Kornimate/medical-research-clean huggingface dataset:
posaconazole (mk-5592) intravenous and oral in children with invasive aspergillosis (ia) (mk-5592-104)

Conditions: Invasive Aspergillosis

Summary: this study will evaluate the safety, efficacy, and pharmacokinetics of posaconazole (pos) intravenous (iv) and oral formulations in pediatric participants 2 to \<18 years of age with invasive aspergillosis (ia).


Eligibility criteria:
inclusion criteria: * has a diagnosis of possible, probable, or proven ia per modified 2008/2020 european organization for research and treatment of cancer/mycoses study group (eortc/msg) disease definitions * has one or more of pre-defined risks as per modified 2008 eortc/msg disease definitions * has a central line (e.g., central venous catheter, peripherally-inserted central catheter) in place or planned to be in place prior to beginning iv study treatment. * has clinical symptoms consistent with an acute episode of ia, defined as duration of clinical syndrome of \<30 days. * participants weigh at least 10 kg, and may be of any race/ethnicity. * during the intervention period and for at least 30 days after the last dose of study treatment, males agree to be abstinent from heterosexual intercourse or use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause). * female is not pregnant or breastfeeding, and is not a woman of child bearing potential (wocbp) or is a wocbp using a highly effective contraceptive method. a wocbp must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention. exclusion criteria: * has chronic (≥30 days' duration) ia, relapsed/recurrent ia, or refractory ia that has not responded to prior antifungal treatment. * has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis * has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study treatment used. * has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired qt prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of time of first dose of study treatment. * has known hereditary fructose intolerance. * has a known hereditary problem of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. * is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or sponsor staff directly involved with this study. * is on artificial ventilation at the time of first dose of study treatment. * has received any treatment prohibited by the protocol. * has enrolled previously in the current study and been discontinued. * is not expected, in the opinion of the investigator, to survive for at least 1 month after the initiation of study treatment.
predicting exacerbation of copd with wireless telemonitoring

Conditions: COPD

Summary: this is an open-label single-center 6-month prospective clinical trial predicting exacerbation of copd with wireless telemonitoring of respiratory rate, heart rate and sleep in patients admitted to the pulmonary ward of the turku university hospital due to acute exacerbation of copd.

a bed sensor based on ballistocardiogram (bcg) will be used to wireless telemonitoring of respiratory rate, heart rate and sleep for six months after an acute exacerbation of copd.

Eligibility criteria:
inclusion criteria: * consecutive patients treated due to acute exacerbation of copd at the pulmonary wards of the turku university hospital exclusion criteria: * those sleeping with a bed partner and not having separate mattresses * patients with pacemaker

Keywords: copd telemonitoring exacerbation
prospective cohort of patients with critical limb ischemia undergoing revascularization

Conditions: Critical Limb Ischemia

Summary: peripheral arterial occlusive disease is associated with a high risk of cardiovascular events. the critical ischemia stage represents the most severe stage of peripheral arterial occlusive disease, associated with decubitus pain and / or foot ulceration. the severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, and the vital prognosis of the patient. in these patients, the rate of amputation and mortality at 1 year can reach 20%. therefore, the goal of management in a multidisciplinary setting is limb salvage and improvement of the patient's vital prognosis. in the vascular medicine department, the indication and modalities of the revascularization procedure are discussed in a multidisciplinary consultation meeting. surgical revascularization by distal bypass requires venous material that can be used, a receiving artery without diffuse lesions, in direct continuity with the arterial network of the foot, and the absence of co-morbidities against general anesthesia. with the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. of the foot with less morbidity-mortality compared to surgery, especially in patients the most fragile patients. since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with peripheral arterial disease of the lower limbs monitored in the vascular medicine department. the hospital is therefore a privileged place to observe the long-term impact of this medical care on the future of patients with different stages of severity of arterial disease. the objective of this prospective study is to assess the vital prognosis, limb salvage and associated prognostic factors in patients with critical ischemia supported by endovascular revascularization in the vascular medicine service of the ghpsj. the objective of this cohort study is to build a database on critical ischemia in hospitalized patients, to judge the management, monitoring and prognosis of patients.


