Kornimate/medical-research-clean huggingface dataset:
technology-enabled collaborative care for diabetes management during covid-19

Conditions: Type 2 Diabetes

Summary: the overall goal of this research program is to evaluate the effectiveness of a technology-enabled collaborative care program. in this study, we examine the feasibility of such a program, called the technology-enabled collaborative care (tecc) for type 2 diabetes designed to support patients with diabetes and mental health concerns during covid-19.

there is growing concern regarding the impact of covid-19 and social isolation on mental health and wellbeing, particularly adults living with type 2 diabetes (t2dm), who are at greater risk for mental health issues than the general population. self-management education and support for healthy eating, physical activity, glucose monitoring, medication adherence and problem solving are vital components of diabetes care. due to social distancing and limited care and resources, that are likely to persist in the post pandemic phase other innovative service models should be developed and adopted to improve service delivery. the overall goal of this research program is to evaluate the effectiveness of a technology-enabled collaborative care program. in this study, we examine the feasibility of such a program, called the technology-enabled collaborative care (tecc) for t2dm designed to support patients with diabetes and mental health concerns during covid-19.

Eligibility criteria:
inclusion criteria: * age: 18 years and older * clinician diagnosis of type 2 diabetes for at least one year * a1c level of 7.5% or higher within the last 6 months (benchmark is 7%) * access to telephone or internet through computer or mobile * experiencing some distress, score of \*\* on perceived stress scale exclusion criteria: * unable to provide consent * unable to understand english * pregnant or planning to get pregnant during the course of the study
a study to assess the hemodynamic effects, safety, tolerability, and pharmacokinetics of intravenous apd418 in adult participants with heart failure with reduced ejection fraction

Conditions: Acute Heart Failure With Reduced Ejection Fraction

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics, and effect on cardiac function of intravenous apd418 in adult participants with heart failure with reduced ejection fraction (hfref).

this study has an adaptive design, in which dose escalation in part a will inform dose expansion in part b. part a is a single-ascending dose, placebo-controlled study planned to consist of 5 cohorts evaluating 5 doses of apd418. part b is a parallel-treatment group study planned to evaluate 2 doses of apd418 and placebo. participants in part a cannot participate in part b.

Eligibility criteria:
inclusion criteria: * advanced chronic heart failure with reduced ejection fraction (hfref), defined as left ventricular ejection fraction (lvef) less than or equal to (≤) 35% at screening, including documented history of hfref (lvef ≤ 35%) for at least 4 months prior to screening * new york heart association class ii-iv * cardiac index ≤ 2.5 liters per minute per square meter (l/min/m\^2) and pulmonary capillary wedge pressure ≥ 15 millimeters of mercury (mm hg) at day 1 * body mass index 18.0 to 37.0 kilograms per square meter (kg/m\^2), inclusive, and body weight \< 150 kg at screening and day 1 exclusion criteria: * hemodynamically unstable at day 1 or in the opinion of the investigator likely to progress to becoming hemodynamically unstable during the course of the study * treated with carvedilol or at a dose higher than a total of 25 milligrams per day any time within 72 hours of day 1 through the end of the in-clinic observation post-dose period. * receiving any mechanical (respiratory or circulatory) or renal support therapy at screening or day 1 * systolic blood pressure ≤ 90 millimeter of mercury (mm hg) or ≥ 160 mm hg, or heart rate \ 110 bpm, at screening or day 1 * recently treated with inotropic, intravenous (iv) vasoactive or iv diuretic therapy, or expected to require such therapy with these drugs any time from day 1 through the end of study conduct.

Keywords: heart failure with reduced ejection fraction hfref apd418 acute heart failure (ahf)
safety, tolerability and pharmacokinetics of nn1731 in healthy volunteers

Conditions: Congenital Bleeding Disorder; Healthy

Summary: this trial is conducted in japan. the aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor vii analogue (nn1731, vatreptacog alfa (activated)) in healthy japanese male subjects. in addition, the pharmacokinetics of nn1731 will be examined


Eligibility criteria:
inclusion criteria: * japanese male subjects, who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the investigator or sub-investigator * body mass index (bmi) between 18.0 and 27.0 kg/m\^2 (inclusive) exclusion criteria: * any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal electrocardiogram (ecg) findings at the screening, as judged by the investigator or sub-investigator * presence or history of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders * evidence of clinically relevant pathology or a potential thromboembolic risk as judged by the investigator or sub-investigator * presence or history of atherosclerosis, arteriosclerosis or thromboembolic events * any past history of migraine * overt bleeding, including from the gastrointestinal tract
exploratory multi-centre trial in patients with et treated with xagrid®

Conditions: Essential Thrombocythemia (ET)

Summary: this study is hypothesis-generating to explore the impact of jak2 (v617f) mutation status on the treatment response to anagrelide hydrochloride


Eligibility criteria:
inclusion criteria: 1. patients must be able to understand and willing to participate in the study, and provide a personally dated and signed written informed consent form. 2. patients must have a confirmed diagnosis of et according to the world health organisation's criteria. 3. et patients who are uncontrolled, in the investigator's opinion, by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons. 4. patients who have either commenced treatment with anagrelide hydrochloride in the last 7 days or for whom a decision has been documented to commence treatment with anagrelide hydrochloride exclusion criteria: 1. patients for whom treatment with anagrelide hydrochloride is contraindicated, according to the current xagrid smpc. 2. known or suspected intolerance or hypersensitivity to the product, closely related compounds, or any of the stated ingredients. 3. patients participating in an interventional research study. 4. patients on combination therapy or for whom there is an intention to treat with other cytoreductive agents e.g., hydroxyurea, interferon. patients can however use aspirin and other anti-aggregatory products at the investigator's discretion.
gluteal squeeze for left colon distension

Conditions: Colorectal Neoplasms

Summary: good distension of the colon during colonoscopy is essential to detect polyps. gas sometimes escapes the colon through the anus resulting in compromised distension. pressure on gluteal muscles when the colonoscope tip is in the left colon might help preventing this and thus increase visibility. no previous study looked at this.


Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 40 years 2. scheduled colonoscopy exclusion criteria: 1. inflammatory bowel disease 2. history of colorectal cancer or colon resection 3. any colorectal cancer syndromes (fap, hnpcc, sps) 4. patient with poor bowel preparation identified during insertion
therapy™ cool flex™ irrigated ablation system for typical atrial flutter

Conditions: Typical Atrial Flutter

Summary: to demonstrate that ablation with the therapy™ cool flex™ irrigated ablation system is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.

this will be a prospective, multi-center and non-randomized study. all treated patients will receive ablation therapy for typical atrial flutter using the therapytm cool flextm irrigated ablation system. historical data from combined published (pma p060019 cool path) and reported (ide g090109 cool path duo) atrial flutter studies will be used to determine performance goals for study endpoints.

Eligibility criteria:
inclusion criteria: * a signed written informed consent * presence of typical atrial flutter (cavo-tricuspid isthmus dependent) * if subjects are receiving anti-arrhythmic drug therapy (class i or class iii aad) for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. if the subject had typical atrial flutter before starting the aad(s) (class i or class iii) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month aad criteria will not apply * one documented occurrence of the study arrhythmia documented by ecg, holter, telemetry strip, or transtelephonic monitor within the past 6 months * in good physical health * 18 years of age or older * agree to comply with follow-up visits and evaluation exclusion criteria: * prior typical atrial flutter ablation treatment * pregnancy * atypical flutter or scar flutter (non isthmus dependent) * significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (nyha class iii or iv) at the time of enrollment * a recent myocardial infarction within 3 months of the intended procedure date * permanent coronary sinus pacing lead * clinically significant tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve * evidence of intra-cardiac thrombus or a history of clotting disorders * participation in another investigational study * cardiac surgery within 1 month prior to the intended procedure date * allergy or contraindication to heparin
case series study of biliary tract cancer patients in japan

Conditions: Biliary Tract Cancer

Summary: to assess the difference of prognosis between unresectable and recurrent biliary tract cancer and evaluate prognostic factors.

most patients of biliary tract cancer have advanced disease at diagnosis and often relapse despite surgery. combination therapy of gemcitabine and cisplatin could be a standard therapy for this kind of cancer with the evidence of phase iii study compared with gemcitabine alone. however the prognosis and the tolerability of chemotherapy in the patients with recurrent biliary tract cancer after radical resection might differ from those of unresectable biliary tract cancer, because the dose intensity of chemotherapy can be influenced by adjuvant chemotherapy and/or hepatic resection.

Eligibility criteria:
inclusion criteria: * unresectable or recurrent biliary tract cancer exclusion criteria: * none
improving understanding of glioblastoma through preservation of biologically active brain tissue

Conditions: Glioblastoma; Glioblastoma Multiforme; Gliosarcoma

Summary: to collect and preserve glioblastoma tissue during standard of care tumor resection surgery and blood for future molecular and genetic testing. tissue for research will be collected from three different regions within the same tumor to study how these regions differ in their structure, dna, and rna and also to compare the data obtained from this testing to imaging data found in the medical record. the goal of this study is to help us better understand what the glioblastoma tumor tissue looks like and how it functions. this understanding can lead to new therapies for the treatment of glioblastoma in the future.


Eligibility criteria:
inclusion criteria: 1. have the appearance of high-grade glioma on magnetic resonance (mr) imaging if allowed to consent and will undergo the procedure if the frozen is consistent with glioblastoma or gliosarcoma or patients with a history of histologically confirmed diagnosis of world health organization grade glioblastoma or gliosarcoma that are undergoing repeat resection of a recurrent tumor as identified on preoperative mr imaging 2. aged ≥ 18 years old 3. contrast-enhancing tumor volume of at least 10 cc on the preoperative, volumetric mri within 1 month prior to surgery 4. provision of signed and dated informed consent form by participant or legally authorized representative (lar), if applicable exclusion criteria: 1. has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the results of the study or is not in the best interest of the participant, in the opinion of the treating investigator.

Keywords: specimen banking
transcutaneous electrical nerve stimulation in relation to central sensitization in osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: background central sensitization has recently been documented in patients with knee osteoarthritis. so far, the presence of central sensitization has not been considered as a confounding factor in studies assessing the pain inhibitory effect of tens on osteoarthritis of the knee. purpose first, to explore the pain inhibitory effect of burst tens in oak patients. second, to explore the prognostic value of central sensitization on the pain inhibitory effect of tens in oak patients. methods patients with knee pain due to oak will be recruited through advertisements in local media. temporal summation, before and after a heterotopic noxious conditioning stimulation, will be measured. in addition, pain on a numeric rating score and womac subscores for pain and function will be assessed. patients will be randomly allocated to one of two treatment groups (tens, sham tens). follow-up measurements will be scheduled after a period of 6 and 12 weeks. discussion/ conclusion tens influences pain through the electrical stimulation of low-threshold a-beta cutaneous fibers. the responsiveness of central pain-signaling neurons of oak patients who are centrally sensitized may be augmented to the input of these electrical stimuli. this would encompass an adverse therapy effect of tens. therefore it might be interesting to identify a subgroup of symptomatic oak patients, ie. non-sensitized patients, who are likely to benefit from burst tens.


Eligibility criteria:
inclusion criteria: * to be included, patients need to be over 50 years old. * all should have osteoarthritis in at least one knee fulfilling the american college of rheumatology classification criteria and report peak knee pain over the last 24 h of more than 3 on a numeric rating score (0-10 scale). exclusion criteria: * patients are excluded if they have had a knee surgery or intra-articular corticosteroid injection within 6 months * current or past (within 4 weeks) oral corticosteroid use * a history of knee joint replacement or tibial osteotomy * contraindications to burst tens (pacemakers, epilepsy, dermatological conditions, abnormal sensation in the knees, pregnancy) or if they are unable to apply tens independently
is the perfusion index an accurate predictor of return of spontaneus circulation in out-of-hospital cardiac arrest

Conditions: Death, Sudden, Cardiac; Perfusion Index; Return of Spontaneous Circulation

Summary: the purpose of this pilot feasibility study is to evaluate the ability of the perfusion index to predict the return to spontaneous circulation of the out-of-hospital cardiac arrest patient during cardiopulmonary resuscitation. the performance of the perfusion index will also be compared to the current gold standard, end-tidal co2 (etco2).

the aim of this observational research is to measure the predictive performance the perfusion index to predict a return of a spontaneous circulation (rosc) during cardiopulmonary resuscitation (cpr). the research focuses on patients in out-of-hospital cardiac arrest (ohca) and in-hospital cardiac arrest (ihca) treated by the mobile intensive care unit of saint pierre university hospital. the study will be a pilot observational study during cardiac arrest. during the study period a non-invasive sensor will be connected to the patient's finger to measure continously and non-invasively the perfusion index. this non-invasive measurement is done by means of an infrared light which has no known risks for the health of the patient and which is usually used for the measurement of arterial oxygen saturation (sato2). no intervention is planned as no decision will be taken on treatment based on the collected values of perfusion index during the arrest and post-arrest care of the participants. the study will therefore be conducted during conventional advanced life support procedures without rescuers having access to the ongoing measurements. the study will end when the participant returns to spontaneous circulation (racs) or when patients is admitted to the emergency ward, whichever comes first in a time frame of maximum two hours. the decision to stop resuscitation procedures will be made in accordance with the european resuscitation council (erc) recommendations and the resuscitation termination rules (tor) for cardiac arrest. pulsatility index values will be sampled at a 0.5 hertz frequency. these values will be tested for their ability to predict rosc within 2 minutes. similarly, etco2 values (as a gold standard) will be analyzed from the time of first measure. the sensitivity and specificity of the collected values of etco2 in the prediction of rosc will be compared, at the end of the study to the diagnostic sensibility and specificity of different thresholds of the perfusion index. the patient's consent will be requested at the moment when he/she recovers consciousness allowing the comprehension and signature of a consent after the cardiac arrest.

