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Recruiting

Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression

Low Birth Weight Kangaroo Mother Care Postpartum Depression Neurodevelopmental Outcome +1

The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were admitted to the neonatal intensive care unit (NICU) more than standard of care KMC. The main questions it aims to answer are: * Does longer KMC decrease the incidence of postpartum depression in mothers of low birthweight infants in a low-resource setting? * Does longer KMC improve neurodevelopmental outcomes of low birthweight infants at 6, 12, and 18 months in a low-resource setting? * What are the barriers to practicing KMC in low birthweight infants following hospital discharge in a low-resource setting? * What is the prevalence of paternal depression in a low resource setting? * Is it cost effective to admit preterm mother-infant dyads to the KMC ward following NICU discharge? Researchers will compare (extended admission to the KMC ward) to (standard of care KMC) to see if extended KMC decreases PPD in mothers of preterm infants in low-resource settings. Participants (infants) will: * At time of discharge from the NICU, when clinically stable, spend either \< 2 days in the KMC ward with their mothers or spend longer in the KMC ward until discharge. * Return to clinic at routine follow-up visits (at 2 weeks and at 6-8 weeks) where mothers will be screened for postpartum depression and fathers will be screened for depression. * Return to clinic for neurodevelopmental screening at 6, 12, and 18 months where mothers will be screened for postpartum depression and perceived social support and fathers will be screened for depression.

Начало: 01.12.2024 Край: 30.09.2027 Възраст: 1–89 г.

Zambia University of Alabama at Birmingham NCT06545760

Recruiting Phase 1

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Chronic Hep B Chronic Hepatitis b Chronic Hepatitis HBV

This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.

Начало: 29.11.2024 Край: 30.10.2028 Възраст: 18–75 г. Treatment

Hong Kong, Moldova, New Zealand Tune Therapeutics, Inc. NCT06671093

Recruiting Phase 4

Prospective evaluation of potential effects of repeated gadolinium-based contrast agent (GBCA) administrations of the same GBCA on motor and cognitive functions in neurologically normal adults in comparison to a non-GBCA exposed control group—ODYSSEY

Long term potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA–exposed control group effects regarding.

Trial status: Authorised Changes from baseline in the composite endpoint (Years 1 to 4) and in each individual test of motor and cognitive function (Years 1 to 5) will be assessed., Evaluation of AEs. The recording of AEs that occur after signing of the informed consent form (ICF) at Screening, will be done at baseline and at each annual visit. Signs/symptoms, onset date/time, severity, causality, seriousness, treatment and outcome will be recorded., Total gadolinium concentrations in blood plasma and urine samples collected at baseline and at each annual visit will be determined. If the CE-MRI is obtained at the same visit, the blood and urine samples will be obtained prior to imaging. The co-primary endpoints are the change from baseline to Year 5 in motor function and in cognitive function as expressed by the composite z score, defined as the weighted sum of the z scores of the individual tests. Since each of these tests is considered equally important, each test will be assigned an equal weight.

Начало: 27.11.2024 Възраст: 18–64 г.

France, Germany, Italy Iqvia Rds France 2024-515462-14-00

Recruiting Phase 3

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

Non-squamous Non-small Cell Lung Cancer

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.

Начало: 27.11.2024 Край: 25.03.2030 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +22 AstraZeneca NCT06627647

Recruiting Phase 1/2

A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

B-cell Malignancy Relapsed Cancer Refractory Cancer B-cell Lymphoma

The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R/R) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.

Начало: 27.11.2024 Край: 02.12.2029 Възраст: от 18 г. Treatment

Australia, Brazil, China +5 BeOne Medicines NCT06634589

Recruiting Phase 2

Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

B-cell Non-Hodgkin Lymphoma Follicular Lymphoma (FL) Large B-Cell Lymphoma (LBCL)

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of Surovatamig (AZD0486) monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for LBCL.

Начало: 27.11.2024 Край: 14.06.2029 Възраст: от 18 г. Treatment

Australia, Brazil, Canada +12 AstraZeneca NCT06526793

Recruiting Phase 1

A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients

Advanced or Metastatic Solid Tumors

This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine recommended phase 2 dose of KGX101 mono and combo with envafolimab. Participants will: 1. Take drug KGX101 mono or combo with envafolimab every 3 weeks; 2. Visit the clinic for checkups and tests. Schedule will be about 6-8 times in the first month and then about every 3 weeks afterwards.

Начало: 27.11.2024 Край: 30.03.2027 Възраст: 18–75 г.

