cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Left Ventricular AutoThreshold

This study will collect data on a new feature for future heart failure devices via an external non-implantable system.

ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold feature.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
* Patients who are willing and capable of participating in all testing associated with this study
* Patients who are 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
* Patients with pre-existing leads other than those specified in this investigational plan (unless the Investigator intends to replace them with permitted leads)
* Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
* Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
* Patients with a prosthetic mechanical tricuspid heart valve
* Women who are pregnant
Adequate Dosage of Sugammadex on Thyroid Surgery

This study was designed to compare two dosage of sugammadex after tracheal intubation for optimal condition of continuous intraoperative neuromonitoring in thyroid surgery to protect recurrent laryngeal nerve.

Vocal cord paralysis is not a rare complication in thyroid surgery. Nerve monitoring technique has been developed, and many clinicians use the technique for saving the concerned nerves. Many studies showed that the effect of sugammadex on reverse of neuromuscular blocking after tracheal intubation. However, optimal dosage was not founded for sugammadex.

This randomized controlled trial is to compare 1 mg/kg and 2 mg/kg as dosage of sugammadex for optimal continuous intraoperative neuromonitoring in thyroid surgery to prevent vocal cord paralysis.

Eligibility Criteria:
Inclusion Criteria:

* The patients who need to open thyroid surgery

Exclusion Criteria:

* Who doesn't agree to enroll
* Who has to receive other drug rather than rocuronium for muscle relaxant
Sperm Phenotype and Differentially Methylated Regions

Testicular dysgenesis syndrome (TDS) is known to cause epigenetic abnormalities in spermatozoa. Anogenital distance (AGD) is considered to be a suitable clinical marker of TDS, but the direct link between AGD and epigenetic abnormalities is still missing.

Infertile men (n=10) presenting with shortened AGD and a control group of normal semen donors (n=10) with normal AGD will then be asked to provide one semen sample each. Using a flow cytometer and sorter (FACS) their spermatozoa will be sorted into populations of spermatozoa with/without DNA fragmentation or with/without chromatin decondensation. These sorted populations of spermatozoa will then be examined for differences in epigenetic imprinting differences using whole genome expression analysis. Whereas the sorting of spermatozoa will be carried out in Basel, the epigenetic analysis will be carried at the University of Geneva.

A subset of 10 men with shortened AGD (together with a control group of 10 fertile donors with normal AGD) will be asked to provide up to three semen samples, each of which then will be sorted with FACS into subpopulations with/without DNA fragmentation and into subpopulations with/without chromatin decondensation.

Spermatozoa with fragmented DNA will be separated through FACS-sorting of spermatozoa with intact DNA using the YoPro 1-dye, which has been shown to correlate significantly with the degree of DNA fragmentation in the nuclei of sperm.

In addition, spermatozoa with abnormal chromatin remodelling will be separated through sorting from spermatozoa with condensed chromatin using the fluorochrome chromomycin A3 (CMA3), which competes for protamin for binding to the minor groove of DNA thereby correlating with the persistence of histones in the sperm nuclei. Pilot experiments have demonstrated the highly significant and close correlation of CMA3 with anilin blue staining. Anilin blue staining is not suitable for the sorting experiment, because it requires fixation of the spermatozoa. Sorting based on CMA3 can be carried out with living spermatozoa.

The sorted and anonymized samples will then be sent frozen in dry ice to a laboratory at the University of Geneva for the assessment of differences in the epigenetic imprinting of the DNA using whole genome expression studies.

Eligibility Criteria:
Inclusion Criteria:

* infertile men with known anogenital distance

Exclusion Criteria:

* sperm concentration must be more than 15 million/ml to allow appropriate sorting with flow cytometry...
ivWatch Sensor: Device Validation for Infiltrated Tissues

A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Pass health screen by clinician
* 18 years or older

Exclusion Criteria:

* Fail health screen
Educational Intervention to Promote Control Behaviors and Prevention of Dengue

This study will assess the effect of an educational nursing intervention in adults to promote dengue control and prevention behaviors, in comparison with the usual strategy of a health service provider institution. The intervention uses the Nola Pender Health Promotion Model as a theoretical framework. Findings will be assessed using the nursing outcomes "risk control" and "participation in health care decisions" from the Nursing Outcomes Classification (NOC).

