cyrilzakka/clinical-trials huggingface dataset:
GlySure Acute Care Settings Study

The company who have developed the GlySure product have previously carried out a study to be able to show that the GlySure system is accurate in measuring blood sugar (glucose) levels. This was done with patients in the intensive care unit (ICU) after heart surgery.

The company now want to confirm that the GlySure product is accurate at measuring blood glucose levels on all patients who stay in the ICU.

This clinical study requires 40 patients and is to check the safety of a continuous Glucose Monitoring System (GlySure) and it's performance in comparison to separate individual blood glucose testing using a hand held blood tester called i-STAT. Each patient must be in the study for at least 36 hours.

The main benefit of continuous blood glucose monitoring is that it gives a true picture of the glucose status of a patient and this can potentially help avoid the glucose level dropping too low (hypoglycaemic) or staying too high (hyperglycaemia) as clinicians can intervene based on 'real-time' data on the glucose levels.

In this study patient treatment is not dictated by the data measured during the study. Clinicians are blind to the results on the GlySure monitor.


Eligibility Criteria:
Inclusion Criteria:

1. Patient or legal representative MUST be willing to sign an informed consent document
2. Patient is male or female aged 18 years or above
3. Patient requires a Central Venous Catheter (CVC) to be inserted as part of disease management and treatment
4. Patient is expected to remain in the intensive care unit for at least 36 hours post enrolment to the study

Exclusion Criteria:

1. Patient or legal representative is unable to provide written informed consent
2. Patient who is pregnant
3. Patient who is currently being administered Mannitol and/or may require the administration of Mannitol whilst in the ICU
4. Patient with history of pulmonary embolism (PE)
5. Patient with history of thrombosis
6. Patient with known hyper-coagulation
7. Patient with known history of heparin hypersensitivity
8. Patient with history of heparin induced thrombocytopenia
9. Participation in a clinical study involving an unlicensed pharmaceutical product or device within the 3 months prior to enrolment in this study
10. Patient with known hypersensitivity/allergy to adhesive I.V. dressings such as 3M Tegaderm film or StatLock® devices
11. Patient who is being managed in a cardiac ICU setting after cardiac surgery
A Long-Term Study of Rovalpituzumab Tesirine

The purpose of this long-term, extension study is to provide ongoing safety and efficacy follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed the primary analysis and that is closing.


Eligibility Criteria:
Inclusion Criteria:

* Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab tesirine in a parent study.
* Additional eligibility criterion for Arm A: subjects who discontinued the study drug in the parent study have completed the treatment emergent adverse event reporting window.

For subjects who elect optional retreatment in Arm A, must meet additional criteria before receiving rovalpituzumab tesirine retreatment including:

* Tolerated their initial 2 doses of rovalpituzumab tesirine.
* Achieved clinical benefit as defined by stable disease or better, and is determined that the subject would potentially benefit from additional treatment.
* Experienced radiographic disease progression at least 12 weeks after the second dose of rovalpituzumab tesirine.
* Received no other systemic anti-cancer therapy after rovalpituzumab tesirine treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic, kidney, and liver function, per protocol.
* In subjects with central nervous system (CNS) metastases, documentation of stable or improved status as described in the protocol.

Exclusion Criteria:

* Subjects not previously enrolled in a rovalpituzumab tesirine study.
Clinical Trial of PLA2R-IgG4 Detection Kit (Time-resolved Fluorescence Immunoassay)

The goal of this observational clinical trial is to compare assessment reagents with clinical diagnostic criteria in patients with membranous nephropathy. The main questions it aims to answer are:

* Evaluating the sensitivity and specificity of the test reagent in the diagnosis of membranous nephropathy.
* Evaluating whether the clinical diagnostic performance of the test reagent meets the requirements for auxiliary diagnosis of membranous nephropathy.

Participants will provide approximately 4ml of blood. Researchers will compare the levels of anti-PLA2RIgG4 in patients with membranous nephropathy and patients with other renal diseases,to see if there is a significant difference.


Eligibility Criteria:
Inclusion Criteria:

* PLA2R-induced membranous nephropathy group

  1. Pathological examination showed that patients with membranous nephropathy were positive for PLA2R by immunohistochemistry, and the symptoms were not completely relieved; (24 h urine protein quantification\<0.3g or urine protein /creatinine (uPCR)\<300mg /g is regarded as complete remission)
  2. In patients with nephrotic syndrome (serum albumin ≤ 30.0g /L, clinical manifestations show moderate to large amount of proteinuria (urine protein\>3.5g /L or urine protein /creatinine ratio ≥ 3500mg /g), and their serum anti PLA2R antibody detection shows positive.
* Secondary membranous nephropathy group Patients in nephrology department who have ruled out primary membranous nephropathy.

the patient has the remaining serum samples of normal test, and the serum volume of the sample is not less than 1ml.

Exclusion Criteria:

1. The amount of centrifuged serum sample after blood collection is less than 1ml or the amount of residual serum in normal test is less than 1ml;
2. Non-serum samples, plasma samples;
3. Patients with mental or cognitive disorders;
4. No samples with definite clinical diagnosis;
5. Samples with incomplete information.
Mechanisms of Acute Kidney Injury in Severe Infections

Renal perfusion and neutrophil-mediated inflammation will be assessed in the kidney in sepsis patients with acute kidney injury using positron emission tomography. For marked water will be used for renal perfusion and a newly developed PET tracer molecule (11C-GW457427) with specific binding to neutrophil elastase which provides a measure of the amount of infiltrating neutrophils in the renal parenchyma for inflammation. The study is performed in a PET-CT camera where anatomical imaging takes place at the same time as the PET examinations.

To study renal perfusion and neutrophil-mediated inflammation 10 critically ill patients with sepsis and acute kidney injury (AKI) and 5 healthy volunteers as controls will be recruited and examined at one time with marked water followed by neutrophil elastase tracer. At the same time, a CT scan is performed for anatomy. Plasma levels of inflammatory mediators will be measured. Clinical data will be collected. The endpoints are changes in renal perfusion and increased presence of neutrophil elastase in the renal parenchyma.

Eligibility Criteria:
Inclusion Criteria:

Patients with sepsis and AKI

* \> 30 years
* At least AKI stage 1 according to KDIGO where the last plasma creatinine is measured within 24 hours of the examination

Healthy volunteers

* \> 30 years
* No previously known kidney disease
* Normal plasma creatinine value

Exclusion Criteria:

* Chronic renal failure (CKD stage \>3a) or dialysis
* Instability in vital functions that makes PET-CT examination unsuitable
* Claustrophobia or other reasons that make the patient unable to lie still during the examination.
* Pregnancy and breastfeeding
cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes

Collection of venous blood samples in male T1D patients to evaluate the behavior of different biomarkers (beta-hydroxybutyrate, lactate, glucose) during and after morning Aerobic (60% of VO2 max) and Symptom Limited Maximal Exercise Test.

Compare values and trends of different biomarkers (glucose, lactate and beta-hydroxybutyrate) before, during and after morning aerobic and symptom limited maximal exercise (cycling) to predict glycemic fluctuations (hypo- and hyperglycemic events) during and after exercise in order to create treatment algorithms to prevent these events.

Endpoint:

• Evaluate values and trends of glucose, lactate and beta-hydroxybutyrate before, during and after morning exercise in venous blood.

Eligibility Criteria:
Inclusion Criteria:

* Male adults (18-40 years old) with T1D, diagnosed since \> 1 year
* Using a CGM (Dexcom G5) or willing to wear a CGM (Dexcom G5) for the duration of the study.

The CGM must be applied \>48h before the exercise test

* Participants are on intensified insulin therapy (MDI) or insulin pump therapy (CSII)
* 6% ≤ HbA1c ≤ 8%
* Having a self-reported moderate activity level on the iPAQ (Internationally Physical Activity Questionnaire).
* C-peptide \<0.2 nmol/l
* The Physical Activity Coefficient has not changed in the 2 months prior to the first Exercise Test.
* 20kg/m2 \< BMI \< 25kg/m2

Exclusion Criteria:

* Recently diagnosed T1D (\< 12mo)
* Participants not on MDI or CSII
* Musculoskeletal disorder that affects cycling or is a contra-indication for vigorous physical activity
* Cardiorespiratory disease or ECG abnormality that is a contra-indication for vigorous physical activity
* Having an acute illness (e.g. influenza) that interferes with glucose metabolism
* Having a metabolic disorder (different from diabetes) or takes drugs known to have significant interference with glucose metabolism, such as systemic corticoids as judged by the investigator
* Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticoids as judged by the investigator
* Presence of concomitant pathology such as heart failure, liver failure, kidney failure defined as eGFR \<45mL/min
* Patient not able or willing to sign the patient informed consent
Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fed conditions


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects between the ages of 18 and 45 years (inclusive).
2. Voluntary consent to participate in the study.
3. Body Mass Index (BMI) between 18 and 30 (inclusive).
4. Female subjects of childbearing potential - not surgically sterile or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception from screening through completion of the study: abstinence, hormonal (oral, implant, transdermal, or injection) for at least 3 months prior to the first dose of the study, barrier (condom with spermicide, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
5. No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

1. A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
2. A history of allergic or adverse responses to irbesartan and hydrochlorothiazide, or any comparable or similar product.
3. Subjects who (for whatever reason) have been on an abnormal diet or have had substantial changes in eating habits within 30 days prior to study initiation.
4. Subjects must not have made a blood donation of one pint or more within 30 days prior to study initiation.
5. Subjects must not have made a plasma donation within 14 days of study initiation.
6. Participation in a clinical trial within 30 days prior to study initiation.
7. Use of any over-the-counter (OTC) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study.
8. Use of any prescription medication within 7 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential, or hormone replacement therapy.
9. Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem, ketoconazole, MAOI, antidepressants, neuroleptics, verapamil, quinidine, erythromycin, etc., within 30 days prior to or during the study.
10. Smoking or use of tobacco products within 6 months prior to or during the study.
11. Female subjects who are lactating.
12. Positive serum pregnancy test for female subjects.
13. Positive blood screen for HIV, Hepatitis B or Hepatitis C.
14. Positive screen for alcohol or drugs of abuse, and history or presence of alcoholism or drug abuse within 6 months prior to the study start.
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.


Eligibility Criteria:
A) Eligibility criteria for prospective pregnancies:

Inclusion Criteria:

1. Diagnosis of insomnia disorder prior to pregnancy.
2. Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.
3. One of the following:

   1. Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception.
   2. Exposure to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
   3. No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.

Exclusion Criteria:

* Exposure to any orexin receptor antagonist other than QUVIVIQ - including BELSOMRA® (suvorexant), DAYVIGO® (lemborexant), any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during the current pregnancy or within 5 half-lives of the respective medication prior to conception.

B) Eligibility criteria for retrospective pregnancies:

Inclusion criteria:

1. Diagnosis of insomnia disorder prior to pregnancy.
2. Pregnancy has ended.
3. Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.

Exclusion criteria:

* Exposure to any orexin receptor antagonist other than QUVIVIQ - including suvorexant, lemborexant, any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during pregnancy or within 5 half-lives of the respective medication prior to conception.
Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients

prospectively compared Exclusive Enteral Nutrition with Infliximab in the clinical outcomes, mucosal healing, nutrition improvements, adverse effects and gastrointestinal microbiota changes on Chinese Children With active Crohn's Disease


Eligibility Criteria:
Inclusion Criteria:

patients:

1. Pediatric active Crohn's disease ( CD) patients who were newly diagnosed at the Children's Hospital of Fudan University from October 2020 to Sep 2022，CD was diagnosed according to the Porto criteria and based on a combination of history, physical and laboratory examination, endoscopy with histology, and imaging of the small bowel (capsule endoscopy or magnetic resonance imaging or enhanced computerized tomography).
2. SES-CD\>4 and PCDAI \>10 at initial
3. For the patients whose fecal will be analyzed shouldn't take antibiotics or probiotics within the 1.5 months prior to the study and during the treatment.

healthy controls:

1. free medical history
2. had not taken antibiotics or probiotics within the 1.5 months prior to donate their fecal

Exclusion Criteria:

1. patients who had gene mutation or combined with other intestinal diseases such as tuberculosis or EB infection
2. for patients in the EEN group who could not finish the daily prescribed volume of formula for any reason; for the patients in the IFX group who could not finish the first 4 times IFX injection for any reason.
3. patients who were administered EEN, corticosteroids, immunosuppressive drugs, or biological agents prior to the study;
4. patients who could not attend consecutive follow-up sessions;
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

The goal of this study is to evaluate the efficacy in preventing HIV infection of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF), in adolescent girls and young women.


Eligibility Criteria:
Key Inclusion Criteria:

* Incidence Phase

  * HIV-1 status unknown at initial screening and no prior human immunodeficiency virus (HIV)-1 testing within the last 3 months.
  * Sexually active (has had \> 1 vaginal intercourse within the last 3 months) with cisgender male individuals (CGM).
* Randomized Phase

  * Negative fourth generation HIV-1 antibody (Ab)/antigen (Ag) test confirmed with central HIV-1 testing.
  * Estimated glomerular filtration rate (GFR) ≥ 60 mL/min at screening.
  * Body weight ≥ 35 kg.

Key Exclusion Criteria:

* Prior receipt of an HIV vaccine.
* Prior use of long-acting systemic HIV pre-exposure prophylaxis (PrEP) or or HIV PEP (postexposure prophylaxis).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression

DLBCL has the highest frequency out of all lymphoid malignancies. With the recent development of antitumor agents targeting intracellular/extracellular cell signaling pathways, patients have access to various treatment options after relapse. Therefore, for the purpose of developing effective treatment strategies, large-scale genomic data accumulation is necessary to understand the mechanism of relapse and refractory state of DLBCL.

* To understand the mechanism of relapse by genome sequencing with tissues/blood obtained at diagnosis and relapse in patients with diffuse B cell lymphoma who relapsed after standard chemotherapy, to evaluate their response and survival following a salvage therapy depending on the genomic sequencing results, and to understand the prognostic or predictive value of genomic mutation.
* To understand the predictive value of genetic information with regard to the response to salvage chemotherapy and survival outcome in patients with newly diagnosed/relapsed or refractory large B cell lymphoma
* To determine the association between gene mutation, treatment response and prognosis in relapsed/refractory diffuse large B cell lymphoma (DLBCL), and to develop a clinically applicable platform by establishing a genetic data register based on prospective studies

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed DLBCL
* DLBCL who relapsed or were refractory to first-line treatment with rituximab-based immunotherapy
* Available for genomic analysis of tissues both at diagnosis (paraffin-embedded and stored) and at relapse (paraffin-embedded)
* Aged ≥18 years
* Written informed consent for participation in the prospective cohort study
* Written informed consent to peripheral blood collection and genetic testing of human tissues

Exclusion Criteria:

* No lymphoid malignancy, e.g. myeloid leukemia
* Any of the following lymphoid malignancies:

  1. Plasma cell dyscrasia, amyloidosis
  2. Hodgkin lymphoma
  3. Subtypes of B cell non-Hodgkin lymphoma, other than DLBCL
  4. T or NK(Natural Killer) cell non-Hodgkin lymphoma
  5. Other diseases in the WHO(World Health Organization) classification of lymphoid malignancies
* Experienced a relapse before
* Insufficient or no tissue sample at diagnosis for genomic analysis
* Can not understand or provide written informed consent
* Who do not provide written informed consent to blood collection and genetic testing
Towards Understanding the Phenotype of Cardiovascular Disease in CKD - TRUE-Type-CKD Study

Premature cardiovascular disease (CVD) is the leading cause of death in patients with kidney disease (CKD). Excessive cardiac mortality is thought to be secondary to non-atherosclerotic processes, with left ventricular (LV) hypertrophy (LVH) and remodelling being the predominant phenotypical features. Along with other risk factors, subclinical ischaemia and haemodynamic perturbations associated with haemodialysis (HD) are thought to contribute to the ultimate development of LV systolic and diastolic dysfunction. The development of these adverse features reflects a specific cardiomyopathy due to CKD and subsequently, to uraemia. Patients receiving hemodialysis (HD) have a higher incidence rate of heart failure (predominantly with preserved ejection fraction), with phenotypically eccentric hypertrophic remodelling, systolic and diastolic dysfunction as well as high rate of interstitial myocardial fibrosis. Detection and ultimately reversal of the development of this CKD-related cardiomyopathy are important goals for improving the CVD, morbidity and mortality of CKD patients.The objectives of this study are, firstly, to investigate the complex myocardial phenotype in patients with various stages of CKD, secondly, to relate the CMR-measures to outcome, and thirdly, to be able to estimate the effects of chronic uremia/hypervolemia. Deciphering the predominant driver of remodelling on an individual level may help to personalise anti-remodelling strategies. Native T1 and T2 mapping imaging provide non-invasive imaging tools to detect myocardial fibrosis and oedema, respectively. Prognostic associations of these measures may clarify the relative prevalence of adverse phenotype and their relative contribution to adverse events and poor outcome. The role of chronic water retention and uraemia may be associated with interstitial myocardial oedema promoting further the remodelling process.


Eligibility Criteria:
Inclusion Criteria:

1. Adults \>18 years of age
2. Able to provide informed consent
3. Chronic kidney disease stages G3-5 (eGFR\<59 ml/min/1.73m2)

Exclusion Criteria:

1. Absence of absolute clinical indication for MRI studies (MR unsafe or incompatible devices, aneurysm clips, cochlear implants, loose metal foreign objects)
2. Absolute contraindications to gadolinium contrast agent (previous allergic reaction or pregnancy),