Kornimate/medical-research-clean huggingface dataset:
prevalence and impact on quality of life of airway disease in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis; Airway Disease

Summary: the investigators assess the prevalence of airway disease associated with idiopathic pulmonary fibrosis in korea, and evaluate the effect of these airway diseases on the symptoms and quality of life of patients with idiopathic pulmonary fibrosis.

idiopathic pulmonary fibrosis (ipf) is defined as a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, and limited to the lungs. it is characterized by progressive worsening of dyspnea and lung function and is associated with a poor prognosis. the main symptoms of patients with ipf are dyspnea on exertion and a persistent dry cough or mildly productive cough. in many ipf patients, cough is often the first symptom, preceding dyspnea on exertion sometimes by years. it affects upwards of 70-85% of patients with ipf. chronic obstructive pulmonary disease (prevalence rate 4-18%) and asthma (prevalence rate 5.9-9.9%) are the airway disease whose main symptoms are also dyspnea and cough. to date, the effect of airway disease has not been well studied in patients with idiopathic pulmonary fibrosis, and the prevalence is unknown in korea. unlike idiopathic pulmonary fibrosis, airway disease is a treatable, modifiable disease, so treatment of these diseases may improve qol in ipf patients. therefore, this study's purpose is a. identify the prevalence of airway disease in ipf patients b. identify differences in qol and symptoms according to presence of airway disease c. identify the symptomatic improvement after active treatment for the airway diseases

Eligibility criteria:
inclusion criteria: * ipf patients exclusion criteria: * patients on systemic steroid * patients with acute exacerbation within the last 6 months * pft+bdr, mbpt contra-indication * spo2 \< 90%

Keywords: idiopathic pulmonary fibrosis airway disease
suture material for closure of hysterotomy

Conditions: Cesarean Section; Complications, Wound, Hematoma

Summary: retrospective chart review evaluating different suture types on surgical outcomes for cesarean delivery and vaginal birth after cesarean delivery outcomes when different sutures are used.

cesarean sections are one of the most common surgeries performed in the united states; approximately 1 out of 3 births are completed by cesarean delivery. in 2014, 1,284,551 cesarean deliveries were performed. unfortunately, even with this being a very common procedure some surgical topics have not been fully evaluated. one of these topics is the choice of suture for repair of the hysterotomy (uterine) incision. several suture materials are available, yet only polygatactin-910 and catgut have been evaluated in a single study. in this study, only surgery complications were evaluated. catgut was found to be associated with less risk of receiving a blood transfusion, otherwise no differences were found. one of the most common suture materials used at our institution is poliglecaprone 25, however no long term studies have been completed for this indication. in addition, no studies have evaluated the risk of uterine rupture with trial of labor after cesarean after using poliglecaprone 25 to repair the hysterotomy. this information could be very useful in counseling for patients. as the cesarean delivery rates continue to climb, information on appropriate technique for surgery are needed.

Eligibility criteria:
inclusion criteria: * pregnant women who underwent a cesarean delivery or vaginal birth after cesarean exclusion criteria: * unable to give consent
study evaluating the effect of corticosteroids on mylotarg® infusion-related adverse events in patients with leukemia

Conditions: Leukemia, Myelocytic, Acute; Infusions, Intravenous

Summary: the purpose of this study is to evaluate the effect of corticosteroids on the frequency and severity of mylotarg® infusion-related adverse events, to evaluate the effect of corticosteroids on the efficacy of mylotarg® induced complete response (cr) and complete response with incomplete platelet recovery (crp) at one-month post treatment.


Eligibility criteria:
inclusion criteria: * patients with cd33 positive, resistant or relapsed aml. * patients \> 18 years of age. * ecog performance status 0-2. exclusion criteria: * fever (\>38), chills or hypotension (systolic bp\<105mmhg) in the 48 hours preceding therapy. * use of corticosteroids, diphenhydramine or acetaminophen within 24 hours of enrollment. * participation in any other mylotarg® protocol.

Keywords: leukemia mylotarg safety adverse events
patient-reported outcomes for lemborexant in chinese participants with insomnia

Conditions: Insomnia

Summary: this study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(lem). patient self-evaluation reports and safety events will be collected at baseline and 4 visits during treatment.

this study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(lem). adult patients diagnosed with insomnia (including chronic and short-term insomnia) in the fifth edition of the diagnostic and statistical manual of mental disorders (dsm-5) and isi ≥10, clinically judged to need pharmacological treatment will be enrolled.patients will be administered with lem, and patient self-evaluation reports and safety events will be collected at baseline and each visit during treatment.

Eligibility criteria:
inclusion criteria: * adults (≥18 years) and agreed to participate in the study, regardless of gender. * diagnosed with insomnia according to dsm-5. * insomnia severity index (isi) score \>10. * subjects who can guarantee at least 7 hours of bedtime. * subjects signed informed consent forms after the prescription. exclusion criteria: * beings unable to understand the questionnaire. * phq-9 scores ≥ 20. * gad-7 scores ≥ 15. * suicidal thoughts/behaviors in the past one month or history of suicide, etc. * severe psychiatric disorder in the judgment of the investigator prevents completion of the trial. * history of serious illness, mental illness, medication use, and uncontrolled poor sleep habits that the investigator believes interfere with the study evaluation or the safety of the subject. * according to the precautions listed in the instructions, there are any contraindications or other conditions for which the use is prohibited (such as narcolepsy, severe liver damage, pregnant, nursing or pregnant women, etc.). * other conditions not considered appropriate for participation by clinicians.

Keywords: insomnia lemborexant
non invasive breath based acetone-meter- easy check

Conditions: Type 1 Diabetes

Summary: segment 1- this segment will include two main steps: step 1-calibration: during this step we plan to collect paired measurements of capillary blood glucose using reference method and data generated by the non invasive study device. samples will be obtained at specific time points during 4 hours: at fasting, and after consuming standard liquid meal at 60, 120, 180 and 240 minutes. at each time point capillary blood glucose will be measured using the invasive reference method. the paired reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. this model will convert the acetone values measured by study device to blood glucose values. step 2-validation: during this segment the second step of this segment we plan to evaluate the validity and reliability of the non-invasive breath-based glucometer compared to standard invasive reference glucometer. results will be compared using a clark error grid. segment 2- during this segment we plan to collect paired measurements of capillary blood glucose beta hydroxybutyrate using reference method and acetone values generated by the non invasive breath based study device. samples will be obtained at specific time points during 4 hours after overnight fasting, while basal insulin will be suspended, which is accepted to produce ketosis.


Eligibility criteria:
inclusion criteria: * signing an inform consent form * type 1 diabetes diagnosed at least 12 months prior to study inclusion * males aged \> 18 years old * 23\< bmi \< 28 (segment 1 only) * treatment with insulin pump (segment 2 only) * willing to perform all study related procedures exclusion criteria: * psychiatric disorder * patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease * patients who are not willing or are not capable of performing the protocol requirements * participating in another study that includes investigational drug or investigational equipment * patients who are under low carbohydrate diet * patients who are known as heavy alcohol drinkers

Keywords: glucose monitoring non-invasive glucometer self glucose monitoring
how diabetic patient are taken care in cardiology service actually?

Conditions: Diabetes

Summary: care of the diabetes is multidisciplinary with the involvment either private and hospital specialist


Eligibility criteria:
inclusion criteria: * evey patient admitted in cardiology department more than 24 hours * 18 years old and above * accepted to participate * patient treated by insuline and/or with oral antidiabetic treatment * type 2 diabetes exclusion criteria: * type 1 diabetes * patient admitted for angiography * iatrogenic hyperglycaemia

Keywords: cardiology diabetes
safety study of xl147 (sar245408), in combination with paclitaxel and carboplatin in adults with solid tumors

Conditions: Cancer; Non-Small Cell Lung Cancer; Endometrial Carcinoma; Ovarian Carcinoma

Summary: the purpose of this study is to evaluate the safety and tolerability of xl147 in combination with paclitaxel and carboplatin in adults with solid tumors. xl147 is a new chemical entity that inhibits pi3 kinase. inactivation of pi3k has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells. in clinical practice, the combination of paclitaxel and carboplatin is an accepted treatment regimen for various solid tumors, including ovarian cancer, endometrial cancer and non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of: * advanced solid tumor that is no longer responding to therapies or * advanced or recurrent endometrial carcinoma or * advanced or recurrent ovarian carcinoma or * unresectable (stage iiib or iv) nsclc * ecog performance status 0-1 (ecog status of 2 may be considered following discussion and agreement with sponsor) * adequate organ and bone marrow function as defined by hematological and serum chemistry limits * at least 18 years old * both men and women must practice adequate contraception * informed consent exclusion criteria: * restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with pi3k, akt, or mtor inhibitors, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin c, small-molecule kinase inhibitors, non-cytotoxic hormonal agents * known allergy or hypersensitivity to any of the components of the treatment formulations * taking oral corticosteroids chronically or \> 1 mg/day warfarin * not recovered from the toxic effects of prior therapy * history of diabetes mellitus. * uncontrolled intercurrent illness * pregnant or breastfeeding * congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study. * hiv positive * diagnosis of another malignancy may exclude subject from study

Keywords: solid tumors nsclc ovarian cancer endometrial cancer
comparison of a crossboss first versus standard wire escalation strategy for crossing coronary chronic total occlusion: the "crossboss first" trial

Conditions: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Summary: crossboss first is a single-blind randomized controlled trial that will randomize 246 patients undergoing clinically-indicated chronic total occlusion percutaneous coronary intervention, to upfront use of the crossboss catheter vs. antegrade guidewire escalation strategy the "crossboss first" study has two primary objectives. the primary efficacy objective is to compare the procedure time required to cross the cto or abort the procedure with a crossboss first vs. antegrade wire escalation strategy. the investigators hypothesize that upfront use of the crossboss catheter will be associated with shorter procedure time required for cto crossing compared with an antegrade wire escalation strategy. the primary safety objective is to compare the frequency of procedural major adverse cardiovascular events (mace) with upfront use of crossboss vs. a guidewire escalation strategy. the investigators hypothesize that upfront use of the crossboss catheter will be associated with similar incidence of mace compared with an antegrade wire escalation strategy. the secondary endpoints are: (1) technical and procedural success4-6; (2) total procedure time (defined as the interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter); (3) fluoroscopy time to cross the cto and total fluoroscopy time; (4) total air kerma radiation exposure; (5) total contrast volume; and (6) number of wires, microcatheters, balloons, and stents used.


Eligibility criteria:
inclusion criteria: * age 18 years or greater * willing and able to give informed consent * undergoing clinically-indicated cto pci with a planned antegrade crossing approach exclusion criteria: * plan for primary retrograde approach for cto crossing * ostial ctos (within 5 mm of vessel ostium)
assessment of the analgesic effects of pf-06273340 in healthy volunteers using evoked pain endpoints

Conditions: Healthy

Summary: this study will examine the activity of 2 different doses of pf-06273340 on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 18 and 55 years, inclusive. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg or clinical laboratory tests. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. * subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen
an open study of tipepidine hibenzate in adolescent patients with depression

Conditions: Depression; Adolescent

Summary: accumulating evidence suggests a role of g protein-coupled inwardly-rectifying potassium (girk) channel in the pathology of excitement of nerve, and the medicine with the action (like the tipepidine hibenzate) is expected as a new curative medicine of adolescent depression. the purpose of this research is to confirm the effect by carrying out the additional dosage of the tipepidine hibenzate to the adolescent patients with depression. if suggestion is obtained by this research about the effect on adolescent patients with depression of tipepidine hibenzate, it can contribute to development of the medical treatment of adolescent patients with depression.


Eligibility criteria:
\[inclusion criteria\] 1. depressive episode for icd-10 criteria. 2. patients are treated with antidepressants (ssri ; fluvoxamine, paroxetine, sertraline, escitalopram, snri ; milnacipran, duloxetine, nassa; mirtazapine), mood stabilizers (lithium, sodium valproate, carbamazepine, lamotrigine), atypical antipsychotics (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone) or not treated. 3. patients are stable for 4-weeks for medication. \[exclusion criteria\] 1. patients with a previous hypersensitivity to tipepidine hibenzate. 2. patients treated with typical antipsychotics and antidepressants except inclusion criteria 2. and mood stabilizers except inclusion criteria 2. 3. pregnant or breast-feeding women
the safety and efficacy of twp-101 in patients with advanced solid tumor

Conditions: Advanced Solid Tumor

Summary: this is a multi-center, phase ia/ib, open clinical study to evaluate the safety and efficacy of twp-101 in patients with advanced solid tumor. this study consists of two parts (part a and part b). part a was a dose escalation study, and part b was a dose expansion study.


Eligibility criteria:
inclusion criteria: * pathologically or cytologically confirmed advanced solid tumor that failed, couldn't tolerate or refused standard treatments; * ecog score 0 or 1; * at least 1 measurable lesion according to recist 1.1 exclusion criteria: * known hypersensitivity to any ingredient of twp-101; * receiving any anti-cancer drugs within 4 weeks; * history of serious systemic diseases; * history of serious autoimmune diseases; * pregnancy or lactating women.
pros following low-dose irradiation for osteoarthritis

Conditions: Osteoarthritis

Summary: the goal of this observational registry study is to collect data related to patient reported outcomes (pain, function, quality of life, toxicity) in osteoarthritis (oa) patients receiving standard of care radiation therapy (rt).

this is a single-institution, single-arm, prospective, observational study of patients with osteoarthritis who are being treated with standard of care radiation therapy (rt). the purpose of this non-interventional study is to systematically collect data related to patient reported outcomes (pain, function, quality of life, toxicity) with the goal of optimizing approaches to management with radiation therapy and clinical care during follow up. the primary endpoint of this study is a change in visual analog pain scale (vaps) at 3 months post radiation and a variety of secondary endpoints are aimed at assessing disease control, patient function, avoidance of invasive surgery, and toxicity. participants will complete patient-reported outcome surveys for pain and joint-specific functional assessment.

Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * established diagnosis of oa of at least 1 joint * inadequately controlled pain due to oa despite attempts with 2 or more other treatment modalities and visual analogue pain score of 4 or greater. * will undergo radiation as part of their standard of care for oa. * at least 55 years old * ability to read and speak english. exclusion criteria: * any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine ß-hcg results, obtained within 2 weeks of ct simulation for radiation planning, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses). * estimated life expectancy less than 6 months. * radiation treatment for shoulder oa * patient weight greater than 550lbs

Keywords: osteoarthritis radiation therapy
m1231 in participants with solid tumors

Conditions: Metastatic Solid Tumors; Esophageal Cancer; Non-Small Cell Lung Cancer

Summary: this study is to establish a safe and tolerable dose and to investigate pharmacokinetics and the first clinical efficacy signals of m1231 as a single agent in participants with solid tumors (part 1) and with metastatic non-small cell lung cancer (nsclc) and esophageal squamous cell carcinoma (part 2). dose escalation will be followed by the dose expansion once the maximum tolerated dose (mtd) or recommended dose for expansion (rde) has been defined.


Eligibility criteria:
inclusion criteria: for part 1 and 2: * the investigator reviews the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female with an early undetected pregnancy for part 1: * locally advanced or metastatic disease that is intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the investigator * participants with solid tumors expressing or likely to expressing egfr and muc1, including but not limited to lung cancer, squamous esophageal cancer, head and neck squamous cell carcinoma, breast cancer and ovarian cancer, should be prioritized for enrollment for part 2: * cohort a: participants must have progressed on at least 2 prior lines of therapy * cohort b: participants must have progressed on at least 1 prior line of platinum therapy and for microsatellite instability-high (msi-h) at least 1 prior line with pembrolizumab * eastern cooperative oncology group (ecog) performance status less than 1 * tumor accessible for biopsies and agreement to conduct fresh tumor biopsies at screening and before first dosing exclusion criteria: * participants not recovered from adverse events (ae) (less than or equal to grade 1) related to previous therapies (excluding grade 1 neuropathy and alopecia) * participant has a history of a second malignancy within 3 years before the date of enrollment * known brain metastasis * unstable angina, myocardial infarction, congestive heart failure or a coronary revascularization procedure within 180 days of study entry * cerebrovascular accident/stroke * diagnosis of fever within 1 week prior to study intervention administration * life expectancy of less than 4 months * steroid therapy for anti-neoplastic intent taken less than 7 days prior to the first dose of study intervention * major surgery within 4 weeks prior to start of study intervention * received growth factors (including erythropoietin (epo), darbepoetin, granulocyte-colony stimulating factor (g-csf), granulocyte macrophage-colony stimulating factor (gm-csf), and platelet stimulators or transfusions within 2 weeks prior to the first day of study intervention

Keywords: m1231 non-small cell lung cancer metastatic solid tumors esophageal cancer maximum tolerated dose pharmacokinetics
plantar forces mid-term after hemiarthroplasty with hemicap for hallux rigidus

Conditions: Hallux Rigidus

Summary: the purpose of this study is to examine variabel pressure gradients of the 1st toe, 2-5th toes and the metatarsal distal caput in patients who have had surgery with a partial proximal hemiarthroplasty in the 1st metatarsalphalangeal joint (mtp) between 2006-2014. also, to examine these variables and compare them to the totalt range of motion and pain, to find out if the measured pedobar pressure can be used identify the well treated patient and the poorly treated patient. the pedobar pressure gradients will be compared with a control group with healthy feet.


Eligibility criteria:
inclusion criteria: * patients who has hemicap 1. mtp joint. exclusion criteria: * patients who haad revision surgery, for example removal of hemicap and desis og 1. mtp joint.

Keywords: hemicap hallux rigidus