Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety of a trivalent inactivated influenza vaccine,formulation 2011-2012, in dialysis patients

Conditions: Influenza

Summary: the purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (formulation 2011-2012).

the immune response to influenza vaccine was poor in dialysis population than general population. the investigators want to evaluate another booster vaccination can improve the immune response in dialysis population. all enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). the investigators will collect serum of participants 3 weeks, 6 weeks, 9 weeks and 18 weeks post vaccination and evaluate the difference of immune response in these 3 groups.

Eligibility criteria:
inclusion criteria: 1. males and non-pregnant females and aged more than 18 years; 2. willing and able to adhere to visit schedules and all study requirements; 3. subjects read and signed the study-specific informed consent. exclusion criteria: 1. subject or his/her family is employed by the participated hospital; 2. subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months; 3. history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication; 4. personal or family history of guillain-barré syndrome; 5. an acute febrile illness within 1 week prior to vaccination; 6. current upper respiratory illness, including the common cold or nasal congestion within 72 hours; 7. subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°c) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough; 8. female subjects who are pregnant during the study. 9. patients who receive hemodialysis therapy less than 3 months. 10. treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent; 11. immunodeficiency, or under immunosuppressive treatment. 12. receipt of any vaccine within 1 week prior to study vaccination or expected receipt between visit 1 (study vaccination) and visit 2 (final collection of blood samples); 13. receipt of any blood products, including immunoglobulin in the prior 3 months; 14. any severe illness needed to be hospitalization within three months. 15. underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.

Keywords: influenza vaccine dialysis vaccine seroprotection seroresponse seroconversion safety of the vaccine
reducing symptom burden through physical exercise in melanoma patients

Conditions: Malignant Melanoma

Summary: the aim of the clinical trial is to determine whether regular exercise can reduce fatigue in adult patients with stage iib-iv melanoma undergoing immunotherapy or targeted therapy. additionally, we will investigate whether a supervised exercise program improves patients' quality of life, cognitive skills, and physical fitness compared to a control group without structured exercise. we will also examine other health outcomes and various blood parameters, such as interleukins and metabolites, to understand how regular activity can affect metabolism and immune function. after the initial assessment at the clinic, patients will be randomly assigned to two groups. those in the intervention group will participate in a 12-week exercise program, which includes a 60-minute personalized and supervised online training session twice a week. in weeks 3, 6, and 9, one training session will be held at the clinic. furthermore, patients in the intervention group are encouraged to complete a self-administered 20-minute exercise session once a week. the control group will not receive a supervised exercise program. following the 12-week intervention period, another assessment will be conducted at the clinic. all patients will then enter a 6-week follow-up phase, during which neither group will receive supervised exercise training. after this follow-up phase, a final assessment of all outcomes will take place at the clinic.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years with malignant melanoma (stage iib - iv) receiving adjuvant immuno- or targeted therapy * patients already on the same treatment protocol for at least 3 months * sufficient knowledge of german * completed and signed written consent form and completed medical history form * medical clearance for the exercise program and performance diagnostics * ability to participate in the exercise program * willingness to visit the study hospital for training sessions and examinations exclusion criteria: * confirmation of contraindications for physical exercise by the attending physician (e.g. fracture risk in the case of bone metastases) * untreated, symptomatic, known brain metastases * severe neurological or cardiac impairment according to acsm criteria * confirmation of respiratory insufficiency by the attending physician * life expectancy less than 3 months * physical or mental conditions that would not allow implementation of the exercise program or study protocol * excessive physical activity (i.e. \>150 minutes/week of moderate to intense physical activity and systematic intense strength/endurance training at least twice a week for one hour)

Keywords: exercise fatigue physical activity checkpoint inhibitors braf/mek inhibitors melanoma quality of life
werewolf flow 50 during acl reconstruction

Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Arthrofibrosis of Knee

Summary: the aim of this study is to compare the outcomes, ease of use, and cost of the werewolf flow50 device to the institutional standard of care which is does not include the use of electrocautery devices during anterior cruciate ligament reconstruction (aclr) surgery in patients 12-18 years of age using a randomized control trial design. the investigators hypothesize that a lower proportion of participants who undergo aclr and are randomized to the werewolf flow50 procedure will experience post-operative arthrofibrosis compared to those randomized to standard of care (control group).

the investigators foresee minimal risks to participants. the werewolf flow50 is an fda approved medical device to be used in the knee joint. he surgeon performing each surgery has used both the werewolf flow50 device (according to fda-approved indications for use) and no electrocautery device as standard of care during acl reconstruction surgery. there is minimal risk associated with the subsequent mri. participants may experience slight discomfort from the confined space, flashing lights in their eyes, or temporary warmth/reddening of the skin following mri. participants will be informed of these risks and discomforts and pregnant participants or those with any metal and/or electronic devices inside their bodies will not receive the mri. there is the risk of unintended disclosure of protected health information (phi) to individuals outside the research team. to mitigate this risk, data points are entered into a password-protected, hipaa compliant redcap database accessible to only the pis and study personnel. children's colorado affiliated and approved study personal will have access to all study information collected at all involved study sites. however, other study sites will only have access to the information collected on patients enrolled at their site. we believe this system will contribute to the protection of phi. the only phi collected will be visit dates; all participants will be linked to their information via a unique study identifier. the pi will periodically review the status of this protocol. any unanticipated problems will be disclosed to comirb \[colorado multiple institutional review board\] within five days with a cover letter detailing the assessment and actions to be taken.

Eligibility criteria:
inclusion criteria: * ages 12-18 (inclusive) at time of surgery * scheduled to undergo acl reconstruction performed at children's hospital colorado or associated network of care site. exclusion criteria: * underlying congenital or musculoskeletal disorders * pregnant females, prisoners, and wards of the state * persons deemed incompetent and those who have limited decision-making capacity

Keywords: acl anterior cruciate ligament arthrofibrosis knee
clinical study to evaluate the possible efficacy and safety of l- carnitine and sildenafil in children having beta thalassemia with increased tricuspid regurgitant jet velocity

Conditions: Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity

Summary: this study aims to investigate the possible efficacy and safety of l_carnitine and sildenafil on patient with beta thalassemia complicated with increased tricuspid regurgitant jet velocity


Eligibility criteria:
inclusion criteria: * children with beta thalassemia major who have increased trjv more than 2.5m/s. * children age from 6-18 years exclusion criteria: * others hemolytic anemia * young age before 6 years of age * allergy to sildenafil or l-carnitine * patient with documented causes of pulmonary hypertension rather than caused by beta thalassemia. * hepatic dysfunction: serum alanine aminotransferase (alt) 3x. * renal dysfunction: creatinine level greater than or equal to 1.2 mg/dl.
a skills and drills intervention for emergency obstetrics and neonatal care at first referral units of north karnataka

Conditions: Obstetric and Perinatal Complications; Postpartum Hemorrhage; Preeclampsia/Eclampsia; Obstructed/Prolonged Labor; Sepsis; Birth Asphyxia

Summary: to evaluate the effectiveness of a first referral unit (fru) emergency obstetric and newborn care (emonc) skills and drills intervention, to estimate the appropriateness and effectiveness of referrals in intervention arm compared to control arm and to calculate the incremental cost and cost effectiveness of emonc skills and drills intervention.

the aim of this intervention is to improve the quality of care for institutional births with a special focus on improving the quality of emergency obstetric and newborn care (emonc). this intervention will focus on improving the skills and practices of providers and through the improvement of referral networks, ensure timely and appropriate management of complications. the specific objectives include: 1. evaluate the effectiveness of an fru-level basic and emonc skills and drills intervention combined with the existing primary health centre (phc) based nurse mentoring intervention in improving appropriate diagnosis and management of obstetric and perinatal complications. 2. assess the additional benefit of the emonc skills and drills intervention at frus in terms of improvement of obstetric and perinatal outcomes compared to the phc-level intervention alone. 3. estimate the appropriateness and effectiveness of referrals in intervention facilities compared to controls. 4. calculate the incremental cost and cost-effectiveness of the emonc skills and drills intervention

Eligibility criteria:
inclusion criteria: all women age who are referred or admitted directly to the first referral unit for a delivery or with a complication staff working in the first referral units exclusion criteria: no specific exclusion criteria

Keywords: provider skill and self-efficacy appropriate and timely referral for obstetric emergencies intervention feasibility and acceptability
performance and safety of the composite interference screw used in anterior cruciate ligament reconstructions

Conditions: Knee Ligament Injury

Summary: the evaluation of the clinical data has demonstrated the conformity of the composite interference screw (cis), with the relevant essential requirements for its use in orthopaedic applications. the composite interference scres are intended for tibial and femoral ligament/graft fixation in the case or anterior cruciate ligament (acl) reconstructions. it has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. in order to improve the clinical data on the cis, the manufacturer, biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. in this objective, the goal of this study will be to observe the following parameters: 1. objective ikdc score (clinical evaluation) 2. subjective ikds score (functional evaluation) 3. safety (report of any adverse event) 4. follow-up of the patient's recovery


Eligibility criteria:
inclusion criteria: * acute or chronic acl deficiency with complete or partial lesion of the anteromedial bundle requiring primary reconstruction of the anterior cruciate ligament with hamstring tendons * males or females aged froù 18 to 60 years * no history of surgery on the affected knee * patients not under guardianship or judicial protection * signature of non opposition form (consent of the patient exclusion criteria: * history of ligament, meniscal surgery or fracture of the affected knee * pregnancy of breastfeeding women

Keywords: knee ligament injury anterior cruciate ligament rupture anterior cruciate ligament reconstruction knee ligament rupture knee ligament reconstruction
a combined cell therapy approach to the treatment of neuroblastoma

Conditions: Neuroblastoma; Neoplasms, Nerve Tissue

Summary: this study adds an experimental treatment with another type of cells, called dendritic cells. it is hoped that these cells may stimulate the immune system to react against neuroblastoma in much the same way that vaccines cause the immune system to react to certain viruses and bacteria. the physicians conducting this study have observed from previous research that neuroblastoma cells can be recognized by the immune system, and that they can be destroyed by immune cells.the main goal of this study is to see if giving participants this additional anti-neuroblastoma vaccine reduces the risk of relapse following the hematopoietic stem cell transplant.

all patients who are enrolled in this study will receive all treatment at all children's hospital which is located at 501 6th ave south, st. petersburg, fl 33701. this includes autologous cell donation by apheresis, high dose cytotoxic therapy conditioning for autologous hpc transplant, post-transplant follow-up care, and all administration of dendritic cell vaccines and blood draws for post therapy immunological monitoring. all preparation of cellular products, including hematopoietic progenitor cell products for autologous transplantation, and dendritic cell vaccine products, will be carried out in the cell therapy facility located within the moffitt cancer center, which is located at 12902 magnolia drive, tampa, fl 33612.

Eligibility criteria:
inclusion criteria: * must have a histological diagnosis of neuroblastoma or ganglioneuroblastoma and be either newly diagnosed with high risk disease or have failed previous treatment: patients who have failed previous treatment may have had no more than one earlier autologous hpc transplant. * participant is expected to undergo autologous hpc transplantation that is consistent with standard of care. * must have the presence of residual resectable disease for which surgery is clinically indicated, and will be performed at johns hopkins all children's hospital. exclusion criteria: * not an eligible candidate for collection by apheresis or hpc transplant. * history of autoimmune disorder or immune deficiency disorder.

Keywords: children cancer high-risk neuroblastoma
pharmacokinetic interactions between telaprevir and un-boosted atazanavir

Conditions: Hepatitis C, Chronic; HIV Infection

Summary: hypothesis: the telaprevir(tvr) plasma levels (750 mg q8h or 1125 mg/12h )will not be affected when co-administered with un-boosted atazanavir (atv) 200 mg q12h plus two analogues (nrtis) in hcv/hiv-co-infected patients.

objectives 1. primary outcome measures: evaluate the changes in the plasma pharmacokinetic parameters (cmax, cmin, auc, t 1/2, and cl) of telaprevir (tvr) administered at 750 mg/8h together with un-boosted atazanavir (200 mg/12h), taking as reference the pharmacokinetic parameters observed when tvr is administered with atazanavir/ritonavir (300/100 mg/day) 2. to assess the changes in the plasma pharmacokinetic parameters of atazanavir administered as 200 mg/12h with respect to its administration as 300/100 mg/day when administered together with tvr (750 mg/8h or 1125 mh/12h). method: open labelled clinical trial with a planned duration of 24 weeks in which 14 hiv/hepatitis c virus genotype 1 patients under treatment with pegylated α-interferon, ribavirin and telaprevir will be enrolled. a 24 hours pharmacokinetic profile will be obtained after a supervised drug intake while taking tvr and atv/rtv. afterwards, the patients will take un-boosted atv 200 mg bid for 7 - 10 days. subsequently, a new pharmacokinetic profile will be obtained.

Eligibility criteria:
inclusion criteria: * patients over 18 years old co-infected with hiv and genotype 1 hcv under treatment with pegylated α-interferon, ribavirin and telaprevir according to the recommendations of the spanish agency of medicines and health products. * informed consent of the patient. exclusion criteria: * the usual exclusion criteria in clinical practice to start the treatment with these drugs (pegylated α-interferon, ribavirin, telaprevir and atazanavir) according to the spanish and international recommendations (spanish agency of medicines and health products,european association for the study of the liver clinical practice guidelines: management of hepatitis c virus infection. j hepatol. 2011. consensus document of gesida/spanish plan on aids regarding the antiretroviral treatment in adults infected with the human immunodeficiency virus \[updated january 2012\]). * concomitant use of drugs or medicinal products that could alter the pharmacokinetics of tvr or atv. * medical records suggesting malabsorption or presence of diarrhea (\>3 depositions/day) that could interfere with the absorption of the studied drugs.

Keywords: chronic hepatitis c hiv-infection drug interaction
exercise study in subjects with nafld

Conditions: Non-Alcoholic Fatty Liver Disease; Gastrointestinal Microbiome; Exercise

Summary: non-alcoholic fatty liver disease is the most common cause of chronic liver diseases. the benign non-alcoholic fatty liver, characterized by excessive fat accumulation, can evolve into non-alcoholic steatohepatitis and liver cancer. the recommendation nowadays is a lifestyle change with physical exercise and diet to reduce liver fat and improve inflammation. besides this, a leaky gut and dysbiosis have an impact on the liver, and exercise ameliorates the diversity of gut microbiota and permeability of the intestine. the aim of this study is to find out a link between exercise and the gut-liver axis regarding the stage of liver adiposity and define exercise-responsive gut microbiome in nafld patients

for this 12-week randomised controlled intervention 60 subjects between 18 and 70 years old, diagnosed with nafld and body mass index under 35 kg/m2 will be recruited. they will be randomly assigned in a high-intensity aerobic interval training (n=30) and a control group with a sedentary lifestyle (n=30). the intervention group follows a supervised high-intensity aerobic interval training two times per week and additionally, an individualised home workout program to have 3 hours of aerobic training per week. blood samples, adipose tissue biopsy, 24h-urine and faecal samples will be collected at the baseline, midway (only stool) and at the end of the study. dietary intake will be analysed at weeks 0, 6, 12.

Eligibility criteria:
inclusion criteria: * diagnosed nafld * bmi:25 - 35 kg/m\^2 exclusion criteria: * acute illness or current evidence of acute or chronic inflammatory or infective diseases * liver disease (e.g. wilsons disease/alpha-1-antitrypsin deficiency, hepatitis b and c, hemochromatosis) * bleeding disorder, anticoagulation medication * subjects with diagnosed type 1 diabetes or diagnosed type 2 diabetes with insulin or glucagon-like peptide-1 agonist treatment * diagnosed depression and mental illness * any condition preventing physical activity * smokers * alcohol abuse (daily consumption ≥ 30 g for men and ≥ 20 g for women)

Keywords: nafld gut microbiota high-intensity training
mibg scintigraphy as a tool for selecting patients requiring implantable cardioverter defibrillator (icd)

Conditions: Heart Failure; Sudden Death

Summary: the aim of the study is to assess the cardiac innervation in patients with heart failure to better select candidates for an implantable cardioverter defibrillator. cardiac innervation will be assessed using an imaging agent administered intravenously.

the survival benefit provided by implantable cardioverter defibrillator (icd) for primary prevention of sudden cardiac death in heart failure compared to medical treatment alone is well established. first limited to the most severe patients, the indications have gradually been extended in accordance with the results of more recent studies. this beneficial effect in terms of public health is accompanied by an increase in health spending which threatens to grow strongly at short and medium term. however, the majority of icds implanted will not be solicited because of the overall low incidence of severe ventricular arrhythmias in the population meeting the implantation criteria. to optimize our resources, it is therefore important to better assess the risk of sudden death in those patients candidates for icd implantation. the overactivation of neuro-humoral systems plays an important role in the progression of heart failure, and in the occurrence of ventricular arrhythmias. the iodine-123 meta-iodobenzylguanidine scintigraphy (mibg), is a functional imaging method that can noninvasively evaluate cardiac sympathetic innervation. it has been shown that cardiac adrenergic hyperactivation estimated by mibg scintigraphy was associated with a poor outcome, and that its value was independent and superior to other prognostic factors in heart failure. more importantly, the risk of occurrence of major cardiac events is minimal when the cardiac uptake of mibg is high. furthermore, plasma natriuretic peptides (particularly bnp and nt-probnp), which are other indicators of the neuro-hormonal activation used in the diagnosis and assessment of prognosis in heart failure, are predictive of the risk of occurrence of sudden death in the same population. in summary, the mibg scintigraphy and nt-probnp are two prognostic markers in heart failure related to the degree of neuro-hormonal dysfunction, and have a good negative predictive value of mortality. their combined use could therefore help identify patients at low risk of severe arrhythmias.these tests are not currently part of heart failure diagnosis in patients who are candidates for icd implantation.

Eligibility criteria:
inclusion criteria: * indication for icd in primary prevention according to european society of cardiology guidelines exclusion criteria: * secondary prevention indication of icd * acute coronary syndrome within the last 40 days * revascularization procedure (bypass or percutaneous coronary angioplasty) performed within the last 3 months of planned * pregnancy or lactating female

Keywords: heart failure sudden death implantable cardioverter defibrillator mibg scintigraphy