Kornimate/medical-research-clean huggingface dataset:
clinical research on advanced warning factors of respiratory injury in dermatomyositis

Conditions: Dermatomyositis; Respiratory Injury

Summary: dermatomyositis (dm) is a highly heterogeneous autoimmune disease characterized by rash and myasthenia. beside these, respiratory involvement is one of the common complications of dm. interstitial lung disease (ild) occur in approximately 90% of patients with dm, part of them may manifest rapidly progressive-interstitial lung disease (rp-ild), which progresses into respiratory failure that is difficult to correct and leads to death. early identification of rp-ild high risk group is of great significance to improve the prognosis of patients and to conduct following clinical studies. a simple, easy, convenient and reliable diagnostic tool has not yet acquired till now.

dermatomyositis (dm) is a highly heterogeneous autoimmune disease characterized by rash and myasthenia. beside these, respiratory involvement is one of the common complications of dm. interstitial lung disease (ild) occur in approximately 90% of patients with dm, part of them may manifest rapidly progressive-interstitial lung disease (rp-ild), which progresses into respiratory failure that is difficult to correct and leads to death. early identification of rp-ild high risk group is of great significance to improve the prognosis of patients and to conduct following clinical studies. a simple, easy, convenient and reliable diagnostic tool has not yet acquired till now. msg-jiangsu, short for myositis study group-jiangsu, was founded by department of rheumatology and immunology of eighteen tertiary hospitals. clinical research on advanced warning factors of respiratory injury in dermatomyositis (crawford) as a multicenter observational cohort study was started at jun 1, 2020. our cohort plan to recruit 1,000 adult inpatients. what's more, prognostic data from these dm patients were obtained by following up for 1 year. at the same time, clinical data and auxiliary examination results of the baseline dm patients were analyzed to look for factors that are associated with outcomes. then, regression analysis of influencing factors will help us to set up a multi-factor weighted score to forecast the prognosis of dm patients. finally, biological specimen from patients at baseline are used to look for biomarkers that predict prognosis by rna-sequencing, whole exon sequencing, proteomic screening and so on.

Eligibility criteria:
inclusion criteria: * adult patients meet the diagnostic criteria for dermatomyositis of bohan and peter exclusion criteria: * complicated with other connective tissue diseases * complicated with cardiovascular and respiratory disease caused by other reasons * interstitial lung disease caused by environment and drugs * patients with key research missing data or without informed consent

Keywords: dermatomyositis respiratory injury advanced warning
inappropriate shock reduction with parad+ rhythm discrimination

Conditions: Tachycardia

Summary: isis- icd study has been designed to evaluate the impact of parad+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up

the primary endpoint is to demonstrate that 95% of patients implanted with parad+ algorithm are free from inapproporiate shock compared to 92.5% in general icd population.

Eligibility criteria:
inclusion criteria: 1. patient eligible for implantation (according to current accepted guidelines, or scheduled for implant (primo-implant, replacement, upgrade) with a paradym/paradym rf (crt-d or dr-icd) within the next 30 days, or has already been implanted within the last 30 days 2. patient in sinus rhythm, or patients with paroxysmal atrial tachyarrhythmia or patients with persistent atrial tachyarrhythmia in whom a cardioversion is planned within three months exclusion criteria: 1. any contraindication for icd therapy 2. atrial lead not implanted 3. patient with permanent atrial tachyarrhythmia 4. patients implanted with a ventricular assist device (vad)

Keywords: primary prevention secondary prevention
clinical effects of a formula with modified protein levels and fat blend in preterm infants

Conditions: Infant, Premature, Nutrition

Summary: this study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend.

when an infant is born prematurely, the supply of nutrients supporting normal growth and development is interrupted. there is less time to accrue adequate nutrient stores and foetal tissue. the nutritional goal for the preterm infant is to have satisfactory functional development and catch up on growth to match the rate of a full term infant. to achieve this, it is recommended for the infant to have adequate protein intake and suitable fat blend.

