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NCT07671547
The goal of this clinical trial is to learn if Naderin works to prevent low white blood cell counts in people with breast cancer receiving first-line chemotherapy. The main questions it aims to answer are: 1. Does taking Naderin lower the number of people who get low white blood cell counts during chemotherapy? 2. Does taking Naderin help people finish all of their chemotherapy treatments without interruptions? Researchers will compare people who receive chemotherapy with Naderin to people who receive chemotherapy alone to see if Naderin helps prevent low white blood cell counts. Participants will: Receive standard AC chemotherapy for breast cancer Either receive Naderin along with chemotherapy or receive chemotherapy alone Have regular blood tests to check white blood cell counts Complete all 4 chemotherapy cycles Key finding: The study found that 14 out of 100 people who received Naderin developed low white blood cell counts, compared to 39 out of 100 people who did not receive Naderin.
NCT07670221
Taste alteration is a common and distressing symptom experienced by women with breast cancer receiving taxane-based chemotherapy. This symptom may negatively affect food intake, nutritional status, psychological well-being, and quality of life. Although several approaches have been suggested for the management of chemotherapy-related taste alteration, evidence regarding structured nurse-led self-management interventions in this patient group remains limited.
NCT07666464
Intrapleural enzyme therapy (IET) is regarded by recent guidelines as a "rescue" therapy for managing complicated pleural infections; however, it is associated with significant side effects, including pleural bleeding, pain, and fever. Pleural irrigation with saline may serve as an alternative, yet evidence supporting its effectiveness is limited to a single small- scale, single-center randomized trial. The objective of the study is to compare the risk of treatment failure at 30 days (defined as a composite outcome that includes death, the need for thoracic surgery, or additional intrapleural enzyme therapy) between an early pleural irrigation strategy and standard care for complicated pleural infections.
NCT07226986
The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter referred to as AAA617) with an androgen receptor pathway inhibitor (ARPI) in participants with metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI and with or without prior taxane exposure, and (b) in Phase II evaluate the preliminary efficacy of AMO959 in combination with AAA617 and ARPI in participants with mCRPC who have failed one prior ARPI, but who have not yet been exposed to taxane treatment.
NCT07425782
The goal of this clinical trial is to compare the efficacy and safety of a venetoclax-based consolidation therapy versus conventional consolidation chemotherapy in newly diagnosed adult patients with high-risk acute myeloid leukemia (AML) who have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned for transplantation. The main questions it aims to answer are: Does consolidation therapy with a venetoclax-containing regimen lead to superior clinical outcomes compared to conventional chemotherapy in this specific patient population? What is the comparative safety profile of the venetoclax-containing consolidation regimen versus conventional chemotherapy in these patients? Participants will be randomly assigned to receive either the venetoclax-based consolidation therapy or the conventional consolidation chemotherapy before undergoing transplantation.
NCT07189325
Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades. Over the last twenty years, several disease-modifying therapies with variable benefit/risk profiles have been introduced leading to dramatic changes in the prognosis of MS. First, several moderately effective therapies , with good safety profile, have allowed to decrease the frequency of relapses along with a possible, albeit limited, effect on medium- and long-term disability. More recently highly effective therapies (HET), with immunosuppressive properties, have dramatically reduced clinical and MRI disease activity and significantly improved patient's prognosis. Anti-CD20 therapies (B-cells depleting therapies, given either intravenous or subcutaneous), one of the main HET, have demonstrated higher efficacy than platform therapies in several phase 3 randomized clinical trials and their use within the very first years of the disease seems to be associated with improved long-term outcomes. Taking all of this into account, the investigators hypothesize that RRMS patients who experience a de-escalation from anti-CD20 therapies to platform therapies after 40 years will not experience disease activity accrual and disability worsening.
