Kornimate/medical-research-clean huggingface dataset:
neodoppler: new ultrasound technology for continuous monitoring of cerebral circulation pilot

Conditions: Preterm; Patent Ductus Arteriosus; Sepsis; Asphyxia; Stroke; Pulmonary Hypertension; Congenital Heart Disease

Summary: non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term/premature infants and sick neonates. for many years, the ultrasound group in trondheim has been at the forefront in the development of new ultrasound technology for the diagnosis and monitoring of disease. several methods previously developed in this research group are today widely used in hospitals around the world. in this project the investigators aim to test a new ultrasound technology that allows continuous monitoring of cerebral blood flow in sick neonates and pre-term children. this technology was ce-certified in october 2022, and in this project the investigators will test the ce-certified version with the newest available approved software.

a new ultrasound technology called neodoppler has been developed, which can measure blood flow in the brain over time. the product is approved for clinical use (ce approved). a pilot study, with with inclusion of different patient groups in need of continuous monitoring, will be conducted to map variability of cerebral hemodynamics. these studies include: 1. a feasibility study on healthy preterm- and term born neonates to map what is normal cerebral blood flow in neonates born before gestational week 32, in gestational week 32-37 and at term. 2. a study including preterm neonates with patent ductus arteriosus to look at the connection between the heart's function and the brain's blood flow. 3. studies of sick neonates including conditions such as perinatal asphyxia, stroke, pulmonary hypertension and congenital heart disease to study how different medical conditions influences cerebral blood flow. 4. a study on cerebral blood flow during ongoing procedures such as intubation, anesthesia, spinal puncture and peripheral and central arterial- and venous catheter. 5. a study of how infection, sepsis and meningitis affects cerebral blood flow.

Eligibility criteria:
inclusion criteria: * open fontanelle * healthy preterm or term born neonates * neonates with a medical condition of interest according to the different cohort studies: patent ductus arteriosus, perinatal asphyxia, stroke, pulmonary hypertension, congenital heart condition or infection/sepsis/meningitis * neonates in need of procedures exclusion criteria: * caregivers not understanding/speaking norwegian or english * caregivers not giving their consent

Keywords: cerebral doppler monitoring continuous neonate
observational study to evaluate clinical performance and safety in total knee arthroplasty

Conditions: Total Knee Arthroplasty; Knee Disease; Total Knee Replacement; Osteo Arthritis Knee

Summary: the aim of this study is to assess the long-term performance and safety of hls kneetec cementless and hybrid fixation knee prosthesis when used in standard medical practice.

it is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in french sites where total knee arthroplasty with hls kneetec cementless and hybrid fixation knee prosthesis is performed routinely all patients treated with hls kneetec (cementless or hybrid versions) implant will be included. all eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study. patients will be assessed according to the usual practice of the investigator at each participating site before surgery and then at the follow-up (fu) visits as following: 4 months (+/- 2 months); 1 year (+/- 2 months); 5 years (+/- 12 months) and 10 years (+/- 12 months).

Eligibility criteria:
inclusion criteria: * male or female aged 18 - 80 years old at the time of the surgery * implanted (or with an indication) with an hls kneetec cementless or hybrid fixation according to the instructions for use (ifu) * patients agree to consent to collect data from their medical records and agree to answer questionnaires for the purposes of the study. exclusion criteria: - patients under guardianship and/or those who, according to the investigator or his delegated research team, will not be able to comply with the study procedures. (e.g. illiteracy, recent psychotic or manic disorders and/or inability to comply with routine follow-up visits.)

Keywords: knee arthroplasty prosthesis implants hls implants arthroplasty
iscador qu as supportive treatment in colorectal cancer (union international cancer control, uicc stages ii-iv)

Conditions: Colorectal Cancer

Summary: efficacy and safety of a supportive treatment with european mistletoe extract iscador® qu ("quercus", i.e. from oak tree) in patients with colorectal cancer (union for international cancer control, uicc stages ii-iv), in addition to post-operative conventional oncological therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional therapy only. primary endpoints: reduction of adverse effects of conventional therapy; reduction of therapy or disease induced symptoms (both are quality of life parameters and evaluated after 1 year); prolongation of disease free and/or overall survival (dfs, os) after 5 years. prospective observational confirmation study of previous retrospective cohort study. as this is a non-interventional cohort study, all therapies and measurements are performed on directive by the treating physician and/or request by the patient only.

