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NCT ID: NCT04269265 Active, not recruiting - Yellow Fever Clinical Trials

The Effect of Inflammation and Damage to Lymph Node Structures on Durable Protective Immunity Following Yellow Fever Vaccination

Start date: July 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Hypothesis: Infections other than HIV can cause LN inflammation and collagen damage to the fibroblastic reticular cell network (FRCn), which will lead to CD4 T cell depletion and impaired vaccine responses. This protocol will study yellow fever vaccine (YFV) in two cohorts of people, one from Uganda and the other from Minnesota where we collect lymphoid tissues (LT) and peripheral blood monocytes (PBMCs) before and after vaccination using a new technique to catalog infectious burden of the individual, determine the relationship between IA, Infections, and immune response.

NCT ID: NCT03989596 Active, not recruiting - Sarcoma Clinical Trials

Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas

SINDIR
Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

After a screening, which consists of biopsy, physical examination, initial diffusion-weighted magnetic resonance imaging (DWI-MRI) or body computed tomography (CT) scan, blood tests and case analysis on Multidisciplinary Team (MDT) meeting, a patient will receive the hypofractionated radiotherapy 10x 3.25 Gy with regional hyperthermia (twice a week) within two weeks. The response analysis in CT or DWI-MRI and toxicity assessment will be performed after at least 6 weeks. At the second MDT meeting, a final decision about resectability of the tumor will be made. In case of resectability or consent for amputation, if required, a patient will be referred to surgery. In case of unresectability or amputation refusal, the patient will receive the second part of the treatment which consists of 4x 4 Gy with hyperthermia (twice a week).

NCT ID: NCT03964870 Active, not recruiting - Clinical trials for Malignant Hyperthermia

Spanish Registry of RYR1 and CACNA1S Polymorphisms

Start date: December 5, 2018
Phase:
Study type: Observational

Study design: The Spanish registry of RYR1 and CACNA1S polymorphisms (RYCA) is an anonymous descriptive observational multicentre study that aims to identify and catalogue the variants or polymorphisms in the RYR1 and CACNA1S genes in the Spanish population. Secondarily, its correlation with the binding mutations described in both genes at European level by the EMHG will be evaluated to assess the incidence of malignant hyperthermia in Spain. The RYCA registry complies with the highest standards of European and international homologation, both with regard to computer security and the protection of personal data (Data Protection Law 15/1999). Hypothesis: Performing a Spanish registry of RYR1 and CACNA1S polymorphisms will contribute to describe the variants present in our environment and determine their relationship with MH susceptibility. Objectives: - Describe the national polymorphisms of the RYR1 and CACNA1S genes - To evaluate the incidence of genetic MH susceptibility according to the recommendations of the EMHG. The presence of polymorphisms in a population that has not been studied before may have a difficult correlation with the mutations described in the EMHG webpage. Eligibility Criteria: The sample contained in the registry will originate from the genetic data of patients unrelated to HM who have been sequenced the RYR1 and CACNA1S gene by another pathology. The data related to the genetic analysis will be provided without identifying data of the patient or the clinical history. There will be no possibility of identification of the patient by the team responsible for the RYCA registry, so the request for informed consent is not viable. There will be no selection of participants or patient follow-up. Methodology: A preliminary pilot study will be conducted in an unselected anonymous cohort of the sequenced exome database of the RYR1 and CACNA1S gene at the La Fe Health Research Institute (IISlaFe). The population contained in this database is random and unrelated to HM and the patients are anonymous, so we do not have access to personal data or medical history. If the analysis is feasible, a request for collaboration will be transferred to the Genetics Services / Research Units with experience in the exome sequencing of the RYR1 and CACNA1S genes. Anonymous readings will be requested to carry out the registration and description of the variants existing in the Spanish population and their relationship with the variants described by the EMHG. Variables: The registry will include the chromosomal coordinates, number of total patients included, number of patients whose variant is in heterozygosis, number of patients whose variant is in homozygosis and allelic frequency. Thus, for each of the genes of interest, and making use of their respective chromosomal coordinates, information regarding the variants that these might include will be extracted. Sample size. Sample size calculation is not considered since it is a descriptive record.

NCT ID: NCT03702348 Active, not recruiting - Chikungunya Fever Clinical Trials

Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever

Start date: July 23, 2018
Phase: Early Phase 1
Study type: Interventional

Common symptoms of chikungunya fever are persistent arthritis and arthralgia, such symptoms can lead to impairment in functionality. The objective of this study is to evaluate the efficacy of a resistance exercise protocol on the functionality of individuals with chronic musculoskeletal manifestations of Chikungunya fever. Quality of life, number of painful joints, intensity of pain, number of recurrence of exacerbation and thermography are secondary outcomes that will also be evaluated. The protocol uses elastic resistance to strengthen muscle groups that stabilize the main joints affected by Chikungunya Fever. The sessions will be 2 times a week for 12 weeks. The control group will not be submitted to the intervention during the 12 weeks, being contacted through telephone calls. After the reevaluation at the end of the 12 weeks the control group will perform the same protocol. The sample will be characterized and the effect size and the mean difference will be calculated. Intention-to-treat analysis and rate of adherence will also be calculated.

NCT ID: NCT03591003 Active, not recruiting - HIV Infections Clinical Trials

"Persistence of Neutralizing Antibodies Against Yellow Fever (YF) in HIV-infected Patients"

Start date: June 2015
Phase:
Study type: Observational

Participating countries: Belgium Context: In June 2013, WHO notified that "a single dose of YF vaccine is sufficient to confer sustained life-long protective immunity against YF disease and that a booster dose is not necessary". . For HIV infected persons the recommendation was less stringent and the position paper concluded that hiv infected persons may "hypothetically, benefit from a second dose or booster dose ".1 Recently, WHO changed the recommendations about a booster dose of YF vaccine, based on the fact that serum neutralizing antibodies against YF are still at detectable levels after 20-35 years and probably lifelong in immunocompetent patients. Unfortunately, data on persistence of Neutralizing antibodies Titers (NT) in immunocompromised patients are missing and only few studies reported data about HIV-infected patients. Additional data are needed. Primary objective: To assess presence / persistence of Neutralizing Titers (NT) of antibodies after YF immunization in HIV-infected patients. Secondary objectives: 1. To identify risk factors for early and late waning of NT after YF immunization 2. To modelize kinetics of NT after YF immunization in different subpopulations of HIV patients, including population of young HIV patients infected vertically 3. To identify risk factors for absence of seroconversion in the year after YF immunization 4. To compare persistence of NT in HIV patients infected vertically or not vertically 5. To quantify seroconversion rate after YF vaccination Methodology / study design This study is a single arm, non randomized, cross-sectional, multicenter study in AIDS Reference Centers from Belgium. The maximum duration of the study for each patient will be 1 visit, consisting of: - the screening and inclusion visit (single visit V1) to check the patient eligibility, sign informed consent, perform the biologic tests necessary for the study and answer the questionnaire - whenever possible, an additional serum / plasma sample coming from serabank / plasmabank will be identified for each patient. This sample must have been taken during the year following YF immunization. - data about patient's HIV history has to be extracted from the HIV database or from patients' file Estimated enrolment 750 patients + 30 patients infected vertically with HIV Primary outcome Number of HIV patients with protective YF NT ≥ 1:10 at different timepoints after YF immunization Secondary outcomes 1. Number of patients with protective YF NT ≥ 1:10 in the year following YF immunization 2. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) for absence of seroconversion in the year following YF immunization 3. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) of early waning (before 10 years) of YF NT 4. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) of late waning (after 10 years) of YF NT Eligibility Inclusion criteria 1. Infection with HIV-1 (vertical transmission or not) 2. Immunization with at least one injection of YF vaccine (Stamaril®,17D strain Rockefeller, Sanofi Pasteur) with proof of vaccine administration 3. Informed consent signed prior to any study procedure Exclusion criteria Inability to give informed consent Substudies - Whenever possible, an additional sera or plasma sample from the year following YF vaccine will be selected and analyzed to assess early seroconversion rate - Whenever possible, an additional sera or plasma sample from the year before YF vaccine will be selected and analyzed to assess seroconversion rate - In CHU Saint-Pierre, an additional cohort of patients infected vertically with HIV will be selected and will participate to the study

NCT ID: NCT03515668 Active, not recruiting - Hyperthermia Clinical Trials

Dopamine and Muscle Function in the Heat

Start date: April 20, 2018
Phase: N/A
Study type: Interventional

our goal is to study the effects of dopamine activity, using Ritalin ingestion, on neuromuscular function over the course of a progressive heating and cooling protocol developed in our lab. We hypothesize that Ritalin will minimize the previously reported progressive impairment in neuromuscular function with hyperthermia compared to placebo, suggesting that dopamine activity preserves neuromuscular capacity with hyperthermia.

NCT ID: NCT03371693 Active, not recruiting - Ovarian Cancer Clinical Trials

Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer

HIPECOV
Start date: September 30, 2017
Phase: Phase 3
Study type: Interventional

A phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS( Cytoreductive Surgery). Patients will be divided into two groups. Group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. Group B will undergo CRS and then go on to intravenous chemotherapy.

NCT ID: NCT03218449 Active, not recruiting - Clinical trials for Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy

Inflammatory Markers for Postoperative Complications in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Start date: June 13, 2017
Phase: N/A
Study type: Observational

Infective complications after cancer surgery had a significant impact on disease-free and overall survival. Postoperative inflammatory markers have been proven useful in predicting infective complications. However, it remains unknown whether these markers can predict postoperative infection in patients receiving cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) which causes the systemic inflammatory response syndrome. Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis were assessed for postoperative complications. Patients were divided into two groups according to the presence of infective complications. Presence of abscess, positive blood, surgical site, urine or sputum cultures, or clinical signs and symptoms with comparable radiologic findings were defined as infective complications. Retrospectively, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio, white blood cell count, platelet count, mean platelet volume, platelet-to-lymphocyte ratio, albumin were collected from preoperative day and postoperative days (POD) 0-14.

NCT ID: NCT02990182 Active, not recruiting - Yellow Fever Clinical Trials

Complementary Study of the Duration of Post-vaccination Against Yellow Fever Immunity in Children

Start date: April 2015
Phase: N/A
Study type: Observational

In a previous study by the researchers' group, the researchers' investigate the duration of yellow fever post-vaccination immunity in vaccinated children between 9 and 23 months of age. However, in this study, samples of children in the pre-vaccine period, also known as unvaccinated children samples (NV) have not been investigated. It is believed that to seek evidence about the immune status in the medium and long term after vaccination against yellow fever is necessary to investigate paired samples of children not vaccinated (NV), with re-evaluation 30-45 days after primary vaccination. The proposed study is to consolidate aspects of humoral (neutralizing antibodies) and cellular (phenotypic and functional parameters of T cells and memory B) by means of complementary longitudinal investigation children, 9-23 months old, unvaccinated (NV) and 30-45 days after primary vaccination.

NCT ID: NCT02968355 Active, not recruiting - Fever Clinical Trials

Clinical Evaluation of the FilmArray® Global Fever (GF) Panel

Start date: March 26, 2018
Phase:
Study type: Observational

This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel.