Kornimate/medical-research-clean huggingface dataset:
hypertonic saline vs. mannitol for elevated intercranial pressure

Conditions: Traumatic Brain Injury; Elevated Intracranial Pressure

Summary: this study examines the role of osmotic agents in controlling brain swelling in brain injured individuals. two osmotic agents -- mannitol and hypertonic saline -- are in common use, and they will be compared in the context of a randomized clinical trial. the goal is to determine if these agent differ in their ability to control episodes of brain swelling.

this single-center, randomized, open label trial will compare (i) 0.9% normal saline infusion and boluses of mannitol (control group) with (ii) 3% hypertonic saline, with intermittent boluses as needed, to treat elevated intracranial pressure (icp) following severe traumatic brain injury. patients will be randomized to one of the two study arms following placement of an icp monitor. raised icp will be defined as an icp greater than 20 mmhg for 20 minutes or longer. in the event of such an event, the appropriate treatment will be administered. the primary endpoint will be success in icp control, operationalized as the proportion of time during which icp is less than or equal to 20 mmhg during the first 120 hours following initiation of monitoring. secondary endpoints include therapy intensity level, incidence of pre-determined severe adverse events, and long-term outcomes measured at 3 and 6 months post-injury.

Eligibility criteria:
inclusion criteria: * closed traumatic brain injury * either (i) gcs score 3-8 (inclusive), or (ii) gcs motor score of 5 or less and abnormal admission ct scan showing intracranial pathology * hemodynamically stable with systolic blood pressure greater than 90 mmhg * at least 1 reactive pupil * age between 18y and 70y (inclusive) * inr less than 1.5 exclusion criteria: * actively on hypertonic saline or mannitol * hypernatremia (\>145 meq/l) * anuric or with creatinine greater than or equal to 2.5 * known seizure disorder * penetrating head trauma * suspected anoxic events * history of, or ct confirmation of, previous brain injury * any injury that, in the opinion of the principal investigator, has a high likelihood of death with the first 72 hours post-injury * any treatment, condition, or injury that contraindicates treatment with hypertonic saline

Keywords: traumatic brain injury hypertonic saline therapy intracranial pressure
a registry study of biomarkers in progression of acute heart failure(bioms-poahf)

Conditions: Cardiovascular Diseases

Summary: the registry study aims to discover the prognostic value of bio-markers in acute heart failure


Eligibility criteria:
inclusion criteria: * 1. patients aged greater than or equal to 18 years with acute exacerbation of chronic heart failure or new heart failure * 2. with typical symptoms of acute heart failure as follows: dyspnea, ankle swelling and fatigue (limited activity endurance), increased jugular pressure, rales and peripheral edema ; * 3. plasma concentrations of bnp: bnp\>100pg/ml * 4. echocardiography: related structural heart disease (left ventricular hypertrophy and/or left atrial enlargement) and/or diastolic dysfunction exclusion criteria: * 1. previous history of cancer or renal replacement therapy * 2.surgery was performed within a month * 3.accompanied by cardiogenic shock, sepsis, pneumonia * 4.eligible patients without informed consent form

Keywords: heart failure
detection of ovarian cancer using an artificial intelligence enabled transvaginal ultrasound imaging algorithm

Conditions: Ovarian Cancer

Summary: ovarian cancer is relatively rare but fatal with an annual incidence rate of 11.8 per 100 000 and a high mortality-to-incidence ratio of \>0.6. the modest diagnostic accuracy of tvu has risen some concerns about the over-treatment.now, with the development of artificial intelligence (ai), we may have a better chance to interpret tvu imagines with high efficiency, reproducibility and accuracy.


