Kornimate/medical-research-clean huggingface dataset:
focus:focus on coronary unstable syndromes

Conditions: Myocardial Ischemia

Summary: study objectives: * to demonstrate that the acute administration of ramipril will control the inflammation process in patients with high-risk acute coronary syndrome (acs) as assessed by the high sensitivity c-reactive protein blood levels. * to demonstrate that the normalization of blood glucose levels with intravenous insulin will improve the inflammation process during the acute phase of an acs as assessed by tumor necrosis factor alpha blood levels.


Eligibility criteria:
inclusion criteria: * subject either not of childbearing potential or is not pregnant and agrees to use contraceptive measure for the duration of the study * subjects presenting within 12 hours after the last episode of chest pain with: * an accelerating pattern of anginal pain * a prolonged or recurrent anginal pain at rest or with minimal effort and * evidence of myocardial ischemia on ecg manifested by at least one of the following ecg criteria: - new persistent or transient st-segment depression or transient or reversible st-segment elevation or new persistent or transient t-wave inversion or abnormal cardiac markers defined as: ck-mb greater than the upper limit of normal troponin t or i level greater than the upper limit of normal. exclusion criteria: * known or suspected pregnancy or actively breast-feeding * female of childbearing potential not using or planning to use a reliable method of contraception * treatment with hormone replacement therapy at time of randomization * angina precipitated by obvious provoking factors * heart failure defined as known ejection fraction less or equal to 40% or nyha (new york heart association) class iii pr iv * type i diabetes mellitus * type ii diabetes requiring insulin therapy * hyperkaliemia * acute chronic inflammatory, collagen tissue disease, auto-immune disease or cancer and/or requiring the use of anti-inflammatory or anti-neoplastic agents at the time of randomization * use of a non-steriodal anti-inflammatory agent, coxibs, or anti-neoplasic agent within last 7 days * use of any oral or intra-venous steroidal agent in the last 7 days before study entry * uncontrolled hypertension * systolic pressure \< 100 mmhg at randomization * likelihood of requiring treatment during the study period with drugs not permitted by the protocol * treatment with any investigational product or device in the last 4 weeks * previous participation into the trial * history of hypersensitivity, allergy, or intolerance to angiotensin-converting enzyme inhibitors. * severe cardiovascular diseases requiring urgent therapy * severe or co-morbid condition * history of cancer not known to be disease free, with the exception of basal cell carcinoma of the skin * clinically important systemic disorder * impaired hepatic function * clinically important chronic or acute renal failure * history of drug or alcohol abuse
the assessment of quality of life in patients with peritoneal dialysis and hemodialysis

Conditions: Peritoneal Dialysis; Hemodialysis

Summary: currently, lots of researches aimed at quality of life of patients with peritoneal dialysis and hemodialysis related issues. there is no study related to establish the predictive model of quality of life. this study will investigate the predictive model of quality of life in terms of peritoneal dialysis (pd) or hemodialysis (hd) patients. these results will offer the further evidence to the government to develop the effective interventions for dialysis patients. the optimal goal is to promote the quality care.


Eligibility criteria:
inclusion criteria: * above 20 years old pd or hd patients * conscious clear and no psychosis * literate and can communicate * willing to participate and sign informed consent exclusion criteria: * not volunteer * subject felt weak or uncomfortable and patients decision to withdraw from the study

Keywords: peritoneal dialysis hemodialysis patients
pharmacokinetics, efficacy and safety study of immunate sd (human plasma-derived coagulation factor viii concentrate) in hemophilia a patients

Conditions: Hemophilia A

Summary: the purpose of this study is to evaluate whether immunate s/d is effective and safe in the treatment of hemophilia a patients. the study consists of 3 parts: part 1 is a pharmacokinetic comparison of immunate s/d and its predecessor immunate. part 2 is an evaluation of efficacy and safety of immunate s/d. part 3 is a pharmacokinetic study of immunate s/d.


Eligibility criteria:
inclusion criteria: - plasma factor viii level as follows: for parts 1 \& 3: subjects with severe hemophilia a (plasma baseline factor viii level \<= 1% measured at time of screening) for part 2: subjects with severe (plasma baseline factor viii level \<= 1% measured at time of screening) or moderately severe hemophilia a (plasma baseline factor viii level \<= 2% measured at time of screening) * males \>= 12 but \<= 65 years of age * \>= 35 kg body weight * previously treated with factor viii concentrate(s) for a minimum of 150 exposure days (as documented in the subject's medical history) * evidence of a protective titer to hav and hbv at the time of screening * immunocompetent as defined by a cd4+ lymphocyte count \>400/mm3 and an absolute neutrophil count (anc) \>1500 * signed informed consent obtained from subject or legally authorized representative exclusion criteria: * documented history of inhibitor to factor viii with a titer \>= 0.8 bu * current evidence of inhibitor to factor viii with a titer \>= 0.8 bu, measured at the time of screening * abnormal renal function (serum creatinine \> 1.5 mg/dl) * hiv-seropositive individuals with any of the following at the time of screening: * cd4+ lymphocyte count \>400/mm3 * aids-related complex * symptomatic aids note: hiv-seropositive subjects with an absolute cd4+ lymphocyte count \> 400/mm3 are eligible to participate. hiv-seropositive subjects receiving highly active anti-retroviral therapy (haart) regimens are eligible for enrollment if they are not excluded by the above criteria * active hepatic disease (alt and ast levels \> 5 times the upper limit of normal) * clinical or laboratory evidence of hepatic cirrhosis including (but not limited to) a recent and persistent inr (international normalized ratio) \> 1.4, the presence of splenomegaly and/or significant spider angiomata on physical exam, and/or a history of esophageal hemorrhage or documented esophageal varices * known hypersensitivity to immunate * the subject is currently participating in another investigational drug study, or has participated in any clinical study involving an investigational drug within 30 days of study entry * the subject is currently receiving, or is scheduled to receive during the course of the study, an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a-interferon, steroids at a dose greater than 10 mg/day) * the subject is identified by the investigator as being unable or unwilling to perform study procedures

Keywords: factor viii deficiency
can structured education promote physical activity in those identified with an increased risk of developing diabetes

Conditions: Prediabetic State

Summary: this study is a three-armed randomised controlled trial that aims to determine the effect of a structured educational programme on physical activity levels and glucose tolerance in individuals with impaired glucose tolerance (igt). the educational programme is designed to promote physical activity by targeting perceptions and knowledge of igt, exercise self-efficacy, and self-regulatory skills. the study will also investigate whether the effectiveness of the educational programme at promoting self-regulatory skills and physical activity is enhanced by the inclusion of a pedometer and personalised step/day goals.


Eligibility criteria:
inclusion criteria: * 2-h blood glucose ≥ 7.8 mmol/l and \< 11.1 mmol/l * fasting plasma glucose \< 7 mmol/l * bmi ≥ 25 kg/m2 (or 23 kg/m2 for those from a south asian ethnic origin) * aged 18 or over exclusion criteria: * taking medication known to significantly interfere with glucose tolerance * participating in regular vigorous physical activity * unable to participate in moderate intensity physical activity * pregnant

Keywords: exercise
ruxolitinib adherence in myelofibrosis and polycythemia vera

Conditions: Adherence, Patient; Adherence, Treatment

Summary: the prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with polycythemia vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. the main purpose is to assess adherence to ruxolitinib using the arms questionnaire. each individual patient will be administered the questionnaire at the first convenient opportunity, regardless of when ruxolitinib is started, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement.

the prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with polycythemia vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. laboratory tests and histologic, cytogenetic, molecular, and radiologic investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. in particular, data related to systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. these data will be collected at the first administration of the arms questionnaire and again after 12, 24, and 48 weeks. if performed, any additional assessments will also be recorded. each individual patient will be administered the questionnaire (arms) at the first convenient opportunity, regardless of the time of initiation of ruxolitinib, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement. if in-person data collection is not possible, the mode of data collection by telephone interview will be adopted. the minimum expected duration of individual patient observation is 48 weeks.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients diagnosed with primary myelofibrosis or secondary to essential thrombocythemia/polycythemia vera or diagnosed with polycythemia vera who are in the treatment with ruxolitinib therapy in accordance with normal clinical practice * obtaining informed consent for data collection and processing * the patient must come to the in-person visit at least once, an occasion on which informed consent to 'study membership will be offered exclusion criteria: * none
use of breast mri for local staging

Conditions: Breast Cancer

Summary: when breast mri is used to determine the extent of local disease, the management changes, resulting in improved outcomes. studies have indicated that breast mri plus mammography is better for detecting tumors. surgeons are now utilizing breast mri to determine the extent of disease in women diagnosed with breast cancer. it has not been established how management of breast cancer patients has been affected by the use of breast mri or how that management has affected the outcome for these patients. this retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast mri.

when breast mri is used to determine the extent of local disease, the management changes, resulting in improved outcomes. studies have indicated that breast mri plus mammography is better for detecting tumors. surgeons are now utilizing breast mri to determine the extent of disease in women diagnosed with breast cancer. it has not been established how management of breast cancer patients has been affected by the use of breast mri or how that management has affected the outcome for these patients. this retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast mri. the medical records of patients who received breast mri for pre-treatment staging of breast cancer will be retrospectively reviewed to see if the mri information affected management. uams surgeons will be asked if the breast mri resulted in: 1. no change in management 2. moderate change in management-what (modified lumpectomy-larger or smaller) 3. significant change-what (contralateral breast, additional quadrants, lump to mast, neoadjuvant chemo)-note less dz than w/o mri, more dz than w/o mri. the medical record of patients who were imaged will be reviewed for presenting symptom, clinical exam, imaging studies (mammogram, breast ultrasound, breast mri) and pathology results. this study is limited to retrospective chart review with the only foreseeable risk being that of disclosure of phi. to minimize this risk, data collection forms will be identified by subject id number. a master list of these id numbers linked to subject medical record number will be maintained in the investigator's file and kept in a secure location accessible only to the study team for purposes of verification of data and validation of results. the medical record number will not be recorded on any other form containing subject phi. the only foreseeable breach of confidentiality would be for the security of the investigator's files to be compromised.

Eligibility criteria:
inclusion criteria: * patients who have undergone a breast mri for staging exclusion criteria: * none

Keywords: breast cancer
subqstim: a post-market study of subcutaneous nerve stimulation in failed back surgery syndrome (fbss) patients

Conditions: Failed Back Surgery Syndrome

Summary: the purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (sqs) plus optimized medical management (omm) versus omm alone in patients suffering from back pain due to failed back surgery syndrome (fbss).


Eligibility criteria:
inclusion criteria: 1. provides written patient informed consent/patient information sheet prior to study-related activities being conducted 2. ≥ 18 years of age at time of informed consent 3. willing and available to attend visits as scheduled and to comply with the study protocol 4. willing and able to undergo assessments as part of the evaluation for eligibility and endpoints 5. willing and able to use the external neurostimulator, recharging equipment (if applicable), and patient programmer per the schedule required by the protocol 6. diagnosed with fbss (i.e.): * has had persistent pain for 6 months following most recent anatomically correct, successful surgery and * there are no further therapeutic surgical options available as assessed by appropriate investigation 7. back pain is considered intractable and has been adequately treated (failed an appropriate trial of at least 3 different classes of back pain treatments (pharmaceutical and/or non-pharmaceutical)) 8. is an appropriate implant candidate for the sqs system exclusion criteria: 1. has been or is currently being treated with spinal cord stimulation, subcutaneous nerve stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system 2. evidence of an active disruptive psychiatric disorder that is significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome, as determined by the investigator 3. has a pain condition unrelated to fbss that is severe enough to overshadow the fbss pain in the opinion of the investigator 4. spinal instability or anatomic compression that requires further surgery 5. spinal fusion at more than 3 vertebral levels 6. currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study 7. allergic or has shown hypersensitivity to any materials of the device system which come in contact with the body 8. history of coagulation disorder or lupus erythematosus 9. involved in current litigation regarding back pain
non-coding rna in the exosome of the epithelia ovarian cancer

Conditions: High Grade Serous Carcinoma; Ovarian Cancer; Exosomes; Prognosis; Early Diagnosis

Summary: this study aims to analyze the expression of micro-rna (mirna) and long non-coding rna (lncrna) by next-generation sequencing in patients with high grade serous ovarian cancer (hgsoc) and benign gynecologic diseases. the candidate mirna/lncrna will be validated as biomarker for the detection and prognosis of hgsoc.


Eligibility criteria:
inclusion criteria: * confirmed primary high grade serous ovarian cancer * willing to accepted debulking surgeries and adjuvant chemotherapy * good performance status * aged 18 years or older * signed an approved informed consents exclusion criteria: * not meeting all of the inclusion criteria
symptom assessment in adult patients with erosive gerd (gastroesophageal reflux disease) or engerd (endoscopic-negative gerd) after treatment with pantoprazole (by1023/m3-343)

Conditions: GERD

Summary: the aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive gerd or endoscopic-negative gerd (engerd). an endoscopy will be performed at study start and study end. during the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (request™ questionnaire). the study duration consists of a baseline period (8 days) and treatment period (28 days). pantoprazole (tablet) will be administered once daily at one dose level. the study will provide further data on safety and tolerability of pantoprazole.


Eligibility criteria:
main inclusion criteria: * written informed consent * outpatients * history of gerd-related symptoms for at least 6 months prior to study inclusion * endoscopically confirmed erosive gerd or non-erosive gerd main exclusion criteria: * acute peptic ulcer and/or ulcer complications * ppis during last 7 days prior to study start * systemic glucocorticoids or non-steroidal anti-inflammatory drugs including cox-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day * intake of ppis in combination with antibiotics for eradication of h. pylori

Keywords: gerd pantoprazole
the early intervention and prevention of diabetes foot

Conditions: Diabetes; Neuropathy, Polyneuropathy (Manifestation)

Summary: peripheral neuropathy is just assessed by determination of vibration sensation, pressure sensation, superficial pain or temperature. the most commonly used technique for diagnosis of peripheral neuropathy is nervous conduction (nc) and electromyography (emg). but emg/nc is bothersome and techniques using electric currents to measure nc and needles to study muscle innervations are uncomfortable. quantitative neurosensory testing (qst) is essential in the evaluation of small-caliber a-delta and c-fibers, the primary transmitters of thermal and pain sensation. qst can demonstrate neurosensory abnormalities when it is non-invasive test, selective to small fibers despite negative emg/ncv finding. the investigators predict qst can be used for the early diagnosis and follow-up of small-fiber neuropathy in diabetes patients. the investigators also predict the early evaluation of diabetes neuropathy with qst can reduce the diabetes patient progress to advance stage of dm foot or limb amputation.

patients will be divide into 4 groups (groups 1 to 4 will be divided by q-sense qst (tsa ii) . the patient groups will be defined as the followings: 1. group 1: 100 diabetes patients without neuropathy, q-sense normal. 2. group 2: 100 diabetes patients with neuropathy, q-sense abnormal but no evidence of paod. 3. group 3: 100 diabetes patients with neuropathy, q-sense abnormal , paod (＋), but no foot ulceration 4. group 4: 100 diabetes patients with neuropathy, paod(＋) , and foot ulceration qst will perform using the medoc device (tsa2001/vsa3001) following previous published procedures.

Eligibility criteria:
inclusion criteria: * group 1: 100 diabetes patients without neuropathy, q-sense normal. * group 2: 100 diabetes patients with neuropathy, q-sense abnormal but no evidence of paod. * group 3: 100 diabetes patients with neuropathy, q-sense abnormal , paod (＋), without foot ulceration. * group 4: 100 diabetes patients with neuropathy, paod (＋), and foot ulceration. exclusion criteria: * poorly controlled hypertension (sbp≥150 under regular medical treatment) * thyroid disease * pregnancy * have been diagnosed malignancy * liver cirrhosis
breadth of donor options for people with inherited diseases requiring allogeneic hematopoietic stem cell transplant in the era of alternative donor transplants using post-transplantation cyclophosphamide

Conditions: Primary T-cell Immunodeficiency Disorders; Common Variable Immunodeficiency

Summary: background: people who have certain immune system diseases often need a procedure called allo hsct. this is short for allogeneic hematopoietic stem cell transplant. this might cure people with these diseases. many people who need allo hsct need donors who are relatives with similar genes. but the disease may also affect those in the donor pool. this may mean there are fewer options for people with inherited diseases. researchers want to collect data on how transplant candidates and their donors are found. objective: to find out how genetic diseases and the ways they are inherited affect the breadth of options for allo hsct donors. eligibility: records from studies that have already been done. these will be for people ages 4 and older who were evaluated for allo hsct or to be donors. design: participants already signed a consent form for their records to be shared. researchers will study the participant data. data will be stored in an electronic system. researchers will use passwords to protect the data.

this protocol is a retrospective review of donor search results for patients with inherited immunodeficiency diseases requiring allogeneic hematopoietic stem cell transplant (allo hsct). the study will involve collecting information related to the donor search for transplant candidates and their prospective donors, using records in cris, crimson, the hla lab, and records in the transplant coordinator office (such as shipping logs of hla typing kits). the study will not involve the use of specimens or participant contact. the participants whose records will be reviewed will be those who were evaluated for allo hsct or donation on an nih primary immunodeficiency transplant protocol at a time when haplo donors were eligible (march 30, 2012 to present for gata2, january 1, 2015 for cgd, october 6, 2015 to present for 16-c-0003, and may 21, 2014 to present for dock8). the principal investigators on the included protocols have granted permission to conduct this study and have verified that none of the original protocols or informed consent documents preclude such a review of clinical data.

Eligibility criteria:
* data analysis only

Keywords: prospective donors immunodeficiency