NCT07653880
This randomized controlled, single-blind clinical trial investigates whether virtual reality (VR)-assisted, video game-based exercise training, added to a conventional pulmonary physiotherapy and rehabilitation program, improves functional level, respiratory parameters, and physical fitness in pediatric patients (5-18 years) following hematopoietic stem cell transplantation (HSCT). Participants attended 24 supervised, face-to-face exercise sessions over 8 weeks (3×/week) under physiotherapist supervision. The Experimental Group received game-based exercise using the Nintendo Wii Fit U platform with the Wii Balance Board and the Breathing Labs Breathing Games software (Slovenia) in addition to the conventional program. Outcomes included the Modified Alpha-Fit Pediatric Test Battery (vertical jump, 6-minute walk test, sit-and-reach, flamingo balance), upper-extremity isometric muscle strength (handheld dynamometry) and handgrip strength (Jamar), pulmonary function tests, maximal inspiratory and expiratory mouth pressures, accessory respiratory muscle architecture by myotonometry (MyotonPro: sternocleidomastoid, upper trapezius, pectoralis major), and ultrasound assessment of pleural thickness, diaphragm thickness, and diaphragm excursion.
NCT04695106
More than 25% of patients referred for diagnostic coronary angiography and percutaneous coronary intervention (PCI) due to acute coronary syndrome (ACS) suffer from non-valvular atrial fibrillation (AF). In this particular setting, balancing between the prevention of thrombosis and the risk of bleeding remains challenging. Oral anticoagulation (OAC) prevents stroke and systemic embolism, but has not been shown to prevent stent thrombosis (ST). Dual antiplatelet therapy (DAPT) reduces the incidence of recurrent ischemic events and ST, but is less effective in reducing the incidence of cardioembolic stroke associated with AF. A common guideline-supported practice is to combine three drugs (OAC, aspirin and clopidogrel) in a triple therapy, which is associated with high annual risk (up to 25%) of major bleeding. Thus, new therapeutic strategies are urgently needed to maintain the efficacy while improving the safety of treatment in patients with AF and ACS undergoing PCI. This is a prospective, randomized, open-label, blinded-endpoint, non-inferiority trial. 1194 patients with non-valvular AF that had undergone successful PCI due to an ACS within the previous 120 hours will be randomized in 1:1 ratio to receive one of the two treatments: dual therapy with dabigatran (150 mg twice daily or 110 mg twice daily) and ticagrelor (90 mg twice daily for 1 month, followed by 60 mg twice daily up to 12 months), or standard therapy according to current guidelines triple therapy with dabigatran (150 mg b.i.d. or 110 mg b.i.d.) plus clopidogrel (75 mg o.d.) plus aspirin (75 mg o.d.) followed by double therapy depending on the bleeding and ischaemic risk. Study treatment will be continued for 12 months. The primary study end-point is the first major or clinically relevant non-major bleeding event (per ISTH), in a time-to-event analysis. The main secondary end-point is a composite efficacy end-point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization (PCI or coronary artery bypass grafting) at 12 months. We expect that dual antithrombotic therapy including reduced dose ticagrelor and dabigatran is at least non-inferior regarding bleeding risk and ischaemic protection, compared to the standard triple therapy in patients with AF and after ACS, treated with PCI.
NCT07647029
This study is a prospective clinical study enrolling breast cancer patients at high risk of chemotherapy-induced thrombocytopenia (CTIT). It aims to investigate the efficacy and safety of hetrombopag in the secondary prophylaxis of CTIT. Breast cancer patients with histologically or cytologically confirmed disease were enrolled after signing the informed consent form and were randomly assigned in a 1:1:1 ratio to three Arms. Stratification factors for randomization included the number of prior antineoplastic treatment cycles (\>2 cycles vs. ≤2 cycles). Arm 1: No prophylactic use of hetrombopag Arm 2: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle Arm 3: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle; the dosage and administration schedule in the second chemotherapy cycle were identical to those in the first cycle; Treatment continued until patients completed the protocol-specified treatment and follow-up, experienced intolerable toxicity, withdrew informed consent, initiated alternative antitumor therapy, died, or met any other treatment discontinuation criteria specified in the protocol, whichever occurred first.
