cyrilzakka/clinical-trials huggingface dataset:
Characteristics of Blood Glucose Variability in Patients With Type 2 Diabetes Mellitus and COVID-19

using intermittently scanned continuous glucose monitoring (isCGM) to clarify the characteristics of blood glucose variability parameters in T2DM patients with NCP, guide the formulation of reasonable clinical treatment measures and make timely and reasonable adjustments, improve the prognosis of patients, shorten the length of hospital stay, and reduce medical costs.

The goal of this observational study is to investigate the characteristics of blood glucose variability in patients with type 2 diabetes mellitus (T2DM) complicated with novel coronavirus pneumonia (NCP) and its effect on disease progression and prognosis.

The main question it aims to answer is:After fully lifting coronavirus disease 2019 (COVID-19) pandemic control measures in mainland China in 12/2022, the incidence of COVID-19 has increased markedly, making it difficult to meet the general time-in-range (TIR) requirement. Therefore, the investigators investigated a more clinically practical TIR threshold and examined its association with the prognosis of COVID-19 patients with type-2 diabetes.

participant population/health conditions：Participants were equipped with isCGM sensors on admission.

According to the outcome, the patients were divided into favorable outcome group and composite outcome group.

patients with NCP who were discharged or died. Clinical data and blood glucose variability parameters were collected by computer blood glucose monitoring technology (CGM). Time in range (TIR), time above target range (TAR), time below target range (TBR), mean amplitude of glycemic excursions (MAGE), absolute mean daily difference (MODD) and other indicators were used.

Eligibility Criteria:
Inclusion Criteria:

1. All patients met the diagnostic criteria of type 2 diabetes mellitus in "Chinese Guidelines for the Prevention and treatment of type 2 Diabetes Mellitus (2020 edition)" formulated by the Chinese Diabetes Society of the Chinese Medical Association, and were previously diagnosed with type 2 diabetes mellitus and newly diagnosed with type 2 diabetes mellitus after admission
2. Patients with mild, moderate, severe and critical COVID-19 in accordance with the guidelines of "Diagnosis and Treatment of novel coronavirus Infection (Trial version 10)"
3. Patients receiving CGM or peripheral blood glucose monitoring during hospitalization

Exclusion Criteria:

1. Cases with incomplete data
2. Non-NCP and non-T2DM patients
3. Patients who did not receive CGM or peripheral blood glucose monitoring
Relationship Obsessive Beliefs and Thought Control

Obsessive beliefs and thought control have been mostly investigated in obsessive-compulsive disorder in the literature. However, there is an increasing body of literature indicating that obsessive beliefs and thought control also play a role in the development of other anxiety disorders. In the study, investigators hypothesised that obsessive beliefs and thought control are effective in generalised anxiety disorder and panic disorder and increase anxiety symptoms and aimed to investigate the accuracy of this hypothesis.

Obsessive beliefs are considered as a compulsive thought system in the cognitive model of obsessive-compulsive disorder. Obsessive beliefs are analysed under six main headings. These are control of thoughts, intolerance of uncertainty, exaggerated perception of responsibility, overemphasis of thoughts, exaggerated perception of threat and perfectionism. Although it is thought to play a role in the development of obsessions, it can sometimes be seen independent of obsessions . This dysfunctional distorted thought system sometimes turns into unnecessary threat perception and may pave the way for mental illnesses in the individual. When these distorted cognitive thoughts come to the mind, the person has an excessive mental effort to control the thoughts. As much as the thoughts cause distress, the endeavour to control the thoughts may cause mental distress in the person. Although all of these dysfunctional thoughts are associated with an obsession, the effect of thought control and obsessive beliefs on other mental illnesses has recently been investigated. In particular, perfectionism and increased threat perception have been associated with anxiety disorders as well as obsessions . Obsessive beliefs have often been associated with obsessive-compulsive disorder. However, there are similarities in the cognitive schemas of obsessive-compulsive disorder and anxiety disorders. Anxiety disorders are characterised by a vague state of anxiety and accompanying physical symptoms. Patients with anxiety disorders may be hypersensitive to some feelings and thoughts. Anxiety attacks may be triggered by exaggerated threat perception in obsessive beliefs. In addition, intolerance of uncertainty is also associated with anxiety disorders. Cognitive distortions have a role in the development of both obsessive-compulsive disorder and anxiety disorders . Obsessive beliefs and thought control have been mostly associated with obsessive-compulsive disorder in the literature. However, it has recently been thought that these dysfunctional compulsive thoughts and the distress experienced to control these thoughts are the cognitive basis of all anxiety disorders. Information on this subject is limited in the literature. Our study aims to contribute to the literature on this subject.

Eligibility Criteria:
Inclusion Criteria:

* with panic disorder patient and generalized anxiety disorder
* no other psychiatric illness such as alzheimer, mental retardation, parkinson disease
* had academic capacity for filling the scales
* no taking any drugs
* being age 18-65
* giving consent to be involved in the study
Metabolomics-Based Detection of Colorectal Cancer

The purpose of this study is to collect specimens to perform metabolic profiling of serum and urine from patients with colorectal cancer, colon polyps and healthy patients.

In this study, metabolite profiling analysis will be carried out on colon cancer patients at the time of diagnosis and during the course of treatment, using patient tissue and serum samples. Samples of serum (1 ml) and tissue specimens (50 mg each) from colorectal cancer patients (stages I-IV) and serum samples from an equal number of age and gender-matched healthy controls will be obtained under identical (8-hour overnight fasting) conditions. Metabolic profiles will be identified using the NMR and MS instruments located in Purdue's on-campus NMR and MS facilities. Multivariate statistical analyses will be used to monitor changing metabolite profiles that indicate changes in disease status. We anticipate that putative biomarkers will be easier to identify in the cancerous tissue, and the concentrations of these metabolites will then be quantified in the patients' serum, that ultimately would allow for easier detection of colon cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with resectable colorectal cancer must have samples collected (serum/urine) prior to surgery and/or after surgery, but prior to starting chemotherapy.
* Patients with metastatic colorectal cancer must have samples collected prior to initiating chemotherapy, and after chemotherapy initiation: every 3 months for up to 24 months.
* Subjects must be ≥ 18 years of age.
* Subjects undergoing screening colonoscopy are able to participate as healthy controls or as patients with colon polyps if colonoscopy identifies colon polyps being present (informed consent will be signed first and samples will be collected; after colonoscopy the samples will be identified as "healthy" or "polyps").
* For patients who underwent biopsy or surgery for colorectal cancer, enough tissue needs to be available for testing, as appropriate per patients groups in the protocol Schema.
* Subjects must be able to attend follow up or treatment visits per investigator's recommendations for up to 24 months for collection of serum/urine specimens.
* Female patients known to be pregnant are not eligible for this protocol.
* Subjects must be able to undergo an 8-hr overnight fast prior to metabolomic testing

Exclusion Criteria:

* Presence of an invasive cancer other than colorectal cancer is an exclusion criterion
The Staff Stop Smoking Project

Participants will be randomised to either standard care or to receive our help to quit programme. The study will only be available to Portsmouth Hospital Trust staff member.

A randomised controlled feasibility study to trial a novel intervention to help NHS staff stop smoking compared to standard care. Participants will attend one-on-one interviews and a support group where they will undertake CO monitoring and mini-spirometry. They will complete questionnaires about their quality of life, other health problems and their general state of health. They will attend the support groups on a weekly basis and have access to support outside of these times.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged 18 years or over
* Willing and able to give informed consent for participation in the study.
* Must work for PHT at QAH and be able to attend weekly meetings for the duration of the study period
* Must be a current smoker

Exclusion Criteria:

-Unable to comprehend the study and provide informed consent e.g. insufficient command of English in the absence of someone to adequately interpret.
Nursing Discharge Teaching for Multimorbid Inpatients

The objective of this study is to estimate the effect size of a nursing discharge teaching intervention on multimorbid inpatients activation level, health confidence, readiness for hospital discharge, experience with discharge care and rate and time to 7-days readmission.

Seniors returning home from hospital have to manage several chronic conditions in addition to their daily tasks. The teaching provided by nurses during hospitalization is essential care to prepare them to manage their health at home. Nevertheless, there is often a gap between professionals' belief that the teaching they have provided to patients has met their needs, and patients' perceptions of the relevance of the teaching content to their home situation. The time available to conduct this teaching is also short during the hospital stay and there is limited knowledge about how to adapt this teaching for patients who must manage multiple chronic conditions at the same time. Thus, there is a real need to develop and test a new teaching nursing intervention to prepare for the return home that takes into account the unique and complex needs and characteristics of patients with multiple chronic conditions. Tailoring teaching to seniors' life situation and level of activation (i.e., knowledge, skills and confidence in managing their health) would best meet the needs of these patients for managing their health at home. An intervention that takes these characteristics into account has been developed and will be tested in this study.

Eligibility Criteria:
Inclusion Criteria:

* 2 chronic diseases or more
* Being discharged home
* Able to speak, read and write in French

Exclusion Criteria:

* Insufficient capacity to consent assessed with the University of California San Diego Brief Assessment of Capacity to Consent (UBACC).
Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.

This is a Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of JYP0015 in adult patients with advanced solid tumors harboring specific RAS mutations.

The study consists of two parts:

* Phase 1 (dose escalation) - Evaluates the safety, tolerability, and pharmacokinetic profile of JYP0015 monotherapy, preliminarily assesses efficacy, and determines the recommended dose (RD) for further evaluation.
* Phase 2 (indication expansion) - Explores the therapeutic potential of JYP0015 monotherapy at the RD across four predefined cohorts:

  1. Pancreatic ductal adenocarcinoma (PDAC)
  2. Non-small cell lung cancer (NSCLC)
  3. Colorectal cancer (CRC)
  4. Other advanced solid tumors Phase 2 will assess both efficacy and safety within these cohorts.

JYP0015 is a potent, orally bioavailable pan-RAS inhibitor that selectively targets the active (ON) form of wild-type and mutant RAS across all three isoforms-HRAS, NRAS, and KRAS.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or pathologically confirmed solid tumors with RAS mutation via molecular tests.
2. Patients with RAS mutation who have disease progression or intolerance after adequate standard treatment
3. Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1
4. Adequate organ function

Exclusion Criteria:

1. Presence of central nervous system (CNS) metastases; however, subjects with previously treated brain metastases may be enrolled if clinically stable.
2. Gastrointestinal (GI) disorders that may interfere with drug administration/absorption, including but not limited to: Dysphagia or inability to swallow tablets， Malabsorption syndrome，Refractory nausea, vomiting, or diarrhea，Chronic GI diseases (e.g., Crohn's disease, ulcerative colitis)
3. Congestive heart failure with New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) \<50%.
4. Any other condition deemed by the investigator to potentially compromise study outcomes or lead to premature termination, including but not limited to: Alcohol or substance abuse，Concurrent severe medical conditions (e.g., psychiatric disorders requiring active treatment)， Familial or social circumstances that may affect patient safety, compliance, or study data collection.
Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.

This study aims to evaluate the impact of Nirsevimab, a monoclonal antibody used for RSV prophylaxis, on reducing RSV- related hospitalizations. It will be conducted at 8 pediatric departments in Tuscany, Italy. First, a matched case-control study investigates the real-world effectiveness of Nirsevimab in preventing RSV-related lower respiratory tract infection (LRTI) hospitalizations during the RSV epidemic season 2024-2025. Second, a descriptive study examines how the Nirsevimab immunization campaign affects RSV epidemiology, focusing on patients' age, comorbidities, infection severity, and clinical outcomes. The findings aim to optimize RSV prevention strategies and inform public health policies.


Eligibility Criteria:
Inclusion Criteria:

Case patients

* Age \<12 months
* Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission
* Positive RSV PCR on nasopharyngeal swab Control patients
* Age \<12 months
* Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission
* Hospitalized for conditions other than respiratory infections

Exclusion Criteria:

* Parental refusal
* Previous immunization with Palivizumab
* Previous maternal RSV vaccine immunization during pregnancy
Multiomics Tumor Evolution Model of NSCLC

The purpose of this study is to determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.

Lung cancer is the leading cause of cancer-related death globally. Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancer and surgery is still the main treatment strategy. This study will determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old;
2. Early-stage NSCLC patients underwent radical surgical resection;
3. Sufficient tumor tissue and blood sample for study use;
4. Available clinical-pathologic data, imaging data and follow-up date;
5. Written informed consent.

Exclusion Criteria:

1. History of other malignant tumors;
2. Evidence of distant metastasis before surgery;
3. Insufficient tumor tissue or blood sample for study use;
4. Clinical-pathologic data, imaging data or follow-up date is not available;
5. Other judgments by the Investigator that the patient should not participate in the study.
Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus

This trial is conducted globally. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide versus Empagliflozin in Subjects with Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening
* HbA1c (glycosylated haemoglobin) of 7.0-10.5 % (53-91 mmol/mol) (both inclusive)
* Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose as documented in the subject medical record) at least 90 days prior to the day of screening

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).For certain specific countries: Additional specific requirements apply
* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
* History of pancreatitis (acute or chronic)
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
* Subjects presently classified as being in New York Heart Association Class IV
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Subjects with ALT (alanine aminotransferase) above 2.5 x upper normal limit
* Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days
* Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
* History of diabetic ketoacidosis
Personalized Vaccine for Patients With Recurrent Malignant Glioma

A single-arm, single-center, open-labeled study will be conducted with an aim to investigate the feasibility, safety, and efficacy of the personalized vaccine for patients with recurrent malignant glioma.


Eligibility Criteria:
Inclusion Criteria:

* age 18-70;
* signed inform consent;
* patients with recurrent malignant glioma; have received surgery, radiotherapy, chemotherapy;
* patients' tumor tissue should have a high mutation load(\>10 TMB); be genetically unstable; at least have 10 neoantigens;
* should be able to provide tumor tissue and peripheral blood for sequencing and flow cytometry analysis;
* at least three months post last operation; one month after the completion of the last anti-drug therapy or radiotherapy;
* have not received any immune therapy;
* at least have one measurable lesion;
* KPS \>60;
* estimated survival \> 3 months
* patients should have adequate organ and bone marrow function;

Exclusion Criteria:

* female patient is breastfeeding or pregnant;
* known history of allergy to peptides or other stimulating factors (i.e. GM-CSF);
* known history of Graft-Versus-Host Disease (GVHD);
* participation in gene therapy;
* other malignancy;
* systemic disease: i.e., severe infection; HIV;
* other conditions upon investigator's judgement;
Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older

The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.

The study duration will be up to approximately 12 months minus the screening period.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday).
* Informed consent form (ICF) has been signed and dated
* A female participant is eligible to participate if she is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

-Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Lidocaine Usage for Pupil Dilatation (Mydriasis)

The purpose of this study is to determine if the mydriatic effect of intracameral lidocaine 1% is as effective as topical cyclopentolate 1% and phenylephrine 10% for achieving effective mydriasis during phacoemulsification surgery.

Former studied done on the effect of Intracameral lidocaine 1% compared to topical mydriatic agents for achieving effective mydriasis during phacoemulsification surgery have compared 2 different groups of patients, ie; One group received topical agents and the other received intracameral lidocaine. The resultant pupil size was recorded and evaluated in the 2 groups. Our purpose is to compare the effect of these agents on the same group of people.

Patients recruited will be invited first for evaluation at least 1 week before the surgery. During this evaluation 1 dose (drop) of topical cyclopentolate 1% and Phenylephrine 10% will be instilled to the evaluated eye 3 times at 10 minutes intervals. After 1 hour from the last instillation pupil diameter will be recorded. In the second part of this study during the phacoemulsification surgery patients will be given intracamerally lidocaine 1% (0.2 ml) and the pupil size will be recorded after 90 seconds. the resultant values will be evaluated/compared.

Eligibility Criteria:
Inclusion Criteria:

* cataract
* men and women
* can read and sign informed consent form

Exclusion Criteria:

* sensitivity to Lidocaine
* sensitivity to Ephrine
* any other ocular surgeries
* diseases like Adie's pupil, Horner syndrome