Kornimate/medical-research-clean huggingface dataset:
creatine monohydrate use for preventing altitude induced depression

Conditions: Depression

Summary: this study involves the use of an investigational drug called creatine monohydrate. this means that the drug has not yet been approved by the food \& drug administration (fda) for treatment of altitude-induced depression. however, the fda has not objected to its use to study its safety and effectiveness for preventing altitude-induced depression. this study will help find out what effects, good and/or bad, creatine monohydrate has on treating symptoms for altitude-induced depression. creatine monohydrate is believed to have an effect on improving symptoms of depression. the safety of creatine monohydrate in humans has been tested in prior research studies; however, some side effects may not yet be known.

subjects will be in this research study if they moved to creech afb from an elevation of less than 2.000 feet within the last month. the purpose of this study is to see if creatine monohydrate is effective in preventing altitude-induced depression. this study will enroll approximately 75 subjects. this study involves the use of an investigational drug called creatine monohydrate. this means that the drug has not yet been approved by the food \& drug administration (fda) for treatment of altitude-induced depression. however, the fda has not objected to its use to study its safety and effectiveness for preventing altitude-induced depression. this study will help find out what effects, good and/or bad, creatine monohydrate has on treating symptoms for altitude-induced depression. creatine monohydrate is believed to have an effect on improving symptoms of depression. the safety of creatine monohydrate in humans has been tested in prior research studies; however, some side effects may not yet be known. creatine monohydrate is a dietary supplement that is believed to aid in the building of muscle mass. the placebo being used in this study is maltodextrin (a sugar). maltodextrin is an fda approved food additive made from a highly processed starch product typically made from corn.

Eligibility criteria:
patients must be able to get care at nellis air force base (a military installation) in order to participate in this study inclusion criteria: * male and female active duty members and dod beneficiaries ages 18-65 * moved to creech afb from an altitude of less than 2,000 feet within the last month exclusion criteria: * preexisting depression as noted in a review of their medical record or on their phq9 (score of 10 or greater) * preexisting anxiety as noted in a review of their medical record or on their gad 7 (score of 10 or greater) * clinical or laboratory evidence of liver disease. * serum creatinine \>1.5 * existing kidney disease * existing type i or type ii diabetes mellitus * taking creatine as a dietary supplement * moved to creech afb from an altitude of greater than 2000 feet * pregnant, breast feeding, or trying to become pregnant

Keywords: depression
comparison of intravitreal bevacizumab injection with combination of suprachoroidal triamcinolone acetonide along with intravitreal bevacizumab injection in the treatment of diabetic macular edema in pseudophakic patients

Conditions: Diabetic Macular Edema (DME)

Summary: patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema

patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema. those patients who had glaucoma history or iop above 21 mm of hg, phakic, corneal opacity, vitreous hemorrhage, proliferative diabetic retinopathy, already received anti-vegf injections, history of pan-retinal photocoagulation for proliferative diabetic retinopathy.

Eligibility criteria:
inclusion criteria: * patients with center involving diabetic macular edema on optical coherence tomography exclusion criteria: * raised intraocular pressure * history of glaucoma * corneal opacity * vitreous hemorrhage * proliferative diabetic retinopathy * anti-vegf injections in last 3 months * history of pan-retinal photocoagulation * contraindications for anti-vegf

Keywords: intravitreal bevacizumab suprachoroidal triamcinolone diabetic macular edema
a clinical trial to explore the safety and efficacy of three different doses of pegaptanib sodium in patients with wet age-related macular degeneration (amd)

Conditions: Macular Degeneration

Summary: the purpose of this trial is to compare the ability of three different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or improving vision in patients with wet amd. the study will also examine the effects of pegaptanib sodium on the cornea and sensory retina of patients with wet amd.


Eligibility criteria:
inclusion criteria: * subjects of either gender, aged 50 years or greater. * subfoveal choroidal neovascularization (cnv) due to amd. * best corrected visual acuity in the study eye between 20/40 and 20/320. * normal electroretinogram, and corneal endothelial cell density of 1500 cells/mm2 or more. exclusion criteria: * any prior photodynamic therapy (pdt) with visudyne or thermal laser to the study eye.

