Kornimate/medical-research-clean huggingface dataset:
nicuseq: a trial to evaluate the clinical utility of human whole genome sequencing (wgs) compared to standard of care in acute care neonates and infants

Conditions: Rare Diseases

Summary: prospective, multi-site, study to evaluate the clinical utility of cwgs in a proband. one group will receive cwgs and a clinical report approximately 15 days after blood samples are received, while the other group will continue to receive standard of care until day 60. the standard of care group will receive cwgs and a clinical report at day 60 as part of secondary and tertiary analyses. both groups will be followed for a total of 90 days.

this is a prospective, multi-site, randomized study to evaluate the clinical utility of cwgs in each proband. throughout this study, each proband will receive soc testing as determined by the site clinical team. upon enrollment in the study, each proband will be randomly assigned to the 15 day cwgs group or the soc group. soc is defined as the management of the proband's care under the same or similar conditions as if the proband was not enrolled in this study. a blood sample from each enrolled proband will be collected and shipped to the illumina clinical services laboratory ("icsl"), which is clinical laboratory improvement amendments (clia)-certified and college of american pathologists (cap)-accredited. icsl will conduct cwgs testing with the trugenome undiagnosed disease test ("trugenome test"). the trugenome test cwgs results will be provided to the principal investigator (pi) or designee who will evaluate each proband test outcome based on the aggregate medical information, informed by the cwgs or soc results.

Eligibility criteria:
proband inclusion criteria 1. current admission in a neonatal intensive care unit/intensive care unit at a participating clinical site at the time of enrollment from day of life 0 to 120 days 2. a suspected genetic etiology of disease, based on objective clinical findings or other phenotypic defects for which a genetic test would be considered 3. must be able to have 1 - 1.25 ml tube of whole blood drawn for testing 4. one parent of the proband must be able to provide written informed consent 5. at least one biological parent must agree to participate and provide at least 4 ml of whole blood for testing exclusion criteria: proband exclusion criteria 1. known non-genetic cause(s) of disease, disorder, or phenotypic defect 2. the phenotype is fully explained by complications of prematurity 3. trisomy 13, 18 or 21 or turner syndrome is the likely diagnosis; such a proband will be eligible if a diagnostic karyotype is normal 4. blood transfusion within 48 hours (each proband will be re-eligible 48 hours after the most recent transfusion) 5. the pi decides that the study is not in the best interest of the proband (for example, the neonate or infant is at a high risk of severe morbidity or mortality within the next 7 days and these risks could be mitigated by alternative testing). subsequent eligibility for enrollment of each proband is at the discretion of the site pi.

Keywords: icu intensive care unit
chymase angiotensin-(1-12) axis in hypertensive disease

Conditions: Hypertension

Summary: determine the presence of the human sequence of angiotensin-(1-12) in plasma of ten untreated hypertensive subjects and after 4 week with lisinopril 40 mg every day. determine the blood pressure reduction with lisinopril 40mg.

determine the presence of the human sequence of ang-(1-12) in the plasma of ten normal male and female hypertensive patients at baseline and after 4 weeks on lisinopril 40mg every day. measure concentrations of ang-(1-12) in either spot urine collections from ten male and female hypertensive patients at baseline and after 4 weeks of lisinopril 40mg every day.

Eligibility criteria:
inclusion criteria: 1. capable of reading, comprehending the consent process and providing written informed consent to participate in the study 2. subject willing to comply with all study visits/procedures and be available for the duration of the study 3. male or female 40 years of age to 75 years of age 4. male and female subjects naive to anti-hypertensive medications or receiving no anti-hypertensive medication for at least 6 months prior to visit 1 5. stage i-ii hypertension defined as a baseline mean seated cuff diastolic blood pressure of equal/over 90 mm hg and equal/less 109 mm hg and/or systolic blood pressure equal/over 140 mm hg and equal/less 179 mm hg on visit 1 6. women may be enrolled if all three of the following criteria are met: have a negative urine pregnancy test at visit 1, for females of childbearing potential are not breastfeeding do not plan to become pregnant during the study and if one of the following three criteria is met have had a hysterectomy or tubal ligation at least six months prior to signing the informed consent form have been postmenopausal for at least one year are of childbearing potential and will practice one of the following methods of birth control though out the study: oral, patch, injectable, or implantable hormone contraception, intrauterine device, diaphragm plus spermicide or female condom plus spermicide. abstinence, partner's vasectomy are not acceptable methods of contraception exclusion criteria: -
glycemic control and treatment satisfaction in children with type 1 diabetes using insulin pumps

