Kornimate/medical-research-clean huggingface dataset:
volume dependent effect of pericapsular nerve block

Conditions: Post Operative Pain; Femur Fracture

Summary: in peng block technique, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves which innervates the hip capsule for providing analgesia without causing muscle weakness. since the peng block is a facial plane block, it causes a volume dependent distribution. there are a few case reposts and cadaveric studies on volume dependent effect of analgesia and motor weakness of peng block. in our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of peng block.

femur fracture is the one of the most common case groups and it is seen mostly in the elderly patient population with comorbidities. for these patients, perioperative, postoperative analgesia and early mobilization are important to reduce cardiopulmonary complications and morbidity. femoral fracture operations are mostly performed under spinal anesthesia especially under unilateral spinal anesthesia to sustain more stable hemodynamics. the lateral decubitus position, which is used for unilateral spinal anesthesia, is a painful position for these patients. intravenous opioids are used for this procedure, however they have possible side-effects, such as sedation, inhibition of respiratory, lower blood pressure. because of these reasons, pericapsular nerve block (peng) has been applied recently to avoid complications. by using peng block , positioning for spinal anesthesia is easier for patients and anesthesiologists, and postoperative analgesia can be provided. by peng block, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves innervating the hip capsule, thus providing analgesia in patients, but muscle weakness is not expected. becacuse peng block is a facial plane block, it shows a volume dependent distribution. there are a few case reposts and cadaveric studies, which are showing volume depend effect of analgesia and motor weakness of peng block. in our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of peng block.

Eligibility criteria:
inclusion criteria: * patients who will undergoing hip arthroplasty surgery * patients over the age of 18 * asa i-ii-iii patients * patients who will be operated under spinal anesthesia exclusion criteria: * asa iv patients, pregnant women * patients who are not suitable for spinal anesthesia * patients diagnosed with alzheimer's and dementia who cannot cooperate * patients who are not suitable for peripheral nerve block (patients with infection in the injection area, with local anesthetic allergy, with coagulopathy) * patients who do not want to participate in the study * patients under the age of 18 * patients switched to general anesthesia

Keywords: pericapsular nerve group block femur fracture postoperative analgesia
psychiatric problems in thalassemic children

Conditions: Psychiatric and Thalassemia; Psychiatry and Thalassemia

Summary: aims of the study : 1. assessment the prevalence of psychiatric problems in thalassemic children . 2. assessment the prevalence of cognitive problems in thalassemic children . 3. determine factors associated with psychiatric and cognitive problems in thalassemic children . sociodemographic information, other associated factors , cbcl (child behaviour check list) and children's sleep habits questionnaire will be collected by thalassemic child's caregiver interview at assiut university ,children hospital , pediatric hematology unit . raven´s colored progressive matrices will be solved by thalassemic patient at assiut university , children hospital , pediatric hematology unit .

beta-thalassemia is a chronic and genetically determined hematological disorder characterized by severe hemolytic anemia as a result of deficient synthesis of β chains of hemoglobin. β-thalassemia major is considered the commonest hemoglobinopathy in the mediterranean area particularly egypt with an estimated carrier rate of 9-10.2 % . from about registered β-thalassemia cases ; 95% of them are β-thalassemia major, and 5% are thalassemia intermediate. it demands frequent blood transfusions to maintain life, while haemosiderosis and other complications of the disease require a continuous and distressing treatment regimen that includes parenteral iron chelation treatment and regular medical supervision. the drawbacks of the disease in many aspects of life become strongly evident during the school age when children ask for independence . it has been related with psychosocial aspect and a significant negative effect on areas of school functioning because of the likelihood of physical deformity, growth retardation and delayed puberty besides the difficulty of management (such as regular transfusion and time-consuming iron chelation treatment) social stigma associated with having thalassaemia have significant psychosocial and emotional impact on patients and their families(3) , so the affected children become more liable to emotional, social, psychological and behavioural problems . no available studies about psychiatric problems among thalassemic children in egypt . also study that were conducted in the age \&lt; 12 years are few .

Eligibility criteria:
inclusion criteria: * 1. age between 6 to \&lt; 12 years. exclusion criteria: 1. patients who had bone marrow transplant and were cured of thalassemia . 2. neurological illness preventing them from expressing themselves and not able to communicate well
sutureless versus conventional thyroidectomy

Conditions: Goiter

Summary: this study was prospective randomized double-blinded clinical trial on patients with thyroid disease who underwent thyroidectomy in the general surgery department, mansoura university hospitals during the period of february 2017 to february 2018.two techniques for vascular sealing were compared: conventional tying and harmonic scalpel


Eligibility criteria:
inclusion criteria: patients of both genders aging above 18 years presented with primary thyroid diseases requiring thyroidectomy including: * solitary thyroid nodule (stn) * multinodular goiter * controlled toxic goiter * inflammatory goiter (thyroiditis) * early-stage thyroid cancer. exclusion criteria: * patients unfit for surgery * patients unwilling to participate in the study * pregnant women * thyroid cancer with lymph node or distant metastasis. * patients with psychiatric disturbances.
ph 1 evaluation of oral ci-1033 in combination with paclitaxel/ carboplatin as 1st line chemotherapy in nsclc patients

Conditions: Carcinoma, Non-Small Cell Lung

Summary: the main purpose of this study is to evaluate the overall safety and maximum dose of ci 1033 in combination with paclitaxel and carboplatin in patients with nsclc.


