Kornimate/medical-research-clean huggingface dataset:
the role of cytokine-serotonin interactions in post-stroke depression

Conditions: Depression

Summary: depression is a common and often serious problem occurring in stroke patients. inflammatory hormones, known as cytokines, are stimulated by an activated immune system and sometimes become active following a stroke. they may be responsible for altering levels of key neurotransmitters and their metabolites in the blood and brain of stroke patients. the investigators' objective is to examine whether increased cytokine activity following a stroke may be the cause of an increased presence or severity of depression or cognitive impairment among stroke patients, as a result of tryptophan depletion and/or kynurenine activation. they are recruiting patients within one month of their strokes and measuring levels of key markers in their blood. patients are assessed for the presence of depressive and/or cognitive symptoms and treated with an antidepressant if needed. the investigators expect to show that cytokine activation is related to depression and/or cognitive impairment among stroke patients.


Eligibility criteria:
inclusion criteria: * age \> 18 years * gender: male or female * language: speaks and understands english * clinical diagnosis of stroke according to world health organization monica project and recent (\< 3 months) cerebral infarctions * written, informed consent * depressed group only: diagnosis of a major depressive episode according to the depression module of the structured clinical interview for the dsm-iv (scid-iv) exclusion criteria: * subarachnoid hemorrhage * intracranial hemorrhage * significant acute medical illness including: drug overdose, severely disturbed liver, kidney or lung function, anemia, hypothyroidism, or uncontrolled diabetes * significant acute neurologic illness including: impaired consciousness, parkinson's disease, huntington's chorea, progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple sclerosis, hydrocephalus, binswanger's disease, or severe aphasia * presence of a premorbid axis i psychiatric diagnosis (eg. schizophrenia, bipolar disorder) * depressed group only: contraindications to receiving treatment with citalopram (including previous nonresponse) or serious risk of suicide

Keywords: stroke depression cytokines serotonin citalopram
a study for tysabri participant preference

Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)

Summary: the primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (sc) and intravenous (iv) natalizumab. the secondary objectives of this study are to evaluate the immunogenicity of sc natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (ms) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on sc natalizumab or switching from iv natalizumab.


Eligibility criteria:
key inclusion criteria: * diagnosis of highly active rrms according to mcdonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (smpc) * in rrms participants who are already on natalizumab therapy, continued treatment must be indicated based on current smpc key exclusion criteria: * progressive forms of ms * contraindication to natalizumab treatment according to natalizumab smpc * concomitant treatment with other drugs for treating rrms * participation in any interventional clinical trial note: other protocol defined inclusion/exclusion criteria may apply.
pharmacology study of aerosolized liposomal

Conditions: Lung Diseases; Cancer

Summary: to determine the overall response rate to liposomal 9-nitro-20 (s)-camptothecin (l9nc) administered by aerosolization in patients with non-small-cell lung cancer (any stage). to determine toxicity profile of l9nc administered by aerosolization for 5 consecutive days per week x 8 weeks, every 10 weeks. to perform a pharmacology study of l9nc in the plasma, and the lungs after aerosolization. a specific protocol will be written for this part.

this is a single-arm, non-randomized phase ii trial of dlpc-9nc administered by aerosol 5 consecutive days per week for 8 weeks every 10 weeks. dose: 0.4 mg/ml of 9-nc in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day) per day x5 every week, x8 weeks, then observe for 2 weeks. one course = 10 weeks. patients that have a resectable lung cancer will only receive one course of treatment and will be operated on about two weeks after completing the 8-week course.

Eligibility criteria:
inclusion criteria: * patients participating in inst 1402c protocol * phase ii study of aerosolized liposomal-nitro-20 (s)-camptothecin (l9nc) in patients with advanced (nsclc) lung cancer are eligible if their tumor is resectable with curative intent as determined by dr. reza mehran.