Eligibility criteria:
inclusion criteria: * women scheduled for transvaginal ultrasound examination for adnexal lesions; * women aged over 18 years old; * women willing to participant in this study evidenced by signing the informed consent. exclusion criteria: * women without adnexa for any reasons at the time of transvaginal ultrasound examination, including but not limited to receiving surgical removal for adnexa; * women with a pathologic diagnosis of ovarian cancer before the transvaginal ultrasound examination; * women with mental abnormal; * women did not cooperate or participate in other clinical trials; * pregnant or lactating women.
effect of vitamin d supplementation in young south african children hospitalized with acute lower respiratory infection

Conditions: Acute Lower Respiratory Tract Infection; Pneumonia; Bronchiolitis

Summary: the purpose of this study is to determine whether vitamin d supplements given to children aged 1 month to 5 years, hospitalized with acute lower respiratory tract infection will improve symptoms and reduce the duration of hospitalization.

in a randomized, double blind placebo controlled interventional study, children aged 1 month to 5 years, who are admitted with acute lower respiratory tract infection (alrti) to dr george mukhari academic hospital will be enrolled. the children will randomized to receive 2500 iu of vitamin d or a placebo. it is intended to enrol 320 children, 160 to receive vitamin d and the other 160 to receive a placebo. this sample size was calculated at 80% power and 5% significance. the children will be enrolled within 24 hours of admission and the intervention (supplement or placebo) will be daily until the child is discharged fron the hospital. the severity of alrti will be assessed using the modified respiratory distress assessment instrument (mrdai) score. the thorough physical examination and classification of severity of the symptoms will be done at enrolment and daily until hospital discharge. blood samples for vitamin d and calcium concentrations will be assessed at enrolment, before the child is given the supplement or placebo. the difference in the improvement in mrdai score between the placebo and the supplement will be assessed by analysis of variance (anova). similarly the difference in duration of hospital stay between the two groups will also be analysed using anova. the association between the vitamin d levels and the mrdai score on admission will also be assessed and analysed using anova. all eligible children will be sequentially enrolled until the desired sample size is reached. a simple randomisation by means of computer generated numbers will be used to minimize selection bias. both the study subjects and the investigators will be blinded to the allocation (treatment or placebo). the unblinding will be done only after the analysis has been completed.

Eligibility criteria:
inclusion criteria: * all children age 1month - 5 yrs, admitted in the paediatric unit of dr george mukhari hospital with an acute lower respiratory tract infection i.e. bronchiolitis and/ or pneumonia exclusion criteria: * children whose caregivers decline participation in the study children with co-morbid chronic respiratory condition(s) children who have received vitamin d supplementation in the past 30 days

Keywords: vitamin d supplementation, pneumonia, bronchiolitis
myofascial therapy in patients with hemophilic arthropathy

Conditions: Hemophilia

Summary: designing a treatment protocol using myofascial therapy for the treatment of pain and restrictions on mobility in patients with hemophilic arthropathy of the knee and ankle. pilot with a small number of patients for assessment the effectiveness and safety of the treatment protocol created. randomized clinical trial to assess the effectiveness of treatment with myofascial therapy in patients with hemophilia. describe the differences in terms of the dependent variables (range of motion, pain and flexibility) in patients with hemophilia who have carried out the treatment. report the relationship between the clinical characteristics of patients and the results obtained after the treatment period.

phase i pilot study with 5 patients with hemophilia for assessment by myofascial therapy protocol designed for this purpose. phase ii. randomized, prospective longitudinal clinical study in patients with hemophilia, to assess the efficacy of an intervention with myofascial therapy.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of hemophilia a and b. * patients older than 18 years. * patients with a diagnosis of hemophilic arthropathy of the knee and ankle. * patients on prophylactic regimen with fviii / fix. exclusion criteria: * patients without walking ability. * patients with a diagnosis of other congenital coagulopathy (eg von willebrand disease). * patients who have developed antibodies to fviii / fix (inhibitors). * patients with neurological or cognitive impairments that impede understanding of questionnaires and physical test. * patients who have not signed the informed consent document.

Keywords: haemophilia arthropathy pain range of motion miofascial techniques
induction ct by cisplatin, 5fu with or without docetaxel in patients with t3 and t4 larynx and hypopharynx carcinoma

Conditions: Larynx Cancer; Hypopharynx Cancer

Summary: the purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. the standard treatment is a combination of 2 drugs (cisplatin and 5fu). the aim of the study is to evaluate the potential benefit of the addition of a third drug (docetaxel) in the chemotherapy regimen. patients will receive 3 cycles of chemotherapy. responders to the induction treatment are treated with radiation with a purpose of larynx preservation. non responders patients will be treated with total laryngectomy.

the purpose of the study is to compare two regimen of induction chemotherapy for patients with t3 and t4 larynx or hypopharynx carcinoma that would be treated with total laryngectomy. the aim of the study is to compare the standard regimen (cisplatin + 5fu) versus the tpf regimen (taxotere + cisplatin + 5fu). responders to the induction treatment are treated with radiation with a purpose of larynx preservation. non responders patients will be treated with total laryngectomy followed by postoperative radiation.

Eligibility criteria:
inclusion criteria: * t3 and t4 larynx and hypopharynx tumor that would be treated with total laryngectomy * biopsy proven carcinoma * adequate biology * performance status 0 or 1 exclusion criteria: * larynx or hypopharynx tumors that could be treated with partial laryngectomy * distant metastasis * prior surgery, chemotherapy or radiation * intercurrent disease that is a contra indication to chemotherapy

Keywords: larynx cancer hypopharynx cancer chemotherapy randomized trial larynx preservation
multiple courses of antenatal corticosteroids for preterm birth study (macs)

Conditions: Pregnancies at Increased Risk of Preterm Birth

Summary: in women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have not had their baby by 14 or more days after being given a single course of antenatal corticosteroids (acs), do repeated courses of acs every 14 days until 33 weeks' gestational age lower the risk of illness or death in babies compared to repeated courses of placebo. children are assessed at 2 years and 5 years for neurodevelopmental impairment.

in women at 26 to 30 weeks gestation, who are at increased risk for preterm birth and remain undelivered 14 or more days following a single course of antenatal corticosteroids (acs), are multiple course of acs every 14 days until 33 weeks effective in reducing the risk of perinatal or neonatal mortality or significant neonatal morbidity, compared to placebo. 18-24 month follow-up: children (18-24 months corrected gestational age) are assessed with the bayley scales of infant development (second edition) to determine neurodevelopmental impairment. 5 year follow-up (macs-5): children are assessed using the child behaviour checklist (1 1/2 - 5) and the behaviour rating inventory of executive function (preschool version) to determine neurocognitive function.

Eligibility criteria:
inclusion criteria: * women who have previously received one completed course of acs, at least 14 days ago and continue to be at increased risk of preterm birth * gestational age greater ≥ 26 weeks and gestational age \< 31 weeks exclusion criteria: * women requiring chronic doses of corticosteroids secondary to medical conditions * women with a contraindication to corticosteroids * women with clinical evidence of chorioamnionitis (temperature ≥ 38°c) * known lethal congenital anomaly (e.g. anencephaly)

Keywords: antenatal corticosteroids preterm birth multiple versus single doses follow-up
hypertension study of ventavis® inhalation therapy in the treatment of patients with pulmonary arterial hypertension (venis)

Conditions: Pulmonary Hypertension

Summary: the purpose of this study is to gain information on safety and efficacy from korean patients who starting ventavis treatment by observational method.


Eligibility criteria:
inclusion criteria: * the treating physician has chosen ventavis as a suitable treatment for the patient * patient with ph and classified as nyha functional class iii or iv and who group 1 exclusion criteria: * any condition that prevents participation in the study, including pregnancy and other contraindications for ventavis treatment (as listed in the current ventavis patient package insert).

Keywords: pulmonary hypertension
feasibility study to improve af outcomes using a digital application for cv risk reduction

Conditions: Atrial Fibrillation

Summary: the pilot portion of this study is to determine the feasibility of utilizing af care to provide lifestyle modification support to patients with atrial fibrillation (af). the prospective, rct portion of this study compare cardiovascular risk factors (cvrf), af knowledge, af symptom severity and burden, and qol between and within the wait list group and the af care group at baseline, 3, 6, and 12 months.


Eligibility criteria:
inclusion criteria: 1. bmi \> 28 kg/m2 and one additional cvrf using ls7 2. access and willingness to engage in digital technology 3. has a valid email address and a cell phone number 4. able to ambulate 5. able to speak/read english exclusion criteria: 1. class iii/iv heart failure 2. mi or cardiac surgery in prior 3 months 3. severe renal/hepatic disease 4. active malignancy 5. current/recent (within 6 months) enrollment in weight loss program

Keywords: text messaging patient education psychometric
npi-0052 and vorinostat in patients with non-small cell lung cancer, pancreatic cancer, melanoma or lymphoma

Conditions: Non-Small Cell Lung Cancer; Pancreatic Cancer; Melanoma; Lymphoma; Multiple Myeloma

Summary: this is a clinical trial examining the safety, pharmacokinetics, pharmacodynamics and efficacy of iv npi-0052 (a proteasome inhibitor) in combination with oral vorinostat (zolinza; a hdac inhibitor) in patients with non-small cell lung cancer, pancreatic cancer, melanoma or lymphoma. proteasome inhibitors block the breakdown of proteins by cells and hdac inhibitors block modification of proteins regulating gene expression in cells. both of these actions preferentially affect cancer cells, and the combination of the two has been seen to have a greater effect in laboratory studies.


Eligibility criteria:
inclusion criteria: 1. karnofsky performance status (kps) at 70% or more. 2. non-small cell lung cancer, pancreatic adenocarcinoma, melanoma or lymphoma for which a standard, approved therapy is not available. patients must have lesions that are evaluable by recist criteria. 3. all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to ctcae (v. 3.0) grade 1 or less(except for hemoglobin). 4. adequate bone marrow, renal, liver function. 5. signed informed consent. exclusion criteria: 1. recent administration of chemotherapy, biological, immunotherapy or investigational agent, major surgery, or radiotherapy. 2. intrathecal therapy. 3. known brain metastases. 4. significant cardiac disease. 5. prior treatment with vorinostat or npi-0052, or other hdaci (including valproic acid) or proteasome inhibitors. 6. known allergy to any component of vorinostat. prior hypersensitivity reaction of ctcae grade \> 3 to therapy containing propylene glycol or ethanol. 7. pregnant or breast-feeding women. 8. concurrent, active secondary malignancy for which the patient is receiving therapy. 9. significant active infection.

Keywords: non small cell lung cancer pancreatic cancer melanoma lymphoma multiple myeloma
how do structural social determinants of health affect akt-mp and outcomes

Conditions: Kidney Diseases; Social Determinants of Health

Summary: our parent award compares two patient-centered methods to facilitate kt evaluation: kidney transplant fast track (ft), a streamlined kt evaluation process; and peer navigators (pn), a peer assisted evaluation program that incorporates motivational interviewing. this pragmatic randomized trial uses a comparative effectiveness approach to assess whether ft or pn can help patients overcome barriers to transplant listing. the aims of the parent study are to: (1) compare ft and pn to assess improvements in kidney transplant (kt) related outcomes and cost effectiveness; (2) examine how each approach effects changes in cultural/contextual factors, concerns about, and ambivalence to kt; and (3) develop a framework for widespread implementation of either approach. recent guidelines encourage using phenx toolkit measures for kidney-disease research and clinical data reporting, but research to date has been limited by cross sectional or retrospective analyses, and incomplete or missing data on key variables, and show limited clinical application or interventions. in addition to the several phenx individual social determinants of health (sdoh) already collected for the parent award, we propose to add phenx structural sdoh, including concentrated poverty, food swamp, race/ethnic segregation, and social vulnerability, to our baseline data collection for all 398 patient participants under the proposed administrative supplement. also, we will add a third assessment to determine how and whether the intervention affected post-transplant outcomes. we will follow patients via their medical records through receipt of kt to determine time to receive transplant (from time evaluation started), and type of transplant received (living or deceased donor kt). at \~6 months post-kt, participants will complete a third interview to assess kt patient reported outcomes, including health-related quality of life (qol) and satisfaction with service.


Eligibility criteria:
inclusion criteria: 1. undergoing kidney transplant evaluation at the university of new mexico 2. greater than or equal to 18 years of age 3. mentally competent exclusion criteria: 1. inclusion across the lifespan - children less than 18 years of age are excluded because all research-related measurements are designed for patients over the age of 18. children less than 18 years of age have dissimilar decision-making authority as a result of their developmental stage and dependency on adult guardians who must make all their transplant-related decisions, as required by all pediatric transplant centers. the proposed study focuses only on adult transplant patients. 2. waitlisted or undergoing evaluation at another transplant center 3. prior kidney transplant 4. incarcerated patients 5. pregnant women 6. active systemic infection 7. non-skin malignancy or melanoma in the past 2 years 8. known cognitive impairment

Keywords: transplant
treating smokeless tobacco use in rural veterans

Conditions: Smokeless Tobacco; Nicotine Dependence

Summary: this is a pilot study designed in an effort to develop and improve access to effective treatments for tobacco use in rural veterans using a tailored intervention approach. specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco users including elevated depressive symptoms, risky alcohol use, and concerns about weight gain. the objectives are to: 1. evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users 2. examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.


Eligibility criteria:
inclusion criteria: 1. use smokeless tobacco on a daily basis 2. be willing to make a quit attempt in the next 30 days 3. reside in a rural location 4. receiving care through the iowa city va health care system or an affiliated community-based outpatient clinic 5. able to provide informed consent 6. telephone access 7. stable residence exclusion criteria: 1. planning to move in the next 12 months 2. terminal illness 3. unstable psychiatric disorder 4. incarcerated 5. institutionalized

Keywords: rural health veterans smokeless tobacco cessation
prevalence and prognostic value of unrecognized myocardial injury in stable coronary artery disease (pumi)

Conditions: Stable Angina Pectoris

Summary: this study includes patients with stable coronary artery disease without previously known myocardial infarction, and investigates the prevalence of clinically unrecognized myocardial damage and its prognostic implication.

a substantial portion of all myocardial infarctions are not clinically recognized, but the myocardial damage can be recognized afterwards e g by magnetic resonance imaging (mri). this study includes patients with stable coronary artery disease without previously known myocardial infarction, and investigates the prevalence of clinically unrecognised myocardial damage (umi), and the prognostic value of umi regarding new cardiac events. in a subset of the patients, the biologic intra-individual variability of troponin and other biochemical markers will be investigated (substudy protocol).

Eligibility criteria:
inclusion criteria: * symptoms of stable angina pectoris according to the treating physician * scheduled for coronary angiography * written informed consent exclusion criteria: * pathological q-wave in the 12-lead resting ecg * known previous myocardial infarction * previous pci (percutaneous coronary intervention) or cabg (coronary artery bypass graft) * history of congestive heart failure * anything that contraindicates a mri investigation (e.g. pacemaker, claustrophobia, intracranial clips) * lack of suitability for participation in the trial, for any reason, as judged by the investigator.
omentectomy vs omental preservation in resectable cancer

Conditions: Cancer of Stomach

Summary: european clinical guidelines do not establish a clear recommendation neither for nor against omentectomy of this segment, the american clinical guidelines recommend omentectomy in view of its potential long-term oncological benefit, and japanese clinical guidelines only recommend 2nd segment omentectomy in locally advanced gastric cancers (stage t3-t4) recommending omental preservation in early gastric cancers (stage t1-t2). faced with this lack of consensus, we propose a randomized, prospective and multicentric study in patients with resectable gastric cancer in stage t3-4 n+/- m0. patients will be randomized into two groups, one where omentectomy of the 2nd omental portion will be performed and another where omental preservation will be performed. the aim of our study is to analyze the disease-free interval and survival between both groups, also comparing postoperative complications and mortality.


Eligibility criteria:
inclusion criteria: * older than 18 years old * resectable gastric cancer * gastric cancer t3-4 n+/- m0 exclusion criteria: * m1 * non surgical patients for medical status * non resectable gastric cancer during surgery * endoscopic resectable gastric cancer