cyrilzakka/clinical-trials huggingface dataset:
A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension

The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Primary open-angle glaucoma or ocular hypertension in both eyes
* Best-corrected distance vision of 20/100 or better
* Stable visual field

Exclusion Criteria:

* Cup-to-disc ratio greater than 0.8
* Laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
* Corneal refractive surgery within prior 6 months
* Past history of any incisional surgery for glaucoma at any time
* Corneal abnormalities that would interfere with tonometry readings
* Current participation in an investigational drug or device study or participation in such a study within 30 days of screening
Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine

Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection \[PJI\]) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as PSAT could be a convenient way to limit catheter-related complications and facilitate ambulatory care.

However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine.

The aim of this study is is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.


Eligibility Criteria:
Inclusion Criteria:

* Patients having an ostéo-articular infection (on material or on native bone) and having an indication of antibiotic treatment suppressive subcutaneous by betalactamine and managed at the Croix-Rousse Hospital
* Patients not opposed to participate to the study

Exclusion Criteria:

* none
Osseointegrated Human-Machine Gateway

Advanced prosthetic devices are currently controlled by electromyography (EMG) signals generated by patient's stump muscles and recorded by surface electrodes attached on the skin. This way of recordings is often unreliable, inconsistent and leading to high prosthetic abandonment rates for individuals with upper limb amputation. The use of implantable electrodes has been long thought as the solution for a more natural control of artificial limbs, as these offer access to long-term stable and physiologically appropriate sources of control, as well as the possibility to elicit appropriate sensory feedback via neurostimulation.

This Clinical Investigation (CI) is performed to clinically test and verify the safety and benefits of a bidirectional interface into the human body that allows permanent and reliable communication using implanted electrodes. These electrodes will provide long-term stable bioelectric signals for an improved control of artificial limbs. The bidirectional interface is based, and requires, the clinically established implant system for bone-anchored prostheses named Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA). The feasibility of the device was initially proven through a proof-on-concept patient who has used the system without any adverse events for more than three years.

This CI is performed to verify the safety and benefits of the Osseointegrated Human Machine Gateway (OHMG) as an enhancement of the OPRA Implant System for patients with upper limb amputation, when used within the intended purpose and according to instructions. The CI will be performed at Sahlgrenska University Hospital and Chalmers University of Technology, Sweden. A maximum of eighteen patients will be enrolled. Each patient will undergo a surgery where the OHMG will be implanted. The patients will participate in 8 follow-up sessions, the last one approximately 13 months after the surgery. The study is prospective, where the patient is his/her own control.


Eligibility Criteria:
Inclusion Criteria:

* The patient is an uni- or bi-lateral, transhumeral or transradial amputee
* At least 2 cm from the joint to the most proximal side of the fixture must be present.
* The patient has at least portion of biceps and triceps muscles present.
* The patient currently has, or has been accepted to have, the OPRA Implant System.
* The patient is younger than 70 and older than 17.
* The patient is willing to participate in all assessment sessions (follow-ups).
* The patient has experience using a surface myoelectric prosthesis.

Exclusion Criteria:

* Patient that has a significant cognitive impairment that prevents her/him from following instructions.
* The patient has any concurrent disease or conditions that might affect the treatment with the OHMG.
* The patient is pregnant.
* The patient is participating in another study.
Risk-taking, Self Control and Humor Styles

Therefore, this study tries to examine relationships among risk perception, risk-taking and humor styles through the mediating role of self-control. The present study used the correlation method. The statistical population consisted of all undergraduate students from University of Bojnord. The number of 400 students from the Faculty of Humanities and Basic Sciences was selected by using cluster sampling. The questionnaires were distributed in the classes among who inclined to participate in this study and they completed the questionnaires as anonymous.


