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NCT ID: NCT05779163 Recruiting - Clinical trials for Advanced Malignant Tumors

A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors

Start date: April 14, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

NCT ID: NCT05780489 Recruiting - Infertility, Female Clinical Trials

Evaluation of Salivary ELISA for Hormone Monitoring in Donors

MINT-II
Start date: April 14, 2023
Phase: N/A
Study type: Interventional

In donors or patients undergoing assisted reproduction treatments (ART) it is necessary to closely control ovarian stimulation to monitor the number and size of developing follicles. Oestradiol (E2) and progesterone (P4) are products of steroidogenesis. Their concentrations increase with the diameter of the growing follicle. In order to assess treatment response and support clinical decisions, accurate and reliable methods to measure E2 and P4 are essential. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients or donors to undergo multiple blood draws. It is often a physically and emotionally painful process, and the most convenient solution is the measurement of hormones concentrations in other biological fluids, such as saliva. Salivary diagnostic tests are a less invasive, inexpensive, and stress-free alternative. The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations in oocyte donors, and, also, evaluate the feasibility of doing saliva E2 and P4 determinations in the IVIRMA clinic labs.

NCT ID: NCT05804032 Recruiting - Multiple Myeloma Clinical Trials

Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma

Start date: April 14, 2023
Phase: Phase 3
Study type: Interventional

The trial aims to demonstrate the non-inferiority of subcutaneous to intravenous isatuximab administration in transplant-eligible patients with newly diagnosed multiple myeloma.

NCT ID: NCT05807399 Recruiting - Clinical trials for Pulmonary Tuberculosis

PanACEA - STEP2C -01

Start date: April 14, 2023
Phase: Phase 2
Study type: Interventional

This is a phase 2B/C, open label platform study that will compare the efficacy, safety of 3 experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1. In stage 2, the experimental arm 4 containing BTZ-043 will be added. The allocation ratio will be changed to co-enrol the remaining participants in arms 1- 3 simultaneously with arm 4. When arms 1-2 are fully enrolled and arm 4 is not, further participants will be randomized 1:1 to control and experimental arm 4. Not all countries will participate in stage 2.

NCT ID: NCT05824988 Recruiting - Clinical trials for Gram-Positive Bacterial Infections

Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease

Start date: April 14, 2023
Phase:
Study type: Observational

The incidence and prevalence of nontuberculous mycobacteria (NTM) infections have gradually increased over the years worldwide (1-3). In China, Mycobacterium avium complex (MAC) was the most prevalent NTM specie (4), while challenged by long treatment duration, frequent drug-induced adverse events, lack of treatment alternatives, poor treatment outcome and high recurrence rate (5, 6). In order to maximize the efficacy of the few available drugs and prevent the development of drug resistance, ensuring adequate plasma drug concentrations are of importance. Despite the role of pathogen susceptibility, determined by minimum inhibitory concentration (MIC), is non-negligible, the evidences regarding its association with treatment outcome are limited, especially for rifamycin and ethambutol. The difficulties in explaining the clinical values of MIC might partially be attributed to the lack of in vivo drug exposure data, which cannot be accurately predicted by the dose administered because of between-patient pharmacokinetic variability (7). Therapeutic drug monitoring (TDM) is a strategy to guide and personalize treatment by measuring plasma drug concentrations and pathogen susceptibility, which might have the potential to improve treatment response to MAC lung disease. In this observational study, the hypothesis is that the drug exposure and/or MIC of antimycobacterial drugs are correlated to the treatment response of MAC lung disease, which is assessed from the perspective of treatment outcome, mycobacterial culture negative conversion, lung function, radiological presentation and self-reported quality of life. Consenting adult patients with culture-positive MAC lung disease will be recruited in study hospital. Respiratory samples (sputum and/or bronchoalveolar lavage fluid) will be collected regularly for mycobacterial culture on the basis of BACTEC MGIT 960 system and MIC will be determined using a commercial broth microdilution plate. Drug concentrations will be measured at 1 and/or 6 months after treatment initiation using liquid chromatography tandem mass spectrometry (LC-MS/MS). The final treatment outcome is recorded at the end of MAC treatment and defined according to an NTM-NET consensus statement (8).

