cyrilzakka/clinical-trials huggingface dataset:
177Lu-TATE-RGD in Patients With SSTR2 and Integrin αVβ3 Positive Tumors

Researchers has conducted extensive research on the treatment of neuroendocrine tumors with 177Lu-EB-TATE and the treatment of FAP-expressing tumors with 177Lu-EB-FAPI, and some researches have revealed 68Ga-TATE-RGD in imaging studies of neuroendocrine tumors to find that the dual-targeted tracer showed an increasing TBR, suggesting the tracer kinetic advantage of TATE-RGD; compared to the single-target tracer DOTATATE, the dual-target TATE-RGD probe has a clear advantage in detecting liver metastases of NETs, and it can be explored for potential therapeutic uses of TATE-RGD in future studies and used for related companion diagnostics in targeted radioisotope therapy (RLT).

Integrin αvβ3 is highly expressed in certain tumor cells and newly formed blood vessels, making it an ideal target for diagnosis and treatment of integrin αVβ3 positive tumors. 177Lu-TATE-RGD is a novel drug developed independently in China, providing an effective target for the treatment of integrin αVβ3 positive tumors. All patients underwent whole-body 68Ga-TATE-RGD PET/CT screening within one week and received a single intravenous injection of 1.48-3.33 GBq (40-100 mCi) 177Lu-TATE-RGD within one week. Blood samples were collected from the vein in 1-2 mL volumes at 5 minutes, 3 hours, 24 hours, 72 hours, and 168 hours after injection to measure radioactivity. Then, whole-body planar and SPECT/CT imaging was performed at 3, 24, 48, 72, 96, 120, and 168 hours after the injection of 177Lu-TATE-RGD. The in vivo radiation dose of 177Lu-TATE-RGD was analyzed and calculated, and the therapeutic effect and response were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients with clear pathological diagnosis and ineffective or progressing clinical conventional treatment;
* tumor lesions with high SSTR2 and RGD untake confirmed on 68Ga-TATE-RGD PET/CT within one week before the injection of 177Lu-TATE-RGD;
* signed written consent.

Exclusion Criteria:

* the exclusion criteria were a serum creatinine level of more than 150 μmol per liter, a hemoglobin level of less than 10.0 g/dl, a white-cell count of less than 4.0× 109/L, a platelet count of less than 100 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation

Assessment of efficacy and safety UK-390,957


Eligibility Criteria:
Inclusion Criteria:

* Premature ejaculation as defined by DSM-IV

Exclusion Criteria:

* History of erectile dysfunction
Investigate Effects of A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants

The goal of this interventional study is to investigate effects of a2 Full Cream Milk on Breastmilk composition and subsequent Infant gut health, crying frequency and sleep patterns in Healthy Full-term Infants.

50 mothers and thier infants will be enrolled into 2 study sites, mother and her child as one subject will be randomized to 2 groups for assigned interventions, a2 Full Cream Milk and conventional Milk (Weidendorf). The study will continue for 14 days, and 3 site visits will be made duing the study period. All data specified in the protocol will be captured and recorded into CTMS for analysis.

Researchers will compare the two groups of participants to see if a2 Full Cream Milk has significantly better breastmilk composition and improve infant's gut health, crying frequency and sleep patterns.


Eligibility Criteria:
Inclusion Criteria:

* Mothers who are 25 to 45 years old;
* Mothers who are exclusively breastfeeding with healthy and full-term infants;
* Infants of these mothers who have been exclusively breastfed since birth, and their parent(s) decides to continue exclusively breastfeeding until at least 120 days of age, birth weight between 2500g and 4500g;
* Willing to sign ICF before the study launched.