Eligibility criteria:
inclusion criteria: * less than or equal to 33 weeks 0 days * birth weight less than or equal to 2000g. * infant is anticipated to receive the study formula for ≥ 3 consecutive weeks * at entry into full enteral feeding, study formula will be provided at 50% or more of total enteral feedings. * written informed consent has been obtained from the parent/legally authorized representative (lar). exclusion criteria: * peri-/intra-ventricular hemorrhage * renal disease * hepatic dysfunction * major congenital malformations * suspected or documented systemic or congenital infections * cardiac, respiratory, endocrinologic, hematologic, gi, or other systemic diseases that may impact growth * suspected or documented maternal substance abuse * infants who have received any experimental treatment or intervention
acamprosate for treatment of compulsive behaviors and craving in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine how many patients with parkinson's disease have compulsive behaviors, and what types of behaviors they have. this study will also determine if acamprosate can be used to treat compulsive behaviors in parkinson's disease patients.


Eligibility criteria:
inclusion criteria: 1. idiopathic parkinson's disease 2. active dopaminergic therapy at stable dose for one month (levodopa or dopamine agonist) 3. able and willing to complete rating scales 4. presence of one or more compulsive behavior based on responses to rating scales (defined as \>5 on the sogs; \>17 on the ybocs-sv and ybocs-cuv; \>1.7 on the scs for women and \>2.1 on the scs for men; \>15 on the ybocs-be, \>5.5 on the cq). 5. written informed consent inclusion criteria (controls): 1. no significant psychiatric disease 2. able and willing to complete rating scales 3. written informed consent exclusion criteria: 1. no anticipated need for adjustment of medications for parkinson's disease 2. current participation in another clinical study 3. history of unstable psychiatric disease (as determined by the principal investigator) 4. women of childbearing age not using appropriate contraceptive methods (oral contraceptives, condoms, surgery)

Keywords: parkinson's disease impulse control behaviors dopa-dysregulation
magnetic anastomosis device relief of malignant gastric outlet obstruction

Conditions: Gastric Outlet Obstruction

Summary: the purpose of this study is to determine if the cook magnetic anastomosis device can be used to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring treatment of gastric outlet obstruction caused by malignancy.

surgical treatments for malignant gastric outlet obstructions carry substantial risks and are associated with postoperative morbidity. external compression from advancing tumor or tissue growth through the stent can cause stenosis or re-obstruction. in these patients, the creation of a patent fistula that allows gastric emptying may significantly improve palliation. minimally invasive techniques that carry no greater risks than enteral stenting may provide a viable palliative treatment. the primary objectives are safety, and successful creation of a gastro-jejunal anastomosis. secondary objectives are successful resumption or improvement in the ability to tolerate po feeding, rate of stent migration, and duration of stent and anastomosis patency.

Eligibility criteria:
inclusion criteria: * patients with unresectable malignancy with, or at risk of developing gastric outlet obstruction with gooss ≤ 2 * karnofsky performance score ≥ 60 exclusion criteria: * patient is unable to understand and execute informed consent * age below 18 years * patients with any prior gastrointestinal surgery that significantly alters gastrojejunal anatomy * implanted cardiac pacemaker, defibrillator or ventricular assist device * requirement for chronic anticoagulation, or with uncorrectable coagulopathy * patients receiving chronic steroids or other drugs that may impair wound healing or formation of an intact anastomosis * simultaneously participating in another investigational drug or device * patients with suspicion of, or documented multiple small bowel strictures

Keywords: endoscopy esophagogastroduodenoscopy gastric outlet obstruction gastro-jejunostomy gastric malignancy duodenal stent malignant gastric outlet obstruction
assessment of primary androgen deprivation therapy for non-metastatic prostate cancer among elderly

Conditions: Prostate Cancer

Summary: the widespread availability of screening coupled with high risks of over diagnosis, over treatment, and a rising risk of dying from competing causes of deaths pose a major challenge for prostate cancer patients and our health care system. data on outcomes and identification of patients who are likely to benefit from therapies are urgently needed to empower patients and health professionals and to allocate limited health resources wisely. the long-term goal of this population-based study is to improve prostate cancer care for elderly patients. in 2004, approximately thirty percent of the 230,110 new prostate cancer cases diagnosed will be in men over age 75. elderly men have a high risk of being diagnosed with prostate cancer, but a relatively low risk of dying of this disease, and are often excluded from cancer trials. while the value of primary androgen deprivation for localized prostate cancer remains questionable, this treatment is widely used among elderly patients. currently, there is insufficient outcomes data to guide treatment choices for elderly patients.the following are the key background considerations that provide the rationale for this proposed project:· prostate cancer is prevalent among elderly men. · over diagnosis and competing causes of death are important issues for elderly men with prostate cancer.· androgen deprivation therapy (adt) is being increasingly used as primary therapy among elderly patients with localized disease· there are insufficient outcomes data to support the use of primary androgen deprivation for non metastatic prostate cancer· preliminary datathe study population in this sub-project is a sub-sample of the large study (irb # 5177 ) and the research methods are identical in both studies.


Eligibility criteria:
inclusion criteria: * diagnosed at age 75 or older. * diagnosed with non-metastatic prostate cancer in 1992-1999. * enrolled in medicare for the 12 months before diagnosis for an adequate assessment of baseline comorbidity. * enrolled in medicare part a and part b through death or the end of the study period to have an adequate claim history of cancer treatment over the follow-up period. * alive for at least 6 months after cancer diagnosis. this criterion will remove men who are diagnosed at death or who are dying and have severe comorbidities, and are therefore poor candidates for 'aggressive' cancer interventions. exclusion criteria: * enrolled in medicare managed care plans during the study period since no medicare claims are available during the period of enrollment. * have other types of cancer. this criterion will ensure that all cancer therapies identified from the medicare claims are for prostate cancer exclusively.

Keywords: prostate cancer
auditory diagnostics and error-based treatment

Conditions: Deafness, Bilateral; Deafness Neurosensory; Deafness Permanent

Summary: the main objective of this study is to assess the effectiveness of an integrated program of fitting and training interventions aimed at reducing unexpected variability and addressing the specific error patterns of each recipient. the participants will undergo 1 visit lasting approximately 2 hours at the radboud university medical center's ent department, where they will undergo a series of diagnostic tests. some of the participants will also be asked to self-administer additional tests using a windows tablet. based on the outcomes of speech recognition tests in quiet at the first visit, the participants will be called for follow-up interventions concerning both the fitting of their ci and personalized auditory training based on their personal error patterns. these interventions will take place over the course of approximately 5 months and will be made up of three follow-up visits and a period of self-administered training through a mobile application on a tablet. one final follow-up visit will check whether any changes from the interventions are retained after four weeks.


Eligibility criteria:
inclusion criteria: * adult (over 18 years old at the time of inclusion ) * post-lingually deafened (the subject had a good mastery of spoken language before onset of deafness) * native dutch speaker * implanted, either unilaterally or bilaterally, with a cochlear implant manufactured by cochlear ltd (i.e., a nucleus ® implant). * implanted with one of the following implants: ci422, ci512, ci522, ci532, ci24m, ci24r, ci24re. * implanted for at least 12 months. exclusion criteria: * known abnormally formed cochlea * known pre-implantation ossification of the cochlea * severe cognitive disorders affecting their ability to understand spoken language * intense facial nerve stimulation * unaddressed electrode tip foldover * more than 4 electrodes deactivated because of malfunction (open/short circuit) or lack of response * additional illnesses or handicaps that could impact ability to participate in study, at the clinician's discretion.

Keywords: cochlear implant speech perception hearing speech prosthesis fitting rehabilitation
clinical application of dual sentinel lymph node staining method in breast cancer

Conditions: Breast Cancer

Summary: this study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(icg) and radioisotope (ri) in breast cancer patients who receive neoadjuvant chemotherapy. over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages. in this study we expects using mixture of indocyanine green (icg) with radioisotope (ri) has potential to improve sentinel lymph node (sln) mapping in breast cancer patients who receive neoadjuvant chemotherapy.

* 5 patients who receive neoadjuvant chemotherapy with cn1-cn2 or ct2 on tnm staging * sentinel lymph node biopsy(slnb) by sentinel lymph node staining method using mixture of indocyanine green (icg) with radioisotope (ri). * indocyanine green (icg) penetrates human tissue to depths of several millimeters to 2cm, and the fluorescence can be detected percutaneously in real time. * using ri only has several disadvantages such as invisibility,interference. ri only detect sound or confirm numerical value through gamma probe. * icg can be visualized with a fluorescence imaging system * confirm identification rate of sentinal lymph node biopsy, and duration of sentinel lymph node biopsy

Eligibility criteria:
inclusion criteria: * breast cancer patients who receive neoadjuvant chemotherapy * cn1-cn2 or ct2 on tumor lymphnode metastasis classification(tnm) * ecog performance status 0 or 1 * consented patients with more than 20 years, less than 70 years exclusion criteria: * history of breast cancer * early stage breast cancer * history of excisional or incisional biopsy or axillary dissection * inflammatory breast carcinoma * cn3 on tumor lymphnode metastasis classification(tnm) * history of hormone therapy or targeted therapy * stage 4 breast cancer * pregnancy

Keywords: neoadjuvant chemotherapy indocyanine green (icg) radioisotope (ri) near infrared fluorescence camera
pms retrospective study of wirion performance in patients undergoing saphenous vein graft (svg) intervention

Conditions: Stenosis

Summary: the objective of this study is to collect data on the use of the wirion system in patients undergoing percutaneous intervention of saphenous vein graft (svg).

wirion system is used as protection device in patients undergoing svg stenting procedure. this retrospective study collects data on the usability of the wirion during the procedure.

Eligibility criteria:
inclusion criteria: * patients underwent percutaneous intervention (pi) of svg stenting in which the wiriontm system was used. * patient is greater than or equal to 18 years of age. exclusion criteria: * undergone cardiac surgery in the past 60 days before the procedure.
cardiopulmonary exercise testing in interstitial lung disease

Conditions: Interstitial Lung Disease

Summary: in patients with interstitial lung diseases (ild) dyspnea is the most often symptom. pulmonary lung function tests often do not show the dyspnea. aim of the study is to evaluate cardiopulmonary exercise testing concerning therapeutic monitoring in ild.


Eligibility criteria:
inclusion criteria: * informed consent provided * ild exclusion criteria: * no informed consent * no ild
a study to evaluate the effect of diltiazem on the pharmacokinetics (pk) of bms-986141 in healthy subjects

Conditions: Ischemic Stroke

Summary: this study is to evaluate the effect of dilitazem on the single-dose pk of bms-986141 with parameters like cmax, auc(inf), and auc(0-t).


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ecg), and clinical laboratory tests including coagulation parameters. 3. subjects with body mass index of 18 to 32 kg/m2, inclusive. 4. women participants must have documented proof that they are not of childbearing potential. 5. men who are sexually active with wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with bms-986141 plus 5 half-lives plus 90 days for a total of 100 days post-treatment completion. exclusion criteria: 1. acute or chronic medical illness, subjects with bleeding diathesis, gastrointestinal ulcer, hepatic disease. 2. history of nausea, diarrhoea, recent surgery, use of tobacco or nicotine containing products, drug or alcohol use, important arrhythmias, sinus bradycardia, chronic headaches, history of multiple events of dizziness, periodontal disease and recent blood donation. 3. prior exposure to bms-986141 or prothrombin complex, any investigational product or placebo within 4 weeks of study treatment start, any prescription or over the counter drugs except those cleared by bms clinical monitor. 4. history of allergy to bms-986141, dilitazem or any other significant drug allergy or adverse reaction to anticoagulants or antiplatelets. 5. evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecgs, or clinical laboratory determinations beyond what is consistent with the target population
radiation therapy or surgery in treating patients with previously untreated vulva cancer with positive groin lymph nodes

Conditions: Vulvar Cancer

Summary: rationale: patient abstract not available purpose: patient abstract not available

objectives: i. compare the efficacy of pelvic node resection vs. bilateral groin and pelvic node irradiation for invasive squamous cell carcinoma of the vulva in patients having positive groin nodes. outline: randomized study. arm i: surgery. deep pelvic node dissection on sides containing positive nodes only. arm ii: radiotherapy. megavoltage (1 mev or greater) to bilateral groin and pelvic nodes. projected accrual: anticipated annual accrual is approximately 200 patients, with an active phase estimated at 2.5-3 years. protocol closed july 1984.

Eligibility criteria:
disease characteristics: see general eligibility criteria patient characteristics: see general eligibility criteria

Keywords: stage iii vulvar cancer squamous cell carcinoma of the vulva
validation of noninvasive blood pressure device

Conditions: Healthy; Hypertension; Hypotension

Summary: this is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers. the purpose of the study is to validate the clinical performance of the masimo noninvasive blood pressure device compared to reference auscultatory measurements.


Eligibility criteria:
inclusion criteria: * age 18 years and older * site 1; stage 1 only: subjects with a history of hypertension (\> 140/85 mmhg) or hypotension (\< 100/60 mmhg) within the last 3 months. stage 2 only: no criterion for blood pressure * site 2; stage 1 and 2: subjects with systolic blood pressure \< 140/90 mmhg. * ability to provide informed consent exclusion criteria: * febrile subjects * subjects displaying respiratory symptoms, or with suspected respiratory illness * subjects whose skin is not intact, e.g. wounded, in or at the vicinity of the cuff placement site * subjects with removed axillary lymph nodes or mastectomies * subjects with peripheral artery disease * pregnant women (patient reported) * subjects deemed not suitable for the study at the discretion of the investigator
efficacy and safety of infliximab biosimilar remsima in psoriasis

Conditions: Psoriasis

Summary: psoriasis is a persistent condition which demands prolonged management, so it puts heavy financial as well as psychological burden on patients. severe psoriasis makes work impossible for patients. if it affects exposed parts of the body, it may lead to decrease in self-esteem, social avoidance, and shame. patients with even mild form of psoriasis have high stigma as compared to other cutaneous diseases. as a result, psoriasis affected individuals experience greater difficulty in social interactions and employment. patients experience symptoms in psoriasis includes bleeding, itching and inflamed joints. psoriatic patients develop psoriatic arthritis approximately at 40 years of age which contributes to fatigue in these individuals. moreover, early age onset of psoriasis leads to more physical impairment. hence, patients get trapped in a vicious cycle as stress leads to further aggravation of disease. the european medicine agency has given its approval regarding the usage of infliximab bio similar remsima for psoriasis after taking in consideration its effectiveness from other studies conducted on ankylosing spondylitis and rheumatoid arthritis. this study is being conducted as no data is present on remsima sc in psoriasis patient in pakistan.


Eligibility criteria:
inclusion criteria: * age between 18-59 years * both genders * diagnosed patient of psoriasis * moderate to severe psoriasis * not responding to topical treatment * not responding to conventional systemic treatments i.e., methotrexate, cyclosporine and phototherapy. * pasi score \>10. exclusion criteria: patient with active systemic lupus erythematosus or ana positive patients. * patient with active tuberculosis. * extremely immunocompromised patient. * patient with cardiac disease. * patient with allergic reaction to remsima. * pregnancy and lactation.