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NCT ID: NCT01782287 Enrolling by invitation - Neoplasm Metastasis Clinical Trials

Proteome-based Immunotherapy of Lung Cancer Brain Metastases

Start date: December 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Trial Hypothesis: Acute, progressing lethal neurooncological process can be transferred into chronic and non-lethal, the survival rates and life quality can be improved by of control of tumor cells (TCs) quantity and targeted regulation of effector functions of tumor stem cells (TSCs). Brief Description: The first line therapy of brain metastases of lung cancer (BMLC) involves allogeneic haploidentical hematopoietic stem cells (HSCs), dendritic vaccine (DV) and cytotoxic lymphocytes (CTLs). TCs and TSCs are isolated from BMLC sample. Dendritic cells are isolated from peripheral blood mononuclear cells and cultured. Tumor sample provides tumor specific antigens to prepare DV. CTLs are obtained from peripheral blood after DV administrations. HSCs are harvested from closely related donor after granulocyte-colony-stimulating factor (G-CSF) administration. Allogeneic HSCs are administered intrathecally 5 times every 2 weeks, at day 1, 14, 28, 42, 56. DV is given 3 times every 2 weeks (day 14, 28, 42) subcutaneously in four points. CTLs are administered every 2 weeks for 3 months, then 3 times every 1 month intrathecally. Six months after the therapy completion, the efficiency is evaluated and the cohort demonstrating efficiency continues the therapy, while cohort demonstrating no efficiency is transferred to active comparator arm. Second line therapy involves DV with recombinant proteins, CTLs and autologous HSC with modified proteome. Autologous HSCs are mobilized by G-CSF. Carcinogenesis-free intracellular pathways of signal transduction able to respond to targeted regulation of therapeutic cell systems with specific properties, are detected in TSCs using complete transcriptome profiling of gene expression, proteome mapping and profiling of proteins, bioinformation and mathematical analysis and mathematical modeling of protein profiles. To find key oncospecific proteins in TSCs and TCs, the targets for TSCs regulation are detected, as well as protein ligands able to regulate reproductive and proliferative properties of TSCs. Using these data of TCs and TSCs proteins, the cell preparations to initiate adoptive immune response are prepared: DV loaded with recombinant proteins analogous to key tumor antigens, CTLs and autologous proteome-based HSCs. Autologous proteome-modified HSCs, DV and CTLs are administered as in the first line therapy.

NCT ID: NCT01812577 Enrolling by invitation - Liver Tumor Clinical Trials

Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions

TPVB
Start date: December 2012
Phase:
Study type: Observational

Percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and after the procedure. During the procedure patients need deep sedation and cannot be collaborative. Furthermore post-operative analgesia is necessary. The aim of this study is to evaluate if the ultrasound-guided paravertebral block (TPVB)with a single injection can provide anesthesia and post-operative analgesia in these patients.

NCT ID: NCT02063321 Enrolling by invitation - Clinical trials for Diabetic Retinopathy

Reading Center - Occurence of Diabetic Macular Edema in Patients With Diabetes Mellitus in Slovak Republic

Start date: December 2012
Phase: N/A
Study type: Observational

The aim of the study is to find out prevalence of diabetic macular edema (DME) in patients with diabetes mellitus in Slovak Republic.The outcome of the project will be epidemiology survey, prevalence of wet form of Diabetic Macular Edema in relation to duration of diabetes, type of diabetes, treatment (insulin vs. OAD or combination) etc. and identification of prognostic factors leading to development of DME.

NCT ID: NCT02146469 Enrolling by invitation - Varicella Clinical Trials

Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine

Start date: December 2012
Phase: Phase 4
Study type: Interventional

The objective of the study is as follows: 1. To know the antibody level during different interval after received 1 dose varicella vaccine. 2. To know safety and effectiveness of received 2 doses varicella vaccine with different interval. 3. To know safety and effectiveness of received varicella vaccine and MMR at the same time. To achieve that, this study selects children with specific varicella vaccine history, gives 1 or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after vaccination. All blood specimens will be tested by a third-party detection institution.

NCT ID: NCT02338375 Enrolling by invitation - Clinical trials for Osteochondral Lesion of Talus

Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product

Cartistem
Start date: December 2012
Phase: Phase 0
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) on currently standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus.

NCT ID: NCT03176927 Enrolling by invitation - Clinical trials for Functional Dyspepsia

Biomagnetic Characterization of Gastric Dysrhythmias III

Start date: December 2012
Phase: N/A
Study type: Interventional

There is a tremendous clinical need for a noninvasive technique that can assess gastric electrical activity and would be repeatable without any exposure to radiation. Investigators developed a new technique allowing to use noninvasive methods to assess bioelectrical activity in the gastrointestinal system. This has enabled to characterize the normal and pathologic physiology of the stomach through the use of noninvasive magnetogastrogram (MGG) records. Primary hypothesis for this proposal is that analysis of gastric slow wave uncoupling and propagation in multichannel MGG discriminates between normal and pathological gastric electrical activity. Eventually, investigators envision this research leading to new insights for gastrointestinal conditions such as gastroparesis, functional dyspepsia and chronic idiopathic nausea that would inform clinical management of these debilitating diseases.

NCT ID: NCT01891162 Enrolling by invitation - Clinical trials for Incontinence Urinary

Assessment of Socioeconomic Status by Brazil and Quality of Life for Urinary Incontinence in Brazilian Women

Start date: December 2013
Phase: N/A
Study type: Observational [Patient Registry]

Age, parity, obesity and a number of comorbidities are the major clinical and lifestyle risk factors for female urinary incontinence and pelvic organ prolapse at the population level. The socioeconomic risks for incontinence have however, conflicting evidence with assorted measures of socioeconomic status. Brazil is a country with enormous social contrasts, and deep inequality. We have a mixed origin of cultures and different economic and regional conditions. We believe that the perception and the impact that has Pelvic floor dysfunction in the quality of life of the woman must vary widely according to socioeconomic status (including household income, highest educational level, family income). There is to date no studies have correlated a criterion for classifying economic official in Brazil with the impact of quality of life (based in KHQ or PQOL) of women with urinary incontinence and pelvic organ prolapse.

NCT ID: NCT01919320 Enrolling by invitation - Clinical trials for Bi-ventricular Failure

SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection

C2 PAS
Start date: December 2013
Phase:
Study type: Observational

Study Purpose The purpose of this PAS is to confirm that patients implanted with the temporary Total Artificial Heart (TAH-t) and supported with the Companion 2 Driver System have outcomes similar to those patients implanted with the TAH-t and supported with the CSS Console. The data collection mechanism for this study is the INTERMACS Registry. Study Objectives Primary Objective 1: To confirm that patients implanted with the TAH-t and supported by the Companion 2 Driver System have outcomes similar to those patients implanted with the TAH-t and supported by the CSS Console. Primary Objective 2: To compare positive outcome rates for all TAH-t patients entered in the Intermacs Registry initially supported with the Companion 2 Driver System to positive outcome rates for all TAH-t patients initially supported by the CSS Console. Primary Objective 3: To review additional data (patient survival, adverse event rates and bridge to transplant rates) to support the conclusion that the use of an artificial heart is reasonable and necessary for the treatment of irreversible biventricular failure in Medicare/Medicaid patients. Secondary Objective: - To evaluate the incidence of adverse events (AEs). The AEs will follow the definitions in the INTERMACS Registry. Study Hypothesis: Primary Objective 1 The primary hypothesis is that the positive outcome rate (defined as transplant , transfer to the Freedom Driver System support, or continuing on implant driver support, whichever occurs first; assessed at three and six months post-implant) for patients supported with the Companion 2 Driver System is non-inferior to the survival rate for patients supported with the Circulatory Support System (CSS) Console. Data Collection The data will be collected as defined in the INTERMACS Protocol and the patients will be followed at one week, one month, three months and six months or until their study endpoint is reached. Data Analysis Primary Objective 1: Data analysis will provide descriptive statistics on enrollment, adverse events, and outcomes for TAH-t patients who were implanted while supported with the Companion 2 Driver System compared to TAH-t patients who were implanted while supported with the CSS Console. Primary Objective 2: Data analysis will provide descriptive statistics on enrollment, adverse events, and outcomes for all TAH-t patients enrolled in the INTERMACS Registry. Phase I as described above was completed; Phase II of Study design is under review by FDA with anticipated initiation in early 2021.

NCT ID: NCT01934244 Enrolling by invitation - Menorrhagia Clinical Trials

Post Approval NovaSure Essure Labeling Study

PANEL
Start date: December 2013
Phase:
Study type: Observational

This post approval, observational study is being conducted to further evaluate the safety of the NovaSure Endometrial Ablation System when it is performed in the presence of Essure micro-inserts.

NCT ID: NCT02073409 Enrolling by invitation - Cystic Fibrosis Clinical Trials

PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis

PREDICT
Start date: December 2013
Phase:
Study type: Observational

Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an increasingly common finding, and the lack of an evidenced-based approach to the diagnosis of NTM disease has been identified as one of the greatest unmet needs within the CF community. Current evidence predicts that the prevalence of NTM will remain relatively high in the CF population. Approaches to NTM disease diagnosis differ widely between centers. This study is observational and follows current best practices. The study will help standardize the diagnosis and collect relevant data associated with the diagnosis of NTM disease to build a framework for future therapeutic trials.