Kornimate/medical-research-clean huggingface dataset:
a study of remternetug (ly3372993) in early alzheimer's disease (trailrunner-alz 3)

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to alzheimer's disease occurring in participants receiving study drug compared to placebo. participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. in addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.


Eligibility criteria:
inclusion criteria: * have a phosphorylated tau (p-tau) result consistent with the presence of amyloid pathology. * have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. * have adequate literacy, vision, and hearing for neuropsychological testing at screening. * have a mini mental status exam (mmse) score consistent with no to minimal cognitive impairment. * have a functional activities questionnaire (faq) score consistent with no to minimal functional impairment. * if currently receiving medications as symptomatic treatment for ad, dose has been stable for at least 30 days before screening. exclusion criteria: * have dementia or significant other neurological disease that can affect cognition. * have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study. * have a history of cancer that, in the investigator's opinion, has a high risk of recurrence. * have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions. * have a clinically important laboratory test result or other abnormality as determined by investigator, prior to randomization, that could be detrimental to the participant or could compromise the study. * have any contraindications for magnetic resonance imaging (mri). * have a centrally read mri that does not meets study entry criteria. prior or current therapies * have ever had prior treatment with a passive anti-amyloid immunotherapy. * have received active immunization against aβ in any other study.
effectiveness of manual therapy in non-specific low back pain

Conditions: Physiotherapy Specialty; Low Back Pain

Summary: low back pain affects many people and involves high medical costs. for this reason, we wish to test the efficacy of dry needling vs ischaemic compression in patients with non-specific low back pain. to this end, an investigation was carried out on 40 patients diagnosed with this ailment, divided into two groups by randomisation to assess the intensity of pain, range of movement, pain threshold to pressure and quality of life, measuring these variables prior to the intervention, immediately, at 48 hours and one week after the intervention.


Eligibility criteria:
inclusion criteria: * signed informed consent form. * presence of non-specific low back pain for more than six weeks. * presence of a palpable tight band nodule in the gluteus medius muscle. * presence of a hypersensitive or hyperirritable point in the tight band. * patients reporting local or referred pain in the area of the latent mgp after mechanical stimulation mechanical stimulation. exclusion criteria: * surgeries in the lumbopelvic region. * diagnosis of herniated discs in the lumbar region. * positive cognitive screening according to the pfeiffer questionnaire. * heterometrics. * age outside the range of 18 to 75 years. * ingested or injected anticoagulant or antiplatelet drugs. * systemic or local infection in the lumbar region. * pregnancy. * presence of fear of needles (belonephobia).

Keywords: dry needling low back pain physiotherapy specialty pain
equivalence of resorption of empagliflozin/metformin administered as combination tablet compared with empagliflozin/metformin as single tablets administered together

Conditions: Healthy

Summary: bioequivalence of an empagliflozin/metformin (fdc) tablet compared with single tablets of two strength of empagliflozin and metformin (part i) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (fdc) tablet compared with single tablets empagliflozin and metformin under fed conditions (part ii).


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects exclusion criteria: 1. any relevant deviation from healthy conditions
clinical and economic implications of genetic testing for warfarin management

Conditions: Blood Coagulation Disorders

Summary: the purpose of this study is to explore how knowing genes that individuals inherit from their parents can make warfarin dosing more safe and effective. this study is being done to determine whether providing doctors with data on the genes their patients inherited and warfarin dosing recommendations based on those genes affects the costs and outcomes of care and after hospitalization for patients from different ethnic/racial backgrounds, and how physicians use this information in decision making.

the overall goal of this project is to develop and assess the effectiveness and cost-effectiveness of strategies that use genetic testing in the management of anticoagulation among racially diverse hospitalized patients. the project has four specific aims. aim 1: to contribute patients initiating therapy at the university of chicago medical center (ucmc) and affiliated hospitals to a genetic registry of a racially diverse set of patients undergoing warfarin therapy. aim 2: to perform a randomized trial to determine the efficacy, costs and cost-effectiveness of existing pharmacogenetic algorithms for the management of warfarin therapy among hospitalized patients of all races. aim 3: to develop clinical pharmacogenetic algorithms for the management of warfarin therapy among hospitalized african american patients. aim 4: to perform a randomized trial to determine and compare the efficacy, costs and cost-effectiveness of existing clinical and non-racially tailored pharmacogenetic algorithms to racially tailored pharmacogenetic algorithms for the management of warfarin therapy among hospitalized african american patients.

