Kornimate/medical-research-clean huggingface dataset:
safety and tolerability during open-label treatment with lcz696 in patients with chf and reduced ejection fraction

Conditions: Chronic Heart Failure With Reduced Ejection Fraction

Summary: the purpose of this study was to collect safety and tolerability data on lcz696 in eligible paradigm-hf patients who received open-label investigational drug. the parent paradigm-hf (nct01035255) trial was terminated early due to compelling efficacy of lcz696 in patients with heart failure with reduced ejection fraction (hfref) after the final pre-specified interim analysis in march 2014.


Eligibility criteria:
inclusion criteria: 1. written informed consent for the extension must be obtained before any assessment is performed. 2. patients who have completed paradigm-hf (protocol clcz696b2314) and are able to be safely enrolled into the open-label trial as judged by the investigator. exclusion criteria: 1. use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 2. history of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, aceis, arbs, or nep inhibitors as well as known or suspected contraindications to lcz696 3. known history of angioedema 4. requirement of simultaneous treatment with both aceis and arbs 5. current acute decompensated hf (exacerbation of chronic hf manifested by signs and symptoms that may require intravenous therapy) 6. symptomatic hypotension and/or a sbp \< 100 mmhg at visit 1 (screening) 7. estimated gfr \< 30 ml/min/1.73m\^2 as measured by the simplified mdrd formula at visit 1 (screening) 8. presence of bilateral renal artery stenosis 9. serum potassium \> 5.2 mmol/l at visit 1 (screening) 10. evidence of hepatic disease as determined by any one of the following: ast or alt values exceeding 3 x uln at visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt 11. pregnant or nursing (lactating) women 12. women of child-bearing potential 13. any condition, not identified in the protocol, that in the opinion of the investigator is likely to prevent the patient from safely tolerating lcz696 or complying with the requirements of the study.

Keywords: lcz696 chronic heart failure arni congestive heart failure (chf) heart failure (hf) acute heart failure syndrome congestive cardiac failure (ccf)
diagnosis of nodules ≤2 cm based on us and ceus compared with current clinical procedure

Conditions: Liver Cancer; Liver Cirrhosis

Summary: due to different etiologies, diagnosis and treatment of hcc in china is different from that in western countries.us is an important screening method for hcc in patients with liver cirrhosis. ceus, as an enhanced imaging method based on us, has the advantages of convenience, non-radiation, low cost, short examination time, and the diagnostic performance of hcc is comparable to that of cect, cemri, and hepatobiliary-specific mri. it is of great significance to consider the cost-effectiveness of each examination based on the principle of cost minimization. therefore, we propose immediate ceus examination for suspicious lesions ≤2 cm screened by us, and determine the diagnostic process of further diagnostic methods based on the ceus results. the aim of this study is to establish a screening and diagnosis process for hcc ≤2 cm suitable for china considering time effect, economic effect and diagnostic efficiency.


Eligibility criteria:
inclusion criteria: 1. patients are at high risk of hcc. 2. the ages of patients are between 18 and 80. 3. patients are with solid liver lesion(s) ≤ 2 cm detected by us. 4. patient signs the informed consent. exclusion criteria: 1. patients are with liver cirrhosis due to congenital hepatic fibrosis or due to hepatic vascular diseases such as hereditary telangiectasia, budd-chiari syndrome, chronic portal vein occlusion syndrome, congestive heart disease. 2. patient's age is \ 80 years old. 3. patients with known hypersensitivity to ceus, cect, cemri, or hepatobiliary-specific mri contrast agents. 4. patient is a pregnant or breastfeeding woman. 5. patient is not diagnosed based on the reference diagnostic criteria required by the study. 6. patient is considered to be unsuitable to participate in the study.