Exclusion Criteria:

* Mothers with infection or have recently taken the flu / covid vaccine in the last 4 weeks;
* Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases that could interfere with the survey;
* Evidence of feeding difficulties or intolerance/allergy to cow's milk (mixed-fed group only);
* Conditions requiring infant feedings other than those specified in the protocol;
* Significant systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastrointestinal, or other); or parental refusal to participate;
* Infants with an acute infection or gastroenteritis at time of enrollment;
* Participation in another clinical trial;
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
CMAB vs IMAB in Metastatic Prostate Cancer

To evaluate the efficacy, safety and survival of two treatment regimens: Continuous Intermittent Maximum Androgen Blockade, using goserelin and bicalutamide in patients with prostate cancer. Primary endpoint is time to progression. Fifteen patients will be evaluated. QoL evaluation is also included.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of D2 of Adenocarcinoma,
* Naivety to treatment
* Valuable bone metastasis

Exclusion Criteria:

* Hematological, liver or renal toxicity Grade IV
* Severe and active infections
Acute Kidney Injury in Septic Critically Ill Patients : Are Aminoglycosides Really Harmful?

The purpose of the present study is to determine whether administration of aminoglycosides in septic critically ill patient is a risk factor for acute kidney injury

Severe sepsis and septic shock despite recent advances in surviving sepsis campaign remain encumbered by a high mortality rate close to 30%. One cornerstone of the management of these patients remains the early and appropriate antibiotic administration, , which must be also active at the site of infection. Aminoglycosides are often administered in combination with beta lactams in this context . According to the progress in pharmacokinetic management achieved over the past decade, their safety and efficiency tended to increase but many uncertainties remain. The purpose of the present study is to determine whether administration of aminoglycosides in septic critically ill patient is a risk factor for acute kidney injury.

Study design: This is an open retrospective monocentric cohort study including septic critically ill patients from november 2008 to january 2010. To determine the incidence and the specific risk of nephrotoxicity of aminoglycosides, only hospitalized patients without initial acute kidney injury or with rapidly improving kidney function during the three first days will be included.Primary outcome will be the occurrence of acute kidney injury assessed with the RIFLE classification (Risk, Injury, Failure, Loss, and End-stage kidney disease) from day 4 to day 15. Patients receiving aminoglycosides will be compared with a control group, i.e. not receiving them. We estimated hazard ratios (HR) and 95% confidence intervals (CI) with adjusted and propensity score (PS)-matched Cox-proportional hazards models.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Admission to ICU with severe sepsis
* Hospitalized and without acute kidney injury or with kidney function improved on the third day were included
* Information provided to the patient or proxy

Exclusion Criteria:

* Renal replacement therapy before day 3
* Patients with renal insufficiency J1 (Day 1 creatinine clearance \<56.25 ml/mn/1, 73m2) but severely altered between Day 1 and Day 3 (creatinine clearance Day 1/ Day 3\> 1 + Day 3 creatinine clearance \<37.5 ml/mn/1, 73m2 ) without renal replacement therapy still necessary before J3
* Prolonged aminoglycosides therapy
Study on the Mechanism of Cognitive Impairment in Patients with Moyamoya Disease

The purpose of this study is to comprehensively evaluate the risk factors for cognitive decline in patients with moyamoya disease, identify imaging target areas associated with cognitive damage in the brain, and explore the changes in brain structure and functional networks resulting from cerebral revascularization, as well as their relationship with cognitive improvement.

Moyamoya disease (MMD) is a chronic occlusive-stenosis cerebrovascular disease that characterized by the stenosis of internal carotid artery termination and the formation of net-like vessel. It is a multifactorial disease caused by genetic, inflammatory, immunological and other environmental factors. The specific pathogenesis of MMD is still unclear. The treatment modalities of revascularization and conservative management have been used in patients with MMD. Due to the long-term low perfusion state of brain tissue, most patients with MMD experience varying degrees of cognitive dysfunction, although the underlying mechanisms remain unclear. We will employ a combination of 256-lead high-density electroencephalography, multimodal magnetic resonance imaging, and biological samples to conduct a comprehensive evaluation of the risk factors associated with cognitive decline in patients with MMD. Our objectives include identifying target imaging areas indicative of cognitive damage in the brain and exploring the structural and functional changes in the cerebral network resulting from revascularization, as well as their relationship with cognitive improvement.

Eligibility Criteria:
Inclusion Criteria:

* The admission cerebral angiography (DSA) examination fulfills the diagnostic criteria for moyamoya disease.
* Please sign the informed consent form.
* Participants must be between 18 and 60 years of age.

