cyrilzakka/clinical-trials huggingface dataset:
Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy

99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan.

The investigators want to set up this study in analogy with the comparison study which was conducted before the introduction of ICG-99mTc-Nanocolloid (99mTc-Nanocoll vs. ICG-99mTc-Nanocoll (NL26699.031.09 -N09DRF). In particular, the investigators want to validate that the hybrid ICG-99m Tc-Nanoscan shows the same preoperative gland involvement on preoperative lymphoscintigraphy and that the intraoperative signal intensities remain the same. All this to maintain the level of current care.

Eligibility Criteria:
Inclusion Criteria:

* Patient who will undergo a sentinel node procedure in routine care.
* Patients \> 18 years;
* Patients presenting with:
* a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities;
* OR patients presenting with a primary oral cavity malignancy T1-2N0
* OR patients with primary penile cancer
* Patients with clinical N0 stage;
* Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion;
* Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting

Exclusion Criteria:

* Patients with known allergy to patent blue dye or nanocolloid;
* Patients who are pregnant or breast-feeding mothers;
* History of hypersensitivity reactions to products containing human serum albumin;
* History of iodine allergy
* Hyperthyroid or thyroidal adenoma
* Kidney insufficiency
* Incapacity or unwillingness of participant to give written informed consent;
Management of Postoperative Pain Following Total Knee Arthroplasty by Using Acupuncture-moxibustion Therapy

Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage following major orthopedic surgery often involves a large, deep incision with considerable tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical costs.

We design a prospective randomized study for postoperative pain control following total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed for surgery of osteoarthritis of knee
* ability to tolerate surgery under general anesthesia.

Exclusion Criteria:

* refusal or the lack of mental ability to provide informed consent
* neuropathic pain or sensory disorders in the leg requiring surgery
* previous surgery of the knee joint
* coagulation abnormalities
* chronic opioid users
* known history of intolerance to acupuncture-moxibustion therapy
Biological Evolution of Whipple's Disease (WHIP)

Whipple's disease (WD), a rare systemic infection by Tropheryma whipplei, lacks research on biological abnormalities pre- and post-treatment. This study explores these abnormalities for their diagnostic and monitoring value.

Whipple's disease (WD) is a rare systemic infection caused by \*Tropheryma whipplei\*. Despite advancements in diagnosis through PCR and biopsy, there is limited research comparing biological abnormalities before and after treatment. This study aimed to characterize these abnormalities and evaluate their potential for aiding in diagnosis and monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one positive PCR test for Whipple's disease and a retained diagnosis at Brest University Hospital between 2010 and 2024
* Major patient

Exclusion Criteria:

* Minors
* No screening test for Whipple's disease
* Opposition to participation
* Protected patients
Exercise Training in Obesity-prone Black and White Women

Overweight premenopausal Black and White women are randomized to either diet-only, diet+aerobic or diet+resistance exercise training. Diet/behavior intervention, with or without the aerobic or resistance exercise training, will be provided throughout the 18 months of study. Major outcomes will include measures of perceived and physiologic difficulty of exercise (cardiac, ventilatory, electromyographic responses to standardized exercise tasks); aerobic fitness; strength fitness; and spontaneous free-living energy expenditure (all derived from doubly labeled water). The results will provide insight into the effectiveness of, and the mechanisms by which, different types of exercise training can improve physical fitness, spontaneous engagement in physical activities of daily living and, in turn, weight-loss maintenance.

Overweight premenopausal Black and White women are randomized to either diet-only, diet+aerobic or diet+resistance exercise training. Diet/behavior intervention, with or without the aerobic or resistance exercise training, will be provided throughout the 18 months of study. Major outcomes will include measures of perceived and physiologic difficulty of exercise (cardiac, ventilatory, electromyographic responses to standardized exercise tasks); aerobic fitness; strength fitness; and spontaneous free-living energy expenditure (all derived from doubly labeled water). The results will provide insight into the effectiveness of, and the mechanisms by which, different types of exercise training can improve physical fitness, spontaneous engagement in physical activities of daily living and, in turn, weight-loss maintenance.

