Kornimate/medical-research-clean huggingface dataset:
isometric exercise for people with raised blood pressure

Conditions: Hypertension

Summary: high blood pressure affects many people in the united kingdom. people with raised blood pressure (140-159/90-99 mmhg) are recommended to make changes in their lifestyle (e.g. smoking/alcohol/diet/exercise) and/or medication in order to reduce their blood pressure. current knowledge suggests that a particular type of exercise - isometric exercise - can lower blood pressure. isometric exercise involves holding a fixed body position for a short period of time. as most of the information about the benefits of this type of exercise comes from laboratory-based studies, researchers want to find out if it is possible for gp practices to offer nhs patients with clinically high blood pressure an isometric exercise plan to do at home and how it might affect their blood pressure over 6 months. they will also find out the experiences of those doing this type of exercise and whether it can be done consistently at home over time.


Eligibility criteria:
inclusion criteria: * aged 18 or over * clinic systolic bp 140-159 mmhg * able to provide informed consent exclusion criteria: * currently taking anti-hypertensive medication * white coat hypertension, as evidenced by averaged home systolic bp \<135 mmhg * inability to undertake study intervention (isometric exercise) * previous history of any of the following: * diabetes mellitus (type 1 or type 2) * ischaemic heart disease (myocardial infarction and/or coronary angina and/or coronary revascularization procedure) * moderate or severe stenotic or regurgitant heart valve disease * atrial or ventricular arrhythmia * stroke or transient ischaemic attack * aortic aneurysm and/or peripheral arterial disease * uncorrected congenital or inherited heart condition * estimated glomerular filtration rate \<45 ml/min (calculated using ckd-epi or mdrd formulae, and taking most recent documented results) * documented left ventricular ejection fraction \<45% and/or left ventricular hypertrophy (by either echocardiography or standard ecg criteria e.g. sokolow-lyon) * documented urine albumin:creatinine ratio \>3.5 mg/mmol * inability to provide informed consent * if female, pregnancy or currently breast feeding * enrolled in another clinical trial of an interventional medicinal product or medical device or other interventional study * medical condition that, in the opinion of the investigator, would make the participant unsuitable for the study

Keywords: isometric exercise exercise hypertension high blood pressure general practice feasibility study
this study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * age \> 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made \> 6 months prior to study entry * screening hba1c \> 7.0% * currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione exclusion criteria: smoking within last 6 months pfts outside of range * type 1 diabetes mellitus * type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with oral antidiabetic agents) * active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (alt) serum glutamic pyruvic transaminase (sgpt) or aspartate transaminase (ast) serum glutamic-oxaloacetic transaminase (sgot) above 2x the upper limit of normal as measured at visit 1. however, patients with elevated alt \>1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.

Keywords: insulin glargine diabetes hba1c
pain sensitivity of subjects with fibromyalgia before and after repetitive transcranial magnetic stimulation treatment

Conditions: Fibromyalgia

Summary: the principal study aims at evaluating the efficiency of rtms maintenance sessions on the clinical effect of a rtms cure in fibromyalgic subjects. this complementary study consists in the evaluation of the experimental sensitivity to mechanical pain (pressure application on the forearm) of subjects presenting fibromyalgia before and after rtms treatment (21 days), and to put the results in relation to the clinical improvement and the psychometric evaluations (depression,fibromyalgia impact questionnaire, catastrophism).


Eligibility criteria:
* inclusion criteria: presence of the criteria from the american college of rheumatology (2010)for fibromyalgia diagnosis, painful state for more than six months, visual analogic scale evaluation \> or = 5, age between 18 and 70, no modification in therapeutic treatment one month before and during the protocol presence of actual or prior antalgic chronic treatment : pregabalin, duloxetine, milnacipran, gabapentin, venlafaxine, laroxyl, grade 1 or 2 antalgic residence in limoges or the periphery, or the ability to come to the hospital for the treatment exclusion criteria: presence of non stabilized psychiatric comorbidity (personality trouble, addiction, suicide attempt, non controlled affective trouble), active epilepsy, previous cerebral traumatism, or cerebral surgery, intra-cranial hyper tension, pacemaker, metallic pieces in the brain, cochlear ocular implant, or any metallic material contra indicating magnetic resonance imaging. clozapine, bupropion, methadon, theophyllin, or other non chemical antalgic technic established during the previous month(kinesitherapy, relaxation, hypnosis...), pregnancy, or administrative and judiciary protection, absence of health insurance. known latex allergy, peripheral neuropathy, nerve lesion or dermatosis at the upper extremities, muscular lesion or pathology at the upper members, use of illicit drugs 48 hours before experimental pain test, use of antalgic or analgesic drug aiming at a punctual treatment during the prior 24 hours.

