Kornimate/medical-research-clean huggingface dataset:
statin for neuroprotection in spontaneous intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage; Statins

Summary: brain injury after spontaneous intracerebral hemorrhage results from pathophysiologic responses in the brain parenchyma due to hematoma formation, release of clot components, and surrounding edema. inflammatory cascade activation in the perihematomal brain parenchyma has been implicated in the pathogenesis of secondary brain injury. statins have been identified as a potential neuroprotective agent that targets the inflammatory response to intracerebral hemorrhage. in preclinical studies, statin treatment in animal intracerebral hemorrhage models has consistently demonstrated neuroprotective and recovery enhancement effects. clinical investigations in humans reported better patient outcomes associated with statin use in patients with intracerebral hemorrhage, including reduced perihematomal edema, lower mortality rates, and improved functional outcomes.


Eligibility criteria:
inclusion criteria: * age of 18 years or older * a clinical diagnosis of supratentorial intracerebral hemorrhage is confirmed by brain ct scan * hematoma volume ≤40ml * the first dose of statin can be given within 24h of intracerebral hemorrhage symptom onset (if the patient is randomized to statin group) * written informed consent exclusion criteria: * presence of intraventricular hemorrhage or subarachnoid hemorrhage * planned surgical hematoma evacuation by open craniotomy prior to randomization (planned minimally invasive surgery is not a contraindication to enrollment) * suspected secondary intracerebral hemorrhage related to trauma, tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, moyamoya disease, or venous sinus thrombosis * unable to swallow a statin pill and have contraindication to position a nasogastric tube * active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (ast), or alanine aminotransferase (alt) ≥2 × the upper limit of normal * known pregnancy, or positive pregnancy test, or breastfeeding * other diseases or abnormalities that the investigator believed might compromise the patient's safety during the study * historical modified rankin scale score ≥2 * life expectancy of less than 7 days * participation in another clinical study within 30 days prior to screening for the present study * prior use of statins within 1 month before intracerebral hemorrhage
peripheral drivers of heart failure progression - the prospective pedal-hf study

Conditions: Heart Failure - NYHA II - IV

Summary: pedal-hf is a registry-based randomized prospective multicenter study. we plan to include 1000 patients who were recently admitted with acute decompensated heart failure at five tertiary heart clinics in germany. for the randomised part, 750 patients will be randomized to care within a heart failure network or usual care. the primary endpoint of the randomized trial is change in nt-probnp from baseline to 6 months of follow-up. all patients (randomized or not) will be followed for two years.

see above.

Eligibility criteria:
inclusion criteria: * patients admitted to the participating study centres with acute decompensated heart failure (adhf), defined as clinical signs and/or symptoms of heart failure, objective structural cardiac abnormalitites according to the esc criteria. exclusion criteria: * age \&lt; 18 years, pregnancy, any condition interfering with the informed consent process, patients placed in an institution by official or court order

Keywords: heart failure network care
evaluation of antithrombotic strategies in stemi patients in china

Conditions: STEMI; Emergent PCI

Summary: east-stemi is the first perspective, multicenter, large-scale registry focusing on the evaluation of real-world medical quality (especially pci quality) and antithrombotic strategies in stemi patients undergoing emergent pci in a regional representative sample in china with 2 years follow-up. clinical decision support tools (including ischemic score, bleeding score, etc) will be developed and validated based on the database. novel biomarkers to predict the prognosis and to support risk stratification will be explored by using the blood samples.


Eligibility criteria:
inclusion criteria: 1. age\>=18yrs 2. stemi patients undergoing emergent pci 3. signed informed consent exclusion criteria: 1. difficult to follow up or obtain accurate information (e.g., long-term overseas stay, speech or mental disorders) 2. other severe diseases (e.g., liver failure, renal failure and advanced stage of cancer)
mechanical device for the relief of hot flashes

Conditions: Hot Flashes

Summary: hypothesis: a mechanical device when applied to the back of the neck at the onset of a menopausal hot flash will attenuate the severity and duration of symptoms providing women with a reassuring non-hormonal intervention to improve quality of life in the menopausal transition. this pilot study will evaluate the effectiveness of this unit. the mechanism of action of the device will not be revealed in advance.

this is a pilot study to test logistics and gather information for planning the definite trial. we will randomly allocate 40 subjects to receive either the active menopod device (n=20) or a sham device with the mechanism disabled (n=20). we will recruit menopausal women with moderate to severe hot flashes (as defined by fda standards this means a minimum of 7 per day). the two primary outcome parameters are the hot flash score which is the product of frequency x intensity (sloan 2001), and the average duration (in minutes) of hot flash episodes over the course of one day. these outcomes will be self-recorded by subjects in a diary designed by our research team on five separate days throughout the course of the study, once during the evaluation phase and once per week over the four week treatment phase. the two summary measures will be the changes from baseline to the last record collected for hot flash scores and average durations. delta values (assessment phase minus fourth treatment period) will be compared between the two treatment groups (active versus sham device) using t tests (ibm spss statistics version 21).

Eligibility criteria:
inclusion criteria: * age range: 40 to 65 years * healthy postmenopausal woman * natural or surgical menopause * fsh \> 30 iu/l * amenorrhea \> 6 months prior to study * minimum of 7 moderate hot flashes per day documented in diary during evaluation phase exclusion criteria: * any therapy for hot flashes prior to or during study * obesity: bmi \> 35 * alcohol abuse * drug abuse * unable to use device as per protocol * unable to complete required documentation * serious medical condition: * coronary heart disease * stroke * chronic renal or hepatic disease * diabetes * depression or other psychiatric illness * cancer

Keywords: menopause hot flash quality of life
clinical trial to evaluate the efficacy and safety of an immunomodulatory therapy for the treatment of patients with moderate to severe covid-19 infection

Conditions: COVID-19 Infection

Summary: an open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment of patients with moderate to severe covid-19 infection

the justification for the use of immunomodulatory therapy is based on the evidence that drugs that are inhibitors of interleukin il6 may prevent the more severe lung tissue damage caused by cytokine release in patients with more severe covid19. several studies have suggested a "cytokine storm" caused by the release of il-6, il-1, il-12 and il-18 with tumor necrosis factor tnf alpha and other inflammatory mediators. increased inflammatory response of lung tissue may result in increased gas exchange at the alveolar-capillary level making oxygenation difficult in patients with more severe forms of the disease and the need for mechanical ventilation. in this regard, it is hypothesized that the use of immunomodulatory therapy should have an effect in reducing the lethal outcome, the need for oxygen therapy, and mechanical ventilation.

Eligibility criteria:
inclusion criteria: * patients with laboratory-confirmed (pcr) covid-19 infection * patients with moderate to severe covid-19 infection * hospitalized patients on clinical centers and cantonal hospitals * patients with radiology-confirmed pneumonia within the clinical condition of covid-19 infection including pulmonary opacity * patients with a clinical indication for pneumonia: increased body temperature (defined as a value above ≥ 36.6⁰c axillary route, ≥ 37.2°c oral route or ≥ 37.8 °c rectal route), and/or dyspnea, and/or cough, and/or spo2 \<96% * patients aged above 18, both genders * patients able and willing to understand the study, adhere to all study procedures and sign a written informed consent form (icf) prior to entering the study or with the assistance of the witness exclusion criteria: * patients not covid-19 positive * patients with mild covid-19 infection * patients who are study subjects in another clinical study for another investigational agent for covid-19 * patients with malignant hypertension * patients with malignant disease and who are treated for malignant diseases in the last 5 years * patients with severe liver and kidney insufficiency * patients who are receiving therapy with an immunomodulatory or immunosuppressive agent * patients aged below 18, female patients who are pregnant or breastfeeding * known allergy to study drug or any component thereof * use of haloperidol, dopamine antagonists, or nonsteroidal anti-inflammatory drugs, except paracetamol.
an open clinical trial to assess the influence of newly prescribed aminobiphosphonates on arterial stiffness

Conditions: Arteriosclerosis; Osteoporosis

Summary: the study tries to reveal if aminobisphosphonates influence aside the bone density also the vascular status in the typical elderly patient population

the subjects - starting bisphosphonate treatment due to medical reasons - will be additionally investigated as outpatients (arterial stiffness, applanation tonometry), for each subject 3 individual dates with a duration of approx. 30 min each are scheduled, prior to therapy with bisphosphonate, after 3 and 6 month of treatment

Eligibility criteria:
inclusion criteria: * patients starting an aminobisphosphonate therapy due to medical reasons broca-index: between -20 and +25% who are willing and capable to confirm written consent to enrolment after ample information has been provided exclusion criteria: * patients with major cardiovascular disease patients participating in another clinical trial 1month prior to inclusion in this study patients unable or unwilling to give informed consent
hrqol during prrt in patients with nets

Conditions: Neuroendocrine Tumors; Quality of Life; Peptide Receptor Radionuclide Therapy

Summary: neuroendocrine tumours (nets) can arise in different locations in the body, and may give rise to hormonal symptoms, which may affect the patients' health-related quality of life (hrqol). up to four cycles of peptide receptor radionuclide therapy (prrt) have been shown effective for symptom alleviation and prolonging survival. the aim of this study is to assess the patient's perspective, regarding changes in their hrqol during, and at long-term follow-up after, prrt. patients with net will rate their hrqol before prrt cycles one and four, and 1-8 years after prrt. the patients' hrqol will be compared to a matched reference population. the investigators hope that this study will reveal specific care needs for patients wiht net and may provide information that will make it possible to deliver a more person-centered care.