Exclusion Criteria:

* Patients with concurrent atherosclerosis, autoimmune diseases, meningitis, brain tumors, Down syndrome, craniocerebral trauma, prior radioactive head irradiation, or hyperthyroidism, which may result in secondary cerebrovascular lesions leading to symptoms associated with smoke syndrome.
* Individuals younger than 18 years or older than 60 years.
* Those with contraindications for magnetic resonance imaging.
* Patients who are unable to complete cognitive brain assessments
Postoperative New-onset Atrial Fibrillation in Cardiac Surgery: DECS-PNAF Project

The DExamethasone for Cardiac Surgery - Postoperative New-onset Atrial Fibrillation (DECS-PNAF) project described in this protocol aims to elucidate how corticosteroids protect cardiac surgical patients from Postoperative New-onset Atrial Fibrillation (PNAF). Patients will be randomized to receive either a single high dose of dexamethasone or a placebo. Continuous ECG-monitoring, echocardiography and biochemical and genomic analyses will be used to investigate the mechanisms responsible for the known protective effect of corticosteroids in the development of PNAF.

Postoperative new-onset atrial fibrillation (PNAF) is a common complication after cardiac surgery, affecting up to 60% of patients. PNAF has been associated with a higher incidence of adverse postoperative outcomes including long-term mortality, and leads to an increased use of resources and higher social costs.

Many studies have investigated potential determinants of PNAF. Established determinants can grossly be divided into inflammatory factors, cardiac functional (echographic) parameters, cardiac electrophysiologic properties and other (demographic) risk factors. Also, a substantial number of studies have investigated pharmacological prophylactic strategies. In these studies, the highest effectiveness has been shown for strategies involving either betablockers, statins and, more recently, corticosteroids.

The DExamethasone for Cardiac Surgery - Postoperative New-onset Atrial Fibrillation (DECS-PNAF) project described in this protocol aims to elucidate how corticosteroids protect cardiac surgical patients from PNAF. The modulating effect of intraoperative prophylactic high-dose dexamethasone administration on the categories of perioperative determinants of PNAF mentioned above will be studied in 164 coronary artery bypass grafting surgery patients. For this, multiple perioperative assessments will be performed using, for example, repeated biochemical assessment of inflammation, genomic analysis of (mainly inflammatory) single nucleotide polymorphisms, continuous electrocardiographic (Holter) monitoring and transesophageal echocardiography.

The DECS-PNAF project is one of the first prospective studies to combine a detailed assessment of multiple categories of PNAF determinants. Moreover, it is unique in studying the effect of prophylactic corticosteroid administration on every one of these determinants.

Eligibility Criteria:
Inclusion Criteria:

* On-pump coronary artery bypass graft (CABG)

Exclusion Criteria:

* age \< 18 years
* preexisting cardiac rhythm disturbances
Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure

We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.


Eligibility Criteria:
Inclusion criteria: Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) \<40%

Exclusion Criteria: Diabetes or HbA1c \>48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent
Post-Approval Study With the KAMRA Inlay

KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye. The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.

This is a post-approval study of the KAMRA inlay performance and potential device-related issues in a broader population over an extended period of time after pre-market establishment of reasonable safety and effectiveness.

Study objectives include:

* Evaluate the long-term performance (effectiveness) and safety of the device;
* Evaluate real-world performance of the device in subjects treated by refractive surgeons with a range of experience levels;
* Evaluate the performance of the device in racial/ethnic subgroups representative of the population for which the device is intended.

In addition, the data from a subset of the first 105 subjects who have been enrolled in this study will be used to validate the KAMRA Inlay Patient Questionnaire (KIPQ) for the assessment of patients who have received the KAMRA inlay for the treatment of presbyopia.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the indications for use for this device;
2. Do not have any of the conditions described in the contraindications in the labeling of the device;
3. Are willing and able to provide informed consent;
4. Are not participating in any other clinical studies during the course of the study.

Exclusion Criteria:

1. Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help; or
2. Subject is not a fluent speaker of U.S. English.
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients

The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of hepatitis B virus (HBV) recurrence following HBV-related orthotopic liver transplant.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* HBsAg-positive candidates for HBV-related liver transplant
* Treatment with antiviral therapy before transplantation as per treating physician's recommendation. (NOTE: It is expected that most patients will receive Lamivudine or Adefovir Dipivoxil pre-transplant. In the case of antiviral resistance, an effective alternative antiviral agent(s) must be used.)

