Kornimate/medical-research-clean huggingface dataset:
efficacy study of combined hepatitis a and hepatitis b vaccine to protect against hepatitis b in hemodialysis patients

Conditions: Hepatitis B

Summary: does vaccinating hemodialysis patients with twinrix® (combination vaccine against hepatitis a and hepatitis b) result in a difference in hepatitis b antibody response in comparison to the monovalent hepatitis b vaccine? hepatitis b infection is an important cause of mortality and morbidity. current standard vaccination practices have low efficacy levels in patients (eg. hemodialysis patients) who are most susceptible of infection. efficacy of the two regiments will be studied.

hepatitis b virus (hbv) is a human pathogen that causes acute and chronic liver infection. immunosuppression may be associated with more frequent persistent infection and hbv infections in renal dialysis patients can become chronic. the routes of transmission of the virus is well established; direct percutaneous inoculation of virus via exchange of contaminated blood, blood products, body fluids, and hemodialysis. the center for diseases control and prevention (cdc) recommends immunization in high-risk groups, including hemodialysis patients. ninety to ninety five percent of healthy, immunocompent adults develop protective anti-hepatitis b surface antibody (anti-hbs) with a primary series of hepatitis b vaccination, but the overall efficacy in renal dialysis patients is much lower. the proportion of hemodialysis patients who develop a seroprotective antibody even with higher doses of vaccination is a median 64% (range: 34-88%). reports suggest that combined vaccination of hepatitis b and hepatitis a (twinrix®: combination vaccine containing inactivated hepatitis a and recombinant hepatitis b) may improve immunogenicity in healthy individuals. in one study, comparing anti-hbs geometric mean titres (gmt) at month 6 of the series, subjects receiving the combined vaccine showed a statistically significant higher response than those who obtained the monovalent vaccines. other studies also reflect the same trend at varying points in the vaccination series. currently, there are 426 patients in the hemodialysis program at st. joseph's healthcare in hamilton and 324(76%) patients are susceptible to hbv infection. our study will determine if the improved immunogenicity observed with combined hav and hbv vaccine will increase the efficacy of hbv vaccine in hemodialysis patients.

Eligibility criteria:
inclusion criteria: * hemodialysis patients * age greater than or equal to 18 * able and willing to give informed consent * undetectable anti-hbs ab level exclusion criteria: * presence of hepatitis bsag, hepatitis bcab * treatment with ivig (intravenous immune globulin) within the last 6 months * hypersensitivity to components of either vaccine * contraindication to intramuscular injections

Keywords: hepatitis a hepatitis b hemodialysis vaccine
photodynamic therapy (pdt) trial for palliation of cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: this research study is a phase iii double arm, multicenter, randomized controlled clinical trial comparing endoscopic retrograde cholangiopancreatography (ercp) and stenting plus photodynamic therapy (pdt) versus ercp with stenting alone in adult patients with unresectable cholangiocarcinoma. the study objectives are to investigate the efficacy of photodynamic therapy (pdt) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of pdt on both cholestasis and health-related quality of life (hrqol).

the study objectives are to investigate the efficacy of photodynamic therapy (pdt) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of pdt on both cholestasis and health-related quality of life (hrqol).

Eligibility criteria:
inclusion criteria: * patient is age 18 years or older * patient is diagnosed with non-resectable cholangiocarcinoma, as determined by ct within 30 days of enrollment and ct shows bismuth tumor stage as: iiia, iiib, iv (bismuth tumor stage i and ii are not eligible to participate) * patients must have adequate organ and marrow function as defined below: * patient's inr ≤ 2 within 30 days of treatment * patient's platelets \> 50,000/cmm within 30 days of treatment * patient's absolute neutrophil count (anc) \> 1,500/cmm within 30 days of treatment * patient's creatinine ≤ 3 mg/dl within 30 days of treatment * patient has the ability to understand and the willingness to comply with the study procedures and provide written informed consent to participate in the study exclusion criteria: * patient was diagnosed with cholangiocarcinoma more than 3 months ago * patient has any metastatic disease * patient has acute porphyria * subjects exhibiting neurologic or cutaneous symptoms will undergo urinary delta-aminolevulinic acid and porphobilinogen dosage tests to determine severity. * patient is pregnant (women of child bearing age must have a negative pregnancy test prior to registration and must agree to use adequate contraception during study therapy) * patient has a concurrent non solid malignancy

Keywords: cancer bile duct
prevention of intrusive memories and posttraumatic stress symptoms after emergency cesarean section

Conditions: Posttraumatic Stress Disorder; Acute Stress Disorder

Summary: this pilot study aims to investigate the effects of a brief computerized intervention (the computer game "tetris") on intrusive memories and other posttraumatic stress symptoms following an emergency cesarean section. patients who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention or usual care within the first 6 hours following the operation. participants will be followed up at one week and one month. it is predicted that participants given the brief computerized intervention will develop fewer intrusive memories and less severe clinical symptoms than those who are not. this will inform the potential future development of a simple computerized intervention to prevent distressing psychological symptoms after a traumatic event such as an emergency cesarean section.


