Kornimate/medical-research-clean huggingface dataset:
phase i study of heme arginate with or without tin mesoporphyrin in patients with acute attacks of porphyria

Conditions: Porphyria

Summary: objectives: i. evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria attacks who are also treated with a standard course of heme arginate. ii. evaluate the safety and tolerability of tin mesoporphyrin when administered to these patients.

protocol outline: this is an randomized, unblinded, multicenter study. patients are randomized to receive heme arginate alone or both heme arginate and tin mesoporphyrin. patients receive a single intravenous dose of tin mesoporphyrin immediately before the first dose of heme arginate. heme arginate is administered daily for 4 days. patients are followed at 3 and 6 days after treatment.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria no chronic or subacute symptoms (present for longer than 2 weeks) --prior/concurrent therapy-- at least 3 weeks since prior treatment with heme arginate or tin mesoporphyrin --patient characteristics-- renal: urinary porphobilinogen at least 40 mg/24 hr other: * not pregnant * fertile female patients must use effective contraception during and 6 months before study * no evidence that symptoms are due to another acute illness * no acute hemorrhagic disorder such as: gastrointestinal bleeding intracerebral hemorrhage * no known sensitivity to heme preparation or tin mesoporphyrin * no other medical condition that might increase risk to patient

Keywords: inborn errors of metabolism porphyria rare disease
development and improvement of an acceptance and commitment-based treatment for the prevention of chronic pain after total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: reducing the incidence of chronic post-surgical pain after total knee arthroplasty (tka) is paramount. nopain, a technology-enhanced acceptance and commitment-based treatment, will be developed, tested and improved for this purpose. the feasibility of nopain will be evaluated in a small sample of patients listed for tka at the irccs istituto auxologico italiano. potential pre-surgical and post-surgical predictors of non-response to treatment will be measured and tested using a machine learning algorithm. the results of this study will be employed to improve the content of nopain or for identification of criteria for patient selection. finally, a randomized controlled clinical trial will be performed. patients listed for tka will be randomized to treatment as usual (tau) or to nopain+tau. primary outcome will be time to complete pain relief, secondary outcomes will include subjective and objective measurements of quality of life and functional recovery.


Eligibility criteria:
inclusion criteria: * having an age between 18 and 80 years * having a diagnosis of oa as determined by medical record review * having undergone a total knee arthroplasty exclusion criteria: * inability to provide informed consent
a phase ii study of a continuous hepatic arterial infusion combination therapy with opc-18 and 5-fu in patients with highly advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the safety and efficacy of a continuous hepatic arterial infusion combination therapy with opc-18 and 5-fu versus bst in patients with highly advanced hepatocellular carcinoma for which resection therapy or local therapy is inapplicable due to advanced vascular invasion.


Eligibility criteria:
inclusion criteria: * patients who are histologically or clinically (diagnostic imaging and tumor marker) diagnosed with hepatocellular carcinoma * patients with a measurable lesion by contrast ct * patients with no remote metastasis (extrahepatic metastasis), confirmed by x-ray, ct, mri, or other means if necessary * patients who have not previously received intra-arterial hepatic chemotherapy exclusion criteria: * patients receiving the herbal medicine shosaikoto * patients with autoimmune hepatitis * patients with a history of hypersensitivity to opc-18 or other interferon preparations

Keywords: opc-18 interferon-alpha fluorouracil
kangaroo mother care implementation research for accelerating scale-up

Conditions: Low Birth Weight

Summary: the implementation research project aims to develop and evaluate models for scaling up kmc in health facilities across india and ethiopia and thereby develop effective approaches to achieve high population coverage

kangaroo mother care (kmc) is the practice of early, continuous and prolonged skin-to-skin contact between the mother and the baby with exclusive breastfeeding. despite clear evidence of impact in improving survival and health outcomes among low birth weight infants, kmc coverage has remained low and implementation has been limited. the multi-site project includes formative research to identify barriers and contextual factors that affect implementation and utilization of kmc and design scalable models to deliver kmc across the facility-community continuum. this will be followed by implementation and evaluation of these models in routine care settings, in an iterative fashion, with the aim of reaching a successful model for wider district, state and national-level scale-up. the aim is to successfully provide kmc to 80% or more of babies born in the study area weighing under 2000 grammes

Eligibility criteria:
inclusion criteria: • all newborns who are less than 2000 gm born within the study facilities during the study period. exclusion criteria: • newborns who are sick per predefined criteria will not be provided kmc until they have been stabilized. criteria for delay of initiation include: critical illness including apnea, decreased respiratory rate \<20 breaths per minute, grunting, cyanosis, severe chest in-drawing, convulsions, unconsciousness, and severe hypothermia \<32°f.

