cyrilzakka/clinical-trials huggingface dataset:
Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors for Elderly People in EHPAD

The device which is the subject of this investigation is a robotic assistance module for the driving of a semi-autonomous electric wheelchair (FRE). It's intended to accessorize the FRE to improve the safety conditions during the driving of a FRE, making it possible to decrease the rate of accident in wheelchair on the one hand, increase the confidence of driving on the other hand, and facilitate the access to the FRE of people not being able to aspire to it without the use of a device of safety of this type.


Eligibility Criteria:
Inclusion Criteria:

* Over 60 years of age,
* Resident in an institution for the elderly or nursing home,
* with a electric wheelchair but expressing driving difficulties
* Having freely consented to participate in the study,
* In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and having given his or her free and informed consent for the person for whom he or she is responsible to participate in the study (in agreement with the patient).

Exclusion Criteria:

* Impaired comprehension preventing the protocol from being carried out,
* Person in an emergency situation unable to give prior consent
Focus Cardiac Ultrasound in Patients With Shock

The aim of this study is to analyze in patients with undifferentiated shock, the concordance of initial treatment before and after Focus cardiac ultrasound (FoCUS) in comparison with the reference one established by an adjudication committee

Focus cardiac ultrasound (FoCUS) has already demonstrated its ability to reduce diagnosis uncertainty in patients with undifferentiated shock. However, adequacy of initial treatment has not been investigated.

In patients with undifferentiated shock, after clinical evaluation, the physician states its hypothesis and initial treatment intention in closed list. He realizes a FoCUS, states another time the hypothesis and begins treatment according to FoCUS results. An adjudication committee with all the patient's file will state the reference hypothesis and treatment

Eligibility Criteria:
Inclusion Criteria:

* Undifferentiated shock defined by systolic arterial pressure \< 90 mm Hg

Exclusion Criteria:

* hemorrhagic shock
* cardiac arrest
* anaphylactic shock
* documented end-of-life
Trueness of Full Arch Scans and Generated Digital Implant Models

The goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible.

The main issues to evaluate are:

* The trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
* The trueness of the generated 3D-printed DIMs.

Participants will provide two types of impressions to compare after osteointegration; the first will be conventional open tray impression used as a gold standard comparator, the second will be digital scans with additional geometric scanning aids coupled with the scan bodies.

Accordingly generated 3D-printed DIMs will be printed and compared to the digital image to evaluate its accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant hybrid dentures.
* Patients having a substantial bone height and width at prospective implant sites to install four standard-size inter-foraminal implants.
* Sufficient crown height space according to criteria of all-on-4.
* good oral hygiene and motivation

Exclusion Criteria:

* Patients with bad oral hygiene.
* Patients with limited mouth opening.
* Vulnerable groups.
* Uncooperative patients.
* Patients receiving or undergoing radiotherapy or chemotherapy.
* Patients with systemic diseases affecting bone metabolism.
* Smokers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics with intravenous(IV) administration of IRX-010 in Healthy Participants.

This is a single and multiple ascending dose, proof of concept study assessing the safe and tolerable dose of IRX-010 in healthy participants. Approximately 81 healthy participants will be enrolled in up to 9 cohorts. The study is conducted in two parts (part A and part B) with 6 single ascending dose (Part A - SAD) cohorts of 9 participants per cohort and 3 multiple ascending dose (Part B - MAD) cohorts of 9 participants per cohort.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female participants who are healthy as determined by medical history and physical evaluation.
* Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically. significant by the investigator at screening and enrolment.
* Have an estimated glomerular filtration rate ≥60 mL/minute/1.73 m2 at screening and enrolment.
* Have venous access sufficient to allow for blood sampling as per the protocol. Weight
* Have a body mass index of 18.0 to 32.0 kg/m2 inclusive, at screening.

Exclusion Criteria:

* Have a history or presence of clinically significant medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, haematological, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicates a medical problem that would preclude study participation.
* Have history (within past 5 years) of, or presence of, uncontrolled asthma, significant rheumatological or autoimmune diseases, including but not limited to systemic lupus erythematosus, RA, Sjogren's Syndrome, or vasculitis; or hereditary angioedema, or common variable immune deficiency.
* Have had lymphoma, leukaemia, or any malignancy within the past 5 years.
* Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (if known) (whichever is longer) prior to dosing
* Have active or latent Tuberculosis (TB), based on a positive medical history, examination, chest x-rays (as per local TB screening guidelines), and/or TB test results.
Effectiveness of Gastrocnemius Stretching

The aims of this study are to: (1) determine muscle activation of the tibialis posterior muscle during different common gastrocnemius stretches and (2) radiographically quantify the tibial-calcaneal angle during the common stretching positions. We hypothesize that stretching over the edge of a step with the arch supported will minimize the activation of the tibialis posterior muscle in addition to increasing the tibial-calcaneal angle.

