cyrilzakka/clinical-trials huggingface dataset:
Excretion of Radiolabelled AZD0837

This is an explorative study and the scientific question to be investigated in this study is if AZD0837 and/or its metabolites AR-H069927XX and AR-H067637XX and other unknown metabolites are excreted into the bile.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive

Exclusion Criteria:

* Significant illness, trauma or surgical procedures.
* Clinically significant laboratory abnormalities.
* Clinically significant medical history.
MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)

Based on the results of recent randomized controlled trials, current international guidelines recommend the initiation of endovascular treatment within 6 hours of symptom onset for acute ischemic stroke. Endovascular treatment may be beneficial in selected patients beyond 6 hour time window. In particular, treatment response to endovascular therapy may be greatly influenced by pretreatment collateral status. The aim of this study is to evaluate whether MRI-based collateral imaging (the Fast Analysis SysTem for COLLaterals, 'FAST-COLL') is feasible and can predict the response to endovascular treatment in a wide range of patients with acute ischemic stroke .


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke
* Age 20 years and older
* Disabling stroke defined as a baseline NIHSS \> 5 at the time of arrival
* Onset (last-seen-well) time to endovascular treatment time \< 12 hours
* Confirmed symptomatic intracranial occlusion, based on CT or MR angiography, at one or more of the following locations: Carotid T/L, M1 MCA, or M1-MCA equivalent (2 or more M2-MCAs)
* Signed informed consent or appropriate signed deferral of consent where approved

Exclusion Criteria:

* Baseline non-contrast CT reveals a moderate/large core defined as extensive early ischemic changes of ASPECTS 0-5 in the territory of symptomatic intracranial occlusion.
* Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic
* Unable to undergo MRI (contraindicated or poor cooperation)
* Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient
* Pregnant females as determined by positive urine hCG test or lactating females
The Effect of Reducing Total Volume of Sprint Exercise on Circulating Levels of BDNF

Regular exercise is well known to be required for good physical health, but exercise can also improve mental health. Although the effects of exercise on mental health have been shown in many studies, it remains unclear how exercise improves mental health. In recent years, the potential role of a specific protein called 'brain-derived neurotrophic factor' (BDNF) has received increasing attention. Higher levels of BDNF in the blood are associated with better cognitive performance, attention, and spatial memory. Conversely, low levels of BDNF in the blood are found in patients with depression, dementia, mild cognitive impairment, and Alzheimer's disease. BDNF can be released during exercise, with greater increases after exercise performed at higher intensities. For example, classic sprint interval training (SIT), which involves four 30-second 'all-out' cycle sprints, has been shown to lead to greater increases in BDNF compared to moderate or vigorous exercise. Although these results suggest that SIT is an effective way to increase BDNF, SIT is not generally considered feasible for patients or untrained members of the general public, because it is a very tiring type of exercise. However, other more manageable protocols have been developed, such as the 'reduced-exertion, high-intensity interval training' (REHIT) protocol, which involves two 20-second 'all-out' sprints within a 10-minute low-intensity exercise session. Although it is clear that BDNF levels increase in an intensity-dependent manner in response to exercise, the effect of exercise volume remains unknown. Exercise intensity is identical for SIT and REHIT, but if BDNF levels increase to a similar extent in response to both protocols, REHIT would constitute a more feasible intervention for use in patients and the general public. The aim of the present study is to compare the effects of REHIT vs. classic SIT on levels of BDNF in the blood. For this,15 study participants will be recruited, who will each complete a SIT session, a REHIT session, and a no-exercise control session. Levels of BDNF will be measured in blood samples taken at rest, as well as directly after exercise, 30 minutes after exercise, and 90 minutes after exercise. It will be determined whether the greater amount of sprint exercise in a SIT session will be associated with a greater increase in levels of BDNF in the blood compared to the REHIT session which consists of a lower amount of sprint exercise.


