Kornimate/medical-research-clean huggingface dataset:
study of telcagepant (mk-0974) in participants with moderate to severe acute migraine with or without aura (mk-0974-011)

Conditions: Migraine

Summary: the purpose of this study is to investigate the efficacy and safety of telcagepant (mk-0974) compared to an approved medication for acute migraine. this study was conducted as a "triple-dummy" design; for each dose of study drug, participants each received 3 forms of study drug (2 capsules of active and/or placebo and 1 tablet of active and/or placebo) and were instructed to take one of each form of study drug at dosing time. the primary hypotheses of this study are that telcagepant is superior to placebo in pain freedom at 2 hours post-dose, pain relief at 2 hours post-dose, absence of photophobia at 2 hours post-dose, absence of phonophobia at 2 hours post-dose and absence of nausea at 2 hours post-dose.


Eligibility criteria:
inclusion criteria: * has at least 1 year history of migraine (with or without aura) * females of child bearing potential must use acceptable contraception throughout trial. exclusion criteria: * is pregnant/breast-feeding (or is a female expecting to conceive during study period) * has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (hiv) disease * has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) * has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption * has a history of cancer within the last 5 years.
treatment of acetabular fractures in elderly patients

Conditions: Acetabular Fracture

Summary: this retrospective study investigates surgical treatment of acetabular fractures in elderly patients (\>60 years of age), either undergoing joint-preserving surgery or joint- replacement. 1 year- outcome with regard to mobility and autonomy is assessed.


Eligibility criteria:
inclusion criteria: * surgical treatment of acetabular fracture between 2009 and 2018 exclusion criteria: * pathological fractures due to neoplasm or metastasis * status after implantation of an endoprosthesis

Keywords: hip joint replacement hip joint preserving surgery
study to assess the safety, tolerability, pharmacokinetics and antiviral activity of abt-267 in hcv infected subjects

Conditions: Chronic Hepatitis C Infection

Summary: the purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of abt-267 (also known as ombitasvir) administered as two-day monotherapy followed by abt-267 in combination therapy with other direct-acting antiviral agents (daas) abt-450 with ritonavir (abt-450/r) and abt-333 (also known as dasabuvir) plus ribavirin (rbv) in patients with chronic hepatitis c virus (hcv) infection without cirrhosis.

an open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of abt-267 as monotherapy for 2 days, followed by abt-267, abt-450 with ritonavir (abt-450/r) and abt-333 plus ribavirin (rbv) combination therapy for 12 weeks in treatment-naïve, non-cirrhotic patients with chronic hepatitis c virus (hcv) infection. the study included post-treatment follow-up for 48 weeks.

Eligibility criteria:
inclusion criteria: * male or female between the age of 18 and 70 years, inclusive, at time of enrollment. * subject has never received antiviral treatment for hepatitis c virus (hcv) infection. * body mass index (bmi) is ≥ 18 to \< 38 kg/m\^2. bmi is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m). * chronic hcv genotype 1-infection for at least 6 months prior to study enrollment. * subject has plasma hcv rna level \> 10,000 iu/ml at screening exclusion criteria: * history of severe, life-threatening or other significant sensitivity to any drug. * females who are or plan to become pregnant or breastfeeding or males whose partner is pregnant or planning to become pregnant. * recent history of drug or alcohol abuse that could preclude adherence to the protocol. * positive test result for hepatitis b surface antigen or anti-human immunodeficiency virus (hiv) antibodies. * any current or past clinical evidence of cirrhosis (e.g., ascites, esophageal varices), or a liver biopsy or fibrotest/aspartate aminotransferase to platelet ratio (apri) or fibroscan® showing cirrhosis or extensive bridging fibrosis.

Keywords: hepatitis c,genotype 1
mobile cardiac telemetry and advanced multi-parameter monitoring in patients wearing a novel device with biometric based medications changes

Conditions: Cardiac Arrhythmia

Summary: to determine the associations among biometric data and previously reported medication changes in the original maps study

1. each center that previously reported making a medication change in a maps patient based on biometric information will complete a case report form detailing the rhythm, symptom, medication and dosage change, and which biometric(s) were used to make this decision. 2. follow up at 6 months will be determined for all patients to assess the impact of the medication change.

