cyrilzakka/clinical-trials huggingface dataset:
Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study

The purpose of this study is to determine whether reading of low-dose thoracic CT scans can be done by a single general radiologist who has been trained to lung cancer screening, and will evaluate the performance in comparison with double reading by experts.

The study will enroll women between 50 and 74 years old, at risk for lung cancer due to their smoking history.

Lung cancer is the leading cause of cancer death, worldwide. Several randomized studies have demonstrated that annual or biennial low-dose CT screening reduces lung cancer mortality. However, these studies involved expert chest radiologists, with double reading being performed in most studies. Furthermore, none of the published studies have evaluated the role of artificial intelligence to serve as second of concurrent reader.

Women with at least 20 pack-year smoking history who quitted smoking less than 15 years ago will be enrolled to have baseline, 1-year and 2-year low-dose CT of the chest.

The CT scans will be read on site by a general radiologist trained to lung cancer screening according to the European lung cancer screening certification program, first without then with the aid of an artificial algorithm trained to lung nodule detection (Veye Chest, Aidence). All CT scans will also be read by 2 chest experts, who will resolve their disagreement by a consensus reading if necessary. Patient management will rely on the double reading by expert. The criteria for positive screen result are as follows: solid nodule \> 500 mm3 (10 mm) or growing (30% volume increase), part-solid nodule with \> 8 mm solid component or new or growing, pure ground glass nodule developing a solid portion.

Eligibility Criteria:
Inclusion Criteria:

* Women aged from 50 to 74 years
* who had smoked at least 20 pack years and quit less than 15 years ago
* Had given their consent and accepted the need for a 2-year follow-up
* Affiliated to the social security system

Exclusion Criteria

* Presence of clinical symptoms suggesting malignancy (weight loss, hemoptysis) or ongoing infection (cough with fever)
* Evolving cancer
* History of lung cancer
* A 2-year follow-up not possible
* Chest CT scan performed within 2 years prior to inclusion
Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy

Cross-sectional study. We will prospectively obtain ddcf-DNA levels in all patients who undergo routine coronary angiography \> 1 year after HT. Our main goal is to evaluate the performance of Donor-derived Cell Free DNA (ddcf-DNA) as a biomarker of CAV.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 and under 80 years old, HT \> 1 year ago

Exclusion Criteria:

* Patients under 18 or over 80 years old
* Multiorgan transplant
* History of acute cellular rejection ≥ 1R or antibody mediated rejection in the previous 6 months
* Concomitant infection by CMV
A Drug-drug Interaction Study Between GLPG1205 and a Cocktail of CYP450 Substrates in Healthy Male Subjects

This will be a Phase I, randomized, double-blind, placebo-controlled, 2 period cross-over, drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1205 or placebo (daily from Day 1 to Day 12) on a single dose pharmacokinetic profile of a cocktail of CYP450 substrates administered to healthy male subjects. The cocktail of CYP450 substrates will consist of 10 mg warfarin (CYP2C9 substrate), 20 mg omeprazole (CYP2C19 substrate) and 100 mg caffeine (CYP1A2 substrate).

Fourteen healthy male subjects will receive during two treatment periods from Day 1 to Day 12 a daily dose of GLPG1205 or placebo. On Day 13, a single dose of the cocktail of CYP450 substrates will be co-administered either with GLPG1205 or with placebo. The two treatment periods will be separated by a wash-out period of at least 28 days.

Also, the safety and tolerability of multiple oral doses of GLPG1205 administered with or without a cocktail of CYP450 substrates in healthy male subjects will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Poor or moderate metabolizer for CYP2C9 or CYP2C19 as determined by genotyping
* Having a contraindication as indicated in the respective Summary of Product Characteristics (or Package Leaflets) for warfarin, omeprazole or caffeine
* Intake of nutraceuticals within 3 weeks prior to dosing or within 6 times the elimination half life
* Intake of enzyme inducing or enzyme inhibiting drugs within 3 months prior to dosing
* Intake of vitamin K within 3 weeks prior to dosing
* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Study on Immediate Placement to Evaluate Astra Tech Osseospeed Implants in an Immediate Loading Protocol in Extraction Sockets and Healed Ridges

This is a study to evaluate immediate implants.

Solitary replacement of teeth by implants in upper maxilla - immediate implants

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* Smoking
* Medical risk patients
Patients With Chronic Pelvic Pain With Vaginal Microbiota

Vaginal microorganisms play an important role in the occurrence and development of many diseases, such as persistent infection of high-risk human papillomavirus (HR-HPV) causing cervical intraepithelial neoplasia and cervical cancer, and the role of microorganisms in chronic prostatitis.


Eligibility Criteria:
Inclusion Criteria:

* Those are aged 20 to 45 years old, have vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.

Exclusion Criteria:

* Those are aged more than 45 years old without HPV infection in the last one year, having no vaginal intercourse, and those can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.
Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer

Non small cell lung cancer is the first cause of cancer related death in France and is becoming an increasing health problem in developing countries.

Recently for patient with no progression disease after first line chemotherapy, new therapies were validated in maintenance (bevacizumab) or switch maintenance treatment (erlotinib, pemetrexed) with improved survival.

Until now, determination of efficiency of treatment is only based on morphological response (RECIST) and remains inappropriate to such cytostatic drugs for which there is no anatomical lesion modification.

Nuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a biologically relevant tool for assessment of tumour response therapies.

The assumption of the study is that FDG PET would allow to earlier detect a lack of response, thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment is maintained up to evidence of progression disease.

However, despite the increasing use of FDG PET for predicting therapeutic response, there are no validated criteria for judging response of maintenance therapy in non-small cell lung cancer.

It seems necessary to determine standardized criteria response, earlier during the course of maintenance therapy in patient with non small cell lung cancer.

The final aim is to optimize survival by an adapted metabolic imaging guided therapy.

The purpose of the study is to optimize survival by an adapted metabolic imaging therapy in patients with advances non-small cell lung cancer.

The primary objective of the study is to evaluate the role of SUV and metabolic volume measured by FDG PETScan in the early prediction of treatment response.

80 patients will be included in 2 years. They will be follow up for one year for monitoring the progression free survival.

Eligibility Criteria:
Inclusion Criteria:

* Age superior to 18 years old
* Effective contraception method or negative pregnancy test at the inclusion
* OMS inferior or equal to 1
* Non-small cell lung cancer stage IIIb or IV
* Non progressive disease after at lest 4 cycles of platinum-based chemotherapy
* Eligible fo maintenance therapy with bevacizumab and/or pemetrexed
* Inform consent signed

Exclusion Criteria:

* Evolution of a second cancer in the 3 years before inclusion
* Pregnancy or breast-feeding
* poorly controlled diabetes
* curatorship or guardianship
* contraindication to iodinated contrast agents
* participation to another clinical research with an experimental drug
* impossible decubitus
* not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons
Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence

To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Symptomatic stress or mixed urinary incontinence for at least 12 months
* Having at least 1 incontinence episode per day over three days

Exclusion Criteria:

* Regular or intermittent users of an urethral catheter
* Pregnant women
* Suffer from severe allergies or anaphylaxis
* Suffer from autoimmune diseases or any unstable or sever cardio-vascular disease
* History of any cancer within the last 5 years
* Previous surgery for the treatment of urinary incontinence, including bulking
Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (T2DM)
* Treated with either stable dose of metformin alone \> or = to 1500mg/day or stable dose of insulin \> or = to 30 units/day and up to 2 OAD medications for at least 8 weeks
* Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening
* Body mass index (BMI) \< or = to 45 kg/m2

Exclusion Criteria:

* For patients who enter the study taking a stable dose of metformin, history of taking OAD medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening
* For patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to screening.
* Use of sulfonylureas during the 8 weeks prior to screening
* Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2) inhibitor
* Ingestion of any medication know to affect glucose metabolism for \>7 consecutive days during the 3 months prior to screening
* Ingestion of prescription or over the counter weight loss medication during 3 months prior to screening
Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

EUROSCUP Fixe is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSCUP Fixe performances and safety

Post market observational study. This study is retropective and prospective, non comparative.

Eligibility Criteria:
Inclusion Criteria:

* Patient who received EUROSCUP Fixe.
* Patient informed of its participation to the study
* Patient aged between 18 and 80 years old (\<80).

Exclusion Criteria:

* Patient presenting a contraindication to EUROSCUP Fixe implantation.
* Patient who refused to participate to the study
* Vulnerable subjects
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.

This is a long-term (10 years), retrospective-prospective, observational, single-arm, monocenter study of patients to be treated with the Materialise TMJ Total Arthroplasty System for TMJ replacement. The study will evaluate the efficiency, safety, clinical performance, accuracy, benefits, and risks associated with long-term use and the impact on life quality and diet of the TMJ system, its fixation devices, TMJ Implant trial, and guides in the adolescent and adult populations.

