Kornimate/medical-research-clean huggingface dataset:
a retrospective study to understand the clinical management of subjects with multiple sclerosis at a site in taiwan over the last 10 years

Conditions: Multiple Sclerosis

Summary: this is an observational, non comparative, non-randomised, open-label, retrospective, single centre study planned to collect the data of subjects diagnosed with multiple sclerosis (ms) as per poser or mcdonald criteria between 1997 and 2007 in taiwan. the clinical features and annual relapse rate in the first five years after the onset of disease have been compared between conventional and optico-spinal ms in the earlier studies. this study aims to understand the clinical care pathway of ms subjects and facilitate the subject's diagnosis before converting to ms.

multiple sclerosis is a chronic, inflammatory disease of the central nervous system (cns) and is characterised by areas of demyelination, or plaques in the cns. the disease is twice as prevalent in women as compared to men and causes considerable disability over time and continues for the lifetime of the subject. subjects with ms are thought to have a genetic predisposition for the disease, though environmental factors such as geographic location and possibly viral infection also play an important role in the process of development of the disease. objectives primary objective: * to understand the clinical care pathways of ms subjects at the site over the last 10 years in order to raise the medical attention of ms diagnosis secondary objective: * to review the pattern of ms treatment regimens in ms subjects at a particular site between 1997 and 2007

Eligibility criteria:
inclusion criteria: * subjects diagnosed with ms as per poser or mcdonald criteria between 1997 and 2007 * edss before treatment was available if subject has started the disease modifying drug treatment.

Keywords: multiple sclerosis expanded disability status scale sclerosis
stem cell transplantation in ocular lesions of behcet's disease

Conditions: Retinitis; Behcet's Syndrome

Summary: the purpose of this study is to find if autologous stem cell transplantation can stop the progression of intractable eye lesions of behcet's disease or even to improve it.

to test in a pilot study the effect of autologous stem cell transplantation in stopping the progression of retinal damage of eye lesions in behcet's disease by repairing the vascular damage, and possibly to improve the lesions.

Eligibility criteria:
inclusion criteria: * behcet's disease * fulfilling the international criteria for behcet's disease (icbd) * ocular lesions with retinal vasculitis * resistant to at least 3 months of combination therapy with pulse cyclophosphamide (1g/monthly), azathioprine (3 mg/kg/daily), and prednisolone 0.5 mg/kg/daily * visual acuity not less than 4 meters finger count * retinal edema confirmed by color photography and oct exclusion criteria: * no vision * active posterior uveitis * fundus not visible

Keywords: retinal vasculitis retinal edema behcet's disease
vitamin d replacement: the effect on statin-related myalgias

Conditions: HMG-CoA Reductase Inhibitors-related Myalgias

Summary: the purpose of this project is to determine if vitamin d supplementation \[10,000 international units of cholecalciferol (vitamin d3) by mouth weekly\] will decrease the rate of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of muscle ache/pain due to statin therapy.


Eligibility criteria:
inclusion criteria: * patients who recently prescribed statins (in the last seven days) or who have had a recent increase in statin dose (in the last seven days) * patients aged 19-89 years old * men and women (not of childbearing potential) * patients receiving statins with concomitant ezetimibe exclusion criteria: * history of alcoholism or malnutrition * receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that affect cholesterol levels

Keywords: vitamin d3 hmg-coa reductase inhibitors (statin)-related myalgias
rapid hormonal cycling as treatment for patients with prostate cancer: the men's cycle

Conditions: Prostate; Cancer; Hormonal Cycling

Summary: objective: to determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.


Eligibility criteria:
inclusion criteria: -patients residing in the following clinical states wit! be considered: a. rising psa: patients with a history of localized disease who have undergone definitive radiation or surgery. these patients must demonstrate progression of disease biochemically as outlined below. patients in this group may not have radiographically evident disease. b. non-castrate metastatic: patients must present with radiographic evidence of metastatic disease at the time of diagnosis or after treatment for localized disease. these patients must show newly detected disease or progressing disease in bone or in soft tissue. biochemical progression is defined as: minimum no. of determinations: 3 interval: \>2 weeks minimal baseline psa value (ng/ml): 2 minimal % increase in range of values: 50% * diagnosis of prostate adenocarcinoma histologically confirmed at mskcc. * patient must have level of serum testosterone above the lower limit of normal. * karnofskcy performance status (kps) \>_70%. * patients must have adequate organ function as defined by the following laboratory criteria: * wbc \>_3500/mm3, platelet count \>_100,000/mm3. * bilirubin \<2.0 mg/dl or sgot \<3.0 x the upper limit of normal. * creatinine \ _60 cc/min. * prior hormonal therapy is allowed as: 1. neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months. 2. one cycle of intermittent therapy up to a maximum exposure of 10 months. * patients must be at least 18 years of age. * patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment exclusion criteria: * clinically significant cardiac disease (new york heart association class iii/iv),or severe debilitating puhnonary disease. * uncontrolled serious active infection. * anticipated survival of less than 3 months. * active cns or epiduraltumor * inability or unwillingness to comply with the treatment protocol, follow-up, or research tests.

