Kornimate/medical-research-clean huggingface dataset:
defining a standard set of value-based patient-centered outcomes for endometriosis

Conditions: Endometriosis

Summary: endometriosis is a chronic disease that affects one out of 10 women. endometriosis care is full of variation. recommendations for optimal management vary between clinician and centers. one way of dealing with this unwanted variation is the shift towards a value -based endometriosis care. value-based healthcare (vbhc) is a strategy focused on the optimization of the balance between outcomes that are important to patients and cost to achieve these outcomes. to do so, for a given condition it is important to define a standardized set of outcomes metrics allowing quality of care monitoring and comparison in order to optimize clinical practices and patient pathways. a common set of outcomes combining clinical outcomes (clinical reported outcome measures, croms) as well as quality of life and functional recovery indicators through patient reported outcome measures (proms). different standardized data sets have already been developed to measure outcomes in other pathologies, however a standardized set of outcome measurements have not yet been determined for endometriosis. the objective of this study is to determine a standard set of outcome measurements for endometriosis.


Eligibility criteria:
inclusion criteria: * profession: gynecologists, radiologist, psychologists, nurses and researchers having an expertise in the field of endometriosis * patient experts having an active role in an endometriosis patient association exclusion criteria: * retirement

Keywords: endometriosis delphi study patient reported outcome measures (proms) clinician reported outcome measures (croms)
combined effects of acute sleep restriction and moderate acceleration (+gz) on physiological and behavioral responses to high mental workload

Conditions: Sleep Deprivation

Summary: fighter pilots have to perform tasks requiring high mental workload during moderate-intensity acceleration phases (2 to 3g) that can last several minutes. when these accelerations are performed in the body axis (+gz), they induce a redistribution of blood flow in the lower limbs associated with a decrease in cerebral blood flow, partially compensated by activation of the sympathetic nervous system (baroreflex). the main hypothesis is that the effects of these prolonged accelerations, even of moderate intensity (\<+4gz), could impair pilots' ability to perform complex cognitive tasks, with potential consequences for flight safety and mission conduct. moreover, flight missions are often performed after sleep debt, which is known to induce cardiovascular responses, sympathetic nervous system activation and impaired mental performance. the secondary hypothesis is that sleep debt (3h of time spent in bed) may increase the impairment of cognitive performance during prolonged acceleration.


Eligibility criteria:
inclusion criteria: * healthy subject (male or female); * tobacco consumption \< 5 cigarettes per day or nicotine-free vapour; * regular physical activity (between 1 and 8 hours per week); * affiliated or entitled to a social security scheme; * having given their consent. exclusion criteria: * presenting an active medical pathology or a history \<6 months (cardiological, renal, hepatic, cutaneous, neurological, psychiatric...), or a significant deviation from normal values observed during questioning, clinical examination or electrocardiogram (ecg); * bmi \> 30 (cardiovascular risk factor); * have a medical contraindication to sporting activities; * taking a medical treatment; * habitual sleep duration \< 6 hours; * presenting a sleep disorder confirmed by questionnaire (pittsburgh sleep quality index questionnaire \> 5); * pregnant or breastfeeding * not covered by a health insurance plan;

Keywords: acceleration mental workload aerospace medicine
the effect of patient advocacy training on advocacy skills, ethical sensitivity, and patient safety culture in nurses

Conditions: Education

Summary: in this study, the aim is to evaluate the effects of patient advocacy training provided to nurses on their advocacy skills, ethical sensitivity, and patient safety culture level.

this research is a randomized controlled trial (rct) conducted to investigate the impact of patient advocacy training on nurses by evaluating its effectiveness in increasing nurses' ethical sensitivity and promoting a positive patient safety culture through bloom's taxonomy. this study, which will deeply examine the relationship between patient advocacy training, ethical sensitivity, and patient safety culture, aims to provide evidence-based insights that can inform nursing education, training programs, and healthcare policies, ultimately contributing to the improvement of patient outcomes and the overall quality of healthcare delivery.

Eligibility criteria:
inclusion criteria: employees who have no obstacles to participating in the training program exclusion criteria: having worked in the hospital for at least six months

Keywords: patient advocacy, ethics, patient safety
effectiveness of self-help for dually-diagnosed persons - 1

Conditions: Dual Diagnosis; Substance-Related Disorders; Mental Disorders

Summary: the purpose of this study is to determine the effectiveness of adding dual focus 12-step self-help groups to standard treatment to improve behavioral outcomes for patients dually diagnosed with substance abuse and psychiatric disorders.


Eligibility criteria:
inclusion criteria: admission to psychiatric day treatment program 18-64 years old exclusion criteria: did not understand or speak english, appeared intoxicated on drugs or alcohol, carried a diagnosis of mental retardation, were deemed actively psychotic by the clinic's intake coordinator, appeared unable to understand and give informed consent.