Time of initial weight loss was defined as the time needed to reach the goal of 25 kg/m2 BMI. The women will then be evaluated one year after this time and the amount of weight gain will be determined.

Eligibility Criteria:
* Normoglycemic
* BMI between 27-30
* Non smoker
* Premenopausal
* Physically untrained
* Family history of obesity
Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention

The DROP study is a prospective, multi center, randomized, open-label trial to test the efficacy and safety of extended catheter pericardial drainage in patients with non-malignant pericardial effusions.

The trial will compared the efficacy and safety of pericardiocentesis alone compared with extended pericardial catheter drainage for the prevention of recurrent effusions in patients with non-malignant pericardial effusions requiring intervention.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* pericardial effusion requiring pericardiocentesis
* non-malignant etiology

Exclusion Criteria:

* known neoplastic etiology
* known bacterial etiology
Natural Killer (NK) Cell Therapy Targeting CD33 in Acute Myeloid Leukemia

This is an open-label, Phase I study of QN-023a (allogeneic CAR-NK cells targeting CD33) in relapsed/refractory Acute Myeloid Leukemia (AML).

The clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-023a in patients with relapsed/refractory AML,where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 19 patients will be enrolled.


Eligibility Criteria:
Key Inclusion Criteria:

* Provision of signed and dated informed consent form (ICF)
* ≥18 years old
* Diagnosis of r/r AML
* Subjects with CD33 positive leukemia cells
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Adequate organ function as defined in the protocol
* Donor specific antibody (DSA) to QN-023a: MFI \<= 2000

Key Exclusion Criteria:

* Allergic to drug used in this study
* Accept other anti-tumor drugs/therapies within certain time of day 0 (first QN-023a dose infusion), time window and drug defined in the protocol.
* received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy
* Acute Promyelocytic Leukemia (APL)
* Central nervous system Leukemia.
* Uncontrolled, active clinically significant infection
* Clinically significant cardiovascular disease as defined in the protocol
* Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
* History of central nervous system (CNS) disease such as stroke, epilepsy.
* Females are pregnant or lactating
* Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
Prediction of the Spontaneous Breathing Test Success Using Biosignal and Biomarker in Critical Care Unit by a Machine Learning Approach

Context:

Several authors have been interested in applying Artificial Intelligence (AI) to medicine, using various Machine Learning (ML) techniques: managing septic shock, predicting renal failure... \[1, 2\] AI has an important place in decision support for clinicians \[3\]. The weaning period is a really important time in the management of a patient on mechanical ventilation and can take up to half of the time spent in intensive care unit. The first weaning attempt is unsuccessful in 20% of patients However, mortality can be as high as 38% in patients with the most difficult weaning \[4\]. Only a few studies have looked at the application of machine learning in this area, and only one has looked at the use of biosignals (cardiac rate, ECG, ventilatory parameters...) \[5-7\]. To improve morbidity, mortality and reduce length of stay, it is essential to be able to predict the success of the spontaneous breathing test and extubation.

Investigators propose to develop a predictive algorithm for the success of a ventilatory weaning test based on biosignal records and others features.

Methods:

It is a critical care, oligo-centric and retrospective study the investigators included biosignal variables extracted from the electronic medical record, such as respiratory (RR, minute volume...), cardiac (systolic pressure, heart rate...), ventilator parameters and other discrete variables (age, comorbidity...). Most biosignal variables are minute-by-minute records. Recording starts 48 hours before the test and stops at the start of the weaning test. The investigators extracted features from these records, combined them with other biomarkers, and applied several machine learning algorithms: Logistic Regression, Random Forest Classifier, Support Vector Classifier (SVC), XGBoost, and Light Gradient Boosting Method (LGBM)...


