cyrilzakka/clinical-trials huggingface dataset:
Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy

Recent reports have suggested that transvaginal NOTES nephrectomy is feasible, yet comparative studies are lacking. The aim of this study was to compare the surgical outcomes of transvaginal NOTES nephrectomy to conventional laparoscopic nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

* female sex,
* indication for nephrectomy due to benign or malignant kidney disease,
* age between 18 and 65 years, and
* legal competence

Exclusion Criteria:

* emergency surgery,
* contraindications to laparoscopic surgery,
* class IV or V as defined by the American Society for Anesthesiologists (ASA),
* body mass index (BMI) of \> 30 kg/m2,
* advanced TNM staging (≥ T3),
* history of major abdominal surgery,
* gravidity or breast-feeding, and
* no written informed consent signed
Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms

The purpose of this study is to determine safety and patients' satisfaction when using Tears Again to treat Dry Eye Symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Suffer from at least two of the following ocular symptoms: burning, stinging, excessive tearing, dryness, grittiness, foreign body sensation ( including patients suffering from blepharitis).
* Use artificial tears or any other treatment for these symptoms three or more times a day.

Exclusion Criteria:

* Known hypersensitivity to Phenoxyethanol.
* Pregnant and lactating women.
* Receive other ophthalmic medication (except for eyelid hygiene preparations).
* Graft-versus-host disease patients.
* Participated during the last month in another clinical trial.
Endotracheal Intubation Devices

The purpose of this study was to compare the four different intubation devices in 6 different scenarios.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (paramedics, nurses, physicians)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Antenatal Platelet Response On Aspirin and Correlation With HDP (Hypertensive Disorders of Pregnancy)

This proposal has three aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of hypertensive disorders of pregnancy (HDP) through a prospective, cohort study using pharmacokinetics, pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.

This proposal has four aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of HDP through a prospective, cohort study using pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.

Aim 1: Establish pharmacodynamic endpoints for aspirin in prevention of HDP Hypothesis: PFA-100 closure time and serum thromboxane/urinary dehydrothromboxane-B2 (dTX-B2) are pharmacodynamic markers of aspirin response and are predictive of HDP high risk pregnant patients.

Aim 2: Explore aspirin pharmacogenetics by assessing the relationship between platelet receptor genotype, aspirin response, and prevention of HDP Hypothesis: Platelet receptor genotype is associated with race and may result in reduced platelet response to aspirin therapy, and increased incidence of HDP.

Aim 3: Assess the utility of circulating microRNA as a marker of aspirin response in pregnancy and risk of HDP Hypothesis: Quantitative expression of selected miRNAs are biomarkers for response to aspirin therapy and risk of HDP.

Aim 4: Evaluate aspirin pharmacokinetics/pharmacodynamics Hypothesis: Individual factors influence aspirin pharmacokinetics/pharmacodynamics and may impact individual dosing of aspirin

Eligibility Criteria:
Inclusion Criteria:

* Pregnant singleton, \<16 weeks' gestation
* At least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, chronic kidney disease, lupus, antiphospholipid antibody syndrome

Exclusion Criteria:

* Contraindication to aspirin
* Current or planned use of any other anticoagulation
* Use of aspirin in pregnancy prior to enrollment
* Known platelet disorder at time of enrollment
Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study

Patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks with continuous adductor canal block along with multimodal analgesia started pre-operatively and continued into the postoperative period. The study will evaluate the feasibility of home discharge within the first 24 hours following total knee arthroplasty. We will also evaluate the pain scores in the first 5 days following the surgery, causes of delayed discharge and any adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. Male and females of 40-70years of age
2. Scheduled to undergo unilateral primary total knee arthroplasty
3. ASA Class I, II

Exclusion Criteria:

