cyrilzakka/clinical-trials huggingface dataset:
Assessment of Clin. Capabilities of LIBERTY® Endovascular Robotic System's Performance & Safety in Periph. Vasc. Interv.

A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions. The study is designed to evaluate the performance and safety of endovascular procedures supported by the LIBERTY® Robotic System. The System is configured to deliver and manipulate third-party commercially available surgical devices that are employed in endovascular transcatheter procedures (guidewires, microcatheters, and guiding catheters).


Eligibility Criteria:
Inclusion Criteria:

1. The subject is age 22-80 years at screening.
2. The subject has been informed of the nature of the study and is willing and able to provide informed consent to participate in the study.
3. The subject has a clinical indication for an elective PVI.
4. The subject is willing and able to comply with all required study procedures.
5. Subject's scheduled procedure is compatible with commercially available peripheral interventional devices that have the following diameter ranges:

   1. Guidewires: 0.014-0.018"
   2. Catheters (Microcatheters): 2-3 Fr
   3. Guide catheter: 4-6 Fr

Exclusion Criteria:

1. Subject is planned to undergo coronary and/or neuro-interventional procedures during study procedure.
2. Subject with vasculature that cannot accommodate the catheter or required accessories according to local routine practice guidelines.
3. Subject with contraindication to endovascular approach to the treatment of peripheral vascular disease, similar or same as contraindications in manual procedures.
4. Target vessel has been previously treated with any type of a bypass conduit.
5. Subject has a contraindication to standard anticoagulation for PVIs.
6. Subject has bleeding or a hypercoagulability disorder.
7. Subject has thrombocytopenia (\<50 x103 per µL).
8. Subject has abnormal, clinically relevant lab results resulting in treatment and/or increased risk to the subject.
9. Subject has an elevated serum creatinine (≥2.5 mg/dL or ≥221 mmol/L).
10. Subject has an active infection requiring antibiotic or anti-fungal systemic treatment.
11. Subject has a known allergy to any material used or any component of the devices used that will be in direct contact with subject's tissue.
12. Subject is pregnant or lactating.
13. Subject with any medical, social, or psychological conditions which, in the opinion of the investigator, would prohibit appropriate consent or impair completion of the study protocol or study procedures.
14. Subject who is incapable, per the investigator's discretion, of following-up with the study visit schedule for any reason.
15. Subject is currently participating in an investigational drug or device study or post market registry, or participated in another investigational drug or device study within one month prior to enrollment.
Photoacoustic Lymph Node Imaging

In this spectroscopic photoacoustic imaging study, the investigators will acquire images (only) to:

1. determine if spectroscopic photoacoustic imaging can acquire high fidelity images in a clinical setting,
2. discover if blood oxygen saturation changes are observable in breast cancer patients during early stages of metastatic invasion, and
3. compare the sensitivity and specificity of photoacoustic imaging with ultrasound imaging for the detection of lymph node metastases.

The results from imaging will not be used in any decision making process. This study is solely used to test the photoacoustic imaging device and evaluate it against the current standard of care. The device is completely noninvasive and uses only safe levels of energy as determined by the American National Standards Institute (ANSI) and the FDA. The device does not pose a serious to the health, safety, or welfare of the patient.

The study is centered on determining whether photoacoustic imaging of blood oxygen saturation can detect lymph node metastases.

Patients who are returning for an ultrasound exam after detection of a suspicious node via magnetic resonance imaging will be enrolled in the study.

Enrolled patients will receive a clinical ultrasound exam, as is the current standard of care. Suspicious nodes will be identified and imaged with combined ultrasound and spectroscopic photoacoustic imaging. Measurements will be acquired with three to five replicates with slightly modified transducer positioning to measure system and intranodal variance of the measurements. One to five contralateral axillary lymph nodes will be imaged to serve as a control and to determine patient-to-patient variability in lymph node saturated oxygen. The distance from the skin to the lymph node will also be measured with ultrasound imaging for each node.

If the ultrasound imaging identifies a suspicious node, patients will undergo ultrasound guided biopsy to confirm the true metastatic state of the nodes. Suspicious nodes will be clipped to facilitate identification at the time of axillary node dissection. During the sentinel node procedure, investigators will use intraoperative photoacoustic imaging to measure the blood oxygenation in the sentinel lymph node immediately prior to its removal. Histology will be performed on all biopsy samples and excised nodes to determine the true metastatic state of the node(s).

