louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00020878: Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
Official title: Celecoxib for Chemoprevention of Primary Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: non-small cell lung cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 21
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco smokers.

PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.

Detailed description: OBJECTIVES:

* Determine the efficacy and feasibility of celecoxib for chemoprevention of primary non-small cell lung cancer in high-risk tobacco smokers.
* Determine the safety and long-term side effects of this drug in this population.

OUTLINE: Patients receive oral celecoxib twice daily for 6 months.

Patients are followed at 2 weeks and then at 6 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6 months.

Eligibility criteria: Inclusion Criteria:

* Age \> 45
* Smoked \> 20 pack years

Exclusion Criteria:

* Concurrent use of NSAIDs
* Hypersensitivity to celecoxib
* Documented allergic-type reaction to sulfonamides
* History of allergic reaction, urticaria or asthma to aspirin or other NSAIDs
* History of liver dysfunction
* Hypertension or cardiac conditions aggravated by fluid retention and edema
* Previous history of gastrointestinal ulceration, bleeding, or perforation
* Renal dysfunction
* End stage respiratory disease
* Unstable angina
* Other malignancy
* Pregnancy
* Concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2C9 and 2D6 enzymes
* Patents with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule

Primary outcomes:
measure: Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers.
timeFrame: 1 year
measure: Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2
timeFrame: 1 year
Secondary outcomes:
measure: Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC
timeFrame: 2 years
measure: Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Jenny T. Mao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06037278: Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study
Official title: MyPAO Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Osteotomy
Acetabular Dysplasia
Periacetabular Osteotomy
Keywords: Customised surgical guides
Lead sponsor: The Royal Orthopaedic Hospital NHS Trust
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A case series to provide post marketing evaluation of the MyPAO surgical planning and patient specific guides technology. This will be a single-centre, multi-surgeon evaluation assessing the safety of the use of these guides in periacetabular osteotomy surgery.

Detailed description: After enrolment, baseline data will be collected including age, sex and ethnicity of the participant. The radiographic measures of centre edge angle of Wiberg and acetabular inclination will be measured by the surgeon and patient reported outcome measures (PROMS) will be collected. The PROMS collected at usual care timepoints in patients undergoing pelvic osteotomy will be collated for use in the dataset. Peri-operative data, including clinician opinion on ease of use, intraoperative dose of radiation used and device associated adverse events, will be recorded and reported in the results.

Eligibility criteria: Inclusion Criteria:

* · Age greater than 18 years

  * Patient undergoing pelvic osteotomy

Exclusion Criteria:

* · Evidence of hip degeneration assessed by the surgeon on x-ray (Tonnis Grade 1 or greater)

  * Known allergy to Polyamide PA12
  * Unable to provide written informed consent

Primary outcomes:
measure: Product safety assessment
timeFrame: 3 months post-surgery
Secondary outcomes:
measure: Proof of concept
timeFrame: 12 months
measure: i-hot12 questionnaire
timeFrame: 12 months post-surgery
measure: Eq-5D
timeFrame: 12 months post-surgery
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: The Royal Orthopaedic Hospital NHS Trust
Study officials:
References:
Clinical trial NCT05990478: A Study of Contrast-Enhanced Mammography (CEM) Scans in People With Breast Cancer
Official title: Contrast-Enhanced Mammography With Early and Delayed Acquisitions in the Assessment of the Extent of Residual Disease Following Neoadjuvant Treatment in Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: breast cancer
Memorial Sloan Kettering Cancer Center
23-224
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 0
Sex: FEMALE
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: Potential research subjects will be identified by a member of the participant's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).

Brief summary: The purpose of this study is to find out whether Contrast-Enhanced Mammography/CEM scans performed 2 minutes and 6 minutes after receiving Iohexol contrast dye can be used to identify the amount of residual disease in the breast following neoadjuvant treatment.


