cyrilzakka/clinical-trials huggingface dataset:
Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint Expression

The myeloma microenvironment is the target of many drugs in development, and it is unclear how they can be combined with reference treatments such as lenalidomide. This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated MM patients. Blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.

This study will provide rational guidance for future combination therapies with lenalidomide.

With the significant increase in the number of therapeutic combinations targeting the tumour microenvironment, it is crucial to better understand the effect of reference myeloma treatments on the different immune populations present in the tumour in order to rationally optimise the combination with new strategies under development. In addition, the identification of biomarkers in the circulating blood that can predict/monitor the impact of new therapies on the immune response is a major challenge.

This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated MM patients. Blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.

Eligibility Criteria:
Inclusion Criteria:

* Patient with newly diagnosed multiple myeloma;
* Patient not eligible for intensive treatment;
* Patient for whom first-line treatment with Lenalidomide-Dexamethasone will be initiated;
* Patient accepting the performance of an additional myelogram at the end of the 1st treatment cycle.
* Patient aged 18 years or older;
* Patient who has given free, informed and written consent;
* Patient affiliated to a social security scheme
* For women of childbearing age, use of effective contraception

Exclusion Criteria:

* Patient with relapsed multiple myeloma;
* Patient eligible for intensive treatment;
* Patient for whom chemotherapy involves treatment other than Lenalidomide-Dexamethasone;
* Patient with a contraindication to lenalidomide treatment
* Pregnant or breastfeeding woman;
* Person subject to legal protection (safeguard of justice, curatorship,guardianship) or person deprived of liberty.
Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia

This is a prospective, randomized, single-blind trial evaluating prehospital patients experiencing moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5. Patients will be randomized to receive ketamine at or morphine by intravenous push.

This study is designed to evaluate if ketamine alone is non inferior to morphine alone for prehospital analgesia. Numeric rating scale pain scores will be compared between recipients of ketamine and recipients of morphine at 15, 30, 45 and 60 min post first injection and at hospital admission.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old
* prehospital moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5

Exclusion Criteria:

* unstable vital signs (systolic blood pressure \<90 or \>200 mm Hg, pulse rate \<50 or \>150 beats/min, and respiration rate \<10 or \>30 breaths/min)
* pregnancy
* breast-feeding
* altered mental status
* unable to give numeric rating scale scores
* allergy to morphine or ketamine
* acute pulmonary edema
* acute coronary syndrome
* renal or hepatic insufficiency
* patient who received morphine for the same acute pain
* acute psychiatric illness
Visceral Fat Area as a Prognostic Biomarker in Clear Cell Renal Cell Carcinoma: A Multicenter Study on Postoperative Survival

This retrospective study included 1030 patients with clear cell renal cell carcinoma (ccRCC) who underwent radical or partial nephrectomy at Wuhan Union Hospital from 2014 to 2023.


Eligibility Criteria:
Inclusion Criteria:

1. primary clear cell renal cell carcinoma confirmed by histopathology;
2. patients≥18 years;
3. availability of preoperative abdominal computed tomography (CT) data;
4. patients with partial or radical nephrectomy.
Chronic Hemodialysis Without Systemic Heparinization : a Randomized Study

Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. In this setting, several procedures theoretically allow dialysis without systemic heparinization, but randomized studies to compare them are lacking. The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (" rises "). Two emerging procedures are increasingly used : continuous pre-dilution of the arterial line (" pre-dilution ") and the use of a specific dialysis membrane (NEPHRAL 400 ST) coated with heparin immediately before use (" heparin adsorption ").

Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. In this setting, several procedures theoretically allow dialysis without systemic heparinization, but randomized studies to compare them are lacking. The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (" rises "). Two emerging procedures are increasingly used : continuous pre-dilution of the arterial line (" pre-dilution ") and the use of a specific dialysis membrane (NEPHRAL 400 ST) coated with heparin immediately before use (" heparin adsorption ").

We propose a monocentric prospective randomized open study to compare " rises ", " pre-dilution " and " heparin adsorption " in chronic hemodialysis patients with contra-indication to the use of LMWH. Main criteria will be extra-corporeal circuit clotting, with dialysis efficiency and tolerance as secondary criteria. Comparison will be made on grounds of " n-of-1 " trial, i.e. series of randomized cross-over tests in individuals. We have planned to include 75 patients in this study, with 1050 LMWH-free dialysis sessions.

