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NCT ID: NCT05794139 Recruiting - Clinical trials for Spinal Muscular Atrophy

Safety and Efficacy of NMD670 in Ambulatory Adult Patients With Type 3 Spinal Muscular Atrophy

SYNAPSE-SMA
Start date: September 21, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of NMD670 in the treatment of ambulatory adults with spinal muscular atrophy type 3

NCT ID: NCT05792488 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Lifestyle Guidance Methods in NAFLD

INDIANA
Start date: October 24, 2022
Phase: N/A
Study type: Interventional

To determine the efficiency of lifestyle modification (due to a dietitian or digital application) compared to standard of care.

NCT ID: NCT05792072 Enrolling by invitation - Neuropathic Pain Clinical Trials

rTMS for the Treatment of Neuropathic Pain in Diabetic Patients

Start date: May 2, 2023
Phase: N/A
Study type: Interventional

Tis study aims to assess whether multiple sessions of sham-controlled HF-rTMS applied to the motor cortex significantly reduces treatment-resistant neuropathic pain in diabetic patients. This study will also investigate the effect of those rTMS sessions on functional connectivity of the M1 with brain areas involved in pain processing, underlying brain metabolism and brain plasticity using rs-fMRI, MRS and Paired-pulse stimulation respectively in those patients. Subjects will be randomized into two groups to receive real or sham rTMS protocol. A washout period of at least 8 weeks will be respected between protocols to minimize carry-over effects. Sham stimulation will be delivered using a sham coil, providing the same auditory and sensory stimuli. One daily rTMS session for 5 days of HF-rTMS, will be delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s

NCT ID: NCT05791409 Recruiting - CLL/SLL Clinical Trials

Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL

AETHER
Start date: April 10, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

In this study, efficacy and safety of 2 regimens that combine the CD3-CD20 T cell engager epcoritamab with venetoclax will be tested in relapsed/refractory CLL and SLL patients. The trial starts with phase I part to establish the recommended dose level (RDL) of epcoritamab in the combination with venetoclax for the phase II trial.

NCT ID: NCT05790759 Completed - Parkinson Disease Clinical Trials

Effect of Haptic Cueing on Long-Range Autocorrelations in Parkinson's Disease Gait Variability

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Parkinson's Disease (PD) patients suffer from gait impairments responsible for falls and bad quality of life: reduced speed and stride length, randomness in the temporal organization of stride duration variability (reduced Long-Range Autocorrelations (LRA)). For years, auditory cueing has been used to modulate PD gait and its effect on LRA is known. Less is known regarding the effects of haptic cueing on PD gait and especially on LRA. This pilot study will compare the spatio-temporal gait parameters and LRA of PD patients tested under three conditions: walking without cueing, walking with auditory cueing and walking with haptic cueing by means of rhythmic vibrations on the patients' wrists.

