Kornimate/medical-research-clean huggingface dataset:
biofreedom french registry

Conditions: Coronary Artery Disease

Summary: prospective, observational multi-center registry to be conducted at up to 25 french interventional cardiology centers. patients will be eligible once they have received at least one biofreedomtm dcs as per standard clinical practice and will be followed for up to 2 years post pci for data collection. the purpose of the registry is to explore the safety and effectiveness of the biofreedomtm dcs in standard clinical practice in france and to serve as part of post market surveillance.

prospective, observational multi-center registry to be conducted at up to 25 french interventional cardiology centers. patients will be eligible once they have received at least one biofreedomtm dcs as per standard clinical practice and will be followed for up to 2 years post pci for data collection. the registry will be purely observational and will not interfere with physician's decisions relating to stent selection or indication for treatment. the purpose of the registry is to explore the safety and effectiveness of the biofreedomtm dcs in standard clinical practice in france and to serve as part of post market surveillance.

Eligibility criteria:
inclusion criteria: * patients treated with one or more biofreedom™ dcs .patients who agree to comply with the follow up requirements. .patients with a life expectancy of \> 1 year at time of consent. .patients eligible to receive dual anti platelet therapy (dapt). * patients who have signed an informed consent exclusion criteria: * patients unable or unwilling to give documented informed consent * patients taking part in another interventional trial which has not completed follow-up for the primary endpoint .patient has received an additional stent different from a biofreedom™ dcs stent during the index procedure. * pregnant or breastfeeding women * planned surgery within 6 months of percutaneous coronary intervention (pci) unless dual antiplatelet therapy is maintained throughout the peri surgical period for non hbr patients * planned surgery within 1 month of percutaneous coronary intervention (pci) unless dual antiplatelet therapy is maintained throughout the peri surgical period for hbr patients * patients under judicial protection, tutorship or curatorship

Keywords: coronary artery disease
follow-up using patient-reported outcome (pro) measures in patients with chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: this randomized controlled trial (rct) will evaluate if pro-based follow-up is at least as effective as usual outpatient follow-up in managing decline in renal function and maintaining patients' quality of life. furthermore, we intend to characterize the target patient group that is suitable for pro-based follow up in a group of patients suffering from renal insufficiency.

this randomized controlled trial investigates the use of patient-reported outcome (pro) follow-up among patients with chronic kidney disease. usual outpatient follow-up visits will be replaced with diagnosis-specific electronic questionnaires filled in by the patient at home. participants in the pro-based follow up will complete a disease specific questionnaire every 3 months. patients with an estimated glomerular filtration rate (egfr) \< 40ml/min are randomized into three groups of follow-up 1. pro-based follow-up (the clinicians use the pro data to decide whether a patient needs a visit or not) 2. pro-based telephone consultations (the clinician use the pro-data to support the communication with the patient) 3. usual outpatient follow-up visits (patients are seen in the outpatient clinic) the aim of this study is to compare the effect on the clinical outcomes, the utilisation of resources, and patient-reported outcome in three types of follow-up in a non-inferiority randomised controlled trial.

Eligibility criteria:
inclusion criteria: * referred to the renal care services at aarhus university hospital or regional hospital central jutland, viborg * estimated glomerular filtration rate (egfr) between 10-39 ml/min 1.73m2. * aged ≥18 years old * ability to provide fully informed written consent for participation in the study exclusion criteria: * patients unwilling to participate in pro-based follow-up * patients who, in the opinion of the consenting professional, cannot speak, read or write danish sufficiently well to complete the pro questionnaire unaided * patients with hearing disabilities * patients with an egfr \> 39ml/min 1.73m2 at their first visit at the hospital * patients who have received (or have a scheduled date to receive) a kidney transplant * a terminal illness that, in the opinion of the consultant assessing eligibility, is likely to lead to the death of the patient within 6 months of starting participation in the study * patients receiving chemotherapy, with end stage chronic obstructive lung disease, or with heart failure with ejection fraction (ef)\< 15 %. * a projected risk of progression to end-stage renal failure within 6 months, determined from albumin/creatinine ratio

Keywords: pro-based follow-up, telepro outpatients, chronic kidney disease
barriers in the process of achieving informed consent from critically ill patients

Conditions: Critically Ill; Ethics; Informed Consent; Study Recruitment

Summary: the study will explore barriers in the process of achieving informed consent from critically ill patients

the barriers will be divided into four major categories: * practical barriers * medical barriers * legal barriers * ethical barriers

Eligibility criteria:
inclusion criteria: * patients considered for inclusion in the norides study exclusion criteria: * none
alberta clinical trial in optimizing hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the effect of enhanced pharmacist care (patient identification, assessment, education, prescribing/titration of antihypertensive medications and close follow-up) on systolic blood pressure (bp) reduction in patients with poorly controlled hypertension in the community setting.