Eligibility Criteria:
Inclusion Criteria

1. Subjects are female age 18 or older with breast cancer and who will undergo surgical SLN biopsy/procedure or axillary dissection.
2. Subjects are capable of giving informed consent.

Exclusion Criteria

1. Subjects have had prior surgery in or near the axillary lymph nodes.
2. Subjects are currently undergoing chemotherapy, radiation therapy, hormone therapy, or targeted therapy for the breast cancer.
3. Subjects will be receiving neoadjuvant therapy prior to the surgical sentinel lymph node biopsy.
4. Subjects are homeless persons or have active drug/alcohol dependence or abuse history.
5. Subjects are pregnant or breast-feeding.
Safety and Performance of Optivantage Multi-use When Injecting Contrast Media for Contrast Enhanced CT Examination

The study is a prospective, single-arm observational multicenter clinical investigation.

The primary objective is to confirm the safety and performance of the Optivantage® Injection System when injecting contrast media to subjects requiring contrast-enhanced CT imaging, in multi-patient use.

Each subject will undergo CT examination in multi-use context using Optivantage Dual-head Contrast Delivery System.

100 subjects are expected to be enrolled. The safety and performance of the injector will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Subject referred for a contrast-enhanced CT examination using a power injector
* Subject or legal representative for children, having provided written informed consent

Exclusion Criteria:

* Subject weighting less than 10 kg
* Pregnant or breastfeading woman subject
* Subject with known allergy or hypersensitivity to contrast media
* Subject has contra-indication(s) to CT scanner and/or contrast medium as per the Summary of Product Characteristics
* Subject with peripherally inserted central catheter, central venous line, or port-A-catheter inserted for injection
* Subject unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study
Walking Training Improves Thyroid and Cardiometabolic Markers in Postmenopausal Obesity

The goal of this clinical trial is to investigate the impact of a 10-week MIWT program on thyroid hormone levels and key cardiometabolic markers in obese postmenopausal women. The main question it aims to answer is:

Does MIWT enhance thyroid function and reduce cardiometabolic risk factors in this population? Researchers will compare MIWT (designed to MIWT group) to non-training intervention (designed to control group) to see if the training program works to improve thyroid function and cardiometabolic risk factors.

Participants in MIWT group will: perform a 10-week MIWT program, four sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 60-80% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions).

Participants in control group will : not perform any physical training and maintain their usual daily activities.

This study aimed to investigate the impact of a 10-week MIWT program on thyroid hormone levels and key cardiometabolic markers in obese postmenopausal women. Thirty-six obese postmenopausal women (BMI≥30 kg.m-2, aged 50-60 yrs.) were randomized to either a moderate-intensity intermittent walking training (MIWT) group (n=18) or control group (CG, n=18). Participants performed a 10-week MIWT program, four sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 60-80% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). Body composition, thyroid hormones (thyroid stimulating hormone (TSH) and thyroxine free (FT4)), lipid profile (triglycerides (TRG), total cholesterol(TC), high-density lipoprotein cholesterol(HDLC) and low-density lipoprotein cholesterol(LDLC)), blood pressure (systolic and diastolic blood pressure) and aerobic fitness (6MWT) were determined before and after the MIWT.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index≥ 30 kg.m-2.
* Age between 50 and 60.
* Amenorrhea for \>12 months.
* Stable eating habits.

Exclusion Criteria:

* Chronic diseases.
* Medical contraindications to physical activity.
* Hormone replacement therapy.
Blood Biomarkers in Pediatric Kidney Transplant Recipients

The objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. The study hypothesizes that blood gene expression profile and donor-derived cell-free DNA biomarkers (omnigraf) can be used to predict acute rejection and monitor its response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients
* Participants undergoing a for-cause kidney biopsy to rule out graft rejection
* Ages 21 years and less

Exclusion Criteria:

* Participants who have opted out of research
* Patients, less than 18 years of age, whose parents or legal guardians are illiterate and cannot read.
* Participants, 18 years and older, who are illiterate and cannot read.
* Participants, less than 18 years of age, whose parents or legal guardians do not speak English.
* Participants, 18 years and older, who do not speak English
* Participants who are pregnant as confirmed by medical records
BIOAVAILABILITY OF GLI/METXR (4/850 mg)

Objective:

The purpose of this study is to evaluate the oral bioavailability of the combination Glimepiride/ extended release Metformin (GLI/METXR) (4/850mg) in healthy Mexican volunteers in fasting conditions.

