Kornimate/medical-research-clean huggingface dataset:
pilot study - patient education and pelvic strength exercises in elderly women with incontinence.

Conditions: Urinary Incontinence

Summary: it will be investigate if women with a diaper grant in aalborg municipality can reduce diaper size and thus costs for diapers in the municipality through meetings with a incontinence nurse and pelvic floor exercises.

incontinence is a world wide challenge especially in elderly women. the participation in pelvic floor exercises can to some extent help women with urinary incontinency. in the municipality of aalborg in denmark, the citizens can get a diaper grant, if they are incontinence. the project will be recruiting women with diaper grants and randomly allocate the women to 3 different groups 1) group training (usual care), 2) individual training and 3) individual training with biofeedback in the form of ultrasound. all groups will receive the same incontinence education from the incontinence nurses and physiotherapists. the women will be offered 6 individual or 10 group base trainings, with increased time between trainings, to increase the participants independency and rely more on home based exercises.

Eligibility criteria:
inclusion criteria: diaper grant * urinary incontinency living in own home in aalborg municipality exclusion criteria: * dementia inability to transport herself to the training facility neurological diseases inability to understand danish or bring a translator
12-week safety and efficacy study of bcx4161 as an oral prophylaxis against hae attacks

Conditions: Hereditary Angioedema; HAE

Summary: this study will evaluate the safety and efficacy of an oral treatment, bcx4161, in preventing acute attacks in subjects with hereditary angioedema (hae). eligible subjects will be randomized to receive one of two doses of bcx4161 or placebo for 12 weeks. the study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of bcx4161 compared to placebo.


Eligibility criteria:
key inclusion criteria: 1. a clinical diagnosis of hae type i or ii 2. documented hae attacks within a defined calendar period; in the absence of documented hae attacks, subjects will be required to enter a run-in period to document attacks 3. access to acute attack medications 4. sexually active women of child-bearing potential and sexually active men must utilize highly effective contraception key exclusion criteria: 1. women who are pregnant or breast-feeding 2. any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study 3. use of c1inh or tranexamic acid for prophylaxis of hae attacks 4. current participation in any other investigational drug study or within the last 30 days 5. history of or current alcohol or drug abuse 6. infection with hepatitis b, hepatitis c or hiv

Keywords: bcx4161 prophylaxis prevention hae hereditary angioedema
simple non-invasive breathing device to improve pulmonary flow pusatility in single ventricle post fontan

Conditions: Single-ventricle

Summary: this is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (opep) in patients with fontan palliation that will examine whether using this device in both the acute and chronic phase will alter fontan hemodynamics and create pulsatility in the fontan circuit and thereby increasing cardiac output. this device is easy to use and poses no significant risk to human subjects. the investigators will measure this through echocardiographic measures including pulsatility in different aspects of the fontan circuit including ivc, hepatic veins, the fontan conduit, and pulmonary arteries and aortic blood flow measurements. after demonstration of how to use the device appropriately, the investigators will have patients use the device after their clinical echocardiogram for their clinic appointment. the investigators will ask them to use the device at home 3-4 times a day for 10-15 mins and have them return in approximately 4 weeks to have another echocardiogram done with the same measurements.

the aortic vti secondary outcome was inadvertently left out of the initial registration and is now reported

Eligibility criteria:
inclusion criteria: * patients with single ventricle with fontan palliation * over the age of 8 years who would be cooperative with breathing through the opep device exclusion criteria: * patients with fontan palliation under the age of 8 years * patients who have interrupted inferior vena cava * patients with abnormal pulmonary artery anatomy
graston technique versus kinesio taping on myofascial pain syndrome after neck dissection surgery

Conditions: Post Neck Dissection Surgery

Summary: this study was conducted to investigate the effect of graston technique versus kinesiotaping on myofascial pain syndrome after neck dissection surgery.

fifty two patients from both genders who had cervical myofascial pain syndrome following a neck dissection surgery participated in this study. their ages ranged from 30 to 50 years. they had been selected from the national cancer institute, cairo university. they were assigned randomly into two groups (a) and (b), equal in number. group (a) received graston technique (iastm), in addition to traditional treatment (range of motion exercises, stretching exercises and strengthening exercises) for 12 sessions performed in a period of 4 weeks (three times weekly). while group (b) received kinesiotaping, in addition to traditional treatment (range of motion exercises, stretching exercises and strengthening exercises) for 8 sessions performed in a period of 4 weeks (twice weekly). pressure pain threshold, visual analogue scale and cervical lateral flexion and rotation were measured pre and post 4 weeks of treatment.

Eligibility criteria:
inclusion criteria: * the subjects were selected according to the following criteria: the patient's ages ranged from 30 to 50 years participated in this study. both genders participated in this study. all patients had a history of mps at utm from 3 to 5 months. all patients had moderate to severe pain (vas score \>4). informed consent was obtained from every patient enrolled in the trial. all patients had myofascial pain syndrome after unilateral modified radical neck dissection surgery. exclusion criteria: * the potential participants were excluded if they meet one of the following criteria: a wound in the affected area a cervical disk lesion myelopathy or radiculopathy cervical spine fracture or spondylolisthesis rheumatoid arthritis epilepsy or any psychological disorders contraindications to iastm. contraindications to kinesiotaping. coagulopathy. hemophilia or other clotting disorders.

Keywords: graston technique (iastm) kinesiotape myofascial pain syndrome
outcomes of elective cancer surgery during the covid-19 pandemic crisis

Conditions: COVID-19; Coronavirus; Cancer; Surgery

Summary: covidsurg-cancer is an international, multicentre, observational cohort study designed to evaluate the 30-day covid-19 infection rates in elective cancer surgery during the covid-19 pandemic. centres can elect to include one or more cancer types in the study, in any combination, depending on local expertise and capacity. during the pilot study, investigators should enrol patients with confirmed diagnoses of: * colorectal cancer * oesophagogastric cancer as a rapid response study to the covid-19 pandemic, included cancer types will evolve throughout the course of the covidsurg-cancer study period, for example, to include breast, liver, pancreatic, gynaecological, urological cancers, or sarcomas.

the rapid emergence of the covid-19 virus has led to a global impact on elective surgical care. we have very little evidence to guide us. the magnitude and effects of these changes are uncertain. the safety of operating on patients electively with the risks of covid-19 postoperative pneumonia is unknown. high-quality data will allow policy planning at regional and hospital level for both this outbreak and future pandemics. covidsurg-cancer will run in parallel to covidsurg (which is capturing outcomes of patients undergoing surgery for all indications with concurrent covid-19). the primary aim is to evaluate the 30-day covid-19 infection rates in elective cancer surgery during the covid-19 pandemic. secondary aims include; comparison of the 30-day postoperative mortality rate in cancer surgery patients that develop covid-19 infection versus those who do not; an exploration of the scale of resource constraints related to the covid-19 pandemic, and their impact on outcomes of elective cancer surgery; to explore variation in the selection of patients for continuing elective cancer surgery during the covid-19 pandemic; to evaluate the impact of the covid-19 pandemic on treatment pathways for cancers with a decision for surgical resection with curative intent. this investigator-led, non-commercial, non-interventional study is extremely low to zero risk. this study does not collect any patient identifiable information and data will not be analysed at hospital-level.

Eligibility criteria:
centre inclusion criteria: - any centre performing elective cancer surgery inclusion criteria (patient): * adults (age ≥18 years) with a confirmed diagnosis of an included cancer type * decision made for surgical management with a curative intent exclusion criteria: * surgery planned with non-curative intent * planned neoadjuvant therapy without a firm date for surgery, or awaiting restaging

Keywords: elective cancer surgery
a phase 2 study of bta798 in asthmatic adults with symptomatic human rhinovirus infection

Conditions: Rhinovirus

Summary: this study aims to evaluate the safety, tolerability and effectiveness of bta798 on * shortening the length and reducing the symptoms of human rhinovirus infection (also known as the common cold), * controlling asthma symptoms, and * lowering the risk of asthma symptoms worsening in subjects with asthma.

subjects with a previous diagnosis of asthma will be pre screened within 90 days prior to enrolment. if a subject develops symptoms of human rhinovirus (hrv) infection they will visit the site for assessment. symptomatic subjects meeting all eligibility criteria will be invited to enroll.

Eligibility criteria:
inclusion criteria: * male and female subjects aged 18-70 years * diagnosis of asthma consistent with global initiative for asthma (gina) steps 1 to 3 * presumptive human rhinovirus infection exclusion criteria: * current severe asthma exacerbation * severe asthma, gina steps 4 or higher * uncontrolled or clinically significant medical condition, disease or event which could impact subject safety and/or study evaluations and/or compliance to the protocol * current smoker, ex-smoker of \ /=10 pack years.

Keywords: human rhinovirus aviragen therapeutics, inc. aviragen therapeutics aviragen
metronomic pld in patients with primary endocrine resistant abc

Conditions: Advanced Breast Cancer

Summary: metronomic pld in patients with primary endocrine resistant abc

efficacy and safety of metronomic pegylated liposomal doxorubicin in patients with primary endocrine resistant advanced breast cancer

Eligibility criteria:
inclusion criteria: 1. females with age between 18 and 75 years old 2. ecog: 0～2 3. life expectancy longer than 3 months 4. histological proven unresectable recurrent or metastatic hr positive/her2 negative breast cancer 5. primary endocrine resistance is defined as: a relapse while on the first 2 years of adjuvant et, or pd within first 6 months of first-line et for mbc, while on et 6. at least one measurable disease according to recist 1.1(except for bone metastasis only) 7. lvef ≥ 55% 8. no radiation therapy within 4 weeks prior to enrollment 9. normal function of major organs: hb ≥ 90 g/l (no blood transfusion within 14 days) ;anc ≥1.5×109 /l；plt ≥75×109 /l；tbil≤1. 5×uln; alt、 ast≤ 3×uln（alt、 ast≤ 5×uln with hepatic metastases）; serum cr ≤ 1×uln 10. be willing to participate in the study, sign informed consent and cooperate with the follow-up exclusion criteria: 1. previous accumulated or equivalent dose of doxorubicin ≥300mg/m2 2. intervals of anthracycline-based adjuvant chemotherapy ≤1 year (time between anthracycline-based adjuvant or neoadjuvant chemotherapy and disease relapse) 3. patients with symptomatic central nervous system metastases. except for patients with stable and asymptomatic brain metastases for at least 8 weeks and no need for glucocorticoids or mannitol treatment before the trial and at least one measurable lesion outside the brain. radiotherapy for brain metastases should be completed at least 4 weeks before the registration 4. pregnant or lactating women and gestational age women who are unable to use effective contraception 5. treatment with investigational products within 4 weeks before the study 6. severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction 7. severe or uncontrolled infection 8. psychiatric drugs abuse and unable to withdrawal or mental disorders 9. other malignancies, except for cured skin basal cell carcinoma and cervical intraepithelial neoplasia.
combination of trastuzumab and nk immunotherapy for recurrent breast cancer

Conditions: Recurrent Breast Cancer

Summary: the aim of this study is the safety and efficacy of trastuzumab plus natural killer(nk) immunotherapy to recurrent breast cancer.

by enrolling patients who have breast cancer of her-2 positive adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using trastuzumab and nk cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: recurrent breast cancer her-2 positive trastuzumab nk immunotherapy
the effects of clonidine on the diuretic response in cirrhotic patients

Conditions: Ascitic Cirrhosis; Hyperactivation of Sympathetic Nervous System

Summary: to examine the effects of the addition of clonidine to diuretics on the mobilization of ascites at short-term (diuretic response and requirement of diuretics) and long-term (readmissions for tense ascites and requirement of diuretics) in cirrhotics with increased sympathetic nervous system. secondary objectives were to study neuro-hormonal,hemodynamic effects and side effects of clonidine and diuretics.


Eligibility criteria:
inclusion criteria: * cirrhotic patients with ascites * plasma norepinephrine level \> 300 pg/ml (normal value: 185 - 275 pg/ml) exclusion criteria: * serum bilirubin concentration above 4.5 mg/dl * prothrombin time below 40% * platelet count below 40 x 10¨9/liter * serum creatinine concentration above 2 mg/dl * gastro-intestinal hemorrhage * alcoholic hepatitis * diabetes mellitus, * hepatocellular carcinoma * respiratory or cardiac failures * hepatic encephalopathy * bacterial infection

Keywords: norepinephrine renin aldosterone hemodynamics spironolactone
the use of contextualised body data in cardiac rehabilitation (cr)

Conditions: Cardiac Rehabilitation

Summary: kics1 study : digital health for current hospital- based cardiac rehabilitation programmes to increase effectiveness and patient outcomes.

cardiac rehabilitation (cr) after a heart attack has shown to be more effective than any other medication given after such an event. it is a recommended therapy by nice. however, only 44% of eligible patients attend rehabilitation and only half of these complete the course. novel ways to increase uptake and compliance are needed. in this study, calorie burn and physical activity data will be collected using a validated, ce marked physical activity monitor, herein referred to as ki monitor. data can be uploaded to an online behaviour change platform that incorporates personalised feedback in the context of their bespoke requirements for cr to empower people to self-care at home using their personal everyday physical activity. this can be closely monitored and support can be given on the contextualised feedback by healthcare professionals. a small pilot study has been carried out to establish wearability of a physical activity monitor in a cr cohort, which has demonstrated a high level of acceptability. we now wish to extend this pilot to a randomised study designed to test the effectiveness of using contextualised body data to influence physical activity in a free-living environment amongst patients undergoing cr, based on the current acpicr standards for daily activity and at-home training. all patients referred for cr will be invited to take part. these will be randomised to the usual care (uc) group or the contextualised data feedback (cdf) group. both groups will wear the ki monitor for eight weeks. the uc group will receive usual care, the cdf group will receive usual care with the addition of contextualised feedback on their activities based on the physical activity data.

Eligibility criteria:
inclusion criteria: all patients referred to the cardiac rehab programme will be invited to take part in the study. exclusion criteria: 1. individuals using a pacemaker or other internal medical device. 2. unable to access a computer or tablet with internet access to view the online platform. 3. unable to access a smartphone or tablet with bluetooth connectivity and internet access to upload data from the activity monitor. 4. unwillingness to take part.

Keywords: cardiac rehabilitation myocardial infarction cabg nstemi stemi angina exercise physical activity heart failure digital health
app-based versus slide-based inter-grader agreement (iga) test for trachoma graders

Conditions: Trachoma

Summary: trachomatous inflammation-follicular (tf) is diagnosed by looking for clinical signs of infection of everted eyelids (conjunctivae) of children. the overall objective of this project is to investigate the effectiveness, acceptability and feasibility of an app-based versus slide-based iga for trachoma graders. fieldwork will take place during routine tropical data trainings. a non-inferiority randomised controlled trial design will be employed, with grader trainees randomised to app- or slide-based training, and then to app- or slide-based iga testing. the training and iga testing method will be compared with field iga test score to determine which method best predicts passing the field iga test.

trachoma graders are currently trained using either slide- or app-based testing systems. the investigators want to formally assess whether the app-based training and testing system leads to better field-based diagnosis than the slide-based training and testing system. the investigators will also ask participants for their views on acceptability of the two systems and conduct a cost-consequences analysis of the two systems. objectives and approach: 1.1 to compare the two classroom iga tests (app-based and slides-based) in terms of their ability to predict trainee success in the field iga test. 1.2 to assess whether the kappa score threshold for the classroom iga tests is appropriate. 1.3 to conduct a cost-consequences analysis of the training systems in order to effectively target the use of an app-based assessment and training system. 1.4 to investigate whether grader trainee characteristics have an impact on trainee performance in the iga tests. 1.5 to obtain feedback on the app-based system's usability and acceptability. 1.6 to compare the two classroom iga training methods (app-based and slides-based) in terms of classroom iga test (app-based and slides-based) outcome and field iga test outcome.

Eligibility criteria:
inclusion criteria: * all trainers and trainee graders who attend selected tropical data training events will be eligible for inclusion in the study. exclusion criteria: * individuals who do not provide consent are not eligible for inclusion in the study.
pain evaluation in radium-223 treated castration resistant prostate cancer patients with bone metastases

Conditions: Castration-Resistant Prostatic Cancer

Summary: this observational prospective single arm cohort study is designed to assess pain and bone pain related quality of life of metastatic castration resistant prostate cancer (mcrpc) patients receiving radium-223 in a real life nuclear medicine practice setting. in addition, overall survival, time to next tumor treatment (ttnt), time to first symptomatic skeletal event (sse), course of blood counts, and safety will be assessed.


Eligibility criteria:
inclusion criteria: * adult male patients diagnosed with crpc with symptomatic bone metastases without known visceral metastases * decision to initiate treatment with radium-223 was made as per investigator's routine treatment practice exclusion criteria: * patients participating in an investigational program with interventions outside of routine clinical practice or participating in another observational study with xofigo

Keywords: observational study bone metastases hormone refractory prostatic cancer xofigo radium-223
the prevention of failure to rescue using early warning scoring

Conditions: Sepsis; Renal Failure; Pulmonary Edema; Cardio-pulmonary Arrest

Summary: the purpose of this study is to assess if, compared with standard paper-based systems, an automated early warning system (ews) resident in a spot check patient monitor, can help to identify deteriorating patients.

the purpose of this study is to assess if, compared with standard paper-based systems, an automated early warning system (ews) resident in a spot check patient monitor, can help to identify patients in the acute care settings but outside of the intensive care unit, who may be experiencing physiological instability and who are in need of rapid clinical intervention by a rapid response team (rrt)/ medical emergency team (met). the development of such an automated system by offers a unique opportunity to assess its user-friendliness, labour-saving effect, feasibility and clinical utility. accordingly, we plan to conduct a research program aimed at assessing this new approach toward patient monitoring. this study will use the hospital's standard of care protocol for the monitoring of vital signs (including timing and vital signs collected) and a commercially available automatic spot check monitor to collect data. no investigational procedures or devices are associated with this protocol.

Eligibility criteria:
inclusion criteria: * all patients admitted to the study units during the period of data collection exclusion criteria: * none

Keywords: patient deterioration unplanned icu admissions rapid response teams