Keywords: 12 step groups self help psychiatric day treatment co-occurring disorders dual diagnosis
a 6-week study in asthmatic children aged 6 to <12 yrs comparing budesonide pmdi 160ug twice daily with placebo

Conditions: Asthma

Summary: this purpose of the study is to investigate if budesonide pmdi 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to \<12 years

phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pmdi 160 �g bid with placebo: a 6-week efficacy and safety study in children aged 6 to \<12 years with asthma

Eligibility criteria:
inclusion criteria: * has a documented clinical diagnosis of asthma for at least 6 months prior to visit 2 that has required daily inhaled corticosteroid in the low dose range or ltra as monotherapy for at least 30 days prior to visit 2. * has a morning clinic pre-bronchodilator fev1 measured at least 6 hours after the last dose of inhaled short acting beta agonist of greater than or equal to 70% and less than or equal to 95% of predicted normal * demonstrated reversibility of fev1 of ≥12% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist or has a documented reversibility of ≥ 12 % within 12 months prior to visit 2. exclusion criteria: * has been hospitalized at least once or required emergency treatment (was seen in the emergency room or had an urgent care visit) more than once for an asthma-related condition during the 6 months prior to visit 2 * has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to visit 2

Keywords: asthma, children, budesonide pmdi
an innovative non-invasive acoustic approach to detect and monitor cerebral vasospasm

Conditions: Sub Arachnoid Hemorrhage; Vasospasm

Summary: the lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic brain injury (tbi) limits the ability to detect and treat this phenomenon. surveillance transcranial doppler ultrasonography (tcd) is the main medical instrument that is utilized to monitor radiographic vasospasm following tbi, yet has its drawbacks such as inaccuracy, highly operator dependent and more. hs-1000 device, an investigational vasospasm detection device, has the potential to safely diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality for vasospasm measurement tool. we aim to evaluate the correlation between the collected and analyzed data from the hs-1000 device and the clinical findings from the tcd tests post-subarachnoid hemorrhage (sah) patients.


Eligibility criteria:
inclusion criteria: * sah patients with a tcd test * male or female in the age range of 18-85 years * expected survival \> 14 days exclusion criteria: * local infection in the ear. * pregnant/lactating women * known allergy or hypersensitivity to any of the test materials or contraindication to test materials * subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s) * any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition) note: as the trial does not affect the patient's management, there is no limitation regarding patient's medications, previous or post study procedures, etc. enrolled patients treatment will not change due to their participation in the trial
otx-15-002: a phase 3 study evaluating the safety and efficacy of otx-dp for the treatment of chronic allergic conjunctivitis

Conditions: Chronic Allergic Conjunctivitis

Summary: the objective of the study was to evaluate the efficacy and safety of otx-dp (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis


Eligibility criteria:
inclusion criteria: * has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen * has a positive bilateral cac reaction to a perennial allergen within minutes of instillation exclusion criteria: * history of refractive surgery (including lasik procedures) within the past 2 years * history of retinal detachment, diabetic retinopathy, or active retinal disease * presence of an active ocular infection or positive history of an ocular herpetic infection at any visit * use any of the disallowed medications during the period indicated * history of iop increase as a result of steroid treatment
behavioral telehealth in low-resource primary care settings for anxiety and depression in youth

Conditions: Depression, Anxiety

Summary: the goal of this clinical trial is to test a brief, behavioral telehealth treatment program (step-up) for depression and anxiety in youths (age 8-16 years old). youths and families will be recruited through participating community health centers and will be randomly assigned to either: (a) receive step-up care from providers at their health center or (b) be referred to care from local community mental health clinicians. youth and families will be interviewed before treatment starts, 16 weeks later, and 24 weeks later to assess how youth are feeling. the main question the study aims to answer is whether step-up improves youths functioning in daily life, anxiety symptoms, and depression symptoms. researchers will compare step-up to referral to community treatment-as-usual mental health services to see if step-up is more effective.