the inclusion criteria for prrt were tumour somatostatin receptor expression higher than that in the normal liver found on somatostatin receptor scintigraphy (krenning score 3 and 4), or on 68ga-dotatoc positron emission tomography (pet), and sufficient bone marrow, liver and kidney function. dotatate was labelled in house with 177lu (idb holland bv, noord brabant, netherlands). up to nine cycles were given, yet a majority of patients received four cycles of prrt. the patients' medical records were reviewed regarding functional status (functioning versus non-functioning tumours), gender, age at diagnosis and at 1st prrt, marital and employment status, prrt cycles received, previous treatments and body mass index (bmi). hrqol was assessed using the questionnaires for cancer in general, eortc qlq-c30, and the gastrointestinal net-specifically eortc qlq-ginet21 at every cycle. from a large random sample (n=4,910) of the swedish adult population, a reference population was extracted. they all had chronical diseases (diabetes, cardiac, respiratory, renal or other specified conditions) and were age and gender matched. the reference population completed only the qlq-c30 questionnaire. in order to investigate how hrqol developed during the eight years after prrt, the questionnaires were sent to 58 patients.

Eligibility criteria:
inclusion criteria: * receiving prrt * net diagnosis exclusion criteria: * not able to speak and read in swedish or english.

Keywords: nets prrt hrqol
evaluation of cirrhosis and malignant hepatic lesions using novel mr contrast agents

Conditions: Hepatocellular Carcinoma

Summary: this study aims to determine whether or not gadoxetate disodium (eovist) enhanced magnetic resonance imaging (mri) has a higher sensitivity for detecting hepatocellular carcinoma (liver cancer) comparison to multi-detector computed tomography (ct).


Eligibility criteria:
inclusion criteria: * alpha-feto protein \> 400 ng / ml or * prior ultrasound with mass suspicious for hepatic malignancy or. * clinical risk of hepatocellular carcinoma or * prior multi-detector ct with mass suspicious for possible hepatocellular carcinoma exclusion criteria: * glomerulo-filtration rate \< 50 ml/ min/1.73 m2 based on a creatinine measurement within three months of the mr study * previous diagnosis of hepatic malignancy * any conditions that would discount the ability to have an mri scan

Keywords: hcc hepatocellular carcinoma mri liver
a long term follow up study of patients who have completed the pep005-016 or pep005-025 studies

Conditions: Actinic Keratosis

Summary: this study is designed to follow up patients who have achieved complete clearance of ak lesions at the day 57 visit having completed the pep005-016 or pep005-025 studies over a 12 month period to assess both recurrence of actinic keratosis (ak) lesions and long term safety in the selected treatment area.

a 12 month long-term follow-up study of patients who have achieved complete clearance of ak lesions at the day 57 in the phase 3 studies pep005-016 or pep005-025.

Eligibility criteria:
inclusion criteria: * patient must have achieved complete clearance of ak lesions (lesion count = 0) at day 57 in one of the following peplin ak clinical studies: pep005-016 or pep005-025 * patient has provided informed consent documented by signing the informed consent form (icf) prior to any study-related procedures exclusion criteria: * concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous peplin ak study) * early termination from study pep005-016 or pep005-025

Keywords: peplin actinic keratosis pep005
the effect of supervised exercise on physical fitness and energy expenditure in post bariatric surgery patients

Conditions: Post-bariatric Surgery

Summary: it is hypothesized that the patients in the exda group will be able to complete a structured exercise program at a level sufficient to accumulate at least 2000 kcal per week, and that the structured endurance activity will increase their physical fitness and total daily energy expenditure compared to the da group.


