Clinical Trials About "medicines agency seizes home test kits over false" RSS

12:04 EST 18th December 2018 | BioPortfolio

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Showing "medicines agency seizes home test kits over false" Clinical Trials 1–25 of 15,000+


Serial SMS Reminders and an Opt-out Mailed FIT Kits to Improve Colorectal Screening Participation: A Single Center RCT

This pilot study is a 2-armed randomized controlled trial assessing the impact of a multimodal approach on colorectal cancer screening participation rates in a Federally Qualified Health Center. The trial will test serial text message reminders and opt-out mailed fecal immunochemistry test (FIT) home kits against a simple reminder text message control. Patients aged 50-74 years, who are registered at a Family Practice and Counselling Network (FPCN) clinic and are overdue for co...

Community-based Distribution of Oral HIV Self-testing Kits

This cluster randomised trial aims to evaluate the impact of a pilot HIVST intervention of oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of home-based rapid HIV testing, through community health workers (CHW) on knowledge of HIV status among the general adult and adolescent population. The primary outcome of the trial is the proportion of individuals who know their HIV status, defined as a self-report of being HIV positive or accepting te...

Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection

Validate a simple and cost-effective Nucleic Acid Test for HIV Detection in order to develop a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection. Blood samples collected will be assayed using the BioHelix Corporation helicase-dependent amplification. A false negative or false positive rate of >1.0% would make this test unacceptable as a screening test for HIV viremia.

Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits

This is a pragmatic, randomized, controlled trial of a geographically randomized intervention in which all eligible patients will receive a mailed fecal immunochemical test (FIT) kit (the GeoMail study). In this study, all ZIP Codes in Dallas County will be randomized to either treatment or usual care. Patients in treated neighborhoods will receive kits at the same time; patients in usual care neighborhoods will receive FIT kits randomly throughout the year. All eligible patien...

KITS: School Readiness in Foster Care Efficacy Trial

The KITS project is a 5-year randomized trial to evaluate a program designed to enhance academic and social-emotional aspects of school readiness for foster preschoolers.

Use of High Cost Monitoring During Letrozole Ovulation Induction

The purpose of this study is to investigate monitoring methods during ovulation induction cycles with letrozole and their effect on pregnancy rates. Monitoring ovulation induction cycles with letrozole can be done with a variety of methods, the two most commonly utilized are home-based urinary LH kits (or ovulation predictor kits) and office-based midcycle follicular ultrasound. Letrozole coupled with follicular monitoring by ultrasound may add extra cost per cycle with no impr...

Agency in Dystonia

In this study, using computerized cognitive assessments combined with multi-modal neuroimaging approach investigators aim to address three specific questions on patients with cervical and myoclonus dystonia: (i) investigate various aspects of the sense of agency and relationship to the severity of dystonia symptoms, (ii) characterize the possible link between abnormalities of movement perception and alteration of sense of agency in dystonia, (iii) (identify the neuronal ...

Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk

This cluster randomized trial will assess whether the provision of multiple oral-fluid based HIV self-test kits to HIV-negative women at high risk of acquiring HIV in western Kenya is an approach that promotes HIV testing among women's sexual partners, facilitates better sexual decision making, and reduces women's risk of acquiring HIV.

Feedback Reports and e-Learning in Primary Care Spirometry

Spirometry is a biomedical test to measure lung function in subject who (may) have a chronic respiratory condition. Performing the test requires a certain level of training and experience from the health care professional who conducts the test, and sufficient cooperation of the patient. Although the test is widely used in primary care in many countries, the quality of the test performance seems limited and needs improvement in order to avoid false-positive and false-negative te...

Mailed Reminders Plus Fecal Immunochemical Testing

Purpose: The investigators propose to test the effectiveness, feasibility, and cost-effectiveness of a mailed reminder with and without FIT kits in a population of Medicaid enrollees in Mecklenburg County.

A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst

This study was conducted to evaluate and compare cryo-survival, re-expansion, and implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM) according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama protocol)with Global Fast Freeze/Thaw Kits (LifeGlobal, Canada).

ATP Expression in Lymphocytes of MS Patients by Means of "ImmuKnow®" Assay.

The purpose of this study is to see if we can find a new way to test how certain Multiple Sclerosis (MS) medications work in the body and to better understand how the medicines change certain substances (cells) found in the immune (protective) system. Blood test will be drawn by doing the following: - Use a new method called the "Immuknow®" Test to see if this method will help to better understand how MS medicines work. - Measure certain levels of immune ce...

A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Doses of Itraconazole and Voriconazole Are Given to Healthy Volunteers

The sponsor wants to investigate how well the test medicine is taken up by the body when given alongside two other already approved medicines. This kind of study is known as a drug-drug interaction study. In this case the other medicines are itraconazole and voriconazole. The sponsor will also look at the safety and tolerability of the test medicine when taken alone, and when taken with the approved medicines.

HOME Study: Evaluation of a Combination Support Package to Increase Uptake of Pre-Exposure Prophylaxis and HIV/STI Testing Among Young Black and Latino MSM in the San Francisco Bay Area.

Home HIV self-testing has been FDA approved and allows users to read their own HIV test results at home, while home sexually transmitted infection (STI) test self-collection allows men to use a swab at home and mail it in for testing. The purpose of this study is to learn how Men who have Sex with Men (MSM) use these new testing options, a set of online support tools, and the option to test with someone to support them (a testing "buddy"). We will also evaluate whether the onl...

Study of Talimogene Laherparepvec in Pancreatic Cancer

The purpose of this study is to find out which doses of talimogene laherparepvec (T-Vec) can be given safely to participants with pancreatic cancer that is either too big to be taken out by surgery or has spread to other parts of the body. The study will also see if T-Vec can cause tumor shrinkage or prevent its growth. To find out which doses are safe, all participants enrolled in this study will receive up to 4 injections of T-Vec. At least two doses will be evaluated in thi...

Stigma and Online Counseling to Increase HIV/STI Testing

The alarmingly high rates of HIV/STI (sexually transmitted infections) observed among Black men who have sex with men (BMSM) necessitate a new model for engaging BMSM. New approaches include addressing stigma related concerns and structural barriers in order to increase HIV/STI testing uptake. This research includes a 2 x 2 factorial design to test an intervention that is aimed at increasing HIV/STI testing uptake among BMSM; our design includes testing HIV/STI stigma focused c...

Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement

Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual screening rates by use of time-to-event analyses (also known as survival analysis). The outcome variable of interest is the first time since randomization to have CRCS, either based on FOBT, FS, or CS. Knowing screening rates will not only enable us to make comparisons between groups, but also over time...

Validation of a Home-Screening Test for Lactose Intolerance

The hypothesis underlying this study is that whilst there is no home-screening test for lactose intolerance, this test would have significant value as lactose tolerance tests and breath hydrogen tests are expensive and time consuming. Therefore, it would be highly beneficial to validate a simple home-screening test. This study will validate a simple home-screening test that uses lactose and not milk.

Identifying Residential Hazards Using Home Test Kits

The purpose of this project is to help families and communities identify and reduce health risks from lead, pesticides and, ultimately, other environmental hazards. We have partnered with the Better Housing League and Baby’s Milk Fund in Cincinnati and nationally with the Alliance to End Childhood Lead Poisoning and the National Center for Lead Safe Housing. The first specific aim of this project is to evaluate a sampling kit for families to assess levels of lead and pesticid...

Sedation Versus No Sedation in a Spontaneous Breathing Trial

An important part of how we decide when a patient is ready to have their breathing tube removed is to have a person breathe without any machine breaths while the breathing tube is still in place. We call this a spontaneous breathing trial. Commonly, while patients have the breathing tube, they are given medications to keep them sedated and comfortable so breathing does not bother them. These medicines are often stopped before the spontaneous breathing trial so they can be more...

Home Pregnancy Test Evaluation Study

This study will evaluate consumer preference and consumer results from a number of commercially available home pregnancy tests. The study is being conducted as a formal assessment home pregnancy tests sold in Western Europe.

Evaluating a Real-Time, Remote Monitoring System for Home-Based HIV Testing

This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based testing.

Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home

The abbreviated diagnostic sleep studies (RP), made at home and transferred telematically to the sleep laboratory, are useful for the diagnosis of sleep apnea and due to a lower cost, it could be an alternative to conventional polysomnography. Objectives: 1) Usefulness of domiciliary study evaluated by percentage of patients diagnosed of SAHS compared with PSG and agreement in the therapeutic decision. 2) Direct costs of patients included in the study. Design: controlled, rando...

Diagnosis Test for Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) is an asymptomatic disease. Diagnosis is based on a oral glucose tolerance test (OGTT) requiring pregnant women to absorb 75g of glucose while fasting since midnight and to stay sober for another two hours. These OGTTs are poorly tolerated by pregnant women. As many OGTT are false positive according to self-monitoring blood glucose (SMBG), the investigators need now to determine the percentage of OGTT results that are false negative. T...

Breast Computed Tomography (CT) as a Diagnostic Tool

Lay Summary The American Cancer Society has recommended that all women over the age of 40 have an annual mammogram for many years. This recommendation has been associated with a substantial decrease in breast cancer deaths. When something suspicious is seen in one of these mammograms, the woman is called back to the clinic for more imaging tests to better determine if that suspicious feature might be breast cancer. These additional imaging tests include repeated mammogra...

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