The study begins with patient inclusion and pre-operative examination, where eligibility is assessed based on inclusion and exclusion criteria. Informed consent is obtained, and if a participant drops out before implantation, a new patient is enrolled. Pre-operative assessments include (CB)CT imaging, collection of demographic details, medical history, and co-morbidities using the Charlson Comorbidity Index (CCI). Other pre-operative evaluations include maximal inter-incisal opening (MIO), occlusion, diet consistency, and several questionnaires to assess quality of life, jaw function, and speech. Pre-operative (CB)CT scans are used for surgical planning and device design.

During surgery and hospital stay, the index procedure marks the patient's enrollment. Surgical details are documented, including the approach, device characteristics, operation time, and complications. Intraoperative adverse events, such as allergic reactions or hematoma, are recorded. A post-operative (CB)CT scan is performed within a week, and patient and surgeon satisfaction, both functional and aesthetic, are recorded. Any post-operative complications are tracked.

For follow-up, the study includes 9 follow-up visits at intervals of 1 week, 4 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years, and 10 years. At each visit, MIO, occlusion, diet consistency, and jaw function are assessed, and patients complete the EQ-5D-5L, OHIP-14, and Helkimo Clinical Dysfunction Index questionnaires. A (CB)CT scan is performed at specific follow-ups, and any post-operative complications, adverse events, or re-interventions are reported. Medication intake is recorded as well.

Eligibility Criteria:
Inclusion Criteria:

* Patients prescribed with Materialise TMJ Total Arthroplasty System for TMJ reconstruction
* Patient who has received and understood the study information leaflet and has agreed to participate in the study and signed the informed consent form (ICF) (adult or legal guardian(s) if minor).

Exclusion Criteria:

* Known hypersensitivity to Titanium, Nickel, or Cobalt-Chrome alloys.
* Patient conditions where there is not enough bone quality or quantity to support the components.
* Active infection in the anatomical area or the vicinity of the site to be implanted, preventing the implantation of the device.
* Patients with marked hyperfunctional habits (e.g., tooth clenching, bruxism).
* Pregnant woman.
* Patient is known to be or suspected of being unable to comply with the study protocol or proposed follow-up visits by the investigator.
Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment

The femoro-popliteal arterial segment is one of the most frequent locations for atherosclerosis. Its management is mainly endovascular (standard and coated-balloon angioplasty, stenting).

However, the structural features of the atherosclerotic disease in regards to patient's risk factors and past medical and surgical histories are not well studied. Furthermore, the histological analysis of the femoro-popliteal arterial segment is rare in the literature, and made difficult mostly because of the length of this segment.

There is a clinical need for better understanding of atherosclerotic lesions in this location, with as further goal, a better management of this disease.


Eligibility Criteria:
Inclusion criteria:

* Age \> 18 years old
* Men and women
* Patient with chronic limb ischemia that is scheduled for transfemoral amputation in the University Hospital of Strasbourg
* Patient giving his -non-opposition to the explantation and use of the femoro-popliteal arterial segment

Exclusion criteria:

* Refusal to give his consent
* Impossibility to give clear information to the patient
* Pregnant and breastfeeding women
* Patient under administrative protection
Glycocalyx and Microcirculation in Sepsis

The aim of this observative, prospective study with cross-sectional design is to explore possible correlations/associations between microcirculation parameters and sublingual endothelial glycocalyx in sepsis. Therefore, 30 critically ill septic patients and 10 healthy controls were enrolled.


Eligibility Criteria:
Inclusion Criteria - septic ICU cohort:

* Sepsis (based on sepsis-3 criteria)
* ICU stay

Inclusion Criteria - healthy controls:

- Adult healthy individuals

Exclusion Criteria (for all groups):

* Underage
* pregnancy
* oral mucosal inflammation or injury
A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma

Single-Arm, Open-Label, Multicenter Clinical Trial. To observe the efficacy and safety of TQB2450 in patients of non-hodgkin lymphoma


Eligibility Criteria:
Inclusion Criteria:

1. Subject has voluntarily agreed to participate by giving written informed consent.;
2. Histopathological confirmed classical Hodgkin's lymphoma;
3. Relapsed/refractory cHL include：a)subject with relapse and progression after salvage chemotherapy followed by autologous stem cell transplantation(ASCT); b) subject with no ASCT: The first-line chemotherapy must be systemic multi-drug combination chemotherapy and subsequent chemotherapy requires at least one first-line chemotherapy must be systemic multi-drug combination chemotherapy; subject which is refractory didn't achieve PR after 2 cycles or didn't achieve CR after
4. Age ranged from 18 to 75 years;
5. At least one measurable disease ;
6. Patients must have ECOG performance status of 0-2;
7. Subject must have adequate organ functions ：Count of Blood Cells:hemoglobin content(HB)≥80g/L; absolute neutrophil count (ANC) ≥ 1.0 × 10\^9 / L; platelet count (PLT) ≥ 75 × 10\^9 / L;; Biochemical examination: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), with the exception of patients with hepatic metastases and Gilbert's syndrome(TBIL≤3×ULN） ; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN，with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) , serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance rate（CCR）≥50 mL/min；Serum amylase and lipase ≤ 1.5 x ULN Blood coagulation function:International standardized ratio(INR)≤1.5×ULN、Activation partial thrombin time(APTT)≤1.5×ULN、Prothrombin time≤1.5×ULN；Doppler ultrasound evaluation：Left ventricular ejection fraction（LVEF)≥50%×MLN;

Exclusion Criteria:

* 1、Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma； 2、 Prior exposure to any anti-PD-1, anti-PD-L1 ， anti-CTLA-4 antibody or CAR-T cell treatment(Any other antibody that has been applied to a T cell synergistic stimulus or checkpoint pathway); 3、Need to therapy with other anticancer during the study; 4、Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment

Phase I, randomized, double blind, placebo-controlled, dose-finding trial. The trial´s goal is to evaluate two different doses of Bryostatin on HIV-1 latency and reservoir in HIV-1 infected patients receiving antiretroviral treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients understanding the trial purpose
* Patients between 18 and 50 years of age
* Patients with chronic HIV-1 infection
* Patients receiving antiretroviral treatment with at least 3 active drugs for at least 2 years
* Undetectable viral load measured by ultra sensitive methods
* CD4+ levels higher than 350 cells/mm3
* Patients committed to use contraceptive methods during the trial and up to 3 months after.

Exclusion Criteria:

* Previous antiretroviral treatment failure, as any viral load outbreak after having had undetectable HIV-1 load. Low grade, transitory outbreaks (\<200 RNA copies/ml) resolved without treatment modifications are excluded
* Patients planned to interrupt antiretroviral treatment during the trial
* Patients receiving immunosuppressant or immunostimulant drugs, including valproic acid.
* Pregnant women
* Bryostatin-1 hypersensitivity
* Being enrolled in another clinical trial or having participated in another clinical trial in the previous 3 months.
Sepsis Metabolomics

The occurrence of sepsis and its relevant multiple organ dysfunction remain a major problem in intensive care units with high morbidity and mortality. The differentiation between non-infectious and infectious etiologies, severity and organ function evaluation, and prognostic assessment are all challenging in routine clinical practice. Many biomarkers have been suggested for these purpose; however sensitivity and specificity even of high-ranking biomarkers still remain insufficient. Recently, metabolic profiling has attracted interest for biomarker discovery. In this study, LC-MS/MS will be perform to identify serum metabolic biomarkers for differentiation of SIRS/sepsis, severity and organ function evaluation, and prognostic assessment among 65 patients. The investigators enrolled 35 patients who were diagnosed with sepsis, 15 patients who were diagnosed with SIRS, and 15 normal patients. Moreover, the sepsis were further divided into sepsis, severe sepsis, and sepsis patients before death. Small metabolites that were present in patient serum samples were measured by LC-MS/MS techniques and analyzed using multivariate statistical methods, such as Principal Component Analysis (PCA), Partial Least Squares-Discriminant Analysis (PLS-DA), and Orthogonal Partial Least Squares Discriminant Analysis. Based on the multivariate statistical analysis above, the investigators could distinguish sepsis from normal and SIRS; distinguish the difference among sepsis, severe sepsis and death. We hypothesis that some metabolites as identified in this study are promising biomarker candidates in the field of sepsis diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* male and female aged 18 years old and over;
* clinically confirmed infection;
* fulfilled at least two criteria of systemic inflammatory response syndrome
* core temperature higher than 38 °C or lower than 36 °C
* respiratory rate above 20/min, or PCO2 below 32 mmHg
* pulse rate above 90/min, and
* white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.

Exclusion Criteria:

* younger than 18 years of age;
* acquired immunodeficiency syndrome;
* reduced polymorphonuclear granulocyte counts (\< 500 μL-1);
* died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.