Keywords: birth weight
easiness-trial - enhancing safety in epilepsy surgery

Conditions: Epilepsy, Temporal Lobe; Amygdalo-Hippocampal Epilepsy

Summary: to conduct a retrospective multicenter cohort study to define surgical benchmark values for best achievable outcomes following surgery for mesial temporal lobe epilepsy. established benchmark serve as reference values for the evaluation of future surgical strategies and approaches.

surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. therefore, monitoring and quality improvement is increasingly important in surgery. for this purpose, different concepts were developed with the aim to assess best achievable results for several surgical procedures and reduce unwarranted variation between different centers. the most common used concept in surgery is a combination of various clinical indicators with a focus on treatment and adverse events which offers a more reliable analysis than single-outcome indicators. the concept of a benchmark establishes reference values which represents the best possible outcome of high-volume centers and can be used for comparison and improvement. benchmark values are established within a patients' cohort for which the best possible outcome can be expected. the aim of our study is the establishment of robust and standardized outcome references after amygdalohippocampectomy for temporal lobe epilepsy. after successful implantation of benchmarks from an international cohort of renowned centers, these data serve as reference values for the evaluation of novel surgical techniques and comparisons among centers or future clinical trials.

Eligibility criteria:
inclusion criteria: * centres with ≥30 seizure-specific resections (excluding vagus nerve stimulation) as an average per year during the 5-year study period * patients who went through mesial temporal lobe epilepsy surgery exclusion criteria: * only neocortical temporal resection * recurrent resection
a confirmatory study of kps-0373 in patients with spinocerebellar degeneration (scd)

Conditions: Spinocerebellar Degeneration

Summary: the purpose of this study is to investigate the superiority of kps-0373 to placebo, and evaluate the safety and pharmacokinetics of kps-0373 in scd patients.


Eligibility criteria:
inclusion criteria: * japanese scd patients with mild to moderate ataxia exclusion criteria: * patients with secondary ataxia * patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Keywords: spinocerebellar degeneration (scd) thyrotropin-releasing hormone (trh) spinocerebellar ataxia (sca) cortical cerebellar atrophy (cca)
the cerebral-respiratory interaction during spontaneous breathing ventilation in neurosurgical patients (ceres-sb)

Conditions: Mechanical Ventilation Complication; Neurological Complication; Respiratory Complication

Summary: mechanical ventilation (mv) is a life-saving supportive therapy and one of the most common interventions implemented in intensive care. to date, only the inspiratory phase of breathing has been extensively investigated, and new mv methods have been implemented to reduce its harmful effects. despite this, lung injury still occurs and propagates, causing multiorgan failure and patient deaths. the expiratory phase is considered unharmful and is not monitored or assisted during mv. in animal experiments, we recently showed that the loss of diaphragmatic contraction during expiration can harm the lungs during mv. during mechanical ventilation, the expiratory phase of breathing is completely disregarded. however, in all conditions that promote lung collapse, peripheral airways gradually compress and close throughout the expiration, potentially worsening lung injury. this cyclical lung collapse and consequent air-trapping may have an impact on the starling resistor mechanisms that regulate venous return from the brain, potentially affecting cerebral perfusion and intracranial pressure. this study will investigate the incidence and the consequences of an uncontrolled expiration and expiratory lung collapse in spontaneously breathing critically ill neurosurgical patients during mechanical ventilation. electrical impedance tomography measurements , oesophagus and gastric pressure, electrical activity of the diaphragm and intracranial pressure will be acquired in a synchronised manner during controlled mechanical ventilation, on a daily bases during assisted mechanical ventilation.


Eligibility criteria:
neurosurgical patients on mechanical ventilation and with ongoing intracerebral pressure monitoring will be included in the study inclusion criteria: * age \>18 years; * mv expected for more than 72 hours; * not pregnant; * informed consent from patient or next of kin. exclusion criteria: * previously demonstrated paralysis of the diaphragm or know pathology of the phrenic nerve or neuromuscular disorder; * chest tube; * patients with clinical conditions that contraindicate the insertion of esophageal/gastric catheters (e.g., esophagus rupture, esophageal bleeding); * pacemaker and/or implantable cardioverter defibrillator, these last being a contraindication for eit; * hemicraniectomy. in case of late hemicraniectomy (after patient inclusion), the patient will drop-out from the study. relative contraindication: in case of skull base fracture the patient can be included only if oesophageal/gastric and nava catheters can be inserted orally.
influence of the covid-19 pandemic on dutch surgical patterns of care

Conditions: COVID-19

Summary: the aim of this study is to determine the impact of the covid-19 pandemic on the dutch surgical care, expressed as number of performed procedures, altered treatment plans, and surgical outcomes in the netherlands during the year 2020.

the aim of this study is to determine the impact of the covid-19 pandemic on the dutch surgical care, expressed as number of performed procedures, altered treatment plans, and surgical outcomes in the netherlands during the year 2020. this was done by executing a nationwide prospective cohort study, under the name "dutch covidsurg ii snapshot study". this study was conducted in collaboration with the dutch institute of clinical auditing (dica). for this study, the surgical audits for lung cancer surgery (dlca-s), upper gastrointestinal cancer surgery (duca), pancreatic cancer surgery (dpca), hepatobiliary surgery (dhba), colorectal cancer surgery (dcra), hip fracture surgery (dhfa), aortic aneurysm surgery (dsaa), and bariatric surgery (dato), were expanded with an additional covid-19 survey, since august 2020. this survey focused on alterations in, or delay of treatment and diagnostics, perioperative outcomes, and specific covid-19 related symptoms and complications during the covid-19 pandemic. all academic-, general community-, teaching- and non-teaching hospitals in the netherlands performing pulmonary, upper gastrointestinal, pancreatic, hepatobiliary, colorectal, hip fracture, aneurysmal or bariatric procedures were approached to participate in the dutch covidsurg ii snapshot study. patients who underwent surgery during the period january 1st 2018 until december 31st 2019, were included in the historical cohort. patients who underwent a surgical procedure in the period january 1st 2020 until december 31st 2020 were included in the study group.

Eligibility criteria:
inclusion criteria: * all patients who underwent pulmonary, upper gastrointestinal, pancreatic, hepatobiliary, colorectal, hip fracture, aneurysm or bariatric surgery * alle patients \>18 years * patients undergoing surgery during the period january 1st 2018 until december 31st 2020 * hospital that performs the surgery has to participate in the study exclusion criteria: * none

Keywords: surgery covid-19
non-inferiority of various gsk bio's influenza vaccine presentations in adults aged 65 years and over

Conditions: Influenza

Summary: this observer blind study is designed to compare the immune response of gsk biologicals' influenza vaccine gsk576389a when administered using various presentations in adults aged 65 years and older. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

the study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female aged 65 years or older at the time of the vaccination. * written informed consent obtained from the subject. * free of an acute aggravation of the health status as established by clinical evaluation before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period. * administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. planned administration of a vaccine not foreseen by the study protocol up to visit 2 after vaccination. * planned administration of an influenza vaccine other than the study vaccines during the entire study period. * vaccination against influenza since january 2007 (including the northern hemisphere nh 2006/2007 or nh 2007/08 influenza vaccine). * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * history of hypersensivity to a previous dose of influenza vaccine. * history of allergy or reactions likely to be exacerbated by any component of the vaccine(s) * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study. * any medical conditions in which intramuscular injections are contraindicated.

Keywords: fluarix influenza infection gsk biologicals' influenza vaccine gsk576389a
acute effect of photobiomodulation in individuals with hypertension

Conditions: Hypertension

Summary: this is a randomized, double-blind and sham-controlled clinical trial that aims to evaluate and compare the acute effect of full-body photobiomodulation (pbm) and modified ilib (intravascular laser irradiation of blood) on blood pressure, endothelial function and arterial stiffness in individuals with hypertension. participants (n=48) will be equally, randomly and secretly allocated into one of 4 groups: panel group; panel sham group; modified ilib group; and modified ilib sham group. participants aged 40 to 60 years old, diagnosed with hypertension and using control drugs for at least 3 months will be included. participants will be assessed at pre- and post-intervention for: bp; endothelial function; arterial stiffness; blood nitrite; and thermography. in the post-intervention period, the ambulatory blood pressure monitoring will also be carried out. participants will receive a single application of pbm, which, depending on the group, may be full-body irradiation from an led panel (660 nm; 25.34 j/cm²; 42.24 mw/cm²), modified ilib (660 nm; 42,462 j/cm²; 35.385 w/cm²), or the respective sham therapies. data homogeneity and normality will be verified by the levene and shapiro-wilk tests, which will determine the choice of subsequent tests. a statistical significance of 5% will be considered.


Eligibility criteria:
inclusion criteria: * sedentary or irregularly inactive individuals (ipaq) * both sexes * age between 40 to 60 years old * clinical diagnosis of hypertension for at least 3 months with difficulty in blood pressure control * hypertension classification up to stage 2 * individuals who have a prescription for hypertension control drugs and have been using these drugs for at least 3 months exclusion criteria: * diabetes diagnosis * smokers * bmi \> 30 kg/m² * cardiac pacemaker use * presence of arrhythmias or other decompensated cardiovascular diseases * musculoskeletal, orthopedic or neurological conditions that make it unable to participate in the procedures * presence of cognitive deficits that make it difficult to understand the assessments * presence of active neoplasia, under suspicion or after 5 years in remission period * presence of tattoos (covering a large body area, or the anterior wrist region) * photosensitive drugs use * pregnant women or under suspicion * presence of epilepsy or seizures * participants who present a systolic blood pressure ≥ 180 mmhg and/or diastolic blood pressure ≥ 110 mmhg on the day of the intervention

Keywords: hypertension photobiomodulation low-level light therapy
assessment of the possible association between left ventricular diastolic dysfunction and carotid atherosclerosis and brain white matter damage

Conditions: Left Ventricular Diastolic Dysfunction

Summary: left ventricular diastolic dysfunction is caused by impaired relaxation and increased left ventricular stiffness with a consequent increase in filling pressures. currently, it is possible to classify it in 3 grades: grade 1 with normal filling pressures, grade 2 and grade 3 with high pressures. diastolic dysfunction is closely associated with several risk factors such as hypertension, diabetes, and obesity, as well as the risk of heart failure, cardiovascular events, and death. in the field of cerebrovascular diseases, however, diastolic dysfunction is still being researched. thus, this study aims to: 1) evaluate the white matter hyperintensities volume in association with the increase of diastolic dysfunction and filling pressures 2) evaluate the possible association with carotid atherosclerosis in case of brain damage caused by dysfunction diastolic 3) understand the mechanism of damage caused by left ventricular diastolic dysfunction on the cerebrovascular system. in order to do this, this study proposes to evaluate in a cohort of patients, between 35 and 65 years, the possible association of diastolic dysfunction with lesions on the cerebrovascular system in a future view of new marker of brain damage and new modifiable risk factor.


Eligibility criteria:
inclusion criteria: * age ≥ 35 and ≤ 65 years * written informed consent exclusion criteria: * previous stroke or tia * arrhythmia or severe cardiac disease * renal disease * psychiatric disease * neurological or neurodegenerative disease * dementia * previous carotid artery stenting or carotid surgery * inability to be subjected mri analysis

Keywords: diastolic dysfunction white matter hyperintensities carotid atherosclerosis
pilot study of the effect of transcutaneous stimulation of the vagus nerve on pain perception and parameters of the autonomic nervous system

Conditions: Pain

Summary: the increased incidence of pain syndromes requires the investigation of pathophysiological coherences as well as searching for new therapies. in the recent years neurostimulating techniques have been a promising approach regarding their analgesic effect. combined with therapeutic standard procedures they can increase these effects and can have a positive impact on co-morbid diseases. the stimulation of the vagus nerve was proved as an efficient analgesic method in animal experiments and open clinical pilot studies amongst humans. despite the lack of controlled approaches applying the method against defined pain syndromes, the stimulation of the vagus nerve has shown up as an effective method treating other psychiatric diseases like depression. the processing of stress, which is involved directly and indirectly in the pathogenesis of pain, seems to be susceptible for vagal stimulation. compared with invasive methods the transcutaneous stimulation offers obvious advantages concerning appliance and occurrence of side effects. there are no studies so far dealing with the neuromodulatory effect on the handling of pain or the clinical therapy of defined (chronic) pain related diseases using the t-vns system. the study hypothesis implies a change of experiencing pain when applying the t-vns in healthy subjects.


Eligibility criteria:
inclusion criteria: * age: minimum: 18 years maximum: no limit * both gender * normal psychiatric medical history * normal neurological report exclusion criteria: * psychiatric disease incl. pain-related diseases * subject is on medication * abuse of drugs or alcohol until 12 weeks before enrollment in the study * actual wearing conditions * pronounced lack of sleep within the last 2 days of enrollment * excessive consumption of alcohol in the last 2 days * peripheral neuropathy * severe neurological diseases (cerebrovascular diseases, traumatic brain injury, epilepsy, morbus parkinson, dementia, systemic neurologic diseases etc.) * migraine * carpal tunnel syndrome or other entrapment syndromes * missing informed consent * pregnancy * active implant (like cochlea implant, vns, pacemaker) * severe internistic diseases (e.g. arterial hypertension, respiratory failure) * malignant diseases within the last five years * severe acute infections (e.g. hiv, hepatitis) * diseases of the ent bodysystem: hearing loss of the left ear which is treated with an hearing instrument, all dermatologic and infectious diseases which affect the area around the pinna and the ear canal * other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject

Keywords: discomfort distress hurt sting