Keywords: amd age-related macular degeneration macular degeneration macugen pegaptanib sodium erg specular microscopy age-related mcular degeneration (amd)
incidence and outcomes of venous thromboembolism

Conditions: Cardiovascular Diseases; Lung Diseases; Pulmonary Embolism; Venous Thromboembolism

Summary: to identify the incidence cohort of olmsted county minnesota residents with deep venous thrombosis (dvt)/pulmonary embolism (pe) from 1966 through 1990. episodes of dvt or pe acquired during hospitalization or in the community were identified for future studies.

background: deep vein thrombosis and pulmonary embolism most often occur during hospitalization for surgery or chronic medical conditions. consequently information on deep venous thrombosis/pulmonary embolism is derived from large referral hospitals, and there are substantial gaps in our understanding of the incidence, risk factors, and outcomes of deep venous thrombosis/pulmonary embolism in the community. this was one of the first studies to compare hospital acquired deep venous thrombosis/pulmonary embolism with deep venous thrombosis/pulmonary embolism among ambulatory residents in a community. design narrative: the five part study: 1. identified the incidence cohort and tested the hypotheses that over the 25 year study period the incidence of deep venous thrombosis/pulmonary embolism had decreased, the extent of testing for suspected deep venous thrombosis/pulmonary embolism had increased, and the number of tests obtained for patients with deep venous thrombosis/pulmonary embolism had increased. 2. determined the independent risk factors for deep venous thrombosis/pulmonary embolism and estimated the population attribute risk due to each independent risk factor for deep venous thrombosis/pulmonary embolism in a case-control study of the incidence cohort and community controls. 3. tested the hypothesis that deep venous thrombosis/pulmonary embolism were independent risk factors for death after adjusting for age, sex and co-morbid conditions. 4. described the occurrence of the post-phlebitic syndrome, pulmonary hypertension, and recurrent deep venous thrombosis/pulmonary embolism over the 25 year study period and identified the independent risk factors for lower extremity venous ulceration. 5. evaluated the accuracy of national pulmonary embolism mortality rates by comparing pulmonary embolism mortality rates calculated from a review of all the inpatient and outpatient medical records of olmsted county deep venous thrombosis/pulmonary embolism patients with death certificate pulmonary embolism mortality rates for olmsted county from the national center for health statistics. the study provided the most complete and comprehensive population based estimates of the incidence, risk factors, survival and outcomes of deep venous thrombosis/pulmonary embolism available to date. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
motivating campus change project pilot study

Conditions: Drinking Behavior

Summary: this study tests the optimization and delivery feasibility of personalized feedback interventions to address harmful alcohol use among college students.

this study builds upon the latest alcohol intervention literature to develop and test the next wave of personalized feedback interventions (pfis) to address harmful alcohol use among college students. the purpose of this research is to determine optimal configuration of pfis to take advantage of the clarity and initial impact of single-component pfis and greater effect size and duration of personalized multi-component pfis. the investigators seek to increase and evaluate engagement with the pfi and text-message materials and boost innovation of both content and process of the intervention. in addition to pfi content and delivery, the investigators will use qualitative and quantitative methods to determine personal relevance of the chosen high-risk events among a sample of students who engage in heavy episodic drinking to better understand duration of pfi effects impacted by fluctuations in drinking associated with high-risk events. prior interventions have targeted drinking in general or a single high-risk drinking event (e.g., spring break), but have not targeted both general and event-specific drinking together. these enhanced intervention effects, could have a significant impact on risks associated with college student drinking, and can be rapidly disseminated and implemented on campuses nationwide to address the public health problem posed by heavy episodic drinking among college students. this study conducts a screening/baseline assessment to collect quantitative data on high risk drinking situations and related norms and screens participants for eligibility for the pilot feasibility study. the purpose of the pilot feasibility study is to test the feasibility of sending participants web-based personalized feedback targeting their general drinking behavior in a single dose (simultaneous) versus broken up into 4 components administered one week apart (sequential) with half of participants in each group also being randomly selected to receive a text message booster component targeting drinking during their upcoming birthday celebration.

Eligibility criteria:
inclusion criteria: * birthday that falls withing summer/ fall 2018 assessment window * at least 1 heavy episodic drinking episode in the past month * at least 3 negative alcohol related consequences on rutgers alcohol problem index/ young adult alcohol problems screening test in the past 3 months * intend to consume alcohol over the week of their birthday * indicate they own a cell phone with text message capabilities and consent to receiving text messages exclusion criteria: * doesn't meet inclusion criteria * unwillingness to participate * failure to provide consent
radial artery bypass graft study of tromsø

Conditions: Coronary Arteriosclerosis; Myocardial Infarction

Summary: the purpose of this study is to answer, among others, the following questions: 1) what are the outcomes when using the radial artery as a bypass graft in coronary artery bypass surgery (cabg)? 2) can multidetector computed tomography (ct) be used to reliably evaluate coronary artery bypass graft patency?

radial arteries have been used as aortocoronary conduits with varying results. the study is based on the first 119 patients operated with this graft at our institution, aiming to answer the following questions: 1. what is the short-term patency (2-3 years) of radial artery bypass grafts in cabg (comparisons are made with saphenous veins and internal thoracic artery grafts)? 2. what complications occur and what in what frequency? 3. what are the clinical outcomes and patient satisfaction after using radial arteries in cabg? (n=119 pt.) 4. can multidetector ct be used to reliably evaluate coronary artery bypass graft patency? (n=45 pt.) methods: questionnaires, record review, coronary angiography.

