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NCT ID: NCT04222452 Active, not recruiting - Hypophosphatasia Clinical Trials

The PORTRAIT Study

PORTRAIT
Start date: July 12, 2021
Phase:
Study type: Observational

Clinical Consequences of Adults Presenting with Hypophosphatasia with Special Focus on Gait, Bone Microstructure and Cognition: The PORTRAIT study Hypophosphatasia (HPP) is an inherited condition that leads to weak bones. Early childhood forms are severe and easily recognized. Adult forms can vary in severity. HPP is often missed by doctors or confused with osteoporosis. This is important because the usual osteoporosis treatments may be harmful to patients with HPP and increase the risk of broken bones. One of the reasons it is missed is a lack of research describing the typical features of HPP, so doctors don't recognize the signs, and don't know when or how to test for it. The PORTRAIT Study will help increase understanding of the burden of disease of HPP on patients. The aim is to examine the effects of HPP on bone structure and strength, physical functioning, cognition, and quality of life. Researchers will study adults with HPP and healthy age- and gender-matched individuals. Blood samples will be collected after an overnight fast. Researchers will use these samples to measure markers of HPP and bone health. Medical history and lifestyle, quality of life and cognitive function will be assessed using questionnaires. Bone mineral density, body composition and bone structure and strength will be measured using dual energy x-ray absorptiometry and high resolution peripheral quantitative computed tomography. Physical functioning will be assessed as participants perform a series of physical performance and gait tests. Magnetic resonance images of the lower limbs will be matched-up with the physical functioning data to create patient-specific musculoskeletal models. Cognitive function tests will be performed to assess cognition and mental health. To reveal the burden of disease of HPP, the data collected from patients with HPP will be compared to that collected from healthy controls.

NCT ID: NCT04221945 Active, not recruiting - Clinical trials for Uterine Cervical Neoplasms

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

Start date: May 12, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.

NCT ID: NCT04221477 Active, not recruiting - Lupus Nephritis Clinical Trials

A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis

REGENCY
Start date: August 10, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

NCT ID: NCT04221451 Active, not recruiting - Sandhoff Disease Clinical Trials

A Multinational, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of Venglustat in Late-onset GM2

AMETHIST
Start date: June 29, 2020
Phase: Phase 3
Study type: Interventional

Primary Objectives: Primary population (adult participants with late-onset GM2 gangliosidosis): To assess the efficacy and pharmacodynamics (PD) of daily oral dosing of venglustat when administered over a 104-week period Secondary population (participants with juvenile/adolescent late-onset GM2 gangliosidosis, GM1 gangliosidosis, saposin C deficiency, sialidosis type 1 or juvenile/adult galactosialidosis): To assess PD response (plasma and CSF GL-1 biomarker and disease specific biomarkers) of venglustat when administered once daily over a 104-week period Secondary Objectives: Primary population: - To assess the PD of daily oral dosing of venglustat and the effect of venglustat on selected performance test and scale over a 104-week period - To determine the safety and tolerability of venglustat when administered orally once daily over a 104-week period - To assess the pharmacokinetics (PK) of venglustat in plasma and cerebrospinal fluid (CSF) Secondary population: - To assess the effect of venglustat on selected performance tests and scale over a 104-week period - To determine the safety and tolerability of venglustat when administered once daily over a 104-week period - To assess the PK of venglustat in plasma and CSF - To assess the acceptability and palatability of the venglustat tablet

NCT ID: NCT04218084 Active, not recruiting - Sickle Cell Disease Clinical Trials

Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease

HOPE Kids 2
Start date: November 11, 2020
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, randomized, double-blind, placebo-controlled study of voxelotor in pediatric participants, aged ≥ 2 to < 15 years old, with Sickle Cell Disease. The primary objective is to evaluate the effect of voxelotor on the TCD (Transcranial Doppler Ultrasound) measurements in SCD participants in this age range.

NCT ID: NCT04217278 Active, not recruiting - Clinical trials for Acute Myeloid Leukaemia

A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT

COSI
Start date: January 27, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Treatment options for older adults with Acute Myeloid Leukaemia (AML) and Myelodysplasia (MDS) are limited. Although stem cell transplantation remains one of the most effective treatments it is associated with severe side effects which have until recently prevented its use in older adults. In the last decade the use of reduced intensity transplants has allowed the extension of the potentially curative effect of transplantation to older patients in whom it was previously precluded. Although a major advance such transplants are associated with a high risk of disease relapse particularly in patients with high risk disease. This study will evaluate new transplant strategies with the aim of improving the outcome of patients with AML and high risk MDS after stem cell transplantation. Three approaches to improve transplant outcome will be studied: 1. Comparing the new pre-transplant consolidation therapy vyxeos with the standard consolidation therapy (Randomisation 1 is now closed to recruitment). 2. Comparing new conditioning therapies in patients under the age of 55 years 3. Comparing new conditioning therapies in patients aged 55 and over All patients will be followed up for a minimum of 2 years.

NCT ID: NCT04214288 Active, not recruiting - Clinical trials for Advanced ER-Positive HER2-Negative Breast Cancer

A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer

SERENA-2
Start date: April 22, 2020
Phase: Phase 2
Study type: Interventional

This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

NCT ID: NCT04211337 Active, not recruiting - Clinical trials for Medullary Thyroid Cancer

A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer

LIBRETTO-531
Start date: February 11, 2020
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

NCT ID: NCT04210219 Active, not recruiting - Clinical trials for Lymphoma, Non-Hodgkin

A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Start date: July 2, 2020
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the recommended Phase 2 dose(s) (RP2D[s]) in B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in Part 1 and to evaluate the safety of JNJ-64264681 at the RP2D(s) in Part 2.

NCT ID: NCT04210154 Active, not recruiting - Haemodiafiltration Clinical Trials

Comparison of Pre- vs Post-dilution Haemodiafiltration in Children

Start date: February 1, 2021
Phase:
Study type: Observational

Cardiovascular morbidity and mortality are increased in children on conventional haemodialysis. Haemodiafiltration (HDF) is a newer type of dialysis which has two main types (post-dilution and predilution HDF). Post-dilution HDF is associated with better vascular health, blood pressure and growth in children. Furthermore, pre-dilution HDF is shown to remove a wider spectrum of uremic toxin compared to post-dilution HDF in adults. The investigators need more data to define the optimum dialysis modality for children.