Kornimate/medical-research-clean huggingface dataset:
atrial pressure electrophysiology pilot study

Conditions: Atrial Fibrillation

Summary: this study examined data elements of hemodynamic, electrophysiologic and electrolyte trends comparing 2 different types of catheters used during a procedure to treat medication resistant atrial fibrillation-radiofrequency catheter ablation. a high flow catheter delivers a high volume of saline during the procedure. the low flow catheter delivers a low volume of saline during the procedure. the patient will be consented and randomized to one of the 2 groups using a computer generated randomization chart. those that are put in the low flow catheter group will be considered the experimental group. all data will be collected before and after the procedure and each patient will act as their own control within each group.

final report

Eligibility criteria:
inclusion criteria: * drug resistant paroxysmal af * ≥ 18 years old exclusion criteria: * left atrial thrombus on tee * patients unable to provide informed consent

Keywords: radiofrequency catheter ablation atrial fibrillation
pcsk9 inhibition in patients with symptomatic intracranial atherosclerosis

Conditions: Stroke; Intracranial Atherosclerosis; Intraplaque Hemorrhage

Summary: this will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and intracranial atherosclerotic disease are randomized to either drug or placebo.

the purpose of this study will be a dataset that lays the foundation for a randomized controlled trial of pcsk9 inhibition in intracranial atherosclerotic disease (icad) patients, designed to show a reduction in the primary endpoint of ischemic stroke recurrence. such a trial would provide evidence for the utility of alirocumab to prevent recurrent stroke in icad. while we are proposing future studies to reduce recurrent icad stroke risk, it should be noted that, in the long term, our research may lead to effective primary icad stroke risk reduction through pcsk9 inhibition in patients at high risk of stroke identified through asymptomatic stenosis, post-contrast plaque enhancement (ppe) or intraplaque hemorrhage (iph) on vwmri.

Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age * ischemic stroke (≤ 1 month from onset) in one major vascular territory on diffusion-weighted mri * icad plaque of a "major intracranial artery," causing \>25% and \<99% stenosis * eligible arteries: vertebral (v4), basilar, pca (p1, p2), mca (m1, m2), terminal ica, and aca (a1) * able to tolerate high-dose statin (atorvastatin 40-80 mg) exclusion criteria: * stroke mechanism other than icad, including history of atrial fibrillation, hypercoagulability, ipsilateral arterial dissection or carotid stenosis \>50%, and rare causes of stroke such as vasculitis or cadasil * bihemispheric stroke or simultaneous stroke in the anterior and posterior circulation * positive pregnancy test * gadolinium or pcsk9 inhibitor allergy * acute or chronic kidney disease with egfr\<30 ml/min/1.73m2 * pacemaker or other mri contraindications per american college of radiology guidelines33 * inability to return for 1-year follow-up clinic visit and vwmri

Keywords: stroke alirocumab intracranial atherosclerosis intraplaque hemorrhage atorvastatin praluent
high flow nasal oxygen therapy in high risk patients of hypoxia undergoing diagnostic bronchoscopy

Conditions: Hypoxia

Summary: the purpose of this study is to determine the efficacy and safety of nasal high flow oxygen therapy during diagnostic bronchoscopy.

hypoxemia is frequently seen during diagnostic bronchoscopy. nasal prong or other existing oxygen supply methods are often difficult to maintain adequate oxygenation during bronchoscopy. in particular, bronchoscopy to patients already showing hypoxemia can be dangerous even though applying conventional oxygen therapy. thus, we want to elucidate the usefulness of nasal high flow oxygen therapy to hypoxemic patients undergoing diagnostic bronchoscopy.

