Kornimate/medical-research-clean huggingface dataset:
berlin prehospital or usual delivery of acute stroke care

Conditions: Stroke

Summary: prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces alarm-to-treatment times, and improves prehospital triage. preliminary analyses suggest cost-effectiveness. however, scientific proof of improved functional outcome compared to usual care is still lacking. the objective of this trial is to show improved functional outcomes after deployment of the stroke emergency mobile (stemo) compared to regular care.

this is a pragmatic, prospective, multi-center trial with blinded outcome assessment of treatment candidates three months after stroke. treatment candidates will be defined as patients with final discharge diagnosis of cerebral ischemia, and onset-to-alarm time ≤4 hours, symptoms not resolved at time of ambulance arrival, and able to walk without assistance prior to emergency. these patients will be included if their emergency call from a predefined catchment area in berlin, germany, caused a stroke alarm at the dispatch center during stemo hours (7am-11pm, monday-sunday). about 45% of stemo dispatches will be handled by regular ambulances since stemo will be already in operation creating the quasi-randomized control group. b_proud uses data from the b-spatial registry. the b-spatial registry has started recruitment in january 2016. however, b_proud recruits patients with symptom onset october 1st, 2016 or later (because data access at the dispatch center had to be established first).

Eligibility criteria:
inclusion criteria: 1. suspected acute stroke according to the dispatcher stroke identification algorithm during stemo hours (7am-11pm, monday-sunday) and within the stemo catchment area inclusion criteria for primary study population: 2. final diagnosis of ischemic stroke (icd 10: i63) or tia (icd 10: g45 except g45.4) 3. confirmed onset-to-alarm time ≤ 4 hours at dispatch 4. pre-stroke modified rankin scale ≤ 3 (being able to ambulate, in routine clinical care, patients with mrs up to 3 are usually deemed suitable for tissue plasminogen activator treatment) exclusion criteria: 1. symptom remission until arrival of emergency medical service 2. malignant or other severe primary disease with life expectancy \< 1 year exclusion criteria for primary study population: 3. major surgery within 4 weeks before study inclusion 4. confirmed stroke within 3 months before study inclusion 5. absolute contraindications for thrombolysis and thrombectomy

Keywords: stroke prehospital telemedicine thrombolysis thrombectomy endovascular treatment functional outcome
comparison of low, moderate and high carbohydrate diet on insulin requirements and metabolic control in type 1 diabetes

Conditions: Type1diabetes

Summary: the scientific basis for dietary recommendations in type 1 diabetes is almost lacking, with the current recommendations being based on type 2 diabetes studies. therefore the overall purpose of this study is to improve the current evidence for dietary recommendations to people with type 1 diabetes. study aim: to compare how a strictly low carbohydrate diet, a moderately low carbohydrate diet and a traditional diabetes diet (with higher amounts of carbohydrates) affect insulin requirements and metabolic control in individuals with type 1 diabetes. carbohydrate intake is 50-60% of the total energy intake in the traditional diabetes diet, 30-40% in the moderately low carbohydrate diet and 15-20% in the strictly low carbohydrate diet with a minimum of 50 g carbohydrates/day. a diet with less than 50 g carbohydrates/day is usually called very low carbohydrate diet or ketogenic and will not be tested in this study. those who wish to participate and meet the inclusion criteria (and none of the exclusion criteria) will be randomized to one of the three diets. the duration of the intervention is 6 months after which the participants will be able to choose their own diet for another 6 months. the main study visits are at baseline (screening and study start), 3, 6, 9, and 12 months. shorter visits will be at 3 and 6 weeks. the participants will meet with a study nurse, dietitian and doctor. they will attend two carbohydrate counting courses before the start of the intervention in order to be able to match their insulin to the amount carbohydrates they eat. participants will receive written materials about their diets with menus and recipes for better adherence to the diet. the primary endpoint is the change in insulin requirements within and between groups (for secondary endpoints please see relevant section). for assessing the different endpoints the participants will provide blood, urine and feces samples for lab analyses as well as register their insulin use, blood glucose, diet, physical activity and any blood ketones or hypoglycemia electronically or in written forms. continuous/flash glucose monitoring (cgm/fgm) will be also used. dietary assessment and adherence will be based on 3-4 day food diaries before every scheduled study visit.


Eligibility criteria:
inclusion criteria: * to have had type 1 diabetes for at least 1 year * age \>=20 years old exclusion criteria: * cardiovascular disease nyha class iiib or more * kidney disease \> stadium 3 * liver disease, alanine aminotransferase (alat) ≥ 2 µkat/l, * bmi \< 18.5 kg/m\^2 * c-peptide ≥ 0.3 nmol/l * pregnant/breastfeeding women, women that plan to get pregnant during study period * other circumstances, which, according to the examiner, make it difficult for an individual to participate.

Keywords: type 1 diabetes low carbohydrate diet randomized trial adults insulin metabolic control
diagnostic benefits of hyperqtm vs. conventional ecg stress test. comparison of hyperq vs. stress ecg in women before angiography

Conditions: Ischemic Heart Disease

Summary: the purpose of this study is to verify the efficiency of the hyperq technology compared with standard ecg analysis in detecting exercise induced ischemia in women who are referred to coronary angiography.

cardiovascular disease (cvd) is the leading cause of mortality in women. in fact, cvd is responsible for a third of all deaths of women worldwide and half of all deaths of women over 50 years of age in developing countries. historically, women have been underrepresented in clinical trials. the lack of good trial evidence concerning sex-specific outcomes has led to assumptions about cvd treatment in women, which in turn may have resulted in inadequate diagnoses and suboptimal management, greatly affecting outcomes. this knowledge gap may also explain why cardiovascular health in women is not improving as fast as that of men. over the last decades, mortality rates in men have steadily declined, while those in women remained stable. the treadmill exercise test is the classic initial investigation for the diagnosis of coronary artery disease (cad), and significant st depression on the ecg is the commonly used indicator of a positive test. compared with men, in women it is known that st depression is less likely to be associated with cad. false positive rates of treadmill exercise testing have been reported to be as high as 67%, while positive predictive value is around 48-50%. coronary angiography is one of the most frequently performed procedures in women; however, non-obstructive (ie, \<50% stenosis) cad is frequently reported. additionally, approximately 30% of women undergoing ptca because of a positive exercise test are found to have normal coronary arteries. a successful outcome in the current study will significantly improve non-invasive diagnosis of cad in women and may reduce the number of unnecessary invasive procedures performed.

Eligibility criteria:
inclusion criteria: * a woman who was referred to angiography. * a woman who is able (i.e. no contraindications) to perform an exercise stress test * a woman who signed an informed consent form. exclusion criteria: * contraindications for an exercise test * wolff-parkinson-white (pre-excitation) syndrome. * left bundle branch block, complete right bundle branch block or qrs duration \> 120 ms, change in qrs morphology during exercise * atrial fibrillation or significant ventricular arrhythmia * treatment with digoxin * pacemaker * having taken beta blockers within 24 hours before the exercise test * pregnancy or suspected pregnancy

Keywords: women ischemic heart disease high frequency ecg exercise stress testing signal processing ischemic heart disease in women
predictive value of fmiso-pet, fdg-pet-ct, dwi-mri and dce-mri scans for patients with anal cancer receiving radiotherapy +/- chemotherapy

Conditions: Anal Cancer

Summary: the purpose of the study is to evaluate the predictive value of 18f-fluoromisonidazol-pet (fmiso-pet), 2-18f-fluoro-2-deoxy-d-glukose-pet-ct (fdg-pet-ct), diffusion-weighted magnetic resonance imaging (dwi-mri) and dynamic contrast-enhanced magnetic resonance imaging (dce-mri) for patients with anal cancer receiving radiation therapy +/- chemotherapy (cisplatin and 5-fu).

the study involves tree mri sessions, two fdg-pet-ct sessions and one fmiso-pet session. the fmiso-pet session is presently not carried out because of delivery problems. the production of 18f-fluoromisonidazol at the department of clinical physiology and nuclear medicine, copenhagen university hospital herlev, denmark has not jet been approved by the danish medicines agency.

Eligibility criteria:
inclusion criteria: * histological confirmation of invasive primary squamous cell carcinoma of the anal canal or perianal region. * tnm stage t1-4, n0-3, m0-1 * treatment with curative intent * age \> 18 years * able to provide informed consent exclusion criteria: * contraindication to mri imaging * cardiac pacemaker * major obesity * serious claustrophobia * other malignant disease (except non-melanoma skin cancer) in a period of 5 years prior to imaging study * poorly regulated diabetes mellitus despite insulin * pregnancy * breast feeding * known allergy to iv contrast agent * major psychiatric illness which would prevent participation in the imaging study * infectious wounds on the legs * unacceptable kidney function * major language difficulties which would prevent participation in the imaging study
the effect of platelet rich plasma for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: the platelet rich plasma (prp) is a new and potential treatment for patients with kinds of musculoskeletal disorders. although few studies have showed beneficial effect of prp for regeneration of peripheral neuropathy in animal study, the associated study in human is rare.

the platelet rich plasma (prp) is a new and potential treatment for patients with kinds of musculoskeletal disorders. although few studies have showed beneficial effect of prp for regeneration of peripheral neuropathy in animal study, the associated study in human is rare. we performe a prospective study to investigate the effect of prp in patients with carpal tunnel syndrome. patients with carpal tunnel syndrome (cts) were randomized into intervention and control group. participants in intervention group received sono-guided injection with 3cc prp and control group received night splint. the evaluation was performed pretreatment as well as on the 1st, 4th, 8th, 12th, 16th and 24 week after the treatment.

Eligibility criteria:
inclusion criteria: 1. age between 20-80 year-old. 2. typical symptoms and signs of cts, such as positive tinel's sign or phalen's test, numbness/tingling in at least two of the first, second, or third digits, and in whom the diagnosis was confirmed using an electrophysiological study. exclusion criteria: 1. cancer 2. coagulopathy 3. pregnancy 4. inflammation status 5. patients who had conditions mimicking cts, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for cts.
recruitment and engagement in care to impact practice enhancement (recipe) for sickle cell disease

Conditions: Sickle Cell Disease

Summary: the goal of this observational study is to help us understand more about the best ways to help individuals living with sickle cell disease (scd) get the best care. the main question it aims to answer is: how to find individuals unaffiliated from scd specialist care use three distinct pathways? once unaffiliated individuals are found using the pathways, investigators will employ linkage coordinators (trained staff) to engage these patients in care. participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life?

the goal of recipe (recruitment and engagement in care to impact practice enhancement) for sickle cell disease is to find unaffiliated patients with scd using three distinct pathways (community, hospital, surveillance) engage them in care using linkage coordinators (lcs; a successful method adapted from hiv care), and understand the contextual factors and implementation support needed to ensure these methodologies can be further scaled up at a national level. this study is significant because information about unaffiliated patients with scd who are not actively engaged in the health system has not been systematically collected and studied in the past. information comes only from experienced clinicians, community groups, patient advocates, and word of mouth. the lack of data about this population is problematic because current implementation studies focus on the barriers related to affiliated patients, with no known strategies identified to engage unaffiliated patients. no previous studies have evaluated the best methods for locating and then engaging and maintaining unaffiliated patients in specialty scd care. this study will contribute to the literature by optimizing different pathways for finding unaffiliated patients, as well as providing evidence on what may work best in different clinical care settings and among different patients to address barriers to care in hard-to-reach populations.

Eligibility criteria:
inclusion criteria: * persons must be \>/= 18 years of age * persons must have confirmed scd * persons not seen by a scd specialist \> 1 year +/- 3 months * literacy in english will be required of the consenting patient or parent/guardian exclusion criteria: * persons \< 18 years of age * persons that are unable to provide informed consent and do not have a designated care-giver that can consent on his/her behalf * persons with sickle cell trait (as per hemoglobin electrophoresis) * persons seen by a scd specialist \< 1 year +/1 3 months

Keywords: sickle cell disease care unaffiliated patients linkage coordinator
foundations of fitness program pilot

Conditions: Pediatric Obesity; Health Behavior; Body Mass Index; Self Esteem

Summary: approximately 17% of us children have obesity resulting in significant childhood co-morbidities and increased lifetime risk of adult obesity, diabetes, cardiovascular disease and cancer. guidelines recommend intensive lifestyle programs as first-line treatment, yet few pediatric practices are equipped to provide this. clinical-community partnerships are well-positioned to address this care gap. this proposal aims to assess whether a community-delivered lifestyle program offered in adjunct to primary care obesity management is feasible, acceptable, effective, and easily implemented in a rural care setting. in this study, approximately 40 children aged 7-13 years old and their caregiver pairs will be recruited from a primary care pediatric clinic. child-adult dyads will participate in a 24-week program that includes 2 phases, a 12-week usual care phase and a 12-week intervention phase. the intervention phase will include bi-weekly meetings of a community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change. a mixed-methods approach using qualitative interviews and study questionnaires, combined with objective measures of adiposity and fitness will assess study outcomes.


Eligibility criteria:
inclusion criteria: * age 7-13 years; * bmi% ≥85th%; * regional pediatric medical home patient; * english speaking child and parent/caregiver; exclusion criteria: * physical or developmental limitation to participation as determined by referring provider
skeletal muscle protein metabolism and insulin sensitivity in overweight individuals: effects of meals with various fatty acid compositions

Conditions: Insulin Resistance

Summary: the aim of the study will investigate whether impairment in the action of insulin to promote the use of glucose in skeletal muscle (insulin resistance) as a result of oral ingestion of a liquid meal rich in saturated fat is linked to reduced ability of muscles to synthesise new protein in response to dietary protein intake, which ultimately may compromise maintenance of muscle size and quality of life and whether partially replacing saturated fat in the liquid meal with omega 3 polyunsaturated fa (n3pufa) will ameliorate these negative effects.


Eligibility criteria:
inclusion criteria: * male, healthy, overweight (bmi\>27 kg/m2 and fat mass \>30%) non-diabetic individuals. exclusion criteria: * diabetes, smoking, cardiovascular disease
early neurological deterioration in patients with acute ischemic stroke

Conditions: Cerebral Infarction

Summary: this study set out to explore the risk factors of early neurological deterioration (end) occurred in patients with acute ischemic stroke and to investigate the corresponding predictors.

end refers to the illness aggravation occurred in the early stage of stroke and often indicates a poor outcome. some clinical scales may play an important role in its diagnoses and treatments. across the reviewed studies, the risk factors of end, which included biochemical parameters, neuroimaging, ect. were explored incompletely and the effective predictors of end is unknown. we aimed to explore the risk factors of end and investigate the predictive value of certain scales.

Eligibility criteria:
inclusion criteria: * subjects with acute ischemic stroke * subjects with detailed progress notes exclusion criteria: * subjects with thrombolysis therapy * subjects with transient ischemia attach * subjects complicated with seriously underlying diseases

Keywords: deterioration risk factors predictors
pmcf study on the safety of linovera® for the treatment of category-i pressure ulcers/injuries

Conditions: Pressure Ulcer

Summary: to assess the safety and performance of linovera® in the treatment of category- i pressure ulcers/injuries.

the aim of this clinical study is to generate further clinical evidence for the use and benefit of linovera® in the treatment of category-i pus. the results of this study will generate further clinical evidence for the use and the benefit of linovera® in this indication. furthermore, the proactive collection of clinical data for linovera® will support the maintenance of this skin oil on the market, so that in the future other patients can receive the product for the treatment of category-i pus.

Eligibility criteria:
inclusion criteria: * adult patient (≥ 18 years) * patients with at least one category-i pu/i (remark: follow-up will be done for one ulcer per patient). * provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the ec prior to all evaluations. * patient naïve to linovera® 2 weeks before visit 1 (only applicable to the area of the skin that will be assessed). * patients which can be potentially followed until their category-1 pressure ulcer/injury is healed throughout the duration of the study, according to the clinicians opinion. exclusion criteria: * age \<18 years * known allergies and/or hypersensitivity to any component of linovera®. * any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures. * any planned intervention that, in the investigator opinion, may affect skin condition of the patient (e.g. chemotherapy or radiotherapy). * simultaneous participation in an interventional clinical trial (drugs or medical devices studies). * any other additional topical treatments applied in the area of the skin that will be assessed.
rectovaginal fistula repair

Conditions: Fistula Vagina; Fistula;Rectal

Summary: this study is a prospective evaluation of quality-of-life after rectovaginal fistula repair at our institution

all patient having undergone rectovaginal fistula repair at uppsala university hospital 2003-2018. an invitation to join the study was sent to all patients. those who answered were then sent rand 36/sf36 questionnaire as a follow-up together with some general questions concerning whether the rectovaginal fistula was healed or not.

Eligibility criteria:
inclusion criteria: * undergone rvf repair at uppsala university hospital 2003-2018 exclusion criteria: * fistula due to gender reconstructive surgery

Keywords: rectovaginal fistula surgical repair quality-of-life
chlorhexidine gel and peribioma periogel use in peri-implant mucositis sites: a split-mouth randomized clinical trial.

Conditions: Peri-implant Mucositis

Summary: the aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis. patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine airflow powders. then, patients will be randomly divided into two groups: the trial group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of biorepair periogel 0.12% for quadrants 2 and 3, with one daily home application for the following 15 days after the visits and the use of biorepair parodontogel toothpaste; the control group will not use any gels. the improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present.

the aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis. patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine airflow powders. then, patients will be randomly divided into two groups: * trial group: split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of biorepair periogel 0.12% for quadrants 2 and 3. home oral care will be continued with 1 application per day of the two gels for the following 15 days after the visits for the same quadrants, and the use of biorepair parodontogel toothpaste. * control group: no application neither of chlorhexidine gel nor of biorepair periogel. the improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present, evaluating periodontal indices at the baseline, after three months and after six months.

Eligibility criteria:
inclusion criteria: * adult patients (18-70 years) * bilateral presence of peri-implant mucositis * patients with high compliance exclusion criteria: * patient with cardiac pacemaker * patients suffering from psychological, neurological or psychiatric disorders * patients suffering from systemic, metabolic or autoimmune diseases * pregnant women

Keywords: non-surgical periodontal therapy