Keywords: rtms fibromyalgia experimental pain
measles vaccine in patients with measles virus-positive, advanced non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer; Measles

Summary: the objectives of the study are to assess the efficacy and safety of live, attenuated measles vaccine as consolidation therapy in patients with measles-positive, non-small cell lung cancer with locally-advanced (stage 3b with pleural effusion) or metastatic (stage 4) tumors in remission.

this is a single-institution, non-randomized phase 1/2 study in patients with locally-advanced or metastatic nsclc in remission after receiving standard systemic chemotherapy of four cycles of combination chemotherapy consisting of four cycles of cisplatin combined with vinorelbine.

Eligibility criteria:
inclusion criteria: * patients in remission after first-line chemotherapy exclusion criteria: * progressive disease

Keywords: measles-positive nsclc measles vaccine consolidation stage 3b with pleural effusion or stage 4 non-small cell lung cancer in remission
randomized controlled trial comparing two different morcellators for holep procedures

Conditions: Benign Prostatic Hypertrophy Requiring Surgical Intervention

Summary: to compare efficiency, in terms of tissue morcellation and removal time, of two commercially available fda-approved morcellators: the versacut and the piranha in subjects undergoing holep procedure for benign prostatic hyperplasia (bph).

holmium laser enucleation of the prostate (holep) with mechanical morcellation is a surgical technique used for treatment of bladder outlet obstruction (boo) secondary to benign prostatic hyperplasia (bph). holep represents a state of the art alternative to transurethral resection of the prostate (turp). holep has been shown to be safe and effective for treating prostates of all sizes and has low perioperative morbidity. a holmium laser fiber is passed through a continuous-flow resectoscope and is used to resect the obstructing prostate tissue (enucleation). after enucleation is performed, the resected tissue is advanced into the bladder. the morcellator is then used to cut the tissue into small pieces which are then removed from the bladder via suction through the morcellator blades (morcellation). we currently use the first commercially available morcellator (versacut, lumenis incorporated, santa clara, ca). the storz continuous-flow resectoscope (karl storz,tuttlingen, germany) is currently used to perform the enucleation portion of the procedure. recently, a new morcellator has been developed (piranha, richard wolf, knittlingen, germany). the wolf morcellator has been reported to remove tissue at a faster rate than the lumenis device

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo holep for bladder outlet obstruction due to the prostate. * able to give informed consent. * age 18 years or older exclusion criteria: * • inability to give informed consent. * age less than 18 years
mindfulness-based cognitive coping for adrd caregivers

Conditions: Caregiver Stress

Summary: this project will evaluate the effectiveness of the mindfulness-based cognitive coping (mcc) intervention to alleviate stress and depressive symptoms of caregivers of individuals with alzheimer's disease and related dementia.


Eligibility criteria:
inclusion criteria: * care for an individual with alzheimer's disease or related dementia (adrd). * own a smartphone or tablet and have internet access. * minimum age of 18 years old. * able to read and speak english. * spend at least 8 hours/week caring for a person with dementia. * plan to stay in the area for six months. exclusion criteria: * severe psychological or physical illness. * cognitive impairment or any serious medical problem that interferes with caregiving role. * caring for adrd patient with a life expectancy less than six months. * unwillingness to participate in all aspects of the study.
long term follow-up after patients underwent total hip replacement

Conditions: Total Hip Replacement; Pain

Summary: the investigators want to contact patients that underwent total hip replacement for the past ten years. the investigators will ask them about their daily living, functioning and quality of life.


Eligibility criteria:
inclusion criteria: 1. total hip replacement from 01.01.2002 exclusion criteria: 1. no

Keywords: quality of life functioning
needleless jet injected (j-tip) lidocaine in children undergoing regional anesthesia prior to knee arthroscopy

Conditions: Knee Injury

Summary: purpose of this study is to investigate the pain outcomes and satisfaction of pain relief for pediatric patients receiving needleless jet-injected (j-tip) lidocaine prior to regional anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic knee surgery compared to femoral nerve block and/or sciatic nerve block with needle injected lidocaine prior to regional and general anesthesia.

the j-tip device has not been reported for use prior to regional block anesthesia prior to femoral or sciatic nerve blocks. the use of the j-tip device for lidocaine introduction prior to femoral or sciatic blocks at arnold palmer medical center has been up to the discretion of the anesthesiologist. it has been anecdotally reported at our institution to have equal or better pain relief for the regional nerve blocks as needle introduction of lidocaine. this study seeks to evaluate the difference in pain from local anesthetic infiltration with j-tip needleless injection device compared to needle injection by use of visual analog scales. * to evaluate efficacy of femoral nerve block after j-tip device lidocaine injection post operatively by use of visual analog scales. * to assess patient and parent satisfaction with j-tip device use by satisfaction questionnaire. * to assess changes in post operative pain medication amounts with j-tip device use.

Eligibility criteria:
inclusion criteria: subjects between the ages of eleven and seventeen undergoing arthroscopic knee surgery. * able to independently complete the visual analog pain scales. * subjects who are neurologically intact at area of injection. * english speaking. exclusion criteria: * subjects with known allergies to lidocaine. * presence of developmental delay. * subjects with blood disorders affecting coagulation. * subjects on blood thinners. * subjects receiving chemotherapeutic agents. * those who use or receive analgesia prior to procedure, except for acetaminophen or non-steroidal anti-inflammatory medications. * any other local sedation at the area of nerve block injection. * non-english speaking * subjects with signs of skin infection or pathology at the injection site.
improving care for patients with diabetes and poor numeracy skills

Conditions: Diabetes

Summary: the aim of this research will be to perform a randomized controlled trial (rct) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of patients with diabetes and low numeracy.

results of the national adult literacy survey (nals) suggest that over 90 million adult americans have poor quantitative skills. numeracy, the ability to understand and use numbers and math skills in daily life, may be particularly important to patients with diabetes because caring for diabetes often requires self-management skills that rely on the daily application of math skills, such as counting carbohydrates, interpreting blood glucose monitoring, applying sliding scale insulin regimens, and calculating insulin to carbohydrate ratios. presumably diabetes patients with poor numeracy have more difficulty with self-management and are at risk for poorer clinical outcomes, but to date, there are no published studies that rigorously examine the role of numeracy in diabetes. we have recently completed the initial development of a new scale to measure numeracy in patients with diabetes: the diabetes numeracy test (dnt). the aim of this research will be to perform a randomized controlled trial (rct) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of patients with diabetes and low numeracy. we hypothesize that a group of patients with poor numeracy who are taught self-management skills that accommodate their poor numeracy will have: (1) improved treatment satisfaction and perceived self-efficacy, (2) improved performance in self-management tasks, and (3) improved glycemic control compared to a control group that receives usual education.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 1 or 2 diabetes; 2. most recent a1c greater than or equal to 7.0%; 3. referred to the diabetes improvement program for diabetes care; 4. age 18-80; 5. english speaking. exclusion criteria: 1. patients with corrected visual acuity \>20/50 using a rosenbaum pocket vision screener, or 2. patients with a diagnosis of significant dementia, psychosis, or blindness.

Keywords: diabetes education health literacy
bibr 1048 dose range finding study in prevention of venous thromboembolism in patients with primary elective total hip or knee replacement surgery

Conditions: Venous Thromboembolism

Summary: the primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of bibr 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(vte) in patients undergoing primary elective total hip and knee replacement.


Eligibility criteria:
inclusion criteria 1. patients scheduled to undergo a primary elective total hip or knee replacement. 2. male of female being 18 years or older. 3. patients weighing at least 40 kg. 4. written informed consent for study participation. exclusion criteria 1. bleeding diathesis, constitutional or acquired coagulation disorders. 2. major surgery or trauma(e.g., hip fracture) within the last 3 months. 3. cardiovascular disease 4. any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks lasting more than 24 hours and / or with cardiovascular pathological findings. 5. deep vein thrombosis(dvt), gastrointestinal or pulmonary bleeding, gastric or duodenal ulcer within the last year. 6. history of or acute intracranial disease 7. liver disease 8. renal disease 9. use of long-term anticoagulants or antiplatelet drugs within 7 days prior to hip/knee replacement operation. 10. pre-menopausal women who are not surgically steriles, are nursing and are of child-bearing potential and are not practising acceptable methods of birth control 11. known allergy to contrast media 12. thrombocytopenia 13. allergy against heparin. 14. active malignant disease or current cytostatic treatment. 15. treatment with an investigational drug in the past month. 16. leg amputee 17. known alcohol or drug abuse
acceptance and commitment therapy-based rehabilitation of post-concussion symptoms

Conditions: Post-Concussion Syndrome; Post-Traumatic Headache

Summary: the investigators aim to evaluate effects of an outpatient rehabilitation program based on acceptance and commitment therapy compared to usual care on function in patients with post-concussion syndrome (pcs) and post-traumatic headache (pth). this study builds on the investigators' previous observational studies and treatment studies in this patient group.

the study is run in an outpatient setting at the department of physical medicine and rehabilitation, st. olavs hospital, trondheim university hospital, norway. all patients are also participants in the observational study: "minimal and mild head injury: an exercise and outpatient follow-up study at st. olavs hospital" (rek number 2018/2159).

Eligibility criteria:
inclusion criteria: * having sustained a minimal hi or mtbi * pcs/ pth had evolved within 1 week after the head trauma. * at least one post-concussion symptoms of at least moderate degree, that affects daily life. * \> 6 months post-injury. * first line treatment has been tried, e.g. psychoeducation, increase of physical activity and pharmacological treatments for headache exclusion criteria: * more than 5 years since last injury. * symptoms are better explained by other conditions. * severe communication problems, typically due to poor knowledge of norwegian. * severe psychiatric, neurological, somatic or substance abuse disorders that will make it problematic to function in a group and/or will complicate follow-up and outcome assessment.

Keywords: acceptance and commitment therapy
transmagnetic stimulation pilot in early stage alzheimer's disease

Conditions: Alzheimer Disease

Summary: alzheimer's disease (ad) is a progressive neurodegenerative condition affecting 6.2 million individuals in the united states, resulting in an annual cost of care of $305 billion. ad is functionally characterized by progressive degeneration of large-scale brain networks (lsbns), including the default mode network (dmn) presumably from the deposition of amyloid plaques and neurofibrillary tangles. available fda-approved medications for ad such as donepezil and memantine offer limited benefit and modest impact on quality of life. in combination with resting state functional mri (rs-fmri), transcranial magnetic stimulation (tms) with intermittent theta burst stimulation (itbs) offers a non-invasive alternative to pharmacotherapy in persons with ad. we propose a pilot trial using rs-fmri to target dysfunctional lsbns in early stage ad.


Eligibility criteria:
inclusion criteria: * established diagnosis of mild cognitive impairment (mci)/mild ad * evidence for central nervous system (cns) amyloidosis (e.g., amyloid positron emission tomography (pet) or cerebrospinal fluid (csf) biomarkers consistent with ad) * prior brain imaging performed * mini-mental state examination (mmse) \>24 * clinical dementia rating (cdr) scale 0.5-1 * stable dose of cholinesterase inhibitors and memantine for at least one month * subjects are between 40-90 years of age exclusion criteria: * non-ad dementia including, but not limited to, lewy body dementia, frontotemporal dementia, vascular dementia, jakob-creutzfeldt disease, etc. * inability to tolerate rs-fmri * contraindication of rs-fmri due to implants or metal * seizure disorder

Keywords: transmagnetic stimulation functional mri guided theta burst stimulation early stage
evaluation of improvements in patient-reported quality of life

Conditions: Breast Cancer; Quality of Life; Physical Activity; Sleep Quality; Stress; Pain

Summary: local intervention trial for the evaluation of improvements in patient-reported quality of life and treatment satisfaction, in breast cancer patients (bcp), as a result of flexible treatment planning supported by rebecca-collected real-world data, in comparison with standard care

local intervention trial which will evaluate the potential of using real-world patient measurements collected by the rebecca system for improving the patient-reported quality-of-life, through just-in-time support consultations, during the first 12 months after radiology and/or chemotherapy treatment. the effects of the rebecca-assisted treatment on qol, in relation to baseline, will be compared against standard the use of rebecca-collected patient information by bcp-supervising health professionals (based on the continuous rebecca real-world measurements), aims to estimate to which extent it: - improves the quality of the provided treatment at 12 months, resulting in an improved qol, in comparison with standard treatment practice it will also evaluate that: * the observed improvements will persist long-term, at least till the point of the 18-month follow-up evaluation * the observed qol improvements will be associated with rebecca's functional life index improvements, as evaluated through the continuous rebecca real world measurements. this will act as an assessment of the rwd use for safer and more effective post-treatment management of interventions with first line chemo/radiotherapies in breast cancer. * the observed qol improvements will be associated with rebecca's prom index improvements, as evaluated through the continuous rebecca real world measurements.

Eligibility criteria:
inclusion criteria: * before patient registration, written informed consent must be given according to national and local regulations. * participants have had histologically proven stage i-iii breast cancer undergoing endocrine treatment (with or without prior chemotherapy) no more than 12 months prior to randomization. * be between 18 and 75 years of age. * have increased life expectancy beyond the initial 3 months post-treatment initiation. * have the ability to understand protocol, participate in testing and willingness to sign a written informed consent. * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. exclusion criteria: * patients that are not willing to sign an informed consent form