Kornimate/medical-research-clean huggingface dataset:
a study of the effect of a disease-specific migraine smart phone application (app) on participant care

Conditions: Migraine

Summary: the purpose of this study is to determine whether using a smart phone application to foster communication between study participants and their doctor will impact care. participants must have a history of migraine or have recently been prescribed a common medicine to treat migraine. the study will last about one year for each participant.


Eligibility criteria:
inclusion criteria: * have a diagnosis of migraine (icd10: g43.\*) since october 2015 or a record of being prescribed a triptan prior to study * have not been prescribed a preventive migraine medication within the past twelve months * have not visited a neurologist in the past year * have an upcoming visit with their atrium health primary care provider exclusion criteria: * do not own an ios or android smart phone with a data plan or are unwilling to install the app on their phone * are currently participating in a clinical trial involving an investigational drug * have previously used the app used in this study * are pregnant at the time of study entry * are not able to provide informed consent * cannot speak and read english fluently
metabolic efficiency with ranolazine for less ischemia in non-st elevation acute coronary syndromes

Conditions: Myocardial Ischemia

Summary: merlin-timi 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine during acute and long-term treatment in approximately 5,500 patients with non-st elevation acute coronary syndromes (acs) treated with standard therapy. the primary efficacy endpoint in merlin-timi 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-st elevation acs receiving standard therapy. the study also evaluates the safety of long-term treatment with ranolazine compared to placebo.

morrow da, scirica bm, karwatowska-prokopczuk e, skene a, mccabe ch, braunwald e; merlin-timi 36 investigators. evaluation of a novel anti-ischemic agent in acute coronary syndromes: design and rationale for the metabolic efficiency with ranolazine for less ischemia in non-st-elevation acute coronary syndromes (merlin)-timi 36 trial. am heart j. 2006 jun;151(6):1186.e1-9.

Eligibility criteria:
inclusion criteria: * hospitalized with non-st elevation acute coronary syndrome * ischemic symptoms (more than or equal to 5 minutes) at rest within 48 hours of study entry * at least one additional risk factor (e.g., elevated cardiac enzymes, st-depression, diabetes) exclusion criteria: * persistent acute st-segment elevation * successful revascularization during the qualifying hospitalization, prior to study entry * acute pulmonary edema, hypotension, or evidence of cardiogenic shock * clinically significant liver disease * end stage kidney disease requiring dialysis * concomitant use of drugs known to prolong the qt interval, or any digitalis drugs * use at study entry of drugs that are strong inhibitors of cytochrome p450 3a4 * pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control additional study entry criteria will be evaluated during initial screening.

Keywords: acute coronary syndrome myocardial infarction heart attack angina chest pain ischemia non-st elevation acute coronary syndrome
dupilumab for aspirin-exacerbated respiratory disease

Conditions: Aspirin-exacerbated Respiratory Disease

Summary: subjects with physician-diagnosed aspirin-exacerbated respiratory disease (aerd) who remain unacceptably symptomatic with a snot 22 score \> 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in aerd.

this is a single blind, placebo controlled trial to be conducted in adult patients with aerd to determine the efficacy and safety of dupilumab in treating symptoms of chronic rhinosinusitis. all subjects will be treated with the fda-approved and the commercially available dose for adult atopic dermatitis of 300 mg every 2 weeks administered subcutaneously, based on the observed efficacy and safety of this dose. in addition to atopic dermatitis, this dose has also been shown to be efficacious in adult asthma.15 patients will not be treated with a loading dose since other studies of dupilumab in asthma and chronic rhinosinusitis with nasal polyposis have not used a loading dose. there will be a one month screening period to determine the patient's eligibility and establish symptom control and baseline parameters. patients will continue their background medications for chronic rhinosinusitis with nasal polyposis and asthma. these medications may include nasal corticosteroids, nasal antihistamines, systemic antihistamines, leukotriene receptor antagonists, 5 lipo-oxygenase inhibitors, inhaled corticosteroids, long-acting beta agonists, and long acting muscarinic antagonists. these controller medications will not be dispensed or supplied by the sponsor.

Eligibility criteria:
inclusion criteria: 1. patients 18 years and older with a physician diagnosis of aspirin-exacerbated respiratory disease, as defined by a physician diagnosis of asthma, chronic rhinosinusitis with nasal polyposis, and a convincing clinical history of nsaid sensitivity 2. all subjects must have a snot 22 score ≥ 19 despite standard medical therapy. this minimal snot 22 was calculated by taking the range of snot 22 scores in studies of normal controls plus 8.9, which is the minimal clinically meaningful improvement in snot 22 score detected by patients. 3. able to understand and willingness to sign informed consent 4. able to comply with study procedures exclusion criteria: 1. patient \< 18 years of age 2. pregnancy or breast feeding 3. current tobacco use 4. significant, uncontrolled medical conditions 5. ongoing malignancy or history of malignancy in remission within the past 12 months 6. current treatment with immunosuppressive medications except chronic oral steroids 7. currently increasing dose of aeroallergen immunotherapy (patients on stable dose of aeroallergen immunotherapy will be allowed to participate) 8. treatment with omalizumab, reslizumab, mepolizumab within 4 months of enrollment
impact of hyperoxia and involvement of the immune system in diving accident

Conditions: Decompression Sickness

Summary: the impact of oxygen therapy in many pathologies has been subject of recent work, arguing both favourable and harmful effects. consequently, one can wonder about the influence of hyperoxic gas mixture during diving on the genesis of decompression sickness, but also about the systematic application of normobaric and hyperbaric oxygen in case of proven decompression sickness. in mammals, normoxic concentrations have been redefined at 20-100 mbars at the extracellular level and below 10 mbars in the mitochondria. under hyperbaric conditions, most of the oxygen being dissolved in blood plasma, a state of hyperoxia is established which escapes the usual delivery and regulation system represented by red blood cells. the results of our team's previous work suggest a specific effect of diving on the levels of circulating mitochondrial dna (mtdna), suggesting cellular destruction linked to hyperoxia/hyperbaria. in fact, our studies, carried out on both animals and human divers, have shown that diving accident leads to an increase in mtdna levels and an immune reaction through the mobilisation of leukocytes. the main objective of this study is to compare the influence of oxygen partial pressure levels on the evolution of clinical and biological variables during hyperbaric oxygen therapy sessions in healthy versus injured divers.


Eligibility criteria:
inclusion criteria: * healthy subject with no contraindications to diving or patient admitted to the hospital for suspicion of a diving accident or patient admitted to the hospital for hyperbaric oxygen therapy exclusion criteria: * contraindication to diving or contraindication to hyperbaric oxygen therapy
engage psychosocial intervention for cancer symptoms

Conditions: Advanced Breast Cancer; Advanced Prostate Cancer; Advanced Lung Cancer; Advanced Colorectal Carcinoma; Advanced Colorectal Adenocarcinoma

Summary: the goal of this clinical trial is to test the efficacy a new psychosocial symptom management intervention called engage for patients with stage iv breast, prostate, lung, or colorectal cancer. participants will be randomized to engage or a supportive care intervention. patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.

pain, fatigue, and distress are highly prevalent, co-occurring, and interfering symptoms in patients with advanced cancer. this trial will test a brief telehealth delivered psychosocial intervention called engage. engage aims to help patients decrease symptom interference and improve their quality of life. patients with stage iv cancer (breast, prostate, lung, or colorectal) and moderate-to-severe symptom interference will be randomized to engage or supportive care. patient-reported outcomes will be assessed at baseline, 2 months, and 4 months. aim 1 is to determine engage's efficacy for reducing symptom interference (primary outcome) at 2 months (primary endpoint). aim 2 is to determine engage's efficacy for improving secondary outcomes at 2 months. aim 3 is to test the maintenance of engage's effects on primary and secondary outcomes at 4 months. an exploratory aim seeks insights for future implementation efforts using mixed-methods data collection from patients, oncology providers, and clinic leaders.

