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NCT ID: NCT03975894 Recruiting - Sickle Cell Disease Clinical Trials

TAPS2 Transfusion Antenatally in Pregnant Women With SCD

TAPS2
Start date: May 2, 2019
Phase: Phase 2
Study type: Interventional

Sickle Cell Disease (SCD) is a serious inherited blood disorder affecting red blood cells. When oxygen levels drop the red cells become abnormally shaped and unable to move through the blood vessels easily. Blood and oxygen do not reach body organs, resulting in episodes of severe pain and other complications. Pregnant women with SCD have an increased risk of both sickle and pregnancy complications, including raised blood pressure. Their babies may grow more slowly in the womb, are more likely to be born early and need special care, and have a higher risk of dying. The only treatments currently available for women with SCD are Hydroxycarbamide (which cannot be used during pregnancy) and blood transfusion. Currently, blood transfusion is only used during pregnancy to treat emergency complications. It has been suggested that giving blood transfusions throughout pregnancy could improve outcomes for both mother and babies. In Serial Prophylactic Exchange Blood Transfusion (SPEBT), sickle blood is mechanically removed and simultaneously replaced with donor red cells. A trial is needed to assess SPEBT given every 6-10 weeks, starting before 18 weeks of pregnancy, compared to standard care. This trial will evaluate outcomes for women (e.g. hospital admission, frequency of crisis) and their infants (e.g. early delivery, birthweight). However, the feasibility of such a study needs to be assessed before embarking on a large multicentre trial. This study is therefore a feasibility study in which we will randomly allocate participants to have either SPEBT or standard care. The study will be carried out in multiple maternity units in England and last two years. The willingness of eligible women to join the study will be assessed, along with how many participants remain part of the study until the end and if participants find the intervention acceptable.

NCT ID: NCT03975829 Recruiting - Glioblastoma Clinical Trials

Pediatric Long-Term Follow-up and Rollover Study

Start date: November 4, 2019
Phase: Phase 4
Study type: Interventional

A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.

NCT ID: NCT03975647 Recruiting - Clinical trials for HER2-positive Breast Cancer

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

Start date: October 2, 2019
Phase: Phase 3
Study type: Interventional

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

NCT ID: NCT03973307 Recruiting - Bladder Cancer Clinical Trials

UroX Biomarker Bladder Cancer Study

Start date: January 21, 2019
Phase:
Study type: Observational

This is a prospective observational study looking at urine samples from participants under referral for a standard of care investigative cystoscopy and biopsy. The study aims to test if the UroX™ biomarker (a measurable indicator of a biological condition) can be detected in urine samples from participants who may later test positive following a biopsy for bladder cancer. The study aims to assess the value of the biomarker as a screening tool for bladder cancer. Patients with and those without bladder cancer are required for the study.

NCT ID: NCT03969329 Recruiting - Clinical trials for Secondary Hyperparathyroidism

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

Start date: December 20, 2019
Phase: Phase 3
Study type: Interventional

Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects between ≥ 2 to < 18 years of age, with chronic kidney disease (CKD) on hemodialysis

NCT ID: NCT03969069 Recruiting - Fecal Incontinence Clinical Trials

Assessment of Faecal Incontinence With MAPLe

Start date: May 30, 2019
Phase:
Study type: Observational

Faecal incontinence (FI) is the involuntary passage of gas, liquid or solid stool and is experienced by an estimated 1-10% of the population. The symptom is multifactorial and associated with many medical conditions and diseases. The symptom is investigated using structural and functional testing of the pelvic floor. Current investigation techniques have poor correlation between symptom severity and investigation results. These techniques are unable to provide prognostic outcomes, resulting in undirected referrals for treatment based on symptoms alone. This study aims to improve the assessment of FI through additional testing using Multiple Array Probe Leiden (MAPLe). This is a non-invasive medically certified device that detects the electromyography of the pelvic floor, how muscles respond to voluntary nervous stimulus, to identify areas of weakness. The aim of this study is firstly to identify which patient groups benefit from additional testing with MAPLe, and secondly to identify if directed treatment has been achieved. The study will take place across two NHS trusts, both with specialist pelvic floor services. Participants referred to each trust with FI who meet the inclusion/exclusion criteria will be recruited from designated pelvic floor clinics and referrals for anorectal physiology (ARP). Each participant will undergo routine anorectal physiological assessment with Anal Ultrasound (AUS) and High Resolution Anal Manometry (HRAM) and additional assessment with MAPLe. Participation is complete unless treatment has been advised, these participants will undergo repeat assessment with MAPLe at 6 months. Average participation will be 12 months. The results will be analysed to identify non-inferiority of MAPLe vs current techniques using Bland Altman method. Regression and correlation studies will be performed to identify which groups have benefited from assessment with MAPLe. An expert panel of specialists in the field of pelvic floor will be convened to determine the clinical utilisation of MAPLe.

NCT ID: NCT03969004 Recruiting - Clinical trials for Cutaneous Squamous Cell Carcinoma

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

Start date: June 4, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: - To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT - To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT - To assess cemiplimab pharmacokinetics and immunogenicity in human serum

NCT ID: NCT03968393 Recruiting - Stroke Clinical Trials

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery

ASPIRE-AF
Start date: June 14, 2019
Phase: Phase 4
Study type: Interventional

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.

NCT ID: NCT03967080 Recruiting - Prostate Cancer Clinical Trials

Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI

ARPC-MRI
Start date: February 5, 2019
Phase:
Study type: Observational

This small study will investigate the feasibility of using multi-parametric MRI to introduce and support adaptive radiotherapy treatments for high-risk prostate cancer.

NCT ID: NCT03963661 Recruiting - Stroke Clinical Trials

Investigating Usability of c-SIGHT in the Homes of Brain Injury Survivors

c-SIGHT
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

A brain injury can damage the brain, so that it no longer receives information about the space around one side of the world. If this happens, people may not be aware of anything on one side, usually the same side they also lost their movement (the most affected side). This severe condition is called spatial neglect. Currently there is no recommended diagnostic test or clinically-proven treatment for the condition. In a recent study, the investigators found a long-lasting reduction in neglect if people practiced picking-up an object with their unaffected hand. This intervention is called Spatial Inattention Grasping Home-based Therapy (SIGHT). It requires people to lift wooden rods of different lengths. Once a person is familiar with the task, they can practice on their own at a time convenient to them in their homes. The investigators have developed the first computerized version of SIGHT (c-SIGHT) as well as a novel diagnostic test for neglect using portable low-cost motion-tracking technology that can be used in the patient's home. In the proposed study, the investigators will investigate how usable and acceptable this technology is in people's homes. Stroke survivors (recruited from community settings) will undergo a 7-day self-led training at their homes with c-SIGHT. At the end of the intervention, 1:1 semi-structured interviews will be carried out with both stroke survivors and carers to investigate usability and acceptability of c-SIGHT. Moreover, spatial neglect, carer burden and motor function will be assessed pre- and post-completion of c-SIGHT.