see summary

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of colorectal cancer, uicc stage ii-iv * age between 18 (austria: 19) and 85 years * no previous malign tumor * surgical resection of the tumor if indicated * (post-operative) conventional oncological therapy and measurements, or passive after-care ("best care") * follow-up for several years feasible * patient gives written consent to use the anonymized date for evaluation exclusion criteria: * anal cancer * other iscador® sorts than qu in the test group * other mistletoe preparations in the test group * any mistletoe preparation in the control group * non-oncological immunomodulating, -stimulating or -suppressive drugs (e.g. echinacea, interferons, polyerga®, bcg, azathioprine). allowed are approved tumor inhibiting immuno- or targeted therapies (e.g. bevacizumab, cetuximab) and tumor specific vaccines * hiv infection, aids, organ transplantation * high-dose systemic glucocorticoids * contraindications for iscador® qu (allergy against mistletoe, acute inflammatory disease or fever \> 38.5°c, active tuberculosis, hyperthyreosis with not-adjusted metabolism, primary brain or spinal tumor, brain metastases) * known mistletoe intolerance * patients participating in another clinical study with non-approved substances

Keywords: colorectal cancer mistletoe supportive treatment long-term study non-interventional cohort study controlled study with parallel groups
postoperative pain after i̇ntracanal procedures

Conditions: Endodontically Treated Teeth

Summary: aim: the aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.post-operative pain values of the participants will be recorded and evaluated with the vas scale. postoperative pain values of the techniques will be compared with statistical evaluation.

aim: the aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.materials and methods: the study will be carried out on 140 patients with molar teeth diagnosed with irreversible pulpitis. after the root canal preparation is completed, the patients will be divided into 4 groups according to the irrigation activation system; conventional syringe irrigation (csi), eddy, endoactivator (ea) and xp-endo finisher (xpf). after the irrigation process is completed, the root canals will be filled using gutta-percha and canal sealer and the treatment will be completed in one session. pain values at 6, 24, 48, 72 hours and 7 days after treatment will be evaluated at a 0.05% significance level using the kruskal-wallis test.

Eligibility criteria:
inclusion criteria: * healthy patients ranging between 18 and 60 years in age * patients that experienced moderate-to-severe pain represented on a visual analogue scale (vas) * maxillar and mandibular molar teeth were diagnosed with symptomatic irreversible pulpitis exclusion criteria: * any systemic disease and pregnancy in the patient * having used analgesic-anti-inflammatory in the last 12 hours and cortisone for the last 6 months * the patient has bruxism * teeth with severe damage * teeth with calcified canals * teeth with pain to percussion * teeth with periapical radiolucency * teeth with root resorption * teeth with an immature / open apex * teeth with previous rct

Keywords: eddy endoactivatör xp-endo finisher postoperative pain
study of voncento® in subjects with von willebrand disease

Conditions: Von Willebrand Disease

Summary: this is a multi-centre, open-label, single-arm, phase 4, post-marketing study to further investigate the efficacy and safety of voncento in subjects with von willebrand disease (vwd) in whom treatment with a von willebrand factor (vwf) product is required as on-demand therapy, for prophylactic therapy, or during surgery. subjects will be treated with voncento either as an on-demand regimen (eg, to treat a non-surgical spontaneous or traumatic bleeding event) or prevention regimen (eg, to prevent an anticipated bleeding event) at a dose prescribed by the investigator in accordance with the voncento summary of product characteristics (smpc), or with a prophylaxis regimen (regular treatment with voncento at a frequency of 1-3 times per week). voncento will also be given to prevent and treat any surgical bleeding events.


Eligibility criteria:
inclusion criteria: * diagnosis of severe type 1, 2a, or 3 vwd where von willebrand factor: ristocetin cofactor (vwf:rco) is \<20% at screening * desmopressin acetate treatment is ineffective, contraindicated, or not available for subject (type 3 vwd subjects only). * evidence of vaccination against hepatitis a and b or presence of antibodies against hepatitis a and b due to either a previous infection or prior immunization. * written informed consent given. * require a vwf product to control a non-surgical bleeding (nsb) event or for ongoing prophylactic therapy. exclusion criteria: * known history or suspicion of having vwf or fviii inhibitors * acute or chronic medical condition, other than vwd, which may affect the conduct of the study * known or suspected hypersensitivity or previous evidence of severe side effects to voncento, vwf / fviii concentrates, or human albumin. * participated in another interventional clinical study within 30 days before the first administration of voncento or at any time during the study. * females who are pregnant, breast-feeding or who have a positive pregnancy test at screening * alcohol, drug, or medication abuse within 1 year before the study. * currently receiving a therapy not permitted during the study. * previous participation in a voncento / biostate study.
proyecto sol: a risk reduction intervention for hispanic men who have sex with men (msm)

Conditions: HIV Infections

Summary: the purpose of this project is to determine the acceptability, feasibility, and the preliminary efficacy of an hiv prevention behavioral intervention (proyecto sol) to reduce behaviors associated with hiv acquisition among hispanic men who have sex with men (hmsm). the primary goal of the intervention is to motivate and assist participants in forming and carrying out a "safer options for life" plan, thereby reducing their risk of hiv acquisition or transmission.


Eligibility criteria:
inclusion criteria: * self-identify as hispanic or latino; * be between 18 and 49 years of age; * be a resident of south florida (miami-dade, broward or palm beach counties) and not planning to move out of the area for the next 9 months; * self-identify as male; * have had at least one episode of unprotected anal sex with a man in the preceding 3 months; * have had 2 or more male sex partners in the preceding 3 months; * be hiv negative or of unknown serostatus; * speak english and/or spanish; * provide informed consent. exclusion criteria: * have previously participated in any phase of this study; * self-identify as transgender; * not being a resident of south florida.

Keywords: hiv seronegativity hiv risk behavior unprotected sex men who have sex with men gay latino unsafe sex
sweden cancerome analysis network - breast recurrence (scan-b-rec)

Conditions: Metastatic Breast Cancer

Summary: prospective multicenter observational study to assess molecular drivers of metastatic breast cancer and disease evolution upon therapeutic pressure. the main aim is to develop and validate prognostic, predictive and pathogenic markers in clinically well-characterized population-based material of breast cancer tumors and the corresponding normal tissue.these data will be used to characterize recurrent breast cancer on a molecular level, study tumor evolution, develop biomarkers of response/resistance to targeted therapy in the metastatic setting, enroll patients on targeted treatment clinical studies and to elucidate mechanisms of resistance to therapy.


Eligibility criteria:
inclusion criteria: 1. patients with pathologically confirmed advanced breast cancer (abc), including locally advanced inoperable disease and stage iv disease. 2. age \> 18 years. 3. performance status according to eastern cooperative oncology group (ecog) ≤ 2. 4. abc must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination, computerized tomography (ct-scan), magnetic resonance imaging (mri), bone scintigraphy or positron emission tomography (pet). 5. patients must have a radiological evaluation done maximum 6 weeks prior to inclusion. 6. signed informed consent according to ich/gcp, and national/local regulations. exclusion criteria: untreated psychiatric disorders that will impair the patient's ability to comply with study treatment or protocol.

Keywords: metastatic breast cancer molecular profiling circulating tumor dna circulating tumor cells
cresemba® in treating chinese patients with ifd caused by aspergillus species or other filamentous fungi

Conditions: Invasive Fungal Disease

Summary: this study is a post-approval commitment study, and is designed to further evaluate the safety and efficacy of isavuconazole in a relatively larger chinese population who will receive isavuconazole treatment in a post-marketing setting. this is a single arm, prospective, multi-center study. this study is seeking chinese patients with proven, probable or possible invasive fungal disease (ifd) caused by aspergillus species or other filamentous fungi. all the participants will receive isavuconazole treatment. the longest treatment duration in this study is 84 days (up to 180 days for participants diagnosed with im). the primary objective is to characterize the safety and tolerability of isavuconazole through observing the treatment emergent adverse events.


Eligibility criteria:
inclusion criteria: * proven, probable, or possible ifd caused by aspergillus species, mucorales species or other filamentous fungi * body weight \>40 kg at screening exclusion criteria: * either chronic aspergillosis, aspergilloma, or abpa * advanced hiv infection with cd4 count \< 200 or acquired immunodeficiency syndrome-defining condition * people who are unlikely to survive 5 days or participants on mechanical ventilation * severe hepatic impairment (child-pugh class c) * familial short qt syndrome * concomitant use of efavirenz, ritonavir, etravirine, rifampicin/rifampin, rifabutin, nafcillin, ketoconazole, or st. john's wort in the 5 days prior to first administration of study intervention

Keywords: isavuconazole invasive aspergillus invasive mold
the evaluation of bococizumab (pf-04950615;rn316) in reducing the occurrence of major cardiovascular events in high risk subjects

Conditions: Cardiovascular Disease

Summary: this study evaluates the pcsk9 inhibitor, bococizumab (pf-04950615;rn316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of ldl-c \>/= 70 mg/dl (1.8 mmol/l) or non-hdl-c \>/= 100 mg /dl (2.6 mmol/l).

the trial was terminated prematurely on november 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents. these indicated that bococizumab was not likely to provide value to patients, physicians, or shareholders. the decision was not based on a recommendation by the independent data monitoring committee to stop the program.

Eligibility criteria:
inclusion criteria: * must be on background lipid lowering treatment. * must be at high risk of a cv event. * must have an ldl c \>/=70 mg/dl (1.8 mmol/l) or non-hdl-c \>/= 100 mg/dl (2.6 mmol/l). exclusion criteria: * planned coronary (pci or cabg) or other arterial revascularization. * new york heart association class iv congestive heart failure or left ventricular ejection fraction \< 25% by cardiac imaging. * chronic renal insufficiency with creatinine clearance of \<30 ml/min/1.73m\^2 by mdrd formula or with end state renal disease on dialysis. * history of hemorrhagic stroke. * prior exposure to bococizumab or other investigational pcsk9 inhibitor.

Keywords: myocardial infarction stroke hyperlipidemia
the effect of sumatriptan and placebo on cilostazol induced headache

Conditions: Migraine

Summary: to develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). if the headache responds to sumatriptan, the model can be used to test new drug candidates.

there remains a great need for more effective anti-migraine drugs with fewer side effects. human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. the investigators' group has shown that cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (mo). to validate this model, the headache must respond to specific migraine treatment with sumatriptan. hypothesis: cilostazol induces a migraine-like headache in both healthy subjects and in mo-patients and induced headache responds to a specific anti migraine drug; sumatriptan. aim: developing a pragmatic and valid model for the testing of new anti-migraine drugs.

Eligibility criteria:
inclusion criteria: healthy: * healthy subjects of both sexes * age 18-70 years * weight 50-90 kg. * females were requested to use effective contraception. migraine patients: * migraine patients who meet ihs criteria for migraine with or without aura of both sexes * 18-70 years * 45-95 kg. exclusion criteria: healthy: * any type of headache (except episodic tension-type headache \< 1 day per week) * serious somatic or psychiatric disease * pregnancy * intake of daily medication (except oral contraceptives). migraine patients: * any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week) * serious somatic or psychiatric disease * pregnancy * intake of daily medication (except oral contraceptives)
the paclitaxel (albumin-bound) combined with cisplatin, pd-1 inhibitors and imrt in the treatment of nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study in to observe the effectiveness and safety of paclitaxel (albumin-bound type) combined with cisplatin, pd-1 inhibitor and imrt in the treatment of locally advanced nasopharyngeal carcinoma.

this trial is a prospective, open, single-arm phase ii clinical trial. the trial will enroll 40 patients with nasopharyngeal cancer stage iii-iva (uicc 8th edition). subjects will receive paclitaxel (albumin-bound) combined with cisplatin and pd-1 inhibitor (sintilimab) neoadjuvant therapy and radical concurrent chemotherapy and radiotherapy.

Eligibility criteria:
inclusion criteria: * pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma * the stage is ⅲ-ⅳa (uicc 8th edition) * initial treatment patients without anti-tumor therapy * no history of other malignant tumors * male or female, aged 18\~70 years old * sufficient liver and kidney function: total bilirubin ≤ upper limit of normal (uln); ast and alt ≤ 2.5 times uln; alkaline phosphatase ≤ 5 times uln; creatinine clearance ≥ 80 ml/min * sufficient blood function: neutrophil count (anc) ≥2×109/l, platelet count ≥100×109/l and hemoglobin ≥9 g/dl * no serious heart, lung, liver, kidney and other important organ dysfunction * karnofsky score ≥70 points * no autoimmune diseases * sign informed consent exclusion criteria: * has performed anti-tumor treatment, including chemotherapy, radiotherapy, and surgery * discovery of distant metastases before treatment * receive live attenuated vaccine within 4 weeks before enrollment or plan to receive live attenuated vaccine during the study period * active, known or suspected autoimmune diseases * known history of primary immunodeficiency * known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation * women who are pregnant or breastfeeding * disagree to sign the informed consent form * patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons * simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research) * known allergic to possible chemotherapy drugs * accompanied by serious uncontrollable infections or medical diseases * major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, unable to tolerate radiotherapy and chemotherapy * laboratory examination: total bilirubin\>upper limit of normal (uln); ast and/or alt\>1.5 times uln and accompanied by alkaline phosphatase\>2.5 times uln