cyrilzakka/clinical-trials huggingface dataset:
Benefit of Spectral Information in Patients Suspected for Lung Cancer

Purpose The aim of the study is to investigate the utilization of photon counting CT (PCCT) and the spectral information provided to determine the impact of spectral information on follow-up examinations.

As secondary aims we will compare conventional CT, CT + 18Flouro-deoxy-glucose (18F-FDG) positron emission tomography (PET) and PCCT + 18F-FDG PET for the tumor-node-metastasis (TNM) staging of lung cancer patients.

PCCT with and without spectral information to assess the need for additional work-up,TNM classification, and sensitivity/specificity for malignant lesions. Patients will be randomized for reading with or without spectral information available within a clinical setting. The clinical readings are performed as a structured reports of all significant findings. Including both malignant and benign findings. Furthermore, in case additional follow-up/work-up is needed based on the guidelines on incidental findings by the American College of Radiology (ACR), this will be reported as well. If lesions suspicious of pulmonary malignancy is present, a provisional TNM classification is provided based on the scan findings.

After 3 months, the patient record is reviewed where additional examinations that can be attributed to the PCCT scan are recorded. The financial impact is calculated by a health economist based on the findings. PET/CT, conventional CT and PCCT combined with PET will be assessed retrospectively for comparison. Endpoints are number of supplementary examinations and cost savings. Sensitivity and specificity for any malignant finding. The T, N and M stages are assessed separately as diagnostic measures by the McNemar's test with a reference standard from the Danish Lung cancer register. The number of malignant lesions will be determined by reviewing the patient records incl. pathology assessment if available 12 months after inclusion of the last patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of lung cancer refered to Copenhagen University Hospital as per the guidelines from the danish national health authorities from either the general practitioner or from the department of pulmonology.
* Informed consent

Exclusion Criteria:

* Patients who cannot tolerate intravenous iodinated contrast
* Already verified lung cancer from another institution
* Comorbidities that exclude the patient from receiving treatment
* Lack of reference standard in the form of either histology or follow-up
* Known extrapulmonary malignancy
* Technical limitations within the scans/reconstructions
* other
ShapeMatch Cutting Guide Functional Outcomes Study

Randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria.

This study will be a prospective, randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria. Forty-eight cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. Another forty-eight cases enrolled will receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. And the last forty-eight cases will receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has signed an ethic commission approved study specific Informed Patient Consent Form.
2. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
3. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
4. Patient is a candidate for a primary total knee replacement.
5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Patient has a Body Mass Index (BMI) ≥ 40.
2. Patient age ≥ 80.
3. Patient has a varus or valgus deformity greater than 10 degree or flexion contracture greater than 20 degree.
4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
5. Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.
6. Patient requires bilateral total knee replacements, or has a history of contralateral partial or total knee replacement.
7. Patient has any implanted device that would be incompatible with MRI procedures.
8. Patient has chronic heart failure (NYHA Stage ≥ 2)
9. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
10. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget"s Disease) leading to progressive bone deterioration.
11. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
12. Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
13. Patient has a known sensitivity to device materials.
14. Patient is a prisoner.
A Study to Evaluate the Safety and Effectiveness of Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population

A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of MAILI PRECISE With Lidocaine Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or above (subject to the time of signing the informed consent form) , gender is not limited;
2. According to Allergan Infraorbital Rim Scale (AIHS), the subjects were judged by blinded evaluator as having "moderate" or "severe" infraorbital rim hallowing (grade 2-3) in each eye, and both eyes must meet the requirements but do not need to have the same score;
3. The injection investigator believes that the hallowing of the infraorbital rim area of the subject can be corrected to grade 0 or grade 1;
4. Able and willing to follow the investigator's guidance, following the treatment restrictions in this protocol, and completing all the visits of this trial as required ;
5. Able to complete the self-assessment of effectiveness without the use of glasses (contact lenses are accepted if the subject wear contact lenses for all the follow-up visits);
6. Volunteer to participate in this clinical trial and sign the Informed Consent Form.