Eligibility criteria:
inclusion criteria: * at least one target lesion that is unidimensionally measurable as defined by response evaluation criteria in solid tumors (recist ; appendix b.2 ) and has not been previously irradiated; a tumor that expresses at least one member of the erbb family of receptors (as determined by immunohistochemical evaluation by a sponsor-designated core laboratory) exclusion criteria: * prior chemotherapy, biologic therapy, immunotherapy, treatment with herceptin, or treatment with investigational agents (including ci 1033); hormonal therapy within 28 days prior to baseline disease assessment (to exclude the possibility of a hormone-withdrawal response); prior definitive radiation therapy to the primary cancer site; not yet recovered from the acute effects of surgery or palliative radiotherapy; brain metastases.
evaluation of the relationship between missed appointments and adherence to medical indications

Conditions: No-Show Patients; Therapeutic Adherence and Compliance; Type 2 Diabetes Mellitus; COVID-19

Summary: we will conduct a cross-sectional study involving adults with type 2 diabetes mellitus. our primary objective is to evaluate the association between nonattendance and participants' adherence to both pharmacological and non-pharmacological medical recommendations, as well as covid-19 prevention measures. additionally, we will assess the adherence rates to these medical recommendations, covid-19 prevention protocols, and the recommended health care practices and controls for patients with type 2 diabetes mellitus.

non-attendance at outpatient visits and lack of adherence to medical recommendations are prevalent issues that negatively impact the health care system. while tools exist to assess pharmacological adherence, evaluating adherence to non-pharmacological recommendations remains challenging. some studies suggest using nonattendance as an objective and easily measurable marker of adherence. the aim of this study is to evaluate the association between nonattendance and adherence to medical recommendations in adults with type 2 diabetes mellitus. we will conduct a cross-sectional study involving adults with type 2 diabetes mellitus. we will evaluate the association between participants' nonattendance and their adherence to both pharmacological and non-pharmacological medical recommendations, as well as covid-19 prevention measures. additionally, we will assess the adherence rates to these recommendations, covid-19 prevention measures, and the recommended health care practices and controls for patients with type 2 diabetes mellitus.

Eligibility criteria:
inclusion criteria: * adult patients (over 18 years old), affiliated with the medical insurance of the hospital italiano de buenos aires for at least two years. * patients with a diagnosis of type 2 diabetes mellitus at least 2 years before the date of entry to the study will be included. exclusion criteria: * refusal to participate or to the informed consent process. * difficulties with language or comprehension (includes pathologies that alter the understanding of the indications or compliance with them (dementia, encephalopathy, intellectual disability, psychiatric disorders). * recent hospitalization (the month before the phone call). * medical follow-up outside of hospital italiano de buenos aires. * work as health personnel. * communication failure (wrong phone number or no response to 3 calls on different days and times)

Keywords: no show patients patient compliance type 2 diabetes mellitus covid-19
avelumab in combination regimens that include an immune agonist, epigenetic modulator, cd20 antagonist and/or conventional chemotherapy in patients with relapsed or refractory diffuse large b-cell lymphoma (r/r dlbcl)

Conditions: Diffuse Large B-Cell Lymphoma

Summary: study b9991011 is a multi-center, international, randomized, open label, 2 component (phase 1b followed by phase 3), parallel-arm study of avelumab in combination with various agents for the treatment of relapsed/refractory (r/r) diffuse large b-cell lymphoma (dlbcl).

the target study population of this phase 1b/3 registrational study is patients with r/r dlbcl who have completed at least 2 (but not more than 4) lines of prior rituximab-containing multi-agent chemotherapy, and/or in whom autologous stem cell transplant (asct) has failed, or who are not candidates for asct or who are not eligible for intensive chemotherapy. patients who are ineligible for intensive second line chemotherapy must have received at least one prior rituximab-containing combination chemotherapy regimen. the study will assess the safety, efficacy, pharmacokinetics (pk), immunogenicity of the 3 avelumab-based combination regimens tested, and collect patient reported outcome (pro) data.

