Kornimate/medical-research-clean huggingface dataset:
robots paired with tdcs in stroke recovery

Conditions: Stroke

Summary: the purpose of this study is to evaluate if multiple therapy sessions of transcranial direct current stimulation (tdcs non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * first single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior * cognitive function sufficient enough to understand experiments and follow instructions * fugl-meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist) exclusion criteria: * botox treatment within 6 weeks of enrollment * fixed contraction of the affected limb * complete flaccid paralysis of the affected limb * history of hemorrhagic stroke * ongoing use of cns active medications * ongoing use of psychoactive medications * presence of additional potential tdcs/tms risk factors including damaged skin at site of stimulation, presence of a magnetically/mechanically active implant, metal in the head, family history of epilepsy, and personal history of seizures

Keywords: stroke cerebrovascular accident cerebral stroke cva robotic therapy upper extremity recovery tdcs non-invasive brain stimulation
efficacy and safety of dexmedetomidine added to modified pectoral's block

Conditions: Breast Cancer Female

Summary: the pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by the infraclavicular block approach and the intercostal abdominis plane blocks . many additives were used in combination with local anesthetics in pecs block to prolong the postoperative analgesia (fentanyl, dexmedetomidine).

60 patients scheduled for modified radical mastectomy surgery under general anesthesia. group i (bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified pecs block with 30 ml of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfascial plane, and 20 ml injected between the pectoralis minor muscle and the serratus muscle.group ii (bupivacaine + dexmedetomidine group) : preoperative ultrasound guided modified pecs block with 30 ml of 0.25% bupivacaine plus dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfascial plane , and 10 ml injected between the pectoralis minor muscle and the serratus muscle.

Eligibility criteria:
inclusion criteria: * asa i - ii patients * weight 50- 100 kg * age 18-60 years exclusion criteria: * history of bleeding diathesis * relevant drug allergy * opioid dependence * sepsis * those with psychiatric illnesses that would interfere with perception and assessment of pain will be excluded from the study
epidemiology of schizophrenia in bulgaria

Conditions: Schizophrenia

Summary: the purpose of this study is to provide accurate, reliable information on schizophrenia clinical management in order to detect unmet medical needs of this disease in terms of: * patient characteristics. * diagnostic and treatment approaches: initial and subsequent.


Eligibility criteria:
inclusion criteria: * patients with schizophrenia * above 18 years * signed informed consent exclusion criteria: * below 18 years * consent refused

Keywords: schizophrenia epidemiology schizophrenic patients' social and health characteristics
forgotten voices: addressing unmet needs in brain tumor caregivers

Conditions: Caregivers; Neuro-Oncology; Brain Cancer

Summary: to conduct a mixed-method phase ia define trial of caregivers' participation in calm therapy with post-session surveys and individual exit interviews in order to evaluate suitability and adapt the calm intervention to the needs of caregivers in neuro-oncology.

exploring caregivers' experiences of calm intervention will inform more effective, targeted, supportive care for this traditionally underserved group in need of emotional support. we will use the data from this study to adapt the calm intervention to the specific needs of caregivers in neuro-oncology

Eligibility criteria:
inclusion criteria: * caregiver participants must be the caregiver of a brain cancer patient who is currently enrolled in dod ca200896 (irbhm20022755) * fluent in english * willing and able to attend a minimum of 3 calm sessions via telehealth * a caregiver is defined as the primary person who provides ongoing support to the brain cancer patient; it is not necessary that the caregiver lives with the patient or is related * patient participants must have enrolled in the linked hm20022755 study exclusion criteria: * person does not consider themselves to be a caregiver of the patient * caregiver does not have a loved one (patient diagnosed with brain cancer) enrolled in dodca200896 (irb hm20022755) * caregiver does not speak english * caregiver is unable to provide consent * caregiver does not have access to telehealth * caregiver is under the age of 18 * professional caregivers who received financial compensation for their services are ineligible

Keywords: calm
study of inflammatory role of epstein-barr virus (ebv) in atrophic and erosive forms of oral lichen planus

Conditions: Lichen Planus, Oral

Summary: oral lichen planus (olp) is a chronic inflammatory and relapsing. the average prevalence is 1 to 4%. the clinics forms are many and symptoms are varied. the erosive form, painful and debilitating is characterized by erosive areas, ulcerated on an erythematous base with or without a keratinocyte lichenien network. the literature data moving towards an autoimmune origin, but the pathophysiological mechanisms of olp remain unknown. this project represents the first part of a comprehensive project to examine the oral pathogenesis of different viruses (herpes and papillomavirus hpv) and centered on epstein-barr virus (ebv).