Eligibility criteria:
inclusion criteria: 1. rygb or gb surgery patients who are at least 12 weeks post surgery 2. bmi of 40 or more 3. age 18-70years 4. sedentary lifestyle (energy expenditure of \<35 kcal/kg/day measured by 7-day physical activity recall and no regular moderate physical activity exceeding 20 min/day within the previous 3 months) 5. willingness to alter physical activity in accordance with the intervention programs 6. english or spanish speaking. exclusion criteria: 1. body weight \> 180 kg 2. cardiovascular disease 3. pulmonary disease 4. uncontrolled hypertension (resting dbp \>100 or sbp \>180 mm of hg) 5. visual or hearing impairment 6. functional limitations (difficulty walking one-quarter mile or climbing 10 stairs) 7. abnormal ecg on vo2max test ( \>1 mm st segment depression at \< 5 mets or with symptoms such as atrial fibrillation, complex ventricular arrhythmias and 3rd degree atrioventricular block) 8. known liver disease due to causes other than nonalcoholic steatohepatitis (liver transaminases \> 2.5 times the upper limits of normal \[sgpt\>105 u/l, sgpt\>120 u/l\] or total bilirubin \>1.5 mg/dl) 9. hematocrit of less than 30% 10. current alcohol abuse (\>7 drinks or 210 g/wk for women and \>14 drinks or 420 g/wk for men) 11. recreational drug abuse 12. current use of any drugs capable of inducing weight loss (e.g., orlistat, sibutramine, topiramate, etc.) 13. major neuro-psychiatric illnesses impeding competence or compliance 14. pregnancy and lactation 15. chronic renal insufficiency (serum creatinine \> 2 mg/dl) 16. untreated thyroid disorders such as hypothyroidism and hyperthyroidism; and 17) bariatric surgical complications including anastomotic leak, wound complications, thrombotic disorders, intestinal obstruction, stomal complications, gi bleeding, recurrent severe abdominal pain, bilious vomiting.

Keywords: weight loss
a feasibility study implant of the wise® crt system with an intracardiac pacemaker to achieve totally leadless crt

Conditions: Heart Failure

Summary: assess the safety and efficacy of the co-implantation of the wise crt system with an intracardiac pacemaker to provide totally leadless crt.

the wise crt system is an implantable cardiac system to provide left ventricular (lv) pacing stimulation in conjunction with a co-implanted system that provides right ventricular (rv) stimulation. in combination, the devices deliver biventricular (biv) pacing. single-arm, prospective, multicenter, observational study.

Eligibility criteria:
inclusion criteria: * patient with a class i or iia (1) or (2) indication for implantation of a crt device according to current available guidelines 1,2,4 (with additional qrs criteria on class iia (1)): * class i: nyha ii, iii, iv, ef ≤ 35%, lbbb, qrs ≥ 150 ms * class iia (1): nyha ii, iii, iv, ef ≤ 35%, lbbb, qrs ≥ 130 to \< 150 ms * class iia (2): nyha ii, iii, iv, ef ≤ 35%, non-lbbb, qrs ≥ 150 ms * patient or legally authorized representative can provide written authorization and/or consent per institution requirements * male or female, aged 22 years or above * meets criteria for one of the two patient groups * group a: de novo totally leadless crt implant in whom the physician believes a totally leadless approach would be beneficial (e.g., wish to avoid lifelong transvenous lead implant, anatomical constraints, history of device infection). * patients with symptomatic af and an uncontrolled heart rate who are candidates for av node ablation (irrespective of qrs duration and lvef), and in whom the physician believes a leadless pacing approach would be beneficial. * patients with high degree av block who have an indication for permanent pacing (with a lvef ≤ 50%), are expected to require ventricular pacing more than 40% of the time, and in whom the physician believes a leadless approach would be beneficial. * group b: upgrade chronic intracardiac pacemaker to crt * patients with existing intracardiac pacemakers with greater than 20% rv pacing, who have developed symptomatic hf. exclusion criteria: * patient who is or is expected to be inaccessible for follow-up visits * female participant who is pregnant, lactating, or planning pregnancy during the course of the study * inability to comply with the study follow-up or other study requirements * history of chronic alcohol/ drug abuse and currently using alcohol/ drugs * non-ambulatory (or unstable) nyha class 4 * life expectancy less than 12 months * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * patient who is enrolled in another clinical study that could confound the results of this study (note: patients enrolled in complementary study are eligible for enrolment)
bapineuzumab in patients with mild to moderate alzheimer's disease (apoe4 non-carrier)

Conditions: Alzheimer's Disease

Summary: this is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate ad. approximately 230 study sites in the us and canada and up to 35 sites outside of north america will be involved. patients will be randomized to receive either bapineuzumab or placebo. each patient's participation will last approximately 1.5 years. bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.


Eligibility criteria:
inclusion criteria: * diagnosis of probable ad * age from 50 to less than 89 * mini-mental status exam score of 16-26 inclusive * brain magnetic resonance imaging (mri) scan consistent with the diagnosis of ad * stable doses of medications (cholinesterase inhibitors and memantine allowed) * caregiver able to attend all clinic visits with patient exclusion criteria: * significant neurological disease other than ad * major psychiatric disorder * significant systemic illness * history of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years * smoking greater than 20 cigarettes per day * anticonvulsants, anti-parkinson's, anticoagulant, or narcotic medications * prior treatment experimental immunotherapeutics or vaccines for ad * women of childbearing potential * presence of pacemakers, csf shunts, or foreign metal objects in the eyes, skin or body