Kornimate/medical-research-clean huggingface dataset:
registry of acute stroke under novel oral anticoagulants - prime

Conditions: Ischemic Stroke; Intracerebral Hemorrhage; Oral Anticoagulation; Cardiovascular Diseases; Vascular Diseases

Summary: the registry of acute stroke under novel oral anticoagulants-prime (rasunoa-prime), an investigator-initiated study, is a german multicenter, prospective, observational registry. it is performed at about 50 certified stroke-units and supported by an unrestricted grant from different pharmaceutical companies to the heidelberg university hospital. rasunoa-prime is designed to assess the emergency management of acute ischemic and hemorrhagic stroke patients with atrial fibrillation (af) under different anticoagulation schemes pre stroke: non-vitamin k antagonist oral anticoagulants (noac), vitamin k antagonists (vka), and no anticoagulation.

the main purpose of this observational cohort study is to assess routine emergency management of acute stroke patients with af under different anticoagulation schemes before the index stroke. the investigators will address the following aims and objectives: 1. describing emergency management of stroke patients (is and ich) with af in clinical routine including early diagnostic, therapeutic and preventive procedures and assessing variations in emergency management of patients with af by anticoagulation schemes pre stroke. 2. identifying variations in risk of early complications (e.g. symptomatic secondary intracerebral haemorrhage in ischemic stroke patients) with af by different anticoagulation schemes pre stroke. 3. determining factors influencing outcome of stroke patients with af at three months and clarifying the potential influence of different anticoagulation schemes pre stroke. the registry consists of 2 separate substudies that cover two different patient cohorts: ischemic stroke and intracerebral hemorrhage. the study will collect information from prospectively enrolling neurology departments with certified stroke units across germany. the principal investigator, prof. dr. med. roland veltkamp, is affiliated with imperial college london, uk, and heidelberg university hospital, germany.

Eligibility criteria:
ischemic stroke substudy: inclusion criteria: * age \>= 18 years * informed consent * acute ischemic stroke with either symptoms lasting ≥ 24h or evidence of infarction in brain imaging * anticoagulation with noac * anticoagulation with vka * no anticoagulation * previous/present atrial fibrillation exclusion criteria: * no informed consent * symptom-onset \> 24 h hemorrhagic stroke substudy: inclusion criteria: * age \>= 18 years * acute primary intracerebral hemorrhage * - a) anticoagulation with noac * - b) anticoagulation with vka * - c) no anticoagulation * previous/present atrial fibrillation exclusion criteria: * no informed consent * symptom-onset \> 24 h

Keywords: registry of acute stroke under novel oral anticoagulants
phaseii,open-label,pilot study evaluating the safety+efficacy of certican ® in the prevention of chronic graft-versus-host disease+late pulmonary complications after allogeneic hematopoietic cell transplantation blood

Conditions: Condition After Allogenic Peripheral Stem Cell Transplantation (SCT)

Summary: in this prospective study is to examine whether the use of everolimus in patients after allogeneic sct as part of gvhd prophylaxis for a further review in clinical studies is appropriate.


