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About 196,903 results

Natural History and Development of Spondyloarthritis
https://clinicaltrials.gov/ct2/show/NCT01422694

Aug 4th, 2022 - The purpose of this protocol is to study the natural history of spondyloarthritis (SpA) in children and adults. Spondyloarthritis encompasses a spectrum of immune-mediated inflammatory diseases that exhibit overlapping features, but differ from other types of inflammatory arthritis in genetic predisposition, pathogenesis, and outcome. Ankylosing spondylitis (AS), the most common form of SpA, fr...

Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
https://clinicaltrials.gov/ct2/show/NCT03793179

Aug 5th, 2022 - PRIMARY OBJECTIVE: I. To evaluate overall survival (OS) in each of the 2 experimental arms (Arms A and B) to control (Arm C). SECONDARY OBJECTIVES: I. To evaluate progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for Arm C versus each of Arms A and B. II. To evaluate best objective response rates per RECIST 1.1 for Arm C versus each of Arms A and B. I...

Testing Pembrolizumab Versus Observation in Patients With Merkel Cell Carcinoma After Surgery, STAMP Study
https://clinicaltrials.gov/ct2/show/NCT03712605

Aug 5th, 2022 - PRIMARY OBJECTIVE: I. To compare recurrence free survival (RFS) and overall survival (OS) as co-primary endpoints across the two arms. SECONDARY OBJECTIVES: I. To evaluate adverse events. II. To evaluate distant metastasis free survival (DMFS). III. To evaluate the impact of radiation on clinical outcomes (OS, RFS, DMFS). OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive ...

Pilot Study of Reduced-Intensity Hematopoietic Stem Cell Transplant of DOCK8 Deficiency
https://clinicaltrials.gov/ct2/show/NCT01176006

Aug 5th, 2022 - Background Mutations in the Dedicator of Cytokinesis-8 (DOCK8) gene are responsible for an immunodeficiency disease characterized by: severe cutaneous and sinopulmonary infections with bacterial organisms; extensive cutaneous viral infections with Herpes simplex, Herpes zoster, Molluscum contagiosum, and Human Papilloma Virus; a marked elevation in serum IgE levels and eosinophilia; homozygous ...

Skin Immunity Sample Collection Involving Blisters and Biopsies
https://clinicaltrials.gov/ct2/show/NCT03921515

Aug 5th, 2022 - The incidence of community-associated (CA) staphylococcal infections, especially those caused by methicillin-resistant Staphylococcus aureus (MRSA), has increased in recent years. Skin and soft tissues are the primary sites for these infections. Although many patients without apparent underlying immune dysfunction suffer from recurrent and persistent skin infections with S.aureus, patients with...

Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthri...
https://clinicaltrials.gov/ct2/show/NCT03926195

Aug 5th, 2022 - The primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis. Results of this study may be pooled with the results of a separate study being conducted in participants with inflammatory bowel disease (Protocol GS-US-418-4279;...

"Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in Children"
https://clinicaltrials.gov/ct2/show/NCT03069976

Aug 5th, 2022 - The used antibiotic is Metronidazole (Flagyl), during 14 days, as induction therapy or rescue therapy. Study participants will provide blood and stool samples in order to evaluate bile acids profile and microbiome, before and after the course of metronidazole, and then comparison will be made pre- and post-antibiotics. The investigators will determine the benefit of oral metronidazole therapy t...

Evaluating Safety and Efficacy of Tivozanib (AV-951) in Cholangiocarcinoma
https://clinicaltrials.gov/ct2/show/NCT04645160

Aug 5th, 2022 - Background: Cholangiocarcinoma (CCA) is an aggressive biliary tract malignancy that remains a clinical challenge with limited treatment options and poor survival. Combination chemotherapy with gemcitabine and cisplatin is the most validated first-line treatment, but the response rate approaches only 22% and median progression free survival is 8 months. Cytoplasmic accumulation of the nuclear ex...

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan
https://clinicaltrials.gov/ct2/show/NCT04875533

Aug 5th, 2022 - A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults 60 years of age and older in Japan, Korea, and Taiwan

tDCS for Post COVID-19 Fatigue
https://clinicaltrials.gov/ct2/show/NCT04876417

Aug 5th, 2022 - For survivors of severe COVID-19, overcoming the virus is just the beginning of an uncharted recovery path. As the number of confirmed COVID-19 cases exceeds 27 million globally and 6 million in the US, the number of patients who experience persistent symptoms during recovery is rapidly growing. In COVID-19 patients, common acute symptoms include cough, fever, dyspnea, musculoskeletal symptoms ...

Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)
https://clinicaltrials.gov/ct2/show/NCT04822142

Aug 5th, 2022 - Congenital cytomegalovirus infection (cCMV) is the main non-genetic cause of sensorineural hearing loss (SNHL), and a major cause of neuro-disability. High maternal CMV prevalence seems to be consistently associated with high prevalence of cCMV infection but the associated morbidity might be different from one population to another. There exists no serologic marker useful to differentiate non-p...

In Vivo Study of THC-induced Immune-genome Changes at Single Cell Solution in HIV-infected Humans
https://clinicaltrials.gov/ct2/show/NCT04920539

Aug 5th, 2022 - In this study, the investigators hypothesize that THC alters the immunogenome in a cell type-specific fashion and alters cytokine production via epigenetic regulatory mechanisms and that these alterations differ between HIV-infected and HIV-uninfected host genomes. To test these hypotheses, the investigators propose defining the epigenomic and transcriptomic alterations at single cell resolutio...

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
https://clinicaltrials.gov/ct2/show/NCT03130777

Aug 5th, 2022 - To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment...

A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
https://clinicaltrials.gov/ct2/show/NCT04923178

Aug 5th, 2022 - Background: Rare histological variants of the GU tract include bladder/urachal adenocarcinoma, squamous cell carcinoma, and small cell carcinoma; variants of urothelial carcinoma including plasmacytoid, sarcomatoid; renal tumors including sarcomatoid renal cell carcinoma and renal medullary carcinoma; penile cancers; micropapillary, giant cell, lipid rich, clear cell and nested variants, large ...

Surufatinib or Surufatinib Combined With Vinorelbine for Non-Small Cell Lung Cancer
https://clinicaltrials.gov/ct2/show/NCT04922658

Aug 5th, 2022 - A phase II study to assess the efficacy and safety of Surufatinib or Surufatinib combined with Vinorelbine as third-line and posterior line treatment in patients with NSCLC

A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)
https://clinicaltrials.gov/ct2/show/NCT04732221

Aug 5th, 2022 - This is a two-part (Phase 2/Phase 3) study of MK-5475, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH). The first part (Phase 2) will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of MK-5475 during an optional 24 month extension period. The trea...

Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-768...
https://clinicaltrials.gov/ct2/show/NCT04738487

Aug 5th, 2022 - The primary hypotheses are that coformulated pembrolizumab/vibostolimab is superior to pembrolizumab alone with respect to (1) overall survival (OS) in participants with programmed cell death 1 ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%, TPS ≥1% and TPS 1% to 49%; and (2) progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent...

To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
https://clinicaltrials.gov/ct2/show/NCT04754594

Aug 5th, 2022 - The Phase 2 portion of the study will include approximately 200 pregnant women randomized 1:1 to receive BNT162b2 or placebo (saline) at 27 to 34 weeks' gestation. IRC review of safety data through 7 days after the second dose for all Phase 2 participants will be completed. The Phase 3 portion of this study will assess the safety, tolerability, and immunogenicity of BNT162b2 among pregnant wome...

Immunogenicity of the BNT162b2 Covid-19 Vaccine in Elderly People Aged 85 and Older in Greece
https://clinicaltrials.gov/ct2/show/NCT04756817

Aug 5th, 2022 - Real world data regarding the effectiveness and safety of the new COVID-19 vaccines in older people are currently lacking. The sparse data from Phase II/II trials suggest a reduction in antibody responses in older people compared to younger participants. The over-85 age group was the first group to receive the BNT162b2 mRNA Covid-19 vaccine in Greece according to the national priority vaccinati...

Fistula Reintegration Pilot
https://clinicaltrials.gov/ct2/show/NCT04748653

Aug 5th, 2022 - This is a pilot study to test the feasibility and acceptability of a multi-component facility-based intervention designed to be provided adjunct to genital fistula surgery incorporating: health education, psychosocial counseling, physiotherapy, and economic investment. We will include a total of 30 women in the study, and follow them for 6-months using a mixed-methods strategy for feasibility a...