Kornimate/medical-research-clean huggingface dataset:
safety of tiotropium + olodaterol in chronic obstructive pulmonary disease (copd) patients in taiwan: a non-interventional study based on the taiwan national health insurance (nhi) data

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the aim of this real world study is to assess the safety profile of tiotropium/olodaterol (tio/olo).


Eligibility criteria:
patients treated with tio+olo: inclusion criteria: 1. at least one prescription for tio+olo (fixed dose combination (fdc) or free combination) as a new initiation between 1st january 2014 and 31st december 2019. 2. aged ≥ 40 years on the index date. 3. at least one diagnosis of copd at any time prior to or on the index date. 4. at least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs. 5. at least one record in the health insurance system database. exclusion criteria: 1. any use of tio+olo in free or fixed form within one year prior to the index date. 2. individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date. patients using other long-acting β2-agonists/long-acting muscarinic antagonists (lama/labas): inclusion criteria: 1. at least one prescription for lama+laba (fdc or free combination) other than tio/olo as a new initiation between 1st january 2014 and 31st december 2019. 2. aged ≥ 40 years on the index date. 3. at least one diagnosis of copd at any time prior to or on the index date- 4. at least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs. 5. at least one record in the health insurance system database. exclusion criteria: 1. any use of lama+laba in free or fixed form for one year prior to the index date. 2. individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.
lateral ridge augmentation using autogenous bone blocks or xenogenic bone block grafts loaded with recombinant human bone morphogenic protein 2

Conditions: Missing Teeth

Summary: since there are no clinical studies available comparing the gold standard (autogenous bone graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded with rhbmp-2 in combination with a collagen membrane for localized ridge augmentation, the present exploratory study has been designed. the aim of the present study is therefore to test whether or not the application of a xenogenic bone block loaded with rhbmp-2 will results in clinically, radiographically and histologically similar outcomes as the gold standard (autogenous bone block) for the regeneration of chronic ridge defects. the investigators expect that there is no difference in bone quantity and quality between the two methods and that the use of the test treatment will be more user and patient friendly according to the patient perception/acceptance since no second surgical site will be necessary as well as cause less complications.


Eligibility criteria:
inclusion criteria: * requiring implant therapy for the reconstruction of 1 to 4 missing teeth * revealing insufficient bone volume for implant placement (cases where less than 50% of the implant surface would be surrounded by native bone) requiring bone augmentation procedure exclusion criteria: * medication with a contraindication for implant therapy * previous administration of inductos * skeletal immaturity * any active malignancy or patient undergoing treatment for a malignancy * an active infection at the operative site * persistent compartment syndrome or neurovascular residua of compartment syndrome * pathological fractures such as those observed in (but not limited to) paget's disease or in metastatic bone * contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, * contraindications on ethical grounds, * pregnancy, * intention to become pregnant during the course of the study, * breast feeding, * treatment with other investigational products, * other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc), * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject, * participation in another study with investigational drug within the 30 days preceding and during the present study, * previous enrolment into the current study, * enrolment of the investigator, his/her family members, employees and other dependent persons, * patients where autogenous bone cannot be harvested.
tsk (tryptophan - serotonin - kynurenine) biomarkers assessment in stroke

Conditions: Cerebral Infarction

Summary: single-center, prospective, descriptive and biomedical research with controls, without health product. depression is the second risk factor for stroke as tobacco smoking following hypertension. peripheral abnormalities in serotonin parameters were described in depression and tobacco smoking. the investigators hypothesized dysregulations in pathways of serotonin (5-ht), which has notably complex vasomotor effects and of kynurenine which could have cognitive dysfunction effects. the aim of this study is to evaluate simultaneously the involvement of serotonin and kynurenine pathways parameters in patients suffering from a cerebral infarction shortly after the onset (less than 4 hours and a half), within a 2 days follow-up (day 1 and day 2) and 3 months after the cerebral infarction.

tryptophan (trp), an essential aminoacid, is metabolized in the serotonin (5-ht) or in the kynurenine (kyn) pathway. serotonin is catabolized to 5-hiaa (5-hydroxyindole amino acid) by monoamine oxidase a (maoa). the trp to kyn transformation is regulated by indoleamine 2,3-dioxygenase (ido). the primary objective was the measurements of serotonin and kynurenine pathways parameters which were performed in blood and urine samples using different hplc techniques and of serotonin transporters and receptors which were determined in blood platelets. the results in patients were compared to those measured in controls matched for age, gender, tobacco consumption and season of inclusion. the secondary objective was to evaluate the potential relationships between these 5-ht and kyn pathways biomarkers concentrations, maoa and ido enzymatic activations and clinical outcome and criteria.

Eligibility criteria:
study population : patients who had positive mri diagnosis of cerebral infarction less than 4.30 hours after the clinical onset. experimental group : inclusion criteria: * age ≥ 18 ans * cerebral infarction with a medical care to emergencies less than 4.30 hours after the symptoms onset. * written informed consent signed by the patient, or by a trusted person then by the patient himself if permitted by his condition. exclusion criteria: * cerebral infarction with a medical care to emergencies more than 4.30 hours after the symptoms onset. * patient with subarachnoid haemorrhage, cerebral hematoma. * pregnant woman * patient under guardianship or trusteeship, or safeguard justice. control group : * matching criteria for age, gender, tobacco smoking, inclusion season
a study of duvelisib in combination with rituximab or obinutuzumab in subjects with previously untreated cd20+ follicular lymphoma (contempo)

Conditions: CD20+ Follicular Lymphoma

Summary: a two-arm, phase 1b/2 study of duvelisib administered in combination with rituximab or obinutuzumab in subjects with previously untreated cd20+ follicular lymphoma.

this is a two-arm, open-label, phase 1b/2 trial designed to evaluate the safety and efficacy of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in subjects with previously untreated cd20+ fl. the study will be conducted in two parts, a safety lead-in (part 1) followed by a randomized, 2-stage design in part 2. each treatment arm will be assessed independently for dose limiting toxicity (dlt) within part 1.

Eligibility criteria:
inclusion criteria: * diagnosis of cd20+, follicular lymphoma that has not been treated * cd20-immunophenotyping of tumor to document b-cell follicular lymphoma * stage ii disease with bulky disease (≥ 7cm lesion), stage iii, or stage iv disease * disease that requires treatment based on the investigator's opinion (e.g., meets gelf criteria) * at least one measurable lesion that is \> 1.5 cm in at least one dimension * eastern cooperative oncology group (ecog) performance status \ =60%) exclusion criteria: * received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy. * clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma * severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs * prior allogeneic hematopoietic stem cell transplant * prior, current or chronic hepatitis b or hepatitis c infection * human immunodeficiency virus (hiv) infection or human t cell lymphotropic virus 1 (htlv-1) infection

Keywords: follicular lymphoma previously untreated
right-sided colon tumor, laparoscopic versus open surgery, in an eras protocol

Conditions: Colon Tumor

Summary: register study. patients who had been operated for right-sided colon tumor or benign adenoids between year 2011 to 2012. the study compare open surgery with laparoscopic surgery in an eras (enhanced recovery after surgery) protocol. hypothesis: operation of right-sided colon tumor and large benign adenoids, a better selection of patients for open or laparoscopic surgery can improve short term results.


Eligibility criteria:
inclusion criteria: * right-sided colon tumor or large benign adenoids exclusion criteria: * none
lucrin® depot efficacy and safety monitoring study in patients with advanced prostate cancer and lower urinary tract symptoms (luts)

Conditions: Advanced Prostate Cancer; Lower Urinary Tract Symptoms

Summary: the purpose of the study is to determine the influence of gnrh (gonadotropin releasing hormone) analogue - lucrin depot 11.25 mg (lucrin depot 3.75mg - in ukraine) administration on intensity of lower urinary tract symptoms (luts) in patients with diagnosed locally advanced and/or metastatic prostate cancer and luts.

the remaining target is: - to assess the intensity of luts in polish and ukrainian patients with locally advanced and metastatic prostate cancer, previously untreated with hormonal therapy

Eligibility criteria:
inclusion criteria: * age \> 50 years * locally advanced (t3-t4) and/or metastatic (n+/m+) hormone-sensitive prostate cancer, confirmed by histological examination * presence of lower urinary tract symptoms (luts)-ipss \>0 * treatment with lucrin® depot is the routine therapy in the patient. the decision as to lucrin® depot choice will not be associated with patient's participation in the study, but will result from the best medical knowledge and practice. * until inclusion into pmos the patient has not been treated with gnrh analogue. * the patient, before inclusion into the study, has not been treated by surgery (radical prostatectomy). exclusion criteria: * patients will not be included into the study if any contraindications to treatment with lucrin® depot exist, or if there are other treatment options which, according to the present medical knowledge, are potentially more beneficial for the patient. * physician or patient can stop treatment at any moment, if any indications or reasons exist.

Keywords: prostate cancer lower urinary tract symptoms hormonotherapy lhrh analogue androgen deprivation therapy (adt)
blood levels of abacavir in hiv infected adolescents

Conditions: HIV Infections

Summary: the way abacavir (abc) behaves in the body differs between children and adults, but little is known about abc in adolescents. it is unclear if adult doses of abc are appropriate for adolescents. the purpose of this study is to determine the blood levels of abc in hiv infected adolescents who are on abc-containing regimens.

abc is approved for the treatment of hiv in adults and children, but it is unclear if currently recommended abc doses are appropriate for adolescents. previous data suggest abc clearance in children is about twice that found in adults, but limited data exist on the pharmacokinetics of abc in adolescents. this study will evaluate the 8-hour pharmacokinetics of abc in hiv infected adolescents who are currently on abc-containing treatment regimens. there will be two groups in this study. group 1 participants will be 13 to 17 years old. group 2 participants will be 18 to 25 years old. all participants will receive a 300 mg dose of abc as either a single-agent tablet or a combination tablet of abc, lamivudine, and zidovudine (whichever they are currently taking). participants will have a medical history assessment and a physical exam at screening and study entry. participants will also be asked about adherence to their abc-containing regimen at study entry. during the 8-hour drug level study, blood collection for pharmacokinetic analysis will occur prior to taking abc, and at 0.5, 1, 2, 3, 4, 6, and 8 hours after taking abc.

Eligibility criteria:
inclusion criteria: * hiv-1 infected * cd4 count greater than 100 cells/mm3 * viral load less than 100,000 copies/ml * have taken an abacavir-containing regimen for at least 8 weeks prior to study entry * weight more than 83 lbs (37.5 kg) * ability and willingness to swallow study medications * consent of parent or guardian, if applicable exclusion criteria: * any grade 3 or greater toxicity within 14 days prior to study entry * participation in pactg p1018 * cdc category c opportunistic infections or hiv-1 associated cancer requiring drug therapy at the time of study enrollment * treatment with immune modulators, including interleukin-2 or intravenous gamma globulin, within 30 days of study entry * received therapeutic vaccines or any hiv-1 vaccine given for primary prevention within 30 days of study entry * surgical or medical problem affecting gastrointestinal motility or absorption (e.g., ileus, ulcerative colitis) or liver function * history of chronic alcohol use * any clinically significant disease other than hiv-1 infection that, in the investigator's opinion, would represent an increased risk for the participant or compromise the outcome of the study * chemotherapy for active cancer * pregnancy or breastfeeding

Keywords: treatment experienced
aortic stenosis associated left ventricular remodeling - an investigation of genetic and gender specific differences in 170 patients undergoing aortic valve replacement surgery

Conditions: Aortic Valve Stenosis

Summary: the goal of this study is to investigate the genetic and gender specific differences, in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis. patients referred for surgical aorticvalve replacement will be offered to participarte in the study. the main questions the study aims to answer are: 1. low-gradient aortic stenosis is associated with differences in valvular concentration of the genes that code for mast-cell chymase, angiotensin-ii, ace, ace2 and angiotensin receptor 1 and 2. 2. low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system. 3. gender differences in lv remodelling associates with different levels of sexual hormones. patients participating in the study will be asked to undergo: * cardiac ultrasound, mr- and ct-scan prior to surgery * blooddraw prior to surgery. * heartmuscle biopsy during surgery * cardiac mr-scan 1 year after surgery.


Eligibility criteria:
inclusion criteria: 1. severe as (estimated by the local heart team, aortic valve area\<1cm2) referred for avr at the cardiology department at odense university hospital 2. age \> 18 years 3. signed informed consent exclusion criteria: 1. bicuspid aortic valve. 2. lv systolic dysfunction (lvef\<50%). 3. patients with concomitant moderate-severe aortic valve regurgitation. 4. concomitant moderate-severe mitral valve regurgitation. 5. moderate to severe nephropathy (s-creatinine \>200 mmol/l) 6. unwilling to participate in the study. 7. claustrophobia. 8. permanent cardiac devices (pacemaker and icd)

Keywords: low flow low gradient aortic valve stenosis
knee injury decision

Conditions: Bone Fracture; Knee Trauma

Summary: at this time, there is no standardization for knee trauma care in children. each physician is free to resort or not to radiography to verify or dispel bone fracture, depending on radiographic device availability. this decision is based on trauma severity, clinical features, and physician experience. knee traumatisms are a common reason of consultation. in emergency departments, radiographic use is widespread for those traumatisms, but not in private practice. most of those knee traumatisms includes soft tissue lesion, for which radiography gives no details. yet, radiography exposes bone fracture which may require a specific orthopaedic care. then, it seems beneficial to highlight simple and reproducible clinical criteria in order to identify severe knee traumatisms, requiring radiography to assess bone fracture. those criteria should have a sensibility close to 1, and the highest specificity. such criteria could significantly decrease the number of radiography thus irradiation, emergencies waiting time, and consultation expenses without missing bone fracture. ottawa knee rules for adults are: age 55 years older, tenderness at head of fibula, isolated tenderness of patella inability to flex to 90°, inability to bear weight on 4 steps both immediately and in the emergency department. presence of one of those criteria required front and profile radiography to assess bone fracture. however, few studies have been conducted among children, and they do not confirm the use of those criteria targeting fracture screening. data are contradictory and they do not allow concluding that such criteria could be of benefit for children. moreover, studies only consider adults clinical criteria. this study would be the first to implement specific paediatric criteria, which make this study original.


Eligibility criteria:
inclusion criteria: * age range from 1 to 17 years old included * knee traumatism (distal third of femur and proximal third of tibia/fibula) * traumatism not older than 7 days exclusion criteria: * isolated knee wound * loss of awareness * paraplegia

Keywords: fracture children knee clinical criteria decision making
the analysis of heart rate variability with 24hrs holter ecg and serum cardiac fibrosis markers in critical illness patients who are with cardiogenic shock, with ecmo or iabp support, or with apach ii score >25)

Conditions: Cardiogenic Shock,; With ECMO or IABP Support,; With APACH II Score >25)

Summary: the study is to show the prognostic factor of hrv parameter and cardiac fibrosis markers in critical illness patients

the analysis of heart rate variability with 24hrs holter ecg and serum cardiac fibrosis markers in critical illness patients who are with cardiogenic shock, with ecmo or iabp support, or with apach ii score \>25)

Eligibility criteria:
inclusion criteria: * critical illness patients who are with cardiogenic shock, with ecmo or iabp support, or with apach ii score \>25) exclusion criteria: * pacemaker rhythm, not sign the permit

Keywords: ecmo apach ii score
clinical comparison of topical application of alvogyl versus hyaluronic-acid gel in management of pain and palatal wound healing

Conditions: Wound Healing

Summary: the aim of the study is to evaluate the effect of application of alvogyl versus hyaluronic acid in decreasing postoperative pain and promoting healing in the palatal wound following the free gingival graft procedure

postoperative pain and bleeding are the most common complications after palatal graft harvesting, also postsurgical swelling have been reported. although hemostatic agents, mechanical barriers, bioactive materials, antibacterial and antiseptic agents and herbal products have been found effective in preventing such complications, an ideal support could not be specified for this purpose. further, undesired side effects such as delayed wound healing/foreign body reaction have been reported . no gold standard has been identified, thus there is a need for further investigations aiming to reach the best possible treatment modality for pain relief and prevention of reported complications following harvesting of palatal graft .

Eligibility criteria:
inclusion criteria: * patients with mucogingival defects scheduled for free gingival graft * age from 18 years up to 60 * medically healthy patient exclusion criteria: * systemic diseases that may be a contraindication for any surgeries. * loss of maxillary premolars and molars. * pregnancy or lactation * smoking
subfoveal choroidal thickness and visual acuity after intravitreal injection of ranibizumab in diabetic retinopathy

Conditions: Subfoveal Choroidal Thickness; Intravitreal; Ranibizumab; Visual Acuity; Diabetic Retinopathy

Summary: the aim of this study is to compare subfoveal choroidal thickness (sfct) and the visual status before and after intravitreal injection of ranibizumab in diabetic macular edema (dme) with the use of 3d-oct by enhanced depth spectral-domain imaging (edi-oct) with fixating other factors.

diabetes is a metabolic disorder affecting the ocular vasculature. although the principal posterior segment changes in diabetes usually occur in the retinal vasculature, additional changes are also observed in the choroid which provides an important blood supply to the outer retina. diabetic choroidopathy involves choroidal abnormalities occurring in diabetic patients and may participate in mechanisms that lead to the decrease of visual acuity. several studies demonstrated the possibility of imaging of the choroid using spectral-domain oct. many studies investigated variation in the choroidal thickness (ct) occurring with changes in age and axial length, or in different ocular diseases, diabetic macular edema (dme) is a major cause of visual loss in diabetic patients. oct (optical coherence tomography) is a non-invasive imaging technique, that was used to obtain a high definition segments of retina. lately, edi (enhanced depth imaging) spectral-domain oct has been explained. (edi) program routinely captures a cross sectional picture with the choroid near the zero delay line to enhance sensitivity on the external edge of the choroid. functional imaging findings also presented a decrease in choroidal flow of the blood in eyes with diabetic retinopathy. the current purpose of (edi-oct), which employing the enhanced depth of field from the inverted picture by locating the oct device near to the eye, has helped the researchers to study the anatomic variations in the choroid in diabetic eyes.

Eligibility criteria:
inclusion criteria: * age from 50 to 70 years. * both sexes. * patients suffering from diabetic macular edema (dme). exclusion criteria: * high myopia more than 6 diopters. * previous injections or retinal surgery.