Methods: A prospective, longitudinal, open label, non randomized study, was performed, 24 volunteers were administrated with a single oral dose of GLI/METXR (4/850 mg).

Blood samples were collected over 30 hours. Plasma concentration of both drugs were measured by using high-performance liquid chromatography (HPLC). Plasma concentration-time curves were plotted for each volunteer, and pharmacokinetic parameters (PK) were calculated. the pharmacokinetic parameters to be determined are: Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke, T1 / 2 of glimepiride and metformin Adverse events were determined using clinical and laboratory test results, throughout the study. The statistical analysis will be descriptive for plasma concentrations with respect to time and the pharmacokinetic parameters of Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke, T1/2 of glimepiride and metformin.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Mexican volunteers, considered healthy according to standard screening assessments
* Aged between 18 and 50 years old
* Body mass index (BMI) was 18 to 27.5

Exclusion Criteria:

* Those with a history or evidence of cardiovascular, renal, hepatic, gastrointestinal, neurologic, muscular, metabolic, or hematologic abnormality
* Any acute or chronic disease
* Any drug allergy and female volunteers positive to urinary pregnancy test or breastfeeding
Impact of Twice-daily Measurement of Expired CO During Hospitalization on Smoking

The main objective of this study is to show that the repeated (twice-daily) measurement of expired CO during hospitalization helps reduce smoking.

Smoking in France represents 25 billion euros per year in care, hospitalizations and drugs and 78000 deaths / year are linked to a pathology attributable to this addiction. In addition, active consumption of cigarettes is a destabilizing factor for chronic respiratory diseases. During hospitalization for acute respiratory illness, evaluation of smoking cessation remains declarative. Although stopping advice and possibly nicotine replacement therapy are prescribed, no objective measure of smoking is performed to assess the adequacy of this attitude.

This project aims to objectively evaluate smoking during hospitalization by measuring twice daily exhaled CO. The impact of this intervention on the duration of hospitalization and smoking 3m after initial admission will also be evaluated. Tobacco consumption patterns based on reason for hospital admission and background pathology will be highlighted.

Secondary objectives include:

* To measure the impact of expired CO measurement during hospitalization on the smoking status 1 month and 3 months after initial admission.
* To determine smoking patterns during hospitalization according to reason for admission and background pathology.
* To measure the effect of iterative CO measurement on the duration of stays.
* To measure and compare the quality of life of patients.
* To study the variability of expired CO measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in pneumology for acute respiratory illness or scheduled hospitalization, for a minimum duration of 48h.
* Signature of informed consent
* Patient able to perform all visits and follow the procedures of the study
* Affiliatedor beneficiary of French social security (national health insurance)

Exclusion Criteria:

* Subject who can not read and / or write French
* Expected travel that precludes study completion
* Patient in palliative care
* Inability to maintain apnea more than 8 seconds
* Participation in another clinical trial or administration of an off-label drug within 4 weeks prior to inclusion
Fractional CO2 Laser Delivery of Topical Insulin Versus Platelet Rich Plasma in Treatment of Atrophic Post Acne Scars

compare the efficacy and safety of treating atrophic post acne scars with topical insulin versus Platelet rich Plasma PRP combined with fractional ablative Co2 laser

Acne vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition commonly manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. The pathogenesis of acne vulgaris involves the interaction of multiple factors that ultimately lead to the formation of its primary lesion, which is known as "comedo".

Because of its long duration and exposure to affected areas, acne is associated with a major deterioration in a patient's quality of life and well-being .

Up to 95% of acne sufferers have some degree of acne scarring, with 30% reporting severe acne scarring. Scarring from acne is common when medical care is delayed or is not sufficient, although it can also occur even when treatment is adequate .

About 90% of acne scars are related with collagen loss (atrophic scars), whereas the remaining 10- 20% show collagen gain (keloidal or hypertrophic scars). Resulting from the contraction of fibrous tissue, atrophic scars appear as depressions. Atrophic acne scars can be classified into three distinct types: boxcar, icepick, and rolling.

Eligibility Criteria:
Inclusion criteria:

patients aged equal or more than 18 years with atrophic post acne scars.