Eligibility criteria:
inclusion criteria: * youth is a patient in a participating community health center. * youths meet criteria for clinically significant anxiety and / or depression as indexed at baseline assessment by either: * research diagnosis of anxiety (social anxiety disorder, generalized anxiety disorder, separation anxiety disorder) and / or depressive disorder (major depressive disorder, persistent depressive disorder). * scores in the clinically elevated range on a standardized anxiety and / or depression symptom measure . * youth lives with a legal guardian (hereafter referred to as "parent") \>= 50% of the time who consents to study participation. * youth speaks english. * parent speaks english or spanish. exclusion criteria: * youth requires alternate treatment as indexed by: * current clinically significant post-traumatic stress disorder symptoms (meets diagnostic criteria in research interview and / or scores in the clinically elevated range on a standardized symptom measure) at baseline. * current suicidal ideation with plan at baseline and / or suicidal behavior within the last year. * current substance dependence at baseline. * experience of physical or sexual abuse within the six months prior to baseline. * parent /guardian does not identify anxiety and / or depression as a treatment priority at baseline. * youth is in an active, alternate psychosocial intervention for anxiety or depression that would be concurrent with study participation. * youth is on an unstable regimen of psychotropic medication (i.e., receives medication but has not been at a stable dose for at least 8 weeks, or if medication has been discontinued for less than 4 weeks) at baseline. * youth is receiving lithium or and anti-psychotic medication at baseline. * youth is placed in a special education program for greater than 50% of the school day and / or youth school placement is below the second-grade level at baseline. * youth is placed in foster care at baseline.
survey of cabozantinib tablets used to treat people with hepatocellular carcinoma

Conditions: Hepatocellular Cancer

Summary: this study is a survey in japan of cabozantinib tablets used to treat japanese people with a type of liver cancer called hepatocellular carcinoma. the study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. the main aim of the study is to check for side effects from cabozantinib. during the study, participants with hepatocellular carcinoma will take cabozantinib tablets according to their clinic's standard practice. the study doctors will check for side effects from cabozantinib for 12 months.


Eligibility criteria:
inclusion criteria: participants with unresectable hepatocellular carcinoma that has progressed after cancer chemotherapy (regardless of previous treatment history) exclusion criteria: participants who has a history of hypersensitivity to any component of cabozantinib.
preoperative inflammatory biomarkers and postoperative day 1 drain amylase value predict pancreatic fistula after pancreaticoduodenectomy

Conditions: Pancreatic Fistula; Pancreas Cancer; Inflammatory Response

Summary: particularly, pancreatic fistula is the most common and serious complication after pancreaticoduodenectomy (pd) and is reported in up to 40% of cases. the aim of this retrospective single-center study was to investigate the utility of the combination of preoperative inflammation biomarkers (pibs) with postoperative day 1 drains amylase (pod1-d.a.) levels in predicting grade c pancreatic fistula (pf).

data from a prospective collected database of 317 consecutive pds performed at the university campus bio-medico di roma during the years 2005-2019, have been retrospectively analyzed. local ethical committee approved the study. patients undergoing pd for periampullary neoplasms were included in the study. all patients underwent to pd with pancreaticojejunostomy reconstruction. two surgical drains were always placed at the end of the surgery. data regarding pibs, as full blood count including white blood cell (wbc) count, lymphocytes, neutrophils and platelets counts, neutrophil-to-lymphocyte ratio (nlr), derived neutrophil-to-lymphocyte ratio (d-nlr), platelet-to-lymphocyte ratio (plr) and pod1-d.a. levels were collected and positive predictive values (ppv) and negative predictive values (npv) were computed to investigate the probability to develop pf combining pibs and drains amylase values.

Eligibility criteria:
inclusion criteria: * patients underwent pancreaticoduodenectomy (pd) for periampullary neoplasms * patients underwent pd with pancreaticojejunostomy reconstruction. * patient with data of blood count in first postoperative day exclusion criteria: * none of the above criteria

Keywords: pancreatic fistula pancreatic anastomoses surgical drain management inflammatory biomarkers
added value of cone beam ct guidance to electromagnetic navigation bronchoscopy for the diagnosis of pulmonary nodule.

Conditions: Lung Cancer; Pulmonary Disease

Summary: a monocentric prospective and randomized trial aiming to compare the diagnostic yield and safety of electromagnetical-guided bronchoscopy (enb) procedures coupled to trans-bronchial lung cryobiopsies for the diagnosis of pulmonary nodule when performed either in a "standard" bronchoscopy suite or in a hybrid room with cbct guidance and the use of the crosscountry technique as required.


Eligibility criteria:
inclusion criteria: * pulmonary nodule of maximum 30mm of largest diameter * nodules can be either solid or subsolid (including ggo) without evidence of loco-regional or distant metastasis that could be biopsied, and no evidence for an infectious underlying disease. * a multidisciplinary discussion is performed for each case before considering its inclusion in the study in order to validate the indication of enb-guided biopsy. of note, any other endoscopic or trans-thoracic procedure should be tried before considering enb if it could achieve the diagnosis according to the investigator's judgment. exclusion criteria: * patient eligible for a direct surgical resection of the nodule * other exclusion criteria are a higher risk of bleeding (platelets count lower than 80,000/mm³, a systolic pulmonary arterial pressure (spap) higher than 45 mmhg at transthoracic ultrasonography, prothrombin time international normalized ratio - inr \>1.5, activated partial thromboplastin time - aptt \>35, uninterrupted anti-coagulant/anti-aggregant therapy), and the presence of any contraindication to general anesthesia as determined by the principal investigator (significant cardiac comorbidities, hypercapnia, severe hypoxia...). no strict limits for inclusion were applied regarding diffusing capacity for carbon monoxide (dlco), forced vital capacity (fvc), and forced expiratory volume in 1 second (fev1).
feasibility study of sentinel navigation surgery in early gastric cancer using fluorescence (senorita4)