Annually, there are 390 million cases of dengue, mostly due to the inadequate application of sanitary behaviors in the management and control of the vector, having as background the lack of knowledge of the population in the appropriation and incorporation of sanitary measures in the different environments. In addition to the cognitive and behavioral component, dengue has cultural, political, social and economic causes.

The evidence indicates that, from health education, educational interventions have been developed to reduce the disease, but most of them have not been carried out in rural areas following a theoretical framework that guides the intervention that leads to an impact on health promoting behaviors.

The use of the NOC results makes it possible to visualize the impact of nursing care and constitute scientific support for the advancement of the nursing discipline.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years old.
* Inhabitant of the rural area.
* Participant in health promotion and disease prevention programs.
* Initial score less than or equal to 3.5 on the NOC outcomes: risk control and participation in health care decisions.

Exclusion Criteria:

* People with a score less than or equal to 24 on the cognitive mini mental test.
* Incomplete registration of information in databases of a health service provider institution.
* People with dengue (dengue with warning signs, and severe dengue).
* People who do not have mobile phone availability.
* Illiterate people.
Vaccine Effectiveness of RV1 in a Naïve Population

Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The cumulative risk of GE hospitalizations and hospital stays of \< 24 hours is 1/25, which would amount to 13,600 Canadian children \< 5 years. The incidence of nosocomial RV infections is an average of 8/10,000 patient-days in children \< 5 years. An immunization program with a live-attenuated monovalent oral RV vaccine (RV1 - Rotarix® from GSK) will be implemented, free of charge, in the Province of Quebec in November 2011. To provide an accurate portrait of the disease and give critical information to the public health agencies as they struggle to control costs, we aim to evaluate the accuracy of surveillance for RV and other diseases with similar characteristics; estimate selection bias in passive laboratory-based surveillance; and estimate the agreement between surveillance time-series created from passive and active surveillance data sources.

In November 2011, Quebec implemented a publicly-funded RV1 vaccination program with its routine administration at 2 and 4 months of age. From February 1, 2012 - May 31, 2014, we conducted prospective, active surveillance for acute rotavirus gastroenteritis at The Montreal Children's Hospital and Centre Hospitalier Universitaire Sainte-Justine, located in Montreal, and Centre Hospitalier Universitaire de Sherbrooke, located in Sherbrooke. Active surveillance was approved by Research Ethics Boards at each hospital.

Eligibility Criteria:
Inclusion Criteria:

* Child less than 3 years old

Cases:

* Acute gastroenteritis (within 7 days of hospital visit)
* able to provide a stool specimen for RV ELISA testing
* Rotavirus positive

Controls:

* Visited the ED or admitted for a non-rotavirus gastroenteritis
* Visited the ED or admitted for acute respiratory infections without gastroenteritis symptoms

Exclusion Criteria:

* Immunocompromised children
* Prior history of intussusception
* Admission to NICU between 6 to 15 weeks of life, for \>6 weeks
* Child less than 56 days of life (8 weeks)
* Child vaccinated with Rotateq (Merck)
Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury

The goal of this randomized clinical trial is to compare two different orotracheal tubes in patients which require orotracheal intubation for general anesthesia. The main questions it aims to answer are:

* To assess the presence of laryngeal injury
* To evaluate the consequences in voice quality
* To ask for the presence of symptoms as sore throat, hoarseness, and cough

Participants will be randomly assigned into two groups, one will use conventional endotracheal tube and the other will use Triglotix® endotracheal tube.