Exclusion Criteria:

* Multi-organ transplantation recipients
* Liver re-transplantation except for primary non-function
* Presence of a hepatoma (larger than 5.0 cm as a solitary node) or 2 to 3 multi-focal nodes (larger than 3.0 cm each) (Milan Criteria) based on information available at baseline visit (CT scan, MRI).
* Patients requiring an OLT (Orthotopic Liver Transplant)due to fulminant hepatitis B
* OLT patients receiving a liver graft from a donor that is positive for HBsAg
* Patients using interferon pre-transplant (as interferon cannot be used post-transplant)
* History of IgA (immunoglobulin A) deficiency
* History of hypersensitivity to blood products.
* HIV or HCV positive
* Use of an investigational product, or participation in another clinical trial during the course of the study (with the exception of quality-of-life or repository studies)
* Pregnancy or planned pregnancy during the course of the study
Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus

The aim of this study was to evaluate the effect of ramipril on the endothelial function and on the number of endothelial progenitor cells (EPCs) in systemic lupus erythematosus (SLE) patients.

The early detection of additional risk factor for cardiovascular diseases (CVD) such as endothelial dysfunction and low number of EPC in SLE patients, and an intervention proven effective could reduce the cardiovascular morbidity and mortality. No study assessed the effect of ramipril on endothelial function and EPCs in SLE patients.

Eligibility Criteria:
Inclusion Criteria:

* SLE according 1997 modified American College Rheumatology criteria
* age older than 18 years
* stable treatment for lupus for at least 3 months

Exclusion Criteria:

* previous coronary artery disease
* hypertension
* dyslipidemia (LDL\>149 mg/dL)
* renal insufficiency (creatinine ≥1.4 mg/dL)
* diabetes
* smoking
* obesity (BMI≥30)
* pregnancy
* menopause
* patients taking statins or angiotensin convertor enzyme inhibitor within the last 6 months
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

M1095-PSA-301 is a Phase 3, multicenter, randomized, parallel-group, double-blind, 3-arm, placebo-controlled study to investigate the efficacy and safety of sonelokimab 60 mg every 4 weeks (with and without an induction regimen) versus placebo in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be ≥18 years of age .
2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
3. Participants have moderate to severe active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.

Exclusion Criteria:

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
3. Participants with a diagnosis of inflammatory bowel disease.
4. Participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
5. Participants who have an established diagnosis of arthritis mutilans.
6. Previous exposure to sonelokimab.
7. Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.
Association of Processing Speed Dysfunction and Brain Functional Abnormality in ECTS

Epilepsy with centrotemporal spikes (ECTS) is the most common epilepsy syndrome in children. Language impairment has been widely investigated in patients with ECTS, but little is known about the cognitive dysfunction of processing speed and its neuroimaging mechanism.

OBJECTIVE To investigate the processing speed dysfunction in patients with ECTS, and the associated brain functional abnormality using functional magnetic resonance imaging (fMRI) and 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET).

DESIGN, SETTING, AND PARTICIPANTS This study prospectively enrolled ECTS patients (n = 28) from June 2019 and June 2021. Twenty age- and gender- matched healthy children and another twenty children with extracranial tumors were enrolled as controls. Patients with ECTS and healthy controls underwent neuropsychological testing and fMRI examination. In addition, ECTS patients and children with extracranial tumors underwent 18F-FDG PET examination.

Eligibility Criteria:
Inclusion Criteria:

* (a) age between 6 and 18 years; (b) 18F-FDG PET examination more than 48 h since the last seizure, (c) no structural abnormalities associated with epilepsy detected on routine MRI

Exclusion Criteria:

* (a) any history of other neurological or psychiatric disorders; (b) pre-scan plasma glucose level \> 120 mg/dl before 18F-FDG PET/CT examination;(c) any contraindications for MRI examination ; (d) head movement (translation \> 3 mm or rotation \> 3 degree ) during MRI examination