Exclusion Criteria:

1. Atrophy in the infraorbital area;
2. Previous trauma to the infraorbital area, or residual defects, deformities, or scarring in the periorbital or cheek area before screening;
3. The investigator considers that there is a large lower eyelid fat pad that will affect the treatment outcome;
4. The front most part of the eyeball protrudes forward more than the front most part of the cheek;
5. Hyperpigmentation in the infraorbital area (excluding dark circles which are not caused by hyperpigmentation).
Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients (BMN 270-301)

This Phase III clinical study will assess the impact of BMN 270 (compared to FVIII prophylaxis) on the number of bleeding episodes irrespective of exogenous FVIII replacement treatment in the efficacy evaluation period (EEP) (from Week 5 post-BMN 270 infusion (Study Day 33) or the end of FVIII prophylaxis plus the washout period (3 days for products of standard half-life or plasma-derived and 5 days for products of extended half-life), whichever is later, to last visit by the data cut-off for the 2-year analysis, hereafter referred to as "Post FVIII Prophylaxis to Last Visit"). The study will also assess the impact of BMN 270 (compared to FVIII prophylaxis) on: the number of bleeding episodes requiring exogenous FVIII treatment in "Post FVIII Prophylaxis to Last Visit", FVIII activity as measured by chromogenic sustrate assay at Week 104 following intravenous infusion of BMN 270, usage of exogenous FVIII replacement therapy in "Post FVIII Prophylaxis to Last Visit", health-related quality of life patient-reported outcomes at week 104 following intravenous infusion of BMN 270. The study will also evaluate the safety of the BMN 270.


Eligibility Criteria:
Inclusion Criteria:

1. Males ≥ 18 years of age with hemophilia A and residual FVIII levels ≤ 1 IU/dL as evidenced by medical history, at the time of signing the informed consent.
2. Must have been on prophylactic FVIII replacement therapy for at least 12 months prior to study entry.
3. Treated/exposed to FVIII concentrates or cryoprecipitate for a minimum of 150 exposure days (EDs).
4. No previous documented history of a detectable FVIII inhibitor, and results from a Bethesda assay or Bethesda assay with Nijmegen modification of less than 0.6 Bethesda Units (BU) on 2 consecutive occasions at least one week apart within the past 12 months.

Exclusion Criteria:

1. Detectable pre-existing antibodies to the adeno-associated virus 5 (AAV5) capsid.
2. Any evidence of active infection or any immunosuppressive disorder, except for HIV infection
3. Any evidence of active infection or any immunosuppressive disorder, including HIV infection (effective as of Protocol Amendment 3)
4. Significant liver dysfunction.
5. Prior liver biopsy showing significant fibrosis.
6. Evidence of any bleeding disorder not related to hemophilia A.
7. Platelet count of \< 100 x 10\^9/L.
8. Creatinine ≥ 1.5 mg/dL.
9. Liver cirrhosis of any etiology as assessed by liver ultrasound.
10. Chronic or active hepatitis B.
11. Active Hepatitis C.
12. Active malignancy, except non-melanoma skin cancer.
13. History of hepatic malignancy.
14. History of arterial or venous thromboembolic events.
15. Known inherited or acquired thrombophilia, including conditions associated with increased thromboembolic risk, such as atrial fibrillation.
The Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer

The objective of this study is to evaluate intermittent fasting after the treatment of breast cancer with surgery and radiation therapy. All participants will either delay their first meal of the day or advance their last meal to achieve an approximate 16-18 hour fasting period four times per week. Over six months, the innovative protocol will 1) assess adherence, and is expected to 2) improve body composition, quality of life and inflammatory and metabolic variables linked with outcomes after breast cancer treatment. The long-term goal of this project is to incorporate this dietary strategy as a standard component of care for breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast stage I-III
* completed any chemotherapy prior to initiation of the trial (adjuvant endocrine therapy is permitted)
* BMI \> 25 kg/m2 or body fat% greater or equal to 31%
* have a schedule amenable to nutrition and dietitian counseling described within the study protocol as determined by the treating radiation oncologist
* have access to the internet and email with capability to join Zoom calls

Exclusion Criteria:

* Metastatic breast cancer
* Currently receiving chemotherapy
* Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149, diastolic blood pressure over 99, or hemoglobin A1c greater than 8.9.
* Diabetic condition requiring the usage of insulin
Clinical Study on the Intervention of Xuesaitong Soft Capsules in Post-Intervention Patients with Acute Coronary Syndrome and Clinical Research Protocol

To assess the effects of Xuesaitong soft capsules on platelet function, clinical efficacy, prognosis, and safety in the treatment of acute coronary syndrome, 400 patients with acute coronary syndrome who underwent PCI were treated with Xuesaitong soft capsules (mainly containing ginsenosides) for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with acute ST-segment elevation myocardial infarction, acute non-ST-segment elevation myocardial infarction, or unstable angina according to Western medical standards. Inclusion Criteria.
2. Within 4 weeks post-PCI.
3. Aged between 18 and 80 years, both male and female.
4. Voluntarily participating in the clinical trial, having signed the informed consent form.