Eligibility criteria:
inclusion criteria: * female, aged 18+ years * had emergency caesarean section within the past 6 hours * have given birth to a live baby at ≥ 37 weeks gestation exclusion criteria: * do not speak french sufficiently well to participate in assessments * have established intellectual disability or psychotic illness * baby was transferred to intensive care unit after the birth
evaluation of physiological variables and detection of blood loss in healthy adults with different subject positioning by the cm-1500

Conditions: Fluid Loss; Blood Loss

Summary: the study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. subjects will wear the study device (cm-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent * ability and willingness to comply with the study procedures and duration requirements * 18 years of age or older * consented and eligible to undergo a single unit whole blood donation exclusion criteria: * females who are pregnant or breastfeeding * undergone an amputation of any upper extremity * diagnosed with dextrocardia * subjects who have a pacemaker * subjects with body hair density which prevents adequate application of device electrodes
effect of dns exercises training on hypertension

Conditions: Essential Hypertension

Summary: purpose of the study this study will be conducted to investigate any significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension.

purpose: this study will be conducted to investigate any significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension. background: the most recent global estimates suggested that hypertension (htn) affected 1.13 billion people worldwide. raised blood pressure (bp) has emerged as the most important risk factor for global morbidity and mortality. hypertensive individuals present slower processing speed, reduced static and dynamic balance, decreased functional mobility during both single and dual tasking and higher fear of falling in comparison to normotensive individuals. these findings expand the body of knowledge about the effects of htn on physical functions like prolonged processing time, disturbed balance and reduced mobility functions, which may guide clinicians in including preventive and rehabilitative strategies to their therapy protocols in order to improve the quality of life of the individuals with htn. hypotheses: null hypothesis: there will be no significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension. research question: will be any significant effect of dynamic neuromuscular stabilization training on postural control in patients with essential hypertension?

Eligibility criteria:
inclusion criteria: 1. sixty men patients with stage two essential htn (more than 140/90 mm hg). 2. their age will be ranged from 50-60 years old. 3. body mass index (bmi) from 25 to 34.9 kg/m2. 4. low levels of physical activity (using the international physical activity questionnaire-short version) (the arabic version of the questionnaire will be used) exclusion criteria: 1. uncontrolled htn. 2. diabetes mellitus. 3. heavy smoker. 4. neurological or musculoskeletal conditions that interfere with gait 5. vertebrobasilar insufficiency (vbi). 6. use of psychotropic drugs. 7. impaired vision and/or hearing. 8. unstable medical conditions. 9. patients who are unable to follow verbal instructions. 10. participation in regular exercise training of any type in the previous 3 months.
a clinical trial for evaluation of adequate dose and safety of dw-3102 in hypercholesterolemia patients

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to evaluate adequate-dose of dw-3102 in the treatment of hypercholesterolemia patients by conducting phase 2a. 4 groups involving placebo group, each groups are composed by 16, will be participated in this trial.


Eligibility criteria:
inclusion criteria: * more than 19 years old * those who meet the fasting serum lipid levels along table * those who are under 350 mg/dl of tg level when fasting exclusion criteria: * the patient of acute arterial disease * the patient of severe heart failure(nyha class iii or iv) * within the last 6 months clinically meaningful treatment that requires that arrhythmias or cardiac conduction disorders * uncontrolled hypertension ( systolic blood pressure ≥ 180mmhg or diastolic blood pressure ≥ 110mmhg or more later) * endocrine or metabolic disease patients known to affect serum lipids or lipoproteins * fibromyalgia, myopathy, rhabdomyolysis, or sudden muscle pain or have in the past, such as statin (hmg coa reductase inhibitors) in patients with muscle -related adverse drug experience of the system * drug malabsorption by gastrointestinal surgery experience (but simple appendectomy and hernia surgery is excluded) or gastrointestinal disorders ( crohn's disease , ulcers , acute or chronic pancreatitis , etc. ) * patients with history of malignancies including leukemia and lymphoma within the past five years * if severe renal impairment or in patients with impaired liver and hematological findings following the same * patients who have participated in another clinical trial within the previous 30 days or prior to the administration of at least five times the half-life of the active ingredient is not elapsed patient ind * those having a known hypersensitivity to hyperlipidemia treatment * patients with hypersensitivity or allergy to cruciferous plants * patients with a history of drug or alcohol abuse within the last 12 months * female patients of childbearing age * in the case of male test subjects , if the spouse does not agree with the use of childbearing age when women work , recognized contraception exclusion criteria presented in section 15 * patient who are inappropriate by investigator's decision
improvement of perioperative care of elderly patients

Conditions: Perioperative Care

Summary: the focus of this study is the development of a perioperative treatment concept for elderly patients, based on individual necessities and risk factors, aiming to improve patient outcome. the planned interventions include preoperative screening for malnutrition, frailty and uncalled-for long-term medication, if required followed by early prophylaxis and treatment of these risk factors, prior to or during surgery.

in germany every second inpatient surgical intervention is performed on patients aged 60 years and above. these patients often offer an extensive set of risk factors such as frailty, malnutrition, poor physical fitness and multi-morbidity that may in turn lead to longer hospitalizations and decline of health and functional status after surgery. an age-related increase in postoperative complications, such as postoperative cognitive dysfunction (pocd) and delirium is associated with a higher rate of postoperative morbidity, mortality and longer hospitalization. early detection of risk factors and implementation of prophylactic measures is important to reduce postoperative complications and improve clinical outcomes in elderly patients. the aim of our study is to develop and verify a protocol - which allows for a systematic evaluation of risk factors and the implementation of prophylactic or therapeutic measures in order to optimize the postoperative outcome. the feasibility of our protocol will be verified in clinical practice by systematic process evaluations.

Eligibility criteria:
inclusion criteria: * age \>64 years * written informed patients consent * forthcoming elective surgery * time interval from inclusion to appointed surgery at least 5 days exclusion criteria: * refusal of consent * illiteracy * poor knowledge ofgerman language * mental disability * vision handicap (not corrected) * hearing handicap (not corrected) * benzodiazepine abuse * drug/ substance abuse * psychosis * parkinson disease * emergency surgery * planned postoperative icu treatment * planned inpatient stay 1 night * cerebral surgery * ophthalmological surgery

Keywords: perioperative geriatric care geriatric assessment postoperative cognitive dysfunction pocd frailty depression physical fitness geriatric anesthesia iadl postoperative functional status quality of life
ambulatory pessary trial

Conditions: Urinary Incontinence

Summary: the purpose of this study is to compare two methods for assessing patients with pelvic organ prolapse for occult stress urinary incontinence. urodynamic testing is the most widely accepted and well-studied method for diagnosing occult stress urinary incontinence preoperatively, but an ambulatory pessary trial is a less expensive option that is available to a wider group of practitioners and evaluates patient while they are engaged in their daily activities.


Eligibility criteria:
inclusion criteria: * female * patients planning to undergo pelvic organ prolapse surgery and preoperative urodynamic testing within 6 months of recruitment. * stage 2 or greater pelvic organ prolapse on pre op pop-q exam * negative stress test on clinical exam * cognitive capacity to complete questionnaires and voiding diary exclusion criteria: * stress incontinence during provocative stress test on pre-operative exam. * occult stress urinary incontinence demonstrated on pre-operative physical exam * known ability to retain a pessary for the 3 day trial * \< age 18 * history of bladder augmentation or artificial sphincter * known neurologic disease effecting bladder (spinal cord injury, multiple sclerosis, parkinson's disease, etc.) * non ambulatory patients * active infections of the vagina or pelvis (pelvic inflammatory disease, infectious vaginitis, etc.) * occult stress urinary incontinence demonstrated on pre-operative physical exam * known ability to retain a pessary for the 3 day trial * \< age 18 * history of bladder augmentation or artificial sphincter * known neurologic disease effecting bladder (spinal cord injury, multiple sclerosis, parkinson's disease, etc.) * non ambulatory patients * active infr

Keywords: pelvic, urodynamic, vaginal wall
observational trial of cardiotoxicity in patients undergoing chemotherapy.

Conditions: Cardiotoxicity; Heart Failure; Dilated Cardiomyopathy

Summary: advances in treatment have led to improved survival of patients with cancer, but have also increased morbidity and mortality due to cancer treatment side effects. cardiotoxicity is one the most frequent side effect which may lead to premature morbidity and death among cancer survivors. the most concerning cardiovascular complications of cancer therapy is myocardial dysfunction, leading to heart failure, and fatal arrhythmias, especially those induced by qt-prolonging drugs. prometey (prospective multidisciplinary observational trial of cardiotoxicity in patients undergoing anticancer therapy) - is russian multicenter observational study assessing cardiotoxicity and its clinical, biochemical and genetic factors in patients on cancer therapy. the objectives of the study are: * to reveal prevalence of cardiotoxic effects of cancer therapy in routine clinical practice in russian federation, * to assess contribution of these effects to mortality of patients on cancer therapy, * to evaluate clinical and economic consequences of cardiotoxicity in patients with cancer, * to develop an individualized model of cardiotoxicity risk factors based on clinical and laboratory parameters. patients: 400 cancer patients with toxic cardiomyopathy and 100 patients with idiopathic or family dilated cardiomyopathy. study duration: 60 months. all patients will undergo complex examination after signing informed consent form(icf): physical exam, echocardiography with speckle tracking analysis, ambulatory 48-hours ecg monitoring, biochemistry, analysis of biomarkers of myocardial injury, fibrosis and inflammation. primary endpoint: all-cause mortality, heart transplantation, cardioverter-defibrillator implantation, hospitalization with heart failure decompensation. secondary endpoints: * thromboembolism, * fatal/ nonfatal myocardial infarction, stroke, * sudden cardiac death, * surgical therapy of heart failure or arrhythmias, * cardiovascular death, * all-cause mortality, * heart transplantation, * cardioverter-defibrillator implantation.


Eligibility criteria:
inclusion criteria: * written informed consent form (icf), * eastern cooperative oncology group (ecog) scale 0-3, * patients with verified cancer on or planned to be on chemotherapy including anthracyclines, * sufficient bone marrow function, including: absolute neutrophils \> 1.5\*10\^9/l, platelets \> 100\*10\^9/l, hemoglobin \> 9 g/dl, * sufficient liver function, including: total bilirubin \< 1.5\*upper normal value, aspartate aminotransferase (ast) and alanine aminotransferase (alt) \< 2.5 upper normal value, * sufficient renal function, including: creatinine clearance \> 50 ml/min. for control group: * verified non-toxic dilated cardiomyopathy. exclusion criteria: * refusal of patient, * sepsis, * coma, delirium, * mental disorders, * left chest radiation therapy, * metastases in central nervous system.
geriatric trauma care program for living alone older adults with injuries

Conditions: Limb Injury; Older Adults; Geriatric; Pain; Geriatric Depression; Barthel Index; Quality of Life; Loneliness

Summary: to examine the long-term effects of the geriatric trauma care program (gtcp) regarding pain, functional disability, depression, loneliness, and health-related quality of life among older adults with traumatic injuries who live alone.

traumatic injuries among older adults represent a significant public health concern due to their potential to severely affect individuals' long-term physical, emotional, and social well-being. older adults who experience traumatic injuries often face substantial challenges during recovery, particularly those living alone who may lack sufficient support systems, exacerbating their vulnerability to chronic health issues. pain, functional disability, depression, loneliness, and diminished health-related quality of life are prevalent adverse outcomes following traumatic injuries, underscoring the critical need for effective, targeted care strategies to address these multidimensional impacts. the geriatric trauma care program (gtcp) is a nurse practitioner-led, digitalized trauma care program designed to provide comprehensive and accessible intervention aimed at improving immediate trauma care outcomes and facilitating sustainable recovery among older adults. while short-term benefits of digitally supported, geriatric-focused trauma interventions have been documented, the long-term effectiveness of such programs, especially for older individuals who live alone, remains less understood. consequently, examining the enduring impact of the gtcp is essential to determine its effectiveness in fostering sustained recovery and improving quality of life for this vulnerable population. this study aims to address this gap by evaluating the long-term effects of the gtcp on pain, functional disability, depression, loneliness, and health-related quality of life among older adults with traumatic injuries who live alone. findings from this research will provide valuable insights for healthcare providers and policymakers to enhance care delivery models, optimize resource allocation, and ultimately improve long-term outcomes for older adults recovering from traumatic injuries.

Eligibility criteria:
inclusion criteria: 1. willing to join this study for three months 2. with limb injuries 3. living alone in a household 4. aged 65 years old or older 5. independent before a traumatic injury 6. having a smartphone. exclusion criteria: 1. with an iss greater than 16 (severe injuries) 2. having cognitive impairments 3. diagnosed with psychiatric illness

Keywords: limb injury geriatric trauma older adults loneliness