cyrilzakka/clinical-trials huggingface dataset:
The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair

Hypospadias is a common anomaly of the male genitalia affecting 0.4-8.2 of 1000 live male babies and varies considerably in severity. The position of the urethral meatus can be classified as anterior or distal (glandular, coronal, or subcoronal; 60-65% of cases), middle (midpenile; 20-30% of cases), or posterior or proximal (posterior penile, penoscrotal, scrotal, or perineal; 10-15% of cases). The subcoronal position is the most common. Most cases are mild and surgical correction is undertaken mostly for cosmetic reasons at the request of the parents or on advice of the pediatrician or surgeon.

Functional success of hypospadias repair depends on the creation of a uniform and adequate caliber urethra up to the meatus. Accordingly, meatal stenosis and urethral stricture are the important complications of surgery, others include urethrocutaneous fistula, diverticula, skin flap necrosis and persistent chordee. Although functional assessment of the repair is possible by observation of the urinary stream and voiding cystourethrography, uroflowmetry is considered to be a more objective tool, especially for the detection of a subclinical urethral stricture. Reports of the results of hypospadias surgery commonly focus on the cosmetic results and incidence of obvious complications, as urethrocutaneous fistulas, and symptomatic urethral Strictures. Few have emphasized the role of uroflowmetry in the postoperative evaluation of children with hypospadias to detect asymptomatic strictures and, despite the simplicity and non-invasive nature of this test, it has not become standard or widely accepted.

We evaluate AUUH experience by use of 'hypospadias objective scoring evaluation' HOSE and uroflowmetry after hypospadias repair. The HOSE is a validated scoring system that incorporates the evaluation of meatal location and shape, urinary stream, straightness of erection, presence and complexity of urethral fistula. The minimum total score is 5, and the maximum total score is 16. The point score is graded as either acceptable or not.


Eligibility Criteria:
Inclusion Criteria:

1. More than six months after last hypospadias repair.
2. Toilet trained children.
3. Patients less than 18 years old.
4. Successful repair of hypospadias with HOSE score more than 10 decided by one of the experts in pediatric urology.

Exclusion Criteria:

1. Patient not welling to participate in our study.
2. Within six months of last hypospadias repair.
3. Patient had urethral intervention within 3 months.
4. Children with any associated neurological or urological abnormality related to the bladder, which could potentially affect flow pattern.
Thiol-disulfide Homeostasis in Patients With Ovarian Cancer

Ovarian cancer is the third most common after endometrial and cervical cancer in societies with a high standard of living; It is the second most common type of gynecological cancer after cervical cancer in societies with a low standard of living, and it is also the deadliest among gynecological cancers. Dynamic thiol-disulfide homeostasis is an antioxidant system that minimizes oxidative damage and prevents cell damage. In the presence of oxidative stress, the thiol groups combine to form the disulfide structure, and when the oxidative stress condition is over, they are separated into thiol groups again. This homeostasis is impaired in conditions that cause oxidative processes such as diabetes, cardiovascular diseases, cancers, rheumatoid arthritis, and chronic kidney failure. This can be determined by measuring the total thiol and native thiol levels. Likewise, the level of ischemia modified albumin increases in the case of oxidative stress. There are studies on this homeostasis in the literature on many types of cancer; There are studies on endometrial cancer and cervical cancer, which are gynecological cancers In this study, the usability of these tests together with other diagnostic tests in the diagnosis of ovarian cancer will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Histopathological diagnosis of ovarian cancer

Exclusion Criteria:

* Having an acute or chronic disease that will cause oxidative stress
* Using alcohol/cigarettes/drugs
* Using antioxidant agents (such as vitamins A, C, E)
Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.

Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current "gold standard."


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 21 years
* Patients undergoing surgery involving cardiopulmonary bypass
* Patients instrumented with a thermodilution catheter

Exclusion Criteria:

* Patients aged \< 21 years
* Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)
Safety and IOP-Lowering Effects of WB007

The study evaluated the safety and IOP-lowering effects of WB007 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This was a 2-part study. Part 1 was a 3-period dose escalation that evaluated 3 concentrations of WB007 ophthalmic solution following a single dose in one eye. Part 2 was a randomized, double-masked, parallel comparison that evaluated two concentrations of WB007 (selected based on Part 1 results) in both eyes compared with timolol 0.5% for 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma in each eye

Exclusion Criteria:

* History of orthostatic hypotension
* Any active ocular disease
* Anticipated wearing of contact lenses during study
* Contraindication to pupil dilatation
Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study

The aim of this study is to clinically evaluate the efficacy of Insulin like Growth Factor (IGF-1) on bone regeneration in intrabony defects.

