Clinical trials

The aim of this clinical trial is to support psychological well-being and facilitate adjustment to parenthood among postpartum mothers and fathers through a midwife-led childbirth review (MLCR). MLCR is a structured 45-60-minute postpartum intervention focused on processing and integration of the individual's childbirth experience, involving active listening, emotional support, and provision of information. In this study, the investigators will employ the MLCR intervention developed by Gamble and Creedy (2009) for women with traumatic birth experiences, adapted for use in the general population of new parents, including both mothers and fathers/partners. This study will compare the effectiveness of three MLCR models - MLCR provided within the first postpartum week, MLCR provided at 6-8 weeks postpartum, and MLCR provided at both time points - with standard postpartum care and with each other.

The goal of this clinical trial is to learn if a comprehensive rehabilitation programme can improve physical function, reduce fatigue, and raise quality of life in adults aged 18-65 with multiple sclerosis (MS). The study will also look at whether the programme leads to changes in brain function using magnetic resonance imaging (MRI). The main questions it aims to answer are: * Does the programme lower the overall impact of MS on daily life? * Does the programme improve walking, balance, and hand function? * Does the programme reduce the impact of fatigue? * Are there changes in brain connections after the programme? Each participant serves as their own comparison. They are tested 3 times: 2 months before the programme starts (T0), right before it starts (T1), and after 2 months of intensive treatment (T2). The period between T0 and T1, when no treatment is given, shows each person's natural changes over time. Participants will: * Attend individual physiotherapy twice a week for 2 months, then 3 follow-up sessions over the next month * Take part in 3 group movement-awareness sessions * Take part in 3 group psychotherapy sessions focused on stress management and relaxation * Receive written nutritional guidance for autoimmune conditions Tests include physical assessments, questionnaires about fatigue and quality of life, tremor measurement, and brain MRI scans. The results may help improve rehabilitation care for people with MS and support their ability to stay active in everyday and working life.

Dear Sir or Madam, You have been invited to participate in a clinical study whose aim is to compare the effectiveness of two different approaches to the treatment of cerebrospinal fluid (CSF) pseudomeningocele - conservative management and interventional treatment (surgical or drainage procedures). CSF pseudomeningocele is a complication that may occur after brain surgery and is characterized by an accumulation of cerebrospinal fluid beneath the skin. At present, there is no clear consensus regarding the optimal treatment approach. How the study will be conducted After enrollment in the study, you will be randomly assigned (by chance) to one of two groups: Conservative management: no surgical intervention, regular follow-up, and wound care. Interventional treatment: simple aspiration/puncture, insertion of a lumbar drain, or reoperation. During the study, you will be followed for a period of 1 year. Follow-up examinations will include clinical assessment and brain imaging (CT or MRI) at 4 months and 12 months after enrollment. Risks associated with the interventional group Simple cyst aspiration/puncture: infection, bleeding into the pseudomeningocele. Lumbar drainage: infection, meningitis, bleeding at the insertion site, cerebrospinal fluid leakage, nerve root irritation, headaches. Reoperation: bleeding, infection, complications related to general anesthesia. Expected duration of participation in the study 12 months Expected total number of participants enrolled in the study 20 participants Benefit of the study The aim of the study is to compare the effect of surgical intervention with conservative management. Compensation for participation Participation in this study is not associated with any financial compensation.

A prospective, two-phase interventional study evaluating the performance, safety, and usability of the SaCoVLM™ video laryngeal mask airway for airway management by military medics with limited intubation experience. The study includes simulation-based training and clinical application in sedated patients undergoing elective surgery.

Hip and groin injuries affect approximately 21% of professional athletes annually, causing significant time loss. As roughly 48% of these cases result from non-contact mechanisms, they are potentially preventable through optimized diagnostic screening. Evidence strongly links restricted hip range of motion (ROM) and strength deficits to an increased injury risk. This project aims to (1) develop a rigorously validated diagnostic testing procedure by comparing different joint positions, movement velocities, and muscle contractions to establish a preventive "gold standard" screening battery. dditionally, (2) pilot targeted prevention interventions over a competitive season. Using a crossover design, the research evaluates three protocols: Strength-focused,Flexibility-focused:and control group. (3) Implement of a Centralized Injury Reporting System. Combining comprehensive diagnostic screening with these practical interventions will yield a powerful tool for clinicians and coaches to effectively reduce the incidence and burden of non-contact hip and groin injuries

This study is a randomised controlled pilot trial designed to evaluate the feasibility, safety, and preliminary efficacy of a 12-week resistance training intervention in children aged 10-14 years. The study adheres to the CONSORT extension for randomised pilot and feasibility trials and incorporates key elements of the SPIRIT guidelines for clinical trial protocols. The primary purpose of the study is to assess feasibility-related outcomes and to generate effect size estimates to inform the design of a subsequent fully powered randomised controlled trial (RCT).

