cyrilzakka/clinical-trials huggingface dataset:
(NOD)-Like Receptors CARD Domain-Containing 4 Levels in Individuals With Periodontitis

NLRC4, an inflammasome , is a cytosolic multiprotein complex involved in the initiation and modulation of the immune response. Periodontitis is a chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. It has been said that proinflammatory cytokines released in the microenvironment of periodontitis can increase the expression of NLRC4 inflammasome genes. The authors think that NLRC4 may play a role in the periodontitis. The aim of this study is to compare the NLRC4, IL-1β and IL-10 levels of healthy and periodontitis individuals.

Periodontitis is a destructive chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. Inflammasomes are cytosolic multiprotein complex involved in the initiation and modulation of the immune response.

Interleukine -1β ( IL-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. Interleukine-10 (IL-10) has been reported to decrease periodontal disease progression rate.

Gingival crevicular fluid shows the cellular response in the periodontium. The most important host-related ingredients are inflammatory markers, including cytokines, enzymes, and interleukins. Saliva analysis is used in the diagnosis of systemic conditions as well as in the diagnosis of oral pathologies.

Both NLRC4 and NLRP3 inflammasomes have been shown to play an important role in the induction of interleukin-1β secretion. Periodontitis is induced by a complex microbial biofilm containing multiple Gram-positive and Gram-negative bacteria (including flagellate microorganisms) capable of activating a large number of NLRs. It has been said that proinflammatory cytokines released in the microenvironment of periodontitis can increase the expression of NLRC4 inflammasome genes. Evidence on the role of inflammasomes in periodontal disease is still very poor. The aim of this study is to compare the NLRC4, IL-1β and IL-10 levels of healthy and periodontitis individuals.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy individuals who does not have a disease under treatment, individuals without regular systemic medication

Exclusion Criteria:

* smoking receiving periodontal treatment in the last 6 months pregnancy menopausal or menstrual period
SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 years or older at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
* The need and willingness to change prior GLP-1 RA treatment to once-weekly semaglutide s.c., as assessed by the investigator.
* HbA1c of 6.5-10% (48-86 mmol/mol) (both inclusive).
* Treatment with any therapeutic dose of GLP-1 RA other than once-weekly semaglutide s.c., as defined in the local label, with or without OADs (metformin, DPP-4 inhibitor, SU, glinide, thiazolidinedione, SGLT-2 inhibitor or alpha-glucosidase inhibitor). All doses of antidiabetic treatments should have been stable for at least 90 days prior to the day of the screening, at investigator's discretion.

Exclusion Criteria:

* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m2 according to Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Study to Improve Healthy Eating for At-Risk Older Adults

This application, funded by the American Association of Retired Persons(AARP) Foundation, is to implement the Healthy Eating for at Risk Older Adults (HERO) initiative. This initiative will address barriers of affordability, and reduced mobility by providing older adults with nutritious foods that are usually difficult to purchase due to high cost; delivering needed foods to individuals in their homes; tailoring food delivery frequency based on level of food insecurity; and offering basic nutrition education.


Eligibility Criteria:
Inclusion Criteria:

* 55 years old or older
* if member of Boston Medical Center's Elders Living at Home Program: Not currently homeless and expect to live at current residence or in the area for next 6 months
* if NOT member of Boston Medical Center's Elders Living at Home Program: Not currently homeless, live at public housing development, and plan to live there for at least next 6 months
* Able to understand, speak and read English

Exclusion Criteria:

* Follows a special diet that cannot be accommodated, as ascertained by clinical judgment of the nurse.
Sunitinib and Atrial Trabeculae Contractility

Rationale:

Recently, sunitinib (a tyrosine kinase inhibitor that is used for treatment of metastatic renal carcinoma and gastrointestinal stroma tumors) has been associated with development of heart failure, possibly by off-target inhibition of AMP-protein kinase. The investigators hypothesize that sunitinib reduces the contractile ability of myocardium and the tolerance against ischemia-reperfusion and that activators of AMP-protein kinase such as atorvastatin and AICAR reverse this unwanted effect of sunitinib.

Objectives:

The primary objective of the study is to investigate the effect of sunitinib on ex-vivo atrial contractile force in absence and presence of ischemia-reperfusion.