Many studies have assessed the effect of dynamic and passive support of the medial longitudinal arch. The posterior tibial tendon is the main dynamic stabilizer of the medial longitudinal arch, although peroneus/fibularis longus, flexor digitorum longus, and flexor hallucis longus also contribute to a lesser degree. Passive structures also a play role in supporting the arch and include the plantar fascia, plantar ligaments and spring ligament. These plantar structures aid in preventing collapse of the arch during weight bearing.

Several studies have demonstrated that increased tension from the triceps surae can lead to flattening of the arch. Gastrocnemius muscle tightness in particular is thought to be partially responsible for many forefoot and midfoot conditions in non-neurologically impaired patients. Therefore, identifying effective ways to stretch the gastrocnemius muscle without creating increased stress through dynamic structures that support the longitudinal arch may be important for the management of individuals with limited gastrocnemius flexibility.

Common ways to stretch the gastrocnemius include a runner's stretch, stretching with the foot fully supported on a ramp, stretching with the arch of the foot supported on the edge of step and the heel dropping down toward the ground and lastly, stretching with the ball of the foot supported on the edge of a step and the heel dropping down toward the ground. To our knowledge no other studies have assessed the muscle activation of the tibialis posterior muscle via indwelling EMG activation in addition to radiographic measurements to determine the effectiveness of common gastrocnemius stretches. Therefore, the aims of this study are to determine muscle activation of the tibialis posterior muscle during different common gastrocnemius stretches and to radiographically quantify the tibial-calcaneal angle. We hypothesize that stretching over the edge of a step with the arch supported will minimize the activation of the tibialis posterior muscle in addition to increasing the tibial-calcaneal angle more than the other stretching positions.

Eligibility Criteria:
Inclusion Criteria:

• 20 healthy subjects between the ages of 18 to 65 years old.

Exclusion Criteria:

* any boney or tendinous foot/ankle operative procedure
* diagnosis of neuromuscular disorder
* any previous ankle fracture or degenerative changes that would limit dorsiflexion range of motion
* no obvious gait asymmetries demonstrated through observation
* participants who are pregnant will be excluded from participation in the study
Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

The investigators will study the effect of microdoses of glucagon at the site of subcutaneous insulin injection. The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.

People with type 1 diabetes will come fasting in the morning to the research facility on two separate days. Both days participants will have a breakfast of their own choice and their regular dose of meal insulin injected. Lyumjev will be used. Frequently collected blood sampled will be analysed for glucose, insulin and glucagon for 3.5 hours. The procedures will be exactly the same both days except that on one of the days they will be randomised to a small dose of glucagon that will be injected at exactly the same site as Lyumjev insulin is injected.

Eligibility Criteria:
Inclusion Criteria:

1: Type 1 diabetes for at least 1 year. 2. Age 18 - 70 years. 3. Last known HbA1c \<86 mmol/mol. 4. Treated with continuous subcutaneous insulin infusion (CSII) by an insulin pump or multiple daily insulin injections (MDII).

Exclusion Criteria:

1. Pregnant women or women trying to conceive.
2. Any chronic disease, including psychiatric illness, judged incompatible with participation in the study.
3. Unfit for participation for any reason judged by the investigators.
4. Known hypersensitivity to glucagon or any of the excipients of the drug formulation.
5. Known phaeochromocytoma. -
A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes

This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day they will be switched to treatment with the alternative delivery regimen. The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Male patients 18-65 years of age
* Type I diabetes mellitus
* Currently on continuous subcutaneous insulin infusion therapy

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring actue treatment within last 6 months
* Use of systemic corticoids in last 3 months
* Treatment with medication known to interfere with glucose metabolism
Accuracy of the Pleth Variability Index to Predict Fluid Responsiveness in Liver Transplantation

The aim of this study is to compare the accuracy of PVI (pleth variability index)

The aim of this study is to compare the accuracy of PVI (pleth variability index)with other hemodynamic variability that measured with PİCCO (SVV, PPV, CVP,CI)to predict the response of cardiac index to volume replacement in patients undergoing liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Elective living donor liver transplantation,
* \>18 years patients

Exclusion Criteria:

Patients with:

* Arrhythmia
* Reduced left ventricular function (EF\<40%)
* Hepatocellular carcinoma
* Pulmonary hypertension
* Fulminant liver failure
* valvular heart disease
Project Healthy Eating in Children. A Study on the Health Effects of Fish Intake in Overweight Children

It has previously been seen that increased fish intake improves the metabolic health of overweight and obese adults, and animal protein improved metabolic health of obese rats. In this project the investigators will investigate whether increased intake of fish or meat improve metabolic health in children aged 9-12 years as well when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in children as measured by glucose tolerance, lipid metabolism and inflammatory markers.