Eligibility criteria:
inclusion criteria: * operated with radial artery coronary bypass at our department during april 2001 - october 2004 * written informed consent exclusion criteria: * for the angiography procedures, standard contraindications are adhered to

Keywords: radial artery angina pectoris infarction bypass angiography
cyproheptadine in severe covid-19 : a unblinded randomized trial

Conditions: Viral Pneumonia; Serotonin Syndrome; Platelet Dysfunction

Summary: this randomized controled open label clinical trial is to evaluate the effect of cyproheptadine on the clinical course of patients presenting a severe sars-cov 2 pneumonia.

observational and biochemical studies have identified an interesting pathway in the pathophysiology of certain clinical-biological characteristics of covid-19, linked to an excess of serotonin. we hypothesize that the antagonism of the action of serotonin could improve the clinical course of patients most severely affected by covid-19. one such antagonist of serotonin with a long track record of safety and tolerability is cyproheptadine. cyproheptadine acts as an antagonist of 5-hydroxytryptamine (5ht=serotonin) receptor subtype 2 as well as histamine-1 receptor. many of the potent effects of serotonin on lung vascular tone, respiratory rate, and systemic vascular beds are mediated by 5-ht receptor subtype 2. investigators will randomize approximately 200 participants, aged 18 and older, who have tested positive for covid-19 and who will be hospitalized at santa cabrini hospital in montreal, quebec, canada, presenting a severe form of covid-pneumonia-19 requiring supplemental oxygen. study eligibility of all participants will be assessed first. once a participant is confirmed eligible and consented, they will participate in the study. participants will be randomly assigned (1: 1) to either take cyproheptadine 8 mg by mouth three times a day for 5 days and receive standard care or receive standard care alone. the dose will be adjusted according to the glomerular filtration rate. on d1, d3, d5, d7 and d10 since randomization, participant's vital signs (including spo2, respiratory rate, fio2 or oxygen flow, heart rate, blood pressure and temperature), blood creatinine, bilirubin, crp, ldh, dimers and platelets the count will be evaluated. any adverse event will be assessed daily and documented.

Eligibility criteria:
inclusion criteria: * men and women age 18 or older * hospitalized and requiring medical care for covid-19 * presenting respiratory failure cause by covid 19 requiring oxygen and/or mechanical ventilation support * with radiographic evidence of pulmonary infiltrate * able to give informed consent or, if unable to do so regarding the medical condition, having relatives able of consenting for the patient exclusion criteria: * pregnancy * patients with pre-existing terminal condition with life expectancy \< 6 months * patients with pre-existing severe lung disease requiring home o2 * history of seizure disorder * history of adverse reaction to antihistamines or to cyproheptadine

Keywords: covid 19
micrometastasis in gastrointestinal cancer

Conditions: Pancreatic Adenocarcinoma; Colorectal Cancer

Summary: prognostic and predictive value of assessing the patients micrometastasis status in blood and bone marrow when diagnosed gi cancer. 2 different patient subgroups are currently studied, patients with cancer of the pancreas and patients with liver metastasis secondary to colorectal cancer. our hypothesis is that patients with detective circulating tumor cells in the blood or disseminated tumour cells in their bone marrow at diagnosis have a more advanced disease than negative patients. this information may be of therapeutic interest.

oncological and overall outcome of the included patients are consecutively registrated at the out-patient clinic. at end of follow-up these survival data are analysed according to the presence of tumor cells in blood and bone marrow, and the prognostic impact of their presence are assessed.

Eligibility criteria:
inclusion criteria: 1. histological proven adenocarcinoma of the pancreas 2. histological/radiological verified colorectal liver metastases 3. consent capable patient 4. signed written, informed consent exclusion criteria: 1. patient'history of other malignancy

Keywords: survival
randomized, double-blind, placebo-controlled study of larazotide acetate in subjects with active celiac disease

Conditions: Celiac Disease

Summary: this study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.

this was an outpatient, randomized, parallel- group, double-blind, multicenter, 8-week study with three treatment arms: larazotide acetate 4 mg tid, larazotide acetate 8 mg tid and placebo tid in subjects with celiac disease. the primary objective was to assess the efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease, as defined by an improvement in the villous height to crypt depth (vh:cd) ratio, obtained by duodeno-jejunal biopsy. secondary objectives included assessment of the safety and tolerability of larazotide acetate, to prospectively validate the components of a composite weighted index of celiac disease activity (celiac disease activity rating score, cedars), individually and as a whole, to to compare the cedars against the clinician global assessment of disease (cga), psychological well being index and the short form 12 version 2 (sf-12 v2) health survey and to assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease.