Keywords: liver cancer ceus diagnostic methods cost optimization
safety to evaluate the efficacy and safety of hip1601 in patients with non erosive reflux disease

Conditions: Non-erosive Gastroesphageal Reflux Disease

Summary: the purpose of this study is to investigate the safety and clinical efficacy of hip1601 in patients with non-erosive gastroesphageal reflux disease.

a multicenter, randomized, parallel, double-blinded, placebo-controlled phase ⅲ study to compare efficacy and safety of hip1601 in patients with non-erosive gastroesophageal reflux disease(nerd)

Eligibility criteria:
inclusion criteria: * 19≤ age ≤ 75 * patients who were not observed mucosal break('not present') according to the la classification(la grade) on the egdesophago-gastro-duodenoscopy * patients who had experienced major symptom within 3 months patients experienced heartburn or acid regurgitation within 7 days of screening day * patients who had experienced major symptom within 7 days before randomization. entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week based on rdq * patients understood the consents and purpose of this trial and signed consent form exclusion criteria: * patients who have erosive gerd, barrett's esophagus(other significant dysplasia of esophagus), gastroesophageal varicose veins, active peptic ulcer, gastrointestinal bleeding or malignant gi tumor confirmed by endoscopy * patients who have a history of gastric or gastroesophageal surgery * patients who have zollinger-ellison syndrome, eosinophilic esophagitis, primary esophageal motility disorder, acute upper gastrointestinal bleeding, functional dyspepsia, ibs, ibd within 3 months before visit 1 * patients with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease. * patients has a severe liver disorder(ast or alt level exceeds 3 times more than normal upper range at visit 1) * has a clinically significant renal failure(mdrd egfr ≤ 59 ml/min/1.73m2 or serum creatinine \>2.0mg/dl at visit 1)
short and long-term effects of surgical repair of pectus deformities

Conditions: Pain, Postoperative

Summary: a large number of institutions have reported their early results with minimally invasive repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed the outcomes relevant to the concerns of the patients and even fewer have reported long-term results following bar removal. even fewer studies have investigated the prevalence and characteristics of long term persistent post-surgical pain following surgical repair of pectus deformities. the reasons as to why acute postoperative pain in some patients persists and becomes chronic whereas in others the pain dies down shortly after wound healing are largely unknown, and why some patients complain of loss of sensibility in wide regions of their chest following surgery also remains unclear.


Eligibility criteria:
inclusion criteria: * minimally invasive repair of pectus excavatum from 2001 throughout 2010. * open surgical repair of pectus carinatum from 2001 throughout 2010. exclusion criteria: * not being able to fill in detailed questionnaires in danish
effectiveness of abt-378/ritonavir plus lamivudine plus efavirenz plus tenofovir df in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to see if a novel 4-drug anti-hiv combination can suppress the growth of hiv in patients infected with the virus.


Eligibility criteria:
inclusion criteria: * have hiv infection. * age 18 to 65 years old. * show no signs of recent illness other than hiv infection. * agree to use a barrier method of birth control during the study and for 30 days after study. exclusion criteria: * are unable to follow study requirements (in the opinion of the investigator). * are pregnant or breast-feeding. * are unable to take medications by mouth. * have chronic nausea or vomiting. * have cancer other than kaposi's sarcoma or basal cell carcinoma. * have active, serious infections (other than hiv) requiring antibiotic injections within 15 days prior to screening. * are taking any medications that are not allowed with abt-378/r and efavirenz. * are taking or have taken any other experimental drugs, antiretroviral drugs, or drugs that affect the immune system within 30 days of start of study without consent of the medical monitor. * are receiving or have received radiation therapy within 30 days of start of study without consent of the medical monitor. * have a history of drug abuse or mental illness that would prevent the patient from following the protocol requirements. * have a history of kidney or bone disease.