Eligibility criteria:
inclusion criteria: * patients after allogeneic stem cell transplantation aged ≥ 18 years * prophylaxes of gvhd with calcineurin inhibitors (ciclosporine a, tacrolimus) and mtx or mmf (previous therapy of acute gvhd with additional prednisone is permitted) * increased risk of chronic gvhd, defined by * male with female donor * hla mismatch class i- or ii towards gvhd * persistant active acute gvhd on day +50 after stem cell transplantation despite of high-dose steroids and cyclosporine * reduction of baseline fev1 or dlco (examined 0 - 50 days before transplantation) of ≥ 25% * new occurrence of acute gvhd between day +50 and +100 after stem cell transplantation * informed concent exclusion criteria: * use (prophylactic or therapeutic) of mtor inhibitors after sct * overlap of acute and chronic gvhd * total cholesterol ≥ 3-fold of upper limit (ul) or triglycerides ≥ 3-fold ul * got, gpt, bilirubin ≥ 3-fold ul (if not related to gvhd) * creatinine ≥ 3-fold ul * confirmed active hepatitis b or c * all circumstances where impaired wound healing might be a risk factor, esp. surgical interventions in the last weeks, ulcers of skin or mucosa * known intolerance to everolimus, sirolimus or other compoments of certican® * lactose intolerance * pregnancy or lactation * women in reproductive age, except of women with the following criteria: * postmenopausal (12 month natural amenorrhea) * postoperativ (≥ 6 months after bilateral ovariectomy with / without hysterectomy) * during therapy and at least 6 months after the last application of everolimus: regular and correct high-effective contraception (pearl-index \< 1; e. g. oral contraception, intrauterine device, implantate, contraceptive patch, combination of barrier methods (condom and cervical cap/diaphragm), abstinence * men, not using one of the following methods of contraception during therapy and at least 6 month after the last application of everolimus: * sexual abstinence * vasectomy * condom * impairments or diseases reducing the ability of informed consent * participation of another study (e.g. for prophylactic immunsuppression in the stem cell transplantation procedure) within the last 60 day before recruitment
propofol versus sevoflurane during fess

Conditions: Sinus Infection Chronic

Summary: good surgical conditions are crucial for an optimal surgery result and safe procedure. minimal blood loss in the surgical field is one of the most important conditions to maintain a good visualization, especially in surgeries with a small surgical field such as a fess (functional endoscopic sinus surgery). the perioperative blood loss is determined by the main arterial and venous pressure, the local pressure and the capillary vascular filling pressure. it has been proposed that propofol is a venodilator, which increases the blood flow, but decreases the capillary pressure. on the contrary, sevoflurane might act mainly on the arterioles, which causes an increase in the capillary pressure. in a previous study it has been demonstrated that despite blood pressure maintenance, propofol causes less bleeding during spinal surgery than sevoflurane. the main aim of this study was to compare both anaesthetics on the perioperative bleeding and haemodynamics during fess. secondary, the postoperative nausea, vomiting, pain scores, surgery duration and length of stay at the post-anesthesia care unit will be evaluated.

2 x 30 patients which are planned for fess surgery are randomized in a sevoflurane group or propofol group. all patients will be induced with propofol (target-controlled infusion (tci) 4 µg/ml) and remifentanil (tci 4 ng/ml) and receive a multimodal intravenous analgesia. patients in the propofol group will receive further intravenous propofol until a bispectral index (bis) value of 50 is reached. the intravenous drip of propofol will be stopped after induction in the sevoflurane group and patients will receive sevoflurane as inhalation anaesthetic (1 mac) until a bis-value of 50. the surgeon will be blinded for patient allocation. the surgical conditions will be graded postoperatively by the surgeon who performed the operation using the validated boezaart grading scale. the endoscopic images will be evaluated in addition by 3 blinded surgeons using this same scale. besides the surgical conditions, haemodynamic parameters, nausea and vomiting scores (ponv), visual analogue score (vas), surgery duration, length of stay at the post-anesthesia care unit and postoperative analgesia and anti-emetics are registered.

Eligibility criteria:
inclusion criteria: * patient planned for fess surgery exclusion criteria: * patients which receive anticoagulants * patients which have coagulation disorders * patients with high bleeding risk * patients with arterial hypertension * other decided by surgeon

Keywords: haemodynamic peripheral blood flow fess
a 12 month site randomized trial in adults with type 2 diabetes mellitus and history of cardiovascular disease

Conditions: Diabetes Mellitus, Type 2; Cardiovascular Diseases

Summary: coordinate-diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease.

patients with type 2 diabetes mellitus and a history of cardiovascular disease will be enrolled in this study. the study will randomize a minimum of 42 us cardiology clinics to an intervention arm vs. control arm. the clinic-level multi-faceted educational intervention will include strategies to develop cardiology and endocrinology partnerships and guideline-recommended care pathways with measurement and feedback to improve the care of patients with type 2 diabetes mellitus and cardiovascular disease. patients must be enrolled during a routine visit in a cardiology clinic, and the clinic must have at least 3 physicians and/or apps on staff with independent patient populations.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * diagnosis of type 2 diabetes mellitus (t2dm) * history of at least one of the following conditions: 1. coronary artery disease (defined as prior mi, coronary revascularization (cabg or pci), and/or obstructive cad (≥50%) as documented by angiography or cta) 2. stroke and/or carotid artery stenosis (≥50%) 3. peripheral arterial disease (defined as claudication with abi\<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency) * ability to communicate with site staff and understand and provide written informed consent and proof of health insurance portability and accountability act (hipaa) authorization exclusion criteria: * determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator * gfr\<30 ml/min/1.73m2 * already on all guideline-recommended therapies for t2dm and cvd * absolute contraindication to any of the guideline recommended therapies for t2dm and cvd

Keywords: coordinate-diabetes coordinate t2dm diabetes mellitus, type 2 cardiovascular disease prevention
accuracy of continuous and non-invasive hemoglobin monitoring

Conditions: Gastric Cancer

Summary: the primary purpose of this observational study is to investigate the accuracy on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy.


Eligibility criteria:
inclusion criteria: * laparoscopic gastrectomy under general anesthesia exclusion criteria: * atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
survey on the treatment of hypertension in patients with type 2 diabetes

Conditions: Hypertension; Type 2 Diabetes

Summary: multi-centre survey of type 2 diabetic patients who are currently on anti-hypertensive treatment. data collection for each patient will take place at one visit. to observe the proportion of diabetic patients on antihypertensive treatment reaching the bp\<130/80 mmhg. to observe the proportion of diabetic patients on antihypertensive treatment reaching the bp\<130/80 mmhg by treatment groups. to observe the proportion of patients achieving a therapeutic glycemic response defined as hba1c=\<7%. to observe the proportion of patients achieving fasting plasma glucose\<110 mg%. to identify factors for not achieving bp\<130/80 mmhg. to describe percentage of patients with positive proteinuria (including microalbuminuria) by treatment groups .


Eligibility criteria:
inclusion criteria: * provision of written informed consent * patient was diagnosed with type 2 diabetes * patient is on antihypertensive treatments for at least 3 months, with the same regimen for a minimum of 4 weeks prior to survey exclusion criteria: * patients are critically ill, had mental health problems or difficulty in communication * patients who are unwilling or unable to provide informed consent * involvement in the planning and conduct of the study (applies to both astrazeneca staff or staff at the study site).

Keywords: hypertension bp diabetes anti-hypertensive treatment ace-i arb
clinical and biological database in colon cancer and colic tumors

Conditions: Cancer Colon

Summary: developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. the investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.

as the second leading cause of cancer-related death in france, colorectal cancer is a major public health problem. each year, 37 000 cases are newly diagnosed in france and 17 000 patients die of the disease. colorectal cancer is due to molecular and genetic damages involved in all tumorigenesis steps, transition from healthy tissue to adenoma and finally to invasive carcinoma stage. the investigators hope that a to better understand tumor invasion and metastatic scattering processes will allow therapeutic innovation and the emergence of new biomarkers. however, the study of early tumorigenesis phases as well as advanced stages of the disease is currently limited due to a lack of tissue samples. in this context, the montpellier cancer institute (icm) decided to initiate a biological collection dedicated to the tissular and blood samples of patients with colorectal cancer.

Eligibility criteria:
inclusion criteria: 1. patient undergoing colon cancer surgery (stage i, ii, iii and iv) 2. patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer 3. patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp), 4. patient with familial polyposis eligible for colectomy 5. age \> 18 years 6. signed informed consent exclusion criteria: 1. patient not affiliated to social protection system 2. patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons 3. patient under guardianship 4. minor patient

Keywords: cancer colon tumor colic
phielix et al.: hepatic fat content and adipokines

Conditions: Type 2 Diabetes Mellitus

Summary: thiazoledinediones decrease blood glucose by their insulin-sensitizing properties. here the investigators examined whether pioglitazone (pio) improves insulin sensitivity independently of glycemic control and whether adipokines or non-esterfied fatty acids (nefa) serve as mediators.


Eligibility criteria:
inclusion criteria: * well controlled patients with type 2 diabetes (hb1ac \< 8%) * no insulin therapy * no co-morbidities * stable medication use for the last 6 months * stable body weight the last 6 months * no diet in the last 6 months exclusion criteria: * hb1ac \> 8% * insulin therapy * diabetes-related co-morbidities, like cardiovascular disease, neuropathology * unstable medication use * unstable body weight in the last 6 months (\> 5 kg) * following a diet in the last 6 months
an intermediate size expanded access protocol of elamipretide

Conditions: Mitochondrial Diseases; Barth Syndrome

Summary: choosing to participate in an expanded access program is an important personal decision. talk with your doctor to learn more about this program. the treating physician must contact stealthbiotherapeutics using the expanded access program contacts provided. elamipretide will only be made available after careful review of an individual request submitted by the treating physician. the initiation and conduct of the treatment with elamipretide for an individual patient, and compliance with this treatment guideline, will be under the full and sole responsibility of the treating physician.


Eligibility criteria:
key inclusion criteria: 1. ≥1 year and ≤ 80 years of age or ≥12 years for barth syndrome in spies-007 2. patients with genetically confirmed rare primary mitochondrial diseases including barth syndrome 1. observed cardiomyopathy, renal impairment, neuropathic, or ophthalmic manifestation 2. where such disease is serious or life-threatening and no comparable or satisfactory alternative therapy options available. 3. patients without genetic confirmation of a rare disease with known mitochondrial dysfunction but do exhibit serious or life-threatening clinical manifestations of mitochondrial dysfunction. 4. is self-able or has caregiver willing and able to administer sc injection. 5. would potentially benefit from treatment with elamipretide and cannot be treated satisfactorily with any approved medicinal product in the opinion of the treating physician. key exclusion criteria: 1. known hypersensitivity to elamipretide or any excipients. 2. women who are pregnant, are planning on becoming pregnant, or are breast-feeding. 3. patients receiving any other investigational agent within 30 days of dosing. 4. any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety.

Keywords: barth
assessment of the prevalence of steatotic liver disease associated with metabolic dysfunction in patients with heterozygous familial hypercholesterolemia

Conditions: Heterozygous Familial Hypercholesterolemia

Summary: the main goal of the steato-fh study is to determine the prevalence of liver steatosis within the heterozygous familial hypercholesterolemia patient population.

investigators will include patients being followed for heterozygous familial hypercholesterolemia in their centers. the prevalence of hepatic steatosis will be studied non-invasively, using fibroscan ®. in addition, coronary calcium score (cac scores) will be evaluated and a biocollection will be performed.

Eligibility criteria:
inclusion criteria: * patient aged 35 or over * consultation at nantes, rennes or angers university hospital during the inclusion period * with a diagnosis of familial hypercholesterolemia defined by the presence of a genetic variant, acmg classes 4 \& 5 on ldlr, apob or pcsk9 * patient not objecting to inclusion in study (no written objection) exclusion criteria: * protected patients: minors, adults under guardianship, curatorship and/or safeguard of justice * pregnant or breast-feeding * active viral hepatitis * hemochromatosis * other genetic or autoimmune hepatitis * current treatment with a drug likely to cause hepatic steatosis, including amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals * current oral corticosteroid therapy unless dose has been stable for ≥ 3 months * current pathological alcohol consumption (≥ 60 g/day in men and ≥ 50 g/day in women)

Keywords: masld heterozygous familial hypercholesterolemia steatosis fibrosis
self-management of low molecular weight heparin therapy

Conditions: Thromboembolism

Summary: there is very little data available on compliance with self-injected low molecular weight heparins (lmwh), but what there is, definitely shows that compliance represents a significant problem. we therefore aim to a) record drug use problems of patients including compliance, b) develop a "sop" for first instruction by a pharmacist and for subsequent pharmaceutical care and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control) provided in the pharmacy to patients with a prescription for a lmwh as an outpatient treatment. hypothesis: intensive pharmaceutical care in ambulatory patients who self-inject low molecular weight heparins results in improved compliance, more safety and satisfaction as well as in fewer complications.

patient recruitment in community pharmacies enables the testing of the feasibility of the interventions under daily-practice conditions and facilitates the recruitment of a larger number of patients. data collection: * telephone interviews with structured questionnaires at the beginning and at the end of the therapy * monitored self-injection in the study center or at patient's home (direct observation technique \[dot\]) * compliance measurement: answers from patient interviews, comparing number of used syringes vs. number of prescribed syringes (analogue "pill count"), measuring residual volume in recycled syringes * recording of the fine motor skills by the adapted "disabilities of the arm, shoulder and hand" questionnaire (dash questionnaire)

Eligibility criteria:
inclusion criteria: * patients are recruited from orthopedic clinics, an emergency department and from community pharmacies with a prescription for a lmwh as an outpatient treatment. * self-application of the lmwh * german / english speaking -\> clinical setting: * dalteparin -\> daily life setting: * all lmwh (ready-to-use syringes) * control group: self-application or application by another person (family member, medical person, etc.) exclusion criteria: - patient's home far away from study center

Keywords: heparin, low-molecular-weight compliance drug safety self-administration ambulatory care pharmaceutical services
safety and bioactivity of axt107 in subjects with neovascular age-related macular degeneration (namd)

Conditions: Neovascular Age-related Macular Degeneration

Summary: the goal of this clinical trial is to understand the safety of axt107 injected suprachoroidally in participants with namd. the main question\[s\] it aims to answer are: * safety of the maximum tolerable dose of axt107 * bioactivity and duration of action of axt107 injected suprachoroidally participants will be injected with axt107 and will be followed on a regular monitoring visits through 9 months post single injection.


Eligibility criteria:
inclusion criteria: * 50 years of age or older * presence of active subfoveal choroidal neovascularization (cnv) (any subtype) or juxtafoveal cnv with leakage affecting the fovea secondary to amd and the area of the cnv lesion must beat least 50% of the total lesion size confirmed by the investigator * evidence of subretinal or intraretinal fluid or retinal cystic changes evidenced by spectral domain optical coherence tomography (sd-oct) at screening accompanied by finding on sd- oct suggestive of cnv secondary to amd confirmed by the investigator * bcva in the study eye between 65 and 25 etdrs letters (20/50 and 20/320 snellen equivalent) at baseline (day 0) * bcva of 34 etdrs letters or better (20/200 or better snellen equivalent) in the non-study eye at baseline (day 0) * able and willing to give signed informed consent and follow study instructions * has been/is a prior partial responder to an anti-vegf agent exclusion criteria: * previously treated patients who are non-responders to anti-vegf as determined by the investigator * any prior use of brolucizumab; use of aflibercept within 8 weeks or use of ranibizumab or bevacizumab within 6 weeks from baseline (day 0) in the study eye * any concurrent disease that would require medical or surgical intervention during the study in the study eye (e.g., retinal detachment, significant cataract) * any condition that may preclude improvement in visual acuity or affect the evaluation of the study eye after resolution of amd (e.g., extensive macular hemorrhage ≥ 50% lesion size, media clarity insufficient to obtain quality images, presence of diabetic retinopathy) * other causes of cnv (e.g., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, and multifocal choroiditis) in the study eye confirmed by the investigator * chronic uveitis or ongoing clinically significant infection or inflammation (e.g., keratitis, scleritis) in either eye