Kornimate/medical-research-clean huggingface dataset:
pain and disability outcomes in post amputation patients

Conditions: Limb Pain, Phantom; Residual Limbs Pain; Disability Physical

Summary: the objective of this study is to evaluate efficacy of varied medical and procedural therapies used to treat pain after surgical amputation of a limb. the primary outcome will be assessment of pain severity at rest and with movement as measured by pain scores on numerical rating scale (nrs) 0 to 10, where 0 is not pain and 10 is the worst pain possible, taken on post-operative day 1, day 7, 30 days, 90 days, 6 months, and 1 year (+/- 3 days at each time point).

the objective of this study is to evaluate efficacy of varied medical and procedural therapies used to treat pain for surgical amputation of a limb. at present there are number of different type of therapies are performed in the patients who is going through an amputation of any limb for management of their pain adequately such as peripheral nerve block, epidurals, peripheral nerve stimulators etc. however, the effects of these different procedures performed at different time intervals have not been evaluated for their effects on phantom pain and somatic pain long term after the procedures in these group of patients. we will be collecting the following data from these patients to see if there is any particular intervention done at particular time of the procedure ( before the amputation vs. after the amputation) affect the long term outcome of these patients such as development of phantom pain, or chronic pain the primary outcome will be assessment of pain severity at rest and with movement as measured by pain scores on numerical rating scale (nrs) 0 to 10, where 0 is not pain and 10 is the worst pain possible, taken on postoperative day 1, day 7, 30 days, 90 days, 6 months, and 1 year (+/- 3 days at each time point). the secondary outcomes will be 1) phantom limb pain severity as rated on nrs 2) residual limb (stump) pain as rated on nrs 3) phantom limb sensations 4) pain disability index scores 5) morphine milligram equivalents. these secondary outcomes will be assessed at the same intervals as the primary outcome. this study will help us to find out if there is any utility of any of these procedures performed at particular time of the procedure helps them more than the others for development of somatic or phantom pain.

Eligibility criteria:
inclusion criteria: 1. ages between 18 and 89 years old, inclusive 2. patients scheduled for surgical limb amputation at penn state hershey medical center exclusion criteria: 1. patients who cannot cooperate or consent 2. patients who cannot understand or speak english 3. patients with a history of chronic regional pain syndromes 4. patients suffering from alcohol and/or drug abuse -based on previous dx listed in the mrn 5. bmi \>50

Keywords: amputation
prevention of post-mastectomy lymphoceles by padding

Conditions: Mastectomy

Summary: lymphoceles, or seromas, are the most frequent complication following mastectomy and are associated or not with axillary dissection occurring in 10 to 90% of cases. it is defined as the presence of a palpable post operative serous accumulation that is bothersome for the patient and requires a puncture and drainage or even several repeated punctures. the presence of seromas is therefore associated with discomfort and pain. seromas could also be responsible for increased morbidity due to complications such as infection, suture separating, lymphedema, prolonged of hospital stay, or a delay in initiation of adjunct treatment (e.g. chemotherapy, radiotherapy). some risk factors have been identified, such as obesity, increased post operative drainage of j1 to j3, and arterial hypertension. different measures have demonstrated the benefits of limiting axillary lymphoceles after dissection : placement of a drain, padding and delay in shoulder mobility. studies have shown that axillary padding decreases lymphocele development and shortens the length of hospital stay. some studies based on padding of the mastectomy site also have shown a decrease in post operative seromas; however no study has been done on the usefulness of padding in the mastectomy site alone because they include both padding and a drain or padding of the axillary area. the padding technique the investigators employ is performed at the donor site in breast reconstruction by latissimus dorsi muscle flap, demonstrating a reduction in the rate of seromas. in this study, the classic technique will be compared to padding in the mastectomy site with short drainage (48h).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * female gender * patients with infiltrating or in situ breast cancer * indication of surgical treatment by mastectomy * patient providing written informed consent * patient with health insurance coverage * ability to provide voluntary written informed consent exclusion criteria: * informed consent cannot be obtain * pregnant or lactating women * patients undergoing immediate breast reconstruction * patients with cancer untreatable by mastectomy, non curative mastectomy: partial mastectomies, preventive mastectomies (brca genetic mutations) * patients under legal protection or unable to come to a center * patients unable to express voluntary consent * patients receiving post operative anticoagulants or platelet antiaggregants * patients requiring postoperative anticoagulants * bilateral mastectomy

Keywords: padding lymphoceles prevention
the patients with gestational diabetes were interfered with qigong.

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: the goal of this clinical trial is to learn about in women with gestational diabetes's health conditions. the main question\[s\] it aims to answer are: * can qigong control blood glucose in women with gestational diabetes? * can qigong improve mood and sleep in women with gestational diabetes? participants will required to follow the research team for 3 months of qigong practice。 if there is a comparison group: researchers will compare qigong groups to see if qigong's effects.


Eligibility criteria:
inclusion criteria: * 20 years old≤ age ≤ 40 years old; * those with clear awareness, acceptable reading and language expression skills, and barrier-free communication; * singleton pregnancy; * gestational age between 24 and 28 weeks, with the upper limit of gestational age set at 28 weeks at the time of inclusion to allow for at least 8 weeks of intervention; * body mass index (bmi) is lower than 40; * agree to participate in this project and sign the informed consent form. exclusion criteria: * those with previous gdm and diabetes; * artificial insemination; * those with serious obstetric complications and contraindications; * participants in other planned and supervised exercise programs or researchers during the study.

Keywords: gestational diabetes mellitus in pregnancy qigong non-drug therapy
the role of dietary carbohydrate and fat availability in the regulation of hepatic lipid content

Conditions: NAFLD; Overweight and Obesity; Metabolic Syndrome; Diabetes

Summary: the purpose of this study is to investigate dietary compositions effect on liverfat measured by magnetic resonance imaging.

overweight but otherwise healthy men will be included in the study which is a randomized diet intervention study in a cross over design. the study involves 2 intervention periods of 5 days each, during which the participant ingests two different types of experimental diet. participants will in randomized order (determined by block randomization) ingest a diet with low carbohydrate and high fat content, and a diet with high carbohydrate and low fat content.

Eligibility criteria:
inclusion criteria: * healthy men being 18-50 years old. * overweight (bmi 25-35) * low to moderate physical activity level, defined as ≤ 1 weekly session of aerobic exercise. * non-smokers * no use of medicine exclusion criteria: * fasting blood glucose indicating overt diabetes (≥7 mmol/l) * hba1c \>48 mmol/mol * fasting plasma triacylglycerol indicating dyslipidemia (≥2.2 mmol/l) * fib-4 score \>1.45 * contraindications for mr-scan: abdominal height exceed limitations of the mr-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia.
urothelium tissue engineering using biopsies from transurethral resection of prostate

Conditions: Spina Bifida; Urothelial Neoplasm; Bladder, Neurogenic; Bladder Exstrophy; Hypospadias

Summary: different clinical conditions can require urinary bladder augmentation or replacement. tissue engineered bladder has been clinically evaluated but is not recommended due to diverse side effects. thus, there is a real interest for the development of regenerative approach with innovative scaffolds and cell transplantation. the investigators propose the use of urothelial cells obtained by trans-urethral resection of prostate or bladder (turp) to obtain a tissue engineered urothelium in association with different scaffolds.

bladder biopsies will be obtained during cystoscopy, conserved in culture medium (dmem®), digested by dispase and sowed on collagen-coated culture support. keratinocyte serum free medium (ksfm) will be used for proliferation. microscopy, immunohistochemistry, rna extraction, reverse transcription and quantitative polymerase chain reaction (rt-qpcr) will be performed during passages. cell culture conditions will be optimized to improve proliferation and avoid loss of differentiation. the investigators will develop scaffolds based on sodium alginate hydrogels, followed by freeze-drying to generate porous sponges (at -20°c and -80°c). cultured cells will be associated to these original scaffolds and to other scaffolds, for example alginate hydrogels or collagen cell carrier (ccc), cultivated for 28 days and analyzed. histological and immunohistological appearance of cellularized scaffolds will be compared to assess the effectiveness of each scaffold for tissue engineering in urothelium. cellularized scaffolds will be studied in vitro (transepithelial electrical resistance, impermeability, ability to be stitched, resistance to urine) and in vivo in ectopic location (subcutaneous location in nude mice) or in orthotopic location (bladder augmentation in small animal).

Eligibility criteria:
inclusion criteria: * patient needing a transurethral resection of prostate (turp) * weight of prostate (evaluated by ultrasonography)greater than or equal to 30 grams * affiliation to a social security system * patient over the age of majority * patient receiving complete information on research organization without opposition to the use of biological specimen exclusion criteria: * patient for whom no turp is realized during endoscopic procedure * patient for whom no resection is realized on the bladder neck * patient with prostate weight estimated under 30 grams * patient who opposed to the realization of the study

Keywords: tissue engineering collagen scaffold alginate scaffold urothelial cells
2177gccc:id'ing tx targets and biomarkers for ocular surface disease in pt w/ ogvhd

Conditions: Dry Eye Disease; oGVHD

Summary: evaluate and study the immunologic changes to the ocular surface in cancer patients.

this is a longitudinal natural history study to evaluate and study the immunologic changes to the ocular surface in cancer patients. two groups of subjects will be recruited for the study: 1) pre-bone marrow transplant cancer patients. they will be evaluated every 3 months for 2 years.2) normal control patients. they will be evaluated every 6 months for the duration of the study. during each study visit, in addition to standard of care exams, certain biological specimens ( ocular surface wash, mucocellular material, corneal filaments, or impression cytology of conjunctiva, blood, or serum) will be collected.

Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years of age) who visit the eye clinic either in the umgccc within the umd hospital or the umd faculty physicians ophthalmology practice at the umd professional building or satellite locations for initial visits or established visits. * the patient must be able to understand and sign and date the informed consent form approved by the irb. exclusion criteria: * vulnerable populations: neonates, children, prisoners, institutionalized individuals. * inability or refusal to provide informed consent. * history of ocular surgery (except refractive surgery or cataract surgery)
stepping up for inflammatory arthritis

Conditions: Arthritis, Psoriatic; Arthritis, Rheumatoid

Summary: this study will examine the benefits of a monitored physical activity program for participants with rheumatoid arthritis (ra) or psoriatic arthritis (psa) using a wearable activity device (e.g.fitbit). the goals of this pilot study are to examine 1) whether an incentive is better than no incentive in maintaining an increased level of physical activity and 2) the benefits of physical activity on patient reported disease activity in inflammatory arthritis.

rheumatoid arthritis (ra) and psoriatic arthritis (psa) are chronic, systemic inflammatory disorders affecting 1-2% of the us population. ongoing chronic inflammation and lack of exercise due to arthritis are each associated with pain, fatigue, depression, muscle loss, obesity, and development of chronic diseases such as cardiovascular disease and diabetes, all of which impact physical functioning and quality of life. increases in physical activity can significantly impact each one of these outcomes and are likely to positively impact a patients experience of their disease. this study will examine the benefits of a monitored physical activity program. this study will use a wearable activity device (e.g. fitbit) to monitor step counts and will incentivize one group to achieve higher step counts than the control group. the primary goal of this pilot study will be to determine whether one incentive (loss aversion) is better than no incentive in increasing step counts and maintaining an increased level of physical activity. additional outcomes of interest are patient reported disease activity (using the rapid3 patient reported outcome) and physician measured disease activity, quality of life assessments and weight loss.

Eligibility criteria:
inclusion criteria: * a diagnosis of ra or psa by a rheumatologist * followed by a penn rheumatologist * age 18-80 * a rapid3 score of 3 * an active email account * owns a smart phone and able to download an application * willing to take internet based surveys weekly and allow data from a smart phone application to be uploaded exclusion criteria: * inability to walk or regular use of a wheel chair or assistive device (e.g., walker or cane) * hospitalization within the past 30 days * heart or lung disease that precludes participation in an exercise study
acupuncture for chemotherapy-induced nausea and vomiting

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: the purpose of this study is to clarify whether the matching acupoints is more effective than a single point by electroacupuncture in the management of chemotherapy-induced nausea and vomiting .

patients were assigned to four sessions of electroacupuncture(ea) at the cv12, st36, cv12+st36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and adverse eventswill be assessed.

Eligibility criteria:
inclusion criteria: 1. be diagnosed as cancer and need to accept chemotherapy. 2. the score of karnofsky ≥70 3. patients of either gender and older than 18 years 4. patients receiving chemotherapy both outpatients and inpatients 5. patients receiving chemotherapy either he first or multiple cycle, but the patient will be taken in only one time 6. to receive chemotherapy containing cisplatin(ddp≥75mg/m2) or joint chemotherapy programmes of anthracyclines(adriamycin≥40mg/m2 or epirubicin≥60mg/m2) 7. life expectancy≥ 6 months 8. willing to participate in the study and be randomized into one of the four study groups. exclusion criteria: 1. to receive radiotherapy and chemotherapy 2. gastrointestinal tumors 3. patients with serious liver disease or abnormal hepatorenal function (ast,act, and tbil are 3 times more than normal, bun and cr are 2 times more than normal) 4. presence of cardiac pacemaker 5. active skin infection 6. nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolyte disturbances) 7. patients unable to provide self-care or communication 8. nausea and/or vomiting resulting from mechanical risk factors (i.e., intestinal obstruction) 9. brain metastases 10. women in pregnant and lactating period
minimally-invasive cardiovascular hemodynamic optimization (micho) versus early goal-directed therapy (egdt) in the management of septic shock

Conditions: Severe Sepsis; Septic Shock

Summary: early intervention in the treatment of septic shock, including early goal-directed therapy (egdt) in the first 6 hours of disease presentation, has been shown to significantly decrease mortality. however, this approach requires invasive hemodynamic monitoring, thus limiting its widespread application in the emergency department setting. a minimally invasive protocol utilizing esophageal doppler monitoring (edm) may be of benefit and practical if it is shown to result in similar outcome as egdt.


Eligibility criteria:
inclusion criteria: * adult patients \>= 18 years old * source of infection * two or more of systemic inflammatory response syndrome criteria * systolic blood pressure \ = 4 mmol/l * a central line has been placed for cvp/scvo2 monitoring exclusion criteria: * pregnancy * acute stroke * acute cardiogenic pulmonary edema * status asthmaticus * unstable cardiac dysrhythmia * active hemorrhage * acute seizure * drug overdose * trauma * requiring immediate surgery * do-not-resuscitate status

Keywords: emergency department hemodynamic optimization esophageal doppler monitoring early goal-directed therapy
primary upper limb deep vein thrombosis. is first rib resection necessary?

Conditions: Paget Schroetter Syndrome

Summary: the purpose of the study is to compare outcome of patients with effort thrombosis who were treated operatively to those treated nonoperatively


Eligibility criteria:
inclusion criteria:\\ \* patients treated for upper extremity dvt exclusion criteria: * none
iu health krannert personalized medicine study

Conditions: Coronary Artery Disease

Summary: randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (pci).

the study will randomize patients who have completed pci and who are prescribed dual antiplatelet therapy to a genotype guided arm, in which cyp2c19 pharmacogenetic testing will be performed and a standard therapy arm without genetic testing. the study will examine the impact of pharmacogenetic testing on physician medication choice and clinical outcomes.

Eligibility criteria:
inclusion criteria: * patients with ischemic heart disease, who are prescribed dual antiplatelet therapy after percutaneous coronary intervention (pci). enrollment has to occur during index hospitalization or during outpatient visit for cath lab procedure. exclusion criteria: * pregnant or breastfeeding. * unwilling or unable, in the opinion of the investigator, to comply with instructions on prescribed medicines. * prior known allergy or intolerance to clopidogrel.

Keywords: cytochrome p-450 cyp2c19 pharmacogenetics platelet aggregation inhibitors percutaneous coronary intervention
randomized study regarding preventive jaw- and swallowing intervention for patients with head and neck cancer

Conditions: Head and Neck Neoplasm; Trismus; Deglutition Disorders

Summary: the study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). the patients will be randomized into either an intervention group (performing a preventive jaw- and swallowing exercise protocol before and during radiotherapy) or a control group no performing a exercise protocol. all patients will be encouraged to eat or drink for as long as possible during the therapy. all patients will meet with a speech-language therapist weekly during radiotherapy.


Eligibility criteria:
inclusion criteria: * head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx) * receiving radiohterpay (+/- chemotherapy) with curative intent * no previous trismus or dysphagia exclusion criteria: * surgery due to head and neck cancer * previous treatment for head and neck cancer * tracheostomized patients * no teeth * inability to perform exercise intervention * inability to independently fill out questionnaires in swedish * previous neurologic or neuromuscular disease
new formulation and food effect study of biib074

Conditions: Trigeminal Neuralgia (TN); Other Neuropathic Pain

Summary: the primary objectives of the study are to assess the relative bioavailability of the biib074 direct compression formulation (dcf) to the biib074 roller compaction formulation (rcf) and to determine the effect of a high-fat meal on the pharmacokinetics (pk) of the biib074 dcf. the secondary objective of the study is to assess the safety and tolerability of biib074 administered as the dcf following single oral dose administration in healthy participants.


Eligibility criteria:
key inclusion criteria: * must have a body mass index between 18 and 30 kg/m2, inclusive. * must be in good health as determined by the investigator, based on medical history and screening evaluations. * ability to consume and tolerate the entire high-fat breakfast within a 30-minute timeframe. key exclusion criteria: * history of, or positive test result at screening for, human immunodeficiency virus (hiv). * positive test result at screening for hepatitis c virus antibody. * positive test result at screening for hepatitis b virus (defined as positive for hepatitis b surface antigen and/or hepatitis b core antibody). * previous exposure to biib074. * consumption of xanthine/caffeine-containing products (e.g., energy drinks, coffee, tea, caffeinated soda) within 48 hours of day -1 and an unwillingness to refrain from product use during study participation. * history of alcohol or substance abuse (as determined by the investigator), a positive urine drug screen or alcohol breath test at screening or day -1, or an unwillingness to refrain from alcohol, or illicit or recreational drugs, during the study. * history or evidence of habitual use of tobacco- or nicotine-containing products within 90 days of screening, or a positive cotinine screen at screening or day -1. note: other protocol defined inclusion/exclusion criteria may apply
china lung cancer screening (clus) study version 3.0

Conditions: Lung Cancer

Summary: clus version 1.0, had proven that ldct led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (nct02898441). clus version 2.0 evaluated the efficacy of new techniques (ai, afi and mtb) in fostering the implementation of lung cancer screening (nct03975504). the present multi-center study is performed to evaluate the effectiveness of different lung cancer screening strategy and validate our previous findings. 100,000 high-risk subjects (age 45-75) were recruited to take ldct screening (baseline + 2 biennial repeated ldct screening). follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. blood samples were stored in a biobank. management of positive screening test was carried out by a pre-specified protocol.


Eligibility criteria:
inclusion criteria: * eligible participants were those aged 45-75 years, and with either of the following risk factors: 1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years; 2. malignant tumors history in immediate family members; 3. personal cancer history; 4. professional exposure to carcinogens; 5. long term exposure to second-hand smoke; 6. long term exposure to cooking oil fumes. exclusion criteria: * had a ct scan of chest within last 12 months * history of any cancer within 5 years