Eligibility criteria:
inclusion criteria: * warfarin-naive patients * ages 18 and older * are undergoing inpatient anticoagulation initiation with warfarin for diagnoses that necessitate anticoagulation exclusion criteria: * patients who are not warfarin-naive * 17 years of age or younger

Keywords: coumadine genotype genes warfarin
fluid balance during exercise in the heat with water, flavored placebo, or a carbohydrate-electrolyte beverage intake (the apex study)

Conditions: Dehydration

Summary: the purpose of the apex study is to determine whether carbohydrate-electrolyte beverage intake promotes fluid balance during exercise in the heat compared with water or placebo intake.

exercise in the heat has large effects on cardiovascular strain, the ability to regulate core body temperature, and performance because of an increase in the reliance on body fluid distribution to the skin to maintain adequate sweat rates and heat dissipation. carbohydrate-electrolyte beverage intake during exercise in the heat may improve fluid balance and subsequent physical performance. the participants will be assigned each arm in a randomized, counterbalanced, cross-over fashion separated by at least 2 weeks. participants will be placed in a heated environment for the duration of the exercise intervention.

Eligibility criteria:
inclusion criteria: * males aged 18-35 years * healthy (no uncontrolled disease) exclusion criteria: * no medications that influence fluid balance * no uncontrolled disease

Keywords: dehydration fluid balance exercise heat body weight performance
vegf-antagonism and endothelial function in age-related macular degeneration (amd)

Conditions: Macular Degeneration

Summary: the objective of this study is to evaluate the effects of 2 intravitreal injections with ranibizumab or avastin on endothelial function in subjects with neovascular macular degeneration compared to patients with dry amd.


Eligibility criteria:
inclusion criteria for active treatment: * age: 50 - 80 years * diagnosis of neovascular macular degeneration suitable for intravitreal anti-vegf therapy * stable medication for general conditions for at least 1 month * written informed consent for participation in the study inclusion criteria for controls: * age: 50 - 80 years * diagnosis of "dry" amd * "dry" amd is defined as at least age-related-eye-disease-study (areds) category 2 in both eyes and no evidence of neovascularization in either eye * stable medication for general conditions for at least 1 month * written informed consent for participation in the study exclusion criteria for all subjects: * myocardial infarction, unstable angina, stroke within 3 months prior to study entry * thoracic or cardiac surgery and/or coronary intervention/revascularisation procedure (within 3 months before randomization) * uncontrolled symptomatic congestive heart failure (nhya\> ii) in the last 4 weeks prior to study * renal insufficiency (creatinine clearance \< 50ml/min) * ventricular tachyarrhythmias * poorly controlled hypertension, defined as resting blood pressure ≥ 160/100 mmhg * symptomatic hypotension * long acting nitrates * smoking (\>5 zig./d) * diabetes mellitus * dyslipidemia (ldl-cholesterol \> 4.5 mmol/l) * liver disease (alt or ast \>3x uln) * alcohol or drug abuse * hypersensitivity to the active substance or to any of the excipients * active or suspected ocular or periocular infections * patients with active severe intraocular inflammation * malignancy (unless healed or remission \> 5 years) * disease with systemic inflammation (e.g. rheumatoid arthritis, m. crohn) * participation in another study within the last month

Keywords: macular degeneration age-related maculopathies
automated stereognosis to treat loss of tactile function after brain injury

Conditions: Stroke; Chronic Brain Injury; Peripheral Neuropathy

Summary: researchers aim to determine whether the retrieve system for tactile training can improve tactile function (sense of touch) in the hand after brain injury when used at home for 6 weeks.

all participants who have been found eligible for this study and given informed consent will be randomized into two groups- either participants will begin retrieve training immediately following an initial assessment, or wait 8 weeks before beginning training. during the study, participants will have a retrieve tactile training system delivered home for use over 6 weeks. investigators will take three days to teach participants how to use the system. each week for the remainder of the 6 weeks, participants will use this system for 4+ days per week on their own, and for 1 day supervised. during each supervised day, participants will complete approximately 1 hour of training while supervised over video chat with researchers. participants' tactile function will be assessed at three separate time points: once within one week before beginning training, once within one week after completing training, as well as once either 8 weeks before or 8 weeks after the training. this assessment has a required survey component, as well as an optional in-person clinical assessment component.