Eligibility criteria: Inclusion Criteria:

* Any women \>18 years of age at time of informed consent
* Diagnosed with breast cancer and schedule for NAT

Exclusion Criteria:

* History of kidney disease, creatinine level \>1.3 or eGFR \<45.
* Known allergic reaction to gadolinium or iodinated contrast media.
* Contraindication to contrast-enhanced breast MRI.
* Lesion not included in the field of view of either pre- or post-NAT MRI or CEM
* Presence of pacemakers or automated implantable cardioverter defibrilator
* Pregnant women

Primary outcomes:
measure: Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Joao Machado Horvat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02579278: Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion
Official title: Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Rectal Cancer
Keywords: EMVI
Extramural Venous Invasion
mrEMVI
Rectal Cancer
ctDNA
Neoplasm DNA
MRI
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 adult patients presenting with primary colorectal cancer proven on biopsy with no evidence of metastatic disease on CT and who are eligible for curative surgery

Brief summary: This study does not involve randomization or treatment. Eligible patients have colorectal adenocarcinoma with no metastases eligible for curative surgery. A pre operative staging scan must have been completed within 6 weeks prior to surgery. Two x 20ml blood samples will be taken from each patient, one prior to and one during or within 24hrs after surgery. Patients are annually followed up to 3 years.

Detailed description: A multicentre observational study, ctDNA aims to provide the evidence base for metatstatic disease being caused by vascular methods of spread by determining if there is a link between EMVI status and ctDNA

Eligibility criteria: Inclusion Criteria:

1. Have a biopsy-confirmed colorectal adenocarcinoma
2. Is eligible for curative surgery
3. Has no metastatic disease on CT scan
4. Has completed pre-operative staging scan within six weeks prior to surgery
5. Have provided written informed consent to participate in the study
6. Be aged 16 years or over

Exclusion Criteria:

1. Have metastatic disease (including resectable liver metastases)
2. Have a synchronous second malignancy
3. Are contraindicated for any imaging able to determine EMVI status

Primary outcomes:
measure: To determine if there is a link between EMVI status and ctDNA
timeFrame: Up to 2 years
Secondary outcomes:
measure: To investigate whether ctDNA levels change during surgery according to EMVI status
timeFrame: Up to 2 years
measure: To investigate the effect of ctDNA status on patient survival outcomes
timeFrame: At 1, 2 and 3 years
Other outcomes:
Locations:
city: Margate
country: United Kingdom
facility: Queen Elizabeth the Queen Mother Hospital
state: Kent
city: Hammersmith
country: United Kingdom
facility: St Mary's Hospital (Imperial)
state: London
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Imperial College London
name: Gina Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02800278: Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly
Official title: Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Odontoid Fracture
Osteoporosis
Surgery
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients over 65 y admitted for low traumat odontoid fracture

Brief summary: Usually, cervical spine fractures are not considered as osteoporotic fractures. However, recent studies show that odontoid fractures are the most common fractures of the cervical spine in elderly and may occur in a context of low trauma energy. Thus, the goal of this observationnal study is :

* to describe the different type of odontoid fracture and to characterize bone status in elderly patient (\>65 y) who underwent odontoid fracture in a context of low trauma energy.
* To describe short and long term outcomes

Detailed description: All patients over 65 y admitted for low trauma odontoid fracture will be consecutively included in the study after informed consent. The investigators will record:

* clinical risk factor of osteoporosis and health habits including accomodation
* type of fracture and characterization of the odontoid fracture on imaging (standard X ray / MRI / QCT)
* Bone status : bone mineral density on DXA, lab tests for secondary osteoporosis check-up, previous vertebral fracture on VFA or X ray
* osteoporosis managment : nutrition, vitamin D, anti-osteoporotic drugs
* treatment of the fracture : surgical / non surgical
* adverse event during hospitalization
* lenght of hospital stay
* type of discharge

Follow-up à 3 and 12 months : dead vs alive ; accomodation ; autonomy ; new fracture