A secondary objective is to explore if atorvastatin or AICAR prevent sunitinib-induced deterioration of contractile function of human atrial trabeculas. Study design: Lab

Study population: 44 (+22) patients undergoing CABG cardiac surgery with extracorporal circulation Intervention (if applicable): none (pharmacological interventions will only be performed ex-vivo in isolated atrial tissue) Main study parameters/endpoints The developed force in ex vivo atrial trabeculas during standardized stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery with extracorporal circulation

Exclusion Criteria:

* Use of oral antiarrhythmics
* theophylline use
* Use of sulfonylureas
* Atrial arrythmias
* Right ventricular failure
Evaluation of New Histoprognostic Criteria in a Retrospective Study of Colon Cancers Operated at Amiens University Hospital

Colon cancer is a very common cancer. Prognosis and adjuvant treatment depend on the pathological results. Histoprognostic new factors have recently been published by several authors, but their validity is still debated.


Eligibility Criteria:
Inclusion Criteria:

* All patients operated on for colon adenocarcinoma between 2004 and 2009 at the University Hospital of Amiens

Exclusion Criteria:

* Non-operated patients
* Patients operated on before 2004 or after 2009
* Patients operated in another center
* The other histological types
* Vicinity of tumors invading the colon by contiguity
* Colic metastasis
* Patients whose blocks or blades were not found in the archives.
ADAs to Alemtuzumab

The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period

Primary To quantify the longitudinal changes in alemtuzumab ADAs over a 24 month period.

Secondary

1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2.
2. Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions.
3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.
4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels.
5. Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with RRMS who are being treated with alemtuzumab at Barts Health NHS Trust will be approached to participate in the study.
2. Patients must be willing and able to undergo blood tests.

Exclusion Criteria:

1. Ineligible for alemtuzumab under NHS England prescribing guidelines.
2. Those unable to comply with study requirements, including frequency of visits. Abnormal baseline investigations (WBC\<3 x 10\*9/l, lymphocytes \<1.0 x 10\*9/l, neutrophil count \<1.5 x 10\*9/l, platelet count \<100 x 10\*9/l, haemoglobin \<110 g/l, LFT \>/3x upper limit of normal of site reference ranges, potassium \<2.8 mmol/l or \>5.5 mmol/l, sodium /,125 mmol/l, creatinine \>130 umol/l).
MRI of Sacroiliac Joints: Evaluation of Accuracy of Dixon Sequences in the Diagnosis of Axial Spondyloarthritis

The investigators hypothesize that the T1 Dixon post-Gadolinium and T2 Dixon sequences will show good diagnostic performances for active sacroiliitis compared to the reference test (Short tau inversion recovery) and clinical-biological criteria, which will allow a better diagnosis of active sacroiliitis


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* The patient has a clinically diagnosed axial spondyloarthritis (axSpA) (ASAS or AMOR classification)
* Patient has an active axSpA (BASDAI\>4)

Exclusion Criteria:

* The subject is participating in another study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breastfeeding
* The patient has a contra-indication
Universal Genetic Testing for Cancer Risk Reduction

The purpose of this research study is to see if offering genetic testing for cancer-related genes is feasible and acceptable for patients presenting for gynecology clinic visits, instead of needing to see specialized providers or needing to meet specific criteria. The primary aim to assess the proportion of patients who undergo genetic testing, and the proportion of patients with pathogenic variants.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients between ages of 25-39 years at the time of visit
2. Receive gynecologic care at an affiliated NYU Langone Health (NYULH) site listed in this protocol.

Exclusion Criteria:

1. Personal history of ovarian, fallopian tube, primary peritoneal, or uterine cancers
2. Previously undergone germline testing for ovarian cancer risk variants (prior commercial saliva-based kits, such as 23andMe, are acceptable)
3. History of bilateral salpingo-oophorectomy
4. Visit related to pregnancy or immediately postpartum (within 2 weeks)
Thoracentesis: Symptoms and Prediction of the Need for Therapeutic Thoracentesis

Recurrent fluid surrounding the lungs is associated with poor quality of life, the main symptom being dyspnea. These patients are in need of recurrent removal of the fluid using drainage. The mechanism causing dyspnea is not fully understood.

By using ultrasound to evaluate the movement of the diaphragm before and after removal of fluid and the patients symptoms before removal of fluid and until next removal the research group aims to clarify the temporal development in symptoms and the role of the diaphragm.

The researchers will also evaluate the ability of the pulmonologist and patient to predict when the patient will need the next removal of fluid in patients with recurrent unilateral pleural effusion.