Eligibility Criteria:
Inclusion Criteria:

* be a student of the college

Exclusion Criteria:

* Unwillingness to study And not being a student at university
Feasibility Study Evaluating the Silva Module During the Anaesthesiology Consultation Before an Elective Surgery

In this feasibility study, feasibility, acceptability and an initial clinical efficacy of the new module of Hypnosis and Virtual Reality (or Digital Sedation), Silva, will be evaluated. This feasibility study meets objectives of Oncomfort's design validation and design verification steps. Silva will be tested on a sample of 10 patients in the environment where the product is intended to be used, a hospital environment. If results do not fit with user needs, design will be adapted according to results and a new phase of design validation will be implemented. The Silva module is a Digital Sedation module designed for management of pain and anxiety in perioperative patients.

Subjects will be recruited during the anaesthesiology consultation preparing to an elective surgery.

First, subject will be asked to self-assess anxiety and comfort. In order to evaluate anxiety, subject will use a 0-10 rating Visual Analogue Scale (VAS) where 0 = no anxiety at all, and 10= the worst imaginable anxiety. The same scale will be used to measure the level of comfort where 0 means no comfort at all and 10 very comfortable.

Subject should be positioned laying on a reclining chair during the session. This session will last for 30 minutes. After the experiment, participants will be asked to rate anxiety, level of comfort, level of immersion and dissociation.

Several questions will be asked to the patient to evaluate his/ her experience, the Silva module, and the sensations experienced.

The study will be ended by an evaluation of adverse event (AE) and the evaluation of the caregivers.

Eligibility Criteria:
Inclusion Criteria:

• Subject more than 18 years old

Exclusion Criteria:

* Deaf subject
* Blind
* Non-proficiency in French (Module language)
* Psychiatric disorder
* Head or face wounds
* Neurological disease
* Chronic pain and/or chronic analgesics consumption
* Medication affecting the autonomic nervous system
* Dizziness
A Study of SHR-9803 for Injection in Patients With Advanced Solid Tumors

This is an open label, multi-center, multiple doses Phase I/II study to evaluate the safety, tolerability ,pharmacokinetics and efficacy of SHR-9803 for injection in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. 18-75 years old, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1
4. With a life expectancy ≥ 3 months.
5. Pathologically diagnosed advanced solid tumor.
6. At least one measurable lesion according to RECIST v1.1.
7. Adequate bone marrow reserve and organ function.
8. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Exclusion Criteria:

1. Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
2. Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
3. Previous or co-existing malignancies；
4. Severe bone damage caused by bone metastasis， including uncontrolled tumor-related pain;
5. Have active or prior documented autoimmune disease;
6. Have used corticosteroids (\> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 2 weeks;
7. With poorly controlled or severe cardiovascular disease;
8. A history of interstitial pneumonia/non-infectious pneumonia;
9. Severe infection 1 month before the first dose;
10. Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
11. With a history of inflammatory bowel disease, or those who have experienced intestinal obstruction or gastrointestinal perforation within 3 months prior to the first dose;
12. Have received more than 30 Gy of pulmonary radiation therapy within 6 months prior to the first dose; Have received major surgery，Systemic chemotherapy, endocrine therapy, monoclonal antibody therapy, macromolecular targeted therapy or other investigational products within 4 weeks; or palliative radiotherapy within 2 weeks; or oral small-molecule targeted drugs within five half-lives;
13. Have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1;
14. Received live-attenuated vaccines within 4 weeks prior to the first dose.
15. Known to have had an allergic reaction to other monoclonal antibodies.
Influence of Hypocaloric Diet on Urinary Lithogenic Factors of Obese Patients With Kidney Stones

The objective of this study is to evaluate the influence of low-calorie diet on serum and urinary metabolic parameters of obese adults with urinary calculi and lithogenic metabolic abnormalities.

Objective: to evaluate the influence of low-calorie diet on serum and urinary metabolic parameters of obese adults with urinary calculi and lithogenic metabolic abnormalities.