Eligibility Criteria:
Inclusion Criteria:

* Apparently health young male volunteers

Exclusion Criteria:

* Age \<18 y or \>40 y
* BMI \> 35 kg/m2
* participation in a structured exercise training programme at any time in the preceding 6 months
* suffering from acute (e.g., common cold, Covid-19, flu, etc) or chronic disease (e.g., diabetes, heart disease, cancer, etc)
* answering 'yes' to one or more questions of a standard physical activity readiness questionnaire (PAR-Q)
* resting heart rate ≥100 bpm
* clinically significant hypertension (\>140/90 mm Hg)
The Brain Health Study: A Pragmatic, Patient-Centered Trial

The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.

Detailed description: eRADAR stands for "electronic health record (EHR) Risk of Alzheimer's and Dementia Assessment Rule." It is a low-cost tool or algorithm that uses readily available EHR data elements to identify high-risk patients. The investigators will conduct a pragmatic randomized controlled trial to assess the impact of implementing eRADAR as part of a supported outreach process on dementia detection rates. The investigators will also explore the impact of eRADAR implementation on healthcare utilization and patient experience.

Eligibility Criteria:
Inclusion Criteria:

* No prior diagnosis of dementia (defined from EHR diagnosis codes) and not receiving medications for dementia
* Active patient at participating clinic
* Adequate data to calculate eRADAR score

Exclusion Criteria:

- Currently receiving hospice care
A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

During hemodialysis treatments, patients receive heparin to prevent clotting. The purpose of this pilot study is to determine if the amount of heparin administered during a patient's hemodialysis can be individualized using an equation for heparin dose adjustment.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Stable hemodialysis prescription prior to study enrollment
* Dialyzing through a native fistula or Gore-Tex graft
* Blood access must be able to provide a blood flow rate of 400 ml/min

Exclusion Criteria:

* Non-compliance with dialysis
* Hematocrit less than 28%
* Active Infection
* Diagnosis of Heparin-Induced Thrombocytopenia (HIT)
Confocal Laser Endomicroscopy

Confocal laser endomicroscopy (CLE) is a new diagnostic technique that allows microscopic examination of the digestive mucosa during ongoing endoscopy. Different types of tissue and diseases can be diagnosed immediately, and analysis of the in vivo microarchitecture is helpful to better target standard biopsies and reduce the number of biopsies required. CLE necessitates an intravenous injection of a fluorescent marker, e.g. fluorescein, to obtain 'optical biopsies' with a high level of magnification (up to 1000 fold). To date, more than 1000 endomicroscopy procedures have been performed in the world and different publications have shown the safety, feasibility and excellent diagnostic yield of CLE. No complication related to IV injection of fluorescein has been reported. However, all these data come from a very limited number of expert centres and need to be confirmed and validated at the multicenter level. The aims of this multicenter trial are: 1) to standardize CLE in all centres equipped in France, 2) to ensure the safety of intravenous fluorescein injection, 3) to test the diagnostic value of CLE in various conditions representative of the large spectrum of different cancerous and non-cancerous digestive diseases.


Eligibility Criteria:
Inclusion criteria:

* Patient between 18 to 70 years-old
* Symptoms or disease requiring an upper GI endoscopy or a colonoscopy performed under general anaesthesia
* Written informed consent obtained

Exclusion criteria:

* No indication for upper GI endoscopy or colonoscopy
* Treatment by beta-blockers
* Coagulopathy
* Dialysis for impaired renal function
* Pregnancy or breast-feeding
* Known allergy to fluorescein
* Pace-maker
* Severe cardiac or liver disease
* Emergency context- Zenker's diverticulum (for upper GI endoscopy) or recently complicated colonic diverticulosis (for colonoscopy)
* Patient's refusal
Study on How Fiasp® Can Influence Blood Sugar Levels of type1 Diabetic Patients in Their Daily Lives, With the Help of the Freestyle Libre® Device