Eligibility criteria:
inclusion criteria: * those that completed the maps study and that had medication changes based wholly or in part on biometric information. exclusion criteria: * those patients from the maps study that did not have medication changes.
vitamin d intervention trial in healthy chinese

Conditions: Vitamin D Deficiency

Summary: to determine the dose-response between the doses of vitamin d3 supplements and raised serum levels of 25(oh)d and also the dose of vitamin d3 required to achieve circulating 25(oh)d ≥ 75 nmol/l;

recent epidemiological studies suggested that serum 25-hydroxyvitamin d \[25(oh)d\] concentration ≥75 nmol/l appeared to be optimal for preventing cardiometabolic diseases and improving bone health. to achieve this goal, a daily intake of 1000 iu or equivalent amount from other sources, is needed, which is twice as much as the rda recommended by chinese nutrition society. meanwhile,epidemiological evidences show that large proportions of chinese may suffer vitamin d insufficiency or deficiency whereas the current rda in china might be too low to provide adequate vitamin d for people's health. in order to fill up this gap, therefore, it is essential to determine the dose-response between the doses of vitamin d3 supplements and raised serum levels of 25(oh)d and also the dose of vitamin d3 required to achieve circulating 25(oh)d ≥ 75 nmol/l.ultimately, the current study will provide important evidence for establishing optimal vitamin d requirement for chinese people

Eligibility criteria:
inclusion criteria: * age: 20-45 years. with vitamin d deficiency (25(oh)d \< 50 nmol/l) exclusion criteria: * bmi \< 18.5 kg/m2, or bmi ≥ 25 kg/m2 * total intake of calcium from diet or supplements \>1200mg/d, or fasting serum calcium level ≥2.75 mmol/l * participating in other clinical studies within previous 3 months * taking vitamin d supplements within previous 3 months * using medications that may affect vitamin d metabolism in previous 3 months; * concomitant with clinical conditions, like liver dysfunction (serum alanine transaminase (alt) ≥40 u/l; and/or aspartate transaminase (ast) ≥40 u/l; glutamyl transpeptidase （ggt）≥50 u/l; serum creatinine \ 120 µmol/l; urea nitrogen (un) \ 18 mg/dl, and/or urine acid \ 420 µmol/l; which may affect vitamin d metabolism; * history of drug or alcohol abuse (\>40 g/d) * women during pregnancy or lactation * individuals with mental disorders or current use of antidepressants, the conditions which may affect him or her understanding and unwillingness to the intervention; * having clinically diagnosed aids, hepatitis a, hepatitis b, tuberculosis and other infectious diseases.

Keywords: vitamin d deficiency dose response
stimulus-response and parkinson's disease (srlearning)

Conditions: Parkinson's Disease

Summary: in a computerized experiment, visual stimuli will be presented to the parkinson's disease patients and to the controls. they will respond to each image by acting on the keyboard in a specific manner. each participant will repeat that task 384 times per session. a break will be inserted every 12 tests so that participants can rest. the experiment consists of three sessions. each image will be presented three times. for the first two presentations it is assumed that a link will be created between the image and the task, and the image and action. in the third presentation, the same task and the same action will be maintained or will be swapped. in this way, it can be checked whether associations thus generated will affect the performance of the participants when tasks and actions will be incongruent.