Eligibility criteria:
inclusion criteria: * english speaking * be able to communicate and consent for themselves * have experienced a brain injury more than 6 months prior to the date of study participation * have chronic tactile deficits in at least one hand as a result of their brain injury * have sufficient motor ability in their affected hand(s) to complete reach and grasp tasks * have sufficient motor ability in their affected hand(s) to raise their arms above their head * have sufficient motor ability in their affected hand(s) to hold objects * have wireless internet and a laptop or mobile device at home for video conferencing * live in the greater dallas area exclusion criteria: * significant cognitive deficits that would preclude them from understanding instructions * significant communication deficits that would preclude them from consenting for themselves
mi-rnas and specificity of hs-tnt in symptomatic ed patients

Conditions: Coronary Artery Disease; Myocardial Infarction

Summary: biomarkers play a key role in the diagnostic workup of patients presenting to an emergency department (ed). european and american guidelines recommend cardiac troponin (t or i) as the biomarker gold standard for the diagnosis of non-st-elevation myocardial infarction (non-stemi). today, high-sensitivitiy assays are available and allow an early diagnosis of non-stemi and the detection of troponin in individuals that would have been classified as unstable angina with former assays. as many patients are detected with elevated troponin values with the high sensitivity assays, specificity for non-stemi has inevitably decreased. micro-rnas (mi-rna) are new biomarkers with a wide spectrum of detectable conditions that allow specific identification of myocardial infarction. the aim of this study is to develop a biomarker protocol that combines the high sensitivity of cardiac troponin t and the high specificity of mi-rna profiles for early and safe identification of non-stemi in ed patients.


Eligibility criteria:
inclusion criteria: * patients admitted to the emergency department ("chest pain unit"), dept. of cardiology, university hospital heidelberg * symptoms suggestive of acs incl. chest pain, dyspnea, atypical pain * age \>= 18 years * written informed consent exclusion criteria: * mental disorders, dementia * pregnancy, breast feeding * age \< 18 years

Keywords: cardiac troponin t micro-rna sensitivity specificity
investigating auto adjusting dynamic afo

Conditions: Lower Limb; Fusion, Congenital; Lower Limb Fracture; Ankle Foot Injury

Summary: offloading ankle foot orthoses (afos) are devices designed for people following lower-limb reconstruction to restore mobility by reducing mechanical loading through the injury site and redistributing it proximally. while they perform well for some users, their current form limits full functional potential and may put joints proximal to the injury at risk of long-term damage. this study is directed toward designing and testing a lightweight, variable stiffness, dynamic brace that can adjust in response to user activity.


Eligibility criteria:
inclusion criteria (healthy volunteers): -able to run continuously for 1 minute inclusion criteria (all other volunteers) * prescribed an offloading ankle-foot orthosis (afo) for walking/running * use prescribed offloading afo at least 20 hours per week * prescribed afo strut length of at least 200 mm * able to run continuously for 1 minute exclusion criteria (healthy volunteers): * limited sensation in the lower limbs * use an assistive device exclusion criteria (all other volunteers): * unable to ambulate (walk/run) continuously with afo for at least 1 minute * unable to sit, stand, or negotiate a step onto lab treadmill

Keywords: ankle foot orthotic
adjuvant durvalumab for esophageal cancer

Conditions: Esophageal Cancer

Summary: adjuvant durvalumab vs placebo for 1 year after complete resection of esophageal cancer following neoadjuvant ccrt.


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous esophageal cancer, irrespective of pd-l1 status * the enrolment should be done during the time interval from 20 days to 56 days after complete resection after neoadjvuant ccrt (no residual tumor after operation) * clinical tumor stage before neoadjuvant ccrt should be t3-4n0m0 or t1-4n1-3m0 * available tumor specimen for biomarker analysis acquired before neoadjuvant ccrt or at operation exclusion criteria: * other pd-1 or pd-l1 inhibitors history * mean qt interval corrected for heart rate (qtc) ≥470 ms using bazett's correction * current or prior use of immunosuppressive medication within 28 days before the first dose of medi4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid * active or prior documented autoimmune disease within the past 2 years note: subjects with vitiligo, grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
dose dense chemotherapy in elderly patients > 80 years old with dlbcl

Conditions: DLBCL; Old Age; Debility

Summary: multi-center retrospective analysis of patients with dlbcl aged ≥80 years old treated with r-chop-14 compared to other regimens. patient data including baseline characteristics, histology, dose intensity and treatment outcomes will be extracted from hospital medical electronic records. relative dose intensity (rdi) will be calculated as the percentage of the dose intensity achieved divided by the intended dose intensity. primary endpoints are overall (os), progression-free (pfs) and event-free survival (efs), defined as time from diagnosis to death, death or progression/relapse, progression/relapse or treatment discontinuation.