1. ASA 3, 4
2. Revision surgery
3. Narcotic dependent (opioid intake morphine equivalent \> 10 mg/ day for more than 3 months)
4. Other sources of chronic pain like fibromyalgia
5. Patients with associated significant cardiac, CNS or respiratory disease (poor cardio-respiratory reserve)
6. Major conduction defects in EKG (bifascilular block, CHB); significant valvular heart disease
7. Recent MI/ Stroke/ CHF (in the past 3 months)
8. BMI\> 35
9. Obstructive sleep apnea (AHI \> 15)
10. Patients with coexisting hematological disorder or with deranged coagulation parameters.
11. Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
12. Psychiatric illnesses
13. Uncontrolled diabetes mellitus
14. Lack of informed consent.
15. Allergy to any of the drugs used in the study
16. Preoperative neurological deficits
17. Use of walking aids preoperatively
18. Living alone (Lack of Chaperone/home help)
19. Language barrier
20. Contralateral leg weakness
21. Pregnancy
Accuracy of Ultrasonography for the Diagnosis of Pneumoperitoneum in the Emergency Department

Pneumoperitoneum could be due to life threatening conditions and its quickly diagnosis is important in the emergency department (ED). Signs and symptoms are non-specific and radiography has low accuracy in the acute setting. Computed tomography (CT) is considered the gold standard, however it is not a cost-effective option in the vast population of patients with abdominal pain. Ultrasonography is able to detect as little as 2 ml of free air, however diagnostic accuracy of ultrasonography remains unclear. This study evaluates the accuracy of ultrasonography for the diagnosis of pneumoperitoneum, the most accurate abdominal scan and the most accurate echographic sign for the detection of free air.

Methods Consecutive patients presenting to ED for acute abdominal pain and with a diagnosis of pneumoperitoneum at CT or at surgery (study group) and a similar number of patients without a diagnosis of pneumoperitoneum (control group) undergo abdominal ultrasonography in a standardized protocol that include 10 scans for each patient registered on a video of 5 seconds. The videos are randomly reviewed by 4 sonographers and by 2 physicians with no experience in ultrasonography blind to final diagnosis and to all clinical data with the aim of detecting for each scan pneumoperitoneum. Accuracy of ultrasonography for the diagnosis of pneumoperitoneum will be calculated considering CT or surgery as gold standard. Furthermore intra and interobserver agreement and the accuracy of each ultrasonographic sign and scan will be calculated.


Eligibility Criteria:
Inclusion Criteria:

* All patients more than 18 years with acute abdominal pain

Exclusion Criteria:

* Refused consent
* Less than 18 years old
* Not possible to perform ultrasonography
Effects of Global Postural re-Education Program

The postural alterations present in the seniors people act as predisponent form of incapacities that provoke alterations in the quality of life. The objective of this study is to evaluate the biomechanical characteristics of the balance of elderly people, before and after treatment with Global Postural Re-education. This research is characterized by experimental method of investigation.Thirty elderly people (30 women) will be randomized to two different groups from Group of Studies of Third Age - GETI, at University of the State of Santa Catarina:

* fifteen elderly women will be submitted to the Global Postural Re-education (GPR) program and to the GETI program of activities
* fifteen elderly women will be submitted only to the GETI program of activities.

At baseline the subjects will be screened for balance measurements with the chattecx balance system and Berg Scale. These measurements will be repeat immediately after the intervention. The subjects randomised to the GPR program will participate in posture retraining techniques of approximately forty minutes, one time a week for ten weeks. The independent t test for pairs of random samples will be used, with level of significance of p≤0,05.


Eligibility Criteria:
Inclusion Criteria:

* Senior that accomplish physical activity in the GETI (group of studies of the third age - Santa Catarina State University)

Exclusion Criteria:

* Visually impaired person
* Vestibular disorder
* Neurologic disorders
* Use of prostheses and ortheses
* Cancer
Early Preparation With Gonadotropin- Releasing Hormon (GnRh) Agonists Injection With Frozen-Thawed Embryo Transfer?

The study intended to include \>200 infertile women with impaired ovulation who will be subjected to HRT at D-21 of previous menstrual cycle (Group A) or D-1 of menses of replacement cycle (Group B). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. Clinical pregnancy was diagnosed by measurement of β-human chorionic gonadotropin level and was confirmed 2-weeks later by TVU.

