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NCT ID: NCT05237284 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)

HIMALAYA
Start date: April 13, 2022
Phase: Phase 2
Study type: Interventional

This is a parallel treatment, Phase 2, randomized, double-blind study to assess the efficacy, safety, tolerability, PK, and PD of twice daily (BID) oral SAR443820 compared with placebo in male and female participants, 18 to 80 years of age with ALS followed by an open-label, long-term extension period. Study ACT16970 consists of 2 parts (A and B) as follows: Part A is a 24-week, double blind, placebo-controlled part, preceded by a screening period of up to 4 weeks before Day 1. On Day 1 of Part A, participants will be randomized in a 2:1 ratio to the SAR443820 treatment arm or matching placebo arm as listed below: - Treatment arm: SAR443820, BID - Placebo arm: Placebo, BID Randomization will be stratified by the geographic region of the study site, region of ALS onset (bulbar vs other areas), use of riluzole (yes vs no), use of edaravone (yes vs no) and use of the combination of sodium phenylbutyrate and taurursodiol (named Relyvrio in the United States of America [USA] and Albrioza in Canada) (yes vs no). Participants will attend in-clinic study assessments at baseline (Day 1), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 16, Week 20, Week 21, Week 22, Week 23, and Week 24. All ongoing participants at Week 24 will rollover to open-label extension Part B. The Week 24 Visit is the end of Part A and the beginning of Part B. Part B is an open-label, long-term extension period that starts from Week 24 and continues up to Week 106. The objectives of Part B are to provide extended access to SAR443820 participants in Part A and to further evaluate the safety and efficacy of long-term SAR443820 treatment. The treatment assignment of participants at randomization in Part A will remain blinded to Investigators, participants, and site personnel until the end of Part B. Every participant, except those who discontinue Investigational Medicinal Product (IMP) treatment permanently in Part A, will receive BID oral tablets of SAR443820 in Part B.

NCT ID: NCT05229900 Terminated - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of SGN-ALPV in Advanced Solid Tumors

Start date: April 21, 2022
Phase: Phase 1
Study type: Interventional

This study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have three parts. Parts A and B of the study will find out how much SGN-ALPV should be given to participants. Part C will use the dose and schedule found in Parts A and B to find out how safe SGN-ALPV is and if it works to treat solid tumor cancers.

NCT ID: NCT05227456 Terminated - Dysmenorrhea Clinical Trials

Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

FEATS
Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess the efficacy of an implantable etonogestrel device in reducing hysterectomy rate in patients with a failed endometrial ablation.

NCT ID: NCT05218096 Terminated - Myasthenia Gravis Clinical Trials

Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis

Start date: April 27, 2022
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of ALXN2050 (120 milligrams [mg], 180 mg) in participants with generalized myasthenia gravis (gMG). Safety will be monitored throughout the study.

NCT ID: NCT05217563 Terminated - Pain, Procedural Clinical Trials

Reframing Needle-related Pain

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

The present research study aims to examine the efficacy of a brief parent-led memory reframing intervention to foster more adaptive (i.e., more accurate and positive) pain memories and less future needle pain and fear for a two-series needle procedure (approved vaccines to protect against COVID-19; e.g., BioNTech Pfizer). The intervention will draw from recent data and extant memory reframing and narrative-based intervention techniques to promote more accurate/positive pain memories by teaching parents more adaptive styles of reminiscing with their children about a needle procedure (i.e., a COVID-19 vaccine).

NCT ID: NCT05198349 Terminated - Clinical trials for Metastatic or Locally Advanced Unresectable Solid Tumors

First in Human Study of M1069 in Advanced Solid Tumors

Start date: March 2, 2022
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and early signs of efficacy of M1069 in participants with advanced solid malignancies.

NCT ID: NCT05194839 Terminated - Clinical trials for Palmoplantar Pustulosis

A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

Start date: January 5, 2022
Phase: Phase 2
Study type: Interventional

A 12-week Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis followed by an Open-label Extension Phase.

NCT ID: NCT05190302 Terminated - Clinical trials for Peripheral Nerve Block

Determination of the Sensitivity, Specificity & Receiver Operating Characteristic of Nerve Stimulation Receptor as a Decision-making Tool During US Guided PNB

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

Although the superiority of ultrasound guidance over neurostimulation (NS) has been demonstrated, it has its limits, namely when used for a deeper block (device limits) or if used by a less experienced operator (ability to recognize structures, to correctly position the needle). In addition, its use has failed to consistently prevent intra-neural injection. The question of the usefulness of NS in addition to ultrasound is therefore still relevant. A great geographical disparity exists in the habits of nerve localization. The reluctance to use NS stems mainly from doubts about its effectiveness. The threshold used to consider that the needle is sufficiently close to the nerve and the one used to exclude an intraneural injection have been disputed in several studies. Another weakness of studies concerning NS since the advent of ultrasound guidance is the impossibility of generalizing the results. All clinical studies were performed in an academic setting, and a large majority of them specify that the blocks were performed by - or supervised by - regional anesthesia experts. The only study that attempted to determine the sensitivity of NS used ultrasound as a gold standard. The choice of the ultrasound position as the gold standard is debatable, since it is dependent of the operator. The clinical success of nerve blocks would be a better standard. No study to date has made it possible to calculate the specificity and sensitivity of NS in addition to ultrasound guidance, and therefore, to obtain the positive and negative predictive values of the technique. Obtaining these values could allow each clinical setting or individual to determine the contribution of NS to their rate of success, as a modest increase in the success rate or a minimal decrease in the risk of neuropathy would be clinically significant. The hypothesis is that the sensitivity and specificity of NS justifies its use in combination with ultrasound guidance in most settings, but that the gain in efficiency varies depending on the context (for example depending on the local success rate). To determine the required sample size to test this hypothesis and plan for a definitive study on the question, the investigators need to know what is the local failure rate (incidence of studied event) and what could be the possible rate of patient enrollment. This preliminary, feasibility study will aim to confirm that the local failure rate is compatible with the 5% rate observed in the literature.

NCT ID: NCT05179057 Terminated - Clinical trials for Adenovirus Infection

Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

Start date: April 26, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).

NCT ID: NCT05177770 Terminated - Prostate Cancer Clinical Trials

Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer

Start date: January 17, 2022
Phase: Phase 2
Study type: Interventional

This trial will look at the safety and preliminary efficacy of SRF617 in combination with etrumadenant and zimberelimab in patients with metastatic castration-resistant prostate cancer (mCRPC).