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NCT ID: NCT06315387 Recruiting - Cholecystitis Clinical Trials

Safety, Tolerability and Pharmacokinetics of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Multiple Oral Administration in Healthy Volunteers

Start date: December 4, 2023
Phase: Phase 1
Study type: Interventional

Study of safety, tolerability and pharmacokinetic parameters of different doses of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers

NCT ID: NCT06313801 Recruiting - Gastric Cancer Clinical Trials

Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions

Start date: January 19, 2023
Phase: Phase 2
Study type: Interventional

After the initial diagnostic laparoscopy the Control group patients undergo 6 courses of polychemotherapy according to the FLOT scheme; the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered. After the initial diagnostic laparoscopy the Study group patients undergo courses of polychemotherapy according to the scheme FLOT (the 1st, the 3rd, the 5th courses) and mFLOT (the 2nd , the 4th, the 6th courses) in the amount of 6 (six, 3+3); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with dPIPAC sessions using docetaxel (thus excluding it from the system administration) in the 2nd , the 4th, the 6th courses of polychemotherapy. Control diagnostic laparoscopy is not performed in the group No 2, its function is performed by the revision at the PIPAC session of the 6th course of polychemotherapy, which corresponds to the time interval of the Control group. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered.

NCT ID: NCT06304753 Recruiting - Clinical trials for Chronic Heart Failure With Low Ejection Fraction

ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction

BOT-IMPROVE-HF
Start date: October 27, 2023
Phase: N/A
Study type: Interventional

BOT-IMPROVE-HF is a two-center, parallel group study designed to evaluate the efficacy of up-titration of heart failure treatment using digital remote monitoring after hospitalization due to heart failure decompensation. Patient will be randomized before discharge using a simple computer generated sequence to either remote monitoring or usual care group. Patients' condition in the "remote monitoring" arm will be assessed by mini-program based on a personal messenger and laboratory rests results will be asked by phone call. If these measures show safety and tolerability of the doses of the drugs, they will be increased to target or maximally tolerated doses. The follow-up period will be 6 months - 24 weeks. Patients of the usual care group will be followed by their general practitioner and/or cardiologist. All patients will be contacted after 6 months to assess outcomes.

NCT ID: NCT06299943 Recruiting - Stroke Clinical Trials

Biofeedback Gait Training by Target Biomechanical Parameters in the Early Recovery Period of Stroke

TargetGait
Start date: January 24, 2022
Phase: N/A
Study type: Interventional

Single-blinded controlled clinical trial. Biofeedback training courses based on target biomechanical gait parameters are being studied. For targeted biofeedback training, various biomechanical parameters are used: parameters of the gait cycle, EMG or kinematics of joint movements. The number of sessions is 8-11 for each patient. Clinical gain analysis is carried out before and after a course of training. Changes in biomechanical parameters that occurred at the end of the training course are assessed in comparison with those before training, and both statuses (before and after training) are compared with similar gait parameters in a group of healthy adults.

NCT ID: NCT06299878 Recruiting - Melanoma Stage Iii Clinical Trials

MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns]

CRISTINA
Start date: January 1, 2022
Phase:
Study type: Observational

The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are: - radiological and pathological response rate to three doses of antiPD1 agents; - do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery. After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years.

NCT ID: NCT06299852 Recruiting - Clinical trials for Oligometastatic Disease

Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer

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

This study involves two non-randomized groups of patients: the observation group and the comparison group. The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who received treatment with trastuzumab-emtansine and had a history of SRT. The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer. These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT. The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine, remains unexplored. This study plans to evaluate the effectiveness of combining systemic therapy and local control methods (SRT) in patients with oligometastatic HER2-positive breast cancer. It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied. This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses, long-lasting disease remissions, and potentially cure.

NCT ID: NCT06296732 Recruiting - Neuroblastoma Clinical Trials

Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification

ANLAP-R
Start date: October 19, 2023
Phase:
Study type: Observational [Patient Registry]

Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume/patient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma.

NCT ID: NCT06296121 Recruiting - Multiple Myeloma Clinical Trials

A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma

DARVIVA
Start date: December 21, 2023
Phase: Phase 3
Study type: Interventional

The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy.

NCT ID: NCT06292351 Recruiting - Alzheimer Disease Clinical Trials

DMB-I in the Treatment of Alzheimer Type Dementia

Start date: December 27, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of DMB-I for the treatment of patients with Alzheimer type dementia.

NCT ID: NCT06288633 Recruiting - Bradycardia Clinical Trials

Cardioneuroablation for Bradyarrhythmia

CARDIOBOOST
Start date: March 4, 2024
Phase: N/A
Study type: Interventional

This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker implantation