The study intended to include \>200 infertile women with impaired ovulation who will be subjected to HRT at D-21 of previous menstrual cycle (Group A) or D-1 of menses of replacement cycle (Group B). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. The classic Testart slow freezing and rapid thawing protocol was applied on stage-2 pronuclear embryos. Endometrial thickness was measured in the midsagittal plane using transvaginal ultrasound (TVU). Clinical pregnancy was diagnosed by measurement of β-human chorionic gonadotropin level and was confirmed 2-weeks later by TVU.

Eligibility Criteria:
Inclusion Criteria:infertile women with impaired ovulation -

Exclusion Criteria:

-
Molecular Mechanisms of Helium-Neon Laser on Melanocyte Regeneration in Skin Equivalent Vitiligo Model

This current three-year proposal aims to clarify the mechanisms of melanocyte destruction and regeneration in vitiligo lesions using both traditional cell culture and skin equivalent model (organotypic culture).

Melanocytes (MCs) are melanin-producing cells of the skin that are derived from neural crest cells. Vitiligo vulgaris is a common depigmentation disorder resulting from destruction of functional MCs in the affected skin. Although this disorder affects all races and occurs in approximately 1% of the world population, its pathogenesis remains obscure. Recovery from vitiligo is initiated by the activation, proliferation, and migration of melanoblasts (MBs) to the epidermis. The subsequent maturation of MBs leads to production of melanosomes that will be transferred to the juxtaposed keratinocytes. The beam of a low-energy laser produces a temperature elevation of less than 0.5 ℃. Therefore, light-mediated reaction by such laser irradiation is referred to as biostimulation. Mitochondrial cytochrome c oxidase is considered as a photoacceptor of low-energy laser. Low-energy He-Ne laser has numberous clinical applications. Our previous studies showed that He-Ne laser irradiation can induce repigmentation in vitiligo vulgaris. However, the exact mechanisms of He-Ne laser irradiation in repigmentation are not elucidated thoroughly. In the past, we have demonstrated the coexistence of both antikertinocyte (anti-KC) and antimelanocyte (anti-MC) IgG antibodies (Abs) in vitiligo patients and explored their potential roles in vitiligo. This current three-year proposal aims to clarify the mechanisms of melanocyte destruction and regeneration in vitiligo lesions using both traditional cell culture and skin equivalent model (organotypic culture). In the first year, we shall focus on the regeneration of MCs and MBs by He-Ne laser with or without the presence of anti-MC IgG antibodies from vitiligo patients, as well as the involved photodynamic mechanisms. Our goal for the second year is to investigate the regeneration of MCs and MBs by He-Ne laser with or without the presence of anti-KC IgG antibodies from vitiligo patients. In the final year of our project, we shall explore the effects of He-Ne laser combine antibody-dependent cellular cytotoxicity (ADCC) on the regeneration of MCs and MBs. Our results will provide more information for the effectiveness of He-Ne laser irradiation in treating vitiligo.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults and patients with vitiligo

Exclusion Criteria:

* systemic disease
Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses

The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.


Eligibility Criteria:
Inclusion Criteria:

* Be no less than 18 and no more than 39 years of age.
* Sign Written Informed Consent and investigator to record this on Case Report Form.
* Be willing and able to adhere to the instructions set out in the protocol.
* Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
* No extended wear in the last 3 months.
* Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.
* Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.
* Achieve visual acuity of 6/9 (20/30) or better in each eye.
* Require a visual correction in both eyes (no monovision allowed).
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Clinically significant corneal staining
* Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
* Has had refractive surgery.
* Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease \[e.g., Human immunodeficiency virus (HIV)\].
* History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).
* Pregnancy, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial or in last 30 days
Study to Evaluate the Safety & Performance of the Xpert(TM) Stent in Treating Below-the-knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic CLI.

The purpose of this study is to evaluate the safety and performance of the Xpert(TM) self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in patients undergoing percutaneous intervention for the treatment of documented chronic critical limb ischemia (CLI).

Peripheral arterial disease (PAD) of the lower extremities affects roughly 25 million Americans annually. The diabetic population is particularly prone to the most severe clinical problems associated with PAD and the amputation rate amongst such patients is elevated five-fold. It has been shown that patients who undergo amputation for PAD/CLI have a much higher mortality rate in the months that follow.