Keywords: nsclc l9nc aerosolized liposomal 9-nitro-20 (s)-camptothecin
mirror speech entrainment: a novel technique for voice personalized speech entrainment for nonfluent aphasia

Conditions: Aphasia Non Fluent; Stroke; Aphasia

Summary: the goal of this clinical trial is to test the use of voice personalization through artificial intelligence (ai) voice cloning on speech entrainment tasks to improve language production of persons with aphasia (pwa). the main question the study aims to answer is: - what is the impact of personalized voice on speech entrainment in pwa compared to traditional speech entrainment? speech entrainment is a technique used by speech-language pathologists to improve the speech production of pwa. traditionally, speech therapists act as the model for participants to speak along with to improve their speech production. this study proposes the use of one's own voice (digitally altered) to improve speech production. the study uses a mobile health approach to administer speech entrainment treatment through a mobile app. * smartphones with the mobile app pre-installed will be mailed to participants at no cost. * participants will complete treatment in the comfort of their homes. * the experimental treatments involve: mirror speech entrainment (speaking along to one's own voice) and traditional speech entrainment (speaking along to someone else's voice).


Eligibility criteria:
inclusion criteria: * adults between the ages of 18-70 years old * dominant english-speaking * aphasia due to left hemisphere stroke exclusion criteria: * individuals with aphasia due to other causes such as dementia, alzheimer's disease and parkinsonism * non-dominant english adult speakers * persons with significant difficulties with language comprehension * persons with concomitant cognitive disability * persons with uncorrected sensory deficits.

Keywords: aphasia nonfluent aphasia speech entrainment speech synchronization
impact of pharmaceutical interviews on the medication adherence of epileptic patients

Conditions: Epilepsy

Summary: many studies have reported a disparity in medication adherence among epileptic patients. in this population, medication possession ratio (mpr) is an index of medication adherence. mpr is defined as the ratio of the number of days of treatment delivered to the number of days in the period of interest. no-adherents patients are defined by a mpr of less than 80% , in whom an increase in seizures and the rate of hospitalization can be observed. a pharmacist-led intervention and medication information to epileptic patients could improve patient medication adherence to antiepileptic drugs, and possibly decrease the frequency of seizures, hospitalizations and the health costs generated by these hospitalizations. this intervention could also improve patient knowledge about their medications. the aim of this study is to evaluate the effectiveness of a pharmacist-led intervention on medication adherence of epileptic patients with the mpr. secondary objectives include the comparison of medication adherence with health insurance score, the evaluation of patients knowledges about their medications, community pharmacists' satisfaction about community hospital network, the comparison of the seizure free patient rate and the comparison of the rate of patient in whom seizure have decreased by 50%


Eligibility criteria:
inclusion criteria: * epileptic patients seeing a neurologist in the neurophysiology clinic with a regular follow-up by the lille university hospital reference center * adult over 18 years old * living at home * socially insured patient * in the case of cognitive problems, the presence of a reliable caregiver managing the medications exclusion criteria: * inpatients * patient under curatorship, guardianship and/or institutionalized * dementia * patient who has participated in a therapeutic education program (tep) about his epilepsy within the previous two years * administrative reasons: impossibility to receive informed information, impossibility to participate in the entire study, lack of coverage by the social security system, refusal to sign the consent form. * switching to home care by a registered nurse for treatment management

Keywords: treatment adherence epilepsy hospital pharmacy clinical pharmacy pharmacist intervention
caribbean and south america team-based strategy to control hypertension

Conditions: Hypertension; Blood Pressure

Summary: the catch cluster randomized trial will test the implementation and effectiveness outcomes of implementing and scaling up a team-based care strategy for blood pressure control in colombia and jamaica.

the catch study includes a two-year ug3 planning phase and a four-year uh3 implementation phase. in the uh3 implementation phase, we will first conduct a cluster randomized implementation trial to test the effectiveness and implementation of a team-based care strategy for hypertension control among patients with hypertension in 40 clinics from colombia and jamaica (20 in each country). twenty clinics will be randomized to the team-based care intervention and 20 to provider training intervention. a total of 1,680 patients (42 per clinic) with uncontrolled hypertension will be recruited into the study and followed for 18 months for effectiveness and implementation outcomes. a post-intervention study visit will take place 6 months after the end of the 18-month intervention to evaluate the sustainability of the implementation strategies. we will subsequently conduct a pre- and post- scale-up comparison study to implement the team-based care strategy in all remaining public primary care clinics that provide chronic disease management in jamaica and primary care clinics in the seven participating departments in colombia. a pre- and post- scale-up comparison design will be used to assess barriers and implementation outcomes before and 12 months after the scale-up intervention at the clinic, primary care physician, nurse/pharmacist, and community health worker (chw) levels.

Eligibility criteria:
inclusion criteria for clinics: * serving \>300 hypertensive patients during the previous year * clinic visits and bp medications are free of charge to patients * not sharing physicians, nurses, pharmacists, or community health workers (chws) with other clinics inclusion criteria for participants: * men or women aged ≥ 21 years who receive primary care from participating clinics * average untreated bp ≥140/90 mm hg among individuals without a history of clinical cardiovascular disease (cvd), chronic kidney disease (ckd), or diabetes; average untreated bp ≥130/80 mm hg among individuals aged ≥65 years or those with clinical cvd, ckd, or diabetes; or average treated bp ≥130/80 mm hg from six bp readings at two screening visits * not pregnant or planning to become pregnant in the next 18 months * able and willing to give informed consent * no plans to change primary care clinic in the next 18 months * not an immediate family member of staff at the primary care clinic
frequency parameter used to apply ultrasound-guided neuromodulation percutaneous

Conditions: Low Back Pain

Summary: in the daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (lbp). regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation. in the field of physiotherapy, ultrasound-guided percutaneous neuromodulation (pnm) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. the objective of the study is to analyze that the effect of pnm on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic lbp. forty subjects will be recruited, which will be divided into 2 groups: group 1 to which pnm will be applied to the sciatic nerve at 250 microseconds, 3 hz) during 90 seconds; group 2 to which pnm will be applied to the sciatic nerve in at 250 microseconds, 10 hz during 90 second. the pnm intervention with nmp will consist in the single application of an asymmetric rectangular biphasic current.


Eligibility criteria:
inclusion criteria: * diagnosis of lower back pain * having no other therapy exclusion criteria: * other pathology (discal hernia, injured limbs, neurological pathology) * belenophobia
patient reported outcomes with lasik: prowl-2

Conditions: Laser in Situ Keratomileusis

Summary: this study evaluates a questionaire designed to measure satisfaction and ophthalmic-related quality of life (qol) of 300 civilian participants prior to and three months following state-of-the-art laser in situ keratomileusis (lasik).

the lasik quality of life collaboration project (lqolcp) is a government partnership among the fda's center for devices and radiological health (cdrh), the department of defense, and the national eye institute (nei). this project examines patient-reported outcomes (pros) following lasik surgery. this three-phased project is part of fda's ongoing effort to better monitor and improve the safety and effectiveness of lasers used in lasik surgery. prowl-2 is the third phase of the larger lqolcp project. the primary objective of prowl-2 is to explore the psychometric properties of a computer-based questionnaire assessing the patient-reported outcomes of satisfaction and ophthalmic-related quality of life before and over a period of 3 months following lasik. this questionnaire initially developed and examined in prowl-1 (a military population) will be examined psychometrically in a civilian population. prowl-2 is a prospective, multi-center, observational study in which a participant's pre-operative status will serve as the baseline for one-month and three-month post-surgical comparisons. three hundred (300) participants planning to undergo refractive surgery using lasik for myopia, hyperopia, or astigmatism will be enrolled in this study from five (5) clinical sites across the united states. additionally, routine clinical data will be collected pre- and post-operatively (e.g., best corrected visual acuity, manifest refraction, wavefront aberrometry, conreal topography, and other clinical assessments) and questionnaires will be independently administered pre-operatively and at the one-month and three-month post-operative visits.

Eligibility criteria:
inclusion criteria: * investigators will be instructed to base subject eligibility on the professional use information for their specific laser and keratome system, including but not limited to subjects who: * are aged 21 years or older. * have the ability to give informed consent. * speak and read english fluently. * have not previously had any form of refractive surgery, including prior lasik or cataract surgery. * may benefit from increased spectacle independence. * have been determined to be a good candidate for the lasik procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations. * have a treatment target of bilateral emmetropia. of note, an eye must be treated within 7 days of the fellow eye. * express willingness and potential ability to return for all follow-up examinations through the 3-month follow-up exam under the care of the treating investigator. * have access to a computer with internet service.

Keywords: myopia hyperopia astigmatism patient-reported outcomes patient satisfaction refractive error emmetropia dry eyes glare halos patient expectations
levosimendan compassionate use in pediatric patients with advanced decompensated heart failure

Conditions: Heart Decompensation

Summary: open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites.


Eligibility criteria:
general eligibility all patients must meet at least one of the following definitions of failed standard therapy of decompensated heart failure: definition for failure of standard therapy: 1. decompensated heart failure refractory to standard therapy (milrinone of ≥0.5mcg/kg/min for \>48 hours with ef \<35%) including any of the following: * (sao2 - smvo2) \> 30 % or lactate \>3 and/or * need for second inotropic agent and/or * need for positive pressure ventilation and * patient not qualifying for long term ventricular assist device support or transplant at the time of assessment. 2. cardiogenic shock with acute decompensated heart failure (requiring positive pressure ventilation and addition of inotropic support with or without use of milrinone with ef \<35%) refractory to therapy for more than 48h including any or all of the following: * (sao2 - smvo2) \> 30 % or lactate \>3 * patient not qualifying for long term ventricular assist device support or transplant at the time of assessment. * potential need for short-term mechanical circulatory support. 3. failure to wean off ecmo support with use of standard inotropic / vasoconstrictor support. inclusion criteria: 1. male or female, ≤18 years of age with acute or acute on chronic decompensated heart failure. 2. male or female, ≤18 years of age on ecmo support and unable to wean from ecmo support. 3. informed consent signed by the subject's parents or their legally acceptable representatives indicating that they understand the purpose of and procedures required for expanded access and are willing to participate in the study. 4. patients meeting one of the following definitions of failed standard therapy of decompensated heart failure exclusion criteria: 1. patients \< 36 weeks gestational age 2. patients weighing \< 2 kg 3. obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade 4. estimated glomerular filtration rate (egrf) \< 30 ml/min/1.73m2. 5. known allergic reaction or sensitivity to levosimendan or excipients. 6. a history of torsades de pointes, uncorrectable hypo- or hyperkalemia, uncorrectable hypo- or hypercalcemia 7. pregnant, suspected to be pregnant, or breast-feeding. 8. inability or unwillingness of subject or legal guardian/representative to give written informed consent.
bosentan in children with pulmonary arterial hypertension extension study

Conditions: Pulmonary Arterial Hypertension

Summary: the main objective of the future 2 study was to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension who completed future 1 study.


Eligibility criteria:
inclusion criteria: * signed informed consent by the parents or the legal representatives. * patients who completed the future 1 study. * patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of future 1. * males or females \>= 2 and \< 12 years of age at enrollment in future 2 (this study). females who are menstruating must have a negative pregnancy test. a reliable method of contraception must be considered, if appropriate. exclusion criteria: * intolerance to bosentan despite dose reductions. * any clinically significant laboratory abnormality that precludes continuation of bosentan therapy. * pregnancy or breast-feeding. * known hypersensitivity to bosentan or any of the excipients. * premature and permanent study drug discontinuation during future 1.

Keywords: bosentan pulmonary arterial hypertension children future 1
comparison of the effects of concentric and eccentric isokinetic exercises in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study aims to compare the effects of concentric and eccentric isokinetic exercises on proprioception and muscle architecture in 42 patients with knee osteoarthritis enrolled the study.

this study aims to compare the effects of concentric and eccentric isokinetic exercises on proprioception and muscle architecture in patients with knee osteoarthritis. 42 patients will be included in this study. patients will be divided into three groups; concentric exercise group (n:14), eccentric exercise group (n:14) and control group (n:14). a conventional physiotherapy program and a standard therapeutic exercise program will be applied to all subjects. in addition to these exercise and physiotherapy programme, concentric and eccentric exercise groups will perform the exercises related to their groups. all three groups will participate in this program for a total of 18 sessions 3 times a week for 6 weeks. all groups will be subject to re-evaluation after 6 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of primary knee osteoarthritis according to american college of radiology * being radiographically k-l grade 2-3 * presence of symptoms for at least 3 months * patients who have been planned a conventional physiotherapy programme because of knee osteoarthritis * presence of functional capacity for outpatient physical therapy exclusion criteria: * patients with seconder knee osteoarthritis * history of lower extremity or spine surgery * history of intraarticular injection in last 1 month * patients with neurological disease that will affect muscle strength, balance and coordination

Keywords: concentric eccentric muscle architecture proprioception