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NCT ID: NCT05117853 Recruiting - Thyroid Disease Clinical Trials

Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Thyroidectomy

Start date: November 1, 2021
Phase: Phase 3
Study type: Interventional

- Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy. - The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia. - Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery. - Injecting indocyanine green and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands. - This randomized clinical trial aims to investigate whether using autofluorescence and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia.

NCT ID: NCT05117177 Recruiting - Solid Tumor, Adult Clinical Trials

New Formulation Study of Inupadenant (EOS100850) in Patients With Cancer

Start date: July 14, 2021
Phase: Phase 1
Study type: Interventional

A Multicenter, Open-Label, Phase I Clinical Study to assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulation in Participants with Advanced Solid Tumors

NCT ID: NCT05115734 Recruiting - Critical Care Clinical Trials

Acylcarnitine Profile After Intensive Care

Start date: November 3, 2021
Phase:
Study type: Observational

The aim of the study is to compare the acylcarnitine profile of critically ill survivors of a prolonged stay in ICU with the profile of survivors of short ICU length of stay. The second aim is to assess the evolution of the acylcarnitine profile over time in survivors of a prolonged ICU stay.

NCT ID: NCT05115110 Recruiting - Clinical trials for Spinal Muscular Atrophy (SMA)

A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy

MANATEE
Start date: June 2, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Risdiplam works by helping the body produce more survival motor neuron (SMN) protein throughout the body. This means fewer motor neurons - nerve cells that pass impulses from nerves to muscles to cause movement - are lost, which may improve how well muscles work in people with SMA. RO7204239 is an investigational anti-myostatin antibody that is designed to target myostatin. Myostatin plays an important role in the regulation of skeletal muscle size by controlling growth. Inhibiting myostatin may help muscles grow in size and strength. RO7204239 in combination with risdiplam, which is designed to increase the amount of SMN protein throughout the body, has the potential to further improve motor function and clinical outcomes for people living with SMA. This trial will study the safety and efficacy of RO7204239 in combination with risdiplam in patients with spinal muscular atrophy (SMA). The trial has two parts; Part 1 is the dose-finding part in SMA patients that are either ambulant (aged 2-10 years) or non-ambulant (aged 5-10 years) within separate cohorts, and Part 2 is the pivotal part in SMA patients aged 2-25 years that are ambulant.

NCT ID: NCT05114850 Recruiting - Heart Failure Clinical Trials

Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®

Start date: April 20, 2022
Phase:
Study type: Observational [Patient Registry]

Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.

NCT ID: NCT05111626 Recruiting - Gastric Cancer Clinical Trials

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer

FORTITUDE-102
Start date: March 14, 2022
Phase: Phase 3
Study type: Interventional

The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.

NCT ID: NCT05111132 Recruiting - Anesthesia Clinical Trials

Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study

Start date: October 29, 2021
Phase: N/A
Study type: Interventional

This study will be conducted on pediatric patients up to 14 years of age. The effect of two fluid challenge regimes on cerebral and peripheral NIRS will be assessed, in a randomized double blinded controlled trial. The findings will be correlated with two ultrasound measures, previously validated as markers of fluid responsiveness.

NCT ID: NCT05110924 Recruiting - Elderly Clinical Trials

RCT Treatment Versus Non Treatment of Low-risk BCCs in Elderly

BASINEL
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

This study will be a randomized controlled trial (RCT). Patients with a minimum age of 75 years who consult at the dermatology department of the Ghent University Hospital and who are diagnosed with minimum one lesion suspicious for a low-risk basal cell carcinoma will be asked to participate in this study. Rationale: Basal cell carcinomas (BCCs) represent 70% of all skin cancers. These tumors do not metastasize but are locally invasive if left untreated. There is a high incidence of BCC in elderly and clinicians frequently face important treatment dilemmas. The approach to BCC in elderly should be investigated thoroughly, since current data on health-related quality of life, complication risks and biological behavior of these tumors is absent, and most guidelines are based on studies in young patients. Objective: The investigators will examine the possibility of not treating all BCCs by collecting data on the in vivo biological behavior of low-risk basal cell carcinomas in elderly patients with state-of-the-art imaging techniques. The investigators want to combine tumor characteristics with patient profiles, in order to estimate whether a chosen treatment will positively affect the patients' quality of life within a predetermined timeframe. Study design: Randomized controlled trial (RCT) with study visits every 6 to 12 months for a total follow-up period of 36 months. Study population: Patients consulting at the Department of Dermatology of the Ghent University Hospital with the minimum age of 75 years and a new diagnosis of (a) low-risk basal cell carcinoma(s). Intervention: Evaluation of the impact on the quality of life and the complication risks in both study arms. In addition, survival data will be gathered in both study arms. In the non-treatment arm, there will be an evaluation of the biological behavior of these low-risk basal cell carcinomas using in vivo imaging devices. Patients in the treatment arm will receive standard care. Patients in the non-treatment arm will be closely monitored: the tumor will be evaluated using non-invasive imaging devices. Patients will be asked to fill in a questionnaire concerning their HrQoL at consecutive time points. Also patient-reported side effects will be evaluated via a questionnaire. The investigators will compare standard treatment versus non-treatment (1:1 allocation) in a randomized controlled trial. Subjects can withdraw from participating in this study at any time for any reason without any consequences.

NCT ID: NCT05107635 Recruiting - Clinical trials for Postural Tachycardia Syndrome

Inappropriate Sinus Tachycardia Registry

Start date: March 1, 2022
Phase:
Study type: Observational [Patient Registry]

The primary objective of this registry is to capture the real-world data on the outcome of AtriCure Isolator® Synergyâ„¢ Surgical Ablation system (or future iterations) when used to ablate cardiac tissue in patients with Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS) using sinus node sparing hybrid ablation procedures. This is an observational, retrospective and prospective, multicenter, open-label patient registry.

NCT ID: NCT05101187 Recruiting - Clinical trials for Invasive Aspergillosis

Olorofim Aspergillus Infection Study

OASIS
Start date: March 31, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).