Despite medical advances in the fields of pharmacology and wound care, the vast majority of patients who present with CLI will ultimately require amputation in the absence of improved blood flow. Recently, much attention has been directed towards less invasive endovascular solutions for treating patients with CLI. This study will evaluate approximately 140 subjects with Rutherford Class IV-VI PAD in a multi-center study in order to accurately estimate limb salvage rates for this treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient has documented wound care greater than or equal to 2 weeks prior to enrollment
* Subject understands the duration of the study and its follow up visit requirements
* Female subjects of childbearing potential have a negative pregnancy test less than 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
* Subject has documented chronic critical limb ischemia in the target limb for two weeks with Rutherford Category 4, 5 or 6
* Subject must have one of 5 approved non-invasive test results of the target limb within two weeks of enrollment.

Exclusion Criteria:

* Life expectancy of less than 12 months
* Cerebrovascular accident (CVA) or myocardial infarction (MI) within 3 months prior to enrollment
* Inability to walk (with assistance is accepted)
* Previous bypass surgery to target limb less than 30 days prior to study procedure
* Acute thrombus at the lesion site(s)
Study of Children's Well-being After the COVID-19 Pandemic in Belgian French-speaking Primary Schools

In order to limit the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a significant numbers of measures were taken worldwide. It has been shown that the pandemic and its consequences, such as lockdown and isolation, can have a significant long-term impact on the well-being of children.

This study follows the initial DYNAtracs study on SARS-CoV-2 transmission in primary schools. In Belgium, 2488 children and 444 school attenders in 11 primary schools of the Federation Wallonia Brussels are invited. Every participant will be invited to answer a well-being questionnaire. This study aimed to document the children and workers well-being in the primary schools of Belgium after the COVID-19 pandemic. The results of the study should contribute to improved decision making regarding measures for schools and children well-being in the context of current and future pandemics.

The objective of this study is to document the well-being of children and workers after the COVID 19 pandemic in primary schools of the Federation Wallonia-Brussels.


Eligibility Criteria:
Inclusion Criteria:

* All children between the ages of 6 and 12 years and all school attenders from selected primary schools were invited to participate.

Exclusion Criteria:

* Refusal or absence of written informed consent before enrolment
Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children

This study will test the effectiveness of a family-based, cognitive behavioral therapy (CBT)-based program for preventing anxiety disorders in at-risk children.

Anxiety disorders are among the most common mental disorders in children and adolescents, and they are associated with short- and long-term impairment in social, academic, familial, and psychological functioning. The children of parents with anxiety disorders are more likely to develop anxiety disorders themselves, because of genetic factors and the atmosphere in which they are raised. Previous research indicates that the risk of anxiety disorders among children can be reduced through preventive therapeutic interventions. In children with anxiety disorders whose parents also have anxiety disorders, therapy that includes their family is more successful than therapy focused only on the child. This study will test the effectiveness of a preventive, family-based therapy for children whose parents have anxiety disorders.

Participation in this study will last 1 year. First, interested participants will be asked to perform a screening assessment. This will include providing information about the symptoms, behaviors, and functioning of parent and child participants; filling out questionnaires; and videotaping the child and parent participants interacting. If, after the screening, participants are selected to continue with the study, they will be randomly assigned to receive either information monitoring or family-based cognitive behavioral therapy. Child and parent participants assigned to information monitoring will receive a booklet with information on coping with anxiety. Child and parent participants assigned to family-based cognitive behavioral therapy will meet with a study clinician for eight, weekly, 1-hour intervention visits, during which participants will learn skills to reduce anxiety. After completing the weekly visits, participants in this group will also receive three monthly booster sessions, in which coping skills will be reviewed. In addition to the screening visit, all participants will undergo identical assessments at three more time periods: 9 weeks, 6 months, and 12 months after entering the study. All participants will also receive monthly phone calls throughout the study to monitor the children's anxiety symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Parents of child participant have a current, primary anxiety disorder

Exclusion Criteria:

* Child has an anxiety disorder or is currently in treatment for anxiety