The aim of the project is to verify the usability of a computer program for automatic evaluation of the Box and Block Test performed by seniors aged 65 and over and to determine whether it is more advantageous to use it in clinical practice compared to the usual manual evaluation of the Box and Block Test by an occupational therapist.

Surgical correction of the prolapse in the anterior compartment remains one of the major challenges in urogynecology. Paravaginal defect in level II of vaginal fixation results in the majority of cystoceles. Clinically, these defects are often combined and/or may be bilateral. Hence, careful assessment and individualized planning of the surgical procedure is essential to optimize cystocele repair outcome. Several surgical techniques and approaches have been used for cystocele repair. After the ban on transvaginal meshes, the interest in native tissue repair has risen. Paravaginal defect repair is an effective surgery for paravaginal defect reconstruction. There is a current trend to utilize transvaginal surgery instead of more invasive transabdominal surgery. A novel method of transvaginal paravaginal defect repair - TOCR (transobturator cystocele repair) was suggested. The principle objective of the present trial is to compare its efficacy and safety to preexisting method of native tissue cystocele repair.

Prehabilitation refers to interventions aiming to improve patients' resilience and functional capacity before a known stressful event, e.g., scheduled surgery. These interventions usually consist of physical activity and psychological and nutritional support. There is substantial evidence of the positive effect of multimodal prehabilitation among patients treated surgically for non-gynaecological cancers; however, no prospective data are available in gynaecological cancer patients. PHOCUS trial is a prospective randomised trial aiming to evaluate the role of multimodal prehabilitation in patients with gynaecological cancer. Sixty-four patients will be randomised in single institution within 36 months with a 1:1 ratio into ARM A: control arm which will be provided with a basic information and standard of care support; ARM B: active arm undergoing multimodal prehabilitation composed of physical activity and psychological and nutritional support. All patients will be assessed at standard intervals (three times during the trial) by a spectrum of non-invasive tests, evaluating physical functional capacity, postoperative morbidity, nutritional status, level of stress and anxiety, and quality of life.

A prospective study that investigates the changes in LA echocardiographic parameters after PFA for paroxysmal AF.

This single-center retrospective observational study includes all human milk donors collaborating with the milk bank at České Budějovice Hospital between 2021 and 2025. Using anonymized data extracted from the hospital database, the study will quantify the frequency of donations and the individual and cumulative volume of donated human milk and will assess the impact of key maternal and perinatal factors - including age, BMI, parity, mode of delivery, and timing of donations - on the quantity and quality of donated milk, based on routine biochemical and microbiological parameters.

This randomized, controlled, five-arm, parallel-group trial will evaluate the effects of 8 weeks of supervised resistance training and developmental position-based exercise, with or without real-time non-invasive intra-abdominal pressure biofeedback, in adults aged 40 to 60 years with chronic low back pain. The trial will compare supervised gym-based agonist-antagonist paired set resistance training with OHMTRACK, supervised gym-based resistance training without OHMTRACK, supervised physiotherapy-based developmental exercise with OHMTRACK, home-based developmental exercise with OHMTRACK, and an active control condition. Primary outcomes will assess changes in pain and physical function after the intervention. Secondary outcomes will include neuromuscular coordination, postural stabilization, cardiovascular, respiratory, metabolic, behavioral, feasibility, and follow-up outcomes.

Tinnitus (ringing or buzzing in the ears) affects approximately 10-15% of the adult population and significantly reduces quality of life in many patients. In a substantial proportion of cases, tinnitus is associated with dysfunction of the temporomandibular joint (TMJ) and cervical spine - this subtype is called somatosensory tinnitus. This randomised controlled trial investigates the effectiveness of a multimodal intervention combining: (1) physiotherapy targeting TMJ and cervical spine dysfunction, (2) a structured combined exercise program (aerobic + resistance + breathing), and (3) psychological support (cognitive-behavioural psychoeducation) in patients with chronic somatosensory tinnitus. The study also examines the acute effects of different types and intensities of physical exercise on tinnitus perception, and performs psychometric validation of Czech-language tinnitus assessment questionnaires. Participants (N=160, aged 18-70 years) will be randomly assigned to either the multimodal intervention group (8 weeks, 5 sessions/week) or a control group. Follow-up assessments will be conducted at 3, 12, and 24 months. The primary outcome is the change in the Tinnitus Handicap Inventory (THI) score.