Endotracheal intubation is necessary in some patients undergoing surgical procedures and patients requiring mechanical ventilation in the intensive care unit. However, endotracheal intubation is associated with known complications. In post-surgical patients subjected to orotracheal intubation, the incidence of dysphagia, sore throat, hoarseness and cough is 43%,38%27%,32% respectivelly. These figures increase in cases of prolonged intubation, such as those in intensive care units, where reported rates are 76% for sore throat, 63% for hoarseness and 49% for dysphagia. No significant endotracheal tube design improvements have been developed over the past few decades addressing these issues.

The present study aims to compare the incidence of laryngeal injuries, and related symptoms as sore throat, hoarseness, swallowing problems, bucking and coughing between two defined sample populations: those utilizing a conventional endotracheal tube (ETT-C) and those employing the new Triglotix® endotracheal tube (ETT-T) in patients undergoing elective surgery requiring general anesthesia and mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Elective perianal surgery requiring intubation for general anesthesia
* Duration range 30-90 minutes

Exclusion Criteria:

* Difficult airway
* American Society of Anesthesiologists physical status (ASA) \> III
* Morbid obesity (body mass index \>40 kg/m2)
* Patients not suitable for outpatient surgery
* Patients with history of previous neck surgery
* Patients with history of dysphagia
* Patients with comorbidities as diabetes and hypertension.
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)

This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* A subject must be 12 years of age or older, of either sex, and of any race.
* A subject must have at least a 2-year history of SAR which exacerbates during the study season.
* A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
* A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

* A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
* A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
* A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
* A subject who is participating in any other clinical study.
* A subject who is part of the staff personnel directly involved with this study.
* A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
* A female subject who is breast-feeding, pregnant, or intends to become pregnant.
* A subject previously randomized into this study.
* A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone for the treatment of MDD in pediatric outpatients (7-17 years).


Eligibility Criteria:
Inclusion Criteria:

* Male or Female outpatients betw een 7-17 years of age
* Primary diagnosis of major depressive disorder (MDD)
* Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
* Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion Criteria:

* Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other than MDD that is the primary focus of treatment (de novo patients only)
* History of suicidal behavior, or requires precaution against suicide
* Not generally healthy medical condition
* Seizure disorder
A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies

The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Non-hematologic malignancy that has progressed or no standard therapy is known
* Four weeks from last chemotherapy or two weeks from last non-cytotoxic therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* No more than 3 prior chemotherapy regimens in advanced/metastatic setting
* Absolute neutrophil count \>=1,500/mm3 and platelets \>=100,000/mm3
* Bilirubin \<=1.5 x Upper Limit of Normal (ULN), Aspartate aminotransferase \<=2.5 x ULN
* Serum creatinine \<=1.5 x ULN
* Men and women \>=18 years
* Women of Child Bearing Potential (WOCBP) must use adequate method of contraception throughout and up to 4 weeks after the study

Exclusion Criteria:

* WOCBP and men not using adequate method of birth control
* WOCBP who are pregnant or breastfeeding
* Prior radiation \>=25% of bone marrow containing skeleton
* Uncontrolled, significant, or active cardiovascular or pulmonary disease or infection or psychiatric disorder
* Neuropathy
* Active brain metastases
* Inability to swallow capsules
* History of gastrointestinal disease, surgery or malabsorption, or requiring use of a feeding tube
* Concurrent chemotherapy, hormonal therapy, immunotherapy, or radiotherapy
Intravitreal Injection of Bevacizumab and Gas for Diabetic Premacular Hemorrhage With Active Fibrovascular Proliferation

Diabetic premacular hemorrhage occurs when blood from preretinal neovascular tissue is entrapped between the retina and the posterior hyaloid in the macular area. It may occur spontaneously or secondary to traction from a localized posterior vitreous detachment. This complication may greatly disturb the central vision and may be an important stimulant of fibrovascular proliferation.

