cyrilzakka/clinical-trials huggingface dataset:
Impact of Electrolyte Intake (Sodium, Phosphorus) on the Growth of Premature Newborns

Extrauterine growth restriction (EUGR) is a common complication in the medical management of premature newborns. The long-term consequences of EUGR are weight and height restriction, metabolic disorders, and neurodevelopmental disorders. The main risk factor for EUGR is nutritional deficiency, particularly protein and energy. Additionally, appropriate intakes of electrolytes, particularly sodium and phosphorus, are essential to promote harmonious growth. Adequate sodium intake is essential to ensure satisfactory growth, especially in premature babies due to their higher body water content. Adequate phosphorus intake is also essential because of its involvement in the formation of lean mass, with sufficient protein intake, and in phosphocalcic metabolism.

At the Regional University Maternity of Nancy, parenteral and enteral nutrition prescriptions for each premature newborn are made using the Logipren® prescription assistance software, based on ESPGHAN recommendations. Despite this theoretical security, it seems that they are not strictly respected. At the same time, premature newborns typically show weight loss often greater than -1 z-score.

The objective of this research is to study the impact of electrolyte intake (sodium and phosphorus) on growth trajectories and the incidence of EUGR in premature newborns discharged from the Nancy Maternity Hospital in 2023. The secondary criteria are to describe sodium, phosphorus, protein and calorie intake and compliance with ESPGHAN recommendations; assess the true prevalence of stunting in our study population; and the impact of meeting electrolyte intake recommendations on children's growth trajectory, taking into account protein and calorie intake.


Eligibility Criteria:
Inclusion Criteria:

* Neonates born between January 1st 2023 and December 31st 2023
* Neonates born before 37 SA
* Neonates hospitalized at the Nancy Maternity Hospital in Neonatology

Exclusion Criteria:

* Neonates transferred at the Nancy Maternity Hospital after 48 first hours of life
Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU

Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU

Prospective clinical study in ICU with sedated ventilated patients with dexmedetomidine, establishing incidence of success, failure of moderate sedation or failure of dexmedetomidine, to evaluate the effectiveness of this drug sedation in moderate sedation

Eligibility Criteria:
Inclusion Criteria:

-Adult patients ventilated requiring sedation in ICU with RASS objective more than -2

Exclusion Criteria:

* contraindication: intracranial lesion, hepatic failure
* pregnancy
A Study of Safety, Pharmacokinetics, Pharmacodynamics of JNJ-61610588 in Participants With Advanced Cancer

The purpose of this study is to evaluate the safety and tolerability of JNJ-61610588 in participants with advanced cancer in order to determine a recommended Phase 2 dose (RP2D) for further evaluation in specific tumor types.

The purpose of this study is to see if JNJ-61610588 is safe and useful for treating participants with advanced cancer. This study consists of up to 4 parts. Part 1 will determine what dose of JNJ-61610588 can be given safely to advanced cancer participants. Part 2 will look at how participants with metastatic non-small cell lung cancer respond to a safe dose of JNJ-61610588. Parts 3 and 4 will test whether the dose of JNJ-61610588 identified in Part 1 is a safe and effective therapy for participants with specific types of advanced cancers (lung, pancreas, cervical, colorectal, head and neck). Participants will receive study drug in an outpatient setting. Participants safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* The participant has a solid tumor. Parts 2 and 3 are limited to participants with non-small cell lung cancer. Part 4 is limited to participants with small cell lung, head and neck, pancreatic, colorectal, and cervical cancers
* Tumor progression following at least one prior standard therapy
* The participant has a radiographically measurable tumor. Evaluable disease is acceptable for Part 1 only
* The participant is willing to consent to provide a tumor tissue sample (fresh biopsy) before (Parts 2 and 3) and after (Part 2 only) receiving the study drug
* The participant is able to carry out daily life activities without difficulty
* The participant does not have significant side effects from previous anti-cancer treatment
* The participant has adequate organ and blood cell counts
* Sexually active participants must use medically acceptable methods of contraception during the course of this study

Exclusion Criteria:

* The participant has a history of major surgery or treatment other cancer therapy within 2-6 weeks before starting the study
* The participant has an untreated brain tumor
* Current severe, uncontrolled systemic disease including an ongoing, active infection requiring treatment with antibiotics
* The participant has high blood pressure or diabetes that is not well-controlled with medication
* History of clinically significant heart problems
* History of severe side effects toimmunotherapy
* The participant is pregnant, breastfeeding, or planning to become pregnant or father a child
* Positive for Hepatitis B, Hepatitis C, or HIV
* The participant has received anticoagulant therapy with the exception of aspirin within 1 week of starting the study
Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke

The goal of this clinical trial is to test the cooling effect of cooling blanket in patients with heat stroke. The main questions it aims to answer are:

* the cooling rate of cooling blanket in patients with heat stroke
* the relationship between cooling blanket and outcomes in patients with heat stroke

Participants will accept the cooling blanket or non-cooling blanket according to the randomization group.

Researchers will compare cooling rate and outcomes to see if the cooling blanket can accelerate the cooling speed and improve the prognosis of patients in heat stroke.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* diagnosed as heat stroke
* informed consent of patients or family members

Exclusion Criteria:

* need immediate cardiopulmonary resuscitation
* body temperature \&lt;39.5℃ on admission
* with the underlying disease of severe organ damage
* pregnant women
Feraccru® Real World Effectiveness Study in Hospital Practice ( FRESH )

The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectiveness, patterns of use and tolerability.

The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectiveness, patterns of use and tolerability. By describing the characteristics of patients treated with Feraccru® and their outcomes, this study will provide the medical community with important information to support treatment decisions for their patients. This will ultimately support improvements to patient care, including the long-term outcomes of patients with IBD and IDA

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged ≥ 18 years at the time of initiation .
* Patient presenting with mild to moderate IDA that is secondary to either Crohn's disease (CD) or ulcerative colitis (UC) defined as Hb ≥9.5 g/dL and \<13.0 g/dL in males, or Hb ≥9.5 g/dL and \<12.0 g/dL in females
* Serum ferritin concentration \<30 microgram/L or transferrin saturation of \<20% .
* Patient receiving Feraccru® since the time of UK launch in June 2016.

Exclusion Criteria:

* Patient receiving Feraccru® as part of an interventional clinical trial.
* Patients with severely active IBD or requiring corticosteroids at the time of initiation on Feraccru®.
* Patient with an IBD flare, as determined by the clinician.
* Patient with medical records that are not available for review.
* Patient not willing or unable to consent to study participation, or patient is deceased at the start of data collection period
Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial

Project's goal is evaluate an online tool the research team created called Empowered Survivor (ES) against a free online self-management intervention developed for cancer survivors by the National Cancer Institute and the American Cancer Society called Springboard Beyond Cancer.

600 patients who have completed treatment between one and three years ago and are currently cancer-free will be recruited via the New Jersey State Cancer Registry or the Cancer Registry of Greater California and randomly assigned to ES or Springboard Beyond Cancer. Participants will complete measures at baseline, 2, and 6-months post-baseline. The investigators will also complete a process evaluation of Empowered Survivor.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years;
* Diagnosed with a first primary invasive oral or oropharyngeal cancer between 1 and 3 years ago;
* Currently cancer free (but can have experienced a recurrence);
* Has internet access;
* Read English;
* Has sufficient vision to read a survey and complete an online intervention

Exclusion Criteria:

-
Use of an Insulin Infusion Conversion Equation (IICE) to Control Blood Glucose in Hospitalized Patients

Insulin infusions are commonly used in hospitalized diabetics to control blood sugar, and they are effective. However, insulin infusions require the use of limited resources. Insulin infusions are therefore changed to insulin shots as a patient recovers. Once an insulin infusion is stopped and shots are started, blood sugar control is harder to maintain. This is, in part, because physicians have different ideas on how to dose insulin shots in hospitalized patients. A math equation has been developed by the research staff that attempts to predict the effective doses of insulin shots in patients whose insulin infusion have just been stopped. The math equation was developed for patients with type 2 diabetes mellitus. In this study, all patients will be treated with the same type of insulin shots, with doses of the insulin shots chosen either by the math equation or by the judgment of the patient's physician. The study will then follow blood sugar values for 24 hours to see if the math equation is effective. If the equation is proven to be effective, a new tool will exist for physicians to determine the best dose of insulin shots for type 2 diabetics. Such a tool would, in turn, allow for widespread use of insulin infusions to determine a patient's insulin needs before discharge from the hospital. Blood sugar control for type 2 diabetics that are inpatient or outpatient would improve as a result, with potentially far reaching public health benefits.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients at an urban, mixed academic and community tertiary care hospital who were on IV insulin were enrolled.
* Patients were taken from medical, general surgical, and cardiothoracic services, and were located both inside and outside the intensive care unit (ICU).

Exclusion Criteria:

* At time of enrollment, patients with type I diabetes mellitus,
* active acute or chronic pancreatitis,
* history of pancreatic surgery,
* use of a self-titratable insulin pump, or
* history of β-islet cell transplantation were excluded.
* At time of randomization, patients with insulin drip rates ≤ 2 units/hr, ∆ in serum creatinine of \> 20% in previous 24 hours, or
* those without caloric intake while on IV insulin were excluded.
18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer

This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.

This is an trial designed to evaluate the positive predictive value of 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing PSA levels. Patients will receive a single dose of 18FDCFPyL PET and undergo a PET imaging study. 18F-DCFPyL Injection is an 18F-labeled small molecule that targets the extracellular domain of PSMA. One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with ≤ 333 MBq (≤ 9 mCi) of 18F-DCFPyL via this catheter. The dose range for 18F-DCFPyL will be 7 - 9 mCi. The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of prostate cancer
* Biochemical recurrence was defined as a PSA of 0.2 or more ng/mL measured more than 6 weeks after prostatectomy or a PSA of 2 or more ng/mL rise above nadir following radiation therapy (ASTRO Phoenix consensus definition)
* Age ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
* Ability to understand and willingness to sign a written informed consent document
* Willing to comply with clinical trial instructions and requirements

Exclusion Criteria:

* History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
* Presence of prostate brachytherapy implants unless approved by the PI
* Administration of another radioisotope within five physical half-lives of trial enrollment
* Radiation or chemotherapy within 2 weeks prior to trial enrollment
* Estimated glomerular filtration rate (eGFR) \< 15 ml/mmol
* Serum total bilirubin \> 3 times the upper limit of normal
* Aspartate transaminase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal
* Inadequate venous access
* Claustrophobia or any other condition that would preclude PET imaging
* Patients must not be receiving ADT except per criteria directly below. Patients who received in the past must have a serum testosterone that is recovered to at least 100 ng/dL.
* Patients who have been on ADT +/- novel hormonal agent (NHA) and developed M0 CRPC
Multiparametric Diagnostic Model of Thick-section Clinical-quality MRI Data in Detecting Migraine Without Aura

Recently, radiomics combined with machine learning method has been widely used in clinical practice. Compared with traditional imaging studies that explore the underlying mechanisms, the machine learning method focuses on classification and prediction to propose personalized diagnosis and treatment strategies. However, these studies were based on thin-section research-quality brain MR imaging with section thickness of \< 2 mm. Clinical, the usage of thick-section clinical setting instead of thin-section research setting is especially important to shorten the acquisition time to reduce the patient's suffering. Here investigators want to build multiparametric diagnostic model of migraineurs without aura using radiomics features extracted from thick-section clinical-quality brain MR images.


Eligibility Criteria:
Inclusion Criteria:

* right-handed
* International Headache Society criteria for episodic migraine without aura

Exclusion Criteria:

* addition (including alcohol, nicotine, or drug)
* physical illness
PERTRIAL - Perla® Preservation Solution

Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient.

The purpose of the PERTRIAL clinical investigation is to demonstrate the Performance and Safety of Perla® Cold Preservation solution.


Eligibility Criteria:
Donor kidney / liver eligibility criteria:

Inclusion Criteria:

* Donor kidney / liver suitable for preservation
* Donor age equal or over 18 years old
* Donor meets one of the following conditions:
* Donor after brain death (DBD), standard and extended criteria (SCD \& ECD)
* Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled)

Exclusion Criteria:

* Donor participating at the same time in another Clinical Investigation

Recipient eligibility criteria:

Inclusion Criteria:

* Patient registered primary kidney or liver transplant candidate, male or female
* Patient ages ≥ 18 years old
* Patient who has signed written informed consent

Exclusion criteria:

Patient recipient will not be included if any of the following conditions exists:

* Prior solid organ or bone marrow transplant
* Multi-organ transplant
* Contraindications to transplantation (Active infection, active malignancy, pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method)
* Participation in another clinical trial
* Patient unable to give consent
Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+

The purpose of this study is to determine whether fractionated RIT with Epratuzumab and radiolabeled Epratuzumab are effective in the treatment of relapsing or refractory ALL.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* B-ALL (OMS) with \>=20% of blasts in bone marrow
* CD22+ expression \>=70% of the blast population
* All previously treated ALL patients who have experienced relapse or treatment failure
* At least 15 days since previous treatment
* Performance status 0 - 2
* Creatinine clearance \>= 50 ml/min (Cockroft formula).
* Serum bilirubin \<= 30 mmol/l
* Written informed consent

Exclusion Criteria:

* T-ALL
* Meningeal involvement
* CD22 expression on tumor cells or \< 70%
* HIV positive
* Active Hepatitis B or C
* Active infection within 7 days of starting treatment
* Left ventricular ejection fraction \< 50%.
* Contra-indication to 90Y-DOTA-hLL2
* Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Participation at the same time in another study in which investigational drugs are used
* Absence of written informed consent
coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants

This is a cross-sectional cohort study which aims to compare the invasive and non-invasive assessments on aortic blood pressure and cardiac funtion in subjects without history of cardio-vascular disease. Left ventricular (LV) filling pressure, LV volume, and aortic blood pressure will be measured invasively. Non-invasive assessment includes echocardiography,aortic, and carotid blood pressure measurement.


Eligibility Criteria:
Inclusion Criteria:

* Over or equal to 18 years old;
* Agree to participate the study and sign informed written consent;
* Any change of drugs which effect the hemodynamics during 1 month prior to enrollment;
* Proposed to perform coronary angiography and left left ventriculography in hospital;

Exclusion Criteria:

* Non-sinus rhythm or frequent extra systoles;
* Identified coronary artery disease via coronary angiography;
* Diagnosed pulmonary vascular or parenchymal disease;
* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis;
* Stenosis or insufficiency of valves (moderate and above);
* Heart transplant;
* Congenital heart disease;
* Inadequate imaging or doppler parameter quality in echocardiography.
Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children

Laparoscopic fundoplication is increasingly performed in paediatric surgery. Many types of fundoplication are performed, each has advantages and disadvantages. The Nissen operation is the most frequently performed procedure in the U.K., however it can be associated with post-operative dysphagia. The relative benefits between Nissen and other fundoplication techniques in children are still uncertain.

The aim of our study was to compare the long-term outcomes following laparoscopic Nissen fundoplication with laparoscopic Thal fundoplication in children.


Eligibility Criteria:
Inclusion Criteria:

* Gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious complications (e.g. apnoea, aspiration pneumonia, oesophagitis)

Exclusion Criteria:

* Patients who had previous anti-reflux surgery, previous open abdominal surgery, if parents declined to participate into study
Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease

This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 703802 and to assess the efficacy of different doses and dosing regimens of ISIS 703802 on glucose and lipid metabolism, and liver fat in participants with hypertriglyceridemia, Type 2 diabetes mellitus (T2DM), and nonalcoholic fatty liver disease (NAFLD).


Eligibility Criteria:
Key Inclusion Criteria:

* Plasma triglycerides (TG) at Screening greater than (\>)150 milligrams per deciliter (mg/dL) and at qualification of \>150 mg/dL.
* Documented history of hepatic steatosis with baseline magnetic resonance imaging (MRI) indicating hepatic fat fraction (HFF) greater than (\>) 8%.
* Diagnosis of Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) \>6.5 and less than or equal to (≤) 10% at Screening.
* Must have been on a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to Screening.
* Body mass index between 27- 40 kilograms per meter square (kg/m\^2), inclusive, at Screening.

Key Exclusion Criteria:

* Type 1 diabetes mellitus.
* Active chronic liver disease, alcoholic liver disease, Wilson's disease hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, genetic hemochromatosis, known or suspected hepatocellular carcinoma, history of or planned liver transplant for end-stage liver disease of any etiology.
* Documented history of advanced liver fibrosis.
* History of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy, or variceal bleeding.
* History of clinically significant acute cardiac event within 6 months before Screening.
* History of heart failure with New York Heart Association (NYHA) greater than Class II.
* Use of Insulin or insulin analogs, glucagon-like peptide-1 (GLP-1) agonists, and peroxisome proliferator-activated receptor gamma (PPARᵞ) agonists (pioglitazone or rosiglitazone).
* Weight change \>5% within 3 months before Screening.
* Conditions contraindicated for magnetic resonance imaging (MRI) procedures including any metal implant (example, heart pacemaker, rods, screws, aneurysm clips).