Eligibility Criteria:
Inclusion Criteria:

* overweight (iso-BMI \> 25)
* 9-12 years
* healthy

Exclusion Criteria:

* diagnosed diseases such as diabetes, CVD, intestinal diseases, arthritis
* prescription medications affecting the metabolism of glucose, lipids or the immune system
* use of supplements containing long chain n-3 fatty acids
* high intake of fish
* food allergy
Pounds Off Digitally Study: A Podcasting Weight Loss Intervention

Participants in both the existing and enhanced podcast groups will lose weight. The enhanced podcasting group will have a greater increase in weight loss, elaboration, self-efficacy, and perceived control than the existing podcast group.

We will conduct a weight loss intervention study among adults. Using the weight loss podcast that receives the highest rating from a previous content analysis, we will conduct an intervention comparing the best existing weight loss podcast to an enhanced podcast. The enhanced podcast will be based on theoretical constructs that have been shown to be effective in producing weight loss in other research studies. We will then evaluate the effectiveness of podcasting to promote weight loss in adults. Weight change from baseline to 12-weeks and changes in psychosocial measures will be used to assess differences between the existing podcast, enhanced podcast, and control conditions. In conclusion, this research study aims to find innovative and inexpensive ways to help people lose weight. Podcasting has the possibility of reaching a wide range of age and ethnic groups and will allow people to receive weight loss information when and where it is convenient for them.

Eligibility Criteria:
Inclusion Criteria:

be 18-50 years old be overweight or obese (BMI between 25-35) but not severely or morbidly obese live in the Chapel Hill area be able to attend an introduction meeting and weigh-in before the study and a weigh-in after the study have access to the Internet and a computer with a sound card have a working MP3 player that can connect to a computer have access to a scale be willing to be randomized to any group

Exclusion Criteria:

smoker current major health or psychiatric diseases, drug or alcohol dependency, uncontrolled thyroid conditions, eating disorder, or pregnancy participation in a weight loss program or taking weight loss medications
Effects of Common Meals on Appetite and Satiety

The objectives of this study are to assess the impacts of meals composed of lean steak and potatoes (with a small portion of broccoli) in comparison to other common entrée/starch food combinations on metabolic and appetite responses.

The objectives of this study are to utilize a novel, ecologically sound approach to assess the acute impacts of meals composed of lean steak and potatoes to other common entrée/starch food/vegetable combinations on metabolic and appetitive responses. Appetitive responses will serve as the primary outcome. Combinations for comparison will include lentil and sweet potato chili, macaroni and cheese, fish tacos, chicken and pea fried rice, pita and hummus, and creamy pork pasta.

Eligibility Criteria:
Inclusion Criteria:

* ages of 18-50 years
* BMI between 18-26

Exclusion Criteria:

* special dietary needs (e.g., gluten-free, etc.),
* 5% weight change in the previous 2 months,
* smoking, and substance use.
A Case-control Study of Costa Rican Adults With Myocardial Infarction

This observational case-control trial sought to identify and characterize different exposures associated with nonfatal acute myocardial infarction in Costa Rican adults. Exposures assessed included dietary variables and adipose tissue fatty acids.


Eligibility Criteria:
Inclusion Criteria:

* Cases were eligible if they met the World Health Organization criteria for MI

Exclusion Criteria (Cases):

* Died during hospitalization
* Were 75 years or older on the day of their first MI
* Were physically or mentally unable to answer the questionnaire
* Had a previous hospital admission related to cardiovascular disease

Exclusion Criteria (Controls):

* Ever had an MI
* Were physically or mentally unable to answer the questionnaire
Systemic Lupus Erythematosus in Gullah Health

Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by the production of autoantibodies, multiple organ involvement, and diverse clinical symptoms and immunologic manifestations. African Americans are at a disproportionately higher risk of developing SLE, develop SLE at an earlier age, and have increased morbidity and mortality compared with European Americans. Our central study hypothesis is that there are specific genetic factors that interact with environmental exposures leading to the development of SLE. The African American Gullah population from the Sea Islands of South Carolina and Georgia are unique in their genetic homogeneity with minimal non-African genetic admixture, making them an ideal cohort to address questions of environmental and genetic influence on the development and progression of SLE.


Eligibility Criteria:
Inclusion Criteria:

* Age 2 years and above;
* Self-identified as African-American "Gullah" from the Sea Island region of South Carolina;
* Have had at least 4 of the 11 diagnostic criteria for SLE as designated by the American College of Rheumatology (ACR), be a relative of a known SLE patient, or be an unrelated healthy Gullah control;
* Ability to speak and understand English;
* Ability and willingness to give informed consent

Exclusion Criteria:

* Race defined by participant as other than Black or African-American;
* Being a prisoner, mentally ill patient, or institutionalized individual;
* Unwilling or unable to give informed consent
Physical Activity and Insulin Sensitivity Dynamics

The study investigates the role of one single bout of exercise in mediating enhancement of muscle insulin sensitivity following a single bout of exercise. Furthermore, the study is aiming to elucidate the temporal development in insulin signaling, at the early timepoints of insulin stimulation that may be responsible for the enhanced muscle insulin sensitivity.

This will be investigated in young healthy males subjected to a one-legged knee-extensor exercise followed by a hyperinsulinemic-euglycemic clamp, a setup known to enhance muscle insulin sensitivity.

The participant arrives fasting at 8:00 AM, having abstained from alcohol, nicotine, and caffeine for the past 24 hours and refrained from strenuous physical activity for the past 48 hours. The participants are then subjected to a one-legged knee extension exercise performed by the participant from 9:00 AM to 10:00 AM.

Groin catheters are inserted into the femoral artery and vein using ultrasound guidance and sterile technique

Two hours after the completion of the exercise, a catheter is inserted into an arm vein (antecubital vein) and groin catheters are inserted into the femoral artery and vein using ultrasound guidance and sterile technique. Four hours after the exercise ends, a hyperinsulinemic-euglycemic clamp is commenced. The clamp begins with a bolus injection of insulin, followed by a continuous infusion. Glucose is infused concurrently to maintain constant blood glucose levels.

Throughout the procedure, blood samples are collected every 5 minutes from the femoral catheters, and blood flow is measured using ultrasound Doppler. Muscle biopsies from the vastus lateralis of both legs are taken before the clamp starts and at 3, 6, 10, and 20 minutes after the clamp's initiation. Following the 20-minute mark, the clamp continues until steady-state is achieved to determine tissue-specific and whole-body insulin sensitivity.

Over the course of the experiment, a total of 10 muscle biopsies and approximately 150 mL of blood are collected. The experimental part of the study is expected to conclude by 4:30 PM. Participants are provided with food and beverages and observed for 1 hour before being allowed to leave the research laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals (no known diseases)
* No use of medication
* Non-smokers
* Male
* Aged 22-35 years
* Fitness level (VO2max, i.e., maximal oxygen uptake) between 30-50 mL O2/min/kg
* BMI between 28 and 35

Exclusion Criteria:

* Women
* Failure to meet all inclusion criteria
* Physical activity level (e.g., running, cycling, fitness, etc.) exceeding 6 hours per week
* Acute illness within 2 weeks prior to the study days
* Use of recreational drugs within 2 weeks prior to the study days
Intraoperative Blood Pressure and Cognitive Performance

The purpose of this study is to prospectively determine the association between incidence of neurological morbidity and minimum fractional blood pressure reached during laminectomy procedures under general anesthesia in hypertensive and normotensive subjects 40 years old and older.


Eligibility Criteria:
Inclusion Criteria:

* English as first language, or as a learned language as long as the patient is proficient
* No history of any neurological disease with the exception of patients without functional impairment who suffered a single episode of transient ischemic attack
* No history of axis I psychiatric diagnosis or drug abuse
* 40 years old or older
* Undergoing laminectomy under general anesthesia
* Must not take antihypertensive medication for purposes other than treatment of hypertension

Exclusion Criteria:

* Anyone who do not fit the inclusion criteria.
Biomechanical Properties in Intensive Care Unit (ICU) Survivors 12-month After Discharge

Intensive care unit (ICU) admission is associated with muscle weakness and ICU survivors report persevering limitation of physical capacity for years after discharge. Limited information is available about the underlying biomechanical properties responsible for this muscle function impairment.


Eligibility Criteria:
Inclusion Criteria:

* ICU length of stay \> 72 hours
* Informed consent

Exclusion Criteria:

* BMI\>30
* Neuromuscular or psychiatric disease