Eligibility criteria:
inclusion criteria: * histologically proven, untreated diffus large b-cell lymphoma (dlbcl) * diagnosis between 2005 - 2019 * age ≥80 at diagnosis exclusion criteria: - diagnosis revision at a later timepoint
intensive lifestyle intervention for type 2 diabetics: the kp tlc pilot

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine if a healthy lifestyle intervention can significantly improve blood sugar control in type 2 diabetics over a course of 3 months.

peer reviewed research studies have proven the benefits of lifestyle interventions including the reversal of coronary artery disease and of diabetes. experts agree that such a lifestyle must include a diet rich in whole, grown foods while low in saturated fat and cholesterol; regular physical activity; and healthy ways to cope with stress. there are several challenges with implementing such lifestyle interventions such as educating the general public and health care providers to the components of this lifestyle and in getting people to adopt these healthy lifestyle changes. while retreat-style, intensive lifestyle programs have shown that these obstacles can be overcome, they require monetary and time investments generally not feasible for the general public. a community-based, lifestyle program such as 'the coronary health improvement project' program offers similar potential benefits at a more reasonable cost. it does so through an intensive education (32 hours total) taught over 4 weeks, followed by an 8-week consolidation period which include live or dvd based group sessions, discussions led by a program facilitator, and medical monitoring. kaiser permanente, the leading health maintenance organization in the nation, places special focus and significant resources into preventive medicine and health promotion, providing services to thousands of plan members but none with the level of intensity of 'the coronary health improvement project'. this study aims to determine if 'the coronary health improvement project' program can significantly improve blood sugar control in kaiser plan members with uncontrolled diabetes.

Eligibility criteria:
inclusion criteria: * english-speaking patients \> 18 years of age, with at least 6 months of membership, who have type 2 diabetes. * patients must have a recent hba1c lab value \> 8.0, and have had at least 2 previous hba1c measures during the previous 6-12 months. * patients with hba1c values that are consistently \> 8.0 over the previous 6-12 months will be invited to participate. exclusion criteria: 1. current excessive alcohol use (drinking \> 14 alcohol beverages per week for men or \> 7 per week for women or \> 4 per day for men or \> 2 per day for women on 2 or more occasions each month) 2. current use of illegal or street drugs, 3. severely decreased functional capacity (shortness of breath or chest pain at rest or with minimal activity), and/or 4. suicidal thoughts or depression, will 5. patients with severely limited physical ability

Keywords: diabetes
reducing deaths after surgery in low- and middle-income countries: a pilot cluster randomised trial

Conditions: Post-operative Complications

Summary: surgpass is a pilot randomised cluster trial utilising a pre-operative checklist with the aim of reducing deaths after surgery. if surgpass is successful, the intervention will be implemented in a separate full-scale cluster randomised trial.

title: reducing deaths after surgery in low- and middle-income countries: a pilot cluster randomised trial aim: this pilot randomised cluster trial aims to evaluate the feasibility of a large-scale cluster randomised trial to assess the effectiveness and implementation of a pre-operative checklist to reduce deaths after surgery. if this pilot study is successful, we aim to assess the intervention in a separate full-scale cluster randomised trial. * objective 1: to determine feasibility and fidelity of delivering the intervention. * objective 2: to determine the rate recruitment to inform how long it will take to recruit to a future cluster randomised trial. * objective 3: to obtain information on postoperative outcomes to help inform the outcomes used and sample size of the future cluster randomised trial. design: pilot cluster randomised trial. inclusion: adult (\>18 years old) non-pregnant patients undergoing emergency abdominal surgery with an incision of ≥5cm. exclusion: patients undergoing minimally invasive surgery, or surgery for appendicitis. intervention: surgpass is an intervention of a preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions. comparator: usual care as per local practice at that site. follow-up period: 30-days from surgery. number of participants: 300 participants: 25 participants in each of 12 clusters (hospitals), from 6 countries. outcomes: since this is a pilot study, there are no pre-specified primary outcomes. however, there are four key outcomes of interest to assess ahead of the main phase randomised clinical trial. * outcome 1: measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only) * outcome 2: measure duration of time to recruit 25 participants per cluster (to determine duration of potential full trial) * outcome 3: measure 30-day overall complication rates to inform overall sample size of potential full trial

Eligibility criteria:
inclusion criteria: * patients undergoing emergency major abdominal surgery (i.e., midline or non-midline) with an incision greater than or equal to 5cm * patient must not be pregnant * adults only (greater than or equal to 18 years old) exclusion criteria: * minimally invasive surgery * surgery for appendicitis

Keywords: pilot cluster surgical safety