In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed.

In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed.

Eligibility Criteria:
Inclusion Criteria:

Systemically healthy male and female patients of age \>18 years Intrabony defects - two wall or three wall defects Probing pocket depths (PPD) of \>5mm.

Exclusion Criteria:

Medically compromised patients Pregnant women Heavy smokers Patients who underwent radiotherapy or chemotherapy are excluded
Hepatitis C: Grading and Staging by MR

To compare MR imaging findings with biopsy for grading and staging early hepatitis C.


Eligibility Criteria:
Referral only
Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

Accumulating evidence suggests that regular consumption of foods and beverages rich in flavanols, such as cocoa, tea, apples and wine, may have cardiovascular benefits. Several well-controlled randomised human intervention studies have shown that cocoa flavanols have beneficial effects on blood pressure, endothelial function and other biomarkers of cardiovascular health. These vascular improvements have been correlated in time with changes in plasma flavanol metabolites. The health benefits of flavanol consumption are therefore likely dependent on changes in their absorption, distribution, metabolism and excretion (ADME). Recent studies have provided detailed information regarding the absorption and metabolism of cocoa flavanols. However, there is a lack of information on whether there are changes in flavanol absorption and metabolism with increasing age.


Eligibility Criteria:
Inclusion Criteria:

* signed consent form
* Caucasian
* Good general health
* No allergy to milk products or sensitivity to alkaloids/caffeine,
* No gastrointestinal disorders (e.g., chronic constipation, diarrhoea, inflammatory bowel disease, irritable bowel syndrome, or other chronic gastrointestinal complaints)
* Not diabetic or suffering from hypertension (140/90 mm Hg),
* No anaemia or gall bladder problems.

Exclusion Criteria:

* those on a weight reducing dietary regimen
* Taking any dietary supplements
* Consuming more than 15 units (120g) of alcohol per week
* Taking anti-inflammatory medication
* Smokers
* Those with sensitivities to chocolate, reduced calorie sweeteners, dairy, nuts or gluten,
* Vegetarians or vegans.
Utility of Tracheal Ultrasonography for the Confirmation of the Endotracheal Tube Placement

The aim of this study is to compare tracheal ultrasound with direct visualization of tracheal rings for the confirmation of endotracheal tube placement in intubated patients. We hypothesize that this method is more reliable, cheap, and readily available for all emergency physicians.

Confirmation of the ETT placement has utmost importance in the management of airway in emergency medicine (EM). Visual examination of the tube (fogging), auscultation, chest x-ray, capnography, capnometry and fiberoptic bronchoscopy are the main tools used for confirmation with increasing diagnostic utilities. Recently, tracheal ultrasonography (US) was introduced as a reliable, cheap and readily available method of confirmation of ETT placement.

Eligibility Criteria:
Inclusion Criteria:

* adults (\>=18 years)
* intubated in the ED
* during the shifts of the researchers (TM, OFC).

Exclusion Criteria:

* anatomical, traumatic or tumoral defect(s) at the site of sonographic imaging
A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs)

The purpose of this research study is to evaluate the safety and effectiveness of injection with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery) as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal filler) in patients undergoing cutaneous correction of the nasolabial folds (NLFs).

This study included an Initial and a Repeat Treatment period.

The Initial Treatment period was a subject and evaluator-blinded, randomized split face study in which subjects received DGE in one nasolabial fold and Restylane in the other nasolabial fold. Both safety and efficacy were evaluated.

In the Repeat Treatment Period, participants received DGE in both NLFs. Safety was evaluated.

Eligibility Criteria:
Inclusion Criteria (abbreviated list):

* Bilateral nasolabial folds (NLF) with severity score of 3 or 4 on the 6 point scale.

