Kornimate/medical-research-clean huggingface dataset:
compare remote patient management and standard care in crt-d and icd-patients to assess the effect on heart failure

Conditions: Heart Failure; Ventricular Tachycardia; Cardiac Desynchronization

Summary: this pilot study is to prospectively evaluate the benefit of clinicians being able to access icd device information in a timelier manner and treat fluid overload with a pre-defined pattern using the medtronic optivol, medtronic carealerts and medtronic carelink in conexus-enabled devices (remote arm) as compared to the same devices without medtronic optivol, medtronic carealerts and medtronic carelink available to the treating physician (standard arm).


Eligibility criteria:
inclusion criteria: * implantation of a market-approved medtronic connexus crt-d- or dr-icd-device * patient consents to study * ability to replace follow-ups with carelink follow-ups * ability to attend all follow-ups at study center exclusion criteria: * permanent af * less than 18 years of age * life expectancy less than 15 months * participation in another clinical study * pregnancy
food, fun, & fitness internet program for girls: outcome evaluation

Conditions: Obesity

Summary: the purpose of this project is to reduce health disparities in obesity risk among 8-10 year old african american girls using a culturally sensitive and developmentally appropriate internet-based program with no face-to-face interaction. this study will conduct an outcome evaluation to test short and longer term effects on obesity risk.

this research will conduct an outcome evaluation on a promising web based obesity prevention program for 8-10 year old african american girls. a pilot study with 80 girls established its feasibility: recruitment goals were met; attrition rates were \< 10%; logon rates to the online program were 74.5%; and statistically significant increases in fruit and vegetable consumption and time spent being physically active were observed. the outcome evaluation will recruit 400 child-parent pairs to examine short and longer term effects of the program on obesity risk. it will also conduct mediation analyses to examine pathways of effect. at the end of the study, the web based program will be hosted on the cnrc web site. although the use of the internet as a method for changing health behavior is not new, the use of an internet program alone, with no face to face interaction, is novel. this is one of the first programs to attempt this, particularly in an at-risk population.

Eligibility criteria:
inclusion criteria: * 8-10 years old * healthy * african american * parent willing to participate in data collection * internet access * personal email address exclusion criteria: * mental, physical, or medical conditions that limit fruit-vegetable consumption, physical activity, or ability to fully participate in the program and/or complete baseline and post assessment data collection * taking medications that influence dietary behaviors, appetite, and/or physical activity

Keywords: physical activity fruit and vegetable water girls african american online
continuous chest compressions vs aha standard cpr of 30:2

Conditions: Out of Hospital Cardiac Arrest

Summary: the primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (ccc) versus standard american heart association (aha) recommended cardiopulmonary resuscitation (cpr) with interrupted chest compressions (icc) in patients with out-of-hospital cardiac arrest (oohca). the primary null hypothesis will be that the rate of survival to hospital discharge is not affected by use of continuous compressions with passive or positive pressure ventilation (intervention group) versus cpr with compressions interrupted for ventilation at a ratio of 30:2 (control group).

the primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (ccc) versus standard american heart association (aha) recommended cardiopulmonary resuscitation (cpr) with interrupted chest compressions (icc) in patients with out-of-hospital cardiac arrest (oohca). for this study, ccc consists of a series of three cycles of continuous chest compressions without pauses for ventilation followed by rhythm analysis or until restoration of spontaneous circulation (rosc), whichever occurs first. icc consists of series of three cycles of standard cpr each cycle comprised of chest compressions with interposed ventilations at a compression:ventilation ratio of 30:2 (per aha guidelines) followed by rhythm analysis or until rosc, whichever occurs first. in either patient group, the duration of manual cpr before the first rhythm analysis will be 30 seconds or 120 seconds. this treatment period will be followed by two cycles of compressions then rhythm analysis (i.e. each of approximately 2 minutes duration) in either group. other aims of the trial are to compare survival to discharge among patients grouped by first-recorded rhythm or other a priori subgroups, as well as to compare neurological status at discharge, mechanistic outcomes or adverse events between control and intervention groups.

Eligibility criteria:
inclusion criteria: * age 18 years or more (or local age of consent); * initial fire/emergency medical services (ems) chest compressions provided by resuscitation outcomes consortium (roc) study participating agency dispatched to the scene; * lack of the exclusion criteria below exclusion criteria: * ems witnessed arrest; * written do not attempt resuscitation (dnar) orders; * obvious primary asphyxia or respiratory cause of arrest (drowning, strangulation, hanging) * advanced airway placed prior to roc ems arrival, or pre-existing tracheostomy * traumatic cause (blunt, penetrating, burn) of arrest; * known prisoners; * known pregnancy; * uncontrolled bleeding or exsanguination * mechanical compression device used during study-assigned compression cycles

Keywords: cardiac arrest cardiopulmonary resuscitation
study investigating novoeight®/novoeight® (turoctocog alfa) in mexican haemophilia a patients

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: the trial is conducted in north america. the aim of the trial is to assess the safety of turoctocog alfa under conditions of routine clinical care in patients with haemophilia a in mexico


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * male and female patients with haemophilia a * age range is 0 years and above * the decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * known or suspected allergy to turoctocog alfa or related products * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
a multiple ascending doses study of cm326 injection in healthy subjects

Conditions: Asthma

Summary: this is a single-center, randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, pk profile, and immunogenicity of multiple sc administraion of cm326 at different doses in healthy subjects. 40 healthy male subjects will be enrolled in the study. the drug will be administered by dose-escalating principle at 4 dose levels: 55 mg q2w, 110 mg q2w, 220 mg q2w, 220 mg q4w.


Eligibility criteria:
inclusion criteria: * male healthy volunteers, aged between 18 and 65 years of age inclusive, with a body mass index (bmi) within 18-26 kg/m2 (inclusive); * medical history, vital signs, physical examination, 12-lead electrocardiogram, chest x-ray and abdominal color ultrasound are normal or abnormal with no clinical significance; * all variables of clinical laboratory tests are normal or abnormal with no clinical significance; * subjects and partners agree to take effective contraception throughout the study (from screening to 3 months after the end of treatment); * capable of understanding the nature of the study and voluntarily signing the informed consent form. exclusion criteria: * known allergy to monoclonal antibody drugs or other related drugs, or allergy to excipients of cm326 injection; * history of any clinically serious disease or history of circulatory, endocrine, neurological or hematological, immune, psychiatric, and metabolic diseases; * history of asthma and allergic reactions; * use of any prescription drugs within 2 weeks prior to dosing, use of traditional chinese medicine or over-the-counter drugs within 1 week prior to dosing; * received any marketed or investigational biologics within 5 half-lives (if known) or 12 weeks (whichever is longer) prior to dosing, or any investigational non-biologics within 5 half-lives (if known) or 4 weeks (whichever is longer) prior to dosing.
efficacy and safety of l arginine to prevent preeclampsia

Conditions: Preeclampsia

Summary: randomized double-blind controled clinical trial to assess the efficacy and safety of l-arginine to prevent preeclampsia. applied to pregnant women with risk factors for preeclampsia. the main result was the development of preeclampsia as well as side effects to taking l arginine besides perinatal outcomes

two groups were formed. one received l arginine 3 grams orally at day from the 20th week of pregnancy. the other group received placebo. each three weeks were evaluated in search of high blood pressure and proteinuria. the follow-up was until the end of pregnancy and two weeks after this

Eligibility criteria:
inclusion criteria: * one or more risk factors for developing preeclampsia (nulliparous, previous history of preeclampsia, chronic hypertension, bmi ≥30) exclusion criteria: * pregnant women carriers of chronic renal failure * pre gestational diabetes * multiple pregnancy and were removed for some reason they received medication that would interfere with the interpretation of results (aspirin)

Keywords: l arginine preeclampsia
eylea age-related macular degeneration (amd) post-marketing surveillance in japan

Conditions: Macular Degeneration

Summary: this study is a regulatory post-marketing surveillance in japan, and it is a local prospective and observational study of patients who have received eylea for age-related macular degeneration (amd). the objective of this study is to assess safety and effectiveness of eylea using in real clinical practice. a total of 4,000 patients are to be enrolled and assessed in 3 years standard observational period. an annual follow-up survey will be conducted for 5 years at the longest after standard observational period.


Eligibility criteria:
inclusion criteria: * patients who received eylea for amd exclusion criteria: * patients who have already received eylea

Keywords: eylea age-related macular degeneration
carbon impact of anesthesic gas

Conditions: Gas; Inhalation; Anesthesia

Summary: assessing the impact of anesthesia practice on global warming and carbon footprint becomes part of the standard of care and is growing concern within the anesthesia community. global warming potential (gwp) is a measure of how much a given mass of greenhouse gas contributes to global warming over a specified time period. inhaled anesthetics have various gwp20: 349 for sevoflurane and 3714 for desflurane. however, gwp20 and cde20 alone are not sufficient to evaluate the environmental impact of anesthetic gases. other parameters must be included in the analysis: fresh gas flow (fgf), carrier gas (air, o2, n2o) and potency of the anesthetic gas. unfortunately, the majority of trials did not fully consider the fgf reduction and the fact that desflurane can be administered with new closed or very low-flow anesthesia circuits as opposed as the recommended 2l/min that must be used for sevoflurane according to its monography in canada. most of the calculations were made on a purely theoretical approach that could be different from actual measurements based on a strictly monitored anesthesia practice. when continuous and accurate gas monitoring and analysis is used as recommended nowadays, the use of closed or semi-closed-circuit anesthesia with very low fgf might allow for a reduction of more than 80% of the anesthetic gas administration and its consequent pollution. by properly monitoring the anesthesia depth and analgesia adequacy, the investigators can reduce the gas consumption. the proposed study will aim at determining whether with the help of high-quality monitoring (bis and nol) and high-end ventilators that allow minimal fresh gas flow, the use of desflurane remains more polluting than sevoflurane.