Eligibility Criteria:
Inclusion Criteria:

* Computerized health report (CHR)
* Spontaneous breathing test should have been performed

Exclusion Criteria:

* Spontaneous breathing test has not been performed,
* Biosignal (cardiac, respiratory) are not registered in the CHR
* Patient died before the spontaneous breathing test
* Opposition to the study has been expressed.
Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment

Patient with Tetralogy of Fallot need live-long surveillance after initial operative correction (rTOF). MRI is an established and important component of the standardized follow-up in this patient population. A new score will be used to summarize the multitude of MRI-based parameters into a single number. Individual modificators are assigned to the components of the score. The value of each modificatory will be determined as a result of this feasibility trial. This new compound score is designed to anticipate any deterioration of cardiac function, arrhythmias or sudden cardiac death. This feasibility study is the first step to establish this score and find initial values for the modifies that are assigned to the more than 40 biomarkers from MRI, clinical examinations and serum parameters that are included in this new score.

Patient with Tetralogy of Fallot need live-long surveillance after initial operative correction (rTOF). MRI is an established and important component of the standardized follow-up in this patient population. Though a large number of diverse MRI-derived parameter have been shown to correlate with the incidence of major adverse cardiac events in patients with rTOF, there is not a single MRI-derived parameter that reliably predicts the incidence of heart failure, malignant arrhythmias or sudden cardiac death - the most common major adverse cardiac events in this group (rTOF-MACE). This feasibility trial is set to evaluate the feasibility of a weighted compound risk score based on about 40 parameters derived from MRI and augmented by clinical as well as serum-based biomarkers. This trial will recruit 70 consecutive patients with rTOF and correlate the new compound score with the clinical course over 2 years and the incidence of any change in therapy due to cardiac reasons. At the end of the trial each of the contributing parameters of the compound score will have been assigned a modifier based on its statistical relevance for the prediction of patient-specific rTOF-MACE or any change in cardiac related therapy. Based on this feasibility trial we aim to use the weighted compound score in a large multicenter trial to proof its applicability and relevance to short, medium and longterm prognosis of this special patient group.

Eligibility Criteria:
Inclusion Criteria:

* rTOF; age above 16; eligible for MRI-exam

Exclusion Criteria:

* any contraindications to MRI; unstable patient; unresponsive patient
An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone

This was an open label, randomized, single dose, three period crossover pharmacokinetic study of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub groups (Group 1, n=18 and Group 2, n=12).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers between 18 and 60 years of age, inclusive (at screening).
* Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m))2.
* Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the start of the study. The parameters measured included those shown in Appendix 3 of the Study Protocol.
* Subjects with a negative urinary drugs of abuse screen (including alcohol), determined within 14 days of the start of the study.
* Subjects with negative HIV and Hepatitis B and C results.
* Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study.
* Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
* Subjects and sexual partners must have used effective contraception methods during the trial and for 3 months after the last dose, for example:

  * Oral contraceptive + condom
  * Intra-uterine device (IUD) + condom
  * Diaphragm with spermacide + condom
* Subjects must have been available to complete the study.
* Subjects must have satisfied a medical examiner about their fitness to participate in the study.
* Subjects must have provided written informed consent to participate in the study.

Exclusion Criteria:

* A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
* Receipt of regular medication within 14 days of the first study day (including high dose vitamins, dietary supplements or herbal remedies).
* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
* A clinically significant history of previous allergy / sensitivity to Hydrocortisone.
* A clinically significant history of drug or alcohol abuse.
* Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
* Participation in a New Chemical Entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks.
* Subjects who had consumed more than 2 units of alcohol per day within seven (7) days prior to the first dose or had consumed any alcohol within the 48 hour period prior to the first dose.
* Donation of 450ml or more blood within the previous 12 weeks.
* Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).
Monocytosis and Culprit Vessel in STEMI Patients

Increased white blood cell count at the onset of an acute ST elevation myocardial infarction has been shown to be associated of increased incidence of heart failure and mortality. Now monocytes which are a subset of white blood cells may have a prognostic value for patients presenting with acute ST segment elevation myocardial infarction. A monocyte count of greater than 800/mm3 following acute myocardial infarction has been shown to be associated with increased incidence of left ventricular dysfunction. The investigators study would retrospectively collect data on patients with ST elevation myocardial infarction, looking for an association between high monocyte count and the culprit vessel causing the myocardial infarction. The investigators would also investigate whether monocytosis would be a marker of poor prognosis.


Eligibility Criteria:
Inclusion Criteria:

* STEMI

Exclusion Criteria:

* Patients on antibiotics and steroids
Neoadjuvant SLOT Versus SOX in Patients With Locally Advanced, Resectable Gastric/Esophagogastric Junction (EGJ) Cancer

gastric cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the 5-year survival of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer.

Two arms, phase 3 study of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer. 380 Patients will be enrolled in this trial. The primary objective of this study is to determine the 5-year survival of the two arms.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven gastric or GE junction adenocarcinoma;
* Age: 18 to 70;
* ECOG 0-2;
* Adenocarcinoma of the stomach or GE junction according to staging classification TNM Scannographic: T3-4 N0/N + M0 ;
* Completion of baseline quality of life questionnaire
* Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl);
* Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
* liver functions (serum bilirubin ≤ 1.5UNL, AST/ALT ≤ 3 times(normal value)
* Written informed consent

Exclusion Criteria:

* Previous chemotherapy;
* Active infection requiring antibiotics
* Pregnant, lactating women
* Psychiatric illness, epileptic disorders
* Concurrent systemic illness not appropriate for chemotherapy
* History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
Comparison of Caudal Block Combined With General Anesthesia and Penile Block and Intravenous Fentanyl in Pediatric Surgeries

Urogenital surgery is one of the most frequently performed surgical procedures in the pediatric patient population. There is no consensus on which analgesic method is most effective for pain control in these patients. In clinical practice, if there are no contraindications, caudal block or penile block combined with intravenous fentanyl can be preferred as an analgesic method.

In this study, the results of these two analgesia methods will be compared with the research.Randomly selected participants will be compared by looking at parameters such as postoperative questionnaire results, walking time and urination time.


Eligibility Criteria:
Inclusion Criteria:

* 4 months - 12 years old male patient
* Acceptance of participation in the study
* Patients Planned for Urogenital Surgery
* ASA I-II Patients

Exclusion Criteria:

* \<4 months, \>12 years male patient
* Female patient
* Not accepted to be included in the study
* ASA status III-IV
* History of bleeding disorder
* Spinal cord disease
* Obstructive sleep apnea
* Developmental delay
* Behavioral disorder
* Allergy to any drug in the protocol
UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy

To compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival. Secondary endpoints are overall survival and tolerance. A total of 200 patients will be included.


Eligibility Criteria:
Inclusion Criteria:

* metastatic breast cancer
* objective response or stabilisation after 6 to 8 cycle of a first line chemotherapy
* time period between the end of chemotherapy and randomization \< 4 weeks
* age over 18 years
* Performance status (OMS) \< 2.
* Life expectancy \> 3 months
* Biological criteria before randomization: Neutrophiles \> 1.5 x 109 G/L; Pl. \> 100 x 109 G/L; Hb \> 10 g/dl; Creatininemia \< 1,5 UNL; Bili. \< 2 UNL; Transaminases \< 2,5 UNL; Alcalines Phosphatases \< 2,5 UNL
* Signed written informed consent

Exclusion Criteria:

* Metastatic breast cancer having received more than one chemotherapy line.
* Tumor progression under chemotherapy
* Free interval between primary tumor and metastases \> 5 years, with estrogen receptors and without visceral metastases
* Free interval between primary tumor and metastases \< 18 months after adjuvant chemotherapy if first lime chemotherapy only led to a tumor stabilization
* Concomitant hormonotherapy
* Other cancer
* Symptomatic brain metastases
* Any uncontrolled severe disease except breast cancer (especially cardiac failure with LVEF \< 50% or coronary insufficiency
* Psychiatric disorder
* Other concomitant trial
* Male patient
* Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
* History of high dose chemotherapy with bone marrow transplantation