Exclusion Criteria (abbreviated list):

* Pregnant/lactating women.
* Subjects who have an allergy to lidocaine, prilocaine or other amide-type anesthetic.
* Had a chemical peel at the NLF area within 4 weeks prior to study entry. In addition, subjects were restricted from undergoing chemical peels at the NLF area for the duration of the study.
* Had any treatment with Botox® injections in the upper 1/3 of the face within 2 weeks prior to entry into the study, or in the lower 2/3 of the face within 24 weeks prior to entry. In addition, subjects were restricted from receiving Botox injections in the face for the duration of the study.
* Received prior therapy to the face and/or neck (e.g., dermabrasion, face-lift, Thermage®,laser resurfacing, contour threads, non-ablative laser treatments) within 24 weeks prior to study entry. In addition, subjects were restricted from undergoing such therapy for the duration of the study.
* Had previous tissue augmentation at the NLF area within 24 weeks prior to study entry. In addition, subjects were restricted from undergoing tissue augmentation at the NLF area for the duration of the study.
* Had previous treatment at the NLF area with permanent implants (e.g., silicone,Softform®) or long-lasting fillers (e.g., RadiesseTM, Sculptra®, ArteFill® \[Artecoll\], or Bio-AlcamidTM). In addition, subjects were restricted from undergoing treatment with permanent implants or long-lasting fillers at the NLF area for the duration of the study.
* Had evidence of scar-related disease or delayed healing activity within one year prior to study enrollment. (Note: subjects with scars were eligible for study enrollment, although scars at the intended treatment sites were not treated.)
* Had a history of keloid formation.
* Had a history of hypo- or hyperpigmentation of the skin.
* Had any infection, unhealed wound, or active inflammatory process (e.g., skin eruptions such as cysts, pimples, rashes, or hives) at the injection site(s).
* Immunocompromised/immunosuppressed (e.g., HIV-positive, transplant recipient, or presently receiving chemotherapy).
Study to Investigate the Safety and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects

To investigate the safety, tolerability and pharmacokinetic characteristics of LC28-0126 in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 20 and 45 years at screening.
* Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive)

Exclusion Criteria:

* Participation in a clinical research study within the previous 2 months
* Regular alcohol consumption \>21 units per week.
Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects

The purpose of this study is to establish PK similarity in the treatment of BAT1706 and comparators.

This is a Phase I, randomized, double-blind, single-dose, 3-arm parallel group study to compare the PK, and to evaluate the safety, tolerability and immunogenicity, of BAT1706, EU-Avastin and US-Avastin after a single IV infusion in healthy adult male subjects.

A total of 129 healthy male subjects who meet the required entry criteria will be randomly assigned to one of three treatment groups in a 1:1:1 ratio to receive a single IV infusion of either BAT1706, EU-Avastin or US-Avastin. A total of 117 evaluable subjects are required.

Initially, subjects will be administered the study drug in staggered groups; the first group will comprise 3 subjects, the second group 6 subjects and the third group 9 subjects. Within each group subjects will be randomized to ensure equal numbers of subjects receive each of the three treatments.

There will be at least 48 hours between administrations of study drug to each group. Prior to administration of study drug to the next group, the safety and tolerability findings of the preceding group will be reviewed by the Principal Investigator. The next group will be dosed provided there are no serious or unexpected drug-related safety issues. Each subject will be required to remain in the clinical center for 48 hours after dosing for safety evaluation.

After the first 3 groups have been evaluated, the Principal Investigator will decide whether to proceed with continuous enrolment according to the clinical center capability.

Eligibility Criteria:
Inclusion Criteria:

1. Adult males aged 18 to 50 years inclusive and body weight 65 to 100kg.
2. Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs and 12 ECG.
3. Subjects whose clinical laboratory test results are normal, or where outside the reference range are judged as not clinical relevant.

Exclusion Criteria:

1. Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric or allergic disease excluding mild asymptomatic seasonal allergies.
2. Subject with a psychiatric disorder or considered unsuitable for inclusion by the investigator.
3. History or current clinically significant, excluding mild asymptomatic seasonal allergies, hypersensitivity or allergic reactions including known or suspected drug hypersensitivity to any component of the study drug formulations or comparable drugs.
4. Any biological drug within 3 months or monoclonal antibodies within 9 months of study drug administration.
5. Intake of herbal remedies within 14 days prior to study drug administration.
6. History of alcohol abuse or a positive alcohol test on screening or admission to the clinical center.
7. Any persons who are:an employee of the Principal Investigator, clinical center, Clinical Research Organization (CRO) or Sponsor;a relative of an employee of the clinical center, the Investigators, CRO or the Sponsor.
Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam

The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.

The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis. This is a multi-center, double blind, randomized, parallel designed study which consists of 2 weeks of treatment and a follow-up visit 2 weeks later.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient, male or female of any race, and at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
* Mild to moderate, plaque-type psoriasis
* Target lesion on the trunk or extremities (excluding palms/soles, elbows, or knees) with a score of 2 or 3 for each of erythema, scaling and plaque thickness
* Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization Forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

Exclusion Criteria:

* Female subjects who are pregnant (positive urine pregnancy test) breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
* Known allergy to clobetasol propionate or other topical corticosteroids; or to any component of the investigational formulations
* Subjects who have not complied with the proper wash-out periods for prohibited medications
* Medical condition that in the opinion of the investigator, contraindicates the subject's participation in the clinical study
* Skin disease/disorder that might interfere with the study related diagnosis or evaluations
* Evidence of recent alcohol or drug abuse
* History of poor cooperation, non-compliance with medical treatment or unreliability
Healthcare Utilization in Liver Cirrhosis Patients, a Multicenter Retrospective Cohort Study

Multicenter, retrospective cohort study investigating healthcare utilization in compensated and decompensated liver cirrhosis patients, including disease course and characteristics associated with healthcare utilization and, for example psychosocial factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Liver cirrhosis, based on biopsy, fibroscan or diagnostic imaging data

Exclusion Criteria:

* Known malignancy with hepatic metastasis at baseline
* Liver transplantation at baseline
Effect of an Informative Anxiety and Stress in Patients Requiring an Oral Biopsy

In clinical practice, patients scheduled for biopsy often suffer substantial stress before, during or after the procedure. In particular, most patients feel uncomfortable both with the procedure itself and with the idea of the results of the biopsy.

Providing adequate information is crucial, though there is no agreement as to which is the best way to present such information. Although verbal information provided by the professional is the most common scenario, the use of written information in the form of explanatory leaflets, as well as audio recordings or videos, has also been proposed The present study was carried out at the Dental School of Universidad de San Carlos (Guatemala) to evaluate the hypothesis that an audiovisual intervention providing information on oral biopsy is able to reduce patient anxiety and stress.

A prospective, randomized clinical trial was carried out involving. A total of 120 patients were therefore finally randomized, following the Consort Statement guidelines, with the definition of two groups: a control group (n = 60) that received standard verbal information, and an experimental group (n = 60) that received information in the form of a video

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were a patient age of over 18 years and the presence of an oral lesion/s requiring biopsy.

Exclusion Criteria:

* Patients with decompensated systemic disorders, poor general condition, a history of psychiatric disease or psychoactive drug use were excluded, as were pregnant women and individuals failing to sign the informed consent document.
Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk

Intraoperative hypotension is a common situation. It increases postoperative morbidity and mortality, especially in patients at high postoperative risk undergoing high-risk surgery. Intraoperative hypotension is partly related to anesthesia, and mainly to the combined, dose-dependent, synergistic effect of hypnotics and opioids. Monitoring sedation and monitoring analgesia reduce intraoperative consumption of each anesthetic agent. To date, the beneficial effect of combined sedation and analgesia monitoring on the reduction of intraoperative hypotension has only been found in one study, involving major abdominal surgery. Up to now, no study has been designed to demonstrate the benefit of monitoring the two components of anesthesia on postoperative organ dysfunction and mortality.

The study propose to evaluate the relevance of a combined optimization of hypnotic and opioid agents on the most frequently encountered dysfunctions related to intraoperative hypotension.


Eligibility Criteria:
Inclusion Criteria:

* patients affiliated to the French Social Security;
* informed and signed consent to participating in the study;
* planned postoperative hospitalization \> 48 hours;
* patients over 75 years of age with at least one of the following postoperative risk factors:

  * ischemic coronary disease;
  * history of compensated or prior heart failure;
  * stroke;
  * significant arrhythmias: fibrillation or auricular flutter with ventricular response \> 100/minute, multiform QRS complex) or cardiac conduction abnormalities (trifascicular block, auriculoventricular block of the second or third degree);
  * peripheral vascular disease;
  * chronic obstructive pulmonary disease;
  * chronic respiratory failure;
  * renal insufficiency, defined by a creatinine \> 175 µmol.l-1 (2 mg.dl-1);
  * insulin therapy for diabetes;
  * active cancer;
  * chronic alcohol abuse;
  * dementia.
* elective or emergency high-risk surgery under general anesthesia with a combination of hypnotic and opioid, and intubation or placement of a supraglottic airway control device:

Non inclusion criteria:

* Patients who meet one or more of the preoperative following criteria will not be included:
* acute heart failure or acute myocardial infarction;
* acute respiratory failure or pneumonia;
* septic shock;
* acute stroke;
* cardiac surgery;
* open chest surgery;
* opioid free anesthesia;
* intraoperative ketamine at a dose \> 0.2 mg.kg-1;
* lidocaine or dexmedetomidine by continuous infusion;
* refusal to participate in the study;