Kornimate/medical-research-clean huggingface dataset:
determine the effect of intraocular pressure (iop), optic nerve imaging, venous congestion in volunteers prone position 5 hours

Conditions: Blindness

Summary: the purpose of this study is to provide data that would give the investigators a better understanding of the physiologic changes that occur and may contribute to post operative blindness. an improved understanding may lead to the development of protocols or devices that reduce the chance of catastrophic visual loss.

post operative vision loss resulting from nonocular surgery is a devastating, poorly understood and potentially preventable complication. ischemic optic neuropathy, affecting both the anterior or posterioir portions of the optic nerve, is the most common cause of postoperative vision loss(povl). other, less common causes include retinal artery occlusion, retinal vein occlusion, retinal embolism, and cortical blindness. the estimated incidence of povl in patients undergoing general anesthesia is 1/60,000. the incidence dramatically increases in cardiopulmonary bypass and prone spine surgery with estimates at 1/1600 and 1/1100, respectively. the etiology is unknown but it is thought to be multifactorial, and several potential risk factors have been identified, including degree of hypotension, preoperative hematocrit, external compression of the eye, blood loss and prone position. the investigators are proposing eight volunteers in two different sessions of 5.5 hours each. the first session the volunteer will lie prone of the flat jackson table and the second session the volunteer will spend 5 hours prone on the jackson table with a table elevation of 6 inches. the following measurements will be done: intraocular pressure (iop) with a device called the tonopen-xl, the nidex nm 200 to visualize the retinal optic nerve imaging, refractometry, ultrasound, corneal thickness pachymetry, measurement of proptosis, measurement of pupillary reflex, the volunteers do not receive anesthetic medications or intravenous fluids and will provide a baseline for comparision with patients enrolled in the prospective study.

Eligibility criteria:
inclusion criteria: * subjects willing to consent exclusion criteria: * individuals unable to tolerate prone position for 5 hours * individuals unable to tolerate contact lens placement * females who are pregnant * individuals with a sensitivity to proparacaine hcl 0.5% or tropicamide 1% * individuals who are unable to have repeated mesaurements of intaocular pressure

Keywords: ischemic optic neuropathy cortical blindness
evaluation of the efficacy of "lifespan integration" (li) therapy in patients with complex post-traumatic stress disorder

Conditions: Post-Traumatic Stress Disorder Complex; Psychiatric Disorder; Abuse Neglect; Abuse Physical; Abuse, Sexual; Abuse Domestic; Abuse Verbal

Summary: the study aims to evaluate the efficacy of a relatively new type of psychotherapy called lifespan integration (li) in patients suffering of complex ptsd


Eligibility criteria:
inclusion criteria: * patients diagnosed with complex ptsd * french speaking * first time following an li type of therapy * psychotropic treatment is allowed exclusion criteria: * no other parallel psychotherapy is accepted (if the patient underwent recently any other type of psychotherapy, a "wash out " period of minimum 4 weeks is required ) * no active manic episode at the time of inclusion * no active psychotic episode at the time of inclusion * no chronic psychotic disorder diagnosis * no autistic spectrum disorder diagnosis , * no intellectual deficit

Keywords: lifespan integration therapy psychotrauma type ii abuse victims complex post-traumatic stress disorder psychotherapy
post stroke motor learning

Conditions: Stroke; Hemiparesis

Summary: noninvasive brain stimulations (nibs) will be used in chronic stroke patients to improve motor learning. functional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients.

transcranial direct current stimulation will be used for nibs

Eligibility criteria:
inclusion criteria: * stroke with at least slight deficit exclusion criteria: * epilepsy * contraindication to tdcs and/or to fmri * presence of metal in the head * inability to understand / complete behavioral tasks * chronic intake of alcohol or recreational drugs * major health condition * presence of pacemaker (for the fmri part only) * pregnancy

Keywords: stroke
study of aripiprazole as an adjunctive therapy in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: to examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy co-administered with either an selective serotonin reuptake inhibitor (ssri) or a serotonin-norepinephrine reuptake inhibitor (snri) in patients with major depressive disorder.


Eligibility criteria:
inclusion criteria: 1. patients who are either inpatients or outpatients 2. patients who have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial 3. patients diagnosed as having either "296.2x major depressive disorder, single episode" or "296.3x major depressive disorder, recurrent" according to dsm-iv-tr, and for whom the current episode of major depressive disorder has been ongoing for more than 8 weeks 4. patients with a ham-d17 total score of 18 or more exclusion criteria: 1. female patients of child bearing potential who wish to become pregnant during the treatment period, or within 4 weeks after study completion/discontinuation 2. female patients who are pregnant, possibly pregnant, or breast feeding 3. patients judged to be unable to tolerate any type of antidpressant treatment (including drugs not being used in the current episode of major depressive disorder), based on treatment history to date 4. patients who have previously received electro-convulsive therapy 5. patients who have participated in clinical studies on medical devices or other drugs within the past month 6. patients at risk of having serious adverse events or developing symptoms that could interfere with safety and efficacy evaluations (such as symptoms of fibromyalgia syndrome overlapping with symptoms of depression), based on previous medical history 7. patients with a history or a complication of diabetes 8. patients with thyroid disease (excluding patients who are stabilized on drug therapy for at least 3 months) 9. patients with a history of serotonin syndrome or psychotropic neuroleptic malignant syndrome 10. patients with a history of seizure disorder (epilepsy etc.)
radiological imaging in patients tested for covid-19

Conditions: COVID-19; Coronary Artery Disease; Cardiovascular Diseases

Summary: it has become apparent that patients with co-morbidities have an increased risk of mortality from coronarvirus disease 2019 (covid-19). however, the impact of subclinical respiratory and cardiovascular disease on the outcome of patients with covid-19 is currently unknown. this observational study will assess the impact of incidental cardiovascular calcification on radiological imaging on the outcomes of patients with covd-19.

it has become apparent that patients with co-morbidities have an increased risk of mortality from coronarvirus disease 2019 (covid-19). however, the impact of subclinical respiratory and cardiovascular disease on the outcome of patients with covid-19 is currently unknown. subclinical respiratory and cardiovascular disease can be identified on radiological imaging. for example, calcification in blood vessels can identify cardiovascular disease, intra-thoracic and intra-abdominal fat is associated with coronary artery disease, and lung diseases can be identified on ct and x-ray. the impact these radiological features on the outcomes of patients with covid-19 is currently unknown. this study aims to assess the radiological imaging of patients tested for covid-19 in order to identify the presence of co-existing respiratory and cardiovascular disease and assess their impact on clinical outcomes. all patients tested for covid-19 with current or previous (last 3 years) radiological imaging will be included in this study. radiological images will be de-identified and assessed for the presence of cardiovascular calcification. information on covid-19 tests and clinical factors will be obtained from routinely collected data. additional clinical information will be obtained from electronic health records as required.

Eligibility criteria:
inclusion criteria: * one or more positive rt-pcr test for covid-19. * one or more ct or chest x-ray available performed within the last 3 years exclusion criteria: * no available radiological imaging within the last 3 years
clinical effectiveness of in-office bleaching activated with a led/laser device

Conditions: Tooth Discoloration

Summary: there is a controversy in the dentistry literature about how the use of associated light to activate 35% hydrogen peroxide gel during in-office tooth bleaching may increase the bleaching effectiveness. the studies that demonstrated an increased level of bleaching using light activation employed lower hydrogen peroxide gels while the ones reporting no statistical difference employed higher hydrogen peroxide gels. the hypothesis of this study is that the effectiveness of light activation tooth bleaching in dependent on the hydrogen peroxide concentration employed.

the aim of this study is to compare the color change and tooth sensitivity of in-office bleaching using different hydrogen peroxide concentrations and with or without light activation. sixty patients will be enrolled in this trial and divide equally into 4 groups according to the combination of the main factors hydrogen peroxide concentration (35% or 20%) or led/laser activation (yes or no). three 15-min applications will be performed in each clinical appointment. a led/laser device will be used in the respective groups for three 1-min application with an interval of 2 min. the same procedure will be repeated one week later. the color change will be assessed after hte 1st and 2nd session, after 1 week and 6 months of the end of the treatment using a value-oriented shade vita classical and a spectrophotometer easy shade. the tooth sensitivity will be reported by patients using a 0 to 10 visual analog scale. the student t test (α = .05) will be used to compare the tooth color changes and the intensity of tooth sensitivity between groups at baseline and immediately after the first and second bleaching appointments. the fisher exact test and student t test (α = .05), respectively, will be used to analyze the percentage of patients with tooth sensitivity and its intensity.

Eligibility criteria:
inclusion criteria: * participants should be at least 18 years old; * participants should have good general and oral health * participants should have six caries-free maxillary anterior teeth without restorations on the labial surfaces * participants should be willing to sign a consent form * participants should have central incisors darker than shade c2. exclusion criteria: * participants that had undergone tooth-whitening procedures * participants that had labial anterior restorations, were pregnant or lactating. * participants with severe internal tooth discoloration (such as tetracycline stains, fluorosis, pulpless teeth). * participants with bruxism habits or any gross pathology in the mouth

Keywords: tooth bleaching, bleaching agent, hydrogen peroxide
pharmacy-based testing and treatment for gonorrhea and chlamydia

Conditions: Chlamydia Trachomatis Infection; Neisseria Gonorrheae Infection

Summary: chlamydia trachomatis (ct) and neisseria gonorrhoeae (ng) are the first and second most commonly reported sexually transmitted infections (sti) in canada, respectively, and rates are increasing. while ct and ng can cause a variety of non-specific symptoms, an estimated 77% of ct and 45% of ng cases are asymptomatic. consequently, many individuals remain undiagnosed, or have delayed diagnosis and consequently miss effective and well-tolerated therapies and may transmit the infection(s) to sexual partners. untreated ct infection may result in serious sequelae. also, ct and ng infection are associated with increased risk of acquiring hiv and some cancers. access to sti testing and treatment are two of the core pillars in the pan-canadian sexually transmitted and blood borne infections (stbbi) framework for action. currently many canadians lack a primary care physician and many sti specific clinics are centered in urban areas, further challenging access in rural communities. increasing access to these core pillars is paramount to reduce the health impact of stbbis in canada by 2030. the purpose of this study is to implement and evaluate a novel pilot project including pharmacy-based ct and ng management (including specimen self-collection \[pharyngeal, anorectal and/or vaginal swabs, and/or urine sample\], assessment, treatment, and linkage to care) by community pharmacists in nova scotia.


Eligibility criteria:
exclusion criteria: * symptomatic * age less than 18 years * does not understand english * does not have a valid nova scotia health card * is not able to provide informed consent to participate in research

Keywords: pharmacists self-swab pharmacy-based testing pharmacist prescribing
this study is to assess the efficacy of difamilast ointment in mild to moderate atopic dermatitis(ad)

Conditions: Atopic Dermatitis

Summary: this is a phase 3 double blind multi-center study conducted at 40 investigational sites in united states to assess the efficacy and safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate atopic dermatitis.


Eligibility criteria:
important inclusion criteria: 1. subjects who are male or female ≥2 years of age 2. subjects and/or their parent(s)/legal guardian(s) (if subject is under the legal age of consent) provide written informed consent in accordance with federal and/or local laws prior to the conduct of any study-related procedures. 3. subjects who have a diagnosis of ad based on the american academy of dermatology ad diagnostic criteria 4. subjects who have had a diagnosis of ad for at least 6 months prior to screening visit 5. subjects who have ad involvement ≥5% to ≤40% of treatable body surface area (bsa) excluding scalp 6. subjects who have an ad severity of mild (2) or moderate (3) as measured by the iga of ad severity score at screening and baseline visit important exclusion criteria: 1. female subjects who are pregnant or breastfeeding or who plan to become pregnant during the study and through 90 days after the last dose of study drug 2. subjects who have evidence of spontaneous clearance of ad between screening and baseline visits 3. subjects who have a history of unstable ad as assessed by the investigator. unstable ad is defined as disease flares occurring within 4 weeks prior to baseline visit 4. subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, and chicken pox) and/or clinically infected ad 5. subject with greater than mild depression and suicidal ideation prior to screening or between screening and baseline visits 6. subjects who have a known history of alcohol abuse or illicit drugs within 6 months prior to screening etc.,
a study to investigate the efficacy and safety of baxdrostat in participants with uncontrolled hypertension on two or more medications including participants with resistant hypertension

Conditions: Uncontrolled Hypertension; Resistant Hypertension

Summary: this is a phase iii, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (qd) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).


Eligibility criteria:
inclusion criteria: * male or female participants must be ≥ 18 years old * mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmhg and \< 170 mmhg at screening * fulfil at least 1 of the following 2 criteria: 1. uhtn subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the investigator 2. rhtn subpopulation: have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the investigator * estimated glomerular filtration rate ≥ 45 ml/min/1.73m2 at screening * serum potassium (k+) level ≥ 3.5 and \< 5.0 mmol/l at screening * randomisation criterion: * sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmhg at the baseline visit exclusion criteria: * mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmhg * mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmhg * serum sodium level \< 135 mmol/l at screening * has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, cushing's syndrome, aortic coarctation * new york heart association functional heart failure class iv at screening * persistent atrial fibrillation

Keywords: hypertension uncontrolled hypertension resistant hypertension blood pressure baxdrostat cin-107 aldosterone aldosterone synthase
enhanced recovery after surgery in oblique lumbar interbody fusion

Conditions: Enhanced Recovery After Surgery; Spinal Fusion; Lumbar Spinal Stenosis; Lumbar Spondylolisthesis

Summary: this study is a randomized controlled non-inferiority trial designed to evaluate the impact of implementing the 'early recovery after surgery clinical pathway (eras cp)' on patient-reported pain levels at the time of discharge following oblique lumbar interbody fusion (olif) surgery

currently, the effectiveness of the eras has been widely confirmed in patients undergoing colorectal resection, and it has been verified to reduce length of hospital stay and complications. however, the eras protocol for lumbar fusion surgery is based on a few retrospective studies and remains a consensus statement. recent retrospective studies targeting patients undergoing lumbar fusion surgery reported that implementing eras could accelerate post-operative functional recovery and reduce hospital stay. however, there is still a lack of high-quality evidence based on prospective studies. lumbar fusion surgery is known for potentially leading to severe postoperative pain, which poses challenges in consistently applying eras components, such as early ambulation or active oral feeding, after surgery. in light of this, the present study aims to validate the non-inferiority of pain levels at discharge within the eras group and to reconfirm the effects of eras as observed in retrospective studies. patients admitted for olif will be consecutively screened for eligibility. a computer-generated block randomization will be executed at a 1:1 ratio. in the eras group, patients will receive comprehensive education about the treatment process, and a clinical pathway that includes active ambulation and pain control will be protocolized and implemented. should non-inferiority be demonstrated in both intent-to-treat and per-protocol analyses, non-inferiority will be declared.

Eligibility criteria:
inclusion criteria: 1. lumbar degenerative disease, requiring interbody fusion of 1-2 segments between l2 and s1 2. capability of independent (or assisted) ambulation for at least 30 minutes with 1. taking intermittent breaks 2. enduring any discomfort 3. voluntary informed consent to participate in the study. exclusion criteria: 1. previous history of lumbar interbody fusion 2. manual muscle testing grade 3 or below 3. neuropsychiatric disorders such as major depressive disorder 4. musculoskeletal disorders other than lumbar degenerative diseases (inflammatory, myopathic, infections, etc.) 5. diagnosis of malignant neoplasm 6. refusal to participate in the study
self-management for head and neck lymphedema and fibrosis [promise trial]

Conditions: Lymphedema of the Head and Neck

Summary: the goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (lef-smp) to improve lef self-management and reduce lef-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (hnc) survivors.

in hnc survivors with lymphedema and fibrosis (lef), the investigators will: 1) compare the effects of in-person lef-smp, telehealth lef-smp, and usual care on lef severity; 2) compare the effects of in-person lef-smp, telehealth lef-smp, and usual care on lef-related symptom burden, functional impairments, and quality of life; and 3) compare the effects of in-person lef-smp, telehealth lef-smp, and usual care on lef-related knowledge, skills, self-efficacy, and self-care adherence.

Eligibility criteria:
inclusion criteria: * \>18 years of age * post hnc primary treatment * no evidence of cancer (ned) * completion of initial lymphedema therapy for head and neck lymphedema * unable to obtain lymphedema therapy due to barriers noted above * history of lymphedema on the face and neck, with or without fibrosis * ability to understand english in order to complete questionnaires * ability to perform self-care activities for lef management * ability to provide informed consent * having an electronic device (a computer, tablet, ipad, or smartphone) and internet access at home * a valid email address exclusion criteria: * recurrent or metastatic cancer * any other active cancer * acute infection * acute congestive heart failure * acute renal failure * cardiac or pulmonary edema * sensitive carotid sinus * severe carotid blockage * uncontrolled hypertension * venous thrombosis * pregnant people * incarcerated patients

Keywords: lymphedema fibrosis head and neck cancer survivorship self-management