Method: prospective study of 50 patients, aged over 18 years, with a body mass index above 30 kg/m2, urinary calculi and lithogenic metabolic abnormalities. Will be excluded from the study patients with psychiatric diagnoses other than depression, patients with inability to attend to clinical follow-up, patients with nephrocalcinosis, patients with urinary tract infection, patients with cystinuria and patients subjected to previous surgeries to treat obesity. Each patient will be evaluated monthly on the same day by urologist and nutritionist. On the first evaluation, will be done anamnesis, anthropometric measurements of weight, height, waist, bioimpedance and requested total serum calcium, phosphate, sodium, potassium, urea, creatinine, uric acid, and PTH, pH venous blood, urine tests type I, culture of urine and urine tests of calcium, oxalate, phosphate, sodium, potassium, citrate, magnesium, creatinine, uric acid, cystine and computed tomography for evaluation of urinary calculus. In the second evaluation, 30 days after, anthropometric measures will be repeated, bioimpedance and nutritional assessment will be made with recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day and requested total serum calcium, phosphate, sodium, potassium, urea, creatinine, uric acid, and PTH, pH venous blood, urine tests type I, culture of urine and urine tests of calcium, oxalate, phosphate, sodium, potassium, citrate, magnesium, creatinine, uric acid, cystine. Patients will be monitored monthly for 3 months with anthropometric measurements, bioimpedance and strengthening of nutritional recommendations. By the end of the third month, patients will be submitted to two series of serum and urine tests as before the diet. The results of serum and urine tests from the beginning of dietary treatment will be compared to those of the end of the treatment with Student T test. P\<0.05 are considered significant.

Eligibility Criteria:
Inclusion Criteria:

* body mass index above 30 kg/m2 and urinary calculi on tomography and lithogenic metabolic abnormalities.

Exclusion Criteria:

* psychiatric diagnoses other than depression
* inability to attend to clinical follow-up
* nephrocalcinosis
* urinary tract infection
* cystinuria
* previous surgeries to treat obesity
A Study of JNJ-40411813 in Healthy Japanese Male Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single dose and multiple dose administrations of JNJ-40411813 in Japanese healthy adult male participants.


Eligibility Criteria:
Inclusion Criteria:

* Be a Japanese man
* Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
* Blood pressure (after the participant supine for 5 minutes) between 90 and 140 millimeter of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
* During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention, a participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak. Recommended highly effective methods of contraception in this study for female partners of male participants to use in addition to the male participant wearing a condom during include: a) oral hormonal contraception, b) intrauterine device, c) intrauterine hormone-releasing system, and d) bilateral tubal occlusion
* A participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study intervention

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
* Known allergies, hypersensitivity, or intolerance to JNJ-40411813 or its excipients
* Test positive for human immunodeficiency virus (HIV) antigen/antibodies, hepatitis A antibody immunoglobulin M (IgM), syphilis, hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV) antibodies at screening
Fluid and Nutrition in Elective Hip Surgery

The purpose of this study is to determine whether fluid or glucose administration before hip replacement surgery minimizes postoperative muscle breakdown (catabolism), fatigue and disturbances in carbohydrate metabolism.

1. How can a simple and safe way to measure the body's tendency to transient diabetes associated with surgery?
2. Can fluid or glucose administration before elective hip surgery, minimizing post-operative muscle breakdown (catabolism), fatigue and disturbances in carbohydrate metabolism?

Eligibility Criteria:
Inclusion Criteria: Patient scheduled for hip surgery. Exclusion Criteria: Endocrinological disorders.
Randomized Controlled Trial of Project Body Neutrality

This study tests a single-session intervention (SSI) targeting risk factors for depression and eating disorders among sexual and gender minority (SGM) adolescents. Youth ages 13-17 who identify as sexual or gender minorities will be randomized to the intervention condition (Project Body Neutrality SSI) or a control (supportive therapy SSI). Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project Body Neutrality leads to reductions in depression and eating disorder symptoms compared to the control.


Eligibility Criteria:
Inclusion Criteria:

* Identify as a sexual or gender minority individual per self-report
* 13-17 years old at the time of enrollment
* English proficiency per self-report
* Report having body image concerns per self-report
* Score of ≥ 2 on the Patient Health Questionnaire-2 (PHQ-2; Kroenke et al., 2003), - indicating elevated depressive symptoms
* Did not participate in a past study involving Project Body Neutrality per self-report
* Residing within the United States per IP address
* Passes comprehension of consent language assessment

Exclusion Criteria:

* Fail to meet the above-listed inclusion criteria
* Exit the study prior to condition randomization
* Failure to pass the data integrity measures
* Duplicate responses from the same individual in baseline or follow-up surveys
Edwards SAPIEN-3 Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation

Transcatheter aortic valve replacement (TAVR) is a good alternative treatment for patients with severe aortic valve stenosis with similar mid-term success rates as compared to surgery. Periprosthetic aortic regurgitation (PAR) after TAVR remains an important limitation of this technique. Moderate to severe PAR occurs in 15-45% of the cases and it is an independent predictor of mortality after TAVR. Little is known about potential differences in severity of PAR among different types of aortic valve prosthesis. The current randomized study aims to evaluate potential differences between the Edwards SAPIEN bioprosthesis and the Medtronic CoreValve® system with main focus on PAR and additional focus on other clinical and imaging endpoints. Primary objective of this study is to investigate the difference in the severity of PAR, measured with 3-dimensional transesophageal echocardiography (3DTEE), between patients undergoing the implantation of the Edwards SAPIEN bioprosthesis versus patients receiving the Medtronic CoreValve® bioprosthesis. Secondary objectives of this study include: investigating the value of different imaging modalities in evaluating periprosthetic regurgitation after TAVR and studying the difference in clinical endpoints according to VARC-2 definitions and quality of life after TAVR between two available aortic valve prostheses.


Eligibility Criteria:
Inclusion criteria

In order to be eligible to participate in this study, subjects must meet all of the following criteria:

* Patient is ≥18 years of age and diagnosed with severe symptomatic aortic stenosis, judged inoperable or at high surgical risk (EuroSCORE \> 15% or other criteria that make surgery high risk by a consensus among cardiologists and cardiac surgeons in the heart team) and deemed eligible for transfemoral-TAVI.
* Aortic annulus diameter ≥ 18 and ≤ 29 mm as assessed with MSCT.
* No contraindications to study requirements such as MRI or TEE.

Exclusion criteria

* Patients unable or unwilling to give informed consent.
* Patients who are excluded from this study because of the size of their aortic annulus diameter.
Examining the Relationship Between Core Muscles and Bladder Issues in Children

The goal of this observational study is to learn about functional bladder problems in children. The main questions it aims to answer are:

* Does bladder symptoms in children have an effect on core muscles?
* How do core muscles change based on an increase or decrease in these symptoms?

The study will be a novel investigation that elucidates the current state by comparing core muscle function outcomes with the type and severity of symptoms in children with lower urinary tract symptoms. It will shed light on the necessity of evaluating not only electromyographic activity during urination but also the overall function of core muscles in children with lower urinary tract symptoms. Additionally, identifying core muscle dysfunctions in children with lower urinary tract symptoms will provide a new perspective in treatment. Consequently, the project will not only contribute to the literature but also serve as a pioneering study that draws attention to the necessity of physical therapy consultation and a multidisciplinary approach in clinical assessment and treatment processes for pediatric urologists. The comprehensive and objective project aims to conduct a reference study on the subject, and the project results will lay the foundation for the development of prevention and improvement strategies. Data will be collected using non-invasive transabdominal ultrasound and surface electromyography to evaluate core muscle functions, and symptom questionnaires. The relationship between core muscle functions and lower urinary tract symptoms in children will be examined. Research Questions: Does lower urinary tract symptoms have an impact on core muscle functions in children? How do core muscle functions change according to an increase or decrease in these symptoms? The study is a cross-sectional research.

Eligibility Criteria:
Inclusion Criteria:

* To have a diagnosis of lower urinary tract symptoms according to the International Children's Continence Society (ICCS) diagnostic criteria,
* To have a normal neurological examination,
* Not to have received pelvic floor rehabilitation in the last 6 months,
* To be between the ages of 6 and 18.

Exclusion Criteria:

* To have structural (anatomical) problems in the urinary system such as ectopic ureter, urethral valve issues,
* To have congenital and/or spinal cord injury, acquired neurogenic problems such as spinal dysraphism, pelvic trauma,
* To have active febrile illness or urinary tract infection, or any biomechanical problem such as congenital thoracic deformities that may hinder or affect the evaluation,
* To have cognitive or mental impairment in the child and/or parent.