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NCT ID: NCT05334368 Recruiting - Clinical trials for Hypereosinophilic Syndrome

Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

DESTINY
Start date: September 6, 2022
Phase: Phase 3
Study type: Interventional

This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy. The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. Participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.

NCT ID: NCT05330325 Recruiting - Clinical trials for SGA, Turner Syndrome, Noonan Syndrome, ISS

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

REAL 8
Start date: August 10, 2022
Phase: Phase 3
Study type: Interventional

The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.

NCT ID: NCT05329883 Recruiting - Clinical trials for Urinary Tract Infections

Multicentric Study on Infections of the Urinary Tract After Stent Removal (MINUS-trial).

MINUS
Start date: November 25, 2021
Phase:
Study type: Observational [Patient Registry]

The MINUS-trial is a multicentric prospective observational study in which consecutive patients, 18 years of age and older who receive a ureteral stent during any endoscopic procedure will be approached to participate. Their stent will be removed in outpatient office or by string extraction at home with or without antibiotic prophylaxis (depending on the standard of care of the participating center). A urine sample will be taken before stent removal and patients will be asked to complete a questionnaire to assess symptoms of urinary tract infection (UTI) after stent removal. If the patient experiences symptoms of UTI (urgency, frequency, dysuria or haematuria) that exceed the usually experienced post-cystoscopy symptoms, they have to provide a urine sample. The purpose of this study is to provide multi-institutional, multinational, observational data on the incidence of UTI after stent removal with or without antibiotic prophylaxis in the outpatient setting in patients with a sterile urine culture prior to the intervention of stent placement and no demonstrated infection during the stent has been in situ. The primary outcome is the presence of a febrile or non-febrile urinary tract infection after stent removal. Secondary objectives are to identify risk factors for post-stent removal UTI and identify differences in UTI incidence between cystoscopic stent removal in the outpatient setting versus string-removal by the patient in the home environment.

NCT ID: NCT05327894 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

Interfant-21
Start date: December 15, 2022
Phase: Phase 3
Study type: Interventional

This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.

NCT ID: NCT05327530 Recruiting - Clinical trials for Locally Advanced or Metastatic Urothelial Carcinoma

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

Start date: August 17, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.

NCT ID: NCT05326412 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD

AERIFY-3
Start date: May 19, 2022
Phase: Phase 2
Study type: Interventional

This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). The total study duration for each part (Part A and Part B) is approximately 36 weeks: - 4-week screening period - 12-week treatment period - 20-week followup period

NCT ID: NCT05325866 Recruiting - Solid Tumors Clinical Trials

A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

FORTITUDE-301
Start date: September 23, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.

NCT ID: NCT05322005 Recruiting - Meniscus Tear Clinical Trials

Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injection of Polynucleotides

Start date: October 26, 2020
Phase: N/A
Study type: Interventional

This is a non-randomized multicentre study for the evaluation of the clinical performance and safaty of the augmentation-to-surgery and conservative treatments for the degenerative meniscopathies, with injection of polynucleotide gel.

NCT ID: NCT05321550 Recruiting - Low Back Pain Clinical Trials

The Nociceptive Flexion Reflex as a Diagnostic Tool of Central Sensitization

NFR-CS
Start date: April 21, 2022
Phase:
Study type: Observational

This experimental study will investigate whether the decreased NFR threshold and increased NFR temporal summation, which are frequently observed in chronic pain patients, are only symptomatic manifestations that occur in the involved limb and indicate peripheral sensitization or generalized manifestations that are also present in the non-involved limbs and thus indicate central sensitization. To gain an idea of the presence of central sensitization, this study will also investigate whether there are increased perception and decreased pain thresholds in response to electrical, thermal, and mechanical stimulation, as well as whether there is a decreased conditioned pain modulation. To investigate this, it is essential to examine different pain populations and locations, in particular, acute pain versus chronic pain populations to compare peripheral versus central sensitization, respectively. Recently, our research group has shown that patients with a traumatic origin of chronic neck pain (chronic whiplash-associated disorders) show central sensitization in contrast to patients with a non-traumatic origin (chronic idiopathic neck pain) who demonstrate only indications for peripheral sensitization. Therefore, this study will also distinguish between complaints of traumatic and non-traumatic origin. The measurements will be performed at different locations, namely the lower and upper limbs. To determine whether the differences depend on the measurement location (= location where experimental nociceptive stimulation is administered) and symptom location (= location of clinical nociceptive stimulation), different patient populations will be compared with each other, as well as with a healthy control population. In acute and chronic whiplash patients and patients with acute and chronic idiopathic neck pain complaints, the complaints are primarily localized in the upper limb. It is hypothesized that in chronic neck pain patients (both whiplash and idiopathic neck pain patients) abnormal values are found in both the upper and lower limbs compared to the healthy controls due to central sensitization. In acute neck pain patients (both whiplash and idiopathic neck pain) only abnormal values in the arm are expected and not in the leg as a result of peripheral sensitization. It is hypothesized that patients with neck pain of traumatic origin will show a stronger sensitization than those with neck pain of non-traumatic origin. In acute and chronic low back pain patients, the complaints are primarily localized in the lower body quadrant. As a result of central sensitization in the chronic low back pain patients, abnormal values are expected in both the upper and lower limbs, while only abnormal values in the leg are expected as a result of peripheral sensitization in the acute low back pain patients. Finally, this study will investigate whether chronic low back and neck pain patients show a similar pattern of central sensitization as fibromyalgia patients, a population with generalized complaints that are primarily attributed to central sensitization.

NCT ID: NCT05319353 Recruiting - Clinical trials for Cytomegalovirus (CMV)

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Children and Teenage Transplant Recipients With CMV Infection

Start date: November 13, 2023
Phase: Phase 3
Study type: Interventional

The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) adult tablet formulation or other formulation based on PK modeling. The participants will be treated with maribavir for 8 weeks. Participants need to visit their doctor during 12-week follow-up period.