NCT ID: NCT05790616 Recruiting - Hypoxia Clinical Trials

Accuracy of Pulse Oximeters During Profound Hypoxia

APO
Start date: January 28, 2023
Phase: N/A
Study type: Interventional

This study is designed to calibrate and determine the accuracy for SpO2, pulse rate and respiratory rate of the newly in-house build Test Device wrist 1 (TDw1, or EVA) at Philips. SpO2, pulse rate and respiratory rate during hypoxia will be calculated by using data of well-known reference devices, including: - A reference SpO2 sensor of Nellcor placed at a fingertip, that reflects also continuously the pulse rate Will be used to compare with the test device. - A reference respiratory rate device that calculates the respiratory rate based on detection of end-tidal CO2 peaks by capnography. - Oxygen saturation in arterial blood samples (SaO2), determined by a co-oximeter will be used to calculate the accuracy of the test device. During the study the following devices will be additionally used by the volunteers: - AppleWatch 7 - TDw2, watch build by philips, using the PPG and software technology developed by Philips - A smartphone that detects reflected PPG signals from the reflected screen at the handpalm, by the build in frontfacing camera (TDc) of the smartphone Volunteers will undergo progressive hypoxia (9 min/% O2) from 21 to 10% O2 in an altitude room, resulting in a volunteer's SpO2 of 73%. During this deliberated hypoxia, the volunteers wear the test and reference devices. This study consists of 4 sub-studies (NI = non-invasive; IN = invasive with an arterial line): - NI (Fast-Sitting): volunteers are seated in the hypoxia room in which the ambient oxygen concentration decreases at a speed of 9 min/% O2. If the volunteer reached a SpO2 ≤73% for more than 1 minute, he/she leaves the hypoxia room. And will breath air with 21% oxygen. Volunteers wear TDw1 and TDw2 and the reference devices. - NI(Fast-Lying): identical to NI(Fast-Sitting) but volunteers lay on a mattress. Volunteers wear TDw1 and AppleWatch 7 and the reference devices. - NI (Slow-Sitting): identical to NI (Fast-Sitting), but after one of the volunteers reaches a SpO2 ≤73% for more than one minute, oxygen in the room increases at a speed of 9 min/% O2 until normal ambient air oxygen concentration of 21%. Volunteers wear TDw1 and AppleWatch 7 and the reference devices. - IN(Fast-Sitting): identical to NI(Fast-Sitting) but the volunteer's oxygen saturation in blood samples withdrawn via an arterial line is measured in the laboratory. The NI studies include 18 healthy participants in each sub-study. After the first volunteers have completed the study, small adaptations in the software of the study devices is still possible, e.g. to increase the quality of the PPG-signals. After the three sub-studies are completed, the algorithm for conversion of raw PPG signals to SpO2, pulse rate and respiratory rate will be defined and fixed for the test devices. During the IN-study, which can only be started after completion of all NI studies, an arterial catheter will be inserted in the radial artery of the 12 participating volunteers, in order to take several blood samples to measure oxygen saturation in the blood (25 samples at well-defined moments during the study per volunteer). Using these results of arterial oxygen saturation, the accuracy of the test devices can be calculated.

NCT ID: NCT05789524 Recruiting - Hemophilia A Clinical Trials

The Efficacy and Safety of SerpinPC in Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B

PRESent-2
Start date: July 6, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of prophylactic SerpinPC administered subcutaneously (SC) to participants with severe hemophilia A (HemA) (with or without inhibitors) or moderately severe to severe hemophilia B (HemB) (without inhibitors) as part of the SerpinPC registrational program. This study consists of 3 parts: Part 1: dose-justification phase, Part 2: dose-confirmatory phase, Part 3: extension phase for participants who complete either Part 1 or Part 2. This adaptive design study has a randomized dose-justification component to investigate the efficacy and safety of SerpinPC as a therapeutic option, principally for participants with HemB without inhibitors. SerpinPC has a novel mechanism of action compared with marketed treatments and those that are in development.

NCT ID: NCT05789082 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Krascendo 170
Start date: June 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of divarasib combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).

NCT ID: NCT05788198 Recruiting - Depression Moderate Clinical Trials

Integrated Depression Care

IDECA
Start date: April 25, 2023
Phase: N/A
Study type: Interventional

The Integrated DEpression CAre (IDECA) Programme is a multi-faceted intervention strategy aiming to improve guideline adherence and shared care practices for depression management in both providers and patients, as measured through a set of process and clinical outcome indicators (primary outcome measure).

NCT ID: NCT05786911 Completed - Vaginal Delivery Clinical Trials

Postpartum Fatigue and Pain Versus Nutritional Status, With Epidural Analgesia

Start date: October 27, 2022
Phase:
Study type: Observational

The objective of this preliminary observational study is to evaluate, in the patient, a correlation between a food habit and nutritional status score of the parturient and a postpartum fatigue (FSS) and pain (ENA) score on day 1, 3 and 7.