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years * clinical and/or histological diagnosis of erosive or atrophic olp * no signs of severe dysplasia at the sampling exclusion criteria: o immunosuppressive or anti-inflammatory therapies at the inclusion
exploration of continuous glucose monitoring on the intensive care unit

Conditions: Hypoglycemia, Hyperglycemia

Summary: both hyperglycemia and hypoglycemia in patients at the intensive care unit (icu) are strongly associated with increased morbidity and mortality. accurate and timely measurements of glucose levels in this population are therefore crucial. continuous glucose monitoring (cgm) appears promising for this purpose, but it is not yet used in the icu due to insufficient knowledge about its reliability in critically ill patients. the aim of this study is to investigate the discrepancy between cgm and point-of-care measurements in icu patients and whether this discrepancy is consistent across all icu patient groups/characteristics. this study investigates whether continuous glucose monitoring can be used in the intensive care setting.

hyperglycemia is present in up to 50% of patients admitted to an intensive care unit (icu) and is strongly associated with elevated morbidity and mortality rates. therefore, it is important to monitor glucose levels closely. in the icu, glucose monitoring primarily relies on periodic measurements through point-of-care (poc) meters, which involve invasive blood sampling from venous or arterial lines. to maintain blood glucose concentrations within acceptable ranges, a possible improvement is continuous glucose monitoring (cgm), which is now used to manage glucose levels in diabetic patients in general settings and has shown significant benefits. studies on the use of cgm in the icu setting are limited. if cgm reliably measures glucose levels in critically ill patients, it enables earlier intervention and might help to predict hypo- or hyperglycemia based on measurement trends. objective: to investigate the discrepancy between cgm and poc measurements in insulin-dependent icu patients and to study whether these potential discrepancies between cgm and poc vary across patient-related factors, like gender, age, comorbidities, medication use, disease severity scores, treatment in icu. study design: prospective, multi-centre, single-arm intervention, exploratory study intervention: all study participants receive one cgm sensor to monitor glucose levels. a second cgm sensor will only be applied if the first cgm sensor needed to be replaced within 8 days after insertion. the measurements will be blinded to all except the research team.

Eligibility criteria:
inclusion criteria: * patients admitted to the icu * insulin-dependent as defined in local protocol * age: ≥ 18 y * expected length of stay in icu more than 2 days exclusion criteria: * pregnancy * no informed consent * therapeutic hypothermia (less than 34 degrees celsius) * platelet count less than 50,000/μl at time of inclusion * use of hydroxyurea * use of acetaminophen more than 4 g/day

Keywords: intensive care units insulin continuous glucose monitoring
effect of the aquaretic tolvaptan on nitric oxide system. a dose-response study (dova)

Conditions: Nephropathy

Summary: tolvaptan is a selective vasopressin receptor antagonist (v2r) that increases free water and sodium excretion. inhibition of v2r increases vasopressin concentration in plasma, which stimulates v1-receptors in the vascular bed and may change both central and brachial hemodynamics and plasma concentration of vasoactive hormones. the purpose of the study is to measure the effects of tolvaptan on renal handling of water and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide (no)-inhibition with l-ng-monomethyl-arginine (l-nmma).


Eligibility criteria:
inclusion criteria: * men and women, age 18-40 years * body mass index (bmi) 18,5-30 kg/m2 exclusion criteria: * anamnestic or clinical signs of heart, lung, lever, kidney and brain disease * neoplastic disease * drug abuse * alcohol abuse * medical treatment except peroral anticontraceptive * pregnancy * smoking * abnormal blood and urine sample * abnormal ecg * blood donation within a month before examination * arterial hypertension (\>140 mmhg systolic and/or 90 mmhg diastolic)

Keywords: tolvaptan l-nmma healthy subjects nephrology
telehealth self-management coaching sessions to improve quality of life in pancreatic cancer survivors and their family care givers

Conditions: Metastatic Pancreatic Adenocarcinoma

Summary: this clinical trial evaluates the impact of telehealth self-management coaching sessions on quality of life in pancreatic cancer survivors and their family care givers (fcgs). patients with pancreatic cancer experience many symptoms because of the disease and treatment, which can have a negative impact on quality of life. patients and their families have unmet needs during treatment, including a lack of quality of life programs that offer support to patients. supporting patients and families on managing the physical symptoms, emotional well-being, social well-being and spiritual well-being with telehealth self-management coaching sessions may help improve quality of life, manage symptoms from treatment, and support families in their role as caregivers during treatment.


Eligibility criteria:
inclusion criteria: * • patient: documented informed consent of the participant and/or legally authorized representative * assent, when appropriate, will be obtained per institutional guidelines * patient: age: ≥ 18 years * patient: eastern cooperative oncology group (ecog) ≤ 2 * patient: ability to read and understand english or spanish for questionnaires * patient: subjects must have histologically or cytologically confirmed diagnosis of metastatic pancreatic adenocarcinoma who are within 8 weeks of initial diagnosis * family care giver: documented informed consent of the participant and/or legally authorized representative * assent, when appropriate, will be obtained per institutional guidelines * family care giver: age: ≥ 18 years * family care giver: ability to read and understand english or spanish for questionnaires * family care giver: a family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care exclusion criteria: * • an employee who is under the direct/ indirect supervision of the principal investigator (pi)/ a co-investigator/ the study manager * a direct study team member
office practice assessment of carotid atherosclerosis using handheld ultrasound (opaca) study

Conditions: Atherosclerosis

Summary: the purposes of this study are to determine: 1. inter-site variability in cimt image measurement using sonocalctm. 2. if non-sonographer health care professionals working in an office practice setting can be trained to follow a carotid scanning protocol that permits (a) accurate measurement of cimt and (b) determination of plaque presence. 3. if (a) cimt measurements and (b) determination of plaque presence by non-sonographer health care professionals are bioequivalent to those made by a core laboratory. 4. if cimt measurements and plaque assessment performed in office practices lead to meaningful changes in patient and physician behavior related to cardiovascular disease prevention.

phase iv type (observational vs. interventional) observational currently recruiting or not? no randomized? (or not) no blinded? (single, double, or open) primary outcome(s) bioequivalency of carotid imt measurements. secondary outcome(s) variability in carotid imt measurements intention to behavior change in patients effects of carotid imt on physician management type of intervention (e.g., drug; device; behavioral) device name of intervention handheld ultrasound measurement of carotid imt

Eligibility criteria:
inclusion criteria: * males over 45 years and females over 55 years of age with at least one additional risk factor for coronary artery disease. * females 45-54 years old may be enrolled if they have a family history of chd (myocardial infarction, coronary artery bypass graft surgery, angioplasty, sudden cardiac death) in a male first degree relative \<55 or a female first degree relative \<65 years old and at least one additional risk factor for coronary artery disease. exclusion criteria: * age \>70 years * subjects taking cholesterol-lowering medications * active liver disease * active thyroid disease * uncontrolled hypertension * chronic kidney disease * history of coronary artery disease * history of cerebrovascular disease * history of peripheral arterial disease

Keywords: hand held ultrasound office practice atherosclerosis prevention ultrasound training
cardiopet as pet imaging agent to assess myocardial perfusion and fatty acid uptake in known or suspected cad subjects

Conditions: Coronary Artery Disease

Summary: the study is designed to evaluate how safe and how well an investigational imaging product cardiopet™ performs as compared to standard approved imaging products in assessing the function of heart muscle in coronary artery disease patients.

the open label, phase ii, multi center, study objectives are as follows: * to evaluate the diagnostic performance of cardiopet™ in assessing myocardial perfusion as compared to standard tc-99m myocardial perfusion agents with coronary angiography as the standard of reference for cad. * to evaluate the safety of cardiopet™ in known or suspected cad subjects. * a secondary objective is to assess fatty acid uptake at rest and following stress.

Eligibility criteria:
inclusion criteria: * subjects must provide written informed consent prior to any study related procedures; * male and female subjects over 30 years of age with known or suspected cad; * subjects have been evaluated as having known or suspected cad by either exercise or pharmacologic mpi or echocardiography with ≥2 segments of ischemia and have been referred to coronary angiography for known or suspected cad; * subjects must be able to complete all evaluations within 30 days of tc-99m mpi imaging, and must be without any intervention or change in symptoms between the tests. exclusion criteria: * past or present use of medications that target fatty acid uptake or metabolism, e.g. ranexa® (ranolazine); * acute changes in comparison to most recent ecg; * suspected acute coronary syndrome; * chronic renal failure (cr \> 2.5); * anemia (hgb \< 10 within past 2 weeks); * nyha class iii or iv congestive heart failure; * severe heart valve disease; * any exposure to any investigational drugs or devices, within 30 days prior to imaging study; * any acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination; female subjects only: * subject that has a positive pregnancy test or is lactating or the possibility of pregnancy cannot be ruled out prior to dosing. * females not of child-bearing potential require confirmatory documentation in their medical records or must have a negative pregnancy test within 4 hours prior to receiving the test drug and agree to use an acceptable form of birth control for at least 30 days following cardiopet™ administration. male subjects: * reliable contraception method from the first injection with the tracer until 3 months after the last injection with the tracer. the following contraceptive method(s) is (are) allowed during the study: condom. * if your partner becomes pregnant during the study, you should immediately report this to the investigator.

Keywords: cardiopet coronary artery disease myocardial perfusion imaging coronary angiography myocardial fatty acid utilization
efficacy and safety of lucentis® use in patients with diabetic macular edema evaluating a spaced out follow-up after intensive treatment phase

Conditions: Macular Edema; Macular Degeneration; Diabetes

Summary: the study was designed to assess the efficacy and safety of lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.

this was a multicenteric, open-label, phase iiib study, which comprised of 2 groups: the main group and the rescue group. patient's eligibility was assessed during a screening visit (visit 1) which took place 14 days maximum before treatment initiation (visit 2 \[day 0\]). all patients were initially included in the main group and were to receive an initial loading treatment (6 injections during the intensive treatment phase i.e. every month from day 0 to month 5, followed by 2 additional injections at months 8 and 11). patients were to be followed-up every 3 months for 18 months (spaced-out follow-up period). their visual acuity was to be checked at each study visit (months 3, 6, 8, 11, 14, 17, 20, and 23) to assess their response to treatment. patients who responded to treatment were maintained in the main group. patients who did not meet pre defined criteria were moved to the rescue group and treated at the investigator's discretion. the trial was terminated before any patient reached month 12.

Eligibility criteria:
inclusion criteria: * type i or type ii diabetes with hba1c≤10% * visual impairment due to a diabetic macular edema * stable antidiabetic treatment (since more than 3 months) or hygiene-dietary exclusion criteria: * inflammation or infection in one eye * women of childbearing potential without an efficient contraception, pregnant or breastfeeding other protocol-defined inclusion/exclusion criteria may apply

Keywords: ranibizumab diabetic macular edema
response to supplement and placebo in gerd

Conditions: Gastroesophageal Reflux Disease (GERD); Heartburn; Dyspepsia

Summary: the purpose of this study is to investigate the effects of a widely available over the counter supplement marketed for heartburn symptoms on symptoms and health-related quality of life in patients with gastroesophageal reflux disease (gerd). this study is designed as a pilot trial to assess safety and feasibility and to provide preliminary estimates of effect sizes.


Eligibility criteria:
inclusion criteria: * adult humans age 18-80. * fluency in written and spoken english. * heartburn symptoms 3 or more days per week for the past month. exclusion criteria: * individuals taking a proton pump inhibitor (ppi) or h2 receptor blocker with a dose change within 2 weeks of the initial study visit. * individuals with crohns disease, systemic sclerosis, known active ulcer disease, gastric cancer, barrett's esophagitis * significant pain or difficulty with swallowing * heavy alcohol use (defined by \> 6 drinks/week for women and \> 13 drinks/week for men) * concurrent pregnancy * dementia * uncontrolled psychiatric disease * individuals unable to complete a paper symptom diary for 6 of 7 days prior to their baseline visit * subjects whose symptoms are predominantly dyspeptic more than heartburn or reflux * subjects who have used homeopathy for gi symptoms or have received constitutional homeopathic treatment within the past 2 weeks * subjects taking herbal products or other supplements for gerd or dyspepsia related symptoms (includes peppermint oil) * subjects who have taken \> 12 doses of nsaids within the prior 30 days (aspirin ≤ 325 mg daily is allowed) * subjects with lactose intolerance

Keywords: gastroesophageal reflux disease (gerd) heartburn dyspepsia
paediatric use of the abbott sensor based glucose monitoring system

Conditions: Diabetes Mellitus

Summary: accuracy evaluation of the abbott sensor based glucose monitoring system when used by children with diabetes.


Eligibility criteria:
inclusion criteria: * age 4-17 years (inclusive). * have type 1 or type 2 diabetes using insulin administered by injections or continuous subcutaneous insulin infusion (csii). * currently testing blood glucose levels at least twice per day. * each participant has an identified caregiver aged ≥18 years. * in the investigator's opinion, technically capable of using device (participant and/or caregiver). exclusion criteria: * concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition. * currently prescribed oral steroid therapy for any acute or chronic condition. * currently receiving dialysis treatment or planning to receive dialysis during the study. * female participant known to be pregnant. * participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management. * currently using a real-time or professional use continuous glucose monitoring (cgm) or freestyle libre device or is planning to use one during the study, and unwilling to stop use of the device during the study. * known (or suspected) allergy to medical grade adhesives. * in the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered).
combined administration of intravenous and topical tranexamic acid in total knee arthroplasty

Conditions: Degenerative Arthritis

Summary: this prospective randomized controlled trial was conducted to compare the efficacy of tna in terms of total blood loss and the allogenic transfusion rate among the three study groups; intravenous alone, combined intravenous and low dose topical tna and combined intravenous and high dose topical tna. to evaluate the safety of each regimen in view of deep vein thrombosis and venous thromboembolism.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of primary osteoarthritis exclusion criteria: * patients with diagnoses other than primary oa * patients on anticoagulation therapy * patient with chronic renal failure * patient with cva hx * patient with seizure hx * patient with severe chf * patient with acquired or congenital coagulopathy

Keywords: tranexamic acid