Exclusion Criteria:

1. Uncontrolled hypertension after medication (systolic BP \>180mmHg or diastolic BP \> 110mmHg).
2. Increased bleeding risk: history of hemorrhagic stroke; intracranial aneurysm; major trauma or surgery within the past month (including Exclusion Criteria bypass surgery); active bleeding disorders.
3. History of gastrointestinal ulcers or significant gastrointestinal bleeding.
4. Severe organic heart disease, such as LVEF \< 35% or NYHA/Killip heart function grade IV.
5. History of malignant arrhythmias within the past year (arrhythmias affecting hemodynamics requiring medication or electrical cardioversion, or requiring CPR), congenital heart disease, or malignant tumors.
6. Severe liver or kidney dysfunction: ALT or AST ≥ 3×ULN, TBIL≥ 2×ULN, or creatinine clearance \< 30ml/min.
7. Pregnant or lactating women.
8. Recent blood donation or significant blood loss within the past 3 months (≥400ml).
9. History of alcohol abuse (≥28 standard units/week for males, ≥21 standard units/week for females) or frequent alcohol consumption in the past 6 months (≥14 standard units/week).
10. History of drug abuse or dependence within the past year. Participation in other clinical trials and taking trial drugs within the past 3 months.
11. Allergy or intolerance to aspirin or P2Y12 receptor inhibitors.
12. Allergy to any components of the trial drug.
13. Other conditions deemed inappropriate for participation by the nvestigator
CardioRoot Post-Marketing Surveillance Registry

Post-marketing surveillance registry of the CardioRoot graft.

Study objective is to monitor the performance and safety of CardioRoot vascular grafts implanted in a thoracic position. Patient survival rates will be monitored as well as immediate and long-term complications.

Eligibility Criteria:
Inclusion Criteria:

* patients requiring a CardioRoot graft as per the CardioRoot Instructions for Use (IFU)

Exclusion Criteria:

* patients with contra-indications per CardioRoot IFU
* patients requiring consecutive aortic surgery
* patients with coronary artery disease
* patients who require urgent or emergent surgery
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.


Eligibility Criteria:
Inclusion Criteria:

Key Inclusion criteria:

* Male or female participants aged 18 to 80 years;
* Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout;
* Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;
* A self-reported history of at least 2 gout flares in the year prior to screening.

Exclusion Criteria:

Key Exclusion criteria:

* Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug;
* Participants requiring dialysis;
* Participants who had had an organ transplant;
* Persistent chronic or active infections;
* Previous exposure to rilonacept;
* Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days prior to the screening visit.
Changes in the MRI Signal in Patients With Benign Tumors of the Brain and Meninges Treated With Proton Therapy: Impact of TEL and the Biological Dose Received

The main objective is to detect with TESLA multiparametric 3 MRI, the MRI secondary changes to protontherapy irradiation and to correlate them with TEL mapping, physical dose and biological dose. A model should thus be able to be proposed at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven or highly probable grade I meningiomas, histologically proven grade II meningiomas.
* Only meningiomas of the anterior and middle floors of the base of the skull are included.
* Indication of proton therapy retained in RCP and / or proton therapy technical staff (Caen site)
* Patient aged 18 or over
* Patient affiliated to a social security scheme
* Signature of informed consent before any specific procedure related to the study

Exclusion Criteria:

* History of brain or face irradiation.
* Implant or foreign body that can alter MRI imaging.
* Contraindication to MRI (pace maker, claustrophobia ...) - Hypersensitivity to gadoteric acid, to meglumine or to any medicine containing gadolinium
* Genetic radio sensitizing syndrome
* Known neurological comorbidities (stroke, Parkinson's, etc.) that may impact MRI data.
* Simultaneous participation in a therapeutic clinical trial
* Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons
* Pregnant or breastfeeding women
* Persons deprived of their liberty (see article L 1121-6 CSP),
* Adults who are the subject of a legal protection measure or unable to express their consent (see article L 1121-8)
A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of age-related macular degeneration in at least 1 eye
* Best corrected visual acuity of 20/40 to 20/320 in the study eye
* Best corrected visual acuity of 20/200 or better in the non-study eye

Exclusion Criteria:

* History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
* Cataract or refractive surgery in the study eye within the last 3 months
The Effect of Peer Education on the Knowledge and Skill Levels of Nursing Students

This study was planned to determine the impact of peer education and instruction received from the instructor on the knowledge and skill levels of students in the physical assessment of the newborn.