Eligibility criteria:
inclusion criteria: 1 or 2 1. pao2 \< 60 mmhg on abga or spo2 \< 90 % in room air and spo2 ≥ 95% or pao2 ≥ 75mmhg in low flow oxygen therapy 2. planning to diagnostic bronchoscopic procedure (e.g. bronchial washing, bal, bronchoscopic biopsy, ebus-tbna etc.) exclusion criteria: 1. patients who did not agree to provide information 2. patients requiring for emergent intubation 3. patients can not wear or be already applied high flow nasal oxygen therapy 4. patients with unstable vital sign(e.g. severe hypotension, uncontrolled arrhythmia, etc.) 5. patients with multiple organ failures 6. patients with plan to therapeutic bronchoscopic procedure(e.g. intervention)

Keywords: high flow nasal oxygen therapy diagnostic bronchoscopy
phase 1/2a safety and efficacy of aly688 ophthalmic solution in subjects with dry eye disease

Conditions: Dry Eye Disease

Summary: clinical trial evaluating the safety and tolerability of aly688 in subjects with dry eye disease

this is a multi-center, randomized, double-masked phase 1/2a trial designed to evaluate the safety and tolerability of aly688 ophthalmic solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.

Eligibility criteria:
inclusion criteria: * dry eye disease for \> 3 months meeting specific sign and symptom criteria * best correct visual acuity of +0.6 logmar or better * willing to sign informed consent and attend study visits * willing to comply with contraception requirements exclusion criteria: * unable to meet specific sign and symptom criteria * signs of ophthalmic allergic, inflammatory or infectious conditions * use of contact lenses * anatomic abnormalities preventing accurate study assessments * use of medications that influence eye dryness * recent ophthalmic surgery * unwilling to suspend current treatments for dry eye disease
an expert system to reduce depression in primary care

Conditions: Depression; Depressive Disorder, Major

Summary: the purpose of this study is to determine whether a home-based intervention matched to stage of change (readiness) for using effective methods to prevent or reduce depression can improve depression outcomes in primary care.

a variety of effective interventions exist for people who are willing to seek help for depression. however, there is a lack of interventions for individuals who are not willing to seek help or follow through with treatment recommendations. this is the first population-based intervention for depression that is appropriate for individuals in all stages of change-not merely the minority who are prepared to take action. two primary care samples were included: 1) patients at risk for or experiencing depression but not involved in or planning treatment (untreated sample), and 2) patients newly prescribed antidepressant medication (antidepressant sample). patients from both samples were randomly assigned to receive the intervention consisting of telephone assessments, a stage-based workbook, and three individualized, computer-generated reports mailed to the home (n=443), or usual care (n=459). primary outcomes, assessed at 9 months, were change in depression severity, reliable and clinically significant change in depression severity, stage of change for using effective methods or prevent or reduce depression, onset of major depression if experiencing only subclinical symptoms at baseline, and medication adherence. the study design included an examination of whether the intervention effect was moderated by primary care sample, baseline use of effective methods to prevent or reduce depression, and level of depression.

Eligibility criteria:
inclusion criteria: * at risk for or experiencing depression (i.e., beck depression inventory-ii (bdi) score of 10 or higher; current major depression, minor depression, or dysthymia; or past major depression, minor depression, or dysthymia) exclusion criteria: * younger than age 18 * involved in counseling or planning counseling in the next 30 days * taking antidepressant medication or planning to take antidepressants in the next 30 days (exclusion criterion for untreated sample only) * suicidal ideation * severe depression (bdi \> 28) and deemed inappropriate for study by site clinician * bdi \<10 and in the maintenance stage for using effective methods to prevent or reduce depression * history of bipolar disorder

Keywords: depression stage of change intervention randomized clinical trial population-based expert system
intense pulsed light therapy in meibomian gland dysfunction

Conditions: Meibomian Gland Dysfunction

Summary: to evaluate the effect of intense pulsed light on resistant patients with meibomian gland dysfunction


Eligibility criteria:
inclusion criteria: * age of at least 20 years. * the diagnosis of obstructive mgd based on ocular symptoms, plugged gland oriﬁces, vascularity and irregularity of lid margins, and reduced meibum expression (meibum grade of .1, where grade 0 = clear meibum easily expressed, grade 1 = cloudy meibum expressed with mild pressure, grade 2 = cloudy meibum expressed with more than moderate pressure, and grade 3 = meibum could not be expressed even with strong pressure). * failure of at least 3 types of conventional mgd therapy to improve symptoms or objective ﬁndings for at least 1 year before study treatment exclusion criteria: * the presence of active skin lesions, skin cancer, or other speciﬁc skin pathology. * active ocular infection or ocular inﬂammatory disease.
effects of lipoic acid and eicosapentaenoic acid (epa) in human obesity

Conditions: Obesity; Body Fat; Insulin Resistance

Summary: the aim of the study is to analyze the effects of lipoic acid and/or epa supplementation on weight loss, lipid profile, insulin resistance, oxidative and inflammation parameters, metabolomic profile as well as on adipose tissue gene profile in healthy overweight/obese subjects following an energy-restricted diet.


Eligibility criteria:
inclusion criteria: * women * ages between 20 and 45 years, and with regular menstrual cycles * body mass index (bmi) between 27.5 and 39.9 kg/m2 * weight unchanged (± 3 kg) for the last 3 months * all subjects should have an overall physical and psychological condition that the investigator believes is in accordance with the overall aim of the study. exclusion criteria: * use of prescription medication * to suffer from any chronic metabolic or obesity related disease, hepatic or renal systemic disease: hypertension, dislipidemia, type 1 or 2 diabetes, thyroid function disorders, cirrhosis, fatty liver, etc. * food allergies or food intolerance expected to come up during the study * special diets (atkins, vegetarian, etc.) prior three months the start of the study. * eating disorders * surgically treated obesity * pregnant or lactating women or planning to be pregnant in the next two months * alcohol or drug abuse (based on clinical parameters)

Keywords: obesity calorie restriction eicosapentaenoic acid (epa) lipoic acid weight loss insulin sensitivity lipid metabolism adipokines inflammation oxidative stress adipose tissue gene profile metabolomic profile
diagnostic research in patients with rare diseases -solving the unsolved rare diseases

Conditions: Rare Diseases

Summary: most diagnostically unsolved rare disease have a genetic cause. these causes have not been found applying the current methodologies due to technical limitations (e.g. repeat expansions, changes in non-coding (intronic) regions) or, although methodically recorded, their pathophysiological significance but not classified as clinically relevant. a re- and meta-analysis of existing data sets with new algorithms and statistical models as well as the complementation with other omics technologies followed by functional follow-up studies in appropriate disease models (e.g. patient cell lines) allows to elucidate additional causes of diseases and improve the diagnosis of hereditary diseases. in addition to the direct examination of persons affected, the analysis of healthy family members, for example of parents, plays an important role in a so-called trio analysis, especially in the efficient filtering of the extensive data sets for newly created changes, so-called de novo- variants (new mutations). in the context of the outlined analyzes, new disease genes can be found and validated. the gain of scientific knowledge due to a better understanding of basic cell biological mechanisms can contribute to the development of targeted therapeutic approaches. in this context, the solve-rd project has been built and financed by the european union with the ambitions to solve large numbers of rare disease, for which a molecular cause is not known yet by sophisticated combined omics approaches, and to improve diagnostics of rare disease patients. solve-rd fully integrates with the newly formed european reference networks (erns) for rare diseases, and in particular the ern-rnd, -euro-nmd, -ithaca, and -genturis. the anddi-rares network is fully affiliated to the ern ithaca network and will actively contribute to the project, by the ambition of sharing knowledge about genes, genomic variants and phenotypes. the project will first reanalyse 18.000 negative exomes from the different erns performed in a diagnostic or research context (collection of biomaterial, clinical/phenotypic data plus next-generation sequencing has already been performed, and the patient/family has agreed previously in writing that their sample could be used for research related to their disease, with no study related presence required. the project will also propose new multi-omics analyses with new samples needed in 500 patients and their parents in total, justifying the anddi-solve-rd project.


Eligibility criteria:
inclusion criteria: * persons or legal guardian who have given their written informed consent * unclear molecular cause of the disease corresponding to the list of diseases selected by the solve-rd data interpretation force (principal investigator part of the team) * suspected genetic cause of the disease with negative exome reanalysis * healthy parents available for trio analysis exclusion criteria: * person not affiliated to a national health insurance scheme
surgical management of posterior malleolar fractures using the direct or indirect reduction techniques

Conditions: Posterior Malleolus Fractures

Summary: patients with a posterior malleolar fracture were recruited and assigned to the direct reduction (dr) group or the indirect reduction (ir) group. following reduction and fixation of the fracture, the quality of fracture reduction was evaluated in radiograph and ct images. functional outcome was evaluated at the last follow-up.

patients with a posterior malleolus fracture were recruited meeting the inclusion criteria of unstable and displaced posterior malleolar fractures requiring surgical management. patients with open fractures or pathological fractures were excluded. preoperative anteroposterior (ap), lateral, and mortise view radiographs as well as computed tomography (ct) scans were routinely obtained to evaluate the characteristic of the fracture. patients were then assigned to the direct reduction (dr) group or the indirect reduction (ir) group. following reduction and fixation of the fracture using the direct reduction technique or the indirect reduction technique, the quality of fracture reduction was evaluated in radiograph and ct images. functional outcome,including aofas score, ankle range of motion were evaluated at the last follow-up.

Eligibility criteria:
inclusion criteria: * unstable ankle fracture requiring surgical intervention * with posterior malleolar fracture exclusion criteria: * open fractures * pathological fractures
a multidisciplinary, multimodal bundled care approach to chronic pelvic pain

Conditions: Interstitial Cystitis

Summary: the goal of this clinical trial is to compare two different treatment patterns in patients with chronic bladder pain. the main questions the investigators are seeking to answer is if bladder pain improves before and after treatment using a painful bladder scale. the participant will have 5 visits to evaluate your symptoms with questionnaires, at least one procedural visit, and must participate in physical therapy and some kind of behavioral health therapy. this study will assess participant response to a bundled-care approach to chronic bladder pain both pre-and post intervention as well as compared to a group of participants receiving typical care.

objectives: the goals of this research program are to evaluate the patient-reported outcomes of a multimodal care bundle for patients presenting to a multidisciplinary chronic pelvic pain clinic compared to "usual care" in an urogynecology clinic. primary aim: to compare pre and post intervention self-evaluation of pain and function scores in women with chronic pain syndromes with a primary finding of urinary/bladder pain symptoms with or without levator spasm who undergo multi-disciplinary, bundled care compared with usual care in a urogynecology clinic setting. secondary aims: a) to identify and phenotype "non-responders" to a bundled approach to interstitial cystitis/painful bladder syndrome/chronic pelvic pain (ic/pbs/cpp). hypothesis: we hypothesize that a bundled, multidisciplinary care approach will significantly improve patient scores on validated outcomes questionnaires compared to usual care. methods: all treatment plans, medications, and procedures recommended for patients involved in this study are within the current standards of care for ic/pbs/cpp, regardless of treatment arm and are known to be safe interventions. study design: single center, randomized pre-post intervention/prospective cohort study32 of usual fpmrs care vs. multimodal, multidisciplinary care bundle (mmcb). setting: patients will be recruited from an outpatient urogynecology clinic. they will subsequently be randomized to a multidisciplinary chronic pelvic pain clinic at an alternate site vs. continuing usual outpatient care in urogynecology as above.

Eligibility criteria:
* inclusion criteria: * female patient 18 years of age or older * diagnosis of interstitial cystitis/painful bladder syndrome, scoring 6 points or higher on o'leary sant questionnaire * exclusion criteria: active pelvic or bladder infection within past 2 weeks * contraindications to medications or intervention therapeutics * inability to speak or read english * pelvic floor interventional procedure including bladder instillations 4 weeks prior to study recruitment * meets criteria for diagnostic laparoscopy * internal referral (to reduce severity bias) note: patients are not excluded for currently taking any medication on the treatment list. patients can be treated for uti during the study period.
hospital-based program for treatment of severe cardiopulmonary disease with inhaled nitric oxide

Conditions: Pulmonary Hypertension; Lung Disease; Sickle Cell Disease; Cardiac Transplant; Lung Transplant

Summary: the purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed inomax delivery in ambulatory, home-care patients. to understand patient needs, patients with a variety of underlying diseases will be included. safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events.

this study will help develop a comprehensive home care program using inomax delivery systems. this study will enroll a limited number of patients (5-7) from several disease categories in order to develop the experience with testing acute and chronic responsiveness to ino therapy. the following groups will be tested: 1. primary pulmonary hypertension (pph) 2. severe pulmonary hypertension due to congenital (anatomic) heart disease 3. pulmonary hypertension or severe impairment of gas exchange in infants and children with chronic lung disease 4. pulmonary hypertension or severe impairment of gas exchange due to severe chronic lung disease in adults 5. pulmonary hypertension or severe impairment of gas exchange in hematologic and transplant disorders - young children and adults with sickle cell disease, chronic lung disease after bone marrow transplant, cardiac transplant, or lung transplant

Eligibility criteria:
inclusion criteria: * patients with pulmonary arterial hypertension (pah) as defines by a mean pulmonary artery pressure (pap) of 25 mmhg or greater by cardiac catheterization within the previous 12 months and/or patients with chronic lung disease with severe impairment of gas exchange unresponsive to conventional medical management. * if patient is receiving prostacyclin infusion treatment it must have been started at least one month prior to starting ino therapy. patients will not be withdrawn from the study if started on other medications for treatment of pulmonary hypertension. * ability to establish a clinical investigator and a drug shipment site in the local area. exclusion criteria: * the principal investigator has determined that the patient and/or caregiver is/are unable to manage safe administration of home nitric oxide therapy and maintain appropriate drug accountability and storage. * women who are pregnant or nursing.
mindfulness to improve functional outcomes in patients with fibromyalgia or central sensitization

Conditions: Chronic Pain; Fibromyalgia; Central Sensitisation

Summary: the primary aim of the study will be to determine the feasibility of utilizing a web-based mindfulness program in adult patients with chronic pain with a diagnosis of fibromyalgia or central sensitization.

chronic pain has a substantial economic cost and rate of impairment. patients who suffer from fibromyalgia and other pain conditions leading to central sensitization have limited treatment options. the only medications currently approved by the food and drug administration (fda) for the treatment of fibromyalgia includes pregabalin, milnacipran and duloxetine. the international association for the study of pain (iasp) also recommends the implementation of an exercise program and cognitive behavioral therapy. a previous meta-analysis found weak evidence to support mindfulness-based stress reductions (mbsr) in fibromyalgia patients, however more robust clinical studies are needed. in the midst of an opioid crisis, mbsr provides a safer alternative for the treatment of chronic pain. unfortunately, an instructor lead mbsr program is both costly and largely unavailable in rural areas of the country. this web-based mindfulness program provides a treatment option for patients who would otherwise, not have access to alternative medicine therapies.

Eligibility criteria:
inclusion criteria: * age from 30-65 * patients with a diagnosis of fibromyalgia or central sensitization for greater than 6 months who are referred to the interventional pain clinic exclusion criteria: * patients on greater than 120 morphine equivalents per day * patients with untreated psychological illness * patients already enrolled in ongoing trials involving pain management and treatment interventions * patients currently undergoing treatment at the osher center for integrative health or patients with previous or current training in mindfulness.