Eligibility criteria:
inclusion criteria: * male and female adults with celiac disease (as demonstrated by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-ttg) * marsh score ≥ ii at screening * positive serum anti-ttg antibodies as determined by screening serology * willing to comply with a gluten-free diet for the duration of the study exclusion criteria: * has refractory celiac disease or severe complications of celiac disease (eg, eatl-, ulcerative jejunitis, perforation, etc.) * has chronic active gi disease other than celiac disease * has diabetes (type 1 or type 2) or other autoimmune disease that might interfere with the conduct of the study * has hemoglobin value below 8.5 g/dl

Keywords: treatment active celiac remission induction
elimination of microemboli during aortic valve replacement

Conditions: Neurocognitive Outcome After Aortic Valve Replacement

Summary: in a randomized controlled trial patients undergoing aortic valve replacement are recruited into 3 groups. patients receive either an intra-aortic filter (embol-x), designed to reduce solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (dbt), designed to reduce gaseous microemboli from cardiopulmonary bypass (cpb), or no additional device (control-group). cognitive functioning is assessed 3 weeks to 1 day before and 3 months (+/- 1 week) after valve replacement. furthermore, cerebral magnetic resonance imaging (mri) is carried 2-6 days after surgery. primary endpoint is the cognitive outcome of the filter groups compared to the controls. secondary endpoint is the number of acute ischemic lesions after cabg.


Eligibility criteria:
inclusion criteria: * age \> 18 * elective aortic valve replacement * informed consent * german language exclusion criteria: * neurological and psychiatric diseases that would conflict with neuropsychological testing (e.g. stroke, tbi, schizophrenia, etc.); further major surgeries on cpb planned for within 3 months after valve replacement * contraindication against mri assessment

Keywords: cognition neuroprotection cardiopulmonary bypass aortic valve replacement micro-emboli
gait analysis following total ankle replacement and subtalar fusion

Conditions: Ankle Osteoarthritis

Summary: subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoarthritis. patients with osteoarthritis or severe dysfunction involving both the ankle and the subtalar joint may benefit from an tibiotalocalcaneal fusion (ttc) or an ankle replacement and subtalar fusion. with the development of new prosthetic designs and of surgical techniques, total ankle replacements (tar) became a reasonable alternative to fusion with functional and quality of life improvements. a gait analysis of patients that underwent tar and simultaneous subtalar fusion allows to study with precision and reliability the ankle range of motion (rom). on the contrary, in healthy subjects or in patients that underwent isolated tar this is not possible because the ankle rom is influenced by the rom of the subtalar joint in such a way that it is not possible to analyze the two joints separately. also, excluding the role of the subtalar joint, it is possible to accurately analyze and compare the consequences on ankle kinematics of two different prosthetic designs.

patients who previously have underwent tar and simultaneous subtalar fusion are retrospectively reviewed. minimum follow-up after the surgery is 12 months.

Eligibility criteria:
inclusion criteria: * patients who underwent ankle prosthesis (hintegra ankle system, zimmer trabecular metal total ankle) and simultaneous fusion of the subtalar joint with at least 12 months of follow-up willing and capable of adhering to postoperative clinical protocols and functional evaluations and who have signed a specific informed consent form approved by the ethics committee * males or females aged between 20 and 80 years old. * patients with diagnosis of primary not-inflammatory degenerative articular disease exclusion criteria: * patients with body mass index (bmi)\> 35. * patients with active or suspected latent periprosthetic infection * patients who underwent revision surgery. * prosthesis of the hip, knee or ankle, homolateral or contralateral. * fusion failure of subtalar joint. * patients with chronic heart failure (nyha stage\> 2) * presence of neurological disorders, neuromuscular disorders or other major musculoskeletal pathologies * cognitive deficits. * impossibility to match questionnaires due to cognitive disorders or language dysfunctional disorders
impella real-world surveillance of patients using sodium bicarbonate

Conditions: Cardiogenic Shock; High Risk PCI

Summary: the population enrolled in this study are all subjects who received an impella in which a bicarbonate-based purge solution was used.


Eligibility criteria:
left sided impella inclusion criteria: * left-sided impella with bicarbonate in the purge exclusion criteria: * known lv thrombus right sided impella inclusion criteria: * right-sided impella with bicarbonate in the purge exclusion criteria: * known pulmonary thromboemboli * known dvt
evaluation of the digestive and metabolic utilisation of dietary protein in patients with chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: the objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.


Eligibility criteria:
inclusion criteria: * subjects with chronic pancreatitis and taking enzyme replacement therapy exclusion criteria: * patients with hepatic impairment * patients allergic to dairy proteins * urinary incontinence affecting the measurement of nitrogen metabolism * digestive disorder affecting the absorption of nutrients

Keywords: chronic pancreatitis exocrine pancreatic insufficiency enzyme therapy patients with chronic pancreatitis and exocrine pancreatic insufficiency taking enzyme replacement therapy