Nursing education is a process that involves the transfer of theoretical knowledge, skills, and attitudes based on cognitive, affective, and psychomotor domains into clinical practice.The aim is to train nurses who are capable of evidence-based intervention in line with holistic care principles in clinical settings. However, the process of transferring theoretical knowledge and skills acquired by students into clinical practices takes place in complex social environments in clinics, unlike traditional classroom settings.

Among student-centered teaching methods, 'peer education' has gained considerable attention in recent years. If peer-to-peer education can attain similar learning outcomes as standard teaching methods, it is believed that it can be applied to learning objectives encompassing many professional knowledge and skill techniques.

Physical examination of the newborn requires considerable knowledge, skill and experience.

This situation is known to impose limitations on nursing students in applying and learning newborn care based on atraumatic care principles in clinical settings. Additionally, the fear of causing harm to the newborn or inflicting pain experienced by nursing students creates emotional and mental stress situations, making it difficult for the instructor to teach and reinforce care practices in newborn nursing.

Therefore, this study was planned to compare the difference between peer educators and instructors in the physical examination of newborns in nursing students.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Volunteer to participate in the study
* 4th-year nursing students

Exclusion Criteria:

* Non-volunteering
A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

The study is being conducted to evaluate the efficacy and safety of Toripalimab Injection in combination with chemotherapy compared to placebo in combination with chemotherapy in subjects with PD-L1-positive unresectable locally advanced or metastatic urothelial carcinoma who have received no previous systemic therapy.


Eligibility Criteria:
Inclusion criteria

1. Have full knowledge on this study and are willing to sign informed consent form (ICF);
2. Age 18-75 years at time of signing ICF, male or female;
3. The investigator judged that the subject is eligible for platinum-based chemotherapy;
4. Presence of histopathologically confirmed unresectable locally advanced (T4, any N; or any T, N2-3) or metastatic urothelial carcinoma;
5. No prior systemic anti-tumor therapy;
6. Subjects who are able to provide tumor tissue slides (≥ 5 slides) for PD-L1 test and the corresponding pathology report and whose PD-L1 test must be positive before randomization;
7. With at least one measurable lesion as per RECIST 1.1 criteria;
8. ECOG performance status score of 0-1;
9. Adequate function of vital organs.

Exclusion criteria

1. Have received anti-tumor treatments, including chemotherapy, radiotherapy or investigational product within 28 days before randomization;
2. Have received traditional Chinese medicines with anti-tumor activity or immunomodulators (eg. Interferon and Interleukin) within 14 days before randomization;
3. Previous use of anti-PD-1/PD-L1 agent or a drug acting on another co-inhibitory T cell receptor;
4. Subjects who are currently participating in or have participated in a study with investigational product within 4 weeks before administration;
5. Having received systemic corticosteroid therapy (dose equivalent to prednisone \> 10 mg/day) within 14 days before randomization;
6. Subjects with active central nervous system (CNS) metastasis;
7. Grade 2 or higher peripheral neuropathy or hearing loss.
Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes

To compare the glucose response in tube fed subjects with type 2 diabetes of a standard enteral product to that of a diabetes-specific enteral product


Eligibility Criteria:
Inclusion Criteria:

* signed and dated informed consent
* diagnosis of type 2 diabetes
* HbA1c between 7.0 and 9.0%
* 18 - 75 years of age
* currently receiving a standard enteral product
* anticipated duration on tube feeding at least one month
* 100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support
* anticipated life expectancy is more than or equal to 6 months
* free of infections
* no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose

Exclusion Criteria:

* composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
* composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
* significant cardiovascular event less than or equal to 2 weeks prior to study entry
* major surgery less than or equal to 2 weeks prior to study entry
* pre-planned surgery during the study period
* active malignancy, including melanoma and excluding cutaneous malignancies
* severe dementia
* known allergies to medical grade adhesives and/or skin disinfectants
* taking octreotide
* chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
* participation in a concomitant trial