The purpose of this study is to collect information about Fiasp® to evaluate how effective Fiasp® is in treating elevated blood sugar in patients with type 1 diabetes, compared with the participant's previous insulin treatment. The study will also assess how satisfied the participants are with the treatment with Fiasp® and the impact of the treatment on quality of life. The study has also been set up to learn more about how effective Fiasp® is in controlling the glucose levels during the day and night. The duration of the study is expected to be approximately 2 years. The participation is expected to be approximately 6-8 months for each patient.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
* The decision to initiate treatment with commercially available Fiasp® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with T1DM at least 1 year prior to inclusion in the study
* Stable treatment by MDI/CSII for at least 6 months prior to inclusion in the study. Stable treatment is defined as not changing the treatment method, with dose adjustments allowed
* Regular (defined as usage on a monthly basis) user of Freestyle Libre® flash glucose monitoring for at least 6 months as the only continuous glucose monitoring (CGM) system actively used and availability of a full 2 weeks sensor download as "csv" file with 80% completeness of the data (if more sensor data are available, the 2 week data closest to baseline visit will be used)
* Latest HbA1c value measured in the 3 months prior to inclusion in the study between 7.5-9.5%

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Anti-diabetic treatment intensification during the last 3 months prior to inclusion in the study. Treatment intensification is defined as adding new anti-diabetic medication to previous treatment regimen
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, certain intrauterine devices), or sexual abstinence or a vasectomised partner
Evoke Radiofrequency Device for Improvement of Skin Appearance

The aim of the study is to evaluate the safety, efficacy, patient comfort and patient satisfaction after Evoke treatment


Eligibility Criteria:
Inclusion Criteria:

* - Signed informed consent to participate in the study.
* Female and male subjects, 35 - 75 years of age at the time of enrolment
* If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
* In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause).
* General good health confirmed by medical history and skin examination of the treated area.
* Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
* The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.

Exclusion Criteria:

* - Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
* Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane.
* Current or history of skin cancer, or current condition of any other type of cancer, or premalignant moles.
* Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
* Pregnancy and nursing.
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
* Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
* Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
* Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
* Any surgery in treated area within 3 months prior to treatment.
* Six months delay is required if other recent treatments like light, CO2 laser or RF were performed on the same area.
* Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient
Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal

The primary objective of the present trial is to investigate, the mean operative time and to study the frequency and intensity of postoperative shoulder tip pain in patients undergoing laparoscopic surgery, i.e. cholecystectomy, colorectal surgery, hernia repair with AirSeal® compared with standard pressure CO2 insufflation systems. The primary hypothesis is that patients operated with AirSeal® have a shorter mean operative time and decreased frequency and intensity of postoperative shoulder tip pain compared with patients undergoing surgery with standard pressure CO2 insufflation systems.

It is the secondary objective of the trial to evaluate immunologic and anaesthesiological aspects of laparoscopic cholecystectomy, colorectal surgery and laparoscopic hernia repair by observing the immune responses and volume of mechanical ventilation of the two groups through measuring various immunologic factors and ventilation volume/CO2 elimination volume. Surgical side effects will also be measured as secondary objective.


Eligibility Criteria:
Inclusion Criteria:

* Patients recruited for laparoscopic surgery i.e. cholecystectomy, colorectal surgery, hernia repair
* Written informed consent
* ≥ 18 years of age

Exclusion Criteria:

* Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction
* ≤18 years of age
* Pregnancy and lactation
* Previous extensive abdominal surgery
* Acute surgical intervention
Impact of Microparticles on Postoperative Complications in Surgical Patients

Microparticles are cellular fragments which are released actively or passively under conditions of inflammation and stress. The impact of surgical operations on quantity and quality of microparticles remains unknown. In this observatory study we investigate quantitative and qualitative aspects of microparticles during cardiac and abdominal operations.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac or abdominal operations with a minimum expected operative time of 2 hours

Exclusion Criteria:

* Laparoscopic operations
* emergency operations
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants

The primary objective of the study is to:

• Evaluate the safety and tolerability of REGN5381 and REGN9035 administered alone or sequentially.

The secondary objectives of the study are to:

* Evaluate the ability of single intravenous (IV) doses of REGN9035 (compared to placebo) to reverse the acute hemodynamic effects of REGN5381
* Evaluate the hemodynamic effects of single IV doses of REGN5381
* Evaluate the persistence of the hemodynamic effects of single IV doses of REGN5381 and the reversal of REGN5381 effects by REGN9035 (compared to placebo)
* Evaluate the pharmacokinetics of single IV doses of REGN5381 and REGN9035 administered alone or sequentially


Eligibility Criteria:
Key Inclusion Criteria:

1. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the screening visit.
2. Normal or mildly elevated blood pressure as defined in the protocol.

