Kornimate/medical-research-clean huggingface dataset:
optimal vasopressor titration pilot randomized controlled trial

Conditions: Hypotension; Shock

Summary: the purpose of this research study is to determine if it is better to give vasopressors to patients to maintain a higher blood pressure target versus a lower blood pressure target. this study is important because the information we find out will help us know how best to administer vasopressors in patients with shock in the icu.

patients who are admitted to the intensive care unit (icu) commonly suffer from shock, a condition that causes life-threatening low blood pressure. low blood pressure makes it difficult for the body to deliver blood to all of its organs. the standard treatment doctors in the icu use for their patients is to give medications that help increase blood pressure. these medications are called vasopressors. there can be side effects related to using vasopressors. the purpose of this research study is to determine if it is better to give vasopressors to patients to maintain a higher blood pressure target versus a lower blood pressure target. this study is important because the information we find out will help us know how best to administer vasopressors in patients with shock in the icu.

Eligibility criteria:
inclusion criteria: 1. who are receiving vasopressors for distributive shock 2. who are older than 16 years of age at the time of eligibility. 3. who are under the direct care of the icu team regardless of location. 4. who have received a minimum of 30 ml/kg of intravenous fluids (2100 ml for a 70 kg patient) before enrolment or the most responsible physician has good reasons to believe that more fluid resuscitation is no longer required and could be harmful. 5. who the treating physician believes will need vasopressors for at least 6 hours once enrolled. exclusion criteria: 1. have received vasopressors for more than 24 consecutive hours; if vasopressors are discontinued for \>= 2 hours then restarting vasopressors will constitute a distinct vasopressor episode and the clock will be reset. 2. are judged by the treating physician to be in obvious cardiogenic shock after an acute myocardial infarction (based on new st segment elevations on ecg or obvious echocardiographic findings). 3. have obvious haemorrhagic shock as a consequence of a clearly identified source of blood loss. 4. require vasopressors after cardiac surgery as a result of cardiopulmonary bypass-induced hypotension. 5. who have a specific indication for catecholamine therapy other than shock (i.e. angioedema or intracranial hypertension). 6. if the attending team has agreed to withhold or withdraw life sustaining care. 7. concurrent enrollment in interventional trials that do not meet guidelines (see ccctg.ca) for co-enrollment (co-enrollment is permissible if there is no potential interaction between the protocols; this will be addressed case by case). 8. prior randomization in this study.

Keywords: hypotension vasopressors titration tissue perfusion organ failure
effectiveness evaluation of the digital workflow for single-implant immediate loading

Conditions: Single Missing Tooth Rehabilitation

Summary: immediately implantation and immediate prosthesis could preserve the alveolar contour and gingival shape. the visiting time is quiet long. pre-made prosthesis is a way to shorten the visiting time. but the implant has to be placed precisely. novel digital workflow integrating dynamic navigation or static surgical guide to process one-visit single -implant immediate loading is possible. the study is to compare the x-guide dynamic navigation system or static guide system which one could assist the surgery more accuracy and place the prosthesis more smoothly.


Eligibility criteria:
inclusion criteria: * 20 to 80 years old * miss two functional opposing teeth in one quadrant or the same jaw * the situation of oral tissue satisfies the condition of implant immediate loading. exclusion criteria: * catastrophic illness, * diabetes, * cardiovascular diseases, * osteoporosis, * head and neck cancer, * disabled * pregnant.

Keywords: single missing tooth one-visit single-implant immediate loading digital workflow dynamic navigation static surgical guide
efficacy and tolerance of treatment with dha, choline and vitamin e in children with non-alcoholic steatohepatitis

Conditions: Fatty Liver; Liver Fibrosis; Obesity; Metabolic Syndrome; Nonalcoholic Fatty Liver Disease

Summary: the purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (dha), vitamin e and choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (nafld).

sixty children or adolescents (4-16 years) with liver biopsy proven nafld will be enrolled. they will be randomized to treatment with dha, vit e and choline (n=30)or an identical placebo (n=30) given orally for a period of 12 months. all patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise. patients will undergo a medical evaluation every three months during the 12-month study period. liver biopsy will be performed at baseline and at 12 months. anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 12-months study duration. ultrasonography of the liver will be repeated after six months at the end of the study period.

Eligibility criteria:
inclusion criteria: * persistently elevated serum aminotransferase levels * diffusely echogenic liver on imaging studies suggestive of fatty liver * biopsy consistent with the diagnosis of nafld exclusion criteria: * hepatic virus infections (hcv rna-pcr negative) * hepatitis a, b, c, d, e and g * cytomegalovirus and epstein-barr virus * alcohol consumption * history of parenteral nutrition * use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism * autoimmune liver disease, metabolic liver disease, wilson's disease, and a-1-antitrypsin-associated liver disease were ruled out using standard clinical, laboratory and histological criteria

Keywords: nafld nash fibrosis
side branch predilatation strategy in coronary bifurcation lesion stenting (sbps)

Conditions: Coronary Ostium Stenosis; Myonecrosis

Summary: the role of side branch (sb) predilatation during coronary bifurcation lesion percutaneous coronary intervention (pci) is still not established. the predilatation could potentially damage sb ostium by vessel dissection, making subsequent wiring problematic. however, predilatation could eliminate sb ostial stenosis obviating need for further sb treatment after main vessel stent implantation. the aim of the study is to assess in random fashion the periprocedural myonecrosis, complication rates and time for sb rewiring in groups with and without sb predilatation.


Eligibility criteria:
1. inclusion criteria * subject at least 18 years of age. * subject able to verbally confirm understandings of risks, benefits of receiving pci for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. * target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm. * target lesion(s) amenable for pci with balloon angioplasty of the side branch. 2. exclusion criteria * st-segment elevation myocardial infarction (stemi) * non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). * subjects who refuse to give informed consent. * subjects with left ventricle ejection fraction \<30% * subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy * contraindications for 12 months double antiplatelet therapy

Keywords: periprocedural myonecrosis procedure time fluoroscopy time
the pathophysiology of functional neurological disorders

Conditions: Functional Neurological Disorders

Summary: functional disorders, also called psychogenic or psychosomatic are very common, disabling and their costs to society are immense. functional movement disorders are abnormal, involuntary movements, that are illogical in terms of classic neurology. intriguingly, they typically manifest when patients pay attention to them and disappear with distraction. the investigators aim to further the understanding of the pathophysiological mechanisms underlying functional neurological disorders in order to improve treatment. in particular they aim to understand the effect of attention on movement in general, on functional neurological mechanisms and on the sense of agency (of subjective control) over a movement. patients with a functional neurological disorder, patients with an organic neurological disorder and healthy participants will perform simple tasks, such as reaching to a target, while additional tasks will manipulate their attention. the effects of these attentional manipulations will be analysed on several levels: movement performance, analysed by the kinematics and electromyography (emg),and psychophysical measures, such as the sense of agency. if the hypothesis turns out to be true, then changing the attentional focus could be used as a treatment in functional neurological disorders.


Eligibility criteria:
inclusion criteria: * we will recruit three groups of participants: 1. functional neurological disorders, e.g. functional tremor: diagnosed by a neurologist. 2. organic counterpart of the functional neurological disorders, e.g. in the case of functional tremor, the organic counterpart would be organic tremor: presence of an organic tremor according to internationally recognised guidelines and diagnosed by a neurologist. 3. healthy age-matched controls. exclusion criteria * healthy participants: major neurological disorder. all groups: 1. age under 18 or over 80 2. significant impairment in ability to give informed consent for study procedures due to significant cognitive impairment and/or inability to understand study literature, 3. very severe tremor 4. moderate or severe cognitive impairment
effects and safety of opk-88003 dose escalation in type 2 diabetes subjects

Conditions: Type 2 Diabetes Mellitus

Summary: this study will evaluate the effect of dose escalation of once-weekly (qw) subcutaneous (sc) opk-8003 injections vs placebo on hba1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (t2dm) inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.

this clinical trial is a phase 2, double-blind dose escalation regimen of once-weekly opk-88003 in subjects with t2dm. the trial consists of a screening/baseline (up to 2 weeks prior to first dose), treatment period consisting of a dose escalation (8 weeks) and a target dose (22 weeks), and a follow-up period (4 weeks). subjects will be randomly assigned to volume-matched opk-88003 or placebo administered qw.

Eligibility criteria:
inclusion criteria: * men or women aged 18 to 80 years with t2dm treated with diet and exercise alone or on a stable dose of metformin (≥ 1000 mg/day), * bmi ≥27 and ≤45 kg/m2 * hba1c ≥7.0% and ≤10.5% at screening exclusion criteria: * type 1 diabetes mellitus * previous treatment with incretin mimetic drugs * have used insulin for diabetic control for more than 6 consecutive days within the prior year * have had two or more emergency room visits or hospitalizations due to poor glucose control within the prior 6 months * have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase (\>2 x uln).
pilot pragmatic clinical trial to embed tele-savvy into health care systems

Conditions: Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Neurodegenerative Diseases; Mental Disorders

Summary: this cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of embedding the tele-savvy intervention, a psychoeducational program for family and other informal caregivers of older adults living in the community with alzheimer's disease and related dementia (adrd), in two health care systems/clinical sites: uconn health in farmington, connecticut, and emory healthcare in atlanta, georgia.

this cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of embedding the tele-savvy intervention, a psychoeducational program for family and other informal caregivers of older adults living in the community with alzheimer's disease and related dementia (adrd), in two health care systems/clinical sites: uconn health in farmington, connecticut, and emory healthcare in atlanta, georgia. a total of 100 caregivers, 50 at each study site, will participate in this pilot study. at each site, 30 caregivers will be randomly assigned to receive the tele-savvy intervention, and 20 caregivers will be randomly assigned to receive the self-guided caregiving during crisis online program. all 100 caregivers will complete identical self-administered questionnaires to measure the caregiver-specific outcome measures in this pilot study. outcome measures will include caregiver mastery (primary outcome), caregiver response to specific memory and behavioral problems, and caregiver stress. also, we will employ process measures of participation and engagement in the interventions for caregivers in both arms of the trial, as well as implementation outcomes via surveys with clinicians and information technology staff at each of the two clinical sites responsible for programming electronic medical records to enable capture and storage of caregiver outcomes.

Eligibility criteria:
inclusion criteria: * identified by ehr systems and confirmed by a health care provider as a family member or unpaid significant other who provides care at home for an older adult (age 65 or older) living with adrd * english speaking * able to understand study procedures and comply with them for the entire length of the study * access to appropriate video and audio technology to be able to participate in interventions exclusion criteria: * unwilling to be randomized to receive either tele-savvy or caregiving during crisis * planning to admit the person living with adrd to a nursing home on a long-term basis within 6 months of randomization.
drug use survey (dus) of triple therapy (methycobal (mbl)+ myonal (myo)+ non-steroidal anti-inflammatory drags (nsaid)) on the symptom relief of lumbar ddd in china

Conditions: Lumbar Disc Degenerative Disease

Summary: the purpose of this study is to observe the overall satisfaction of patients with degenerative disc disease after receiving triple therapy.

ddd (lumbar disc degenerative disease ) patients who have been prescribed triple therapy (mbl+ myo+ nsaids) over 2 weeks of triple therapy were enrolled in the study. they were asked to assess their overall satisfaction degree on triple therapy.

Eligibility criteria:
inclusion criteria: 1. lumbar degenerative disc disease (ddd) 2. patients who have been prescribed over 2 weeks of triple therapy exclusion criteria: patients who do not meet inclusion criteria for ddd

Keywords: lumbar disc degenerative disease methycobal
a biosensor for tracking seizures: linking a wrist accelerometer to an online epilepsy diary

Conditions: Epilepsy

Summary: this study will assess whether a movement detecting wristwatch can accurately detect seizures and seizure characteristics and record them into an online epilepsy diary. the patients may manually record a description into the online epilepsy diary of the symptoms they experienced before, during or after the seizure.

typically, health care providers receive inaccurate patient self- reports. this pilot trial will document the feasibility of accurately recording and logging seizures into a cloud-based diary, under circumstances of controlled video-eeg monitoring to serve as a comparison "gold standard." more explicitly, we are testing the efficacy of the wristwatch in capturing movement parameters correlated with seizure activity and whether these parameters can be accurately uploaded into an online epilepsy diary. in the future, biosensor data could be valuable to more precisely obtain seizure data for clinical decision making as well as use in clinical trials.

Eligibility criteria:
inclusion criteria: -adults over the age of 18 with known epileptic convulsive seizures already being admitted to the emu for continuous video eeg. exclusion criteria: * patients with only non-convulsive events or only psychogenic non-epileptic seizures. * patients who are unable to provide consent. * patients who have developmental delay.

Keywords: epilepsy seizures wrist accelerometer epilepsy diary seizure detection biosensor
the effect of rosuvastatin in diabetic polyneuropathy: a phase iia randomized double-blind placebo-controlled study

Conditions: Diabetic Polyneuropathy

Summary: to evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus * glycated hemoglobin \<12.0% * signing of informed consent * presence of an abnormality of nerve conduction study * symptoms and signs of diabetic polyneuropathy exclusion criteria: * pregnancy and lactation * foot ulcers * treatment with statins * antioxidant drug and/or supplements one month previous to enrolment * inability to mobilize * renal and/or hepatic failure

Keywords: rosuvastatin diabetic polyneuropathy nerve conduction oxidative stress nerve growth factor
polarization sensitive optical coherence tomography (ps-oct) for retinal imaging

Conditions: Healthy

Summary: the aim of this pilot study is to assess the ability of a new polarization sensitive optical coherence tomography system to obtain high-quality images of retinal birefringence.

glaucoma is the second leading cause of blindness in the world. the current clinical standard-of-care procedure to diagnose glaucoma is visual field testing with disc photography. visual field testing is subjective both in the patient's feedback and the physician's interpretation of this feedback, and disc photography requires a physician's subjective interpretation. as a result, it is estimated that current methods can diagnose glaucoma only after 40% of the nerve fiber layer (nfl) has been lost. since glaucoma leads to significant changes in both nfl thickness and nfl optical birefringence, non-invasive imaging of these properties could potentially enable diagnosis of glaucoma prior to changes in vision. optical coherence tomography (oct) is routinely used in retinal imaging, and its ability to detect changes in nfl health is being actively studied. to detect nfl optical birefringence, a specialized variation of oct termed polarization sensitive oct (ps-oct) is required. because of high noise in ps-oct images, prior studies have been unable to detect nfl changes in birefringence. we have recently developed new methods for performing highly sensitive polarization-sensitive oct. these changes are algorithmic in nature, and use the same optical wavelengths and powers as clinically deployed oct retinal imaging instruments. in benchtop studies, these algorithmic changes improve the signal-to-noise ratio (snr) of ps-oct images. we propose to conduct a pilot study in normal, healthy subjects to evaluate if these changes improve the snr of nfl birefringence images.

Eligibility criteria:
inclusion criteria: 1. male or female subjects between the ages of 18-85 years 2. healthy normal subjects with no significant eye disease, except for mild cataracts 3. subjects with clear enough cornea or clear enough media to permit imaging 4. subjects with refractive error between -5.00 sph to +5.00 sph exclusion criteria: 1. subjects who have occludable narrow angles (without a patent peripheral iridotomy) or any other ocular or systemic pathology, which precludes safe dilation 2. subjects whose eyes have been dilated for over 6 hours will not be eligible for imaging. 3. subjects who do not or cannot understand the instructions for the ps-oct imaging 4. subjects who are pregnant and/or breastfeeding. date of last menstrual cycle will also be included.

Keywords: retinal imaging optical imaging optical coherence tomography polarization sensitive coherence tomography
a study comparing ponatinib and nilotinib in participants with chronic myeloid leukemia

Conditions: Chronic Phase Chronic Myeloid Leukemia

Summary: the purpose of this study is to compare the efficacy and safety of 2 starting doses of ponatinib compared to nilotinib in participants with imatinib-resistant chronic myeloid leukemia (cml) in chronic phase (cp).

this is a multi-center, randomized study to demonstrate the efficacy and safety of 2 starting doses of ponatinib as a treatment for cp-cml compared to nilotinib. eligible participants must have chronic phase chronic myeloid leukemia (cp-cml), be resistant to first-line imatinib treatment and have received no other tyrosine kinase inhibitors (tkis).

Eligibility criteria:
inclusion criteria: 1. have cp-cml and are resistant to first-line imatinib treatment. 2. be male or female ≥18 years old. 3. have an eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. have adequate renal function as defined by the following criterion: • serum creatinine ≤1.5 × upper limit of normal (uln) for institution. 5. have adequate hepatic function as defined by all of the following criteria: * total serum bilirubin ≤1.5 × uln, unless due to gilbert's syndrome * alanine aminotransferase (alt) ≤2.5 × uln or ≤5 × uln if leukemic infiltration of the liver is present * aspartate aminotransferase (ast) ≤2.5 × uln or ≤5 × uln if leukemic infiltration of the liver is present. 6. have normal pancreatic status as defined by the following criterion: * serum lipase and amylase ≤1.5 × uln. exclusion criteria: 1. have previously been treated with any approved or investigational tkis other than imatinib or treated with imatinib within 14 days prior to receiving study drug. 2. have previously been treated with any anti-cml therapy other than hydroxyurea, including interferon, cytarabine, immunotherapy, or any cytotoxic chemotherapy, radiotherapy, or investigational therapy. 3. underwent autologous or allogeneic stem cell transplant. 4. are in ccyr or mmr. 5. have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: * any history of myocardial infarction (mi), unstable angina, cerebrovascular accident, or transient ischemic attack (tia) * any history of peripheral vascular infarction, including visceral infarction * any history of a revascularization procedure, including vascular surgery or the placement of a stent * history of venous thromboembolism, including deep venous thrombosis, superficial venous thrombosis, or pulmonary embolism, within 6 months prior to enrollment * congestive heart failure (new york heart association \[nyha\] class iii or iv) within 6 months prior to enrollment or left ventricular ejection fraction (lvef) less than 45% or less than the institutional lower limit of normal (whichever is higher) within 6 months prior to enrollment.

Keywords: cml cp-cml leukemia leukemia, myeloid leukemia, myelogenous, chronic, bcr-abl positive neoplasms by histologic type neoplasms myeloproliferative disorders bone marrow diseases hematologic diseases