Keywords: prostate cancer hormones 01-085 antifungal antibiotics estrogens lupron testosterone zoladex
platelet rich plasma (prp) in total knee replacement

Conditions: Osteoarthritis; Inflammatory Arthritis

Summary: clinical study to evaluate the effect of platelet rich plasma (prp), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (tkr).

the purpose of this clinical study is to evaluate the effect of platelet rich plasma (prp), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (tkr). the hypothesis is that change in short-term hemoglobin (hgb) levels is less dramatic in patients who undergo tkr with the addition of prp when compared to patients who undergo tkr without prp.

Eligibility criteria:
inclusion criteria: 1. patient is a male or female who is undergoing primary unilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage will be at least 6 weeks later prp in total knee. 2. patient agrees to be blinded to their treatment group assignment. 3. patient is willing and able to return for follow-up over at least a six (6) week post-operative period although longer follow-up is desired 4. patient agrees to participate by signing an irb approved informed consent form exclusion criteria: 1. patient will have a staged bilateral total knee replacement with the second stage to be performed less than 6 weeks after the first stage surgery 2. patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy) 3. patient has a known adverse reaction or sensitivity to bovine (cow) thrombin (used as part of the platelet rich plasma system) or other bovine-derived products 4. patient has hemoglobin \< 12.0 (males), \< 11.0 (females) 5. patient clinically significant anxiety disorder 6. patient is on therapeutic anticoagulation medication and has an inr \> 1.3 7. patient has a severe bleeding disorder 8. patient has a known addiction to drugs or alcohol, including, but not limited to: chronic daily use of narcotic medications for more than 90 days prior to surgery 9. patient is pregnant 10. patient is a prisoner 11. patient is involved in a personal litigation (e.g. worker's compensation) that relates to their knee surgery 12. patient is actively participating in an investigational medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)

Keywords: total knee replacement platelet rich plasma prp biologic randomized
role of intraperitoneal intraoperative chemotherapy with paclitaxel in the surgical treatment of peritoneal carcinomatosis from ovarian cancer. hyperthermia versus normothermia

Conditions: Peritoneal Carcinomatosis

Summary: a randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical surgery-peritonectomy, achieving an optimal r0-r1 cytoreduction (microscopic tumor residues (r0) or macroscopic tumor residues \< 1cm (r1)) followed by hyperthermia against normothermia intraperitoneal intraoperative chemotherapy with paclitaxel


Eligibility criteria:
inclusion criteria: 1. age ranged between 18 and 75 years old; 2. histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian cancer (stage iiic- figo (international federation of gynecology and obstetrics)); 3. karnofsky index \> 70 or performance status ≤2; 4. informed consent form filled out correctly. exclusion criteria: 1. unfulfillment of inclusion criteria; 2. extraabdominal metastasis or stage iv figo (liver, lung, bone, etc); 3. concomitance of another malignant neoplasm; 4. renal, hepatic or cardiovascular dysfunction; 5. intolerance during the treatment; - (6) refusal to participate in the study.

Keywords: ovarian cancer
advers events in patients undergoing gastrointestinal procedural sedation

Conditions: Sedation Complication; Frailty

Summary: investigators will include in our study patients aged 60 and over who have been evaluated in the pre-anesthesia clinic for procedures such as endoscopy, colonoscopy, ercp, peg, eus, and esd, and who have received sedation by an anesthesiologist. patients will be assessed for frailty prior to the procedure; during and after the procedure, respiratory monitoring (spo2, capnography) will be closely observed, and they will be contacted by phone three days later. primary goal of the study is to prospectively investigate the incidence of peri-procedural complications (desaturation, bradycardia, hypotension, etc.) in elderly patients undergoing gastrointestinal procedural sedation, and to assess its relationship with detected frailty using the frail scale.secondary goals of the study are to identify risk factors for adverse events, examine the relationship of these factors with 'asa score - age and frailty scale', and determine their impact on the incidence of adverse events. additionally, investigators aim to research the effects of capnography-based respiratory monitoring on adverse events.


Eligibility criteria:
inclusion criteria: * 60 years and older patients * asa physical state i -iv * patients who are qualified to give written informed consent * elective gastrointestinal interventions performed under the care of the anesthesia team (such as gastroscopy, colonoscopy). exclusion criteria: * asa iv patients * patients using sedative agents / patients already sedated for other purposes * non-consenting patients * patients with any upper airway obstructive pathology or a history of difficult airway * emergency procedures
antibiotic dosing in patients on intermittent hemodialysis

Conditions: Kidney Failure, Chronic; Antibiotics; Hemodialysis

Summary: the adequacy of the currently used dosing regimen of glycopeptides (vancomycin and teicoplanin) and beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim) in patients with end-stage kidney disease receiving intermittent hemodialysis is studied by evaluating pharmacokinetics-pharmacodynamics (pk-pd) target attainment. a population pharmacokinetic study is performed to assist the selection of the optimal individualized dose for patients undergoing intermittent dialysis, taking into consideration as many relevant variables as possible.


Eligibility criteria:
inclusion criteria: * patients with end-stage kidney disease, requiring intermittent hemodialysis * patient receiving antibiotic treatment for documented or presumed infection (vancomycin, teicoplanin, amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim) exclusion criteria: * pregnant woman * absence of written informed consent from the patient * known hypersensitivity or contra-indication to glycopeptides or beta-lactam antibiotics
ultrasound imaging for facilitating labour epidurals in obese parturients

Conditions: Obesity

Summary: the efficacy of an epidural depends mainly on accurate placement of the catheter in the epidural space. therefore, identification of the epidural space is the most vital part of the procedure. obese patients represent the most challenging group for the identification of anatomical landmarks. with the use of ultrasound, we can visualize the images of the anatomical structures in the back. some anesthesiologists believe ultrasound can help in the placement of an epidural, and routinely use it to assist in determining needle entry point in your back as well as estimating the depth at which the epidural space will be found. our hypothesis is that the use of lumbar spine ultrasound imaging will accurately determine the epidural space depth and the epidural insertion point in obese patients.

recent technical advances, especially the evolution of ultrasound technology, have helped to some extent in circumventing some of the limitations of epidural anesthesia. the efficacy of an epidural depends mainly on accurate placement of the catheter in the epidural space. therefore, identification of the epidural space is the most vital part of the procedure. obese patients represent are the most challenging group for the identification of anatomical landmarks, it is important to determine if ultrasound imaging is a useful technique in this population. all the patients will undergo ultrasound imaging of the lumbar spine just before epidural insertion. ultrasound imaging will be performed by one of the investigators. a different anesthesiologist will perform the epidural procedure based on the us information provided by the investigator. the investigator will provide information to the epidural performer on the insertion point, the angle of needle insertion and safe approximate distance before reaching the epidural space to facilitate the epidural performance. to maintain blinding and to prevent performer bias, the exact depth of the epidural space from skin, as seen on the ultrasound will not be disclosed. the investigator, with the aid of an in-built caliper, will measure this distance at a later time before saving the image. the results of this study are expected to determine the clinical reliability of ultrasound imaging in visualizing the anatomical structures relevant to the technical performance of epidural analgesia in the obese population. since technical difficulty in performing epidurals is more commonly encountered in obese patients, ultrasound visualization would improve the overall success of the technique by predicting the depth of the epidural needle to be inserted. in turn, the complication rate would be minimized.

Eligibility criteria:
inclusion criteria: * full term pregnant patients requesting labor epidurals * pre-pregnancy bmi greater than 30 exclusion criteria: * known spinal deformities * previous back instrumentation * pre-pregnancy bmi less than 30

Keywords: ultrasound obesity needle depth
effects of intramuscular (im) oxytocin on pupil diameter and heart rate variability (hrv)

Conditions: Chronic Pain Due to Injury

Summary: the goal of this study is to test the effects of oxytocin on heart rate variability and pupil diameter, both of which have subtle effects on the activity rate of the autonomic nervous system.

this protocol focuses on two measures of autonomic control to quantify central actions of oxytocin. first, the study team proposes to examine the influence of oxytocin on heart rate variability with focus on its effect on high frequency variability, most commonly ascribed to parasympathetic nervous system activity acting to brake sympathetic tone. intranasal oxytocin has been demonstrated to have a large effect size on this measure which can be repeated at frequent intervals. as a secondary assessment of parasympathetic activity, the study team will measure low frequency fluctuation in pupil diameter, termed hippus, which also reflects parasympathetic nervous system activity. this outcome measure can be assessed in 3 seconds using equipment currently being used under institutional review board (irb) approved protocols.

Eligibility criteria:
inclusion criteria: * male or female \> 18 and \< 66 years of age, * body mass index (bmi) \<40 * generally in good health as determined by the principal investigator based on prior medical history * normal blood pressure and resting heart rate without medication exclusion criteria: * hypersensitivity, allergy, or significant reaction to any ingredient of pitocin® * any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the principal investigator, would place the subject at increased risk * women who are pregnant (positive result for serum pregnancy test at screening visit), * women who are currently nursing or lactating, women that have been pregnant within 2 years. * neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis. * previous eye surgery, eye medications, cataracts

Keywords: healthy volunteer oxytocin pupillometry
pioglitazone for heroin and for nicotine dependence

Conditions: Heroin Dependence; Nicotine Dependence

Summary: the goal of the proposed research is to improve the effectiveness of treatments for opioid and for nicotine dependence by testing a novel pharmacological strategy. specifically, pioglitazone, a peroxisome proliferator-activated gamma receptor (pparγ) agonist, will be used as an adjunct to agonist-based treatment.

although treatments for opioid and for nicotine dependence exist, these medications are not universally effective as many patients are unable to stop using or relapse rapidly, suggesting that treatment with a single agent alone is insufficient to facilitate cessation of use in many patients. targeting additional pathways that may contribute to the maintenance of drug-taking behaviors or relapse may be a more effective strategy to treat individuals resistant to first-line approaches.

Eligibility criteria:
inclusion criteria: * 21-55 years of age * physically healthy * able to perform study procedures exclusion criteria: * pregnancy * physical dependence on any other drugs besides caffeine, heroin and nicotine
antiviral effect, safety, and pharmacokinetics of bi201335 +pegifn/rbv in hcv-gt1 (silen-c1&2)

Conditions: Hepatitis C, Chronic

Summary: the objective was to investigate the antiviral effect, safety, and pharmacokinetics of bi 201335 (faldaprevir), given as a soft gelatine capsule, in patients with hepatitis c virus (hcv) genotype 1 infection. combination therapy of bi 201335 (faldaprevir) with pegylated interferon α-2a (pegifn) and ribavirin (rbv), with or without a 3-day lead-in, was assessed in treatment-naïve (tn) and treatment experienced (te) patients.


Eligibility criteria:
inclusion criteria: chronic hcv gt1; therapy-naive to ifn, pegifn, or rbv; hcv vl \>=100,000 iu/ml liver biopsy within 2 years prior to study enrolment showing necroinflammatory activity or presence of fibrosis normal retinal finding on fundoscopy within 6 months prior to day 1 age 18-65 years females and males with adequate contraception exclusion criteria: mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening previous treatment with protease inhibitor evidence of liver disease due to causes other than chronic hcv infection hiv-1 or hiv-2 positive hbv positive decompensated liver disease, or history of decompensated liver disease active or suspected malignancy or history of malignancy within the last 5 years history of alcohol or drug abuse within the past 12 months. usage of any investigational drug within 30 days prior to enrolment, or 5 half-lives, whichever is longer known hypersensitivity to any ingredient of the study drugs condition that is defined as one which in the opinion of the investigator may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study alpha-fetoprotein value \> 100ng/ml at screening; if \>20ng/ml and \ 1.5x uln wiht ratio of direct/indirect \>1. alt or ast levels \> 5x uln inr prolonged to \>1.5x uln exclusion criteria related to pegifn and/or rbv restrictions.
immunotherapy of cd8+nkg2d+ akt cell with chemotherapy to pancreatic cancer

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: a prospective study on the efficacy and safety of cd8+nkg2d+ akt cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: * 1. diagnosed as stage ii-iii pancreatic ductal adenocarcinoma patients by pathologic histology; * 2. pancreatic cancer after radical resection; * 3. eastern cooperative oncology group performance status less than 2; * 4. without radiotherapy or neoadjuvant chemotherapy; * 5. the man or the gestation and lactation women age between 18 to 80 years old; * 6. bone marrow functioned well: anc more than 1.5\*10\^9/ l, plt more than 100\*10\^9/lhgb more than 9 g/dl; * 7. blood biochemical indicators: ast（sgot）less than 1.5 ulnalt（sgpt）less than 1.5 uln, tbil less than 1.5 uln; * 8. pt and ppt are in normal ranges; * 9. three months prior to clinical research did not receive any other clinical research trials; * 10. patients are voluntary, and willing to sign informed consent. exclusion criteria: * 1. patients with other malignant tumors in the past five years; * 2. active viral or bacterial infection and cannot be controlled with appropriate anti-infection treatment; * 3. known as hiv infection, active hepatitis b virus or hepatitis c virus infection; * 4. known allergy to any kind of component of study drugs; * 5. history of connective tissue disease(such as lupus, scleroderma, nodular arteritis); * 6. patients with a history of interstitial pneumoniaslowly progressive difficulty in breathing and hoose sarcoidosissilicosis fibrose pulmonaire idiopathiquehylactic pneumonia or a variety of allergy; * 7. suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not cope with study treatment and monitoring requirements; * 8. at the same time patients participate in any other use of interventional medicine clinical research or checkers.

Keywords: pancreatic cancer