NCT ID: NCT05835453 Recruiting - Gingivitis Clinical Trials

At-home Bleaching Using Clear Aligners

Start date: April 14, 2023
Phase: N/A
Study type: Interventional

The aim of the present project is to clinically evaluate the bleaching effectiveness, tooth sensitivity, gingival irritation and patient´s satisfaction during a at-home bleaching with 10% carbamide peroxide using a conventional bleaching tray or a clear aligner.

NCT ID: NCT05842031 Recruiting - Penile Cancer Clinical Trials

Assessment of Patient Experience and Needs for Patients Undergoing Invasive Inguinal Lymph Node Procedures for Penile Cancer

Start date: April 14, 2023
Phase:
Study type: Observational

To learn more about the patient experience undergoing inguinal (in the groin) lymph node procedures for penile cancer during and after surgery.

NCT ID: NCT05843708 Recruiting - Healthy Subjects Clinical Trials

A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects

Start date: April 14, 2023
Phase: Phase 1
Study type: Interventional

The objectives of this study are: - To evaluate the effect of a low-fat meal on the pharmacokinetics (PK) of vorasidenib following a single oral dose of 40 mg vorasidenib in healthy adult subjects (substudy A) - To evaluate the effect of multiple-dose ciprofloxacin (strong cytochrome P450 [CYP]1A2 inhibitor) on the single-dose PK of vorasidenib in healthy adult subjects (substudy B)

NCT ID: NCT05858268 Recruiting - Cerebral Palsy Clinical Trials

NeuralNET Cerebral Palsy Pilot Study

Start date: April 14, 2023
Phase:
Study type: Observational

The NeuralNET Cerebral Palsy Pilot Study is testing a genetic testing pathway in the NHS for children with cerebral palsy (CP). Other studies suggest that almost one in three peoples' CP is caused by a change in their genes, but more studies are needed to confirm this. A genetic test called whole genome sequencing (WGS) will be used for children who have CP to look for rare changes in genes that cause the condition, and the results of the test will be given to children's doctors within 12 weeks. Knowing that CP has a genetic cause could lead to changes being made to a child's care or treatment that could improve their condition. The study will test 66 children with CP from 3 hospitals, and also their biological parent(s), if they're available. Following informed consent, the investigators will collect a blood sample from everyone taking part which will be sent for WGS. It is important to understand what families think and feel about the testing. The investigators will ask parents/guardians of the children taking part to fill in two questionnaires, one before and one after WGS. Some parents/guardians will also be interviewed after getting the WGS result, to ask about their experience of the testing. The study will take up to 16 months per family. The results of this pilot study will tell the investigators if it is feasible for the NHS to use WGS to test children with CP. If so, a larger study testing more children with CP can then be carried out to help decide if this type of WGS-based testing should be made available through the NHS to children with CP whose clinical care might be changed by the result. The genetic findings from this study will also be made available to other researchers and doctors to do more research into CP that might help improve general understanding of the condition and its potential treatment.

NCT ID: NCT05858489 Recruiting - Clinical trials for Neurocognitive Deficit

Concordance Between Mini-Mental Stats Examination (MMSE) and an Adapted Version of the MMSE in Reunion Island Population (MMS-Run)

MMS-R-ep
Start date: April 14, 2023
Phase:
Study type: Observational

Illeteracy concerns more than 38% of Réunion Island's people older than 65 years old, which makes it an important risk factor for dementia and a limit to neurocognitive test's administration. The MMSRun is a Mini Mental State Examination's version adapted to illeteracy and Réunionese culture, inspired by Hindi Mental State Examination's work. It allows a way better participation during neurocognitive evaluation, but it has never been validated. This study is a peliminary study to a validation, where the concordance between scores obtained from MMSRun and from the consensual version of Mini Mental State Examination proposed by GRECO (Groupe de Réflexion sur les Evaluations Cognitives) - the only french version validated - on a hospitalized and eldery population will be analyzed.