Bevacizumab (Avastin, Genentech, Inc.) is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), which has been used to treat a variety of neovascular ocular diseases. In proliferative diabetic retinopathy, intravitreal bevacizumab has been shown to induce prompt regression of neovascularization and may enhance resolution of vitreous hemorrhage.

In this study, we propose that simultaneous intravitreal injection of gas and bevacizumab may be a useful treatment option in diabetic premacular hemorrhage with active fibrovascular tissue. In this procedure, gas is used to displace the blood while bevacizumab may render the neovascularization less active to decrease the likelihood of recurrent hemorrhage.

In this study, consecutive cases of acute diabetic premacular hemorrhage and active fibrovascular proliferation will receive intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL) during the same setting. Before intravitreal injection, all patients should either have complete panretinal photocoagulation (PRP) treatment or PRP to the peripheral retina. After treatment, patients will maintain a prone position for three days and be followed at regular interval. After vitreous clear-up, further supplementary PRP extending beyond equator will be done. Snellen best-corrected visual acuity measurements, intraocular pressure, slit-lamp examination and non-contact lens biomicroscopic examination will be performed before treatment and at each follow-up visit. Data including the extent of premacular hemorrhage, and the interval between the treatment and clearing of premacular hemorrhage will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Acute diabetic premacular hemorrhage and minor active fibrovascular proliferation

Exclusion Criteria:

* Anticoagulant therapy
* Blood diseases associated with abnormal coagulation
* Proliferative retinopathy severe enough to warrant vitrectomy
Extension Study of the Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy

This multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study CSMS995 0802. During this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe NPDR and low risk PDR.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent provided prior to participation in the extension study
* successful completion of study CSMS995 0804
* willingness to comply with all study requirements

Exclusion Criteria:

* more than 8 weeks interval since the completion of study CSMS995 0804
* premature discontinuation from study CSMS995 0804

Other protocol-defined inclusion/exclusion criteria may apply.
Caribbean Island Urinary Iodine Survey 2018

Many of the Caribbean island nations have no data on iodine status in their populations.

Iodine deficiency in children can reduce IQ but can be easily corrected through a program of salt iodization.

The study will be located at 11 islands of the Caribbean region. At each of the 11 study sites, we will measure the iodine status in school-age children by collecting morning spot urine samples for measurement of urinary iodine concentration (UIC). We will also measure height and weight in all children. We will collect a repeat, next-day spot urine sample in 1/3rd of children to adjust for intra-individual variation in spot UIC and calculate the distribution of population intake.

In well-controlled randomized trials in Europe and New Zealand, even mild-to-moderate iodine deficiency in school-age children reduces IQ (1); thus, its critical to avoid iodine deficiency in this age group. In countries effected by iodine deficiency, its sustainable elimination through iodized salt can contribute to socioeconomic development. The goal to eliminate iodine deficiency was first adopted globally at the World Summit for Children in 1990, and in 1994, WHO and UNICEF concluded that salt iodization is a safe, cost-effective and sustainable strategy to control iodine deficiency (2). In 2005, the World Health Assembly called on national governments to report on their iodine nutrition every three years. However, before the present survey, the ten countries included in this project had no data on iodine status in their populations, and household access to adequately iodized salt was also unknown. Thus, the study objectives were:

* Assess the distribution of iodine intake of school-age children and their iodine status by measuring urinary iodine concentrations;
* Assess the iodine content of household salt and of seasoning powders;
* Based on the above, provide the preliminary evidence base on which to make initial recommendations for iodine strategy/programs in the region.

Eligibility Criteria:
Inclusion Criteria:

1. age at study enrolment 6 to 12 years
2. healthy; no known history of major medical illnesses and taking no chronic medications;
3. residence at the respective study site for 12 months or longer;
4. no use of iodine containing dietary supplements during the last 6 months;
5. no use of X-ray / CT contrast agent or iodine containing medication within the last year.