Eligibility criteria:
inclusion criteria: * man or woman whose age is ≥ 18 years old * patient with critical lower limb ischemia defined by the existence of decubitus pain or a wound (foot ulcer or gangrene) evolving for more than 2 weeks associated with hemodynamic criteria (systolic toe pressure \<30 mm hg and / or systolic ankle pressure \<50 mm hg). * hospitalized in the vascular medicine department * endovascular revascularization gesture discussed and confirmed by multidisciplinary staff exclusion criteria: * patients under guardianship or curatorship * patients deprived of their liberty * patients objecting to the use of their data for this research
simple hygiene versus alcohol based usual care for umbilical cord

Conditions: Infection; Skin Diseases, Bacterial; Granuloma

Summary: the purpose of this study is to determinate whether in newborns just cleaning the umbilical stump when changing diapers (with water and soap if necessary)is effective in preventing local cord infections and not delaying cord separation as just as cord care alcohol, usually applied in our hospital and suggested to parents at dismission.


Eligibility criteria:
inclusion criteria: * appropriate for gestational age newborn exclusion criteria: * not appropriate for gestational age newborn
intra-articular allocetra in osteoarthritis of the of the temporomandibular joint (tmj)

Conditions: Temporomandibular Joint Osteoarthritis

Summary: this study is a single center trial to assess the safety and initial efficacy of intra-articular administration of allocetra to patients with temporomandibular joint osteoarthritis (tmj-oa)

the temporomandibular joint (tmj) is a critical synovial joint enabling jaw movement. tmj osteoarthritis results from factors such as disc dislocation, trauma, overuse, or developmental anomalies, affecting all joint structures, including cartilage, synovium, bone, and ligaments. key pathological features include chondrocyte loss, extracellular matrix degradation, and subchondral bone remodeling. tmj-oa progresses gradually through phases of activity and remission, ultimately leading to a burnout phase. allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state. this study is a single center, open lable safety and initial efficacy trial to assess intra-articular administration of allocetra in patients with tmj-oa who have not responded sufficiently to conventional therapies. the study is comprised of two stages, during which a single treatment of allocetra, will be administered via intra-articular injection into the target temporomandibular joint. patients will be followed for up to a year following treatment.

Eligibility criteria:
inclusion criteria: 1. diagnosed with temporomandibular oa in the target tmj. 2. inflammatory findings by magnetic resonance imaging (mri). 3. acceptable blood workup results (cbc, electrolytes, kidney and liver function). exclusion criteria: 1. prior intra-articular injection to the target tmj within 3 months prior to treatment. 2. any significant injury or surgery to the target tmj. 3. evidence of active local infection in the vicinity of the target tmj or clinically significant active infection anywhere in the body. 4. patients with a known neurological disease or rheumatic condition, a major medical condition that would affect quality of life and influence the results of the study, or other pain of unknown etiology.

Keywords: allocetra temporomandibular osteoarthritis tmj macrophages cell therapy
effects of high voltage pulsed current (hvpc) and low level laser therapy (lllt) on wound healing in diabetic ulcers

Conditions: Diabetic Foot Ulcer

Summary: the purpose of this study was to compare the effects of high voltage pulsed current and low level laser therapy on the healing process of diabetic foot ulcers.

based in the literature review we concluded that lllt and hvpc are effective in the healing wound. we did not meet outcomes of previous clinical studies, where compare the effectivity of two physical technologies. for the high prevalence of diabetic foot ulcers, the amputation risk and the consequent impairment and dysfunction in the quality of life, and the associated high costs for this health problem, it is important that new studies that identified effective treatment alternatives for promoting wound closure.

Eligibility criteria:
inclusion criteria: * ages 30 - 75 years * ulcer located on the legs or feet, stage i or ii (wagner classification system) * diagnosis of diabetes mellitus according to world health organization criteria ( treatment with insulin or an oral hypoglycemic agent, two random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl) exclusion criteria: * uncontrolled diabetes * ulcer infection * lower limb amputation * orthopedic or neuromuscular pathologic conditions

Keywords: complications of diabetes mellitus electric stimulation low-level laser therapy
saturated fatty acids and hdl metabolism

Conditions: Dyslipidemia

Summary: the purpose of this study is to determine whether palmitic acid (c16:0) and stearic acid (c18:0) have different effects on hdl metabolism during the fasted state.

study design: double blind, randomized, cross-over study with two different diets: one diet will be high in palmitic acid (c16:0) and the other diet will be high in stearic acid (c18:0). subjects will receive both diets for 4 weeks with a wash-out period of 4-6 weeks in between. contrast in the intakes of palmitic acid and stearic acid is 6% of energy. a postprandial test will be carried out at the end of each dietary period. study population: accounting for a dropout rate of 20%, 40 healthy men and postmenopausal women, aged between 45 and 70 year, having a bmi (body mass index) between ≥ 18.0 and ≤ 30.0 kg/m2 will be recruited.

Eligibility criteria:
inclusion criteria: * apparently healthy men and post-menopausal women (post-menopausal for at least one year) as judged by study physician * bmi ≥ 18.0 and ≤ 30.0 kg/m2 * aged between 45 and 70 years * willing to comply to study protocol during study * having a general practitioner * agreeing to be informed about medically relevant personal test-results by a physician * informed consent signed * accessible veins on arms as determined by examination at screening exclusion criteria: * having a medical condition which might impact study measurements * use of over-the-counter and prescribed medication, which may interfere with study measurements * use of oral antibiotics in 40 days or less prior to the start of the study; * use of food supplements or plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study; * reported alcohol consumption ≥ 10 units/week (female) or ≥ 14 units/week (male); * reported intense sporting activities ≥ 10 hours/week; * reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening * regular smokers (at least one cigarette (or equivalent) daily or \>7 cigarettes (or equivalent) weekly. smokers who cannot comfortably restrain from smoking for up to 2 days will also be excluded * reported dietary habits: medically prescribed diet, allergy/intolerance to test products that will be provided during the study * blood donation in the past 3 months * drug abuse * reported participation in another nutritional or biomedical trial 3 months prior to screening * fasting triacylglycerol concentrations at screening: ≥ 4.5 mmol/l * serum lipids: treatment recommended according to the "multidisciplinary guidelines cardiovascular risk management" * fasting hba1c ≥ 48 mmol/mol (or 6.5%)

Keywords: palmitic acid stearic acid hdl-metabolism human intervention study
clinical value of 89zr-trastuzumab pet

Conditions: Metastatic Breast Cancer

Summary: information about the presence of human epidermal growth factor receptor 2 (her2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. in daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of her2 receptor information. circulating tumor cells (ctcs), which may provide additional information, have so far not been able to replace the biopsy. to solve this problem, non-invasive whole body visualization and quantification of her2 expression by means of the her2-pet may be a valuable tool. in this prospective multicenter imaging study, eligible patients will receive one her2-pet and ctc analysis in addition to standard work up for metastatic disease. subsequent administration of anti-her2 therapy will be evaluated. referring physicians fill in three questionnaires, one before her2-pet and two after her2-pet.


Eligibility criteria:
inclusion criteria: 1. patients with a history of histological and/or cytological proven her2-positive primary breast cancer. in the netherlands her2-positivity is defined as: * her2 immunohistochemical score of 3+, or * her2 immunohistochemical score of 2+ and positive fish for her2/c-erbb2 amplification. in belgium her2-positivity is defined as positive fish for her2/c-erbb2 amplification. 2. patients with suspected metastatic disease or local recurrence of her2-positive breast cancer and a clinical dilemma: * in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to her2 status of lesions and * in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise. 3. standard work-up with imaging is defined as ct chest and abdomen, bone scintigraphy, as well as fdg-pet. 4. age \>18 years of age. 5. who performance status 0-2. 6. signed written informed consent. 7. able to comply with the protocol. exclusion criteria: 1. pregnant or lactating women. 2. prior allergic reaction to immunoglobulins or immunoglobulin allergy. 3. inability to comply with study procedures

Keywords: her2-pet 89zr-trastuzumab metastatic breast cancer clinical dilemma
inherited thromophilia and thrombotic risks in inflammatory bowel disease during activity and remission

Conditions: Inflammatory Bowel Diseases

Summary: inherited thombopllia and thrombotic risks in inflammatory bowel disease during activity and remission

inflammatory bowel diseases (ibd) are systemic conditions characterized by multiple intestinal and extra-intestinal manifestations related to the associated chronic inflammatory state. among their diverse extra-intestinal complications, venous thromboembolism (vte) remains one of the most under recognized causes of morbidity and mortality in these patients, highlighting the need for a better understanding of the underlying mechanism of hypercoagulability, in addition to the role of acquired and inherited risk factors that further increase the risk of thrombosis with its impact on patients' outcomes.\[1, 2\]

Eligibility criteria:
inclusion criteria: * age (18yrs - 65yrs) both sex exclusion criteria: * presence of acquired cause (pregnancy, recent surgery, history of drug, history of malignant disease, history of blood or blood product transfusion in last 4 weeks)
evaluation of the rotational stability

Conditions: Cataract

Summary: to evaluate rotational stability of the investigational device implanted after cataract surgery.

the primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.

Eligibility criteria:
inclusion criteria: * adults, 18 years or older * subject who diagnosed unilateral or bilateral age-related cataract. * potential postoperative bcva of 0.2 log mar (0.63) or better. * calculated iol power in within the range of investigational iol. * subject is able to understand, agree and sign the informed consent statement. * subject is able and willing to comply with the postoperative follow-up examination schedule. exclusion criteria: * uncontrolled systemic or ocular disease. * extremely shallow anterior chamber. * previous intraocular and corneal surgery. * traumatic cataract. * pregnancy or lactation. * concurrent participation in another drug and device clinical investigation.
efficacy and safety of bimatoprost sustained-release (sr) in patients with open-angle glaucoma or ocular hypertension

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this study will evaluate the efficacy and safety of bimatoprost sustained-release (sr) in patients with open-angle glaucoma or ocular hypertension. the study includes a 12-month treatment period with an 8-month extended follow-up.


Eligibility criteria:
inclusion criteria: - diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require iop-lowering treatment. exclusion criteria: * previous enrollment in another allergan bimatoprost sr study * eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye * anticipated need for laser eye surgery within the first 52 weeks of the study duration * history of glaucoma surgery
predictive value of geriatric oncology screening and geriatric assessment in older patients with solid cancers

Conditions: Frailty; Cancer; Age

Summary: a randomized clinical trial examining the effects of comprehensive geriatric assessment as an add on to oncologic treatment. participants included are cancer patients found eligible for oncologic treatment, age 70 or more, and screened frail with the geriatric 8 screening tool.

this study aims to examine the effects of comprehensive geriatric assessment and interventions on prognosis in the older frail cancer patient in a randomized clinical trial design. patients screened frail with the geriatric 8 screening tool, aged 70 or more, and found eligible for oncologic treatment, will be included. we plan to enrol a total of 322 cancer patients for 12 months. participants will be allocated randomly to either interventional or control group. participants in the interventional group will be offered a comprehensive geriatric assessment and intervention at the start-up of cancer treatment. the comprehensive geriatric assessment will be an add on to standardized cancer treatment offered at the oncologic outpatient clinic at odense university hospital. comprehensive geriatric assessment will be performed by a team consisting of a doctor, nurse and physiotherapist. if needed, referral to a dietician or an occupational therapist for further evaluation will be made. the health issues are assessed using validated tests based on a danish version of the geriatric core dataset (g-code). follow-up on comprehensive geriatric assessment is scheduled for one month after initial evaluation. the randomized groups will be compared with respect to primary and secondary endpoints.

Eligibility criteria:
inclusion criteria: * age ≥ 70 years * living in the region of southern denmark * newly diagnosed solid tumours assessed eligible for antineoplastic treatment * vulnerable or frail (g8 ≤ 14) exclusion criteria: * inability to speak or understand danish * inability to give informed consent * already consulting geriatric outpatient clinic * already receiving active treatment for other coexisting solid tumours, haematologic cancers, or non-melanoma skin cancer or has received oncologic treatment the past year

Keywords: frailty aged neoplasms cancer patients geriatric screening geriatric 8 geriatric assessment randomized clinical trial