This study examines how different phases of the menstrual cycle are associated with selected performance and musculoskeletal parameters in physically active women aged 18-35 years. Participants will track their menstrual cycle using a mobile app for approximately 2 months and attend 3 laboratory visits scheduled to specific cycle phases. At each visit, participants will complete non-invasive assessments including lower-limb strength/performance testing, musculoskeletal measurements (muscle and tendon properties), body composition assessment, and symptom-related questionnaires. The goal is to improve understanding of physiological variability across the menstrual cycle and support evidence-based planning of training, testing, and clinical practice in women.

Patients with extensive burn injuries frequently develop severe skeletal muscle wasting and weakness as part of critical illness-related myopathy and neuropathy. This condition delays ventilator weaning, prolongs intensive care unit (ICU) and hospital stay, and contributes to long-term functional impairment and reduced quality of life. In burn patients, muscle loss is particularly pronounced during the early post-injury phase and is associated with mitochondrial dysfunction and altered neuromuscular signaling. Effective strategies to prevent muscle catabolism in critically ill burn patients remain limited. Although early active rehabilitation is beneficial, many patients are unable to participate due to deep sedation, mechanical ventilation, or clinical instability. Therefore, innovative rehabilitation approaches applicable during the acute phase of critical illness are needed. The REMBRANT (REduction of Muscle catabolism through BRAin activation in burn patieNTs) study is a single-center, randomized, controlled, open-label clinical trial evaluating whether a multimodal brain-activating rehabilitation strategy can attenuate skeletal muscle loss in adult patients with severe burns. Thirty patients with burns involving more than 30% of total body surface area who require invasive mechanical ventilation and prolonged sedation will be randomized in a 1:1 ratio to standard care or an intervention group. Both groups will receive standardized burn treatment and conventional rehabilitation. The intervention group will additionally receive the Burn-Bundle Extended Rehabilitation Program, combining inhalational isoflurane sedation with functional proprioceptive stimulation, repetitive transcranial magnetic stimulation, and virtual reality-assisted rehabilitation when clinically feasible. The primary outcome is change in skeletal muscle mass and strength. Secondary outcomes include ICU length of stay, ventilator-free days, mitochondrial function, and health-related quality of life.

The aim is to determine the effect of extended ablation (pre-specified linear PF/RF lesion set) in addition to PVI in symptomatic persistent AF patients on AF/AT/AFL recurrence. The study is designed as multicenter, randomized trial. Eligible patients are patients with persistent AF (but not long-standing persistent AF) planned for a first-ever AF ablation procedure. Patients will be randomly assigned 1:1 either to: i) PVI-only, or ii) PVI-plus arms. Patients in both groups will undergo catheter ablation using an ablation system capable of performing PF and RF ablation (Sphere-9, Affera, Medtronic). Patients randomized to the PVI-only arm will undergo only PVI. Patients randomized to the PVI-plus arm will undergo PVI plus linear lesions (roof, bottom line, lateral or anterior MI line, and septal line in the LA; intercaval line and cavotricuspid line in the RA). The primary endpoint will be freedom from recurrent AF/AT/AFL, assessed as time-to-first recurrence in the period of 12 months after randomization (post 2-month blanking period). Secondary clinical endpoints will be 1) 12-month differences in AF/AT/AFL burden, 2) AF/AFL/AT-related outcomes (hospitalization or emergency visits), 3) Quality of life according to the AFEQT questionnaire score at 12 months, 4) MACE defined as cardiovascular death, stroke, myocardial infarction, or hospitalization for heart failure. Secondary endpoints will be evaluated throughout the entire (minimum 12-month) follow-up period.

The RTMSECT2 study was design to compare the application of electroconvulsive therapy augmented by transcranial magnetic stimulation. Subject will be compared both within groups and in group using psychometric scales and different deliver energy

This study investigates whether Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition" (NEUROEQUIP-SMA) can improve movement, posture, breathing, and quality of life in children with spinal muscular atrophy (SMA). This therapy uses the horse's rhythmic movement together with targeted sensory and manual stimulation to trigger natural motor reactions starting from the pelvis, lower the threshold for muscle activation, and support coordinated motor patterns. The study compares this method with standard individual physiotherapy based on the same neuro-proprioceptive facilitation and inhibition principles, but performed without the horse. Twenty children aged 2 to 9 years will receive both therapies in two separate 6-day blocks, in random order (crossover design). The researchers will assess muscle fatigue, coordination, breathing function, movement quality and quantity, quality of life, and changes in selected blood biomarkers. The results may help develop better rehabilitation strategies for children with SMA who are receiving modern pharmacological or gene therapy.