Recurrent pleural effusion (PE) is associated with impaired quality of life, the main symptom being dyspnea. The mechanisms causing dyspnea in PE is not fully understood. These patients are in need of recurrent therapeutic thoracentesis.

By evaluating the movement of diaphragma before and after thoracentesis and measure the patients symptoms before thoracentesis and until the next thoracentesis the researchers aim to clarify the temporal development in symptoms and the role of the diaphragm.

The researchers will also evaluate the ability of the pulmonologist and patient to predict when the patient will need the next therapeutic thoracentesis in patients with recurrent unilateral pleural effusion.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Unilateral pleural effusion.
* A minimum of two thoracentesis prior to inclusion.
* Patients must be able to give informed consent.

Exclusion Criteria:

* Bilateral pleural effusions.
* Inability to understand written or spoken Danish.
Regenerative Surgical Treatment of Peri-implantitis

The purpose of the study is to evaluate if surgical treatment of peri-implantitis with enamel matrix derivative (Emdogain®, EMD) will have an additional effect on the healing outcome, changes in the peri-implant microflora and on the inflammatory response in the periimplant pocket at 12 months.

This is a randomised controlled clinical trial. Recruiting 31 patient with periimplantitis at one or more implants in need for surgical treatment.

Randomisation to test group (EMD) with surgical treatment and additional application of enamel matrix derivative (Emdogain®) or surgical treatment alone in the control group (non-EMD).

Treatment of existing periodontitis performed before recruitment. Baseline examination including samples of microbiota and peri-implant fluid followed by surgical treatment. Access surgery to remove chronic inflammatory tissue and clean the implant surface from biofilm and implant stone with hand instrument and ultrasonic device with special tips for implants, followed by polishing the implant surface with a gauze, super floss and rinsing with saline. Allocation with a performed block randomisation at the stage of surgery, after cleaning of implant surface. Application of enamel matrix derivative (Emdogain®) or not, just before closure of flap. After surgery rinsing with chlorhexidine 0.2% twice a day in 6 weeks. No systemic antibiotic used in this study.

Supportive care program, including hygiene instructions and professional cleaning supragingival at implants and teeth at 2 weeks, 3, 6, 9 and 12 months after treatment.

Examination with measurements of pocket depth and bone levels at radiographs at baseline just before surgery and 12 months and prevalence of bleeding on probing, pus or recession as well as full mouth plaque score and full mouth bleeding score at 3, 6, 9 and 12 months.

Microbial sampling performed with endodontic paper points at baseline and 2 weeks after surgery as well 3, 6 and 12 months from implant site with at baseline the deepest pocket.

Sampling of the peri-implant fluid from the peri-implant pocket at baseline, 3, 6, and 12 months from implant site with at baseline the deepest pocket.

Removal of bridges performed to give accessibility at baseline examination/surgery and at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* peri-implant angular bone loss ≥3 mm, measured at radiographs
* deep pocket ≥5 mm combined with bleeding and/or pus

Exclusion Criteria:

* individuals with uncontrolled diabetes (HbA1c \> 7,0%)
* individuals where prophylaxis of antibiotic is indicated
* medication with prednisolon or other anti-inflammatory drug
* medication with gingival hyperplasia known as a side effect
* systemic antibiotic intake the last 3 months
Effect of Angiotensin Receptor Blockade on Insulin Resistance and Adipose Tissue Cytokines in Type 2 Diabetes

The study aims to investigate the effect of acute angiotensin receptor blockade on insulin action/insulin resistance and expressions of selected adipocytokines in subcutaneous adipose tissue in insulin-resistant subjects with type 2 diabetes and healthy controls.

Hypothesis: Changes in adipocytokine concentrations and/or expressions and different reactions to acute in vivo induced hyperinsulinemia and angiotensin receptor blockade will be found in patients with type 2 diabetes compared to healthy subjects. A significant relationships between insulin sensitivity and selected adipokines and intracellular fat content and high energy phosphates in soleus muscle will be documented in healthy individuals, while no significant relation will be found in patients with type 2 diabetes.