NCT01237093
Background: \- Researchers who study health and nutrition are interested in developing more accurate methods of determining what people eat from day to day and how it affects their general health. In particular, better methods are needed to determine if people are accurately remembering what they ate. One possible method involves the use of biomarkers, or indicators in urine, blood, saliva, fat, and hair, which are related to the intake of a particular food in a consistent way. One set of biomarkers in blood samples and hair may be used to determine the relative amount of meat, fish, and soda (corn/sugar cane) in a person s diet. However, more research is needed to study the effectiveness of using these biomarkers to accurately track dietary intake. Objectives: \- To validate the use of biomarkers as representative of specific dietary intake patterns (meat/fish/soda). Eligibility: \- Healthy, nondiabetic men between 18 and 65 years of age. Design: * This study involves an initial screening visit and a 12-13 week inpatient dietary study period. * Participants will be screened with a medical history and physical examination, as well as blood and urine samples and a glucose tolerance test to exclude individuals who have diabetes. * After 3 days of a standard weight-maintaining diet, participants will have a glucose tolerance test and a body fat scan; provide hair, blood, and fat tissue samples; and complete questionnaires and performance tests. * Participants will spend one day in a metabolic chamber to measure their energy expenditure and general metabolism. * Participants will then be randomized into one of eight carefully designed diets for 12 weeks. The diets will differ in the amount of meat, fish, and soda, including one diet where none of the three biomarker-related foods will be permitted. Blood samples will be collected throughout the study diet period. * At the end of the 12-week study diet period, participants will provide additional hair, blood, and fat tissue samples, and will have a second metabolism assessment in the metabolic chamber.
NCT07643948
The study aims to determine the prevalence of drug resistance mutation (DRM) in virally suppressed HIV infection, and the impacts of regimen change and the presence of low level viremia. Adults living with HIV infection on antiretroviral therapy (ART) with full viral suppression would be recruited. Cases are patients planning for regimen switch, while controls are those with and without low level viraemia (LLV) not planned for switch. Blood samples would be collected before and after switch. Sequencing would be performed to identify DRM present in HIV-1 proviral DNA.
NCT04771520
This phase II trial studies the effect of avapritinib in treating malignant solid tumors that have a genetic change (mutation) in CKIT or PDGFRA and have spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Avapritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Avapritinib may help to control the growth of malignant solid tumors.
NCT07080762
Non-surgical periodontal therapy is a widely adopted procedure for the treatment of periodontitis, particularly in its moderate to severe stages. The approach involves the mechanical and manual debridement of subgingival biofilm and calculus through the use of ultrasonic scalers and hand curettes. This method aims to disrupt the pathogenic bacterial load within periodontal pockets and promote clinical attachment gain while reducing inflammation. However, the mechanical removal of biofilm alone may not always ensure complete bacterial eradication, especially in deep or anatomically complex sites. To enhance bacterial disinfection and optimize clinical outcomes, adjunctive use of antimicrobial photodynamic therapy (aPDT) has been introduced. aPDT is a non-invasive technique that involves the activation of a photosensitizing agent by light at a specific wavelength, leading to the production of reactive oxygen species capable of selectively damaging microbial cells. This reaction occurs without affecting surrounding healthy tissues and has been shown to be effective against a broad spectrum of periodontal pathogens. The synergistic effect of combining conventional non-surgical periodontal therapy with aPDT allows for a more comprehensive decontamination of periodontal pockets. In particular, aPDT contributes to the disruption of residual bacterial biofilm that may persist after mechanical instrumentation, thereby potentially improving both short- and long-term periodontal stability. In addition to its antimicrobial action, aPDT may exert a biostimulatory effect, enhancing tissue healing through increased local microcirculation and cellular activity. This study aims to evaluate the clinical efficacy of adjunctive antimicrobial photodynamic therapy following non-surgical periodontal treatment in patients with severe periodontitis. The protocol involves initial subgingival instrumentation using ultrasonic and manual tools, followed by the application of a photosensitizer and subsequent laser activation within the periodontal pockets. The hypothesis of this study is that the addition of aPDT provides superior bacterial reduction and improved clinical outcomes compared to mechanical therapy alone.