Eligibility criteria:
inclusion criteria: * patient : parkinson's disease controls: healthy volunteers paired to patients on sex and age group exclusion criteria: * other neurological condition * known pregnancy or breastfeeding woman * no medical insurance coverage * person under legal protection
peripheral venous catheter trial: 3 day versus no routine change

Conditions: Phlebitis

Summary: the purpose of this study is to investigate the effects of extending the dwell time of peripheral intravenous cannulas on clinical outcomes and cost.

among hospitalized patients, intravenous therapy is the most common invasive procedure. it is associated with a phlebitis rate of between 1.1% and 63% and a central venous catheter related bacteremia rate of approximately 3.0%. catheter related blood-stream infections have an attributable mortality rate of 12% to 25%. factors thought to be associated with these complications include insertion techniques, catheter securement, type of catheter used, type of infusate and additives, post-insertion catheter care and length of time the catheter remains in place. current centers of disease control guidelines provide direction for intravenous therapy management including a recommendation that peripheral intravenous catheters should be re-sited every 72-96 hours. data underpinning the recommendation was collected in 1992, over a decade ago. since that time, there have been improvements in catheter design and composition, and prospective surveillance studies have demonstrated the safety of longer dwell times. to date, these observations have not been validated in adults, using randomized controlled trial methodology. re-siting intravenous cannulas causes discomfort to patients and has a high recurrent cost. the primary aim of the present study is to compare the rates of peripheral catheter-related blood stream infection, catheter-related local infection, phlebitis and obstruction between two groups of patients - those having routine catheter changes every 72 hours and those having catheter changes only when clinically indicated. specific hypotheses: that changing intravenous peripheral catheters when indicated by clinical signs compared to changing intravenous catheters every 3 days reduces the incidence of intravenous catheter related morbidity.

Eligibility criteria:
inclusion criteria: patients are eligible to join the peripheral venous catheter trial if: * they are inpatients at the royal brisbane and royal women's hospital who are at least 18 years of age and * they are scheduled or expected to have a peripheral venous catheter indwelling for at least 4 days. and * they have had their catheter inserted by a nurse from the iv therapy team exclusion criteria: * patients with an existing bloodstream infection * those receiving immunosuppressive treatment

Keywords: phlebitis/etiology infusions intravenous/adverse effects randomised controlled trial phlebitis/prevention adult time factors
using doxepin for urticaria

Conditions: Urticaria

Summary: isolated urticaria in the emergency department is widely treated by physicians with histamine blocking agents such as diphenhydramine, cetirizine, and cimetidine. doxepin is a tricyclic antidepressant that has been shown to have much higher concentrations of histamine blocking activity and therefore may be useful in treating urticaria. the purpose of this study is to compare the effectiveness of using doxepin verses a traditional medication, diphenhydramine (benadryl), in the treatment of isolated urticaria in the emergency department.


Eligibility criteria:
inclusion criteria: * between 18-65 years of age * presenting to upstate adult emergency department at either the downtown or community campuses. * diagnosed with isolated/acute urticaria * requires treatment with antihistamines to alleviate symptoms exclusion criteria: * pregnant women * prisoners * patients with altered mental status/have impaired decision-making capacity. * presenting with symptoms suggesting life threatening illness or anaphylaxis. * patients who have received any antihistamine (h1 antagonist) within the past 2 hours via any route of administration. * patients who have received an h2 antagonist within the past 2 hours. * patient received steroids by any route within the past 4 hours. * patient received epinephrine within the past 20 minutes. * patients currently taking concomitant p-glycoprotein inhibitors. * patients on any of the following cyp2d6 inhibitors: bupropion, fluoxetine, paroxetine, quinidine, tipranavir. * patients with a history of serotonin syndrome. * patients currently taking another tricyclic antidepressant, selective serotonin reuptake inhibitor, and/or serotonin-norepinephrine reuptake inhibitor. * patients who have a condition where an antihistamine may be contraindicated. * patients with a contraindication to anticholinergic medications. * history of adverse effects to tricyclic antidepressants or antihistamines. * patient who, based on their medical history or in the opinion of the clinician, have chronic urticaria, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response. * patients taking antileukotriene compounds (montelukast), calcineurin inhibitors (tacrolimus) or anti-serotonin agents (cyproheptadine)
zonisamide for fibromyalgia & migraine

Conditions: Fibromyalgia; Migraine

Summary: patients with fibromyalgia \& migraine are randomized to receive zonisamide or placebo.

study was not conducted due to logistical problems

Eligibility criteria:
inclusion criteria: * 18-65 with fibromyalgia \& migraine exclusion criteria: * allergy sulfa, liver or kidney disease, pregnant or not using contraception
relationship between atelectasis on ultrasound and pao2/fio2

Conditions: Atelectasis, Postoperative

Summary: the aim of this study is to find out relationship between pao2/fio2 and atelectasis finding on intraoperative lung ultrasound.

patients aged 20\~65 with asa class (american society of anesthesiologists physical status classification) 1 or 2 who are scheduled to undergo general anesthesia by using endotracheal intubation and arterial line cannulation will participate in this study. the patients with abnormal chest x-ray finding, pregnancy, arrhythmia, ischemic heart disease will be excluded from this study as well as the patients who are scheduled to undergo lung or heart surgery. after 5 minutes preoxygenation, patients will be monitored with pulse oxymetry, noninvasive blood pressure. general anesthesia will be proceeded with typical method and endotracheal intubation and arterial cannulation will be proceeded. after ventilator adjustment (tidal volume as 8 times of the patient's ideal body weight), airway pressures(peak and plateau) will be recorded. subsequently, arterial blood sampling will be proceeded while examination of the atelectasis findings on lung ultrasound before surgery. lung ultrasound examination will be proceeded on 6 sections of patient's basal segments of the lung, including anterior, lateral, posterior segment. juxtapleural consolidation, loss of a lines, presence of b lines, air bronchogram, loss of sliding sign and presence of pulse sign on lung ultrasound finding will be investigated and recorded. same ultrasound examination and arterial blood sampling will be followed after surgery ends. the results of pao2/fio2 on arterial blood samplings will be compared with findings on lung ultrasound before and after surgery.

Eligibility criteria:
inclusion criteria: * patients aged 20\~65 * with asa class 1 or 2 * who are scheduled to undergo general anesthesia by using endotracheal intubation and arterial line cannulation exclusion criteria: * the patients with abnormal chest x-ray finding, * pregnancy, * arrhythmia, * ischemic heart disease

Keywords: atelectasis postoperative lung ultrasound
efficacy and safety of so-cheong-ryong-tang on perennial allergic rhinitis

Conditions: Perennial Allergic Rhinitis

Summary: the aim of this study is to investigate the short and long term efficacy and the safety of scrt treatment for par


Eligibility criteria:
inclusion criteria: 1. age 18-60 years 2. presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) with severity score ≥ 2 (0 = no symptom, 1 = mild symptom, 2 = moderate symptom, and 3=severe symptom) 3. presence of nasal symptoms more than 2 consecutive years; and 4. positive reaction to the one or more perennial allergen in skin prick test. exclusion criteria: 1. treatment with nasal/oral corticosteroids within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; or nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week 2. presence of rhinosinusitis (paranasal sinus x-ray demonstrating mucosal thickening, or partial or complete opacification of the paranasal sinuses) 3. presence of hypertension (systolic ≥ 180 mmhg or diastolic ≥ 100 mmhg) 4. presence of abnormal liver function (aspartate transaminase (ast) or alanine transaminase (alt) ≥ 100 iu/l) or abnormal renal function (blood urea nitrogen (bun) ≥ 30 mg/dl or creatinine ≥ 1.8 mg/dl (male), 1.5 mg/dl (female)) 5. presence of neoplasm, severe systemic inflammation, other systemic disease that affects rhinitis 6. history of drug allergy 7. history of anaphylaxis for allergic tests 8. pregnancy or lactation 9. participation of other clinical study within the past 3 months.

Keywords: perennial allergic rhinitis herbal medicine korean medicine so-cheong-ryong-tang
a comparison of single port and four port laparoscopic gallbladder removal

Conditions: CHOLELITHIASIS

Summary: new minimally invasive surgical treatments are often outpatient procedures with low complication rates, promising fast recovery. the traditional physician-reported outcomes such as complication rates, blood loss, and hospital stay are not useful to guide treatment recommendations for one or the other minimally invasive procedure. this study aims to apply patient-reported outcomes developed within the nih framework for cancer research and chronic disease treatment to the comparative effectiveness research in minimally invasive procedures for benign disease.

to establish a pathway for comparative effectiveness using patient reported outcomes in minimally invasive surgery, we propose to use a readily available and easily reproducible model: cholecystectomy. each year in the united states, approximately 750,000 patients undergo a cholecystectomy. patients clearly prefer the laparoscopic approach over the open procedure to abdominal surgery. initial survey data suggest that patients may also prefer even less invasive approaches. currently, the standard operative procedure for a patient with symptomatic gallstone disease is a laparoscopic cholecystectomy performed under general anesthesia with four small abdominal incisions. although postoperative pain and cardiopulmonary and wound complications are much less compared to open cholecystectomy, considerable cost is generated from lost productivity in days off of work after the surgical procedure related in part to pain and the physiologic response to the stress of the operative procedure. anecdotal data suggest that fewer incisions, especially fewer transabdominal incisions, translate into less pain, less need for narcotic pain medication and faster recovery, but randomized trial data are needed. we propose to compare the effectiveness of the novel single-port cholecystectomy with laparoscopic cholecystectomy, the current standard of care.

Eligibility criteria:
inclusion criteria for this study are: 1) patients undergoing cholecystectomy in an elective setting for symptomatic gallstone disease. exclusion criteria for the study are: 1. patients \<18 years of age 2. pregnant patients 3. patients with asa-class \>3 4. patients undergoing treatment for chronic pain with opiates 5. patients with biopsy proven gallbladder cancer 6. patients who cannot provide consent for the study 7. patients not willing to participate in the study 8. prisoners/institutionalized individuals

Keywords: gallstone disease cholecystectomy minimally invasive surgical laparoscopic single port cytokine
hr-hpv multi-site opportunistic screening in liaoning, china

Conditions: Cervical Cancer

Summary: it is universally accepted that the persistent infection of high-risk human papillomavirus(hr-hpv) is the cause of cervical intraepithelial neoplasias and cancer. some researches indicate that the virus load may relate the extent of the disease. the objective of the study is to detect the virus load of 14 types hr-hpv among the participants, using a new hpv dna hybrid capture technology,sequentially find the diagnostic significance of virus load of hpv.

cervical cancer is the most common malignancy in women, the persistent infection of high-risk human papillomavirus(hr-hpv) is the definite cause,especially the infection of human papillomavirus 16/human papillomavirus 18(hpv16/hpv18). some researches indicate the virus load may relate the extent of the disease, but the sample capacity is not enough to receive a conclusive conclusion. and a specific quantity or a range of virus load which closely relates to cervical intraepithelial neoplasia 2(cin2) or worse is not studied. the aim of the study is to prove the association between the virus load and development of cervical intraepithelial neoplasias by detecting 14 types hr-hpv, and find the specific quantitative value or the range to assist physician to diagnose. a detect reagent named dalton hybrid 3(dh3) is used in the study, the mechanism of which is hpv dna hybrid capture technology, the experimental process include seven steps, denaturation, hybridization, the formation of dna-rna heterozygote, capture, detect, rinse panel, read data. study design: the organizations of the study contain ten hospitals in liaoning province in china,patients accord with inclusion criteria(n=10000) sign informed consent and fill out a information form. gynecologist collect cervical cell with sampling instrument. detecting the virus load of hpv16/hpv18 and other 12 types hr-hpv, the positive result is cut-off ≥1.0pg/ml, hpv16/hpv18(+) need colposcopy. the abnormal result of colposcopy requires biopsy, the participant who has abnormal result of biopsy need operative treatment. follow-up observation of all participants lasting 5 years are required.

Eligibility criteria:
inclusion criteria: the patients who are voluntary to accept screening with sexual life exclusion criteria: uterectomy, cancer, other serious illness, physical examination(pregnant women are not exclusive)

Keywords: hr-hpv opportunistic screening virus load multi-site