinique Medipole Garonne
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.

Brief summary: This study aims to assess consequences and causes of hemidiaphragmatic paralysis for ambulatory arthroscopic shoulder surgery in patients with BMI ≥ 30 kg/m².

Detailed description: This prospective observational study will screen patients with body mass index (BMI) ≥30 kg/m² undergoing acromioplasty or supraspinatus tendon repair. Occurrence of post-operative hemidiaphragmatic paralysis will be observed using M-mode ultrasonography and its consequences on patient ventilation: arterial oxygen saturation, dyspnea, success of ambulatory procedure. Causes of diaphragmatic paralysis will be analyzed.

Eligibility criteria: Inclusion Criteria:

* All patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.

Exclusion Criteria:

age \<18 years, brachial plexus neuropathies, severe bronchopulmonary disease, acute respiratory distress, coagulopathies, systemic glucocorticoid use, pregnancy, routine use of opioid medications, intolerance for one or more medications of the study protocol and diabetes.

Primary outcomes:
measure: Failure of outpatient arthroscopic shoulder surgery strategy
timeFrame: the first 6 hours
Secondary outcomes:
measure: Assessment of peripheral nerve block strategy associated with diaphragmatic paralysis
timeFrame: the first 2 hours
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Medipole Garonne
Study officials:
References:
Clinical trial NCT03376165: Post-Operative Myocardial Incident & Atrial Fibrillation
Official title: Longitudinal Study of Patients Undergoing Cardiac Surgery or Implantation of a Percutaneous Valve Prosthesis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Valve Heart Disease
Coronary Artery Disease
Keywords: prognosis
translational research
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 1500
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: All adult patients schedulled for cardiac surgery (coronary artery bypass graft surgery and/or valvular surgery) or transcatheter valve implantation and referred to the University Hospital of Lille with inclusion criteria and no exclusion criteria.

Brief summary: To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for cardiac surgery (coronary artery bypass graft surgery and/or valvular surgery) or transcatheter valve implantation

Exclusion Criteria:

* pregnant woman
* urgent surgery or intervention
* not able to consent to the protocol

Primary outcomes:
measure: major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation)
timeFrame: from the day of intervention to 10 years
Secondary outcomes:
measure: peri-operative myocardial injury
timeFrame: 3 days following intervention
measure: post-operative myocardial infarction (type 5 myocardial infarction)
timeFrame: 10 days following intervention
measure: post-operative atrial fibrillation
timeFrame: 10 days following intervention
measure: major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation)
timeFrame: from the day of intervention to 1 year
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Cardiologie, CHU
Study officials:
affiliation: University Hospital, Lille
name: David Montaigne, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03811665: Stereotactic Body Radiation Therapy Versus Radiofrequency Ablation for Small Renal Masses
Official title: A Prospective Randomized Pilot Trial of Stereotactive Body Radiation Therapy Versus Radiofrequency Ablation for the Management of Small Renal Masses.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Small Renal Masses (SRM)
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The execution of this study is pertinent to evaluating SBRT's short- and long-term efficacy and safety in the treatment of SRMs. This study will be the first to compare RFA and SBRT in the treatment of SRMs.


Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years of age and capable of providing informed consent
* Patients scheduled for treatment of their SRM using SBRT or RFA
* Patients who received a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
* Patients who are willing to have a biopsy 12 months post-procedure
* Patients with renal tumor(s) ≤ 4.0 cm

Exclusion Criteria:

* Patients with large renal tumor(s)\>4.0 cm
* Patients who are unable to have a general anesthetic
* Patients who did not receive a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
* Patients who are unable to comply with post-operative and/or follow-up protocol/phase of study
* Evidence of metastatic disease
* Uncorrectable bleeding diathesis

Primary outcomes:
measure: Treatment failure
timeFrame: 12 Months
measure: Overall Survival
timeFrame: 12 Months
measure: Disease free survival
timeFrame: 12 Months
measure: Disease recurrence
timeFrame: 12 Months
Secondary outcomes:
measure: Tumour Size
timeFrame: 12 Months
measure: Renal Function -eGFR
timeFrame: 12 Months
measure: Renal Function - Serum Creatinine
timeFrame: 12 Months
measure: Renal Function - Creatinine Clearance
timeFrame: 12 Months
measure: Complication Rate
timeFrame: 12 Months
measure: Number of patients that experienced an adverse event.
timeFrame: 12 Months
measure: Change in score for quality of life
timeFrame: 12 Months
measure: Duration of hospital stay
timeFrame: Days
measure: Cost analysis
timeFrame: 12 Months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Anil Kapoor, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02502565: Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia
Official title: Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia: Redefining Early Urate Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperuricemia
Lead sponsor: Washington D.C. Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Howard University
name: AstraZeneca
First posted: 2015-07-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US Veterans with asymptomatic hyperuricemia

Brief summary: An observational study to evaluate the prevalence of US changes of gout in the joints and tendons of patients with different degrees of asymptomatic hyperuricemia. The investigators' findings may support the extension of the spectrum of urate disease, and define a subset of patients that may benefit from early urate-lowering therapy.


Eligibility criteria: Inclusion Criteria:

1. Patients must have at least one serum uric acid level l ≥ 7.0 mg/dL within the last two years without a clinical diagnosis of gout per American College of Rheumatology criteria30 (appendix A).
2. Patients, of matched gender and age, with normal uric acid levels will serve as controls.

Exclusion Criteria:

1. Patients who meet or have met the ACR criteria for Gout, unable to read English, and/or have terminal illness will not be eligible to participate in the study.
2. Patients with a diagnosis of skin psoriasis31, rheumatoid arthritis, or spondyloarthropathies will not be eligible to participate.
3. Patients who are on urate-lowering therapy.
4. Patients with 1 or 2 total knee replacements.

Primary outcomes:
measure: Number of Urate Depositions Detected in Ultrasound
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
city: Washington
country: United States
facility: WashingtonVAMC
state: District of Columbia
Study officials:
affiliation: Washington VAMC
name: Gail S Kerr, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04693065: Pronostic Factors of Long Term Outcome in Patients With Clubfoot Treated by the Ponseti Method
Official title: Pronostic Factors of Long Term Outcome in Patients With Clubfoot Treated by the Ponseti Method
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clubfoot
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by ponseti method

Brief summary: We aim at finding prognostic factors of long term (after growth) function outcome in patient with clubfoot treated by ponseti method, based on a very complete prospective recording of treatment variables and outcome


Eligibility criteria: Inclusion Criteria:

* - Patients treated by ponseti method for clubfoot-

Exclusion Criteria:

* - other malformation associated / congenital

Primary outcomes:
measure: Function at >16 years
timeFrame: at 18 years old or complete bone maturity
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital femme mere enfants
Study officials:
References:
Clinical trial NCT03073265: Apixaban Validation Study - Additional Study on Fresh Samples
Official title: Validation Study Protocol - Additional Study on Fresh Samples STA - Apixaban Calibrator & STA - Apixaban Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation With Apixaban
Keywords: DOAC
apixaban
IVD
Lead sponsor: Diagnostica Stago
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 109
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 treated with apixaban presenting at least one of the listed inclusion criteria.

Brief summary: The objective is to demonstrate the performances of STA® - Apixaban Calibrator \& STA® - Apixaban Control used in combination with STA® - Liquid Anti-Xa to measure apixaban concentration in plasma. Anti-Xa results will be compared to LCMS (liquid chromatography - mass spectrometry) for validation of the assay. For this study, the anti-Xa assay will be performed on fresh samples only.

The results will be used to complete results obtained previously on frozen samples.

Detailed description: About 60 samples from patients on apixaban meeting inclusion/exclusion criteria will be included in this study. Two sites will be in charge of sample recruitment and anti-Xa testing. A third site will be in charge of LCMS testing.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 75 years,
* Weight ≤ 60 kg,
* Haematocrit below normal values as determined by local laboratory or \< 40% for male and \< 37% for female
* Renal impairment documented (creatinine clearance ≤ 80 mL/min as per Cockcroft -Gault equation) or serum creatinine ≥ 1.5 mg/dL
* Co-medication with aspirin or any other NSAIDs (nonsteroidal anti-inflammatory drugs)
* Co-medication with anti-platelet agents

Exclusion Criteria:

* Patients less than 18 years old
* Patients under other anti-coagulant treatment
* Samples that are not collected, stored, or handled in accordance with sample collection procedures defined above.

Primary outcomes:
measure: Method comparison between Anti-Xa method and LCMS to measure apixaban in plasma
timeFrame: The anti-Xa assay will be tested within 6h after sample collection and LCMS will be performed on frozen samples, at maximum 2 months after collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: Moses Cone Memorial Hospital
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Health Nrwork
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06883565: Tertiary Lymphoid Structures Related Genes Predicting Prognosis in Clear Cell Renal Cell Carcinoma: a Retrospective Cohort Study
Official title: Tertiary Lymphoid Structures Related Genes Predicting Prognosis in Clear Cell Renal Cell Carcinoma: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma (RCC)
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 232
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The purpose of this research was to uncover the prognostic significance of tertiary lymphoid structures related genes from ccRCC patients with respect to clinical characteristics and outcomes. This offers a novel perspective on selecting populations for prostate cancer immunotherapy in future scenarios.

Brief summary: The purpose of this research was to uncover the prognostic significance of tertiary lymphoid structures related genes from ccRCC patients with respect to clinical characteristics and outcomes. This offers a novel perspective on selecting populations for prostate cancer immunotherapy in future scenarios.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with renal cell carcinoma

Exclusion Criteria:

* incomplete medical records, inadequate follow-up information, and confirmed non-prostatic acinar adenocarcinoma

Primary outcomes:
measure: Correlation between the high or low score of TLS(tertiary lymphoid structure) related gene model and clinical features
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References:
Clinical trial NCT05653765: Prognostic Value of the AMR Measured After PPCI in STEMI Patients
Official title: Prognostic Value of the Angio-based Microvascular Resistance Use One Single Angiographic View Measured After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Heart Disease
ST Elevation Myocardial Infarction
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 2663
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent PPCI due to STEMI in several chest pain centers in China from January 1, 2012 to October 1, 2022

Brief summary: The goal of this observational study is to learn about in STEMI with Primary PCI Patients. The main questions it aims to answer are:

* To determine the value of AMR in predicting the long-term clinical prognosis of patients with STEMI after PPCI, and to find the best cut-off value.
* Analyze the factors of PPCI affecting AMR and explore the effective measures of PPCI microcirculation protection.

Radiographic images of STEMI receiving primary PCI treatment in several chest pain centers in China will be included. The last image of the infarct-related vessel will be used as a target to calculate its AMR. The relationship between AMR and long-term clinical prognosis was analyzed.


Eligibility criteria: Inclusion Criteria:

* Aged 18 or older
* Type 1 myocardial infarction
* Receive PPCI

Exclusion Criteria:

* Failed to identify culprit vessels.
* Structural heart disease with moderate to severe aortic valve or mitral regurgitation and or stenosis that may affect cardiac function
* Dialysis patients with severe renal insufficiency
* Severe and uncontrollable arrhythmia
* Complicated with dilated cardiomyopathy
* Unable to tolerate dual antiplatelet therapy
* Severe and uncontrollable anemia
* Hyperthyroidism
* TIMI blood flow 0-1 grade after PPCI

Primary outcomes:
measure: MACEs
timeFrame: 12 months
Secondary outcomes:
measure: cardiac death
timeFrame: 12 months
measure: hospitalization for heart failure
timeFrame: 12 months
measure: target lesion revascularization
timeFrame: 12 months
measure: Repeated myocardial infarction
timeFrame: 12 months
Other outcomes:
Locations:
city: Shangqiu
country: China
facility: Shangqiu first people's Hospital
state: Henan
city: Xinxiang
country: China
facility: Department of Cardiology, First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Yongcheng
country: China
facility: Yongcheng Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: Fuwai central China cardiovascular Hospital
state: Henan
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University,
state: Shanghai
Study officials:
affiliation: Fuwai central China cardiovascular hospotial
name: Muwei Li, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01808365: N. Meningitidis Carriage Study
Official title: Neisseria Meningitidis Carriage Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Meningococcal
Keywords: Neisseria meningitidis
Philippines
carriage
meningococcus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects aged between 5 and 24 years attending a school or university in the Philippines.

Brief summary: This carriage study aims to evaluate the presence of meningococcus in Asian populations (and potential for disease) and explore the extent and serogroup distribution of meningococci circulating in the population.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
* Asymptomatic subjects attending a school or university.
* A male or female between, and including 5 and 24 years of age at the time of enrollment.

Exclusion Criteria:

* Subjects who have received a meningococcal conjugate vaccine.
* Use of any investigational or non-registered product within one week before the enrollment visit.
* Acute respiratory tract infection within 14 days of sample collection.
* Immune deficiencies, haematological disorders and oncological disease.
* Use of steroids or immunosuppressant drugs within 14 days of sample collection.
* Administration of antibiotics within the 2 weeks preceding the collection of sample.
* Cranio-facial malformations prohibiting the collection of posterior pharyngeal swabs.
* Child in care.

Primary outcomes:
measure: Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs
timeFrame: At enrollment (Day 0)
Secondary outcomes:
measure: The serogroup (determined by Polymerase Chain Reaction) of any isolated N. Meningitidis colonies
timeFrame: At enrollment (Day 0)
measure: Further characterization of any carried N. meningitidis using Multi Locus Sequence Typing
timeFrame: At enrollment (Day 0)
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: