cyrilzakka/clinical-trials huggingface dataset:
Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM)

The 16-week trial is an open-label cross-over trial which includes heamodialysis patients with T2D and T1D on insulin therapy. During one period, patients carry a non-blinded CGM. In the other period they follow standard procedures (the last two weeks with a blinded CGM). The patients and the dialysis staff can use the CGM measures to regulate insulin and food intake during the non-blinded weeks. The research group will collect the CGM-data during the trial.

Background: Managing diabetes is often problematic in haemodialysis (HD) patients. Low blood glucose is especially common during treatment. Typically, the patient's blood sugar is only measured during treatment if considered relevant. Otherwise, HbA1c is used to control diabetes - a method associated with uncertain in HD patients. An alternative or supplement to the current management of diabetes could be CGM which enables closer observation and management of the diabetes disease. Despite the possibilities of using CGM, there are still few studies in the field which examine the importance of CGM data in relation to the management of diabetes in HD patients.

Aims: To investigate whether the use of CGM data can prevent low blood sugar levels during HD and examins whether the use of CGM data can improve the management of diabetes in HD patients. Furthermore, it is found relevant to investigate if CGM data, selected blood test responses, treatment data, personal data and information about medicines can be used to predict low blood sugar during HD using an algorithm. Thus, the study also aims to develop and validate such an algorithm.

Setting: The trial will be conducted at two dialysis wards (Aalborg and Hjørring) at Aalborg University Hospital.

Subjects: Heamodialysis patients with T1D and T2D on insulin therapy.

Study design: The 16-week trial is an open-label cross-over trial. During one period, patients carry a non-blinded CGM. In the other period they follow standard procedures (the last two weeks with a blinded CGM). The patients and the dialysis staff can use the CGM measures to regulate insulin and food intake during the non-blinded weeks. The research group will collect the CGM-data during the trial. The last four weeks include baseline measures (blinded CGM).

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Chronically ill heamodialysis patients (heamodialysis or heamodiafiltration - treatment)der modtager HD- eller hæmodiafiltrationsbehandling på dialyseafsnit,--
* Patients at dialysis wards in Aalborg and Hjørring, Aalborg University Hospital (center and home patients)
* T1D or T2D and in treatment with insulin
* Being able to use CGM equipment
* Signed consent

Exclusion Criteria:

* Pregnancy or breastfeeding,
* Terms that, in the opinion of the investigator or subinvestigators, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate
* Patients undergoing peritoneal dialysis (PD) or heamofiltration dialysis (HF)
* Acute HD treatment
* Gestational diabetes
IL-2 in Refractory Autoimmune Encephalitis

The purpose of this study is to determine whether low-dose IL-2 is effective in refractory autoimmune encephalitis.

Autoimmune encephalitis is a recently recognized etiology of encephalitis which is mediated by various autoantibodies targeting neural cells or synapses. The responses to immunotherapy is generally good, considerable proportion of patients with autoimmune encephalitis have unfavorable clinical outcomes. Recently, depletion of regulatory T cell (Treg cell) is reported in variable autoimmune diseases and multiple studies have shown that low-dose interleukin-2(IL-2) specifically activates Treg cells to control autoimmunity and inflammation.

Protocol: This study is a single arm open-label study assessing clinical responses to the administration of low-dose IL-2 in autoimmune encephalitis patients who are refractory to first- and second-line immunotherapy.

Objective: To assess the efficacy of low-dose IL-2 in autoimmune encephalitis, resistant to first- and second- line immunotherapy.

Methods: This is a single arm open-label study. Each patients will receive four cycles of subcutaneous Proleukin (Interleukin-2, IL-2) (Week-1; 1.5 million IU (MIU)/d from Day-1 to Day-5, Week-3, -6, -9; 3MIU/d from Day-1 to Day-5) in the hospital. The patients will be followed up for 3 months (Week-21).

Primary outcome - clinical efficacy by modified Rankin Scale Secondary outcome - Immunologic follow-up of Treg cells before, during, and after IL-2 therapy, quality of life, cognitive function, side effect of low-dose IL-2

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Clinical diagnosis of autoimmune encephalitis
* Positive for autoantibody (serum and or CSF) : NMDAR, anti-leucine-rich glioma inactivated-1(LGI-1), contactin-associated protein-like 2 (CASPR2), α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPA) 1, AMPA2, GABAB-R, anti-Hu, -Yo, -Ri, -Ma2, -CV2/collapsing response mediator protein 5 (CRMP5), -amphiphysin, or glutamic acid decarboxylase (GAD)
* Refractory to first-line (high-dose steroid or intravenous immunoglobulin) and second line (rituximab or cyclophosphamide) immunotherapy
* Written informed consent form.

Exclusion Criteria:

* low hemoglobin \<8.0 g/dL, absolute neutrophil count\<1600/mm3, lymphocytes \<600/mm3, platelets \<140,000/mm3
* heart failure (≥ grade III NYHA), hepatic insufficiency (aspartate amino transferase \>200 IU/L, amino alanine transferase, \>200 IU/L), or lung failure
* Positive for HIV serology, active hepatitis B
* Significant abnormality in chest X-ray other than these linked to the diseases under investigation
* Infection
* Other progressive neurological degenerative disease.
* Poor venous access not allowing repeated blood tests
* pregnant or lactating women
Radiological Spectrum Of Fatty Liver Correlate With High Resolution Ultrasonography Of Fibrosis And Cirrhosis

Fatty liver is a condition in which fat builds up in liver. it is very common health issue.it is major public health problems in the world. there is particular concern because fatty liver causes mortality among patients. The incidence and prevalence of disease vary with time. Fibrosis is thickening of connective tissues which is usually as a result of injury and long term inflammation. Cirrhosis is severe scarring of liver which is caused by long term liver damage. The scar tissue replaces healthy tissues which leads to loss of liver function. The Objective of study is to look into radiographic features of fatty liver disease. The high resolution ultrasonography will give more detailed view of disease. The study inclued 150 participants.

The other liver conditions like fibrosis and cirrhosis are also examined and correlated with fatty liver disease. The CT and MRI are used to compare with HR ultrasonographic findings. Descriptive statistics and comparative statistics are used to interpret data.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of fatty liver (steatosis), fibrosis, or cirrhosis.
* Patient consent to undergo imaging and participate in the study.

Exclusion Criteria:

* Other Liver Diseases: Exclusion of patients with other significant liver conditions (e.g., viral hepatitis, autoimmune liver diseases) unless specified.
* Pregnant women may be excluded due to imaging concerns.
* Poor quality or incomplete imaging studies.
* Presence of other severe systemic illnesses that could affect liver function or imaging.
* Recent liver surgeries or invasive procedures that might affect imaging results
Study to Assess the Use of Lanreotide Autogel® 120 mg in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) in Routine Clinical Practice

The main aim of this study is to assess the Progression-Free Survival (PFS) at 12 months of Lanreotide Autogel 120 mg use when administered as part of routine GEP-NET treatment and to follow patient treatment pathways, identify prognostic factors of PFS, evaluate patient's QoL, and patient's and clinician's satisfaction with treatment in routine long-term care setting. The study will provide real-world evidence on the use of Lanreotide Autogel 120 mg and will provide information on topics such as optimization of product usage and identification of best practices and will provide evidence on product effectiveness in a realistic setting.


Eligibility Criteria:
Inclusion Criteria:

* Functioning or non-functioning histopathologically confirmed, locally advanced or metastatic (grade 1 or grade 2 according to the World Health Organisation (WHO) 2017 classification and European Neuroendocrine Tumour Society (ENETS) grading system) GEP-NET G1,G2 (Ki67≤10%, based on recent Ki67).
* Measurable disease, as defined by RECIST 1.0, on a CT scan/MRI obtained up to 6 weeks prior to initiation of treatment with Lanreotide Autogel 120 mg.
* Subject eligible for treatment with Lanreotide Autogel 120 mg or subject currently being treated with Lanreotide Autogel 120 mg administered every 28 days for a period no longer than 5 months prior to inclusion
* Treatment with Lanreotide Autogel 120 mg alone, according to local Summary of Product Characteristics (SmPC).

Exclusion Criteria:

* Lanreotide Autogel treatment for more than 5 months prior to inclusion into the study
* Concomitant anti-proliferative medication/therapies for GEP NET at initiation of Lanreotide Autogel treatment (e.g. Peptide Receptor Radionuclide Therapy (PRRT), cytotoxic chemotherapy, targeted therapy everolimus, sunitinib, interferon, loperamide).
* Has been treated with PRRT, chemotherapy, everolimus, sunitinib or interferon within 3 months prior to initiation of Lanreotide Autogel treatment
* Parallel participation in an interventional study
Health Effects of Oat and Oat Polar Lipids in Human

Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods.

The overall goal is to increase the knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on cardiometabolic test markers of oat and oat based product. The new knowledge will form a base for the development of oat based food products with added health values.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* BMI 18.5 - 28 Kg/m2
* Non smokers
* Consuming a non-vegetarian diet that follows the Nordic diet recommendation.

Exclusion Criteria:

* Fasting blood glucose concentration \>6.1 mmol/l
* Known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome).
* Gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies.
* No antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.
Obstructive Sleep Apnoea in Adolescents With Thoracic Aortic Aneurysm

The objective of this prospective cohort study is to determine the prevalence of obstructive sleep apnoea (OSA) in patients with and without thoracic aortic aneurysm.

The objective of this prospective cohort study is to determine the prevalence of obstructive sleep apnoea (OSA) in patients with and without thoracic aortic aneurysm.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Diagnosis of thoracic aortic aneurysm defined by the following parameters:

Women: at the level of the sinus of valsalva ≥39mm, or ascending aorta ≥42mm. (for controls: \<39mm and \<42mm respectively); Men: at the level of the sinus of valsalva ≥44mm, or ascending aorta ≥46mm. (for controls: \<44mm and \<46mm respectively)

Exclusion Criteria:

* Patients on continuous positive airway pressure (CPAP) therapy for OSA at baseline.
* Patients with known central sleep apnoea.
* Patients on morphine or other opioid medication, heroin addiction, alcohol addiction.
* Patients with moderate or severe aortic regurgitation.
* Patients with moderate or severe aortic stenosis.
* Pregnant patients.
Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial

This study assesses the effectiveness of a nutrition advice programme - The ten steps for healthy feeding of children under two years old - on nutritional status, diet, and morbidity history of children. This is a randomized controlled trial in mostly socioeconomic deprived families (intervention=200; controls=300). Mothers of the intervention group received dietary counseling in the first year of life. Both groups received routine care by their paediatricians and research assessment at 6 and 12 months, 4 years, 8 years and 12 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Newborn infants with birth weight ≥ 2.500 g and gestational age ≥ 37 weeks were considered eligible for the study.

Exclusion Criteria:

* HIV-positive mothers
* Congenital malformation
* Infants referred to intensive care unit
* Multiple pregnancy.
HCV RNA Fingerstick Assay as Useful Point of Care of Diagnostic Tool for Drug Users in Brussels

The main objective of this study is to assess the interest (linkage to care) of the Cepheid GeneXpert HCV VL Fingerstick test in Brussels among drug users or former users in contact with the Réseau Hépatite C Bruxelles organization through different partners of this network.


Eligibility Criteria:
Inclusion Criteria:

* (ex) drug users
* a risk of Hepatitis C infection
* French speaking
* Either patient with a positive serology for HCV who have never performed HCV RNA by Polymerase chain reaction (PCR) by a peripheral venous sampling (due to difficult venous access, financial problem, medical insurance problem or other reasons) either patient with a suspicion of reinfection for whom the HCV RNA PCR by peripheral venous sampling is not reimbursed by health insurance

Exclusion Criteria:

* Age \<18 years
* Cepheid GeneXpert HCV VL Fingerstick will not use to assess the Sustained Virological Response (SVR) at 12 weeks after the end of an antiviral treatment
Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease

This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in Acute Myeloid Leukemia Minimal Residual Disease(AML MRD).

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-020a in patients with AML MRD, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.


Eligibility Criteria:
Key Inclusion Criteria:

* Provision of signed and dated informed consent form(ICF)
* ≥18 years old
* Subject diagnosed of AML MRD.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Adequate organ function as defined in the protocol
* Donor specific antibody (DSA) to QN-030a: MFI ≤ 2000

Key Exclusion Criteria:

* Allergic to drug used in this study
* Accept other anti-tumor drug within 2 weeks of day 0 (first QN-030a dose infusion)
* Prior allogeneic hematopoietic stem cell transplant (HSCT) within 6 months of Day 0, received systemic immunosuppressive therapy within 7 days of Day 0, or likely to require systemic immunosuppressive therapy
* Acute Promyelocytic Leukemia (APL)
* Active central nervous system Leukemia.
* Uncontrolled, active clinically significant infection
* Clinically significant cardiovascular disease as defined in the protocol
* History of central nervous system (CNS) disease such as stroke, epilepsy.
* Females are pregnant or lactating
* Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
* Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
Antibiotic Prophylaxis When Removing Ureteric Stent After Stone Surgery

Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents cystoscopically after stone surgery?

Many patients undergoing stone surgery receive a ureteric stent that should be removed after 14 days. This stent is removed cystoscopically and today this is done without giving antibiotics. Some patients get urinary tract infections subject to this. However the investigators do not know how many of these patients get UTI as most are followed by their primary care doctor. With this study the investigators would like to find out whether it is possible to avoid such infections and also find out how many actually do get infected.

Eligibility Criteria:
Inclusion Criteria:

* stone surgery patients with ureteric stent that should be removed after 14 days

Exclusion Criteria:

* ongoing antibiotic treatment, allergy to trimetoprim-sulfa
Effect of Dual Task on Upper and Lower Extremity Skills in Parkinson's Disease

The aim of the study is to investigate the change of lower and upper extremity skills with dual task in Parkinson's disease patients and to determine the differences between Parkinson's disease patients with different stages of disease and the healthy controls regarding the change of lower and upper extremity skills with dual task.


Eligibility Criteria:
Inclusion Criteria:

* Modified Hoehn \& Yahr (H\&Y) stages 1 to 3
* at least 40 years of age
* 21 or more MoCA score.

Exclusion Criteria:

* other neurologic disorder
* any orthopedic problem that could prevent to participate in the study
* severe dyskinesia or tremor
* visual or speech problems
Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.


Eligibility Criteria:
Inclusion Criteria:

* ≥21 years of either gender or any race
* Potential post-op VA 20/20
* Pre-op astigmatism ≤ 1.0D
* Able to sign the informed consent
* Able to complete all required postoperative visits
* Planned cataract removal by phaco
* Clear intraocular media other than cataract

Exclusion Criteria:

* Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture
* Any corneal pathology and previous corneal refractive surgery
* Patients with unrealistic expectations in anticipated post-op VA
* Happy to wear glasses
* Occupational night driver
Revealing Engagement Patterns Among Endometrial Cancer Patients

The study intends to investigate the personal experiences of endometrial cancer patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.

The data collected from this study will help improve future outcomes for all endometrial cancer patients as well as those in under-represented demographic groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with endometrial cancer
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

Exclusion Criteria:

* Refusal of consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Any serious and/or unstable pre-existing medical disorders
Phase 1 Single and Multiple Dose Study of FPA008 in Healthy Volunteers and Rheumatoid Arthritis Subjects

This is a Phase 1, randomized, double-blind, placebo-controlled study designed in 3 parts to assess the safety, tolerability, and PK of single and multiple ascending doses of FPA008 in adult healthy volunteers (Parts 1 and 2) and adult subjects with active RA (Part 3).

Approximately 56 healthy volunteers will be enrolled at 1 study center in the Netherlands for Parts 1 and 2, and approximately 39 subjects will be enrolled at up to 6 sites in Central and Eastern Europe for Part 3. Dose escalations in Parts 1 and 2 will be driven by an assessment of the safety profile. Review of safety and PK parameters may inform decisions to add cohorts with intermediate dose levels in order to reach an optimal target exposure.

Eligibility Criteria:
Inclusion Criteria:

Part 1 and 2:

* Healthy adult male and female subjects between the ages of 21-55 years inclusive.
* Subject must be willing to remain in the Clinical Research Unit (CRU) for a minimum of 72 hours after each dose.

Part 3:

* RA male and female subjects between the ages of 21-70 years inclusive
* Evidence of active RA disease
* Inadequate response to biologic or non-biologic DMARDs
* Subjects will be required to be on background therapy with methotrexate.

Exclusion Criteria:

Parts 1, 2 and 3:

* BMI \<18 or \>32 kg/m2
* Clinically significant findings in physical exams and laboratory tests at screening and/or baseline
* Unwilling to abstain from alcohol for 48 hours prior to study start, during CRU confinement, as applicable, and for 48 hours prior to study visits.
* Unwilling to abstain from exercise more strenuous than walking during CRU confinement, as applicable, and for 48 hours prior to study visits.

Parts 1 and 2:

* Use of any prescription, non-prescription, or herbal medications as well as supplements or vitamins within 4 weeks prior to dosing, unless approved by the Investigator.
* Smoking more than 10 cigarettes, or the equivalent, per day.

Part 3:

* Current or previous history of inflammatory joint disease other than RA
* Evidence of extra-articular RA disease or systemic involvement
* Currently taking any medications other than those allowed per protocol guidelines
* Any surgical procedure including bone or joint surgery within 12 weeks prior to dosing
* Use of intra-articular (IA), intramuscular (IM), or IV corticosteroids for RA
* Neuropathies and neurovasculopathies
* Concomitant use of statins while on study.