Conditions: Early Gastric Cancer

Summary: senorita 1 trial showed laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer can increase the quality of life. (ryu kw et al. jco 2022) the radioactive isotope is difficult to use because of the hazard of radiation and shortage of materials. the aim of this study is to investigate whether laparoscopic sentinel lymph node biopsy and stomach-preserving surgery using only fluorescence is feasible.

1. injection of indocyanine green (icg) * endoscopic injection of 0.25mg/ml of icg on 4 sites around gastric cancer * identification of sentinel basin using fluorescence laparoscopy * laparoscopic sentinel basin dissection and identification of sentinel node at the back table 2. surgical considerations * conventional gastrectomy is performed if positive sentinel nodes are diagnosed in the frozen section. * if micrometastasis or isolated tumor cells in sentinel basin lymph nodes were diagnosed in permanent pathology, re-operation of conventional gastrectomy is not performed. * however, re-operation of conventional gastrectomy should be performed in case of macrometastasis, deep and lateral margin positive, more than pt2 lesion in the permanent pathology.

Eligibility criteria:
inclusion criteria: * single lesion of adenocarcinoma in preoperative endoscopic biopsy clinical stage t1n0 in the preoperative evaluation of endoscopy and computed tomography * tumor size: less than 3cm * location: 2cm far from the pylorus or cardia * aged 20 to 80 * ecog 0 or 1 * patient who signed the agreement * patient who is suspected to underwent laparoscopic or robotic gastrectomy exclusion criteria: * indication of endoscopic submucosal resection * inoperable due to poor cardiac, and pulmonary function * pregnant * having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen * diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer

Keywords: early gastric cancer sentinel lymph node fluorescence stomach-preserving surgery quality of life
trial comparing treatment with tiotropium inhalation capsules to combivent® inhalation aerosol in copd patients.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium handihaler® 18 mcg daily compared to combivent® mdi cfc inhalation aerosol 2 actuations qid in copd patients currently prescribed combivent® mdi.


Eligibility criteria:
inclusion criteria: * diagnosis of copd * age: \>= 40 years * current or ex-smoker with a \>= 10 pack-year smoking history * use of combivent® mdi for \>= 1 month prior to visit 1 spirometric criteria (determined at study visits): * post-bronchodilator fev1 \<= 70% (visit 1) * pre-bronchodilator fev1 \<= 65% of predicted and fev1/fvc \<= 70% (visit 2) exclusion criteria: * clinical history of asthma * history of thoracotomy with pulmonary resection * history of cf, alpha 1 antitrypsin deficiency or interstitial lung disease * daytime use of oxygen therapy for \> 1 hour per day or if unable to abstain from using oxygen during pfts * any respiratory tract infection or copd exacerbation in 6 weeks prior to visit 1 * recent history 6 months or less of mi * unstable or life-threatening cardiac arrhythmias * hospitalization for chf during past year * malignancy for which patient is receiving chemo or radiation therapy * pregnant or nursing women * known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose * use of spiriva® 3 months prior to visit 1 * symptomatic of prostatic hypertrophy or bladder neck obstruction * known narrow- angle glaucoma * participating in a pulmonary rehab program within 4 weeks of visit 1
ceftobiprole in the treatment of resistant staphylococcus aureus skin and skin structure infections

Conditions: Skin Diseases, Infectious; Skin Diseases, Bacterial; Staphylococcal Skin Infections

Summary: the purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections.

ceftobiprole medocaril is a cephalosporin antibiotic with anti-mrsa (methicillin-resistant staphylococcus aureus) activity. ceftobiprole medocaril is not yet approved for the treatment of complicated skin and skin structure infections. this is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with complicated skin and skin structure infections. the patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. the primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit. the patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).

Eligibility criteria:
inclusion criteria: * diagnosis of an infection consistent with complicated skin and skin structure infections. exclusion criteria: * known or suspected hypersensitivity to any study medication * any known or suspected condition or concurrent treatment contraindicated by the prescribing information * previous enrollment in this study * treatment with any investigational drug within 30 days before enrollment.

Keywords: complicated skin infections infectious skin diseases bacterial skin diseases staphylococcal skin infections cephalosporin