cyrilzakka/clinical-trials huggingface dataset:
RECOVER:Comparison of Renal Toxicity Between Visipaque(Iodixanol)and Hexabrix(Ioxaglate)in Renal Insufficiency Undergoing Coronary Angiography

In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography,coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, we should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. We intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function

Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephrotoxicity of iodixanol with that of ioxaglate, an ionic, dimeric LOCM, in patients with renal impairment.

Eligibility Criteria:
Inclusion Criteria:

* creatinine clearance rates ≤60 mL/min using the Cockcroft-Gault formula
* Patients who undergo coronary catheterization
* Age of 19 or over 19.

Exclusion Criteria:

* pregnancy
* lactation
* having received contrast media within 7 days of study entry
* emergent coronary angiography
* acute renal failure
* end-stage renal disease requiring dialysis
* history of hypersensitivity reaction to contrast media
* cardiogenic shock
* pulmonary edema
* multiple myeloma
* mechanical ventilation
* parenteral use of diuretics
* use of N-acetylcysteine
* use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure.
Condylar Position Changes in Anterior Disc Displacement with Reduction

the goal of this clinical trial is to know if TMJ lavage does change the condyle position in patients diagnosed with unilateral anterior disc displacement with reduction. The main questions it aims to answer are:

* Is the condyle position in anterior disc displacement with reduction joints are the same in normal joints?
* Does TMJ lavage will affect the condyle position, or affects the contralateral condyle position? Researchers will compare condyle position in unilateral anterior disc displacement with reduction to the normal joint using CBCT before and after lavage to see if any changes in position will occur in even side.

Participants will:

Make CBCT for both condyles before lavage and after three months post lavage. Visit clinic after two weeks, one month, and three months to evaluate the clinical data.


Eligibility Criteria:
Inclusion Criteria:

* • Unilateral anterior disc displacement with reduction according to Helkimo's clinical dysfunction index including (Covert et al., 2021a).:

  1. Impaired range of movement.
  2. Impaired TMJ dysfunction.
  3. Muscles pain.
  4. TMJ pain.

Exclusion Criteria:

* • Bilateral anterior disc displacement with reduction.

  * Previous fracture in TMJ.
  * Any pathological lesion in TMJ.
  * Congenital craniofacial anomalies.
  * Any previous surgical procedure in TMJ.
  * Any medically compromised patient (mental deficiency, osteoporosis...)
  * Previous arthrocentesis in TMJ.
  * Partial or complete edentulous patients.
  * Any psychological patient.
Supraclavicular Block vs Retroclavicular Block: Incidence of Phrenic Nerve Paralysis

The aim of this study is to evaluate differences between ultrasound guided supraclavicular versus retroclavicular brachial plexus blocks: two similar brachial plexus nerve block techniques that differ in their needle trajectory and injection site.

To date, there has not been a study that has compared clinically the retroclavicular brachial plexus block to the supraclavicular brachial plexus block or other brachial plexus blocks. The aim of this study is to evaluate differences between ultrasound guided supraclavicular versus retroclavicular brachial plexus blocks, with primary focus on the incidence of diminished ipsilateral hemidiaphramatic excursion (ipsilateral phrenic nerve blockade). We will also evaluate differences between the two techniques in the success of producing surgical anesthesia, procedural time to perform the block (including imaging time and needling time), block onset time, ease of quality ultrasound needle visualization, and incidence of paresthesias, vascular puncture and pneumothorax. Lastly, we will observe and compare the distribution of motor and sensory blockade of the two techniques

Eligibility Criteria:
Inclusion Criteria:

1. patients scheduled for lower arm surgery
2. patients aged 18 years or older
3. patients ASA class I-III

Exclusion Criteria:

1. Patients unable to cooperate or consent to the study
2. pre-existing neuropathy
3. significant pulmonary disease
4. contralateral phrenic nerve or diaphragmatic dysfunction
5. allergy to local anesthetics
6. infection at needle insertion site
7. history of coagulopathy
8. BMI \> 40 kg/m2
Non-contact Intraoperative Optical Imaging During Spinal Procedures

Current spine procedures can suffer from a variety of complications resulting in a high incidence (up to 55%) of misplaced screws and implants. This can lead to devastating clinical consequences, including neurologic and vascular injury, and extensive physical, mental, and economic damage. Surgical navigation has a great potential to reduce these risks through accurate guidance; however present technologies rely on intraoperative imaging that uses ionizing radiation (e.g. computed tomography, or fluoroscopy), which limits surgical anatomy registration updates to less than 3-4 time points during surgery. They also require cumbersome and lengthy set-up and registration of fiducial markers and have limited abilities to account for motion that occurs during surgery and patient positioning. Therefore, the investigators propose a real-time intraoperative optical topographical imaging based surgical guidance system capable of accurately guiding the placement of implanted devices such as screws.

The hypothesis is that optical visualization of surgically exposed anatomy with the Biophotonics and Bioengineering Laboratory (BBL) surgical navigation prototype, when registered with pre-operative imaging (CT or MRI), can accurately estimate subsurface anatomy and allow tracking the position of surgical instruments in real-time, using an intraoperative non-contact optical imaging system during spinal surgical procedures. This is based on the completed preliminary study of 40 spinal procedures. The specific research aim is as follows: Validate the ability of the BBL surgical navigation prototype to function as the sole navigation system during spinal surgical procedures. The study will focus on testing the robustness of the system to appropriately function on a variety of spinal surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age, able to provide consent, or has substitute decision maker available to consent.
* Scheduled to undergo spinal instrumentation surgery involving pedicle or lateral mass screw insertion or brain tumor resection or biopsy.
* Scheduled for pre-operative CT/ MRI scan.
* No contra-indication for a post-operative CT/MRI scan.

Exclusion Criteria:

* Previous spinal decompression with significant laminectomy performed at the level intended for instrumentation
* Previous spinal decompression with laminoplasty performed at the level intended for instrumentation
Safety of Testosterone Undecanoate i.m. in Hypogonadal Men

Treatment of male hypogonadism by testosterone substitution has be monitored in terms of safety. This study relates to safety of a new long-acting preparation.

A reliable form of androgen substitution therapy regarding kinetics, tolerance and restoration of androgenicity is paramount in hypogonadal men. Intramuscular injection of the long-acting ester testosterone undecanoate (TU) offers a new modality.

The objective is to assess safety of TU regarding metabolic and pharmacogenetic confounders in hypogonadal men treated with this new formulation.

This is a longitudinal prospective one-arm open intervention and observation trial. A minimum of 5 individual assessments is a prerequisite. Investigated modulators of safety parameters entering regression models are: nadir and/or delta total testosterone concentrations, body mass index (BMI), and age.

The setting Andrological outpatient department.

Eligibility Criteria:
Inclusion Criteria:

* Men presenting hypogonadism-related symptoms and desiring substitution therapy. Such symptoms are fatigue, loss of libido, depressiveness, change in body composition/weight, decreased physical performance, decrease in aggressive behaviour, disability to cope, decreased work performance, lack of androgenization. At least one of these symptoms has to be accompanied by low total testosterone levels (\< 12 nmol / L).
* All patients have to give written informed consent for the use of their data for scientific evaluation as approved by the Ethics Committee of the Medical Faculty, University of Muenster, Germany and the State Medical Board.

Exclusion Criteria:

* Prostate Cancer
* Breast Cancer
* Desired Paternity
Early Intrapleural TPA Instillation Versus Late

Chest tubes are used for air or fluid removal from the pleural space. When a chest tube is placed, it can be hard for the fluid to drain.Tissue plasminogen activator (tPA) and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase immediately after chest tube placement will help with better fluid draining.

The purpose of this study is to determine the timing and efficacy of early administration and late administration of t-PA/DNase via thoracostomy (n=60). Patients will be identified from the Intensive Care Unit, Coronary Care Unit, and wards/stepdown units. Prior to chest tube placement, patients will be randomized to one of the two treatment arms (early use of t-PA-DNase verus late use of t-PA-DNase). Route of administration will be via their thoracostomy tube over a period of three days twice daily.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age 18 years or older
* Patients with an indication for a thoracostomy tube placement for a pleural effusion

Exclusion Criteria:

* Patients that require a thoracostomy tube for a pneumothorax
* Pregnant women
* Sensitivity to t-PA, or DNase
* Patients taking carbamazepine or nitroglycerin
* Lung volume reduction surgery on side of pleural effusion
Pulse Oximetry Accuracy by Skin Color

This is a prospective, non-randomized, non-blinded comparative study to evaluate the accuracy of pulse oximetry compared to co-oximetry in dark-skinned (Black) compared to lighter-skinned (White) children undergoing anesthesia, using standard FDA performance statistics as measured by mean bias and accuracy root mean squared to evaluate device performance.

This is a prospective, non-randomized, non-blinded comparative study.

There will be no changes to the anesthetic or surgical plan to accommodate this study. Patients undergoing anesthesia will be induced per their anesthetic team. Following endotracheal intubation, the patient will be placed on air (FiO2 21%) at 4 liters per minute fresh gas flow. After a minimum of 3 minutes has elapsed, the anesthesia team will obtain an arterial blood sample of approximately 1 mL. This can be obtained from an arterial line if one is planned for the procedure or already in place by accessing the line per standard procedure. If an arterial line is not placed, the arterial sample will be obtained by percutaneous arterial puncture using ultrasound guidance and a 25-gauge blood gas syringe. The patient's SpO2 will be noted using a pulse oximetry probe placed on the right index finger when the arterial sample is drawn, along with the date/time of sample acquisition. Once the sample is drawn, the patient's anesthetic and surgery will proceed as per his anesthesia team. The arterial sample will be immediately delivered to the Nationwide Children's Hospital laboratory for simultaneous ABG and ABG-CoOx analysis to obtain SaO2S and SaO2C, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-9 years undergoing general anesthesia with or without arterial line placement.

Exclusion Criteria:

* Patients with cyanotic congenital heart disease.
* Patients with bleeding disorders.
* Patients taking blood thinners.
A Study of LY3361237 in Healthy Participants

The purposes of this study are to determine:

* The safety of LY3361237 and any side effects that might be associated with it.
* How much LY3361237 gets into the blood stream and how long it takes the body to remove it in healthy participants.

Participants will be admitted to the clinical research unit (CRU) for 4 overnight stays. The study will last about 12 weeks for each participant, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females, as determined by medical history and physical examination.
* To qualify as Japanese for this study, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
* Between 18 (20 for Japanese participants) and 65 years of age.
* Have a body mass index of 18.0 to 32.0 kilograms per meter squared, inclusive, and a minimum body weight of 45.0 kilograms.

Exclusion Criteria:

* Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-ray and TB testing
* Are immunocompromised
* Have evidence of chronic viral infection have received live vaccine(s) (including attenuated live vaccines) within 28 days of screening or intend to receive during the study (non-live or inactivated vaccinations are allowed). Bacillus Calmette-Guérin (BCG) vaccine must not have been administered within 12 months of screening
* Have had lymphoma, leukemia, or any malignancy or pre-malignant condition within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Comparison of Two Liraglutide Formulations in Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two formulations of liraglutide.


Eligibility Criteria:
Inclusion Criteria:

* Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments
* Body Mass Index (BMI) of 18-27 kg/m\^2 incl.

Exclusion Criteria:

* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the study, as judged by the investigator
* Impaired renal function
* Uncontrolled treated/untreated hypertension
* Any clinically significant abnormal ECG
* Active hepatitis B and/or active hepatitis C
* Positive HIV (human immunodeficiency virus) antibodies
* History of alcoholism or drug abuse during the last 12 months
* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
* Excessive consumption of a diet deviating from a normal diet as judged by the Investigator
Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)

The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.

The standard of care treatment for acute myocardial infarction (AMI) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants, Beta-Blockers, nitrates and Ace-inhibitors. However, because salvaging the viable myocardium is dependent on early reperfusion, only a minority of participants will reach the hospital within the time-window for myocardial rescue. Thus, even if the participant manages their tobacco use, hypertension, lipid levels, diabetes, weight and exercise, many participants will go on to develop Congestive Heart Failure (CHF). Though the medical management for CHF may improve symptoms and slow disease progression, such treatment cannot restore a functioning myocardium. A therapy that could improve the myocardial remodeling process and reduce the incidence or severity of CHF following acute MI would provide a significant benefit. The characteristics and biologic activity of Prochymal®, along with a good safety profile in human trials to date, suggest that Prochymal® may be a good candidate for addressing this unmet medical need.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 21 and 85 years old, inclusive
* First heart attack within 7 days prior to randomization and drug infusion
* Baseline left ventricular ejection fraction (LVEF) 20-45%
* Hemodynamically stable within 24 hours prior to randomization
* Adequate pulmonary function

Exclusion Criteria:

* Previous medical history of heart attack, heart failure, significant valvular heart disease, aortic dissection
* Pacemaker or other device
* Pregnant, breast-feeding, or intends to become pregnant during the study
* Allergy to cow or pig derived products
* Evidence of active malignancy or prior history of active malignancy
* Major surgical procedure or major trauma within the past 14 days
* Autoimmune disease (e.g., Lupus, Multiple Sclerosis)
* Any medical condition, which in the opinion of the Investigator, renders participation unsuitable
* Undergone pharmacologic cardioversion or external defibrillation within 24 hours of randomization.
* Experienced cardiac arrest more than 36 hours after presentation to site or within 24 hours of randomization.
Remote Exercise Programs in Chronic Low Back Pain

Low back pain is a common problem that affects many people at some point in their lives. These people constitute a big part of the disease burden due to their recurrent complaints. About 45% of individuals with chronic low back pain seek medical attention. This situation makes chronic low back pain the second reason for individuals to apply to the hospital.

Exercise therapy is the first option that comes to mind in the management of low back pain. It is seen that exercise therapy both reduces the intensity of pain and reduces the recurrence rate of complaints. When the literature is examined, it is observed that among the exercise models, stabilization exercises can provide more benefits than general exercises in reducing pain and improving disability. The COVID-19 pandemic causes disruptions in face-to-face rehabilitation services. The development of telemedicine and telerehabilitation services, whose popularity is increasing with the advancing technology, gained momentum with these disruptions. With telerehabilitation, long-term treatments tailored to the needs of the patients can be offered, the cost is low, and the patients can exercise at home, on their own, at their own pace, whenever they want. These reasons make telerehabilitation stand out especially during the pandemic period. The aim of the study planned in this context is to investigate short and long-term results of remote and face-to-face exercise training on function and disease symptoms for individuals with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Having low back pain for more than 3 months,
* Pain intensity of 3 or more according to VAS,
* literate,
* A smartphone user,
* Own a smartphone
* Individuals who are able to understand the exercises (total score \>21 on the Montreal Cognitive Assessment Scale (MOCA)) will be included in the study.

Exclusion Criteria:

* Those who have been diagnosed with cervical or lumbar region pathologies,
* Cervical rapiculopathy, thoracic outlet syndrome,
* Having a malignant condition,
* Having systemic diseases such as neurological, psychological, cardiovascular, rheumatological and loss of function due to these diseases,
* History of previous surgery on the spine and upper extremity,
* Acute infection,
* Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.
NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers

Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers using standard laboratory tests and viscoelastic analysis


Eligibility Criteria:
Inclusion Criteria:

healthy

Exclusion Criteria:

intolerance of the study drug history of bleeding disorder or similar
AssocIation of PULSatility and Occurrence of Complications Related to Mechanically Assisted Circulatory Support

The primary objective of this study is to determine whether preserved pulsatility for patients supported by CF-LVAD (continuous flow Left Ventricular Assist Device) is associated with less acquired deficiency of the Von Willebrand factor, a blood glycoprotein involved in hemostasis.

Implantation of LVADs (Left Ventricular Assist Device) is a medium to long-term therapeutic option for patients with end-stage heart failure and isolated left ventricular dysfunction. Nevertheless, LVADs use remain limited by the frequency of their adverse effects, most of which being unpredictable. In the literature, loss of pulsatility seems to be associated with CF-LVADs complications, including bleeding. Accordingly, the primary objective of this study is to determine whether patient's preserved pulsatility is associated with less acquired deficiency of the Von Willebrand factor (VWF), a blood glycoprotein involved in hemostasis. This deficiency, characterized by a decrease or absence of VWF High Molecular Weight Multimers (HMWMs), is present to varying degrees in almost all patients with LVADs and is a major risk factor for bleeding complications in these patients. Pulsatility is estimated by the patient's blood pressure differential, measured 1) at discharge from the operating room (=transfer to care), 2) at discharge from care (=transfer to his or her room), 3) at discharge from the hospital (=transfer to rehabilitation), and then at each follow-up visit up to 6 months post-implantation. The primary endpoint is to determine whether a preserved pulsatility is associated with less acquired deficiency of the Von Willebrand factor ratio of High Molecular Weight Multimers (HMWMs).

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age
2. Patients for whom a decision to implant a left-sided monoventricular assist has been retained after discussion in the RCP of heart failure, transplantation and circulatory assistance (whatever the therapeutic strategy envisaged: waiting for transplantation, recovery or destination therapy).
3. Patients affiliated to a social security system (beneficiaries or beneficiaries entitled to benefits, excluding AME)
4. Signature of an informed consent by the patient or by the trusted person, or a close relative, if the patient is not able to do so

Exclusion Criteria:

1. Heart transplant patients
2. Patients who already had LVAD
3. Chronic renal failure patients on dialysis
4. Patients refusing to give informed consent
5. Patients deprived of liberty or under legal protection (guardianship, curators)
6. Pregnant or breastfeeding women
7. Ongoing participation in another intervention research protocol except LEVOECMO project (NCT04728932) and ANCHOR project (NCT04184635)