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NCT ID: NCT05450692 Active, not recruiting - Clinical trials for Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy

LATIFY
Start date: September 15, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.

NCT ID: NCT05450549 Completed - Healthy Participant Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

Start date: July 14, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL919.

NCT ID: NCT05450484 Recruiting - Esophageal Cancer Clinical Trials

Quantitative Fluorescence Endoscopy Using Durvalumab-680LT in Esophageal Cancer

OPTIC
Start date: April 5, 2023
Phase: Phase 1
Study type: Interventional

Treatment of patients with locally advanced esophageal cancer (EC) is multidisciplinary and consists of neoadjuvant therapy followed by surgical removal of the esophageal tumor and potentially tumor positive lymph nodes. The beneficial effect of the addition of immunotherapy to improve response rates to current treatment strategies has been investigated response to, since only 16 to 43% of EC patients achieve a pathological complete response (pCR) after neoadjuvant therapy and a pCR is associated with better long-term outcomes. Unfortunately, not all patients respond to immunotherapy and the knowledge about biomarkers that predict response to therapy are required. A promising novel parameter is tumor programmed death-ligand 1 (PD-L1) expression, one of the immune checkpoints targeted by cancer immunotherapy. Studies performed in patients with various solid tumors demonstrate improved response to immunotherapy and survival benefit in patients with higher PD-L1 expression. Nonetheless, not all patients with high PD-L1 expression show benefit and some without expression do. Moreover, mostly biopsy-based tests are used to assess PD-L1 status, although these tests are prone to errors, partly due to heterogeneity in tissue expression. Novel methods are needed to gain more insight in the PD-L1 expression in order to better select patients who are likely to benefit from immunotherapy. The investigators hypothesize that quantitative fluorescence endoscopy using the tracer durvalumab-680LT targeting PD-L1 is a promising technique to investigate the heterogeneity of PD-L1 expression.

NCT ID: NCT05450146 Recruiting - Dementia, Mild Clinical Trials

Trial-based Effectiveness and Cost-effectiveness of the Partner in Balance Intervention

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Rationale: Informal care is one of the most important sources of care for dependent elderly people. The Partner in Balance (PIB) intervention aims to prepare and support informal caregivers for their caregiving tasks. Long-term cost-effectiveness evidence is required to support reimbursement decision-making on this PIB program. The investigators hypothesize that 1) caregiver self-efficacy in intervention arm PiB is higher compared to the control arm of usual care; 2) care costs of participants in intervention arm are lower compared to the control arm of usual care. Objectives: The investigators aim to answer the following research questions: - What is the effect of PiB on caregiver self-efficacy compared to usual care? - What is the effect of PiB on caregiver and person with dementia total care costs compared to usual care? - What is the incremental cost-utility ratio of PiB compared to usual care? - What is the annual budget impact of PiB compared to usual care? Study design: Pragmatic, cluster randomised controlled trial. Study population: Informal caregivers of people with early-stage dementia who are community-dwelling and are receiving little or no dementia-related formal ADL-care Intervention: blended E-health informal caregiver support program with online psycho-education and behavioural modelling. It contains personalized goal setting, online modules with option for online communication with care professional, evaluation with care professional. Main study parameters/endpoints: Primary: self-efficacy. Cost-utility: EQ5D, RUD. Secondary: quality-of-life, caregiver burden Data collection: Measurements consist of questionnaires (total duration is approximately 1 hour; administered at home, via telephone, via email or other location if preferred by the participant; take place at baseline, 3, 6, 12 and 24 months).

NCT ID: NCT05450107 Recruiting - Metatarsal Fracture Clinical Trials

Fifth Metatarsal Orthopedic Outcome Trial

FOOT
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Fractures of the shaft, distal to zone three, of the fifth metatarsal often occur after foot distortion. There is very little evidence available regarding the optimal treatment. Currently the most common treatment is prolonged cast immobilization. Operative treatment has been reported as an alternative and could promote early recovery. No comparative study has been published regarding optimal treatment

NCT ID: NCT05449756 Recruiting - Allergy Clinical Trials

A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life

Start date: May 30, 2023
Phase:
Study type: Observational

This is a follow-up study of a randomised clinical trial, called TEMPO (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year of life. The investigators like to know if these children develop allergies or infections in childhood and whether their feeding pattern in infancy plays a role.

NCT ID: NCT05449470 Recruiting - Fall Clinical Trials

A Clinical Decision Support System and Patient Portal for Preventing Medication-related Falls in Older Patients

ADFICE_IT
Start date: July 7, 2022
Phase: N/A
Study type: Interventional

Falls in older adults represents a growing public health challenge. The use of certain medication is recognized as an important modifiable risk factor for falls. Research indicates fall-risk increasing drug (FRID) deprescribing is effective in reducing falls but difficult to initiate and to sustain over longer periods of follow-up. A clinical decision support system (CDSS) and patient portal for communicating medication-related fall risk to fall clinic patients may improve joint medication management between patients and physicians and consequently reduce the incidence of injurious falls.

NCT ID: NCT05449366 Recruiting - Clinical trials for Peritoneal Malignant Mesothelioma

Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma

INTERACT MESO
Start date: February 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Patients primary malignant peritoneal mesothelioma (MPM), without extra-abdominal disease, that are not eligible (or willing) to undergo cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) can be included in this study. Patients will be treated with intraperitoneal (IP) chemotherapy (paclitaxel) in weekly cycles. The primary aim of this study is to determine the maximum tolerable dose (MTD) of IP monotherapy with paclitaxel for patients with MPM. The secondary aims are to assess safety and feasibility of this strategy, and to study the pharmacokinetics of paclitaxel in this setting.

NCT ID: NCT05446324 Recruiting - Endometrial Cancer Clinical Trials

Feasibility of Gallium-68-tilmanocept PET/CT for Sentinel Lymph Node Detection in Endometrial Cancer

SENGA
Start date: February 15, 2023
Phase: Phase 3
Study type: Interventional

This pilot study evaluates the feasibility of 68Ga-tilmanocept PET/CT for SLN mapping in patients with endometrial cancer.

NCT ID: NCT05445843 Active, not recruiting - Clinical trials for Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression = 1% and an STK11 Co-mutation

Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.

Start date: December 6, 2022
Phase: Phase 2
Study type: Interventional

This study aims to assess the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C mutation and a PD-L1 expression < 1% regardless of STK11 mutation status (cohort A), or a PD-L1 expression ≥ 1% and an STK11 co-mutation (cohort B).