The Medtrum TouchCare Nano system with the APGO algorithm is the only patch pump-based automated insulin delivery system available in the Czech Republic. However, until now, no prospective clinical study has evaluated its efficacy and safety under real-world conditions. The RENEW study is the first to address this topic.

The goal of this clinical trial is to evaluate the feasibility, safety, and preliminary effectiveness of applying external continuous negative pressure (ECNP) during less invasive surfactant administration (LISA) in preterm infants with respiratory distress syndrome (RDS). It will also assess whether ECNP can improve surfactant distribution and reduce procedural complications. The main questions it aims to answer are: Does ECNP during LISA improve surfactant distribution and oxygenation in preterm infants with RDS? Does ECNP reduce the occurrence of complications such as desaturation, bradycardia, or apnea during the procedure? Does ECNP reduce the need for repeated surfactant administration? Researchers will evaluate ECNP combined with LISA in preterm infants on HFNC or CPAP to see if it improves outcomes compared to standard methods. Participants will: Receive LISA with ECNP support via a soft thoracoabdominal cuirass Be monitored for procedural complications like desaturation, bradycardia, or apnea Have their oxygenation levels, surfactant distribution, and need for repeated surfactant doses assessed Primary Outcome: The procedure will be considered safe if no more than 20% of participants experience serious adverse events, such as apnea requiring positive pressure ventilation or persistent desaturation. Secondary Outcomes: Completion of LISA without interruption due to complications Reduction of FiO₂ to ≤0.25 within 3 hours post-surfactant administration Avoidance of repeated surfactant doses via the INSURE method

This observational study follows children and adults who were hospitalized with tick-borne encephalitis (TBE) in the Czech Republic. The aim is to better understand how individuals recover from TBE, which symptoms may persist after the infection, and which patients may require additional support during their recovery. Participants are examined several times after hospital discharge (at 2-4 weeks, 3 months, 6 months, and 12 months) to observe changes in symptoms, functional status, and daily activities. Follow-up assessments include evaluation of common post-infection problems such as tiredness, headaches, memory or concentration difficulties, sleep issues, or limb weakness. Symptoms lasting for several months are categorized as post-encephalitic syndrome (PES). The study also assesses how TBE affects daily functioning, school and work performance, and overall quality of life using questionnaires and short functional assessments. In addition, the study includes a public-health component that estimates the broader impact of TBE in the population and evaluates the potential benefits of vaccination in preventing long-term health complications. The findings aim to support improved patient care, follow-up planning, and evidence-based public-health decision-making in the Czech Republic.

This study investigates the effectiveness of an intensive multidisciplinary rehabilitation program for people with multiple sclerosis (PwMS). The program integrates intensive outpatient physiotherapy, psychotherapeutic consultations, and nutritional counseling to enhance motor and cognitive functions, promote neuroplasticity, and improve overall well-being as well as physical performance in PwMS. Through clinical assessments and standardized questionnaires, the study aims to provide scientific evidence on the benefits of comprehensive, non-pharmacological therapy as a core element in MS treatment.

An observational study evaluating efficacy and safety of the Varipulse catheter in pulsed-field ablation of atrial fibrillation

Comprehensive assessment and interventions to promote adherence to inhaled therapy in patients with bronchial asthma and chronic obstructive pulmonary disease involving health care professionals caring for these patients in different settings and using the Five Steps Assessment tool and artificial intelligence methods and tools.

This randomized, controlled, non-inferiority trial aims to compare the efficacy of two sclerosants used in the CLaCS (CryoLaser and CryoSclerotherapy) method for treating telangiectasias and reticular varicose veins. CLaCS is an advanced outpatient procedure that combines Nd\\:YAG laser treatment with sclerotherapy to enhance vein closure and cosmetic outcomes while minimizing side effects. The trial will compare the standard 70% glucose sclerosant with a novel 0.2% Aetoxysklerol (polidocanol) foam prepared using the VARIXIO system. Despite widespread use of CLaCS, no head-to-head studies currently exist comparing these two agents. This study aims to determine whether low-concentration Aetoxysklerol foam is non-inferior to 70% glucose in achieving effective telangiectasia elimination.