Eligibility criteria:
inclusion criteria: * out of hospital cardiac arrest with an indication to initiate chest compressions * in hospital cardiac arrest with an indication to initiate chest compressions exclusion criteria: * pregnant patients * prisoners

Keywords: cardiac arrest perfusion index return of spontaneous circulation end tidal co2
append-ct registry

Conditions: Stroke, Ischemic; Device Related Thrombosis; Atrial Fibrillation

Summary: the append-ct registry is an investigator-driven multicenter retrospective observational database intended to compile cardiac ct follow-up data after watchman flx device implantation and function as a platform for answering clinical and research questions within laac follow-up. the derived studies should support therapeutic decision-making, improve risk-stratification in laac and help generate hypotheses for potential future clinical intervention trials.

an investigator-driven multicenter retrospective observational database enrolling patients from high-volume north american and european centers. the database will include watchman flx implanted patients with a minimum of one follow-up cardiac ct performed within 45-120 days post-procedure. additional timepoints may be entered. cardiac ct scans are to be uploaded and will be analyzed by the core-lab at aarhus university hospital. investigator-reported findings will be systematically reported to the database. this includes information on baseline characteristics, preprocedural planning, implantation details, discharge medication, follow-up imaging and clinical endpoints of interest. as a minimum, investigator-reported endpoints will be collected from patient registries at one-year follow-up by site-investigators. endpoints of interest include ischemic stroke, systemic embolism, major bleeding, mortality, device-related thrombosis, pericardial effusion, vascular complications, and device migration.

Eligibility criteria:
inclusion criteria: * watchman flx laao * a minimum of one follow-up cardiac ct performed within 30-120 days post-procedure. * a minimum of one year clinical follow-up data

Keywords: left atrial appendage occlusion cardiac computed tomography watchman flx
corneal topographer fluorescein patterns

Conditions: Keratoconus

Summary: the objective of this study is to determine if corneal topography can be used to predict the fluorescein pattern of keratoconus lenses on the eye. a corneal topography image will be taken and the computer selected lens will be placed on the eye. after placement of the lens color photographs will be taken of the eye's fluorescein pattern and compared to the computer predicted pattern.

subject population: keratoconus patients who have not undergone corneal surgery 100 subjects who come to uihc for their contact lens care. we will approach them at their visit. we will not call potential participants from a database. if topography is impossible to capture. concommitant corneal disease minors will be excluded

Eligibility criteria:
inclusion criteria: 18 yrs of age or older with diagnosis of keratoconus and contact lens wearer exclusion criteria: noncommittant corneal disease or surgery inability to capture topography measurement
comparative study between different duty cycles of ultrasound diclofenac phonophoresis

Conditions: Undefined

Summary: lateral epicondylitis is a tendinopathy injury involving the extensor muscles of the forearm. these muscles originate on the lateral epicondylar region of the distal humerus. the insertion of the extensor carpi radialis brevis is involved in most cases. transdermal administration of an anti-inflammatory drug to specific area is one of the methods that used to decrease inflammation and increase cell metabolism

lateral epicondylitis is a soft-tissue lesion of the tendinous origin of the wrist extensor muscles at their origin on the lateral humeral epicondyle. the extensor carpi radialis brevis is the area of most pathologic changes. it begins as a microtear of the tendinous origin of the wrist extensor muscles and results in degeneration and reactive granulation tissue formation. activities involving prolonged or repeated gripping, wrist extension, forearm supination, and pronation cause eventual failure of the affected portion of the tendon. the mechanical failure of the tendon results in an ensuring tendinitis and symptoms of lateral epicondylitis. it is aggravated with movements of the wrist, by palpation of the lateral side of elbow, or by contraction of extensor muscles of the wrist. there are different treatment methods for lateral epicondylitis. initially, lateral epicondylitis has been treated with ice, rest, counterforce tennis brace and/or non-steroidal anti-inflammatory drugs. but when the condition is not responding to initial treatment physical therapy is initiated

Eligibility criteria:
inclusion criteria: 1. both sexes will be involved 2. duration of the disease is more than 12 weeks. 3. patient's age ranges from 20 to 40 years exclusion criteria: 1. diabetic patients. 2. hypertension patients. 3. pregnant women 4. cardiovascular patients 5. patients with malunion fractures 6. patients with cervical radiclopathy 7. patients with olecranon bursitis
high dose hyperoncotic serum albumin for the treatment of the acute phase of severe head injury

Conditions: Severe Head Injury

Summary: experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. the main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.


Eligibility criteria:
inclusion criteria: * severe head injury (gcs \< 9) next of kin informed consent exclusion criteria: * cranio cerebral wound pregnancy hypoxemia (pao2/fio2\ 1/2 blood mass renal or cardiac failure,uncontrolled hypertension head injury dating from more than 24 hours at the time of inclusion