China Kangabio AUSTRALIA LTD PTY NCT07260305

Recruiting Phase 2

Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)

Metastatic Breast Cancer

The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) unresectable metastatic breast cancer. There is no formal hypothesis testing in this study.

Начало: 27.11.2024 Край: 07.10.2028 Възраст: от 18 г.

Argentina, Canada, Chile +6 Merck Sharp & Dohme LLC NCT06428396

Recruiting Phase 1/2

A Study of Tetrathiomolybdate (TM) Plus Capecitabine

Triple Negative Breast Cancer Residual Disease

There are two parts to this study. It is a phase 1b followed by a randomized phase 2 study to assess whether adding 3 years of adjuvant tetrathiomolybdate (TM) to standard 6 months treatment of adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer. In the phase 1b part of the study, TM is added to adjuvant capecitabine and pembrolizumab in high risk for relapse triple negative breast cancer (RCB 2, 3, risk for relapse \>60% at 5 years) after completion of neoadjuvant chemo-immunotherapy and surgery to establish the safety of the combination. This will be followed by a randomized phase 2 clinical trial of adjuvant TM and capecitabine vs capecitabine alone. If pembrolizumab was administered in the neoadjuvant setting, it may be continued in the adjuvant setting per investigator discretion.

Начало: 26.11.2024 Край: 26.06.2036 Възраст: 18–80 г.

United States Dartmouth-Hitchcock Medical Center NCT06134375

Recruiting

Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)

Sickle Cell Disease

This study will evaluate the acceptability, feasibility, and preliminary efficacy of a shared decision making intervention for adolescents and young adults (AYAs) with sickle cell disease (SCD). 60 AYAs with SCD ages 15-25 and their caregivers and 8 SCD providers will participate in the pilot pragmatic trial. AYAs, caregivers, and providers will be recruited from Nemours Children's Hospital, Delaware (NCH-DE), Nemours Children's Hospital in Orlando, FL (NCH-ORL), and Nemours Children's Health at Wolfson Children's Hospital in Jacksonville, FL (NCH-JAX). NCH-DE participants (n=30) will receive the SDM intervention including a virtual reality patient health education component, whereas NCH-ORL and NCH-JAX participants (n=30) will receive the SDM intervention with standard patient education materials (print, video). SCD providers will be trained to use the toolkit components and will introduce decision aids during an outpatient clinic visit for AYAs who are candidates for one or more disease-modifying therapies.

Начало: 26.11.2024 Край: 31.12.2026 Възраст: от 15 г.

United States Nemours Children's Clinic NCT05383911

Recruiting Phase 3

One multicenter, randomized, open, phase III clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of metastatic hormone-sensitive prostate cancer with high tumor load.

Metastatic hormone-sensitive prostate cancer with high tumor load

Trial status: Authorised Time to PSA progression., Time to the next bone related event (including fracture, spinal compression, radiotherapy or surgery for bones)., Time to the start of the next anti-prostate cancer treatment., ORR, Safety endpoint. rPFS,OS

Начало: 26.11.2024 Възраст: от 18 г.

Bulgaria, Czech Republic, Poland Jiangsu Hengrui Pharmaceuticals Co. Ltd. 2024-515194-10-00

Recruiting Phase 1

Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays

Malaria

Background: Malaria is a disease caused by parasites transmitted to people by mosquitoes. Around the world, there were 241 million cases and 627,000 deaths from malaria in 2020. Researchers are working to develop vaccines and treatments for this disease. Objective: To learn how malaria develops in people; how the body's immune system reacts to malaria; and how malaria spreads from people to mosquitoes. Eligibility: Healthy people in the Washington DC area, aged 18 to 54 years. They cannot live alone during parts of the study. Design: Participants will be infected with a parasite that causes malaria. The parasite will be in donated blood; it will be given through an IV. Participants will likely develop symptoms within a week after the injection. Researchers will call daily to check on their health. After about 6 days, participants will come to the NIH clinic each day for blood tests. Participants will check in to the NIH clinic around 10 days after the injection. They will stay in the clinic 3 to 6 days. They will have multiple blood tests every day. Participants will be bitten by mosquitoes up to 4 times. Cups containing mosquitoes will be held against their skin for 15 minutes. Participants will begin taking chloroquine close to the end of their clinic stay. Chloroquine is a pill taken by mouth once or twice a day for 3 days. It is FDA-approved to treat malaria. Participants will have follow-up visits 1 and 3 weeks after discharge.