Conditions: T1DM

Summary: background: the use of insulin pumps in pediatric patients with type 1 diabetes(t1d) has expanded, with lack of data comparing between the different devices. objective: to compare prospectively glycemic control, technical difficulties and quality of life (qol) between 3 pump devices during the first year of use . methods: a prospective observational trial, based on clinical data retrieved during 12 months of follow- up. inclusion criteria included t1d patients, ages 1-18 years, who started pump therapy as part of their clinical care in 4 university affiliated medical centers. the devices fully reimbursed by national health insurance are: minimed™ 640g , minimed® veo™, animas® vibe®, and abbott omnipod®. comparison parameters included quality of life (qol), frequency of technical difficulties, skin reactions, discontinuation rate, glycated hemoglobin (hba1c), mean glucose, total daily insulin dose (tdd) , pump setting parameters and bmi.


Eligibility criteria:
inclusion criteria: * diagnosis of t1d recorded by a pediatric endocrinologist * attending periodic clinic visits, and starting pump mode of therapy between may 2015 and march 2017. exclusion criteria: • no restrictions on hba1c value at study recruitment or on use of cgms -
vanderbilt-zambia innovations in global health technologies

Conditions: Malaria Diagnosis

Summary: investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to process capillary blood in order to improve the sensitivity of already approved rapid diagnostic tests (rdts) for detection of human malaria infection. results will be compared to those obtained using unenhanced capillary blood specimens directly applied to approved malaria rdts. participants seeking care for possible malaria in zambia will be recruited to enroll in the study.


Eligibility criteria:
inclusion criteria: * individuals giving written informed consent for themselves * children under the age of 18 for whom a parent or guardian can give consent * individuals seeking care or treatment of suspected or possible malaria * individuals being screened as a contact of someone with recent malaria * other individuals willing to have their blood tested for malaria exclusion criteria: * anyone over 18 unwilling or unable to provide informed consent * anyone under 18 who does not have a parent or guardian to give consent * anyone between the age of 12 and 18 who does not give assent
adipokines as predictors of foot function, pain, and disability in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Healthy Control

Summary: significant increase in the levels of serum adiponectin, ada, and hscrp was reported in all ra patients compared to controls. compared to patients with early ra, the increase in these markers significantly correlated with disease activity (das-esr), lower f-bmd, radiographic scoring, pain, ffi, and functional limitations in patients with established ra. adiponectin showed a negative correlation with serum levels of both ada and hscrp. by using roc curve analysis, optimal cut-off values of adiponectin (28.8 µg/ml), ada (27.3 iu/l), and hscrp (1.6 mg/l) could be used to estimate early ra in 45 % of the patients. similarly, using cut-off values of adiponectin (32.8 µg/ml), ada (26.1 iu/l ml), and hscrp (2.5 mg/l), established ra could be predicted in 55 % of patients with 98-99% accuracy.

the present study attempts to evaluate the efficacy of adiponectin, ada, and foot bone mineral density (fbmd) as predictors of the disease progression in patients with rheumatoid arthritis. a total of 80 ra patients and eighty age and sex-matched healthy controls were included in this study.

Eligibility criteria:
inclusion criteria: * patients who diagnosed with rheumatoid arthritis according to american rheumatology association criteria and radiographic analysis for at least 10 years previously were randomly involved in this study * not receiving any drugs affecting the data obtained * had normal daily diets exclusion criteria: * subjects with obvious ischemic heart disease (angina, myocardial infarction, and lead electrocardiogram abnormalities), * hcv, hbv, chronic liver and kidney diseases, hypothyroidism. * drugs (diuretics; oral contraceptives).

Keywords: rheumatoid arthritis, adipokines, foot function index, f-bmd
a predictive model based on narrow band imaging for early gastric cancerous lesions

Conditions: Early Gastric Cancer

Summary: without high diagnostic efficacy of endoscopic forceps biopsy (efb) and with low diagnostic efficacy of narrow band imaging (nbi) in novice endoscopists and endoscopists of community hospitals in china, it is urgent to improve diagnostic efficacy for gastric cancerous lesions.the investigators will conduct a study to develop and validate a diagnostic model based on nbi for early gastric cancerous lesions under endoscopic observation.

endoscopic forceps biopsy (efb) is considered the gold standard and most commonly used for histological diagnosis of gastric epithelial neoplasia before proper management.many studies have shown that there exist considerable discrepancies between efb and subsequently resected specimens with discrepancy rate of 27.1-44.5%. on the other hand, with low diagnostic efficacy of narrow band imaging (nbi) in novice endoscopists and endoscopists of community hospitals in china, not higher diagnostic accuracy of gastric cancerous lesions could be observed. here, the investigators will conduct a study to develop and validate a diagnostic model based on narrow band imaging for early gastric cancerous lesions under endoscopic observation, trying to improve overall diagnostic efficacy for gastric cancerous lesions.

Eligibility criteria:
inclusion criteria: * suspected of having a cancerous lesions * the age of patients is from 40-80 years * patients must undergo esophagogastroduodenoscopy exclusion criteria: * clinical diagnosis of advanced gastric cancer * acute upper gastrointestinal bleeding * severe systemic diseases * refuse to attend the study
omegaven expanded access protocol

Conditions: Parenteral Nutrition Associated Liver Disease

Summary: omegaven is an intravenous fat emulsion (ife) comprised of omega-3 fatty acids derived from fish oil. it will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole ife source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. the study will evaluate the safety and efficacy of omegaven use in pediatric patients with pn dependence and pnald.


Eligibility criteria:
inclusion criteria: * patients will be pn dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require pn for at least another 30 days * parenteral nutrition associated liver disease (pnald) as defined as a direct bilirubin of ≥ 2 mg/dl on the last two consecutive bilirubins while on pn. other causes of liver disease should be excluded. a liver biopsy is not necessary for treatment. * failed standard/conventional therapies to prevent progression of pnald. * age newborn to 17 years of age * signed informed consent. exclusion criteria: * allergy to eggs and/or shellfish * female who is pregnant or lactating * severe hemorrhagic disorder * other causes of chronic liver disease (hepatitis c, cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,) * 18 years of age or older * parent/legally authorized representative is unwilling to consent.

Keywords: cholestasis short bowel syndrome
the efficacy and safety of liangxue ointment in the treatment of hand-foot syndrome caused by vegfr-tki drugs

Conditions: Hand-Foot Syndrome

Summary: this study was a prospective, single-center randomized controlled trial. the subject of this study is to evaluate the effectiveness and safety of traditional chinese medicine liangxue ointment in the treatment of hand-foot syndrome caused by vegfr-tki drugs.

this study was a prospective, single-center randomized controlled trial. patients with hand-foot syndrome caused by vegfr-tki drugs were randomly divided into the experimental group and the control group at a ratio of 1:1 according to the numerical randomization method. all patients are required to avoid inappropriate local friction of hands and feet; avoid heavy physical labor and sun exposure; eat a light diet, avoid spicy and irritating foods, and keep warm. the control group received urea cream application, and the experimental group received liangxue ointment application.

Eligibility criteria:
inclusion criteria: * ≥18 years old, both men and women are welcome; * patients with pathologically confirmed malignant tumors; * receive treatment with vegfr-tki drugs; * hand-foot syndrome associated with vegfr-tki drugs is judged by the researcher; * no skin lesions on hands and feet before receiving vegfr-tki drug treatment; * no allergies to the traditional chinese medicine components of the trial drug; * be conscious, have language expression or reading skills, and can communicate normally; * estimated survival time ≥3 months; * ecog score ≤ 2; * ability to comply with the trial protocol, as judged by the investigator; * women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of the trial drug; men of reproductive potential or women with the possibility of pregnancy must use highly effective contraceptive methods (such as oral contraceptives, oral contraceptives, intrauterine device, libido control or barrier method combined with spermicide) and continue contraception for 6 months after the end of treatment; * voluntarily participate in this clinical trial, understand the research procedures and be able to sign the written informed consent form. exclusion criteria: * those with skin ulcers on hands and feet; * known allergy to ingredients of liangxue ointment; * have used other targeted drugs and chemotherapy drugs that cause hfs within 4 weeks; * those who have skin lesions on their hands and feet before treatment with vegfr-tki drugs or those who have a history of skin diseases; * use of medications within 2 weeks that may affect study results (topical antibiotics, topical steroids, and other topical treatments); * with serious accompanying diseases, such as severe hypertension, diabetes, thyroid disease, heart disease, and mental illness; * poor compliance and refusal to cooperate with follow-up visits; * other reasons lead the researcher to believe that they are not suitable to participate in this study.

Keywords: axitinib hand-foot syndrome renal cell carcinoma melanoma vegfr-tki
boom-ibd2 pivotal clinical trial

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases

Summary: the boom-ibd2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of ibd.


Eligibility criteria:
inclusion criteria: * male or female * 18 to 85 years of age * diagnosed with ulcerative colitis * ability and willingness to consent to participate by signing the informed consent form * ability to comply with the protocol and willingness to comply with all follow up requirements exclusion criteria: * any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study * any psychiatric or personality disorder at the discretion of the study investigator * any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess) * active clostridium difficile infection of the colon * active cytomegalovirus (cmv) infection of the colon * evidence of colonic perforation * fulminant colitis requiring emergency surgery * microscopic, ischemic or infectious colitis * unresected neoplasia of the colon * colonic stricture unable to pass a colonoscope * current evidence of cancer in the gastrointestinal tract * current participation in another clinical trial * previous history of surgery for ulcerative colitis, or probably to require such intervention * previously implanted with a neurostimulation device or participated in a neurostimulation trial * inability to operate the patient programmer
evaluation of the efficiency of the chronic pain management training program

Conditions: Nursing Caries; Chronic Pain

Summary: the research will be conducted to evaluate the effectiveness of the web-based chronic pain management training program developed for nursing students. it is planned in a randomized controlled triple-blind design with the final year nursing students of the nursing department of çankırı karatekin university in a pre-test-post-test order.


Eligibility criteria:
inclusion criteria: * nursing grade 4 * with internet access * students who volunteered to participate in the research exclusion criteria: * having a diagnosed psychiatric disorder * difficulty in understanding and speaking turkish * graduated from health vocational high school * attending any training on pain and/or having a pain education certificate

Keywords: chronic pain nursing student education web-technology based education
motivational enhancement for spanish speaking individuals - 1

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to compare a three-session spanish version of motivational enhancement therapy (met) to standard treatment to see how well met engages and retains spanish-speaking clients in outpatient substance abuse treatment.


Eligibility criteria:
inclusion criteria: all subjects included unless medical/psychiatrically unstable

Keywords: behavioral intervention
diagnosing tuberculosis in hiv infected children in peru

Conditions: Tuberculosis; Tuberculosis, Pulmonary; HIV Infections

Summary: tuberculosis is a major cause of mortality among aids patients in the developing world. the diagnosis of tuberculosis in hiv infected children is complicated by inefficient and expensive tuberculosis tests and vague diagnostic criteria. this study will evaluate the accuracy and efficiency of several different tuberculosis tests that could be used in developing countries.

hiv infection has been shown to increase mortality from tuberculosis (tb) fivefold in parts of subsaharan africa. increasingly, hiv infected children in developing countries are becoming infected with mycobacterium tuberculosis (mtb) and dying at an early age. this project will evaluate novel approaches to the diagnosis of aids-related pediatric tb in a hyperendemic setting using rapid, cost-effective mtb culture and susceptibility methods based on direct microscopic observation techniques. this study will utilize alternative noninvasive mtb tests that are performed on nasopharyngeal aspirates (npa) and stool. an optional component will assess improved rapid detection of mtb by a semi-nested polymerase chain reaction assay (n2 pcr), a technique appropriate for regional reference laboratories in developing countries. two hundred-sixty children with clinically diagnosed pulmonary tb (including at least 100 hiv infected children) from the hospital del nino, lima, peru, and 260 age-matched controls will be enrolled in this study. mtb will be detected in npas and stool by new and traditional culture methods and by n2 pcr. gastric aspirates from children with a clinical diagnosis of tb will also be tested. children with a positive n2 pcr but without clinical evidence of tb requiring antituberculous therapy will be followed longitudinally.

Eligibility criteria:
inclusion criteria * inability to produce sputum sample * clinical picture suggestive of pulmonary tb, score \> 7 according to the stegen and toledo criteria as adapted by who exclusion criteria * antituberculous therapy

Keywords: pediatrics polymerase chain reaction
effect of variable psv in acute lung injury: part i and part ii

Conditions: Acute Lung Injury (ALI); Acute Distress Respiratory Syndrome (ARDS)

Summary: noisy pressure support ventilation (noisy-psv) would lead to improved lung function, while preserving respiratory muscle unloading. basically, noisy psv differs from other assisted mechanical ventilation modes that may also increase the variability of the respiratory pattern (e.g. proportional assist ventilation) by the fact that the variability does not depend on changes in the patient's inspiratory efforts. the aim of this study is to evaluate the optimal variability for noisy psv in patients with ali based on its effects on respiratory mechanics, breathing comfort, gas exchange, and hemodynamics. the investigators hypothesize that noise in pressure support leads to variations in vt that are able to improve lung function and that physiologic variables respond differently to the degree of variability in pressure support


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * intubated/tracheostomized patients in assisted mechanical ventilation * pao2/fio2 100-300, with peep ≥ than 5 cmh2o. exclusion criteria: * pregnancy * history of chronic lung disease (copd) * presence of thoracic drainage

Keywords: ali ards noisy pressure support ventilation