We hope to demonstrate chat by comparison wit rises, pre-dilution and heparin absorption techniques reduce the rate of extra-corporeal circuit by 30 and 50% respectively. We also hope to show that heparin adsorption (i) better preserves membrane integrity throughout the dialysis session, resulting in enhanced dialysis efficiency ; (ii) avoids extra fluid infusion and ultrafiltration, resulting in better dry weigh achievement and better clinical tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patient
* Low molecular weight heparin contra indicated for at least 3 consecutive hemodialysis sessions.

Exclusion Criteria:

* Acute renal failure
* Access flow \< 250 ml/mn)
* Per dialytic Blood transfusion or parenteral nutritional support
* Systolic BP \< 80 mm Hg
* Hemoglobin \> 13 g/dl
An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer

This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes metastasis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically proven invasive breast cancer - the primary tumor size is at least 5cm or cytologically proven axillary node metastasis
2. no evidence of systemic metastasis pathologically or radiologically
3. age at the time of diagnosis between 20 and 70 years
4. patients with previously untreated primary breast cancer including chemotherapy
5. general performance status with ECOG 0-2
6. sufficient hematopoietic function (absolute neutrophil count of ≥ 1,500/mm3, platelet count of ≥ 100,000/mm3, and hemoglobin of ≥ 10 g/dL)
7. sufficient renal function (serum creatinine level of ≤ 1.5 mg/dL)
8. sufficient liver function (total serum bilirubin level ≤ 1.5 times the upper normal limit; serum AST and ALT levels ≤ 1.5 times the upper normal limit; and serum alkaline phosphatase level ≤ 1.5 times the upper normal limit)
9. sufficient cardiac function (normal electrocardiography within 1 month or LVEF\>50% by echocardiography or MUGA scan within 3 months)
10. patients who agree to enroll this clinical trial and sign the written informed consent voluntarily

Exclusion Criteria:

1. patients with evidence of distant metastases
2. patients with other previous malignancy except breast cancer
3. pregnant (positive hCG test 1 week before registration) or lactating patient
4. uncontrolled serious infection
5. patients with psychiatric disease or epilepsy
6. patients with clinically severe cardiac disease within 6 months such as atrial or ventricular arrhythmia, congestive heart failure, myocardial infarction, or unstable angina
7. male breast cancer
8. patients with poor general condition who are not able to understand or sign the written informed consent
Eplerenone in HIV Associated Abdominal Fat Accumulation

The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle modification to affect sugar metabolism, body fat distribution, and cardiovascular health in HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that aldosterone, a hormone that regulates salt and water balance, is increased in association with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals, aldosterone appears to be higher in individuals with increased belly fat, and increased aldosterone appears to be strongly associated with impaired sugar metabolism. In this study, the investigators will test the effects of eplerenone, which is a medication that blocks the actions of aldosterone, along with lifestyle modification. The investigators hypothesize that eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and reduce fat accumulation in liver and muscle.

The study is 12 months long, with two phases. In the initial, 6-month phase, volunteers are randomly assigned to receive either eplerenone or placebo (an inactive pill). In addition, all volunteers will receive counseling about healthy diet and lifestyle, and will be asked to follow guidelines for a healthy level of physical activity. In the second 6-months of the study, all volunteers will continue to receive lifestyle modification and all will receive eplerenone.

Eligibility Criteria:
Inclusion Criteria:

1. Increased waist circumference based on NCEP guidelines (\>102cm in men and \>88cm in women) and impaired glucose tolerance (either IFG \> 100 mg/dL but \< 126 mg/dL or 2hr glucose \> 140 mg/dl but \< 200 mg/dL, or fasting insulin \>12 uIU/mL)
2. HIV positive for 5y and on a stable ART regimen for at least 12 months
3. Age ≥ 30 and ≤ 65 years of age

Exclusion Criteria:

1. ACE Inhibitor, ARB, verapamil, or spironolactone
2. Potassium supplementation
3. Estimated GFR\<60, creatinine \> 1.5 mg/dL
4. Serum K \> 5.5 mEq/L, ALT \> 2.5 times the upper limit of normal, Hgb \< 11g/dL
5. Uncontrolled hypertension (SBP ≥ 160 or DBP ≥ 100)
6. Current or prior steroid use within past 6 months
7. Known history of diabetes mellitus or current use of anti-diabetic medications
8. Concomitant use of full dose ritonavir, nelfinavir, clarithromycin and other strong inhibitors of CYP34A
9. Use of St. John's Wart (CYP3A4 inducer)
10. Pregnant or actively seeking pregnancy, breastfeeding
11. For women: Pregnant or actively seeking pregnancy, breastfeeding, failure to use an acceptable non-hormonal form of birth control, including abstinence, barrier contraceptives, or non-hormonal IUD.
12. Estrogen or progestational derivative use within 3 months
13. Testosterone use for non-physiologic purposes, or physiologic testosterone replacement for \< 3 months.
14. Current growth hormone or growth hormone releasing hormone use
15. Current viral, bacterial or other infections (excluding HIV)
16. Current active substance abuse
17. Patients with a significant history of cardiovascular disease, including prior MI or stroke
Pain Study of Rectus Muscle Closure at Cesarean Delivery

Suture reapproximation of the rectus muscles at primary cesarean delivery is a common practice about which there are no data. Some Obstetricians believe that suture reapproximation of the rectus muscles increases post-operative pain, and it may decrease adhesions, yet there are no published data to support or refute these claims. The purpose of this study is to assess the effect of rectus muscle reapproximation at cesarean delivery and post-operative pain. We also plan to assess the impact of rectus muscle closure on adhesions as seen at repeat cesarean delivery.

There are more than 1 million cesarean deliveries performed annually in the United States, at a rate of 30.2% of all deliveries. Data are limited regarding optimal surgical closure techniques to minimize adhesions at cesarean. Adhesions are implicated in pelvic pain, infertility, difficult repeat surgery, and bowel obstruction. Practice techniques regarding rectus muscle reapproximation vary widely, and there are no data regarding the impact of this step on pain, and some data suggesting a reduction in significant adhesions. Given the frequency of cesarean deliveries, small changes in surgical technique may yield significant benefits.

We hope to learn 1) whether suture reapproximation of the rectus muscles increases pain, and 2) the degree to which suture reapproximation of the rectus muscles alters adhesions when studied in a prospective, randomized trial.

All patients undergoing primary cesarean delivery at Lucile Packard Childrens Hospital (LPCH) will be offered the study. Once consented, patients will be randomized to one of two standardized closure techniques at cesarean: two-layer uterine closure, peritoneal closure, fascial and skin closure, and either reapproximation of the rectus muscles with three-interrupted sutures, or non-closure. Intra-operative and post-operative pain management will be standardized. Subjects will undergo pain assessments while in-house on post-operative days 1 and 3, and at the standard post-partum clinic visit after 6 weeks. These assessments will require less than 5 minutes of the patient's time. Patients will be shown a pain chart, and will be asked to rate their pain on a scale of 0 to 10 at rest. They will then stand up and rate their pain again. Pain medication usage will also be assessed.

The surgeons will know the groups to which the patients are randomized. The patients and those collecting data on pain scores will not.

Primary Endpoint: combined opioid use and movement pain score (Silverman Integrated Assessment-SIA) 72 post-operative hours.

Secondary Endpoint: surgical complications, maternal satisfaction with analgesia.

Eligibility Criteria:
Inclusion Criteria:

37 weeks gestation Primary cesarean American Society of Anesthesiologists (ASA) class 1 or class 2

Exclusion Criteria:

Chronic analgesia use Vertical skin incision at cesarean Opioid or Non-steroidal anti-inflammatory drugs (NSAID) allergy BMI \>40 Labor
Visual Study of Molecular Genotype in Glioma Evolution

The key molecular changes in the progression of glioma are closely related to tumor heterogeneity, pathological grade, precision treatment and prognosis of glioma. At present, a visually quantitative assessment criteria about the key molecular typing of glioma is still absent. Based on the previous research, this project intends to establish a multi-dimensional database of glioma from clinical, radiomics and microomics levels. The investigators aim to filter out the specific molecular markers in the progression of glioma and explore the intrinsic connection of radiomics features and microomics molecular markers by using bioinformatics integration analysis and artificial intelligence multiple kernel learning. Thus, the investigators could determine the specific molecular mechanism in the progression of glioma, and establish a visually quantitative assessment system of pre-operative precisive grading, molecular typing discrimination and prognosis prediction. The completion of this project is of great significance for improving molecular diagnostic level of glioma, guiding individualized diagnosis and treatment decisions, and improving the survival rate of patients.


Eligibility Criteria:
Inclusion Criteria:

1. postoperative pathological and genetic test confirmed brain glioma;
2. The preoperative Clear and complete multimodal imaging data were collected within 10 days.

Exclusion Criteria:

1. patients who underwent surgery more than 4 weeks after MRI;
2. patients with motion artifacts.
Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks

The purpose of this study is to investigate the incidence of intravascular injection during trigeminal nerve blocks.

The patients who already scheduled for trigeminal nerve blocks will be randomized in a 1:1 ratio to tuohy needle group or quincke needle group after being informed about the study.

Eligibility Criteria:
Inclusion Criteria:

* The patients who scheduled to undergo trigeminal nerve block due to the facial pain

Exclusion Criteria:

* Refusal of the patient
* Pregnancy
* Coagulopathy
* Local or systemic infection
* Allergy to injectate
* Anatomical deformation of the skull
Exercise, Rest Breaks and Ergonomics Modification on Fatigue and MSK Discomfort in Static Workstation

The current study examines the effects of exercise, ergonomic modifications, and rest breaks on fatigue and musculoskeletal discomfort during computer tasks. For the purpose of this project, musculoskeletal discomfort is defined as a constellation of signs and symptoms that include muscle tension, paresthesia, pain, and/or physical strain in soft tissues and bones.

Static workstation workers frequently experience musculoskeletal discomfort which, according to a survey of the literature, may include muscle tension, muscle fatigue, paresthesia, pain, and/or physical strain in soft tissues and bones. The incidence of musculoskeletal discomfort in office workers like computer users is as high as 50%. In various studies on static workstation workers, musculoskeletal discomfort has been reported, either separately or in aggregate, in the neck, shoulders, elbows, wrists, hands, back, legs, buttocks, ankles, feet, and chest.

The current study examines the effects of exercise, ergonomic modifications, and rest breaks on fatigue and musculoskeletal discomfort during computer tasks. For the purpose of this project, musculoskeletal discomfort is defined as a constellation of signs and symptoms that include muscle tension, paresthesia, pain, and/or physical strain in soft tissues and bones.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Age: 25-45 years
* Those static workstation office workers using a computer for at least 6 hours per day.
* Static workstation office workers screened by ROSA.

Exclusion Criteria:

* Discomfort from non-musculoskeletal origin
* Recent history of trauma and receiving any kind of treatment for the current condition
* Severe orthopedic disease
* Any mental and physiological illness that could interfere in the exercise
Effects of Postconditioning On Myocardial Reperfusion

The purpose of this study is to investigate the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction.


Eligibility Criteria:
Inclusion Criteria General Inclusion Criteria

* Subject must be at least 18 years of age.
* Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving postconditioning and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
* Diagnosis of STEMI

  1. presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
  2. ST-segment elevation more than 1 mm in at least 2 contiguous leads

Angiographic Inclusion Criteria

* Target lesion(s) must be located in a native coronary artery
* Target lesion(s) must be amenable for percutaneous coronary intervention
* TIMI flow grade of infarct related arteries \<2

General Exclusion Criteria

* Patients with hemodynamic instability or those with cardiogenic shock
* Target lesion is located in left main stem
* Rescue PCI after thrombolysis or facilitated PCI
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
CCFZ533X2201 - PoC Study in de Novo Renal Transplantation

The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Recipients of a kidney transplant from a heart-beating deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.
* Recipients of a kidney with a cold ischemia time (CIT) \< 30 hours.

Main Exclusion Criteria:

* Recipients of an organ from a non-heart beating donor.
* ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
* Subjects receiving a second kidney allograft, unless the first allograft was lost due to surgical complication.
* Subjects at high immunological risk for rejection
* Subjects at risk for tuberculosis (TB)
* Subject with severe systemic infections, current or within the two weeks prior to randomization/enrollment.
* Any additional contraindication to the use of tacrolimus or mycophenolate mofetil according to the national labeling information of these products (see local product label).