Keywords: hiv
back to basics - effects, narratives and routes of administration of open-label placebo

Conditions: Placebo Effect; Pain; Expectancy

Summary: to date, very little is known about the mechanisms of open-label placebo treatment and there is a lack in highly controlled experimental designs. therefore, the planned project will test well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning response, in an open-label placebo design, investigating their influence on placebo analgesia.

the current project will consist of one experimental study and one qualitative study: 1. the effects of open-label, and deceptive placebo administration on placebo analgesia will be directly compared when both groups have a comparable expectancy-inducing scientific rationale; 2. subjective meaning models will be assessed by comparing subjective narratives of the placebo effect in open-label and deceptive placebo groups in a nested qualitative study. the experimental study will be a randomized experiment with healthy subjects (n=120), and pain will be induced using a standardized heat pain paradigm (medoc, ramatishai, israel; thermo-sensory analyzer (tsa)-ii). effects of the experimental conditions will be assessed both objectively (i.e. heat pain threshold and tolerance) and subjectively (i.e. subjective pain ratings, pain intensity and unpleasantness). furthermore, investigators will randomly select 30 participants to take part in a nested qualitative study in order to qualitatively assess the meaning response by comparing subjective narratives of the placebo effect in the open-label and deceptive placebo groups, as well as in the control group.

Eligibility criteria:
inclusion criteria: * healthy male and female adults aged 18-65 * healthy by self-report statement, thus no known current or chronic somatic diseases or psychiatric disorders * right-handedness (oldfield, 1971), * willing to participate in study exclusion criteria: * medicine or psychology students * any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes) as well as skin pathologies, neuropathies or nerve entrapment symptoms, sensory abnormalities affecting the tactile or thermal modality * current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment * insufficient german language skills to understand the instructions * previous participation in studies using pain assessment (threshold and tolerance) with peltier devices * daily consumption of more than three alcoholic standard beverages per day (a standard alcoholic beverage is defined as either 3dl beer or 1 dl wine or 2cl spirits) * current or regular drug consumption (thc, cocaine, heroin, etc.)
pragmatic trial of messaging to providers about treatment of heart failure at inova

Conditions: Heart Failure

Summary: a randomized, single-blind intervention trial to test the comparative effectiveness of an electronic health record best practice advisory system that informs clinicians of guideline-indicated and fda-approved heart failure medications currently not prescribed to their patients with heart failure versus usual care (no alert and how things are done currently). the purpose of the alert is to stimulate appropriate medication prescription for patients with heart failure and a reduced ejection fraction. this will be done across outpatient inova clinics and at the five inova hospitals.


Eligibility criteria:
inclusion criteria: * age\>18 years * seen by a cardiologist in an inova clinic or inova hospital setting * left ventricular ejection fraction ≤40% exclusion criteria: * opted out of ehr-based research * hospice care * already receiving maximally titrated doses of each of the four classes of evidence- based hfref medical therapy * prior heart transplant

Keywords: heart failure gdmt nyha hfref implementation
reproducibility of 6 minute walk tests for oxygen desaturation

Conditions: Hypoxemia; Anoxia; Chronic Obstructive Pulmonary Disease

Summary: this trial will test the hypothesis that the 6 minute walk test (6mwt) is not reproducible as a measure for oxygen desaturation.