Key Exclusion Criteria:

1. History of unexplained syncope or autonomic dysfunction.
2. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
3. Protocol-defined risk factors for cardiovascular disease.

Note: Other protocol defined inclusion / exclusion criteria apply
Effect of Ski Sport on Physical Performance

The aim of the study is to investigate the effect of ski sport on physical performance, pain, and quality of life compared to sedentary individuals of similar age groups and to examine the existence of gender-specific differences.

The aim of the study is to investigate the effects of skiing on physical performance, pain, quality of life, and gender-specific differences. In this context, aerobic/anaerobic performance, body balance, hand-grip strength, and back-leg-chest strength were evaluated in male and female ski athletes and age- and sex-matched sedentary controls.

In addition, pain experiences, low back pain-related disability level, and quality of life of all participants were questioned using SF 36, McGill Pain Questionnaire (MPQ), Oswestry Low Back Pain Disability Questionnaire (OLBPDQ), and VAS scales.

The data thus collected were used to determine whether skiing had any effect on physical performance and quality of life, as well as the possible impact of skiing on gender-specific differences.

Eligibility Criteria:
Inclusion Criteria:

Skiers Group;

* Being an active athlete for at least the last 2 year and affiliated with the National Ski Federation
* International Physical Activity Questionnaire-Short Form (IPAQ-SF) total score above 3000 METs min/week

Control Group;

* Being healthy and non-athletic with no ski experience
* Having similar sociodemographic characteristics with Skiers Group
* IPAQ-SF total score below 3000 METs min/week

Exclusion Criteria:

* History of surgery and/or serious trauma to the spine, lower and upper extremity,
* Chronic illnesses
* Substance addiction such as cigarette-alcohol, etc.
* During the study; the need of receiving treatment/ interventions due to trauma or any other conditions is concluded with withdrawal from the study
Prevalence of Steatosis and Steatohepatitis in Patients Undergoing Bariatric Surgery; a Biopsy-based Study

To study the prevalence of steatosis, steatohepatitis, and their associated risk factors in obese patients undergoing bariatric surgery.

A prospective single-center biopsy-based study was conducted on 162 sleeve gastrectomy patients. Patient characteristics, including age, sex, diabetes mellitus (DM) status, body mass index (BMI), liver function tests, lipogram, homeostatic model assessment of insulin resistance (HOMA-IR), and steatosis were also assessed using controlled attenuation parameter (CAP), and intra operative liver biopsies were obtained. , The presence of steatosis and steatohepatitis were histologically assessed by two expert pathologists.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic sleeve gastrectomy ≥18 years of age.
* Able to give written informed consent.
* Scheduled, independently from this study, to have a liver biopsy (LB).
* Negative for hepatitis B surface antigen, anti-hepatitis C virus, hepatitis C virus-RNA, and hepatitis B virus DNA.
* BMI greater than or equal to 40, or BMI greater than or equal to 35 with at least one obesity-related comorbid condition (including type 2 diabetes, hypertension, hyperlipidemia, obstructive sleep apnea (OSA), GERD, asthma, venous stasis disease, severe osteoarthritis, or considerably impaired quality of life).
* Unsuccessful nonoperative weight loss attempts.
* Mental health clearance.
* Recent updates have included patients with a BMI of 30-35 with uncontrollable type 2 diabetes or metabolic syndrome as an indication for a laparoscopic sleeve gastrectomy.

Exclusion Criteria:

* Patients with ascites.
* Pregnant women.
* Patients with any active implantable medical device (such as pacemaker or defibrillator).
* Patients who had undergone liver transplantation.
* Patients with cardiac failure and significant valvular disease.
* Patients with hemochromatosis.
* Patients who refused to undergo liver biopsy or blood tests.
* Patients with alcohol consumption above recommended limits (\>14 units/week for women and \>21 units/week for men; 1 unit = 8 g of ethanol).
* Patients with a confirmed diagnosis of active malignancy or another terminal disease.
* Patients participating in another clinical trial within the preceding 30 days