cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer

This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced/unresectable or metastatic breast cancer
* Eighteen years of age or above
* Able to understand and sign an informed consent (or have a legal representative who is able to do so)
* Measurable disease according to RECIST v1.1
* ECOG Performance Score of 0 or 1
* Adequate bone marrow, hepatic, renal and cardiac function
* Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-302

Exclusion Criteria:

* Patients for whom potentially curative anticancer therapy is available
* Active infection or fever \> 38.5°C during screening visits or on the first scheduled day of dosing
* Symptomatic CNS disease
* Known hypersensitivity to any of the components of MM-302 or who have had hypersensitivity reactions to fully human monoclonal antibodies
* Received other recent antitumor therapy
* Pregnant or breast feeding
* Patients with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
The INFUSE Trial - Intervening With Platelet Transfusions in Sepsis

Sepsis is life-threatening and dysregulated response to infection that results in endothelial activation and dysfunction that leads to systemic microvascular leak and multiple-organ failure. This study will identify patients that have sepsis with thrombocytopenia and randomize them to receive a unit of platelets or an equivalent volume of saline.

Sepsis is life-threatening and dysregulated response to infection that results in endothelial activation and dysfunction that leads to systemic microvascular leak and multiple-organ failure. Emerging evidence indicates that platelets occupy a central role in maintaining the balance between vascular health and the response to environmental changes and vascular injury. Platelets are essential for vascular development and required for normal endothelial integrity. Platelets also function at the interface between thrombosis and inflammation. This study will identify patients that have sepsis with thrombocytopenia and randomize them to receive a unit of platelets or an equivalent volume of saline.

Our overall hypotheis is that normal platelet function is required to maintain vascular integrity and can be at least partially restored over the first 24 hours by platelet transfusion in septic patients with thrombocytopenia.

Eligibility Criteria:
Inclusion Criteria

* Provision of informed consent prior to any study specific procedures
* Female and/or male, age \>18 years
* Diagnosis of sepsis based on the Third International Consensus Definitions for Sepsis and Septic Shock
* Platelet count ≤ 50,000/μL

Exclusion Criteria

* Active major bleeding requiring blood transfusion
* Other causes of thrombocytopenia such as idiopathic thrombocytopenic purpura, high clinical suspicion for heparin-induced thrombocytopenia (or other form of consumptive coagulopathy).
IL-6: A Marker for AML Chemo Sensitivity

Acute myeloid leukemia (AML) is a clonal malignancy that arises from the primitive hematopoietic cells within the hematopoietic system. According to SEER cancer statistics, the 5-year survival rate for AML patients stands at a concerning 30%. Despite therapeutic advancements, the development of chemotherapy resistance and the risk of disease relapse pose significant barriers to curative outcomes. Evidence has linked elevated interleukin-6 (IL-6) levels in plasma and bone marrow to a poorer prognosis in AML, with IL-6 potentially fostering chemotherapy resistance through the enhancement of fatty acid uptake and the induction of stromal-like morphological changes in AML cells. However, the role of IL-6 as a potential biomarker for monitoring chemotherapy sensitivity in AML has not been fully elucidated. This study seeks to investigate the correlation between IL-6 levels in bone marrow supernatant and the sensitivity to chemotherapy, offering a clinical perspective that could pave the way for improved prognostic markers and personalized treatment strategies.

In this prospective study, we will collect bone marrow supernatant samples from patients diagnosed with Acute Myeloid Leukemia (AML) to evaluate the levels of Interleukin-6 (IL-6). Our aim is to explore whether elevated IL-6 levels can serve as a predictive biomarker for poor treatment outcomes following standard chemotherapy regimens. The findings may help in stratifying patient risk and personalizing therapeutic approaches in AML treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis aligns with the "Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia (not APL) (2023)";
2. All patients are experiencing their first onset of the disease and have not received any related chemotherapy prior to the study;
3. Patients participate in the study accompanied by family members and sign informed consent documents.

Exclusion Criteria:

1. Patients with concurrent malignancies requiring treatment;
2. Presence of infectious diseases, including SARS, viral hepatitis, or HIV/AIDS;
3. Major surgery performed within the last 21 days;
4. Performance Status (PS) score \>3;
5. Severe liver or kidney dysfunction or serious infection;
6. Severe psychiatric conditions that impair understanding of the study protocol or voluntary withdrawal.
Method Study: Bilateral TAP Block With 24 Hours Infusion

The purpose of this method study in healthy volunteers is to determine the extent of sensory block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block and the influence on the lung function.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 30 years
* written consent
* ASA 1
* BMI between 18 and 25
* males

Exclusion Criteria:

* unable to communicate in Danish
* relevant drug allergy
* alcohol or/and drug abuse
* daily intake of prescription pain medication the last 4 weeks
* pain medication in the last 48 hours
* previously operated abdominal
A Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Participants

The primary objective of the study is to evaluate the pharmacokinetics (PK) of AMG 510 administered as 8 x 120-mg tablets and as water dispersion in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects or healthy female between 18 and 55 years of age (inclusive) at the time of Screening.
* Body mass index between 18 and 30 kg/m2 (inclusive) at the time of Screening.
* Females of nonchildbearing potential

Exclusion Criteria:

* History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
* Inability to swallow oral medication or history of malabsorption syndrome.
* Poor peripheral venous access.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
The Robot-Assisted Laparoscopic Radical Prostatectomy Combined Anterior and Posterior Approach

The goal of this observational study was to compare the perioperative outcomes, postoperative urinary control rates and positive surgical margin (PSM) rates of the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach (AP-RARP) with the Retzius-sparing approach (RS-RARP) and anterior approach (anterior-RARP) in the treatment of prostate cancer. The main question it aims to answer was:

• The early therapeutic efficacy of the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach

Participants has been underwent:

* AP-RARP
* RS-RARP
* anterior-RARP Researchers compared the three groups to see if AP-RARP combines the advantages of anterior and posterior RARP and is a feasible surgical option for the treatment of prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* pathologically diagnosed with prostate cancer by prostate biopsy
* underwent robot-assisted laparoscopic surgery
* the surgery performed by Weidong Gan
* the extended pelvic lymphadenectomy (PLA) is performed on patients with high-risk prostate cancer (PSA≥20 ng/ml or Grade Group 4-5 or clinical stage ≥T2c) and those considered to have a possibility of lymph node metastasis based on imaging evaluation.

Exclusion Criteria:

* Patients with a clinical and pathological TNM stage ≥T3b and N1
* patients with distant metastasis
* urinary incontinence before surgery
* received neoadjuvant therapy before surgery
Comparative Assessment of Adjuvant Effect of Cultured Epidermal Autografts Versus Skin Allografts on Wound Healing of Burns Treated With Widely Expanded Skin Autograft Using Meek Micrografting Technique MEEKADEAU

The investigators intend to conduct a comparative, monocentric prospective double-blind study with intra-subject randomization, to compare the results on wound healing of 2 adjuvant treatments to Meek micrografting technique : Cultured Epidermal Autografts and cryopreserved skin allografts.

10 patients presenting burn wounds over 50% of total body surface area, including at least 40 % of deep burns, will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 18 to 60 years of age
2. Burns \> 50% Total Body Surface Area (TBSA), including deep burns \> 40% TBSA (deep partial thickness and full thickness burns).
3. Patients presenting two 300 cm² (30x10cm) non adjacent burn wound areas, of similar depth assessed by Laser Doppler Imaging, on body anterior side, functional areas excepted.
4. Written informed consent, signed by patient or legal representative (if patient unable to sign).
5. Negative pregnancy test

Exclusion Criteria:

1. Chemical or electric burns
2. Short delay life threatening disease, by itself or when associated with burns.
3. Chronic systemic steroïd intake,
4. Pre-existing diseases interfering with wound healing : inherited connective tissue disorder (Ehlers Danlos syndrome, Marfan syndrome), Epidermolysis Bullosa. Medical treatment interfering with wound healing (retinoids..).
5. Prisonners
6. Pregnant women
7. Patient under guardianship.
8. Participation in another investigational trial within this trial
The FAVOR II China Study

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. The purpose of the FAVOR II China study is to evaluate the diagnostic accuracy of on-line QFR with FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies between online QFR and online QCA, with FFR as the reference standard.

Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography. Lesions are often quantified by QCA, but fractional flow reserve is increasingly used to assess functional significance of identified stenosis. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during medical induced maximum blood flow (hyperemia).

The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy in many centers but the need for interrogating the stenosis by a pressure wire, the cost of the wire, and the drug inducing hyperemia limits more widespread adoption.

QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two angiographic projections. The FAVOR Pilot study (Tu et al.) showed promising results for core laboratory QFR analysis in selected patients. However, the accuracy of QFR when assessed online in the catheterization laboratory is unknown. The purpose of the FAVOR II China study is to evaluate the diagnostic accuracy of on-line QFR with FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies between online QFR and online QCA, with FFR as the reference standard. It is a prospective and multi-center trial with a total of 308 patients conducted at 5 Chinese centers.

Eligibility Criteria:
Inclusion Criteria:

General Criteria:

* Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI
* Age \> 18 years
* Able to provide signed informed consent

Angiographic inclusion criteria:

* At least one stenosis with diameter stenosis of 30%-90% by visual estimate
* Reference vessel size \> 2 mm in stenotic segment by visual estimate

Exclusion Criteria:

General Criteria:

* Ineligible for diagnostic intervention or FFR examination
* Myocardial infarction within 72 hours
* Severe heart failure (NYHA≥III)
* S-creatinine\>150µmol/L or GFR\<45 ml/kg/1.73m2
* Allergy to contrast agent or adenosine
* Factors that might substantially impact the angiographic image quality, e.g, frequent atrial premature beat or atrial fibrillation

Angiographic exclusion criteria:

* The interrogated stenosis is caused by myocardial bridge
* Ostial lesions less than 3 mm to the aorta
* Side branches of the bifurcation lesions with Median Classification of 111 or 101
* Poor angiographic image quality precluding contour detection
* Severe overlap of stenotic segments
* Severe tortuosity of target vessel
IVUS Guided PCI in Patients With Chronic Kidney Disease

The incidence of contrast-induced nephropathy (CIN) is high (\> 25%) in patients with severe chronic renal disease (CKD) who undergo a percutaneous coronary procedure.

The development of CIN is a factor of poor prognosis and is associated with the occurrence of irreversible CKD, the need for dialysis, increased length of stay and hospital costs as well as the risk of death. There is no specific treatment for N-PCI, so its prevention is essential. Although many studies have been conducted to identify, compare and implement different pharmacological strategies for the prevention of CIN before percutaneous coronary procedurse, few per-procedural strategies have been studied to prevent this risk.

Intracoronary ultrasound (IVUS) is an essential tool, used routinely to guide percutaneous coronary procedures thanks to ultrasound, it does not require the injection of iodine contrast.

The main objective is to show that an IVUS-guided "zero-contrast" coronary angioplasty strategy in patients with severe renal impairment decreases the incidence of CIN within 72 hours of procedure.

The incidence of contrast-induced nephropathy (CIN) is high (\> 25%) in patients with severe chronic renal disease (CKD) who undergo a percutaneous coronary procedure.

The development of CIN is a factor of poor prognosis and is associated with the occurrence of irreversible CKD, the need for dialysis, increased length of stay and hospital costs as well as the risk of death. There is no specific treatment for N-PCI, so its prevention is essential. Although many studies have been conducted to identify, compare and implement different pharmacological strategies for the prevention of CIN before percutaneous coronary procedurse, few per-procedural strategies have been studied to prevent this risk.

Intracoronary ultrasound (IVUS) is an essential tool, used routinely to guide percutaneous coronary procedures thanks to ultrasound, it does not require the injection of iodine contrast.

The main objective is to show that an IVUS-guided "zero-contrast" coronary angioplasty strategy in patients with severe renal impairment decreases the incidence of CIN within 72 hours of procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Indication for PCI
* Chronic kidney disease with creatinine clearance ≤ 30 mL/min/1.73m²
* Feasibility of IVUS determined by 2 trained interventional cardiologist
* Affiliated to social security

Exclusion Criteria:

* Iodine contrast injection in the previous 72 hours
* Known allergy to iodine contrast
* Permanent dialysis
* Chronic total occlusion
* Hemodynamic instability
* Legal protection
* Pregnant of breastfeeding patients
* Patients on "AME"
Bioenergetic Alterations After Exenatide Administration

The purpose of this study is to find out how exenatide causes weight loss. Specifically, the study is assessing how exenatide may change how people take in energy (energy intake), as well as how it may effect how people use energy (energy expenditure).

The bioenergetics study is looking at how and why the diabetes drug exenatide causes people to lose weight.Bioenergetics is the study of how your body burns calories.

Adults 18-65 who do not have diabetes and have a body mass index (BMI) between 30 and 40 may be eligible. Women who could get pregnant must be on birth control during the study and women who are pregnant cannot participate in the study.

Subjects will take exenatide for 12 weeks. There are 6 study visits in the Univ. Wisconsin Hospital General Clinical Research Center. Visits range from 1 to 6 hours and include blood and urine tests, resting metabolic rate testing over a four hour period, physical exam, ECG, and a be bone mineral density testing at another clinic during 2 clinic visits of the study.

All study procedures and testing are free of charge.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* BMI between 30 and 40 kg/m2
* Women with a negative pregnancy test at baseline, who are sterile, using contraceptives or in a committed relationship with someone who is sterile or using contraception
* Absence of weight change greater than 3 kg in the previous 6 months

Exclusion Criteria:

* Women who are pregnant or lactating
* Current or recent (6 months) enrollment in a commercial or self prescribed weight loss or exercise program
* Use of weight loss medication
* A history of metabolic disease i.e. renal, endocrine, hepatic or gastrointestinal disease that would impact the outcome of the study
* Presence of medical conditions that are known to affect energy expenditure (i.e. hyperthyroidism, rheumatoid arthritis, AIDS among others)
* History of hypoglycemia
* A history of psychiatric or eating disorder
* Abnormal EKG
* Previous history of pancreatitis
* Previous history of gastroparesis or GI motility disorder
* Use of medications that can affect GI motility
* History of organ transplantation
* Other comorbid conditions which may preclude the subject's ability to complete the study
* Use of a carbonic anhydrase inhibitor such as acetazolamide
Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy

The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status.

This is an open label, multicentre phase II trial of individually escalated radiotherapy up to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same chemotherapy. There are restrictions due to lung function, performance status and pre-treatment weight loss. The main endpoint is progression free survival and additional endpoints are local control, overall survival, toxicity quality of life and relapse pattern.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of NSCLC stage IIIA-B.
* Nonresectable or medically inoperable patients.
* No prior chemo- or radiotherapy for NSCLC.
* PS 0-1.
* FEV1 \> 1 l or \> 40% and CO diffusion capacity \> 40%.
* Patient compliance and geographic proximity that allow adequate follow-up.
* Adequate bone marrow reserve: WBCC \>3.0, platelets \>100, haemoglobin \> 100.
* Written informed concent.
* Effective use of contraception.

Exclusion Criteria:

* Excessive weight loss within 6 months (\> 10%).
* Supraclavicular nodes.
* Apical tumors-pancoast.
* T4 tumors with separate manifestations in different lobes.
* Evidence of active serious infections.
* Inadequate liver function.
* Inadequate kidney function.
* Pregnancy.
* Breast feeding.
* Serious concomitant systemic disorder.
* Second primary malignancy the last 5 years.
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).


Eligibility Criteria:
Inclusion Criteria:

* The subject is not of childbearing potential and signed informed consent.
* Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.

Exclusion Criteria:

* The subject was previously included in this study.
* The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).
* The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence.
* The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.
* The subject has gross haematuria.
* The subject has a history of porphyria.