NCT07575412
This study was designed as a prospective, multicenter, open-label, randomized controlled trial. Eligible participants were patients aged 15-65 years with high risk or relapsed/refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic neoplasms (MDS), diagnosed based on bone marrow morphology, immunophenotyping, genetic testing, and treatment response assessment. The experimental group received SHR2554 combined with azacitidine as an overlapped sequential combination with the mBuCy conditioning regimen, whereas the control group received the mBuCy conditioning regimen, both followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint is 1-year event-free survival (EFS). Secondary endpoints include 2-year overall survival, 2-year cumulative incidence of relapse, transplant-related mortality, incidence of acute/chronic GVHD, and safety profiles.
NCT07267000
This project is about the effect of a 12-week training therapy intervention in patients suffering from non-small cell and small-cell lung cancer. It has widely been accepted that exercise is preventive against certain types of cancer. Individuals following an active lifestyle have a significantly lower risk for several chronic diseases, including cancer, as compared to sedentary ones. However, evidence is still lacking for exercise as part of routine cancer treatment. It has widely been accepted that exercise strongly impacts immune response, and might influence antitumor immune response as well. In this study, patients suffering from lung cancer undergo either a 12-week training program consisting of moderate-intensity continuous exercise (MICE), or a 12-week program with high-intensity interval exercise. Both groups will be compared to a control group receiving standard exercise recommendations. The immunologic response, i.e. cytokine profiles and changes in peripheral blood mononuclear cell (PBMC) characteristics will be the main endpoint. Blood will be taken from the patients at different timepoints, and blood samples will be tested for these immunologic changes. FACS analysis will be used to assess the properties of immune cells and potential changes upon the exercise regimen. Mitochondrial function will be assessed via the Seahorse machine, and mass spectrometry (lipidomics) will be used for the analysis of lipid profile changes.
NCT07626645
Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase. This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema. Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study. ESWT will be administered twice weekly for five sessions. Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.
NCT07608913
This randomized controlled trial aims to investigate the effects of hot spring bath therapy on cognitive function recovery, cerebral hemodynamics, and athletic performance in athletes undergoing altitude training. Participants will be randomly assigned to either a hot spring intervention group, a hot water control group, or a blank control group. The hot spring intervention group receives hot spring baths (38°C, 20 minutes) combined with altitude training; the hot water control group receives hot water baths (38°C, 20 minutes) combined with altitude training; and the blank control group receives standard recovery procedures combined with altitude training. Primary outcome measures include cognitive performance assessments (Stroop test, psychomotor vigilance test) and cerebral hemodynamic indicators (functional near-infrared spectroscopy, transcranial Doppler ultrasound). Secondary outcomes included exercise capacity (maximal oxygen uptake, triathlon performance, 500-meter test), blood lactate, and hematological parameters (white blood cells, neutrophils, platelets). These findings may provide evidence for non-pharmacological interventions to enhance cognitive recovery and brain adaptation during altitude training.
NCT07021079
Muscle deconditioning, characterized by a loss of muscle mass and strength, is a frequent consequence of prolonged lower limb unloading. Beyond muscle mass loss, reduced neural drive contributes significantly to strength decline, highlighting the need for interventions targeting neuromuscular function during immobilization. Focal muscle vibration (FMV) has shown promise in modulating neuromuscular excitability by activating muscle spindle afferents and inducing cortical adaptations. Chronic use of FMV has been associated with significant strength gains and improved neural command. This makes FMV an effective rehabilitation tool. Its simplicity and non-invasiveness further make it a practical countermeasure.
NCT07607548
The gut microbiota and its role in cancer treatment are currently the subject of intensive research. It has long been known that interactions between the microbiome and the host are responsible for the proper functioning of many physiological processes and for maintaining systemic homeostasis. Although the precise mechanisms underlying these interactions remain unclear, they appear to have a significant impact on the development and treatment of various diseases, including cancer. One of the crucial functions regulated by the gut microbiota is the body's immune response. The appropriate quantitative and qualitative composition of the gut microbiota supports the maintenance of a critical balance between pro- and anti-inflammatory processes. Even a slight disruption of this balance can lead to systemic metabolic and biochemical changes, affecting the overall condition of the body and its systems. Chemotherapy and immunotherapy are standard treatment protocols for cancer patients, including those with breast cancer. Despite their proven role in prolonging remission and improving patient survival, their effectiveness remains limited. Regardless of the regimen, the use of cytotoxic drugs does not fully prevent metastasis. In women with breast cancer, the risk of local recurrence or distant metastasis-primarily to the bones, lungs, and liver-is approximately 30% and increases over time following the initial diagnosis. Although the risk of cancer recurrence in this group is largely influenced by the baseline characteristics of the tumor, increasing attention is being paid to the immune response to treatment. The effectiveness of anticancer therapies depends not only on the response of cancer cells but also on the condition of the entire organism, particularly the host's immune system. Recent studies indicate that chemotherapy induces a systemic inflammatory state that may persist long after treatment completion. Prolonged inflammation, along with increased levels of chemoattractants, cytokines, and metalloproteinases, creates an environment conducive to cancer progression and metastasis. Therefore, it is increasingly suggested that chemotherapy-induced chronic inflammation may be a significant factor limiting therapeutic effectiveness. Although the precise mechanisms underlying inflammation during chemotherapy are not fully understood, a growing body of evidence points to a key role of the gut microbiota in this process. Cytotoxic drugs used during chemotherapy disrupt both the quantitative and qualitative composition of the gut microbiota, leading to dysbiosis. Dysbiosis is associated with the overgrowth of pathogenic species and alterations in the profile of microbial metabolites, often favoring those that negatively affect the intestinal barrier. Consequently, inflammation of the intestinal mucosa and increased intestinal permeability are observed during chemotherapy. Bacterial components, collectively known as pathogen-associated molecular patterns (PAMPs), can enter the bloodstream through the compromised intestinal barrier, triggering immune cell activation and systemic inflammation. An important link between the gut microbiota and progressive inflammation involves Toll-like receptors (TLRs), particularly TLR4, which is expressed on the surface of monocytes and recognizes, among other ligands, lipopolysaccharide (LPS) produced by Gram-negative bacteria. This interaction activates transcription factors such as Nuclear factor-κB (NF-κB), leading to the expression of genes involved in the immune response, including pro-inflammatory cytokines such as Tumor Necrosis Factor-α (TNF-α), Interleukin-6 (IL-6), and Cyclooxygenase-2 (COX-2). These cytokines promote tumor progression and metastasis both directly, by acting on cancer cells, and indirectly, by enhancing cell proliferation and angiogenesis. Several studies have reported increased expression and activity of TLR4 in various types of cancer, including breast cancer. Animal model studies have shown that blocking TLR4 reduces tumor metastasis and significantly decreases invasiveness. Therefore, inhibition of TLR4 signaling appears to be a promising therapeutic strategy for counteracting metastasis and chemoresistance. Probiotic therapy may contribute to this effect, as it has been shown to downregulate TLR4 expression and reduce levels of pro-tumor inflammatory mediators. The aim of this study is to evaluate the impact of probiotic therapy on immunological, biochemical, morphological, and anthropometric parameters in a group of women with breast cancer undergoing chemotherapy or immunotherapy. The study will include two visits: one before treatment initiation and another eight weeks later. The main hypothesis is that probiotic supplementation will reduce inflammation associated with systemic breast cancer treatment.
NCT03853434
Although angiographic embolization has been introduced for preoperative management of spine metastases in 1975 and is suggested today by many authors in the management of such pathologies, it needs to be confirmed by RCT. It is a minimally invasive procedure, not free from complications. The recent meta-analyzes, due to the limited number of patients included are not exhaustive about the effectiveness of embolization in the reduction of the intraoperative bleeding, especially in the context of poor / moderate metastasis vascularization. We want to evaluate the efficacy of preoperative angiographic embolization of intermediate / poor vascularized spine metastases in reducing intraoperative blood loss during excision surgery.