Начало: 26.11.2024 Край: 26.11.2027 Възраст: 18–54 г.

United States National Institute of Allergy and Infectious Diseases ( NCT06607003

Recruiting

Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts

Odontogenic Cysts Odontogenic Keratocyst

This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.

Начало: 26.11.2024 Край: 01.01.2028 Възраст: от 18 г.

Hungary Semmelweis University NCT06688851

Recruiting Phase 1

A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification

Metastatic Solid Tumors Advanced Non-squamous Non-small-cell Lung Cancer Advanced Colorectal Cancer Advanced Pancreatic Ductal Adenocarcinoma +3

This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS mutations or amplification, as well as when used in combination with tislelizumab (also known as BGB-A317) in participants with nonsquamous non-small cell lung cancer (NSCLC) and used in combination with cetuximab in participants with colorectal cancer (CRC). The study consists of 2 phases: Phase 1a Dose Escalation and Safety Expansion and Phase 1b Dose Expansion.

Начало: 26.11.2024 Край: 01.12.2026 Възраст: от 18 г. Treatment

Australia, China, New Zealand +2 BeiGene NCT06585488

Recruiting Phase 1

ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

Advanced Solid Tumor

Adcendo ApS is conducting a phase 1 study of an investigational drug called ADCE-T02 (previously known as AMT-754), a tissue factor targeted antibody-drug conjugate which may be used in the future as a possible treatment for advanced solid tumors. The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the recommended dose and the safety and tolerability of ADCE-T02 when given as a single therapy over a range of different dose levels.

Начало: 25.11.2024 Край: 31.12.2026 Възраст: от 18 г. Treatment

Australia, United States Adcendo ApS NCT06597721

Recruiting

Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock

Aortic Stenosis Cardiogenic Shock

The goal of this clinical trial is to learn if acute transcatheter aortic valve implantation (TAVI) is superior to standard treatment (stabilization in an intensive care unit and TAVI subsequently) to treat cardiogenic shock in patients with critical severe aortic stenosis. The main questions it aims to answer are: • Does acute TAVI increase survival compared with standard treatment? Participants will: * Undergo either TAVI within 12 hours after admission or stabilization and TAVI 72 hours or more after admission * Visit an outpatient clinic and be evaluated for quality of life and heart function

Начало: 25.11.2024 Край: 30.10.2027

Denmark Rigshospitalet, Denmark NCT06638268

Recruiting Phase 1

A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis

Healthy Adult Volunteers Active Ulcerative Colitis Active Ulcerative Colitis (UC)

This Phase 1b/2a clinical development plan is focused on the use of NP-201 acetate injection to investigate the pharmacokinetics (PK), safety, efficacy, PD (pharmacodynamic) markers (Phase 1b) and tolerability of NP-201 acetate injection after subcutaneous (SC) injection of multiple doses in healthy adults and in the ulcerative colitis (UC) patient population.

Начало: 25.11.2024 Край: 05.05.2025 Възраст: 18–60 г. Treatment

Australia NIBEC Co., Ltd. NCT06681389

Recruiting Phase 1

A Phase 1 Study of FZ008-145 in Healthy Subjects.

Healthy

The study will be conducted in 5 parts: Part A (single ascending dose \[SAD\] in solution formulation), Part C (food effect \[FE\]), Part D (cold pressor test \[CPT\] to evaluate pain tolerance following single dose), and Part E (multiple ascending dose \[MAD\] in tablet formulation).

Начало: 25.11.2024 Край: 01.06.2026 Възраст: 18–65 г. Treatment

Australia Guangzhou Fermion Technology Co., LTD NCT06685809

Recruiting

Retrospective Acute Care Appendectomy Study

Acute Appendicitis

The purpose of this retrospective study is to compare perioperative data for subjects who have undergone an emergent or urgent robotic-assisted or laparoscopic appendectomy for acute appendicitis.

Начало: 22.11.2024 Край: 01.11.2026 Възраст: от 22 г.

United States Intuitive Surgical NCT06624215

Recruiting

Autologous Testicular Tissue Transplantation

Cancer Sickle Cell Thalassemia Hematologic Diseases

Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells in case of imminent gonadotoxic treatment during childhood. In case of total azoospermia or absence of spermatozoa that can be used for intra-cytoplasmic injection (ICSI) in adulthood, the investigators intend to perform the first in men autologous testicular tissue transplantation to restore fertility.

Начало: 22.11.2024 Край: 29.10.2030 Възраст: 18–50 г.

Belgium Universitair Ziekenhuis Brussel NCT05414045

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