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NCT ID: NCT05139602 Recruiting - Clinical trials for Hidradenitis Suppurativa

A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy

Start date: December 28, 2021
Phase: Phase 2
Study type: Interventional

Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. Despite the clinical benefit anti-tumor necrosis factor (TNF) therapy offers to patients with HS, there remains a significant unmet medical need for patients who fail to achieve adequate benefit with anti-TNF therapy. This study will compare lutikizumab (ABT-981) versus placebo for the treatment of adult participants with moderate to severe HS who have failed anti-TNF therapy. Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS. In the Main Study, participants will be put in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that participants will be assigned to placebo. Around 160 adult participants with moderate to severe HS who have failed anti-TNF therapy will be enrolled in the study at approximately 50 sites worldwide. In the Sub-study, participants will be put in 1 of 2 groups, called treatment arms. Both arms will receive treatment at different dosing intervals. Around 40 adult participants with moderate to severe HS who are naïve to biologic therapy will be enrolled in the study at certain sites. In the Main Study, participants will receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 weeks. In the Sub-study, participants will receive subcutaneous injections of lutikizumab (ABT-981) every week for the first 15 weeks, then either every week or every other week for 36 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.

NCT ID: NCT05139316 Active, not recruiting - Clinical trials for Glycogen Storage Disease Type IA

A Study of Adeno-Associated Virus Serotype 8-Mediated Gene Transfer of Glucose-6-Phosphatase in Patients With Glycogen Storage Disease Type Ia (GSDIa)

Start date: November 8, 2021
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy of DTX401 to reduce or eliminate dependence on exogenous glucose replacement therapy to maintain euglycemia and to maintain or improve the quality of glucose control.

NCT ID: NCT05139173 Active, not recruiting - Clinical trials for Rotator Cuff Pathology

Novel Shoulder Rehabilitation Program (SPARS-REHAB)

SPARS-REHAB
Start date: January 17, 2022
Phase: N/A
Study type: Interventional

Physical therapy is essential for the successful rehabilitation of common shoulder injuries and following shoulder surgery. Patients may receive some training and supervision for shoulder physiotherapy through private pay or private insurance, but they are typically responsible for performing most of their physiotherapy independently at home. It is unknown how often patients perform their home exercises, if these exercises are done correctly without supervision, and how poor adherence might impact recovery. The investigators have recently developed a Smart Physiotherapy Activity Recognition System (SPARS) for tracking home shoulder physiotherapy exercises using sensors in a commercial smart watch and artificial intelligence (AI). SPARS was successful in identifying shoulder exercises in healthy adults in the laboratory setting, and in patients undergoing physiotherapy for rotator cuff pathology. Further inquiry is required to establish the clinical effectiveness of this technology for tracking and improving patient engagement, and to investigate the potential individual impacts of its use.

NCT ID: NCT05139160 Active, not recruiting - Nutrition, Healthy Clinical Trials

Aminoacidemia and Protein Kinetics in Response to the Ingestion of Plant-based Protein Blends

PBP
Start date: August 15, 2022
Phase: N/A
Study type: Interventional

The present investigation aims to study a novel plant based protein isolate blend to determine if it results in similar muscle building responses compared to whey protein isolate.

NCT ID: NCT05139121 Active, not recruiting - Contraception Clinical Trials

Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles

Start date: October 26, 2021
Phase: Phase 3
Study type: Interventional

Study of the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01 in approxmiately 1200 women for up to 13 cycles

NCT ID: NCT05139017 Recruiting - Clinical trials for Diffuse Large B-Cell Lymphoma

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Start date: January 14, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR. With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab [BR] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.

NCT ID: NCT05138861 Completed - Healthy Clinical Trials

A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects

Start date: February 9, 2021
Phase: Phase 1
Study type: Interventional

Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration.

NCT ID: NCT05138835 Completed - Oily Skin Clinical Trials

BOTOX® Cosmetic and Skin Health.

Start date: November 11, 2021
Phase: N/A
Study type: Interventional

This is a two cohort, randomized, double blind, single center study to evaluate the effects of Botox Cosmetic (BTX) on sebum protection. Thirty-four female subjects with moderate-to-high skin sebum concentration will be recruited and randomized in a 1:1 ratio to treatment groups.

NCT ID: NCT05137938 Completed - Depression Clinical Trials

Intranasal Ketamine in Ultra-REsistant Depression (SURE-ECT Non Responders)

SURE-ECT
Start date: October 25, 2021
Phase: N/A
Study type: Interventional

Despite the known efficacy of pharmacotherapy (i.e. antidepressants) and psychotherapeutic interventions in treating depressive disorders, research evidence suggests that 20% to 40% of patients with major depressive disorder (MDD) do not respond adequately to such treatments. These patients are diagnosed with Treatment-Resistant Depression (TRD), and are sometimes treated with convulsive therapy. However, about 10-30% of TRD patients do not respond to convulsive therapy, and are thus diagnosed with Ultra-Resistant Depression (URD). Using an open label pilot study involving subjects, this trial aims to assess the safety, tolerability, and clinical effects of intranasal ketamine (IN) treatment in patients who do not respond to convulsive therapy. Intranasal ketamine (IN) treatment approach has shown promising therapeutic outcomes for patients with TRD, but has not yet been studied on patients with URD.

NCT ID: NCT05137899 Recruiting - Clinical trials for Hepatocellular Carcinoma

Neoadjuvant Combination of Atezolizumab/Bevacizumab Versus Neoadjuvant Radiation Therapy

ADVANCE HCC
Start date: October 18, 2022
Phase: Phase 2
Study type: Interventional

A multicentre, parallel group, randomized controlled Phase II clinical trial evaluating neoadjuvant Atezolizumab/Bevacizumab versus neoadjuvant SBRT in patients with biopsy proven solitary HCC with PVTT involving the portal vein branches. Both arms are considered experimental, and as such, a Simon two-stage design will be initially used within both arms. Only if both arms are deemed of interest for further study will a comparison between arms, using a pick-the-winner design, be conducted. Following the completion of neoadjuvant therapy, study participants will undergo a CT scan or MRI to assess tumour response to neoadjuvant therapy. Hepatic resection will be performed for those participants who meet the surgical resection criteria.