Exclusion criteria:

pregnancy and lactation. Hypertrophic scars. patients suffering from aggressive inflammatory acne. kidney or liver disease. active infection at site of lesion. patients use medications that reduce tissue healing during the study.
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.

A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Able to give written consent
* AHI ≥ 5 on diagnostic night
* Either prescribed APAP, CPAP or Bi-level PAP for OSA

Exclusion Criteria:

* Inability to give written consent
* Anatomical or physiological conditions making PAP therapy inappropriate
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or may think they are pregnant.
Effect of ESWT on ED in Type 2 Diabetics

Diabetes mellitus (DM) is known not only for its widespread prevalence, but also for its significant complications including cerebrovascular disease, coronary artery disease, renal failure, vision loss, and neuropathy. Of particular importance to sexual medicine, diabetes has also been strongly associated with erectile dysfunction (ED).ED is defined as the inability to obtain and/or maintain the erection firm enough to achieve a successful sexual intercourse on a regular basis. It is a more common condition in males with type 2 DM. In the field of sexual medicine numerous studies have shown that extracorporal shock wave therapy (ESWT) is safe, noninvasive, and, most importantly, an effective method for treating vascular ED

ED in DM is often complex and caused by several mechanisms including vascular disease, autonomic neuropathy, hormonal imbalance, and psychogenic factors. However, as the endothelial dysfunction is an important factor contributing to the development of ED in diabetic patients, such patients can be resistant to phosphodiesterase 5 inhibitors (PDE5I) like sildenafil therapy. There are reports of lower efficacy of sildenafil in DM patients compared to general population.In the field of sexual medicine numerous studies have shown that ESWT is safe, noninvasive, and, most importantly, an effective method for treating vascular ED

Before starting the study, clearance will be obtained from the institutional ethical committee and prior informed consent of all the participants will be obtained before conducting the study. Patients will be recruited from outpatient clinic of andrology (Cairo University Hospitals). The patients were randomly divided into two equal groups:

Group (1): (Study group): Men in this group (n= 20) men receive extracorporeal shock wave (ESWT) twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions+sildenafil 5mg) Group (2): (Control group):) will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active low intensity ESWT+sildenafil 5mg

Eligibility Criteria:
Inclusion Criteria:

1. Forty married diabetic type 2 men with mild and moderate ED score (21-8) on Five-Item Version of the International Index of Erectile Function.
2. Patients who will have erectile dysfunction ( ED) from 6 months.
3. Patients with diabetes mellitus ( DM )duration ≥ 5 years with fasting blood glucose level of ≥ 126 mg/dl and glycosalyated haemoglobin (HbA1c ) ≥ 6.5% mg dl.
4. Body mass index ( BMI) will be \< 30 kg/m²
5. The age of patients will be between 40- 60 years.

Exclusion Criteria:

* History of pelvic trauma, pelvic surgery, psychiatric disease.
* Patients with neuromuscular disorders, cardiovascular or pulmonary problems and spinal cord injuries.
* Vascular surgical intervention that recommended for the patients.
* Other renal conditions, respiratory disease, liver failure.
* Prostatectomy and patients with prostatic disease.
* Patients lacking complete follow-up data.
* hypogonadism.
Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU

Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at long term is unknown.

The study will determine chronic kidney injury incidence and quality of life, five years after AK during ICU stay.

Prospective study. All patients who participated ELVIS study (clinical trials: 00875069) can be enrolled in SURIA.

Patients are contacted by telephone. Investigator delivery objective and honest information. If patients accepts the study, answers will be collected.

Collected data are: creatinine serum, two surveys (quality of life and activities of daily living), date of onset of renal replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

ICU Patients included in ELVIS study, AKI requiring renal replacement therapy Length of ICU stay ≥ 48h

Exclusion Criteria:

Pregnant or nursing woman's job
A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma

This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Males and Females, ages 15 years ≥ of age (Except where local regulations and/or institutional policies do not allow for subjects \< 18 years of age to participate)
* Subjects must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma that is unresectable or metastatic
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Subjects have not been treated by systemic anticancer therapy for unresectable or metastatic melanoma

Exclusion Criteria:

* Subjects with active brain metastases or leptomeningeal metastases
* Subjects with ocular melanoma
* Subjects with active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply