Kornimate/medical-research-clean huggingface dataset:
human papillomavirus (hpv) vaccine consistency and non-inferiority trial in young adult women

Conditions: Papillomavirus Type 16/18 Infection; Cervical Intraepithelial Neoplasia

Summary: the study will be extended for subjects who received all three doses of vaccine in finland, denmark and estonia to determine long-term safety and immunogenicity of the hpv-16/18 vaccine. human papilloma virus (hpv) are viruses that cause a common infection of the skin and genitals in men and women. several types of hpv infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). this infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. if a woman is not infected by hpv, it is very unlikely that she will get cervical cancer. this study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of glaxosmithkline biologicals hpv-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.

approximately 750 study subjects received different lots of the hpv vaccine administered intramuscularly according to a 0-1-6 month schedule. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: * a female who enrolled in the hpv-012 (nct00337818) study in denmark, estonia and finland, received three doses of vaccine and completed visit 4 (month 7). * written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (lar) and, in addition, the subject must sign and personally date a written informed assent). exclusion criteria * use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. * administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.

Keywords: non-inferiority immunogenicity hpv vaccine consistency
effect of exercise on the absorption of inhaled human insulin in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: the trial is conducted in europe. this clinical pharmacology trial investigates the effect of exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes more than or equal to 12 months * baseline hba1c less than or equal to 11% * body mass index (bmi) less than or equal to 29 kg/m2 * normal lung volumes * treatment with intensified insulin therapy for at least 3 months exclusion criteria: * any present or history of pulmonary disease * any findings from the cardiopulmonary exercise test compromising safety of moderate exercise * impaired hepatic or renal function * cardiac problems * uncontrolled hypertension * current proliferative retinopathy or maculopathy * treatment with drugs, which may interfere with insulin action, glucose metabolism or recovery from hypoglycaemia (judged by investigator) * current smoking or smoking within the last 6 months * blood donation (more than 500 ml) within the last nine weeks
surgical pulmonary vein isolation efficiency study

Conditions: Paroxysmal Atrial Fibrillation; Coronary Artery Disease

Summary: a substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. paroxysmal atrial fibrillation has adverse short-and long term postoperative effects. pulmonary vein isolation (pvi) seems to be effective treatment for paroxysmal atrial fibrillation. pvi can be done concomitantly with coronary artery bypass grafting, aortic valve replacement for aortic stenosis and combination of them. procedure is well defined and safe. there is a lack of convincing evidence of the effect on postoperative atrial fibrillation burden, quality of life and symptoms especially in correlation with atrial fibrillation paroxysms.


Eligibility criteria:
inclusion criteria: * american college of cardiology (acc)/ american heart association (aha) -indications for cabg * at least 2 ecg-verified (12-channel ecg, holter telemetry) symptomatic paroxysmal atrial fibrillation episodes within last 12 months * duration of the atrial fibrillation episode must not exceed 1 week and it must reverse to sinus rhythm spontaneously or by cardioversion * written and verbal consent exclusion criteria: * prior cardiac surgery * active pacemaker treatment * active anti-arrhythmic treatment(aad) class i and iii * contraindication to oral anticoagulant/heparin treatment * ejection fraction less than 30 % (ef \< 30 %)assessed by transthoracic echocardiography * left atrial diameter less than 55mm assessed by transthoracic echocardiography * renal insufficiency requiring dialysis * heart valve disease requiring invasive treatment * heart anomaly requiring regular controls and/or invasive treatment

Keywords: pulmonary vein isolation paroxysmal atrial fibrillation quality of life
ivig treatment for refractory immune-related adult epilepsy

Conditions: Epilepsy, Cryptogenic; Epilepsy, Partial; Seizure Disorder; Autoimmune Diseases, Nervous System; Limbic Encephalitis

Summary: the purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. this study consists of a single blood sample, which will be tested for possible immune abnormalities. if enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (ivig). the study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including ivig. at present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. the investigators hope that this study will help us understand the cause of some cases that are difficult to treat.

the study is divided into two phases: phase i: the investigators will screen for evidence of neuronal nuclear, cytoplasmic, and cell surface autoantibodies in our population of new onset refractory, imaging-negative young adult epilepsy patients. this part of the study involves obtaining a single blood sample, equal to about 2 teaspoons. phase 2: if a sufficient number of cases are identified, a double-blind crossover study of ivig treatment will be performed in these patients.

Eligibility criteria:
inclusion criteria: * diagnosis of uncontrolled epilepsy with at least two seizures a month for three consecutive months. * age 18 to 50. * clinical semiology or electroencephalogram (eeg) consistent with partial onset epilepsy. * refractory to an adequate trial of two or more main-line anti-epileptic drugs. * ability to keep a seizure diary. * normal brain magnetic resonance imaging (mri) - 3 tesla, seizure protocol; with the exception of hippocampal sclerosis exclusion criteria: * history of severe prematurity or neonatal distress, febrile seizures, moderate or sever traumatic brain injury, stroke, brain tumor, meningitis, encephalitis, neurocutaneous syndromes, or intracranial metal objects. * evidence of psychogenic epilepsy. * history of convulsive status epilepticus. * history of primary generalized epilepsy in a first degree relative. * known serious medical illness.

Keywords: refractory epilepsy cryptogenic epilepsy autoimmune disorders ivig immunomodulatory therapy autoantibodies
awareness of osteoporosis in diabetes mellitus patients

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Osteoporosis; Osteoporosis Risk

Summary: osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. diabetes mellitus patients are at increased risk for developing osteoporosis. identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. this study is aimed to investigate awareness and knowledge of osteoporosis in diabetes mellitus patients.

osteoporosis is a common disease of bone loss. the reduced bone strength predisposes an increased risk for fractures in older individuals. it can affect people from different ethnicity. many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin d, immobility, and chronic inflammation. patients with multiple sclerosis are at high risk of developing osteoporosis due to chronic inflammation and their medications. patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. this study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with diabetes mellitus.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diabetes mellitus * must be between the ages of 18 and 99 * must give consent to participate in the study exclusion criteria: • not giving consent
tongue brush (orabrush) for reducing aspiration pneumonia in stroke patients

Conditions: Dysphagia After Stroke; Aspiration Pneumonias; Ischemic Stroke

Summary: the investigators conduct a controlled prospective experimental intervention study to examine whether the use of a tongue brush (orabrush) can improve the rate of aspiration pneumonia and dysphagia in patients with ischemic stroke. secondary outcomes include the impact on bacterial tongue colonization, the tongue coating index, and the length of stay of the patients.the patients will be recruited in the stroke unit of the department of neurology from november 2024 until approximately october 2026.

as part of a prospective controlled experimental intervention study, patients with ischemic stroke will be recruited in the stroke unit of the university hospital marburg, who are admitted between november 2024 and approximately october 2026. the primary objective of this study is to investigate the impact of a tongue brush (orabrush) on the rate of aspiration pneumonia and dysphagia. secondary outcomes include the analysis of bacterial tongue colonization, the tongue coating index, and the length of stay of the patients. key study parameters include the aspiration rate, the eat-10, the guss, a tongue swab, and a photograph of the tongue to determine the tongue coating index. data will be collected on the day of admission and after a duration of 3-5 days. the study has been approved by the relevant ethics committee.

Eligibility criteria:
inclusion criteria: * ischemic stroke and admission on the stroke unit at the university hospital marburg * minimum age: 18 years * patient is able to consent * consent has been obtained exclusion criteria: * surgery in the oral-pharyngeal region * irradiated patient with a history of tumor in the head and neck region * missing compliance * intake of medications with saliva-altering side effects, existing desire to have children, or pregnancy

Keywords: dysphagia after stroke aspiration pneumonias tongue coating index bacterial tongue colonization ischemic stroke
177lu-dtpa-omburtamab radioimmunotherapy for recurrent or refractory medulloblastoma

Conditions: Medulloblastoma, Childhood

Summary: children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy will be treated with 177lu-dtpa-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting b7-h3.

part 1 is a dose-escalation phase with a 3+3 sequential-group design in which patients will receive a dosimetry dose followed by maximum of two 5-week cycles of treatment doses of intracerebroventricular 177lu-dtpa-omburtamab. part 2 is a cohort-expansion phase in which patients will receive a maximum of five 5-week cycles of intracerebroventricular 177lu-dtpa-omburtamab at the recommended dose determined in part 1. end of treatment will take place within 5 weeks after the last cycle and thereafter the patients will be enter the follow-up period. the patients will be followed for up to 2 years after last dose.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of medulloblastoma. * shh, group 3, or group 4 according to world health organisation (who) 2016 classification. * recurrent (maximum of 2 recurrences for part 1 and 1 recurrence for part 2) or refractory to frontline therapy. prior frontline or second line therapy may involve surgery, craniospinal irradiation, stereotactic radiosurgery, and multi-agent chemotherapy regimens. * have refractory disease, focal or multifocal recurrent disease, or pure leptomeningeal disease. cytological or radiographic remission is allowed; however, not simultaneously. * performance status score of 50 to 100 on lansky (less than 16 years) or karnofsky (16 years or older) scales. * life expectancy of at least 3 months, as judged by the investigator. * acceptable hematological status and liver and kidney function. exclusion criteria: * obstructive or symptomatic communicating hydrocephalus as determined by ommaya patency/cerebrospinal fluid (csf) flow study. * residual disease (nodular or linear) measuring \> 15 mm in the smallest diameter. * ventriculoperitoneal shunts without programmable valves. ventriculo-atrial or ventriculo-pleural shunts. * grade 4 nervous system disorder. stable neurological deficits (due to brain tumor or surgery) or hearing loss are allowed. * uncontrolled life-threatening infection. * received radiation therapy less than 3 weeks prior to the screening visit. * received systemic or intrathecal cytotoxic chemotherapy or intrathecal immunotherapy (corticosteroids not included) less than 3 weeks prior to the screening visit. * received any prior anti-b7-h3 treatment. * non-hematologic organ toxicity grade 3 or above; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity. * other significant disease or condition that in the investigator's opinion would exclude the patient from the trial.
colostrum from mers-cov seropositive camels for sars-cov-2 infection - a placebo-controlled randomized trial.

Conditions: COVID 19

Summary: the study aims to study the efficacy of colostrum from mers-cov-positive camels applied as a nasal spray to covid-19 patients for treatment and prevention of sars-cov-2 infection. this study will compare the usage of colostrum to placebo.


Eligibility criteria:
inclusion criteria: * age over 18 years. * laboratory-proven infection with covid-19 using pcr or another approved kit * hospitalized / community setting-at low-moderate clinical risk according to the news-2 scale with a score of 0-10. * onset of symptoms up to 7 days before inclusion * can sign informed consent * willingness and ability to participate in research exclusion criteria: * pregnant women or lactating * lack of judgment (psychiatric disorder or dementia) * immunosuppressed - hiv with cd4 below 500, chemotherapy, steroids - more than 5 mg per day, solid organ transplants, bone marrow transplants, active hematological or oncological malignancies, biological therapy * neutropenia (less than 2000 neutrophils per cubic meter) or thrombocytopenia (platelet count less than 50000 per cubic meter). * acute or chronic sinusitis. * nasal polyps or any pathology in the nasal cavity * cystic fibrosis * significant disturbance in liver functions (ast/alt more than 5 times the uln) * significant renal dysfunction (gfr lower than 30 ml per minute) * known allergy to colostrum or cow\&#39;s milk * use of another study drug

Keywords: infectivity viral load mers-cov sars-cov-2
the movement imagery ability in patients with familial mediterranean fever

Conditions: Familial Mediterranean Fever

Summary: motor imagery is the mental representation of movement without any doing body movement. a main function of imagery is to aid the self-regulation of thoughts, feelings, and behaviours. studies have shown to be more effective for individuals displaying a higher level of imagery ability when using imagery to improve motor and motivational outcomes, including self-efficacy. the aim of this study is to measure the movement imagery ability in patients with familial mediterranean fever and compare it with healthy individuals.

familial mediterranean fever (fmf) is an autosomal recessive disease characterized by recurrent and self-limited attacks of fever associated with abdominal, chest, and joint pain. previous studies have shown that individuals with fmf are more limited in terms of physical function than the normal population, and depression and anxiety are more common in these individuals. being a lifetime disease, quality of life, and mental health can be affected due to serious complications such as attack frequency, disease resistance, and sometimes amyloidosis. mental imagery is the ability to imaging the movement without doing the physical execution of the movement. during the last years, mental imagery is used in clinical practice as a tool for the treatment of chronic pain. pain differs in patients with rheumatic diseases. stress is one of the predictors of pain in patients with fmf. even if the frequency is variable when attacks happen they may affect patients physically and their mental health and the ability to cope. a main function of imagery is to aid the self-regulation of thoughts, feelings, and behaviors. to use imagery for motor and motivational outcomes firstly the imagery ability levels should be measured.

Eligibility criteria:
inclusion criteria: * having had at least one attack last year * co-operated individuals exclusion criteria: * patients with a neurological disorder, * diagnosed with cancer, * cognitive impairment, * having a primary pathology of the musculoskeletal system, * having previous imagery practice, * having an additional rheumatic disease

Keywords: movement imagery ability pain catastrophizing familial mediterranean fever
a study on effect of health promotion for prevention niddm in people with prediabetes

Conditions: Diabetes Mellitus

Summary: objective - the role of health promotion for patients with impaired fasting glucose on preventing or delay the progression of diabetes mellitus has not been widely investigated in taiwan. the purposes of this study are to explore the nature history of prediabetes, to evaluate the incidence of dm in prediabetes and to establish the cohort of people with prediabetes. further study will be based on this cohort to evaluate the effect of health promotion and to compare the concentration of certain protein in their serum, such as adiponectin. research design and methods -a total of 600 subjects aged 40-60 years with impaired fasting glucose (100-125 mg/dl) were randomly selected from the peng-hu clinics during january 2003 and december 2003. anthropometric, biochemical, and metabolic characteristics will be measured, including weight, height, waist circumference, oral glucose tolerance test, triglyceride, high and low density cholesterol, blood pressure and insulin resistance etc. a questionnaire interviews with subjects regarding demographic characteristics is also performed. 300 subjects will receive education of health promotion. simultaneously, 150 subjects with normal fasting plasma glucose (\<100 mg/dl) will selected for comparison. statistical analysis - descriptive data will be described as means and sds for continuous variables, and analysis of variance (anova) and chi-square tests were used for assessing the significances. bonferroni method was used for post-hoc comparison in anova. multiple linear regressions were used for predicting determinants of fpg. we tested the variables scales in this study for multicollinearity by correlation matrix and vif (variance inflation factor). odds ratios (ors) and the 95% confidence interval (ci) were calculated to estimate the relative risk of diabetes mellitus by logistic regression model. a p-value below 0.05 was considered significant. the statistical analyses were performed with spss statistical package.


Eligibility criteria:
inclusion criteria: * fasting glucose level 100-125mg/dl * ogtt 2hr glucose level 140-199 mg/dl exclusion criteria: * established diabetes mellitus: use of diabetic medication, fasting glucose \>=126 mg/dl, ogtt 2ht glucose level \>=200mg/dl
dynamic infrared thermography as an alternative to ct angiography

Conditions: Breast Cancer

Summary: dynamic infrared thermography (dirt) is an imaging method that does not require ionizing radiation or contrast injection. the study evaluates if dirt can be an alternative to computed tomographic angiography (cta) in perforator mapping. dirt findings are compared with hand-held doppler, cta and intraoperative findings.

in deep inferior epigastric perforator flap (diep) breast reconstruction the blood supply to the diep flap is reestablished by anastomosing the perforator to the internal mammary vessels. the selected perforator is crucial for flap survival as it is the only source of blood supply to the flap. cta allows for precise anatomical description of the origin of perforators, their intramuscular course and point of fascia penetration but expose the patient to ionizing radiation and an intravenous contrast medium. dirt is an imaging method that does not require ionizing radiation or contrast injection. the study evaluates if dirt can be an alternative to cta in perforator mapping. the study is performed in a hospital where dirt and cta have been established preoperative imaging methods that have been used for several years as routine examinations for all diep breast reconstruction patients. 25 patients scheduled for secondary breast reconstruction with a diep flap are included. preoperatively, the lower abdomen is examined with hand-held doppler, dirt and cta. arterial doppler sound locations are marked on the skin. dirt examination involves rewarming of the abdominal skin after a mild cold challenge. the locations of hot spots on dirt are compared with the arterial doppler sound locations. the rate and pattern of rewarming of the hot spots are analyzed. multiplanar ct reconstructions are used to see if hot spots are related to perforators on cta and intraoperative findings. when intraoperative findings confirm that a useful perforator is located at the same localization as indicated with dirt, this perforator is used for diep breast reconstruction. postoperatively the surgical outcome and possible complications related to the selected perforator are evaluated.

Eligibility criteria:
inclusion criteria: * patients scheduled for breast reconstruction with diep flap exclusion criteria: * prior breast reconstruction / abdominal flap surgery

Keywords: diep computed tomography doppler thermography