10-15 patients with type 2 diabetes and 10-15 healthy control subjects will be examined on an outpatient basis. The following examination will be carried out in each subject after 12 hrs fasting:

* Oral glucose tolerance test (75 g of glucose) (in healthy subjects to confirm the normal tolerance of glucose).
* Evaluation of insulin secretion after 1 mg of glucagon i.v.
* Hyperinsulinaemic (75 milly-international unit(mIU)/l) euglycemic clamp study lasting 4 hours combined with indirect calorimetry and biopsy of subcutaneous adipose tissue.
* Hyperinsulinemic (75 mIU/l) euglycemic clamp study lasting 4 hours combined with indirect calorimetry after losartan 100 mg given in the evening and in the morning before the study.
* Proton and phosphorus magnetic resonance spectroscopy.

Before (0 min), at 30 min and in the end of studies c) and d) the blood samples will be taken and biopsies of subcutaneous abdominal adipose tissue will be done.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 Diabetes treated with oral agents and/or diet
2. Healthy volunteers age- and sex-matched to type 2 diabetes, without any concomitant disease

Exclusion Criteria:

1. Type 2 Diabetes

   * treated with insulin
   * clinical evidence of atherosclerotic complications
   * advanced long-term diabetic complications (manifest nephropathy, proliferative retinopathy)
   * other internal disease
   * weight change \>10% 3 months prior to study
2. Healthy volunteers

   * fulfilling the criteria of metabolic syndrome
   * weight change \>10% 3 months prior to study
Exercise Improves Executive Function and Dual-task Decrements

A 12-week multicomponent exercise is effective in improving executive function and gait performance in dual-task conditions.


Eligibility Criteria:
Inclusion Criteria:

* age more than 65 years old
* ability to walk outdoor independently without assistive devices

Exclusion Criteria:

* unstable medical conditions interfering with participation in the study
* diagnosis of dementia, psychosis, neurological disease, and depression
* unable to receive external information for finishing the neuropsychological tests
Topical Rapamycin for Fibrofolliculomas

The purpose of the study is to determine whether topical application of rapamycin can lead to reduction in size and/or number of fibrofolliculomas in BHD patients and may prevent the growth of new ones. Secondary we evaluate rapamycin safety, formula acceptance and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years.
* At least 10 facial fibrofolliculomas, histologically confirmed.
* Entered in a screening program and free of malignancy as determined during screening (already had a baseline MRI or CT-scan).
* Being able to understand instructions.
* Mutation status must be known.
* For females: not pregnant and willing to use both oral and barrier contraceptives during the treatment period.

Exclusion Criteria:

* Not capable of informed consent.
* Age under 18 years.
* Pregnancy or failure to comply with contraceptive measures.
* Proven or suspected malignancy of skin or other organs.
* No histological confirmation.
* Skin lesions other than fibrofolliculoma that might worsen under sirolimus such as active infections.
* Not able to comprehend instructions.
* No proven mutation.
* Less than 10 fibrofolliculomas.
* Planned facial surgery in the treatment period.
* Concomitant disease requiring systemic immunosuppressive treatment
* Concomitant disease requiring facial topical immunosuppressive treatment or facial topical drugs that interfere with rapamycin during trail period or in the 30 days before start trial.
* Tendency to form keloids or hypertrophic scars.
* Drug or alcohol abuse.
An Evaluation of the Long-Term Impact of Assistive AI on Anaesthetists' Ultrasound Scanning for UGRA

A randomised, blinded interventional prospective study evaluating the long-term impact of assistive artificial intelligence on anaesthetists' ultrasound scanning for regional anaesthesia.

This is a randomised, blinded interventional prospective study which will be conducted and reported as per the Consolidated Standards of Reporting Trials - Artificial Intelligence (CONSORT-AI) guidance. The study end points have been defined prospectively, and data will be divided into two cohorts (with vs without ScanNav Anatomy PNB assistance). Participants will be asked to perform ultrasound (US) scanning on healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance, both with and without the device. The US scans will be recorded and blinded expert observers (without knowledge of whether ScanNav Anatomy PNB is in use) will also assess acquisition of an appropriate block view (panel of three experts, one viewing each scan as per the unblinded assessors). The initial assessment will be undertaken after a scanning tutorial and then repeated after 8-10 weeks (to assess longer-term impact of the device).

Eligibility Criteria:
Inclusion Criteria:

1. Anaesthetist in Stage 1 of UK Anaesthesia Core/Specialty Training (CT 1-3)
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study
3. Available to travel and attend the study day in person

Exclusion Criteria:

1. Aged \<18 years of age
2. Unwilling or unable to provide informed consent
3. Expert in UGRA (see definition above)