the study is a randomized, controlled trial of enhanced pharmacist care, with the unit of randomization as the patient. participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up and prescribing/titration of antihypertensive medications or usual care. participants will be patients in alberta with undiagnosed or uncontrolled bp as defined by the canadian hypertension education program. the primary intervention will be enhanced pharmacist care. pharmacists will assess patients with regards to cardiovascular risk reduction including reviewing bp control, treatment goals and determining lifestyle modifications for the patient to undertake to help manage their bp. the primary outcome will be a comparison of difference in change in systolic bp between enhanced care and usual care at 24 weeks follow-up. secondary outcomes include the number of patients at their bp target at 24 weeks, number of new antihypertensive medication starts, number of antihypertensive dosage changes, number of antihypertensive medication changes and number of new prescriptions for asa and cholesterol medications.

Eligibility criteria:
inclusion criteria: 1. overall average (after 2 visits) systolic ≥180 or diastolic ≥110 mmhg in undiagnosed patients without macrovascular target organ damage, diabetes or chronic kidney disease 2. overall average (after 2 visits) systolic ≥140 or diastolic ≥90 for patients with undiagnosed hypertension with macrovascular target organ damage (coronary artery disease, cerebrovascular disease, dm) 3. in patients with diagnosed hypertension, systolic ≥140 (≥ 130 with dm or ckd) or diastolic ≥90, (≥ 80 with dm or ckd) 4. overall average (after 5 visits, for those without macrovascular target organ damage, dm, or ckd and without an existing hypertension diagnosis) systolic ≥140 or diastolic ≥90 mmhg 5. overall average (after 7 days of twice-daily home blood pressure monitoring , for those without macrovascular target organ damage, dm, or ckd and without an existing hypertension diagnosis) systolic ≥135 or diastolic ≥85 exclusion criteria: * patients with hypertensive urgency or emergency: * urgency: sbp ≥ 180 mm hg or dbp ≥ 120 mm hg with no acute signs of end-organ damage * unwilling to participate/sign consent form * pregnancy

Keywords: hypertension pharmacists rural health prescribing
effect of human umbilical cord-derived mesenchymal stem cells on non-cardiac surgery-induced lung injury

Conditions: Ischemic Heart Disease; Lung Injury; Non-cardiac Surgery

Summary: this study is an exploratory clinical study to observe the improvement of lung function before and after the treatment by human umbilical cord-derived mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells on non-cardiac surgery-induced lung injury in patients with ischemic heart disease. the study is a randomized parallel controlled study. patients receive a review of which main content includes symptom improvement, lung function improvement, and adverse events.

this study is an exploratory clinical study to observe the improvement of lung function before and after the treatment by human umbilical cord-derived mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells on non-cardiac surgery-induced lung injury in patients with ischemic heart disease. the study is a randomized parallel controlled study. the research process is as follows: 1. sixteen eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into placebo control group (n=8) or huc-mscs treatment group (n=8); 2. knee replacement was performed under general anesthesia in both groups. in the cell therapy group, 1×10\^6/kg human umbilical cord-derived mesenchymal stem cells were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery. before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the mscs injection, all patients receive a review of which main content includes symptom improvement, lung function improvement, and adverse events.

Eligibility criteria:
inclusion criteria: * the electrocardiogram showed t wave change and st segment depression * new york heart association (nyha) classification of cardiac function ⅰ-ⅱ level * the patient who first time to receive knee replacement * general anesthesia lasted about 2h * signed informed consent exclusion criteria: * does not meet the above selection criteria * unable to sign the informed consent * patients with a malignant tumor, other serious systemic diseases, or psychosis * pregnancy, lactation, and those who are not pregnant but do not take effective contraceptives measures * the patient with a history of an allergic reaction to biological products or drug * the patient has any infectious diseases (including bacterial and viral infections) * the patient with cardiac pacemaker implantation within 3 months prior to enrollment * the patient who had a stroke within 6 months prior to enrollment * unable to comply with the agreed timetable of this study * patients who are participating in other clinical trials * others who are clinically considered unsuitable for this treatment.

Keywords: human umbilical cord-derived mesenchymal stem cells lung injury
peripheral arteriopathy rate in stroke

Conditions: Peripheral Artery Disease

Summary: purpose: to assess the prevalence of peripheral arterial disease (pad) in acute stroke patients. interventions: assessment of the ankle brachial index using the "boso-abi-system 100" (www.boso.de). design: prospective, open, cohort study. study size planned: 1500. follow-up duration: 3 months.


Eligibility criteria:
inclusion criteria: * all consecutive adult patients with acute ischemic or hemorrhagic stroke. exclusion criteria: * congestive heart failure.

Keywords: pad stroke ich prevalence
study on the effect of the intake of a calcium-bicarbonate water on cholesterol levels

Conditions: Hypercholesterolemia

Summary: the goal of this study is to evaluate the hypolipidemic effect (reduction of low density lipoprotein cholesterol "ldl-c" values) of calcium-bicarbonate mineral water "lete" (alkaline water, high in bicarbonate and calcium ions and low in sodium) compared to control oligomineral water "sorgesana" on healthy volunteers

this sponsored, monocentric and interventional study will consist of a screening visit, a baseline visit, a phone contact one month after the baseline visit and two follow-up visits in person, two and four months after the baseline visit. after signing the informed consent and verifying the eligibility criteria, 160 healthy subjects will be randomized in a 1:1 double-blind ratio to one of two study arms. during the baseline visit, informations regarding the patient's medical history, demographic, anthropometric and blood pressure data and concomitant medications will be collected and the patient will be asked to complete a questionnaire related to physical activity assessment and to undergo an evaluation test for proper nutrition. then, a blood sample will be taken for hematochemical analysis to evaluate the study endpoints. finally, during the two follow-up visits, treatment adherence will be assessed, a blood sample will be taken for hematochemical analysis and the patient will be asked to complete the questionnaire and to undergo the evaluation test for proper nutrition. additionally, at the second follow-up visit, anthropometric and blood pressure data will be collected

Eligibility criteria:
inclusion criteria: * healthy subjects * age 18-60 years * ldl-c values \> 116 mg/dl * not already being treated with cholesterol-lowering medications (e.g. statins, ezetimibe, monoclonal antibodies, bempedoic acid) and/or supplements (e.g. fermented red rice, coenzyme q, folic acid, berberine, vitamin e, polyphenols from olive oil, etc.) exclusion criteria: * bmi \ 30 kg/m2 * diabetes mellitus * arterial hypertension * gastrointestinal (e.g. gastro-duodenal ulcer, ulcerative colitis, diverticulosis of the colon, etc.), liver or renal diseases * familial hypercholesterolemia * treatment with drugs that could influence lipid metabolism (estrogen replacement hormone therapy, corticosteroid therapy, insulin therapy) * consumers of fortified foods that could influence lipid metabolism (containing n-3 fatty acids or phytosterols)
avastin for post-photocoagulation macular edema

Conditions: Macular Edema

Summary: to evaluate the efficacy of a single intravitreal bevacizumab (ivb) injection, 0.1ml (2.5mg), against panretinal photocoagulation (prp)-induced macular thickening and visual disturbance in patients with severe nonproliferative diabetic retinopathy (npdr) and proliferative diabetic retinopathy (pdr) and good vision


Eligibility criteria:
inclusion criteria: * patients with proliferative retinopathy or severe non-proliferative retinopathy * bcva of 20/63 or better (56 etdrs letters * no history of macular edema * central retinal thickness of 250mics or more exclusion criteria: * previous treatment. * other ophthalmic diseases. history of nephropathy, heart diseases and pregnancy * media opacities

Keywords: panretinal photocoagulation macular edema intravitreal bevacizumab
online adaptive radiotherapy for cervical cancer

Conditions: Cervical Cancer

Summary: this study aims to evaluate the clinical efficacy and safety of online adaptive radiotherapy for cervical cancer patients received radical radiotherapy. by comparing with image-guided radiotherapy, the study explores the potential advantages of online adaptive radiotherapy in reducing treatment toxicity and improving local control.


Eligibility criteria:
inclusion criteria: 1. 18-70 years old; 2. pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma; 3. 2018 figo stage ib3, ii, and iiic1 4. proposed radical pelvic radiotherapy + concurrent sensitizing chemotherapy (platinum-based (cisplatin 30-40mg/m2 or carboplatin alone), starting concurrently in the first week, ≥5 courses) 5. ecog score 0-2 6. life expectancy greater than 6 months 7. ability to remain lying down for more than 30 minutes 8. patients were fully voluntary and autonomous and co-operated in signing the study informed consent form 9. complete blood count and basal metabolic indexes within 14 days before enrolment must meet the following requirements: neut ≥ 1.5\*109/l, hgb ≥ 60g/l, platelets ≥ 100×109/, blood creatinine \&lt;1.5 mg/dl. ast and alt are within 2 times the upper limit of normal 10. must complete baseline assessments and investigations required before treatment before enrolment 11. be eligible for regular follow-up exclusion criteria: 1. have received radiotherapy or chemotherapy in the past 2. have undergone radical surgery for cervical cancer 3. have a previous history of malignant tumor 4. pregnant or lactating women 5. presence of other serious co-morbidities such as poorly controlled cardiovascular, urinary, digestive, respiratory, hematological and central nervous system diseases.

Keywords: cervical cancer adaptive radiotherapy
the effects of online mat pilates and face-to-face equipment-based pilates on pain, kinesiophobia, and balance in individuals with non-specific low back pain

Conditions: Low Back Pain

Summary: non-specific low back pain (nslbp) is a common musculoskeletal condition that affects a significant portion of the population and often leads to limitations in daily activities, reduced quality of life, and increased levels of kinesiophobi

compare the effects of online mat pilates and face-to-face equipment-based pilates on pain, kinesiophobia, and balance in individuals with nslbp. while both methods emphasize neuromuscular control and alignment, differences in delivery modes and equipment usage may influence outcomes.

Eligibility criteria:
inclusion criteria: * aged between 18 and 60 years * non-specific low back pain for more than 12 weeks * no clear pathological diagnosis * physically and cognitively capable of performing the exercises * pain level between 3 and 7 on the visual analog scale (vas) exclusion criteria: * pregnancy * spinal surgery in the last 6 months * neurological or chronic systemic diseases * movement restriction due to severe pain

Keywords: pain
safety study of cd3/cd19 depleted haploidentical stem cells

Conditions: Acute Leukemias; Aplastic Anemia; Childhood Solid Tumor

Summary: feasibility and toxicity of haploidentical transplantation of cd3/cd19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease.


Eligibility criteria:
inclusion criteria: * patients with primary refractory or relapsed disease (including relapse after previous sct and active disease) * aml in complete remission of refractory * mds raeb-t/secondary aml * all * cml * non-hodgkin lymphoma / hodgkin lymphoma * non malignant diseases (aplastic anemia, thalassemia, scid) * relapsed neuroblastoma * relapsed soft tissue sarcoma (rhabdomyosarcoma, ewing sarcoma, pnet * soft tissue sarcoma with primary bone metastases or bone marrow * in whom no matched donor was available, exclusion criteria: * \< 6 months after previous hsct * active cerebral seizure conditions * massive progression of leukemias or solid tumours before planned trp. * left ventricular ejection fraction \<25% * creatinine clearance \<40ml/min before conditioning * respiratory insufficiency with oxygen demand or dlco \<30% * bilirubin \>4mg/dl, got/gpt \>400 * severe infection (hiv, aspergillosis) * pregnancy
comparison of conventional with sonography assisted breast surgery after neoadjuvant chemotherapy

Conditions: Breast Cancer Surgery

Summary: aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces the resection rate in the case of r1 resection compared to the procedure without sonographic visualisation


Eligibility criteria:
inclusion criteria: * 18 to 80 years * female * presurgical validated breast cancer * unifocal to multifocal findings * palpable and/o non-palpable findings * neoadjuvant chemotherapy * indication for breast conserving therapy * general operation ability and anesthesia ability * consent to conventional breast conserving breast surgery with wire marking * ability and will to follow the study conditions * written declaration of consent after clarification exclusion criteria: * sonographically not clearly delineate resection areal * exclusion criteria for breast conserving therapy * simultaneous participation in other interventional trials that interfere with this study at the investigator's discretion
efficacy and safety of lanthanum in controlling serum phosphate levels in subjects with end stage renal disease who require treatment for high levels of phosphate in their blood

Conditions: Kidney Failure, Chronic

Summary: the purpose of this study is to test how well higher doses of lanthanum carbonate reduce the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease.


Eligibility criteria:
inclusion criteria: * subjects with esrd who currently require treatment for hyperphosphatemia * women of childbearing potential must have a negative serum beta hcg pregnancy test and must agree to abstain from sexual activity or to use acceptable contraceptives from the time of informed consent throughout the study exclusion criteria: * treatment with compounds containing calcium, aluminum or magnesium for use as a phosphate binder * hypocalcaemia * treatment-naive to any phosphate binder with a serum phosphorus \< 5.5 mg/dl * any significant gastrointestinal surgery or gastrointestinal disorders
the study of different dose rituximab in the treatment of itp

Conditions: Purpura, Thrombocytopenic, Idiopathic; Immune Thrombocytopenia

Summary: the project was undertaking by qilu hospital of shandong university in china. in order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pitp).

62 patients with pitp who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group a(n = 32) and group b(n = 30). in group a, rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). in group b, rituximab was given with a single dose of 375mg/m2. the clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for immune thrombocytopenia. 2. male or female, between the ages of 10 \~ 70 years. 3. normal glucocorticoid therapy is ineffective or effective but the maintenance dose is large, without immunosuppressive therapy or immunosuppressive treatment ineffective 4. to show a platelet count \< 30×10\^9/l, or with bleeding manifestations. 5. eastern cooperative oncology group（ecog）performance status ≤ 2 exclusion criteria: 1. current hiv infection or hepatitis b virus or hepatitis c virus infections. 2. severe medical condition (lung, hepatic or renal disorder) other than itp. unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 3. female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 4. have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 5. patients who are deemed unsuitable for the study by the investigator.

Keywords: thrombocytopenia immune thrombocytopenia purpura