over 16 million adults in the united states are afflicted with chronic obstructive pulmonary disease (copd) and is the fourth leading cause of death.(mccrory et al. 1190-209). copd accounts for direct health-care costs of $18 billion.(mccrory et al. 1190-209). oxygen therapy has been shown to decrease mortality in copd patients with severe hypoxemia at rest. oxygen therapy now accounts for the number one expenditure for durable medical equipment. current requirements for oxygen therapy for copd patients include a resting or exercise pao2 or spo2 of 55 mmhg or 88% respectively. we have shown that a resting spo2 of \< 95% is predictive of those at risk of exercise induced hypoxemia in copd patients(knower et al. 732-36) based on continuous spo2 monitoring during a 6 minute walk. although, the reproducibility of a 6 minute walk has been addressed in terms of a hospital test, simulated home test and actual home test (guyatt), its inter-variability is not well studied. we propose to investigate the reliability and inter-variability of the 6 minute walk for oxygen prescription. currently, two programs are providing pulmonary rehabilitation for copd patients in the community. patients perform 6 minute walks under supervision and are monitored by pulse oximetry on a routine basis as part of these programs. we plan to capture the oximetry data in order to determine the reliability of oxygen prescriptions using the 6 minute walk. patients who are performing a 6 minute walk will be eligible for enrollment. protocols for the 6 minute walk are already in place and approved by their respective authority in both of the pulmonary rehabilitation programs. these patients will have repeat 6 minute walks on separate in close proximity to determine the reliability of spo2 on any given day. statistical analysis will be done by the kappa statistic for inter-test agreement in a 3 dimensional matrix. we ask to waive consent for this study as there is no change to the daily routine of the 6 minute walks already being done as part of pulmonary rehabilitation. we plan only to capture the data from these walks.

Eligibility criteria:
inclusion criteria: * taking part in pulmonary rehabilitation exclusion criteria: * inability to perform 6mwt

Keywords: hypoxemia anoxia oxygen dyspnea pulmonary disease chronic obstructive
investigation of intranasal ketamine related changes in attentional brain networks with functional and structural mri

Conditions: Ketamine Treatment

Summary: subanesthetic ketamine is currently used as a rapid-acting antidepressant. it is an antagonist of the n-methyl-d-aspartate (nmda) receptor, but former results indicate that its action also depends on the noradrenaline system and the locus coeruleus (lc). based on this known impact of ketamine on the sympathetic nervous system the aim of this study is to investigate the effects of intranasal esketamine on lc related attentional brain networks in task based functional mri, to relate those attention network changes to behavioural measures and to predict ketamine related attention network changes by brain structure.


Eligibility criteria:
inclusion criteria: * general health (no serious internal or neurologic pre-existing conditions) based on medical history, physical examination and structured clinical interview for dsm-iv (scid) * age 18 to 55 years * right-handedness (due to potential lateralization effects of left-handed subjects) * willingness and competence to sign the informed consent form exclusion criteria: * current or history of psychiatric or neurological disease * current medical illness requiring treatment * current or former substance abuse * pregnancy or current breastfeeding * diagnosis of an axis-1 psychotic disorder in a first-degree relative * known aneurysmal vascular disease based on medical history (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels), history of intracerebral haemorrhage, recent (within 6weeks) cardiovascular event, including myocardial infarction (mi) * significant pulmonary insufficiency, including copd; sleep apnoea with morbid obesity (bmi ≥35), uncontrolled brady- or tachyarrhythmias that lead to haemodynamic instability; history of an mi, haemodynamically significant valvular heart disease or heart failure (nyha class iii-iv) * hyperthyroidism that has not been sufficiently treated * history of brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure * child-pugh class c (severe) hepatic impairment * any contraindication for mri (e.g., mr incompatible implants, etc.) including dental implants causing signal artifacts * failure to comply with the study protocol or to follow the instruction of the investigating team
feeling hot 2: penile skin temperature measurements of nocturnal erections

Conditions: Erectile Dysfunction

Summary: the feeling hot studies focus on the proof-of-principle of using temperature sensing as a tool to detect nocturnal erections. in the feeling hot 2 study the penile skin temperature is investigated during nocturnal erections during overnight ambulatory measurements. simultaneous measurements with the rigiscan will be performed to detect the nocturnal erections and validate the principle of temperature measurements for erectile dysfunction diagnostics.

differentiation in nature of erectile dysfunction (ed) is currently made by nocturnal erection detection with the rigiscan. the rigiscan uses outdated software, measurements are user unfriendly and system components are out of stock. in the search of modernizing erectile dysfunction diagnostics, the question has arisen whether temperature measurements can function as a tool for nocturnal erection detection. with the absence of a pressure component, the patient experience should improve. literature and mathematical modelling studies have shown that the penile temperature increases significantly during erection. however, no studies have used penile skin temperature measurements to detect nocturnal erections. the feeling hot 2 study explores the validity of this measurement set-up for overnight ambulatory measurements of nocturnal erections in the search of modernizing erectile dysfunction diagnostics.