Eligibility criteria:
inclusion criteria: * receiving cancer care at a duke cancer network (dcn) clinic * oncologist confirmed stage iv breast, prostate, lung, or colorectal cancer * worst pain, fatigue, or distress rated at \>/= 3 out of 10 in the past 7 days for at least 2 symptoms * md anderson symptom inventory (mdasi) interference with daily living scale average score of \>/= 3 out of 10 in the past 7 days * eastern cooperative oncology group (ecog) performance status of 2 or lower * at least 18 years old * ability to speak and read english * hearing and vision that allows for successful completion of telehealth sessions exclusion criteria: * significant cognitive impairment indicated in medical chart or during telephone screening on a mental status questionnaire * serious psychiatric condition (e.g., schizophrenia, suicidal intent) that would contraindicate safe study participation * participation in the last 6 months in cognitive-behavioral therapy or acceptance and commitment therapy for cancer symptom management * enrollment in hospice at screening

Keywords: acceptance and commitment therapy cognitive behavioral therapy pain management fatigue management symptom management telehealth psychosocial intervention
bronchoscopy assisted by electromagnetic navigation (emn) in the diagnosis of small pulmonary nodules

Conditions: Pulmonary Nodule Cm

Summary: due to ct screening, a lot of peripheral nodule not accessible to conventional endoscopy will be found. electromagnetic navigation directed bronchoscopy (enb) is a new technique needing validation. the primary aim of the study is to compare enb to radiologically guided bronchoscopy, considered the standard comparator.


Eligibility criteria:
inclusion criteria: * presence on a conventional or low dose chest ct at least one lung nodule 5-20 mm in its largest axis, of indeterminate nature; the nodule must be positive at pet-ct examination (in case of pet-ct negative, only follow-up is proposed) * the pulmonary nodule(s) must be known for less than 6 months * the nodule appearance can be solid, presents as a ground glass opacity with solid component or as pure ground glass opacity * availability for participating in the detailed follow-up of the protocol * signed informed consent. * age \> 18 years exclusion criteria: * nodules found in the context of an active infection or for whom, the clinical context and/or additional available investigations (serology, microbiological samplings, immune abnormalities) show that cancer diagnosis is unlikely * nodules found in the context of an active previously documented disease that can be associated with pulmonary nodules (anthracosilicosis, histoplasmosis, tuberculosis, autoimmune or rheumatoid diseases ...) * calcified nodule * anticoagulation therapy of any type that cannot be suspended for the duration of the investigation * respiratory failure, recent myocardial infarction (less than 3 months prior to the date of lung nodule screening), uncontrolled angina pectoris, congestive cardiac failure, cardiac arrhythmia, uncontrolled infectious disease or any other physical, biological or psychological factor which may prevent adherence to the study protocol or which may impair the patient's tolerance to the endoscopy and/or the general anaesthesia * presence of a implanted cardiac device (pace-maker, defibrillator, ...) * pregnant women

Keywords: lung nodule pet scanner bronchoscopy electromagnetic navigation
iron sucrose in non-dialysis dependent (ndd-ckd) pediatric patients

Conditions: Anemia

Summary: the primary objective of this study is to assess the pharmacokinetics of venofer (iron sucrose injection) in ndd-ckd pediatric patients.


Eligibility criteria:
inclusion criteria: * age \> or = 12 to \< or = 16 years * parent and/or legal guardian able to give informed consent * subject able to give written assent for participating in the study * ndd-ckd defined as: kidney damage for 3 months or longer, or gfr \< 60 for 3 months or longer * hemoglobin indicative of anemia * ferritin indicative of iron deficiency anemia * if appropriate, subject must be willing to use an accepted form of birth control from time of screening through the follow-up period exclusion criteria: * known history of hypersensitivity to any component of venofer * parenteral iron within 14 days of the screening visit * dialysis dependent-ckd * chronic or serious active infection * pregnancy or lactation * subjects with causes of iron deficiency anemia other than ckd * blood transfusion within the last month or anticipated during the study * body weight \< 55 pounds * received an investigational drug within 30 days before screening
open label study to assess the efficacy and safety of akb-9778 in subjects with macular edema due to rvo

Conditions: Retinal Vein Occlusion

Summary: phase 2a open-label study to assess the efficacy and safety of subcutaneous 15mg akb-9778 administered twice daily for 84 days in subjects with macular edema due to rvo.

subjects will participate in the study for up to 168 days. up to 20 subjects will be enrolled in the study. subjects will self-administer study medication as subcutaneous (sc) injections in the abdomen (preferably) twice per day; the first dose each day should be administered in the morning and the evening dose should be administered within 8 to 16 hours after the morning dose. safety assessments will be conducted at each study visit during treatment and aes will be collected throughout the treatment period and during the 56-days observation period visits.

Eligibility criteria:
the following is a abbreviated list of inclusion criteria: * definite retinal thickening due to rvo involving the central macula based on investigator's clinical evaluation and demonstrated by sdoct. * mean central subfield thickness of at least 300 µm by sdoct with presence of intraretinal fluid * etdrs bcva letter score ≤ 76 and ≥ 24. * decrease in vision determined to be primarily the result of macular dema due to rvo and not due to other causes. the following is a abbreviated list of exclusion criteria: * macular edema is considered to be due to a cause other than rvo * any other ocular disease that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), retinal inflammatory, infectious disease, or primary open-angle glaucoma. * high myopia (-8 diopter or more correction). * history of idiopathic or autoimmune uveitis. * history of any ocular surgery within 3 months prior to day 1. * history of panretinal scatter photocoagulation (prp) or focal laser within 3 months prior to day 1. * history of prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to day 1 (e.g., triamcinolone). * history of prior treatment with intravitreal anti-vegf treatment within 16 weeks prior to day 1.
long-term safety and efficacy follow-up study of pneumostem® in patients who completed pneumostem® phase-i study

Conditions: Bronchopulmonary Dysplasia; Respiratory Tract Infections; Premature Birth of Newborn

Summary: this is a 5-year long-term follow-up study of open label, single-center, phase i clinical trial to evaluate the safety and efficacy of pneumostem® in premature infants with bronchopulmonary dysplasia.

bronchopulmonary dysplasia (bpd) is the most common cause of death for prematurely born babies with low birth weights. in addition, many children who recover from this disease suffer from various complications such as prolonged hospitalization, pulmonary hypertension, and failure to thrive. it has been reported that bone marrow-derived mesenchymal stem cells (bm-msc) can differentiate into pulmonary epithelial and pulmonary endothelial cells. some animal studies showed that bm-mscs differentiate into bronchial cells and type 2 pneumocytes in rats with pneumonia and improve the fibrosis that occur after administration of bleomycin. based on the findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged lung as well as bpd that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes, and so on. pneumostem® consists of human umbilical cord blood-derived mesenchymal stem cells and is intended to treat bpd in premature infants. the purpose of the study is to evaluate 3-5 year long term safety and efficacy in patients who completed the earlier part of the phase i clinical trial of pneumostem®.

Eligibility criteria:
inclusion criteria: * all infants who were enrolled in the 2-year follow-up study (nct01632475) of phase 1 clinical trial for the safety and efficacy evaluations of pneumostem® treatment in premature infants with bronchopulmonary dysplasia * infants with a written consent form signed by a parent or legal guardian exclusion criteria: -infants whose parent or legal guardian does not consent to participate in this follow-up study

Keywords: human umbilical cord blood-derived mesenchymal stem cells bronchopulmonary dysplasia respiratory tract infection premature infants
safety and efficacy of the olympus cade system in real-time colonoscopy

Conditions: Colorectal Cancer

Summary: this is a prospective, multicenter, randomized trial to assess the safety and efficacy of the olympus endoscopy computer-aided detection (cade) system, oip-1, in the detection of colorectal neoplasia's during real-time colonoscopy. the aim of this system is to improve physician performance in the detection of potential mucosal abnormalities during colonoscopy performed for primary colorectal cancer screening or postpolypectomy surveillance.

this study aims to provide insight into whether the application of artificial intelligence (olympus endoscopy computer-aided detection (cade) system) increases the detection rate of adenomatous polyps in screening and / or surveillance colonoscopy procedures.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. 45-80 years 3. undergoing colonoscopy for primary crc screening or postpolypectomy surveillance exclusion criteria: 1. lack of informed written consent 2. history of crc or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (fap) 3. prior failed colonoscopy * multiple historic prior failed colonoscopy due to poor bowel preparation or * a single prior failed colonoscopy due to reasons other than poor bowel preparation 4. biopsy/anesthesia/sedation contraindications 5. history of radio- and/or chemotherapy 6. concurrent participation in another competing clinical study

Keywords: ai (artificial intelligence) cade (endoscopy computer aided detection)
predicting factors for the outcome of surgical treatment for patellar instability

Conditions: Patellar Dislocation

Summary: the purpose of the study is: 1. to analyze the success of operative stabilization of the patellar joint with the reconstruction of the medial patellofemoral ligament (mpfl) in terms of the subjective status of the knee, the general quality of life, and physical activity 2. to study the influence of specific preoperative (demographic and anamnestic data of the patient, radiological parameters of the knee joint) and intra-operative factors (place of femoral insertion of mpfl graft, patella height, degree of damage to the cartilaginous surfaces of the knee joint) on the subjective outcome of surgical treatment.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * surgical intervention with mpfl reconstruction * with or without tibial tuberosity transposition (ttt). exclusion criteria: * trochleoplasty, * corrective knee osteotomy * reparative cartilage treatment * reconstruction of other knee ligaments * meniscus repair * movement impairments * plegia * paresis * neuromuscular diseases * participation rejection * rejection to complete the control questionnaires * lack of understanding of the slovenian language

Keywords: medial patello femoral ligament patellar instability reconstruction predicting factors
cyclophosphamide for acute exacerbation of idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: acute exacerbation of idiopathic pulmonary fibrosis (ae-ipf) is a major event of ipf with an annual incidence between 5 and 10% and is responsible for the death of one third of ipf patients. when ae-ipf occurs, it is associated with poor survival with an overall mortality at 3 months upper of 50%. to date, no treatment has been proved to be effective in ae-ipf but the efficacy of cyclophosphamide (cyc) on survival has been suggested, mainly by retrospective series and needs to be confirmed. this confirmation is mandatory to improve prognosis of ae-ipf but also to avoid unsuspected deleterious effect as it as been shown with immunosuppressor in stable ipf.

acute exacerbation of idiopathic pulmonary fibrosis (ae-ipf) is a major event of ipf with an annual incidence between 5 and 10% and is responsible for the death of one third of ipf patients. when ae-ipf occurs, it is associated with poor survival with an overall mortality at 3 months upper of 50%. to date, no treatment has been proved to be effective in ae-ipf but the efficacy of cyc on survival has been suggested, mainly by retrospective series and needs to be confirmed. this confirmation is mandatory to improve prognosis of ae-ipf but also to avoid unsuspected deleterious effect as it as been shown with immunosuppressor in stable ipf.

Eligibility criteria:
inclusion criteria : * ≥18 years of age * definite or probable ipf diagnosis defined on 2011 international recommendations * definite or suspicion of ae defined by ipfnet criteria after exclusion of alternative diagnosis of acute worsening. * efficient contraceptive method within 1 month for women and 3 months for men after the last dose of treatment * affiliation to the social security * able to understand and sign a written informed consent form exclusion criteria: * identified etiology for acute worsening (i.e. infectious disease) * known hypersensitivity or contra-indication to cyc or to any component of the study treatment * patient on mechanical ventilation * active bacterial, viral, fungal or parasitic infection * active cancer * patient on a lung transplantation waiting list * treatment with cyc in the last 12 months * patient participating to another clinical trial * pregnancy or lactation