Kornimate/medical-research-clean huggingface dataset:
cardiac impairments following pediatric cardiotoxic anti-cancer treatment

Conditions: Cardiovascular Diseases; Pediatric Cancer

Summary: this study aims at investigating the feasibility of recruitment and application of a method regarding early detection of subclinical changes in cardiac health after completion of acute cancer treatment during childhood and adolescence.

cardiovascular late effects following treatment for pediatric cancer are problematic. early detection of subclinical changes is hardly possible using conventional diagnostic methods, but seems to be feasible during physical strain (exercise stress echocardiography). this feasibility study examines as main objective the recruitment strategy and investigation method in 10-25-year olds in the first and fifth year after the end of acute anti-cancer therapy (n=40 participants with a history of childhood cancer and n=40 control subjects). the heart function is examined by means of exercise stress echocardiography and spiroergometry in comparison with healthy age- and gender-matched control subjects. secondary aims are the evaluation of aditional echocardiography markers and levels of physical activity.

Eligibility criteria:
inclusion criteria for all participants: * aged between 10 and 25 years * body height of ≥1,40m (required for performing the examination on the semi supine bicycle ergometer) * signed informed assent (minor participant) and consent (legal guardian and full-aged participant) additional inclusion criteria for participants following cancer treatment: * completion of acute cancer treatment with anthracyclines and/or chest radiation * end of treatment 12 months and five years ago (± three months) * medical approval for study participation additional inclusion criteria for healthy control subjects: - appropriate as matched pair with respect to age and gender exclusion criteria: * known cardiovascular diseases (incoherent with cardiotoxic treatment) * inability to follow study instructions (e.g., mental retardation, language) * acute orthopedic injury (e.g., bone fracture) or orthopedic impairments that preclude examination on a bicycle ergometer (e.g., instable prosthetic device) all participants receive a basic physical and cardiological examination at rest as part of the study protocol to ensure capability before performing the exercise stress echocardiography.

Keywords: childhood cancer cardiac impairments late effects early detection prevention stress echocardiography
anaesthesiological routine care for thrombectomy in cerebral ischaemia

Conditions: Cerebral Ischemia

Summary: endovascular thrombectomy is the standard of care for acute ischaemic stroke due to large-vessel occlusion. current guidelines for periprocedural anaesthesiological care give gross recommendations on management of stroke patients during recanalization, but lack detailed information. to determine how anaesthesiologists support endovascular thrombectomy with regard to anaesthetic technique, choice of substances, haemodynamic management, and ventilation. with a multivariate analysis, the investigators will look for the factors of anesthetic management that are independently correlated with a good or bad outcome.

see brief summary

Eligibility criteria:
inclusion criteria: * endovascular stroke treatment involving anaesthesia care exclusion criteria: * in-hospital onset of stroke * inclusion in an interventional study concerning the anaesthesia protocol * age under 18 years

Keywords: endovascular thrombectomy acute ischaemic stroke large-vessel occlusion
metabolic and renal outcomes in cardiac surgery patients receiving sglt2 inhibitors

Conditions: Acute Kidney Injury

Summary: to investigate the potential of preoperative initiation (3 days) and perioperative continuation (until day 2 after surgery) of empagliflozin(sodium glucose co transporter 2 inhibitor(sglt-2i)) 10 mg daily to reduce the acute kidney injury marker neutrophil gelatinase-associated lipocalin (ngal) measured in serum and urine on day 2 postoperatively in patients undergoing cardiopulmonary bypass surgery by comparing a study medication group to a control group in an open-label set-up.

adult patients scheduled for elective cardiopulmonary bypass assisted cardiothoracic surgery will be informed about the study and after receiving informed consent will be divided between two groups in an openlabel fashion: intevention group: takes study medication(10mg empagliflozin once a day in the morning) 3 days prior to surgery, day of surgery and 2 days post-surgery. control group: follows the usual standard of care. at time moment before surgery and before medication is taken blood and urine sample is taken. this is repeated on day of surgery, and the consecutive 2 days after surgery. form these samples biomakers for kidney injury will be measured and compared between groups.

Eligibility criteria:
inclusion criteria: * 18 to 90 years old (inclusive) * undergoing elective cardiac surgery with cardio-pulmonary bypass. * providing informed consent exclusion criteria: current treatment with sglt2 inhibitors. * diabetes mellitus type 1 * bmi\<25 for people with type 2 diabetes * reduced renal function at baseline with egfr \< 30 ml/min. * systolic blood pressure \< 100 mmhg at time of inclusion. * emergency surgery, defined as in need of surgery for medical reasons \< 7 days, i.e. "s1-4" according to the amsterdam umc classification. * female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. * known or suspected allergy to trial products or other drugs in the same class.

Keywords: csa-aki sglt-2i cardiac surgery
synchronization to improve non-adherence to cardiovascular medications

Conditions: Chronic Disease; Cardiovascular Disease; Diabetes Mellitus

Summary: the aim of this study is to evaluate if synchronizing when patients with diabetes and/or coronary artery disease fill their prescriptions improves long-term adherence to these medications.


Eligibility criteria:
we will enroll patients 18 years of age and older who within 6 months of study enrollment have filled ≥ 2 medications intended for long-term use (i.e. maintenance medications) by mail order at cvs caremark. at least 1 of these 2 medications of must be for the treatment of diabetes or cardiovascular disease. in addition, these medications must be delivered on two or more unique delivery dates, there must be at least one refill remaining for all eligible medications and either all or none of their prescriptions must be enrolled in the readyfill@mail program (see intervention description for details).

Keywords: prescription synchronization cardiovascular disease medication adherence randomized controlled trial chronic disease pharmacy benefit design quality improvement
a study of hs-10504 in patients with advanced or metastatic non-small-cell lung cancer(nsclc)

Conditions: Locally Advanced or Metastatic NSCLC

Summary: hs-10504 is a fourth-generation epidermal growth factor receptor (egfr) tyrosine kinase inhibitor targeting egfr c797s mutation. this study will evaluate the safety, tolerability, pharmacokinetics and efficacy of hs-10504 in chinese locally advanced or metastatic nsclc.


Eligibility criteria:
inclusion criteria: * males or females, aged ≥ 18 years. * subjects with histologically or cytologically confirmed locally advanced or metastatic nsclc * progressive disease on or after prior treatment with egfr-tkis. * enrollment will be restricted to participants with evidence of egfr-positive in tumor as determined by local or central testing. * at least 1 target lesion according to recist 1.1. * ecog ps score: 0-1. * estimated life expectancy\> 12 weeks. * men or women should be using adequate contraceptive measures throughout the study. * women must have the evidence of non-childbearing potential. * signed and dated informed consent form. exclusion criteria: * subjects with known oncogenic driver genes other than egfr. * subjects with mixed cell histologic or with phenotypic transformation. * treatment with any of the following: 1. prior or concurrent treatment with fourth-generation egfr tyrosine kinase inhibitors. 2. cytotoxic chemotherapy, any other investigational drugs, traditional chinese medicine with anti-tumor indications, or other anti-tumor drugs within 14 days prior to the first dose of hs-10504 or require continued treatment with these drugs during the study. 3. any local radiotherapy 2 weeks prior to the first dose of study treatment; have received irradiation of more than 30% of bone marrow prior to the first dose 4. uncontrolled pleural effusion or ascites or pericardial effusion. 5. major surgery within 4 weeks before the first dose. 6. cns metastases with symptomatic or active progression. * subjects who have any grade ≥2 residual toxicities from prior therapies. * subjects who have history of other primary malignancies. * inadequate bone marrow reserve or hepatic and renal functions. * subjects with severe or poorly controlled diabetes, cardiovascular diseases or hypertension; subjects with severe arteriovenous thrombotic events, severe infection, clinically significant bleeding symptoms or clinically significant gastrointestinal dysfunction. * hypersensitivity to any ingredient of hs-10504. * moderate to severe pulmonary diseases. * prior history of significant neurological or mental disorders. * women who are breastfeeding or pregnant or planned to be pregnant during the study period. * unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator. * any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.

Keywords: locally advanced or metastatic nsclc egfr c797s hs-10504
thrombolytic care during inter-hospital transfer

Conditions: Stroke

Summary: evaluation of ischemic stroke patients receiving tissue plasminogen activator (rtpa) during air ambulance transfer

the purpose of our study is to evaluate the effect of air ambulance transport on patients presenting with an ischemic stroke and receive tissue plasminogen activator (rtpa). primary outcome will be the evaluation of air ambulance transfer and if it leads to protocol violations or significant delays in therapy. protocol violations include inaccurate dosing or preparation at the outside hospital, uncontrolled blood pressure before and during the flight, unnecessary medication administration before and during the flight and adverse events (intracranial bleeding, allergic reaction) associated with transfer process. additional evaluation will include the effects of vibration of the air ambulance and its effects on the lytic activity of rtpa. rtpa is not supposed to be significantly agitated after it is prepared in solution and there is significant vibration and agitation during air ambulance transfer.

Eligibility criteria:
inclusion criteria: * patients who received tissue plasminogen activator for acute ischemic stroke * presented directly to comprehensive stroke center or were transferred by our air ambulance service exclusion criteria: * transferred by another air ambulance service or ground ambulance

Keywords: tissue plasminogen activator
a new active vitamin d, ed-71 for osteoporosis

Conditions: Osteoporosis

Summary: a prospective, randomized, double-blind study to compare the effect of ed-71 with that of alfacalcidol on fracture incidence


Eligibility criteria:
inclusion criteria: * osteoporotic patients who meet any of the following condition: 1. with at least one fragility fracture, 2. above 70 year-old with bone mineral density below 70% young adult mean, 3. with bone mineral density below 60% young adult mean * women three years or more after menopause or men exclusion criteria: * current disorders such as primary hyperparathyroidism, cushing's syndrome,gonadal insufficiency, poorly controlled diabetes mellitus or other causes of secondary osteoporosis * a history or suspicion of active urolithiasis at any time * use of bisphosphonates in the past 12 months * use of medications known to affect bone in the past 2 months * abnormal serum calcium, urinary calcium, serum creatinine or liver function tests
nab-paclitaxel plus cisplatin with concurrent radiotherapy for patients with locally advanced cervical cancer: a multicentre, single-arm, phase ii trial.

Conditions: Cervical Cancer

Summary: based on the phase i trial completed by the sponsor, the phase ii clinical trial aims to investigate the effectiveness and safety of image guidance volume-modulated arc radiation therapy concurrently with nab-paclitaxel plus cisplatin for patients with locally advanced cervical cancer.


Eligibility criteria:
inclusion criteria: * (1) stage ib3 to iva disease based on the 2018 international federation of gynecology and obstetrics (figo) system; * (2) eastern cooperative oncology group at 2 or less; * (3) life expectancy of greater than 3 months; * (4) left ventricular ejection fraction at ≥55%; * (5) neutrophil count at ≥1500/mm\^3, platelet count at ≥100,000/mm\^3 or hemoglobin at ≥9.0 g/dl; * (6) serum creatinine at \<1.5 times the upper limit of the normal reference range; * (7) alanine transaminase or aspartate aminotransferase at \>2.5 times the upper limit of the normal reference range; * (8) non pregnant or lactating women; * (9) women of childbearing age willing to adopt reliable contraceptive measures; * (10) sign informed consent form. exclusion criteria: * (1) individuals who have previously received chemotherapy with albumin bound paclitaxel; * (2) individuals who have previously received abdominal or pelvic radiation therapy; * (3) individuals who have received neoadjuvant chemotherapy or targeted, immunotherapy, and other anti-tumor treatments prior to concurrent chemoradiotherapy and chemotherapy; * (4) individuals with central nervous system diseases or brain metastases； * (5) other malignant tumors other than cervical cancer have appeared within the past 5 years; * (6) previously experienced sensory or motor neuropathy (grade ≥ 2) ; * (7) the researchers evaluate that the uncontrolled serious medical diseases that will affect the ability of the participants to receive the treatment of the clinical trial, such as complicated with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc; * (8) known to be allergic to paclitaxel; * (9) received other experimental drugs or participated in clinical studies for other anti-cancer treatment purposes within 30 days of the first chemotherapy administration; * (10) serious infections occurring within 4 weeks prior to the start of research treatment, including but not limited to complications of infection requiring hospitalization, bacteremia, or severe pneumonia; * (11) human immunodeficiency virus (hiv) positive individuals; * (12) uncontrolled or active viral hepatitis or infection with human immunodeficiency virus; * (13) researchers determine that it is not suitable to participate in this study.
effects of modified fixed twin block versus removable twin block on skeletal class 2 growing patients with mandibular deficiency

Conditions: Malocclusion; Angle Class II; Mandible Small

Summary: effects of modified fixed twin block versus removable twin block on skeletal class 2 growing patients with mandibular deficiency: a randomized clinical trial

the main objective of the study is to evaluate the effects of the modified fixed tb on class 2 growing cases and to compare its effect to the conventional removable tb research question does the modified fixed twin block have the same effects as removable twin block during treatment of skeletal class 2 growing patients with mandibular deficiency? pico p: growing skeletal class 2 patients with deficient mandible i : modified fixed twin block c: conventional removable twin block o : primary outcome: overjet secondary outcome: soft tissue profile antro-posterior mandibular position mandibular length antro-posterior maxillary position upper and lower incisors inclinations durability of the appliance patient acceptance hypothesis: there is no difference between the modified fixed or removable twin block appliance regarding overjet reduction, dentoskeletal effects and patient perception. 8. trial design: randomized clinical trial parallel group, two arm, equivalent trial with 1:1 allocation ratio.

Eligibility criteria:
inclusion criteria: * skeletal class 2 malocclusion cases (anb ≥ 5 degrees) * overjet ≥ 5 mm * growing patients (cvms 3 or 4) exclusion criteria: * skeletally mature patients 15 years old or above * patients with normal mandible and only protruded upper incisors. * syndromic, cleft patients and patients with dental anomalies * previous orthopaedic or orthodontic treatment * no sex predilection.

Keywords: orthodontics orthopedics myofunctional appliance twinblock
exploring the outcomes and financial impact of a cbt-i group program provided by registered nurses for adults with insomnia

Conditions: Insomnia

Summary: the purpose of this pilot study is to evaluate our rn cbt-i program outcomes and determine utility of this program as a high-value care model targeted specifically to our sleep center patient population. hypothesis: pirs will improve from baseline to 2 month follow up


Eligibility criteria:
* able to speak english * referred to mayo center for sleep medicine cognitive behaviorial therapy program for insomnia * no dementia
comparison between a 1l of polyethylene glycol+ascorbic acid as a split dose bowel preparation for colonoscopy

Conditions: Colon Adenoma; Colonic Polyp

Summary: comparison between a 1l of polyethylene glycol+ascorbic acid as a split dose and oral sulfate solution bowel preparation for colonoscopy study design: prospective, randomized, parallel, multi-center trial in 3 hospitals in korea ( seoul national university hospital, seoul national university bundang hospital, seoul metropolitan government-seoul national university ) patient inclusion criteria - aged 20-75 adults (out-clinic patients) scheduled for colonoscopy for any indication within the normal process of care


Eligibility criteria:
inclusion criteria: * adult out clinic patients scheduled for colonoscopy for any indication within the normal process of care exclusion criteria: * previous history of significant gastrointestinal surgeries (except for appendectomy) * known or clinically suspicious inflammatory bowel disease patients * known or suspected ileus/ gi obstruction * previous history of major cancer or currently on treating cancer * major cardiovascular disease, respiratory disease, liver, hematologic diseases with complication * severe cognitive impairment / dementia / confusion state * past history within the last 12 months or current episode of severe constipation severe constipation * regular use of laxatives or colon motility-altering drugs (i. e. more than 2 - 3 times per week) in the last 28 days prior to screening and/or laxative use within 72 hours prior to administration of the preparation) * women who are pregnant or lactating * known phenylketonuria, glucose-6-phosphate dehydrogenase deficiency * those who were allergic to any preparation components. * those who, in the opinion of the investigator, should not be included in the study for any reason
how active breathing training improves dysphagia in elderly people

Conditions: Dysphagia

Summary: the goal of this clinical trial is to explore the impact of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants enrolled are required to undergo a continuous three-week (21 days) active breathing exercises, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

the investigators have designed a simple and user-friendly training method called "active breathing exercises" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. the goal of this clinical trial is to explore the impact of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants enrolled are required to undergo a continuous three-week (21 days) active breathing exercises, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility criteria:
inclusion criteria: * age over 60 years old. * no hospitalization within the past six months. * with clear consciousness and able to cooperate with questionnaires and training. * the elderly people who voluntarily participate and agree to adhere until the end of the study. exclusion criteria: * complicated with severe liver and kidney failure, tumors, or hematological disorders. * physical disability. * difficulty in mobility.
a two-part, phase 1, single-dose study of il-31 mab (anti-interleukin 31 monoclonal antibody); in healthy subjects and adults with atopic dermatitis

Conditions: Healthy Subjects and Atopic Dermatitis Subjects

Summary: the purpose of the study is to determine safety and tolerability of il-31 mab

healthy volunteers not acceptable for "part 2" (adult subjects with atopic dermatitis) enrollment: (both part 1 and part 2) part 2 will consist of up to 42 patients with atopic dermatitis

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * part 1: healthy subjects * part 2: adult subjects with: 1. atopic dermatitis severity as assessed by physician global assessment rating of 3 or higher (i.e., moderate or greater) on a scale of 0 to 5 2. pruritus severity of at least 7 of 10 on a visual analog scale exclusion criteria: * receipt of systemic immunosuppressants, other than biological agents, or topical calcineurin inhibitors (tacrolimus or pimecrolimus) within 4 weeks prior to study drug administration