Eligibility criteria:
inclusion criteria: * healthy volunteer without (a history of) erectile dysfunction * male * aged 18 - 29 years exclusion criteria: * test subjects who are unwilling to sign informed consent * test subjects with erectile dysfunction * iief-5 score of below 17 * (history of) sickle cell aneamia, atherosclerosis and diabetes type i or ii. * (history of) rem-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea * usage of sleeping pills or benzodiazepines.

Keywords: erectile dysfunction rigiscan nocturnal erection penile temperature
effects of anesthesia on pediatric surgical patients with a history of concussion - phase i

Conditions: Post Concussion Symptoms

Summary: the purpose of this research study is to determine the number of children who have symptoms of a concussion at the time they are scheduled for orthopedic surgery at boston children's hospital. it is currently unknown if anesthesia affects a child with a previously diagnosed concussion. this study is the first phase of a two-part study looking at the effects of anesthesia in children undergoing orthopedic surgery with a previous concussion. currently, the decision to continue with surgery in patients with a diagnosed concussion is based on clinical judgment by the patients.

phase i's specific aim is to estimate the incidence of symptomatic concussion in the pediatric orthopedic surgical population. the first phase of this study requires a member of the research team to administer a paper questionnaire to all eligible, consented orthopedic surgery patients in either the pre-operative clinic or in the day surgery unit over a period of four months. the research member will only approach adolescents that are scheduled for repair of orthopedic traumatic injury as defined in the inclusion criteria. the questionnaire is specifically designed to elicit occurrence and symptoms of a concussion. if the patient answers yes to question 2a, which asks "at the time of the injury do you recall a blow to the head, neck, face or body that resulted in sustained symptoms of concussion (e.g., headache, dizziness, confusion, nausea, vomiting, etc.)?", the research team will administer the 22 item self-reporting symptom scale in the above mentioned scat3. the responses obtained from the questionnaire will be used to determine the incidence of symptomatic concussions, either known or unrecognized, in pediatric patients sustaining an orthopedic injury requiring surgical repair. if the participant scores higher than a 0 on the scat3 the results will be conveyed to the surgeon prior to the start of the scheduled surgical procedure. a copy of the completed scat3 will also be placed in the medical record. the decision to continue with surgery and need to possibly refer the patient to the boston children's hospital sports concussion clinic after the scat3 will remain at the surgeon's discretion. information will be gathered from the questionnaire and the scat3, then entered into the redcap database under a de-identified subject number.

Eligibility criteria:
inclusion criteria: all patients aged 5-21 years of age presenting for repair of orthopedic traumatic injury. orthopedic traumatic injury will be defined as any traumatic injury resulting from a fall, collision (struck by or struck against), vehicle accident, assault or bike-related injury or fracture. exclusion criteria: patients who do not speak english as their first language, or who are unable to respond to the survey's questions on their own will be excluded from study participation.
renalguard system for prevention of contrast induced nephropathy

Conditions: Radiographic Contrast Agent Nephropathy

Summary: the purpose of this study is to determine whether hydration with intravenous saline matched with urine output, using the device renalguard is superior to standard hydration with saline to prevent contrast-induced nephropathy.


Eligibility criteria:
inclusion criteria: * serum creatinine \>1.2mg/dl * glomerular filtration rate (gfr) \< 60ml/min exclusion criteria: * acute renal failure * use of radiological contrast in the latest 7 days * current use of n-acetylcysteine or hydration of sodium bicarbonate * patients in dialysis * emergency procedures

Keywords: contrast nephropathy prevention renalguard