Eligibility criteria: Inclusion Criteria:

* all patients over 65 y admitted for low traumat odontoid fracture

Exclusion Criteria:

* patient \< 65 y
* traumatic odontoid fracture

Primary outcomes:
measure: bone status at the time of odontoid fracture: bone mineral density, prevalent osteoporotic fracture, vitamin D status
timeFrame: from date of inclusion until to 3 weeks after the event. Inclusion will be proposed within 2 weeks after the fracture
Secondary outcomes:
measure: mortality
timeFrame: during hospitalization - 3 and 12 months after inclusion
measure: morbidity
timeFrame: during hospitalization - 3 and 12 months after inclusion
measure: loss of autonomy
timeFrame: discharge, 3 and 12 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: veronique breuil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00273078: Tongue Pressure Recording During Speech
Official title: Experimental Study About Tongue Interactions With Teeth and Palate During Speech, Using Strain Gauge Transducer and Complete Denture. Comparison of Adaptation Phenomenon's Between Patients With New Complete Denture.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complete Toothless
Keywords: Speech,
tongue,
pressure,
transducer,
complete denture
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This research is about tongue's pressure during speech, using a complete denture which allows respecting tongue and speech physiology at the best.

A strain gauge transducer is placed inside this prosthodontics device. During speech, the pressure and the sounds are recording. The analysis of the twos signals should explain what pressure is needed for what sound. The comparison between old complete denture wearers and new one is realized to provide informations about tongue adaptation's phenomenon.


Eligibility criteria: Inclusion Criteria:

new prosthodontics device or change of prosthodontics device male or female Age upper 18 French as native language

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Brigitte GROGOGEAT
Study officials:
affiliation: Hospices Civils de Lyon
name: Brigitte GROGOGEAT, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02839278: Biological Evaluation of a Novel Anti-inflammatory Treatment in Immune-mediated Inflammatory Diseases
Official title: Biological Evaluation of a Novel Anti-inflammatory Treatment in Immune-mediated Inflammatory Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Immunomodulation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate in vitro the impact of a novel anti-inflammatory treatment on costimulatory molecules expressed on monocytes.


Eligibility criteria: Inclusion Criteria:

* Immune-mediated inflammatory disease (non-ST segment elevation myocardial infarction, Rheumatoid arthritis, Chronic obstructive pulmonary disease, Idiopathic pulmonary fibrosis, Crohn's disease, Ulcerative colitis, Cystic fibrosis, Psoriasis, Multiple sclerosis or major depressive episode)
* Patient able to understand the reason of the study
* Patient not opposed to the conservation of biological samples for scientific research

Exclusion Criteria:

* Pregnant woman
* Subject without health insurance

Primary outcomes:
measure: Expression of costimulatory molecules CD86, CD80, CD40 and class II (HLA-DR) on monocytes
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT05235178: The Effect of the CytoSorb® Filter to Remove Anticoagulants From the Circulation During Emergency Surgery for Aortic Dissection
Official title: The Effect of the CytoSorb® Filter to Remove Anticoagulants From the Circulation During Emergency Surgery for Aortic Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Factor X Inhibition
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2022-02-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are anticoagulated with FXa inhibitors beeing operated acutely for acute proximal aortic disease with the use of Cytosorb® hemadsorber intraoperatively.

Brief summary: The direct oral anticoagulants (DOACs) and particularly the FXa inhibitors are a concern in patients presenting with type A aortic dissection as this may contribute to severe bleeding complications. The antidote andexanet alfa (Ondexxya®) can interact with the heparin- anti-thrombin III (ATIII) complex which may neutralize the anticoagulant effect of heparin and the use of andexanet alfa before surgery necessitating heparin-anticoagulation has been reported to cause unresponsiveness to heparin. The investigators have preliminary in-vitro data demonstrating the ability to remove apixaban from reconstituted blod by hemadsorption and are now analyzing if aFXa inhibitor levels may be reduced by hemadsorption in the clinical setting analyzing this in patients using FXa inhibitors being operated acutely for type A aortic dissection.


