Kornimate/medical-research-clean huggingface dataset:
bioequivalency study of losartan potassium 100 mg tablet under fasted conditions

Conditions: Hypertension

Summary: the objective of this study was to prove the bioequivalence of losartan potassium 100 tablet under fasted conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to losartan potassium or any comparable or similar product.
assessing ventilator safety in patients on pressure-support ventilation

Conditions: Acute Respiratory Failure; Mechanical Ventilation Complication; Ventilator-Induced Lung Injury

Summary: asop is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation. we will describe the relationship between three different assessment methods for risk of self-induced lung injury and compare them to a gold standard measurement.

ventilator-induced lung injury (vili) is known to cause significant morbidity and mortality in patients with acute respiratory failure. most studies on vili have involved the effects of inappropriate (often excessive) mechanical ventilator settings. more recently, it has been noted that similar lung damage can be caused by large, patient generated, uncontrolled tidal volumes and driving pressures, which has been termed "self-induced lung injury," or sili. pressure-support ventilation (psv) is a common mechanical ventilation mode often used in patients with active inspiratory efforts to help reduce patient inspiratory work and improve comfort. psv effectively allows spontaneously breathing patients to determine their breath flow-rate and breath duration, eliminating flow and cycle dyssynchrony. however, pressure support ventilation does not allow for physicians to control tidal volume or driving pressure. the risk of sili may thus be increased with psv. several different methods have been proposed to address these challenges. however, to date none of these methods have been compared to assess for concordance in their ability to indicate an increased risk of self-induced lung injury. asop is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation.

Eligibility criteria:
inclusion criteria: * adult patients age ≥18 years with acute respiratory failure receiving invasive mechanical ventilation * managed in pressure-support mode of ventilation exclusion criteria: * actively undergoing a spontaneously awakening trial or sat * patient or surrogate is unable to provide informed consent * currently pregnant * currently incarcerated * acute exacerbation of an obstructive lung disease * known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe * esophageal, gastric or duodenal surgical procedures within the last 6 months

Keywords: self-induced lung injury pressure-support ventilation
approach to sexuality from occupational therapy in people with acquired brain injury in subacute stage

Conditions: Occupational Therapy; Sexuality; Acquired Brain Injury

Summary: objectives: to analyse if people with acquired brain injury in sub-acute situation, as well as their relatives, and/or partners, consider relevant the approach to sexuality during their occupational therapy intervention. methodology: this study presents a qualitative design with a phenomenological approach. twelve participants were interviewed: eight people with acquired brain injury, two relatives and two partners who agreed to participate. the information has been collected through interviews.


Eligibility criteria:
people with acquired brain injury inclusion criteria: * being over 18 years. * have a diagnosis framed within the concept of acquired brain injury. * to be in the sub-acute stage after the acquired brain injury. * take occupational therapy to the neurology service of the rehabilitation unit of the maritime hospital of oza (chuac) for a minimum of two months. exclusion criteria: * do not accept to participate in the study. * present a decrease in the level of consciousness. * present alterations at the cognitive level that suppose a score of less than 20 on the mini-mental state examination (mmse). * present disinhibition after acquired brain damage. * present sensory aphasia. partners and relatives of people with acquired brain injury inclusion criteria: * being over 18 years. * being partner or relative of a person who has a diagnosis framed within the concept of acquired brain injury. * being partner or relative of a person who is in the sub-acute stage after the acquired brain injury. * being partner or relative of a person who takes occupational therapy to the neurology service of the rehabilitation unit of the maritime hospital of oza (chuac) for a minimum of two months. exclusion criteria: * do not accept to participate in the study. * present a decrease in the level of consciousness. * present alterations at the cognitive level that suppose a score of less than 20 on the mini-mental state examination (mmse).

Keywords: occupational therapy sexuality acquired bain injury subacute stage qualitative study
impact of collaborative care for pregnant women with opioid use disorder in low-resource obstetric settings

Conditions: Pregnancy; Postpartum Period; Opioid Use Disorder

Summary: the investigators seek to adapt a collaborative care model (ccm) for community-based, low-resource obstetric settings and to test the effects of this adapted ccm on health outcomes among pregnant, postpartum, and parenting person (pppp) with opioid use disorder (oud) and their families. to achieve this goal, investigators will conduct a nonrandomized, type 1 hybrid implementation-effectiveness study across 3 community-based, low-resource obstetric sites in northwest pa, a region with rates of maternal opioid-related diagnoses 4 times higher than national averages.

our central hypothesis is that person-centered, recovery supports, provided in the ccm will increase medication for oud (moud) initiation and continuation, decrease overdose and reduce child removal rates among pppp with oud. specifically, investigators will: 1. conduct an intervention adaptation project to adapt the pregnancy and women's recovery center (pwrc) ccm for rural and low-resource obstetric settings; and 2. create a common data model to harmonize variables across data sources and data collection processes across study sites. investigators will also: 1. evaluate the effects of the adapted pwrc ccm on outcomes among pppp with oud; 2. determine if improvements in person-centered, recovery supports mediate the relationship between pwrc community and outcomes using causal mediation methods; and 3. identify pwrc community adaptations that are associated with increased moud access, improved outcomes and that facilitate sustainability and scalability. research findings will: 1. provide high-quality evidence on how ccms affect service delivery and health outcomes for pppp with oud, 2. inform stakeholders about ways to adapt ccms for low-resource and rural healthcare settings, and 3. inform policymakers about the adaptations necessary to replicate these models widely.

Eligibility criteria:
inclusion criteria: (stakeholder participant) 1. 18 years or older 2. providing care at participating obstetric site 3. english speaking (patient participant) 1. 18 years or older 2. receiving care at participating obstetric site 3. english speaking exclusion criteria: 1. unwillingness to have participation audio recorded.

Keywords: heal inititative heal moud oud pregnancy postpartum substance
the biomimetic stent and vascular functions study

Conditions: Peripheral Arterial Disease

Summary: the aim of this iit is to determine the potential improvement and impact of the biomimics 3d stent system in the sfa on local vascular function.

the mimics flow study is a single-center, single-blind, investigator-initiated, randomized parallel group trial. the impact of a novel biomimetical stent with a helical curvature provides superior hemodynamic and biomechanical performance and advantages. additionally, it promotes swirling blood flow, elevating wall sheer strength, which is patency-protective and might impact on vascular functions due to completely different vascular properties through altered blood flow. the influence of the novel devices and stent-platforms with improved hemodynamic capabilities with respect to vasomotor of the vessel wall, vascular function and vascular compliance can be measured by fmd, arterial stiffness indices and vascular strain analysis.

Eligibility criteria:
inclusion criteria: * peripheral artery disease * target lesions in the proximal (3 cm distal to the cfa-bifurcation) middle and distal sfa * clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by rutherford 2,3,4 * planed peripheral intervention tasc a-d * subject must be between 18 and 85 years old * female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12 month angiographic evaluation * vessel diameter \>/= 4.0 mm and \</=7.0 mm * target lesion length \< 140 mm (segment to be stented) * willing to comply with the specified follow-up evaluation * written informed consent prior to any study procedures * pretreatment with an adequately sized ballon (1:1 ration to nonstenotic vessel diameter) * usage of biomimics stent as described in the ifu, especially regarding stent diameters and vessel size exclusion criteria: * bifurcational lesions of the cfa and lesions including the first 3 cm of the sfa, due to technical aspects of fmd measurement * requiring stent implantation in the pa * instent-restenosis * thrombolysis within 72 hours prior to the index procedure * aneurysm formations in the femoral artery or popliteal artery * concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy * unstable angina pectoris at the time of the enrollment * recent myocardial infarction or stroke \<30 days prior to the index procedure * life expectancy less than 12 months * septicaemia at the time of enrollment * known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb * known or suspected allergies or contraindications to aspirin, clopidogrel or heparin * presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
spinal anesthesia magnesium infusion

Conditions: Operation

Summary: the aim of this study was to investigate the effect of i.v. infusion of magnesium sulphate during spinal anesthesia on duration of spinal block and postoperative pain.


Eligibility criteria:
inclusion criteria: * asa physical status i and ii, aged between 18 and 65 female patients undergoing abdominal hysterectomy exclusion criteria: * severe cardiovascular, renal and hepatic dysfunction, neuromuscular diseases, using calcium channel blockers, and inappropriate for spinal anesthesia.
a study investigating the effects of an ankle rehabilitation program on high school athletes with ankle instability

Conditions: Chronic Ankle Instability; Ankle Sprains; Ankle Rehabilitation

Summary: a randomized controlled trial investigating the effects of a 4-week ankle rehabilitation program on high school athletes with chronic ankle instability.

a randomized controlled trial investigating the effects of a three different 4-week ankle rehabilitation programs on high school athletes with chronic ankle instability. we will use questionnaires to assess subjective level of function and clinical measures to assess clinical functionality via static and functional balance.

Eligibility criteria:
inclusion criteria: * active for at least 1.5 hours a week, a history of at least 1 significant ankle sprain that required medical intervention, repeated symptoms of pain, swelling, weakness, instability, and repeated episodes of "giving way". exclusion criteria: * presence of any current lower extremity injury (diagnosed by a medical professional within last 3 months with present symptoms), previous surgery to either leg, diagnosed ankle sprain within the past 6 weeks, history of ankle fractures and/or dislocations.
relationship between cervical pain and temporomandibular dysfunction craniovertebral angle, jaw functional limitation and cervical mobility

Conditions: Temporomandibular Disorder

Summary: the aim of this study is to examine temporomandibular dysfunctions, jaw functional limitation, cervical mobility and craniovertebral angles and possible relations between individuals with cervical pain and individuals without cervical pain and to compare the this four variables between the two groups.

this study was conducted with 129 individuals (mean age 34.08:years, m/f=52/77) to determine the possible relationships between cervical pain and temporomandibular dysfunction, craniovertebral angle, jaw functional limitation and cervical mobility. pati,ents were assessed with neck pain and disability questionnaire , fonseka anamnestic index , goniometric measurements, ,cervical mobility measurement. jfsl-20 questionnaire and craniovertebral angle measurement was made by photographic method.

Eligibility criteria:
inclusion criteria: neck pain disability score below 15 not having painting problem for tme being in the age range of 18-50 volunteering to participate in the study exclusion criteria: * he presence of any orthopedic and / or neurological problem that may prevent evaluations. being diagnosed with any psychiatric disorder situations that will prevent evaluation or communication * illiterate individuals * head, neck and maxillofacial surgery operation history * conditions in systemic pathological conditions such as malignant condition, fracture and rheumatoid arthritis
internet-delivered cognitive behavioral therapy (cbt) for health anxiety

Conditions: Hypochondriasis

Summary: hypochondriasis (health anxiety) is common, has many negative consequences for the afflicted individual and is associated with high societal costs. cognitive behavioural therapy (cbt) has proven to be effective when administered in live-sessions. the aim of this study is to investigate whether cbt remains effective when administered via a self-help programme on the internet.


Eligibility criteria:
inclusion criteria: * primary diagnosis of hypochondriasis * at least 18 years old * able to read and write in swedish * computer access exclusion criteria: * drug abuse * concurrent severe depression * no serious somatic illness * previous treatment with cbt for hypochondriasis
dosimetric planning study comparing intensity modulated radiotherapy (imrt) and 4-field radiotherapy for definitive treatment of cancer of the cervix

Conditions: Cervix Cancer

Summary: a theoretical planning study to compare the normal tissue irradiation when using intensity modulated radiotherapy (imrt) as opposed to standard radiotherapy for the definitive treatment of cervical cancer.

radiotherapy in combination with chemotherapy is the standard treatment of locally advanced cervix cancer, however with traditional techniques large volumes of bowel and bladder are irradiated causing short-term and long-term genito-urinary and gastro-intestinal side effects. imrt has the potential to conform precisely to the target and spare normal tissues and reduce side effects. however because there are large dose gradients there is the potential to miss the target due to organ motion. recent studies have documented organ motion and will be used to define the target. approximately 60 planning scans, previously used to treat patients with cervix cancer, will be used to replan using an imrt technique and differences in doses to tumour and normal tissues compared.

Eligibility criteria:
inclusion criteria: * last 60 patients treated definitively for cervical cancer at sunnybrook odette cancer centre exclusion criteria: * no imaging and no anatomical description of disease

Keywords: cervix cancer imrt organ motion target definition
motivation's effect on home exercise in children with obpp

Conditions: Obstetric Paralyses

Summary: the present study examined the effect of motivation on home exercise program and children's functional scores. 33 obpp children (narakas type 2) aged between 0-18 months were divided into two groups. intervention group was motivated via phone. both groups were informed about obpp, performed home exercises and filled exercise diary. intrinsic motivation scale was used for measuring motivation and gilbert and raimondi scoring and active movement scoring were used for evaluating functional improvements at first assessment, 6th week and 12th week. for final comparison, parents were divided into two more groups (highly motivated and motivated group) based on motivation scores.

home exercise program is widely used for treatment of obpp children. the present study examined the effect of motivation on home exercise program and children's functional scores. 33 obpp children (narakas type 2) aged between 0-18 months were divided into two groups. intervention group was motivated via phone. both groups were informed about obpp, performed home exercises and filled exercise diary. intrinsic motivation scale was used for measuring motivation and gilbert and raimondi scoring and active movement scoring were used for evaluating functional improvements at first assessment, 6th week and 12th week. for final comparison, parents were divided into two more groups (highly motivated and motivated group) based on motivation scores.

Eligibility criteria:
inclusion criteria: * being classified as narakas type 2a or 2b * being aged between 0 - 18 months * not having regular physiotherapy and rehabilitation program exclusion criteria: * having a clinical condition such as upper motor neuron lesion that may affect child's affected arm or whole body, * having secondary surgery for orthopedic problems within last 6 months. * mother having an unidentified cognitive problem, * parents having another child with a disability, * parents not willing to participate.

Keywords: obstetric paralysis home exercise motivation rehabilitation parents
to demonstrate the relative bioavailability of geneva and basel (anafranil) 25 mg clomipramine hydrochloride capsules under fed and fasted conditions

Conditions: Depression

Summary: to demonstrate the relative bioavailability of geneva and basel (anafranil) 25 mg clomipramine hydrochloride capsules under fed and fasted conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: antidepressant
human factors analysis in vr for burn treatment

Conditions: Pain; Chronic Pain

Summary: a number of studies have shown that virtual reality (vr) can be used to distract patients from pain and anxiety during painful medical procedures for which medication provides inadequate relief. an inexpensive, commercially available ve could have significant impact in reducing perceived pain involved in a variety of medical procedures. the virtual reality medical center (vrmc) developed an engaging virtual world that proved to be effective in reducing reported pain ratings of participants experiencing several different forms of painful stimuli. the virtual world called icy cool world was found to successfully distract patients from painful stimuli and reduce patients' perceived levels of pain. phase ii looks to expand on these findings and examine the effectiveness as a pain distraction technique for a variety of acute and chronic pain etiologies. the main objective of the clinical investigation will be to expand on the findings from earlier studies and obtain a more comprehensive analysis regarding the clinical versatility of vr pain distraction.


Eligibility criteria:
inclusion criteria: * age 18-65, male or female, any ethnicity as long as candidates can understand and read english adequately. exclusion criteria: * we will exclude participants who meet dsm-iv-tr criteria for alcohol or other substance abuse in the past year, or are currently using any recreational drugs, or taking more than 20 alcoholic drinks a week. in addition, the beck depression inventory ii (bdi-ii) score must be less than 16, with no suicidal ideation.
whole brain vessel wall imaging in stroke patients (wisp): an international multi-center registry

Conditions: Ischemic Stroke

Summary: this is a new vessel wall imaging-based stroke registry which will investigate the clinical utility of the whole-brain intracranial vessel wall magnetic resonance imaging (mri) technique in assessing the etiologies in patients with ischemic stroke.

the registry will focus on investigating the utility of whole-brain vessel wall mri techniques in assessing the etiologies in patients with recent ischemic stroke. patients who have had ischemic stroke (as confirmed by diffusion weighted mri) and have had or will undergo 3d whole-brain vessel wall mri within 8 weeks of symptom onset will be recruited into this study. it is anticipated that a total of 1000 subjects will be recruited from feb 2017 to feb 2019. approximately 12 centers in the us and china will participate in the registry. mri whole-brain vessel wall images will be analyzed for detection and characteristics of various vessel wall pathologies and association between vessel wall imaging findings and patient's clinical information.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * ischemic stroke onset within 8 weeks and confirmed by diffusion weighted mri * ability to read and understand informed consent exclusion criteria: * the cause of stroke has been confirmed to be related to cardiac or extracranial carotid or aorta pathologies. * contraindications to mr imaging including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy. * inability to tolerate mri imaging secondary to an inability to lie supine or severe claustrophobia. * non-compliant with visit instructions, including inability to lie still, hold breath or follow procedure instructions
bucy vs tbicy conditioning regimen for standard-risk all undergoing allo-hsct

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; Busulfan; Total Body Irradiation; Acute Lymphocytic Leukemia

Summary: allogeneic hematopoietic stem cell transplantation (allo-hsct) appears to be an efficient tool to cure standard-risk acute lymphocytic leukemia (all) in first cr (cr1) but the choice between bu-based or tbi-based conditioning regimens still remains controversial. in this study, the safety and efficacy of bucy and tbicy myeloablative conditioning regimens in patients undergoing allo-hsct for all in cr1 are evaluated.

allo-hsct appears to be an efficient tool to cure standard-risk all in cr1. the conditioning regimen with bucy or tbicy is considered as the standard myeloablative regimen for all in cr1, but the choice between bu-based or tbi-based conditioning regimen still remains controversial.in order to analyze the impact of conditioning regimen on long-term survival and relapse, in this study, the safety and efficacy of bucy and tbicy myeloablative conditioning regimens in patients undergoing allo-hsct for all in cr1 are evaluated.

Eligibility criteria:
inclusion criteria: * standard-risk all * achieving cr1 * undergoing hla-matched allo-hsct (related or unrelated) exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)