Eligibility criteria:
inclusion criteria: * asa 1-3 patients, * laparoscopic general, gynecological or urologic surgery requiring general anesthesia without additional regional anesthesia technique * fully consented, * bmi \< 40, * age \> 18yo, exclusion criteria: * post-operative need for a neuraxial or regional analgesic technique * history of active coronary artery disease * serious cardiac arrhythmia (including atrial fibrillation) * history of substance abuse * chronic use of psychotropic and/or opioid drugs * history of psychiatric diseases with the need of medication * history of refractory ponv * allergy or contra-indication to any drug used in the study protocol * refusal of the patient for participation in the study

Keywords: desflurane sevoflurane fresh gas flow environment
utility of breath-holding test in systemic sclerosis

Conditions: Systemic Sclerosis

Summary: this study aims to evaluate the utility of breath-holding test as a marker of pulmonary disease severity in patients with systemic sclerosis.

systemic sclerosis (ssc) is a chronic autoimmune disease of unknown etiology with high morbidity and mortality. ssc manifests by fibrosis of skin and internal organs. although the underlying mechanisms are still subject to investigation, endothelial dysfunction and abnormal immune response are thought to contribute to vascular dysfunction and fibrosis in ssc. pulmonary involvement, such as pulmonary arterial hypertension (pah) and interstitial lung disease (ild) is a major cause of death in ssc. although the 6mwt is generally used for evaluating pah and ild, the utility in ssc is undetermined. several investigators have found weak or moderate correlations of 6mwt in pulmonary involvement in ssc. the 6mwt is influenced by the status of all organ systems involved in exercise (pulmonary, cardiac, peripheral vascular, neuromuscular unit and muscle metabolism) as well as by specifics of test conditions. there is a pressing need for new, practical method which corroborates the current 6mwt for the evaluation of pulmonary disease severity in ssc. breath-holding test (bht) is one of the most useful methods for assessing the sensitivity of peripheral chemoreflex. recent studies have demonstrated that bht was correlated to pulmonary function test. bht can be safely conducted and doctors handle a medical emergency during test easily as well. therefore, this study evaluates the utility of bht as surrogate marker of pulmonary involvement in patients with ssc.

Eligibility criteria:
inclusion criteria: * a diagnosis of systemic sclerosis according to 2013 acr/eular criteria * must understand and voluntarily sign an informed consent form including writing consent for data protection exclusion criteria: * the resting oxygen saturation by pulse oximetry \< 90% in room air * unstable angina or myocardial infarction during the previous month * patients considered unable to the breath-holding test or 6 minute walk test

Keywords: breath-holding test six minute walk test systemic sclerosis
serial vasopressin and copeptin levels in children with sepsis and septic shock

Conditions: Sepsis; Septic Shock

Summary: patients with severe infection can develop very low blood pressure. there are many mechanisms leading to this, and one of them appears to involve a hormone called vasopressin. in children as compared to adults, the mechanism and response to low blood pressure are different for reasons that are not clear. one possibility is the difference in the production and/or response to vasopressin. vasopressin has become part of the treatment of children with low blood pressure in the setting of severe infection, when other treatment has failed, but its use is on the basis of animal and adult studies. the exact timing and dose is uncertain. in this research study, the patients will receive standard treatment for sepsis and septic shock, and the investigators will measure the blood levels of vasopressin and a related compound called copeptin (both are required to understand the mechanism of control involved). blood will need to be taken from patients without any sepsis so as to be able to compare the values in health and in sickness. the patient groups the investigators have chosen for this are those children who will have blood taken anyway as part of their routine care. the aim of this study is to develop an understanding of the body's hormonal response (with respect to vasopressin) to severe infection in children. the long-term aim is to improve the care of critically ill children with severe infection by using the most appropriate dose of vasopressin at the most appropriate time.


Eligibility criteria:
inclusion criteria: control group: * neonates admitted for neonatal jaundice requiring phototherapy * previously well patients admitted for elective gastrointestinal endoscopy, patients admitted for non-specific abdominal pain and * pre-operative patients for circumcision, inguinal hernias and chronic orthopaedic conditions study group: * the investigators will also enroll children with sepsis and septic shock * sepsis will be defined as proposed by the international pediatric sepsis consensus conference. * children will be recruited into the septic shock group if they have sepsis and features of cardiovascular organ dysfunction as defined by the same consensus conference. exclusion criteria: * neonates weighing less than 2.5 kg * neonates less than 36 weeks gestation * children more than 16 years of age * patients with a history of congenital heart disease * patients with chronic renal impairment * patients with chronic liver impairment * patients on active chemotherapy * patients on chronic mineralocorticoids or glucocorticoids therapy * patients on long-term diuretic therapy * patients with central nervous system tumours * patients with developmental delay

Keywords: sepsis septic shock vasopressin copeptin paediatrics
effectiveness and implementation of mpath-crc

Conditions: Colorectal Cancer; Cancer; Rectum Cancer; Colon Cancer

Summary: study investigators are conducting this study to learn how to best implement a new ipad program in clinical practice.

the study team has developed mpath-crc (mobile patient technology for health-colorectal cancer), a patient-friendly ipad program used by individuals immediately before a routine primary care visit. mpath-checkin is a module that is used in conjunction with mpath-crc that consists of questions asked of all adult patients at check-in. mpath-crc is a module specific for patients due for crc screening. to fully realize mpath-crc's potential to decrease crc mortality, the program now must be implemented in primary care practices in a way that encourages routine and sustained use. however, while hundreds of mobile health (mhealth) tools have been developed in recent years, the optimal strategies for implementing and maintaining mhealth interventions in clinical practice are unknown. this study will compare the results of a "high touch" strategy to a "low touch" strategy using a type iii hybrid design and incorporating mixed methods to evaluate implementation, maintenance, and effectiveness of mpath-crc in a diverse sample of community-based practices. the study will be conducted in three phases: 1) in a cluster-randomized controlled trial of 22 primary care clinics, the study team will compare the implementation outcomes of a "high touch" evidence-based mhealth implementation strategy with a "low touch" implementation strategy; 2) in a nested pragmatic study, the study team will estimate the effect of mpath-crc on completion of crc screening within 16 weeks of a clinic visit; and 3) by surveying and interviewing clinic staff and providers after implementation is complete, the study team will determine the factors that facilitate or impede the maintenance of mhealth interventions.

Eligibility criteria:
this study will include three distinct populations of participants: 1) healthcare providers and staff at primary care practices, 2) patients aged 18 and older seen in the participating study sites, and 3) patients aged 50-74 seen in the participating study sites who are eligible for crc screening patient inclusion criteria: due for routine crc screening, defined as: * no colonoscopy within the prior 10 years * no flexible sigmoidoscopy within the prior 5 years * no ct colonography within the prior 5 years * no fecal dna testing within the prior 3 years * no fecal blood testing (guaiac-based test with home kit or fecal immunochemical test) within the prior 12 months patient exclusion criteria: * personal history of crc * first degree relative with crc * personal history of colorectal polyps

Keywords: mortality cancer screening cancer intervention mobile health implementation science
monitoring of delayed ischemia after subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage

Summary: the goal in this research is to develop better ways to detect and treat the damage caused by bleeding in the brain.

patients who suffer from a bleeding in the brain (stroke or hemorrhage) often experience secondary complications that can occur up to 2 weeks after the initial bleeding. complications can include decrease of consciousness, weakness or paralysis, difficulty with speech and language, and worsening of brain damage. these decrease a patient's chances for a good recovery. a brain scan will be used to determine the damage caused by the bleeding, and the brain's electrical activity will be monitored to detect abnormal activity. these measures will be analyzed together with routine medical information to better understand and diagnose complications.

Eligibility criteria:
inclusion criteria: 1. age 18 to 70 years 2. world federation of neurosurgery (wfns) grade iii-iv, and grade v patients who improve within 24h after ventriculostomy 3. diffuse thick or localized thick subarachnoid clot \>1 mm on baseline ct (fisher grade 3-4) 4. ruptured saccular aneurysm demonstrated by ct-angiography or dsa 5. onset of asah clinical symptoms within the preceding 72h 6. treatment of aneurysm within 24 h after admission 7. treatment of aneurysm by clip ligation exclusion criteria: 1. sah due to other causes (e.g. trauma, fusiform or mycotic aneurysm) 2. only a thin diffuse layer or no visible subarachnoid blood in the initial ct 3. admission in a clinical state with unfavourable prognosis (e.g., bilateral dilated, non-reactive pupils for more than 1h) 4. coagulopathy (thrombocytes \ 1.5) 5. pregnancy 6. presence of incompatibilities for mri, such as non-removable metals, artificial joints, electronic devices (pace maker, pumps), etc.

Keywords: subarachnoid hemorrhage