Eligibility criteria: Inclusion Criteria:

* Indication for urgent surgery for proximal aortic disease
* Treatment with FXa inhibitor for more than 2 weeks
* Measured concentration of FXa inhibitor in therapeutic range (\>50 ng/mL) at the time of admission.
* Intraoperative use of Cytosorb® hemadsorber.

Exclusion Criteria:

• Low FXa inhibitor concentration (\<50 ng/mL) at the time of admission

Primary outcomes:
measure: Change in apixaban concentration after 60 minutes of hemadsorption
timeFrame: 60 minutes
Secondary outcomes:
measure: Change in apixaban concentration during hemadsorption
timeFrame: 5-120 minutes
measure: Apixaban concentration follwing hemadsorption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT02636478: Travelling in Patients With Sleep Related Breathing Disorders
Official title: Travel Activities in Patients With Sleep Related Breathing Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Travel, Sleep Related Disorder
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with sleep related breathing disorder

Brief summary: One questionnaire has been configured to ask therapy naive and treated patients about their travel activities. Travel activities include private and professional traveling. Another questionnaire collects medical information.

Detailed description: Including a German sleep committee a new questionnaire has been created to ask patients about their travel Habits. Only travels over a onenightstay were of interest. All detailed Information about the Destination has been asked. A Special Point of interest were the Impacts of traveling. For each Patient a doctor completed the medical history including sleep related breathing disorder and relevant medical conditions e.g. orthopedic Impacts.

Eligibility criteria: Inclusion Criteria:

* patients with sleep related breathing disorder
* informed consent provided

Exclusion Criteria:

* patients with no sleep related breathing disorder
* no informed consent provided

Primary outcomes:
measure: travel activities in sleep related breathing disorder, questionnaire
timeFrame: ten minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Quera Salva MA, Barbot F, Hartley S, Sauvagnac R, Vaugier I, Lofaso F, Philip P. Sleep disorders, sleepiness, and near-miss accidents among long-distance highway drivers in the summertime. Sleep Med. 2014 Jan;15(1):23-6. doi: 10.1016/j.sleep.2013.06.018. Epub 2013 Sep 14.
citation: Sinagawa DM, De Carvalho HB, Andreuccetti G, Do Prado NV, De Oliveira KC, Yonamine M, Munoz DR, Gjerde H, Leyton V. Association between travel length and drug use among Brazilian truck drivers. Traffic Inj Prev. 2015;16(1):5-9. doi: 10.1080/15389588.2014.906589. Epub 2014 Sep 26.
Clinical trial NCT04590378: Pulmonary Embolism and COVID-19
Official title: Evaluation of the Patients With COVID-19 in Terms of Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Pulmonary Embolism
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All COVID-19 patients with positive RT-PCR tests will be analyzed retrospectively. Patients with and without pulmonary embolism will be compared in terms of age, gender, side disease, hospitalization in intensive care, mortality rates etc.

Brief summary: The charts of patients who developed pulmonary embolism in the course of COVID-19 will be evaluated, retrospectively. Clinical features and laboratory data will be analyzed.

Detailed description: Patients with COVID-19 infection will be evaluated retrospectively. Demographic data, clinical and laboratory findings will be recorded. Findings of patients with pulmonary embolism and withour pulmonary embolism will be compared.

Eligibility criteria: Inclusion Criteria:

- All patients with positive RT-PCR for COVID-19

Exclusion Criteria:

- All patients with negative RT-PCR for COVID-19

Primary outcomes:
measure: pulmonary embolism
timeFrame: 1 year
Secondary outcomes:
measure: Intensive care unit
timeFrame: 1 year
measure: mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Uşak University
Study officials:
affiliation: Uşak University Medical School
name: Cevdet Duran, M.D.
role: PRINCIPAL_INVESTIGATOR
References: