Kornimate/medical-research-clean huggingface dataset:
advance direct aortic study

Conditions: Aortic Stenosis; Valvular Heart Disease

Summary: this study is intended to collect data regarding the clinical utility, safety and performance of the medtronic corevalve® system for transcatheter aortic valve implantation (tavi) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (da) is selected.

this study is intended to collect data regarding the clinical utility, safety and performance of the medtronic corevalve® system for transcatheter aortic valve implantation (tavi) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (da) is selected. as part of the study analysis, resource utilization together with the quality of life questionnaires data will provide an important input into cost effectiveness analysis.

Eligibility criteria:
inclusion criteria: 1. severe symptomatic aortic valve stenosis requiring treatment 2. acceptable candidate for elective treatment with the medtronic corevalve® system according to the most recent version of the medtronic corevalve® instructions for use 3. 21 years of age or older 4. patient is willing and able to comply with all protocol-specified follow-up evaluations 5. the patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("patient informed consent form") 6. patient will receive the corevalve® device via direct aortic approach tavi - exclusion criteria: 1. known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated 2. sepsis, including active endocarditis 3. recent myocardial infarction (\<30 days) 4. left ventricular or atrial thrombus by echocardiography 5. uncontrolled atrial fibrillation 6. mitral or tricuspid valvular insufficiency (\>grade ii) 7. previous aortic valve replacement (mechanical valve or stented bioprosthetic valve) 8. evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (cva) or transient ischemic attack (tia) 9. patients with: 1. vascular conditions that make insertion and endovascular access to the aortic valve impossible, or 2. symptomatic carotid or vertebral arterial narrowing (\>70%) disease, or 3. thoracic aortic aneurysm in the path of delivery system 10. bleeding diathesis or coagulopathy 11. patient refuses blood transfusion 12. estimated life expectancy of less than 12 months unless tavi is performed 13. creatine clearance \<20 ml/min 14. active gastritis or peptic ulcer disease 15. pregnancy or intent to become pregnant during study follow up 16. patient is participating in another trial that may influence the results of this study -

Keywords: transcatheter aortic valve implantation heart valve diseases cardiovascular diseases
pilot clinical evaluation of a microwave imaging system for breast cancer detection

Conditions: Breast Cancer

Summary: the trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. it is an active device which uses non-ionizing radiation. microwave imaging is an emerging imaging modality for the early detection of breast cancer. the physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at the microwave frequency spectrum. this study is a pilot clinical evaluation of a microwave imaging system (wavelia #2) for breast cancer detection. the clinical data that will be collected in the context of this study is intended for the assessment of the imaging diagnostic capability and the safety of the investigational device.

this study aims to enrol approximately 103 subjects presenting to the symptomatic breast unit with a breast abnormality who consent to undergo an mbi scan using the wavelia #2 imaging system. the study uses an adaptive design to verify and validate the technical evolutions that have been integrated in the wavelia# 2 prototype on a small patient dataset (30 patients). once the technical performance has been established recruitment will continue to assess the clinical performance of the mbi system compared to standard of care reference imaging. the primary objectives of the study are to assess the performance of wavelia # 2 in the detection of malignant and benign breast lesions, the sizing of malignant lesions for which post-surgery histology data will be available and the differentiation between benign and malignant breast abnormalities by means of features extracted from the mbi images.

Eligibility criteria:
inclusion criteria: * informed consent * female subjects with an investigator assessed discrete breast abnormality of size \> 1cm * able and willing to comply with the requirements of this study protocol * negative urine pregnancy test on the day of microwave imaging procedure (if of childbearing potential) * intact breast skin (i.e., without bleeding lesion, no evidence of inflammation and/or erythema of the breast) * able to comfortably lie reasonably still in a prone position for approximately 15 minutes * have had biopsy more than 2 weeks prior to the microwave breast investigation (if applicable) exclusion criteria: * have a cup size of a or whose breast is deemed too small to allow mbi assessment in the opinion of the investigator * are pregnant or breast-feeding * have had surgery on either breast within the past 12 months * have any active or metallic implant other than a biopsy clip * would be unsuitable for an mbi scan or unlikely to follow the protocol in the opinion of the investigator
pregnancy and childbirth in women with thalassemia yesterday and today

Conditions: Thalassemia

Summary: recent advances in the management of thalassemia have significantly improved life expectancy and quality of life of patients with this hemoglobinopathy, with a consequent increase in their reproductive potential and desire to have children.since an initial report of a successful pregnancy in a woman with thalassemia major by walker in 1969, hundreds of pregnancies have been reported so far, highlighting that women carefully managed in the preconception phase usually carry out a successful gestation and labor, both in case of spontaneous conception and assisted reproductive techniques.


Eligibility criteria:
inclusion criteria: * transfusion dependent and nontransfusion- dependent thalassemia * pregnancy ended with the birth of a live or dead foetus * pregnancy ended in miscarriage or voluntary abortion * pregnancy in progress exclusion criteria: * other types of anemia * pregnancy not initiated despite assisted fertilization practices * subjects unwilling to sign informed consent
pain in oncolgy: evaluation of a non invasive monitoring device (ani). a monocentric prospective study

Conditions: Pain; Cancer

Summary: l'ani (analgesia nociception index the main objective of the research is to estimate the analgesia nociception index (ani) as a parameter giving the possibility of measuring the pain in painful metastatic cancer. the parameter ani is compared with visual analogical scale (vas) score.


Eligibility criteria:
inclusion criteria: * more than 18 years, -no legal protection, - * life expectancy is considered over 3-months * not receiving of béta-blocking, * having a rhythm sinusal without extrasystole * benefiting from a coverage by a social security system exclusion criteria: * pace-maker * diabetes mellitus
study of zg005 combined with bevacizumab versus sintilimab combined with bevacizumab in advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this study is a randomized, open-label, positive-controlled, multicenter phase ii clinical trial. it evaluates the efficacy and safety of zg005 combined with bevacizumab compared to sintilimab combined with bevacizumab in first-line treatment for patients with advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * fully understand the study and voluntarily sign the informed consent form. * 18-75 years of age; * eastern cooperative oncology group (ecog) performance status of 0 or 1； * life expectancy ≥ 12 weeks. exclusion criteria: * patients were deemed unsuitable for participating in the study by the investigator for any reasons.
the therapeutic effects of dextrose injection for myofascial pain syndrome

Conditions: Myofascial Trigger Point Pain

Summary: patients with an myofascial trigger point (mtrp) in their upper trapezius will be divided into three groups: group a receiving mtrp injection with normal saline (control group), group b with hypo-osmolar dextrose (5% dextrose), and group c with hyper-osmolar dextrose (15% dextrose). clinical outcomes and morphological changes will be measured before the injection, one hour after, one week after, two weeks after, and one month after the injection to delineate the therapeutic effects of dextrose injection for an mtrp.

this experiment is designed to evaluate the therapeutic effects of dextrose injection on an myofascial trigger point (mtrp). patients with an mtrp in their upper trapezius will be recruited and be divided into three groups: group a receiving mtrp injection with normal saline (control group), group b with hypo-osmolar dextrose (5% dextrose), and group c with hyper-osmolar dextrose (15% dextrose). clinical outcomes (visual analog scale, pressure pain threshold, range of motion, neck disability index) will be measured before the injection, one hour after, one week after, two weeks after, and one month after the injection. morphological changes of an mtrp before, and after the injection will also be evaluated by sonography. through this study, the definite therapeutic effects, and the better osmolality of dextrose injection for the treatment of an mtrp will be delineated.

Eligibility criteria:
inclusion criteria: * 1). patients should be 20 years of age or older; * 2). they are able to communicate freely; * 3). patients have the diagnosis of myofascial pain syndrome (mps) with a definite myofascial trigger point (mtrp) in the neck base and upper back regions (the upper trapezius muscle). the mtrp is identiﬁed based on the following criteria, as recommended by simons \[simons et al., 1999\]: * (a). a localized tender spot in a palpable taut band of muscle ﬁbers, * (b). recognized pain (as the usual clinical complaint) when the tender spot is compressed, * (c). characteristic and consistent referred pain. * 4). symptoms of mps should be more than 3 weeks. exclusion criteria: * (1). acute or serious medical problems; * (2). cognitive impairment or psychiatric disorder; * (3). coagulopathy or any other bleeding disorder; * (4). taking medication of anticoagulation or antithrombolytics; * (5). sensory deficiency over the body part where mtrps located; * (6). serum hepatitis b or acquired immunodeﬁciency syndrome; * (7). malignancy; * (8). pregnant or likely to be pregnant. * (9). diabetes mellitus

Keywords: myofascial trigger point endplate noise dextrose.
a study to compare two rehabilitation protocols for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the aim of this randomized controlled study is to investigate whether the implementation of blood flow restriction, in which the de-loading factor is delivered by the combined progressive de-loaded walking to running activity on an antigravity treadmill (treatment group), is more effective than the same antigravity protocol alone (control group). participants will be divided as follows: intervention group: anti-gravity treadmill combined with blood flow restriction control group: anti-gravity treadmill both groups will also undergo a standardized knee osteoarthritis management through an aerobic and strength program.


Eligibility criteria:
inclusion criteria: * age included between 45 and 80 years old * patients with knee oa diagnosed by a medical doctor with a radiological confirmation * patients able to provide informed consent and follow all the study procedures as indicated by the protocol * informed consent as documented by signature exclusion criteria: * younger than 44 years old or older than 81 years old included * known drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. * participation in another study with an investigational drug within the 30 days preceding and during the present study * treatment with an injective approach in the previous 3 month * surgical treatment in the previous 12 months.
equivalence of a stable liquid glucagon formulation with freshly reconstituted lyophilized glucagon

Conditions: Type 1 Diabetes

Summary: this study will test the hypothesis that micro-doses of xerisol glucagon (xeris pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of glucagon for injection (eli lilly).

this study will test the hypothesis that micro-doses of a new formulation of stable glucagon, xerisol glucagon (xeris pharmaceuticals), will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon that has poor stability in solution, glucagon for injection (eli lilly).

Eligibility criteria:
inclusion criteria: * age 21 to 80 years old with type 1 diabetes for at least one year. * diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (novolog), insulin lispro (humalog), and insulin glulisine (apidra) for at least one week prior to enrollment. exclusion criteria: * unable to provide informed consent. * unable to comply with study procedures. * current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject. * pregnancy (positive urine hcg), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception. * end stage renal disease on dialysis (hemodialysis or peritoneal dialysis). * hemoglobin \< 11.5 gm/dl. * history of pheochromocytoma. fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor (paroxysms of tachycardia, pallor, or headache; personal or family history of men 2a, men 2b, neurofibromatosis, or von hippel-lindau disease; episodic or treatment of refractory hypertension, defined as requiring 4 or more medications to achieve normotension). * history of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache. * inadequate venous access as determined by study nurse or physician at time of screening. * liver failure or cirrhosis. * any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.

Keywords: bionic pancreas artificial pancreas insulin glucagon clamp
does patient activity level affect 24-hour pad test results in stress-incontinent women

Conditions: 24-hour Pad Test Weight Gain With and Without Activity

Summary: we hypothesised that in women with stress urinary incontinence, the severity of leakage on a 24 hour pad test was affected by activity.

we asked women to perform two separate pad tests, one with normal activity, and another with decreased activity.

Eligibility criteria:
inclusion criteria: * stress urinary incontinence exclusion criteria: * language other than english

Keywords: 24-hour pad test activity stress urinary incontinence
effect of home-exercise programs versus supervised core stability exercises on hypertensive patient with low back pain

Conditions: Hypertension; Low Back Pain

Summary: thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the ababa private physical therapy center in beni-seuf, egypt. they were randomly assigned into two equal groups; the study group a control (n = 15) had a supervised conventional core stability, while the study group b (n = 15) received a home exercise program. in both groups' patients had evaluations before and after their six-week course of therapy. modified-modified schober test was used to assess the active back range of motion (rom), arabic version of oswestry disability index (odi) was utilized to evaluate functional disability, and visual analog scale (vas) was used to measure pain.


Eligibility criteria:
inclusion criteria: * hypertensive patient * patient with chronic back pain * the patients aged 30 to 50 years exclusion criteria: * patients with vertebral fractures * patient with surgical spinal fixation * patient with rheumatic disorders * patient with systemic diseases * patient with multiple sclerosis.
patient experiences and preference of treatment for multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a qualitative (interview) study to explore the experiences of people receiving treatment for mm and to understand what matters most to them when making treatment decisions.

people can receive many lines of treatment for multiple myeloma. we would like to understand more about the experiences of people being treated for multiple myeloma including what matters most to them when considering treatment options, how their experiences have differed with different treatments and if they have any treatment preferences. patients at the christie who have received five or more lines of treatment for multiple myeloma will be eligible to take part in this study. they will be asked to participate in an interview which should take approximately 30 minutes to an hour. during the interview they will be asked questions regarding their experiences and preference for treatment. interviews will be conducted either in person or over the phone depending on patient preference. the interviews will be recorded by the research team using a dictaphone and transcribed by an external transcription service called 1st class secretarial. the transcripts of all participant interviews will be reviewed by members of the research team and experiences will be identified and described.

Eligibility criteria:
inclusion criteria: 1. participants with confirmed mm (per standard disease specific diagnostic criteria) 2. participants must have received ≥ 5 lines of treatment for mm and fit into one of the below treatment categories: 1. subset 1- participants must have received an oral anti-cancer therapy and a bi-specific antibody treatment. 2. subset 2- participants must have received an oral anti-cancer therapy and if they have not had a bi-specific antibody treatment, they must have received at least one iv therapy. 3. aged 18 years of age or over 4. able to provide informed consent 5. able to communicate in english exclusion criteria: 1. aged under 18 2. unable to understand and communicate in the english language 3. unable to provide written informed consent

Keywords: patient experience treatment preference qualitative study patient interviews
proper nutrition, physical exercise and appropriate weight in individuals with long term mental illness

Conditions: Obesity

Summary: based on previous findings that mentally ill inpatients are interested in losing treatment associate weight gain and are capable of adhering to a weight reduction program, this study will investigate the effects of participation in nutrition intervention, physical exercise and will monitor measurement of metabolic profiles (cholesterol, triglycerides and glucose). hypothesis: participants will reduce weight, maintain weight loss and experience reduction in metabolic values and will experience improved quality of life.

study sample: 50 chronic psychiatric inpatients with dsm_iv diagnosis of schizophrenia or schizoaffective disorder, aged 18 or older. exclusion criteria - pregnancy, severe physical illness, refusal to participate. study instruments: q-les-q-18 (quality of life): positive and negative syndrome scale; laboratory test- glucose levels, metabolic profiles (cholesterol, triglycerides). measurements: weight, bmi, pulse intervention: weekly group therapy, lectures on nutrition, physical exercise duration of study: 3 months

Eligibility criteria:
inclusion criteria: * ages 18 and older * men or women * schizophrenia or schizoaffective disorder * bmi greater than 26 * agreement to participate and capacity to provide written informed consent exclusion criteria: * pregnancy * severe physical illness * refusal to participate

Keywords: obesity weight gain schizophrenia schizoaffective disorder antipsychotic induced weight gain
sleep infra-slow oscillations iii

Conditions: Healthy

Summary: in young healthy subjects, we will apply sensory stimuli at specific times during sleep to evaluate the probability that the stimulus evokes an arousal.


Eligibility criteria:
inclusion criteria: * willingness to participate and written informed consent * aged 20 to 40 years at the time of screening * body mass index (bmi) ≤ 30 exclusion criteria: * pregnancy or breast feeding at the time of screening * sleep related breathing disorders * any other sleep related breathing disorder according to aasm criteria * current history of psychiatric disorders according to dsm-v * current chronic treatment that may affect sleep * any significant neurological disorder or other medical disease that may affect sleep * any unstable medical condition * any clinically significant sleep disorder
monoclonal antibody against pcsk9 to reduce elevated ldl-c in subjects currently not receiving drug therapy for easing lipid levels-2

Conditions: Hyperlipidemia

Summary: the primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (sc) monotherapy every 2 weeks (q2w) and monthly (qm), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (ldl-c) in adults with a 10-year framingham risk score of 10% or less.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 to ≤ 80 years of age * national cholesterol education program adult treatment panel iii (ncep atp iii) framingham risk score of 10% or less * fasting ldl-c ≥ 100 mg/dl (2.6 mmol/l) and \<190 mg/dl * fasting triglycerides ≤ 400 mg/dl (4.5 mmol/l) exclusion criteria: * history of coronary heart disease * new york heart association (nyha) iii or iv heart failure * uncontrolled cardiac arrhythmia * uncontrolled hypertension * diabetes mellitus (type 1 diabetes, poorly controlled type 2 diabetes) * uncontrolled hypothyroidism or hyperthyroidism

Keywords: high cholesterol, treatment for high cholesterol, lowering cholesterol, lowering high cholesterol, hypercholesterolemia