Kornimate/medical-research-clean huggingface dataset:
evaluating the safety and effect of abobotulinumtoxina in the gastrocnemius muscle to improve equinus and plantar fasciitis pain

Conditions: Plantar Fasciitis; Plantar Fasciitis, Chronic; Plantar Fasciitis of Both Feet

Summary: the purpose of this research is to collect safety and efficacy data on injection of botulinumtoxina (abobotulinumtoxina /dysort) into the gastrocnemius (calf) muscle to improve equinus (lack of flexibility to bring the top of the foot towards the front of the leg) in subjects with plantar fasciitis and relieve pain associated with this condition. the use of abobotulinumtoxina is considered experimental in this study because it has not been approved by the united states food and drug administration (fda) for the treatment of plantar fasciitis.


Eligibility criteria:
inclusion criteria: 1. at least 18 years old and not older than 75 years. 2. history of plantar fasciitis for a minimum of 6 weeks 3. history and physical examination consistent with plantar fasciitis and a diagnostic ultrasound study showing thickening of the plantar fascia \>5 mm (normal is 3 mm) 4. minimum visual analog scale (vas) score of 4. 5. failed conservative care with at least two of the following treatments: stretching, rest, shoe modifications, insoles or orthotics, physical therapy, or cortisone injection. 6. females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests. 7. subject understands and is willing to participate in the clinical study and can comply with visit and post -injection questionnaire schedules. exclusion criteria: 1. patients with history of diabetes, back issues, nerve issues or previous surgery of the foot or calf. 2. patients with no pain in the heel region. 3. subject is pregnant or breast- feeding.

Keywords: heel pain plantar fasciitis
angioplasty in peripheral arterial disease and endothelial function

Conditions: Peripheral Arterial Obstructive Disease; Intermittent Claudication

Summary: to investigate whether endovascular revascualrization of infrainguinal arterial obstructive disease has an effect on brachial artery reactivity

peripheral arterial disease (pad) is a common manifestation of atherosclerosis affecting a large proportion of the aged population. it is associated with a more or less severe impairment in functional activity and with an increased risk of future cardiovascular events. in pad patients, an increased inflammatory status and a depressed endothelial function, assessed as flow-mediated dilation of the brachial artery have been demonstrated. moreover, a prognostic value has been found in pad patients for both inflammatory parameter and flow-mediated dilation (fmd). one of the reasons of the increased inflammatory activation and endothelial dysfunction in pad patients could be the ischemia-reperfusion injury associated with intermittent claudication. the hypothesis is that repeated episodes of acute inflammation and endothelial dysfunction following ischemia-reperfusion injury linked to intermittent claudication could be in part responsible for the increased inflammatory status and chronically depressed endothelial dysfunction of these patients. taking into account these considerations, it is reasonable to assume that the correction of leg ischemia by interventional procedure, such as peripheral transluminal angioplasty (pta) should determine a reduction in inflammatory mediators and an improvement in endothelial function. the study is a prospective, open, randomised, controlled, single-centre, follow-up evaluation, assessing the efficacy of peripheral catheter interventions in patients with symptomatic pad on endothelial dysfunction and plasmatic procoagulant activity. patients will be randomly assigned to immediate revascularization or to no treatment for one month. the assessment of parameters (brachial artery flow-mediated and nitrate-mediated dilation, plasma levels of c reactive protein, fibrinogen, microparticles and coagulation factors) will be performed at baseline and after 4 weeks in both, patients undergoing interventional procedures and in those, who will not be treated.

Eligibility criteria:
inclusion criteria: * peripheral arterial disease * femoro-popliteal lesion * successful endovascular treatment of lesion exclusion criteria: * persistent claudication after revascularization in arm a * inflammatory or neoplastic disease * pregnancy

Keywords: peripheral arterial obstructive disease intermittent claudication endovascular treatment flow-mediated dilation
the persevere study

Conditions: Pulmonary Embolism; Pulmonary Thromboembolism

Summary: rct of high-risk pulmonary embolism comparing flowtriever system vs. standard of care


Eligibility criteria:
inclusion criteria: 1. age at enrollment ≥18 years 2. objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery 3. high-risk class of acute pe 4. rv dysfunction, as defined rv/lv ratio ≥1.0 5. willing and able to provide informed consent, or if unable, through a legal authorized representative, with permitting research without prior consent as a third option (for europe and uk sites only), provided compliance with irb/ec approvals and adherence to regulatory, ethical and national standards exclusion criteria: 1. prolonged cardiac arrest with loss of consciousness associated with neurological deficit. 2. imaging evidence or other evidence that suggests, in the opinion of the investigator, the patient is not appropriate for catheter-based intervention 3. known pre-existing cteph, or ct signs of chronic pe that may point to pre-existing cteph 4. recent stroke (\<14 days) 5. recent cranial or spinal surgery (\<14 days) 6. life-threatening active bleeding or hemorrhage into a critical area 7. known intracranial tumor 8. end-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute pe), as determined by the investigator 9. known sensitivity to radiographic contrast agents that, in the investigator's opinion, cannot be adequately pre-treated 10. inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (hit) 11. current participation in another drug or device study that may interfere with the conduct of this trial 12. ventricular arrhythmias refractory to treatment at the time of enrollment 13. subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments), including a contraindication to use of flowtriever system per local approved labeling 14. subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions 15. subject was previously enrolled in this study 16. subject has received prior thrombolytic (systemic or catheter-directed) therapy for any reason or thrombectomy (surgical or catheter-based) therapy for index pe, within 30 days prior to randomization

Keywords: pe pulmonary embolism flowtriever cdt catheter directed thrombolysis anticoagulation
ibi310 (anti-ctla-4) in combination with sintilimab in patients with non-small-cell lung cancer (nsclc)

Conditions: NSCLC (Non-small-cell Lung Cancer)

Summary: this is an open label, multicenter, phase ib study evaluating ibi310 (anti-ctla-4) in combination with sintilimab in patients with advanced, recurrent or metastatic non-small-cell lung cancer (nsclc)


Eligibility criteria:
eligibility criteria: 1. aged ≥18 years; 2. ecog 0 \~ 1; 3. histologically /cytologically confirmed r/m nsclc; 4. adequate organ and bone marrow function; 5. expected survival ≥12 weeks; 6. female subjects of childbearing age or male patients whose sex partners are women of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after the last administration; 7. subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol. 8. at least 1 measurable lesion according to the response evaluation criteria in solid tumors version 1.1(recist v1.1). exclusion criteria: 1. had tumors other than nsclc within the past 5 years. 2. had allogeneic organ or stem cell transplantation. 3. the presence of uncontrolled life-threatening illness 4. women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 5. patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks. 6. hiv positive. 7. patients with significantly lower heart, liver, lung, kidney and bone marrow function. 8. severe, uncontrolled medical conditions and infections. 9. at the same time using other test drugs or in other clinical trials. 10. refusal or inability to sign informed consent to participate in the trial. 11. other treatment contraindications. 12. emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct. 13. hepatitis b surface antigen (hbsag) positive and hbvdna ≥1000cps/ml. 14. patients with positive hcv antibody test results can only be included in the study when the polymerase chain reaction of hcv rna is negative.
a migration and bone density study comparing hi-fatigue bone cement and palacos bone cement

Conditions: Hip Arthritis

Summary: the purpose of this scientific study is to compare early migration of hip prostheses in respect to the bone in order to determine whether there is a clinical difference between the two investigated bone cements (which one is best suited for cementation of hip prostheses).

a randomized controlled clinical trial on 50 hybrid hips age above 70 years to the described two surgical procedures will be performed at aarhus university hospital by two orthopaedic consultants. randomization in 10 blocks of ten patients distributed with five patients for palacos cement and five patients for hi-fatigue cement. * 25 cpt femoral stems fixed with hi-fatigue bone cement. * 25 cpt femoral stems fixed with palacos bone cement. all patients will be operated by the postero-lateral approach. the post-operative treatment and training will not differ from the standard.

Eligibility criteria:
inclusion criteria: * primary hip osteoarthritis * sufficient bone quality for total hip arthroplasty * age 71 years and above * no upper age limit if the patient is capable * informed and written consent * patient can only enter the project with one hip exclusion criteria: * planned bilateral hip surgery * neuromuscular or vascular disease in the affected leg * preoperatively not found suitable for a hip arthroplasty * patients with osteoporosis based on former diagnosis or preoperative dexa-scan * fracture sequelae, osteonecrosis or previous extensive hip surgery * patients who cannot refrain from taking nsaid post-operatively * continuous medical treatment with vitamin k antagonists (warfarin) which is known to reduce the bone mass by a factor of 5 * patients with metabolic bone disease * patients with rheumatoid arthritis * postmenopausal women in systemic estrogenic hormone substitution * patients with a continuous need of systemic cortisone treatment * non-danish citizenship * patients who do not comprehend the danish language (read and speak) * senile dementia * alcoholism - defined as men drinking more than 21 units a week and women drinking more than 14 units a week * drug abuse * major psychiatric disease * metastatic cancer disease and treatment with radiation therapy or chemotherapy * severe systemic disease (e.g. hemi paresis and parkinson disease) * systemic hip and spine disease * employee at the orthopaedic department, aarhus university hospital * ongoing case regarding industrial injury insurance of the knee * patients with poor dental status (risk of infection)

Keywords: rsa bone cement
progressive advancements in neurosurgery, data and analysis database

Conditions: Spine Disease; Central Nervous System Diseases; Peripheral Nervous System Diseases

Summary: neurosurgical diseases encompass a highly heterogeneous group of conditions, including oncological, malformative, traumatic, spinal, vascular, infectious diseases, and cerebrospinal fluid dynamics disorders. several systematic reviews on the level of evidence in neurosurgical diseases have documented the low percentage of high-quality scientific evidence in this field of medicine. clinical practice is strongly influenced by individual physician preferences, leading to significant heterogeneity among different centers both in italy and internationally. this overall picture highlights the need for tools that can accurately characterize the numerous diagnostic variables influencing therapeutic outcomes in patients with neurosurgical diseases. primary objective to establish a prospective data collection of adult patients with neurosurgical diseases, providing real-life data on the current management of patients at the fondazione policlinico universitario a. gemelli irccs in rome and the participating centers. secondary objectives to create a database of adult patients with neurosurgical diseases who may be potential candidates for enrollment in clinical trials. to conduct observational research on neurosurgical diseases, particularly in cases where no curative treatment options are currently available. to identify potential predictors of poor outcomes or treatment response. to assess the clinical history and treatment response of patients, including for internal audit purposes (e.g., supporting morbidity \& mortality conferences). to provide support for the development and monitoring of quality indicators related to patient care.


Eligibility criteria:
inclusion criteria: * age at first contact equal to or greater than 18 years at the time of informed consent signature. * diagnosis of a neurosurgical disease. exclusion criteria: * refusal to provide written informed consent.
ivosidenib (tibsovo®) combined with azacitidine according to current smpc

Conditions: Acute Myeloid Leukemia (AML)

Summary: the goal of this non-interventional study is to evaluate quality of life (qol) in adult patients with newly diagnosed idh1 r132-mutated aml who are not eligible to receive standard induction chemotherapy and who are treated with ivosidenib in combination with azacitidine in a real-world setting in germany. the main questions it aims to answer are: * evaluate qol by validated and widely used functional assessment of cancer therapy - leukemia (fact-leu) questionnaire and european quality of life 5 dimensions 5 level version (eq-5d-5l) questionnaire during treatment and follow-up period * assesment of effectiveness in routine treatment (e.g. overall survival, event-free survival, overall response rate) * assessment of drug safety (all adverse events) * description of treatment reality in detail


Eligibility criteria:
inclusion criteria: * age 18 years or older. * newly diagnosed acute myeloid leukemia (aml). * having an isocitrate dehydrogenase 1 (idh1) r132 mutation. * not eligible to receive standard induction chemotherapy. * decision for treatment with ivosidenib in combination with azacitidine as per current smpc. * signed written informed consent\* \*patients are allowed to be enrolled up to 6 weeks after ivosidenib plus azacitidine dose * for patients participating in pros: willingness and capability to participate in pro assessment in german language * other criteria according to current smpc. exclusion criteria: * participation in an interventional clinical trial within 30 days prior to enrollment or simultaneous participation in an interventional clinical trial except for the follow-up period. * patients unable to consent * other contraindications according to current smpc.

Keywords: idh1 r132 mutation
the program si! for cardiovascular health promotion at elementary school

Conditions: Cardiovascular Disease

Summary: the objective of the study is to evaluate the effects of program si! for elementary in different times of exposure for childrens and their immediate environment (teachers and parents). for this purpose, 48 public schools from the community of madrid-south area (spain) were randomly assigned to program si! during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). the main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, their parents and teachers in regards to a healthy lifestyle. for children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry.

the program si! is a multilevel school-based intervention integrating four cardiovascular health-related components (diet, physical activity, human body and emotions management). since the program si! for preschoolers has shown good results in improving healthy lifestyle habits in children aged 3 to 5 years, the investigators have developed the program si! for elementary addressed to children from 6 to 11 years. the objective of the study is to evaluate the effects of program si! for elementary in different times of exposure for childrens and their immediate environment (teachers, parents and school). in the community of madrid-south area (spain), 48 public schools from were randomly assigned to program si! for elementary during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). the main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, and the secondary outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of their parents and teachers in regards to a healthy lifestyle, as well as changes in the school environment. for children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry (weight, height, waist circumference and skinfold thickness). the program si! for elementary is designed for different exposures in a sample of schools never intervened to asses when the intervention has the most effectiveness. besides, as some schools involved in the preschool study continues the program si! for elementary, the investigators can be able to evaluate the impact of the program si! in different school stages, concluding how children keep the adoption of healthy behaviors from early in life.

Eligibility criteria:
inclusion criteria: * children from public schools with canteen services located in the south madrid area of education, having from 1st to 6th grades and at least two classrooms in 1st grade. exclusion criteria: * the coordination team of the she foundation establishes the adherence criteria and the schools not reaching the minimum considered can be excluded. questionnaires scoring from students with special educational needs will be excluded from the analysis of questionnaires, as well as repeat students.

Keywords: cardiovascular health promotion children school intervention
multimodal analgesia for the reduction of postoperative opioid consumption

Conditions: Pain

Summary: the investigators are performing this research study to investigate the efficacy of local infiltration of the surgical wound combining dexmedetomidine, ropivacaine, and ketorolac (treatment group) versus the current standard of care (historical control group), for post-operative pain management.

during this research study, patients recommended for a rectus sheath block during surgery will receive a novel combination of non-opioid drugs. data from the treatment group will be compared to surgical outcomes of a historically matched control group to investigate the ability of this drug combination to reduce post-operative pain and post-operative opioid consumption.

Eligibility criteria:
inclusion criteria: * age greater than 18 years * american society of anesthesiologist physical status classification 1-3 * undergoing surgery requiring a rectus sheath block exclusion criteria: * american society of anesthesiologist physical status classification of 4 or beyond * history of opiate of illicit substance abuse, chronic pain, or neurological dysfunction

Keywords: multimodal dexmedetomidine ropivacaine ketorolac pain management opioid sparing analgesia
autogenic training effects on pre-eclampsia

Conditions: Pre-Eclampsia

Summary: the purpose of study is to find the effects of autogenic training on blood pressure and anxiety in preeclampsia females. there is little of evidence to allow conclusions about effectiveness of autogenic training on preeclampsia therefore this study will add to the growing body of knowledge that if autogenic training is better than any other protocol for preeclampsia and anxiety then it should be a choice of therapy treatment. this study can provide help pregnant females and other society members to think about treatment of preeclampsia and anxiety other than medical approach.

pre-eclampsia is a disorder of pregnancy characterized by the onset of high blood pressure and often a significant amount of protein in the urine. when it arises, the condition mostly begins after 20 weeks of pregnancy. in severe cases of the disease there may be red blood cell breakdown, a low blood platelet count, impaired liver function, kidney dysfunction, swelling, shortness of breath due to fluid in the lungs, or visual disturbances. pre-eclampsia increases the risk of undesirable outcomes for both the mother and the fetus. pre-eclampsia affects approximately 2-8% of all pregnancies worldwide. pre-eclampsia is much more common in women who are pregnant for the first time or have obesity, diabetes and autoimmune disease. randomized controlled trial (rct) will be conducted to find the effects of autogenic training on blood pressure and anxiety in females having pre-eclampsia, the data will be collected from national hospital and sofia clinic via sphygmomanometer and dass-21 scale. sample size of 26 females is taken. non probability convenient sampling will be used. a written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lo1.ttery method to either group a or group b. treatment will be given 3 times per week for 4 weeks. sphygmomanometer will be used to check the blood pressure reading and dass-21 questionnaire will be used to access anxiety in the females. all participants in both groups will be evaluated before and after the treatment program. total duration of the study will be ten months. data will be analyzed by using spss 21.

Eligibility criteria:
inclusion criteria: * diagnose women with pre-eclampsia * blood pressure value more than 90/140 * 2nd trimester * age of 25 to 35 years exclusion criteria: * women with cardiorespiratory diseases and diabetes * previous history of preterm labor or abortion * history of serious mental illness
screening and management of high-risk populations of stroke in dehui city

Conditions: Cerebrovascular Accident; Stroke; Hypertension; Diabetes Mellitus; Dyslipidemias

Summary: this epidemiological survey is to analyze the prevalence rate of stroke and exposure rate of risk factors in sampling population aged 40 years and over (born before december 31,1975) in dehui city, to provide scientific basis for pertinent prevention and control of stroke in jilin province, and to provide valuable data for the high-risk groups to carry out regular follow-up and standardized management.


Eligibility criteria:
inclusion criteria: * aged 40 years and over in dehui city * willing to participate in the study and follow-up visits * signed an informed consent exclusion criteria: * life expectancy\<3 years * unwilling to participate in the study and follow-up visits * living away from dehui city over 6 months * unable to cooperate with examination and questionnaire due to mental disease

Keywords: stroke/epidemiology stroke/prevention and control risk factors cognition surveys and questionnaires