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NCT ID: NCT04475926 Recruiting - Clinical trials for Limb-girdle Muscular Dystrophy

A Study of the Natural History of Participants With LGMD2E/R4, LGMD2D/R3, LGMD2C/R5, and LGMD2A/R1 ≥ 4 Years of Age, Who Are Managed in Routine Clinical Practice

Start date: April 22, 2021
Phase:
Study type: Observational

This study will follow participants who are screened and confirmed with a genetic diagnosis of Limb-girdle muscular dystrophy type 2E (LGMD2E/R4), Limb-girdle muscular dystrophy type 2D (LGMD2D/R3), Limb-girdle muscular dystrophy type 2C (LGMD2C/R5), or Limb-girdle muscular dystrophy type 2A (LGMD2A/R1). These enrolled participants will be followed to evaluate mobility and pulmonary function for up to 3 years after enrollment. Additional participant data will be collected from the time the individual began experiencing LGMD symptoms to the present.

NCT ID: NCT04475445 Recruiting - Clinical trials for Cervicobrachial Neuralgia

Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.

Start date: July 30, 2020
Phase: N/A
Study type: Interventional

Chronic cervicobrachialgia is a public health problem. Epidural injections of corticosteroids and local anesthesics via transforaminal and interlaminar routes both have shown their potential in its treatment. The interlaminar approach offers the advantage of an epidural injection (i.e., direct contact with the nerve root in the epidural space). However, it requires fluoroscopy and can lead to potentially serious complications (compression of the nerve root, spinal cord injury...). The ultrasound-guided injection of corticosteroids via the transforaminal route, which offers the advantage of selectively targeting the symptomatic nerve root, may have the same therapeutic advantages as the interlaminar approach in decreasing unilateral cervicobrachial pain (i.e. a decrease in pain after infiltration) and reduce its risks.The aim of this study is to compare the efficacy of transforaminal vs interlaminar cervical corticosteroid injection.

NCT ID: NCT04470518 Recruiting - Infection Clinical Trials

Impact of Clinical Guidance & Point-of-care CRP in Children: the ARON Project

ARON
Start date: January 6, 2021
Phase: N/A
Study type: Interventional

Impact of clinical guidance & point-of-care CRP test in children: the ARON project Trial Design: multicentre, cluster-randomized, parallel group pragmatic trial Trial Participants and setting: Children aged 6 months to 12 years of age with an acute illness episode presenting to in-hours general practice or out-of-hospital community paediatrics offices Intervention(s) Diagnostic algorithm: 1. Clinical decision tree: clinician's gut feeling something is wrong, dyspnea, temperature ≥40ºC 2. YES to any : point-of-care CRP ≥5mg/L: additional testing or refer to secondary care <5mg/L: safety netting*, only prescribe antibiotics if advised (guidelines) 3. NO to all : are AB considered? YES : point-of-care CRP ≥5mg/L: safety netting*, only prescribe antibiotics if advised (guidelines) <5mg/L: safety netting*, do not prescribe antibiotics NO: safety netting *safety netting advice: - inform parents on what to expect and what to look out for - interactive parent information booklet based on previous research Control: Diagnosis and Treatment/Management as per usual care: - guidance on AB prescribing: o Belgische Commissie voor de Coördinatie van het Antibioticabeleid (BAPCOC) guide (updated November 2019) o RIZIV consensus meeting report "Antibiotics in children in ambulatory care" Primary Endpoint: Antibiotic prescribing rate at index consultation Secondary Endpoint(s) - time until full clinical recovery (during follow up (day 1 to day 30)) - additional investigations (at index consultation and/or during follow up (day 1 to day 30)) - re-consultation (during follow up (day 1 to day 30)) - antibiotic prescribing rate (during follow up (day 1 to day 30)) Exploratory endpoints at the index consultation: - additional investigations (X-Ray, blood tests, urine tests, etc.) During a follow-up period (day 1 to day 30): - referral to hospital - additional investigations (X-Ray, blood tests, urine tests, etc.) - patients with full clinical recovery at day 7 and day 30 - admission to hospital - mortality - cost-effectiveness - patient satisfaction - qualitative study: endpoints Planned Sample Size: 7000 Timing of the intervention: Intervention at index consultation (at presentation to primary care) Follow-up duration: 30 days follow-up Duration of the trial (FPI-CSR): 43 months

NCT ID: NCT04467593 Recruiting - Advanced Cancer Clinical Trials

Safety Study of Whole Body Hyperthermia for Advanced Cancer

MATTERS
Start date: July 28, 2021
Phase: N/A
Study type: Interventional

Millions of patients die of cancer every year. There are several methods to treat cancer, including surgery, chemotherapy, radiotherapy and immunotherapy. Recently, hyperthermia therapy started playing a role in cancer therapy. It has shown effect in animal experiments and clinical practice. The sponsor has developed a novel device to use hyperthermia for advanced cancer. This study is to prove the safety in human patients of this device & therapy and get the first data on efficacy.

NCT ID: NCT04465942 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Immunotherapy in Lung Cancer: Treatment After IO Cessation.

Start date: June 26, 2020
Phase:
Study type: Observational [Patient Registry]

Immunotherapy is now a standard of care for first-line and eventually salvage therapy in patients with stage IV NSCLC and as adjuvant after RT-CT for stage III NSCLC. The aim of the study is determining the therapeutic landscape and the reason for immunotherapy cessation.

NCT ID: NCT04464564 Recruiting - Clinical trials for Agitation in Patients With Dementia of the Alzheimer's Type

Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Start date: September 3, 2020
Phase: Phase 3
Study type: Interventional

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

NCT ID: NCT04464226 Recruiting - Cancer Clinical Trials

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Start date: October 20, 2020
Phase: Phase 3
Study type: Interventional

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.

NCT ID: NCT04463771 Recruiting - Endometrial Cancer Clinical Trials

Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.

POD1UM-204
Start date: January 26, 2021
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.

NCT ID: NCT04458831 Recruiting - Plasma Cell Myeloma Clinical Trials

A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

IONA-MM
Start date: August 13, 2020
Phase:
Study type: Observational [Patient Registry]

Primary Objective: To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting) To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20) Secondary Objective: Not applicable

NCT ID: NCT04458051 Recruiting - Clinical trials for Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

PERSEUS
Start date: August 13, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168