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NCT ID: NCT05000957 Recruiting - Clinical trials for Pelvic Organ Prolapse

Pelvic Organs Prolapse Treatment Using Neodymium Laser

Start date: October 3, 2021
Phase: N/A
Study type: Interventional

The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Max" for preoperative treatment of pelvic organs prolapse I-II degree of severity. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: ultrasonography with Doppler ultrasonography, vaginal health index, histological examination, immunohistochemical examination, optical coherence tomography (OCT) (elastography). Pelvic Floor Distress Inventory Questionnaire (PFDI-20), The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Pelvic Floor Impact Questionnaire (PFIQ-7) will be used to collect feedback on changes in the participants life quality. Genetic testing of 12 gene variants will be carried out. Correlation of genes variants and treatment efficacy will be assessed. Total up to 135 participants with pelvic organs prolapse I-II degree of severity, or any other pathology of pelvic organs, which require surgical intervention will be involved in the study. Participants will be divided into three groups: group with anterior and/or posterior (A/P) colporrhaphy and laser preoperative treatment (laser treatment group), group with A/P colporrhaphy only (control group 1), and group with any other surgical intervention of pelvic area (control group 2), by 45 participants in each. The time intervals between tests will be the same for groups with A/P colporrhaphy, group with any other surgical intervention will be examined before and on the day of surgery without further observation. The main hypothesis of the study is improvement in condition of the vaginal walls after laser preoperative treatment compared with the control group 1.

NCT ID: NCT04996485 Recruiting - Clinical trials for Congenital Ichthyosis

Scientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in Children

Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

This is an experimental non-randomized clinical study aimed at expanding the indications for the use of biological drugs with the aim of using them for the pathogenetic therapy of children with congenital ichthyosis.

NCT ID: NCT04995926 Recruiting - Clinical trials for Limbal Stem-cell Deficiency

Labial Mucosal Epithelium Grafting for Corneal Limbus Substitution

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Earlier approaches for cornea reepithelization in patients with bilateral LSCD included allogeneic corneal limbus grafting from postmortem donor or livingrelated relatives with concomitant systemic immunosuppression (Cheung and Holland, 2017) and cultivated oral mucosal epithelial transplantation (COMET) (Nishida et al., 2004). The novel surgical technique for corneal re-epithelization were described by Liu et al. (2011) and Choe et al. (2019). In both clinical studies, the autologous labial mucosal epithelium graft was transplanted as a surrogate corneal limbus for purpose of treatment the LSCD. Authors reported positive outcomes in terms of anatomical success and corneal status improvement. The purpose of the study is to evaluate the feasibility of the novel surgical intervention in clinical use.

NCT ID: NCT04985643 Recruiting - Multiple Myeloma Clinical Trials

A Study of Real Life Treatment for Multiple Myeloma (MM)

LEADER
Start date: February 18, 2022
Phase:
Study type: Observational

The main aim of this study is to learn how long it takes for people with MM to have a relapse after their first treatment. Not all participants will have a relapse during the study. Participants will visit their clinic every 3 months and be treated according to their clinic's standard practice. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

NCT ID: NCT04981899 Recruiting - Hodgkin Lymphoma Clinical Trials

A Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma

NICE-40
Start date: March 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of Nivo combined with ICE as first salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the fixed dose of 40 mg in combination with ifosfamide, carboplatin, and etoposide (NICE-40) in patients with relapsed/refractory Hodgkin Lymphoma.

NCT ID: NCT04975737 Recruiting - Tuberculosis Clinical Trials

Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac

Start date: January 20, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, randomized (in 1:1 ratio) placebo-controlled study to assess the safety and protective efficacy of the subunit recombinant tuberculosis vaccine GamTBvac against the development of respiratory tuberculosis not associated with HIV infection in volunteers aged 18-45 years.

NCT ID: NCT04975308 Recruiting - Breast Neoplasms Clinical Trials

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

EMBER-3
Start date: October 4, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

NCT ID: NCT04964934 Recruiting - Clinical trials for ER-Positive HER2-Negative Breast Cancer

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

SERENA-6
Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

NCT ID: NCT04963296 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

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

This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

NCT ID: NCT04960709 Recruiting - Clinical trials for Muscle Invasive Bladder Cancer

Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin

VOLGA
Start date: August 5, 2021
Phase: Phase 3
Study type: Interventional

A global phase 3, multicenter, randomized, trial, to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or who refuse Cisplantin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer. The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC). Volga trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 830 patients, who will receive triplet combination, duplet combination of Durvalumab and Enfortumab vedotin or currently approved SOC in the main trial. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system. In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.