Eligibility criteria:
key inclusion criteria: -any of the following as defined by the who, 2016 lymphoid neoplasm classifications and histologically confirmed: * diffuse large b-cell lymphoma (dlbcl), not otherwise specified (nos): germinal center b-cell type (gcb), activated b-cell type (abc) * high-grade b-cell lymphoma (hgbcl) nos * hgbcl with myc and bcl2 and/or bcl6 rearrangements * t-cell histocyte-rich large b-cell lymphoma * ebv+ dlbcl, nos * hhv8+ dlbcl, nos relapsed or refractory disease following at least 2 lines (and a maximum of 4 lines) of prior rituximab containing multi-agent chemotherapy which may include an autologous stem cell transplantation unless patients are not considered suitable for intensive second-line chemotherapy or autologous stem cell transplantation. patients who are ineligible for intensive second line chemotherapy,must have received at least one prior rituximab-containing combination chemotherapy regimen. patients who are ineligible for intensive second line chemotherapy, must have received at least one prior rituximab-containing combination chemotherapy regimen. * baseline measurable disease with at least 1 bi dimensional lesion with longest diameter (ldi) \>1.5cm on ct scan which is fdg avid on pet scan. * a biopsy (archived or screening/recent) will be collected at screening. * at least 18years of age (or ≥20 years in japan). * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1. key exclusion criteria: * active central nervous system (cns) lymphoma. * prior organ transplantation including prior allogeneic sct. * prior therapy with an anti pd 1, anti pd l1, anti pd l2, anti cd137, or anti cytotoxic t lymphocyte associated antigen 4 (ctla 4) antibody (including ipilimumab, tremelimumab or any other antibody, or drug specifically targeting t cell co stimulatory or immune checkpoint pathways).
study in hiv1-positive, virosuppressed patients currently intreatment with ritonavir-boosted protease inhibitors (pi/r) starting cobicistat-boosted darunavir (drv/c - rezolsta)

Conditions: Human Immunodeficiency Virus

Summary: the purpose of this study is to describe the effectiveness of darunavir/cobicistat (drv/c)-based regimens, measured as maintenance of virological suppression 48 weeks after baseline, defined as the day when the treatment with drv/c-based regimen is started, through collection of daily practice data in the italian setting.


Eligibility criteria:
inclusion criteria: * adult greater than or equal to (\>=18 years), male and female patients * documented human immunodeficiency virus-1 (hiv-1) infection * eligible to darunavir/cobicistat (drv/c) treatment according to summary of product characteristics * patients who are able to understand the nature of the study and to provide their consent voluntarily having signed an informed consent form (icf) allowing data collection and source data verification in accordance with local requirements * patients in stable (\>= 12 months) treatment with an antiretroviral (arv) therapy pi/ritonavir (pi/r)-based, being prescribed rezolsta (drv/c) by treating physician * patients virosuppressed (hiv-rna less than \[\ \] 50 copies/ml not confirmed (blips) will be considered acceptable; last value collected being \< 50 copies/ml exclusion criteria: * patient currently enrolled in an interventional study * patient currently enrolled in an observational study sponsored or supported by janssen * estimated glomerular filtration rate (egfr) \< 70 milliliters per minute (ml/min) if any co-administered agent (example emtricitabine, lamivudine, tenofovir disoproxil fumarate, or adefovir dipivoxil) requires dose adjustment based on creatinine clearance * pregnancy or breast feeding at enrollment * allergy or intolerance to sulphonamides * switch from darunavir/ritonavir (drv/r) 600/100 bis in die (bid) * patient currently in mono pi/r therapy * patients to be treated within one year with direct acting antivirals (daas) for hepatitis c virus (hcv) infection * chemotherapy scheduled
atomoxetine for freezing of gait in parkinson's disease

Conditions: Parkinson's Disease; Freezing of Gait

Summary: subjects are being asked to participate in this study to determine the safety and effectiveness of a drug called atomoxetine in the treatment of freezing of gait for parkinson's disease patients. atomoxetine (atm) is an approved drug currently on the market for the treatment of attention deficit. it works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. atm has not been approved by the food and drug administration (fda) to be used in the treatment of pd, but has been found to be well tolerated in this patient population.


Eligibility criteria:
inclusion criteria: 1. diagnosis of idiopathic parkinson's disease according to uk brain bank criteria, hoehn and yahr stage 2-4 2. a positive response to item 14 of the updrs, part 2. 3. age range 18-80 4. ability to walk a minimum of 20 feet without assistive device and with one observed freezing episode which may be triggered by visual cue 5. letter of medical clearance by primary care physician dated within preceding 2 months of subject's initial active study visit. 6. stable on pd medications for ≥ 3 months - exclusion criteria: 1. intolerance to drug class 2. mini-mental status examination \<26/30 3. no observable episodes of freezing of gait despite common visual cues 4. not on stable pd medications for 3 months 5. subjects who whose gait disturbance is due to other conditions not related to pd or fog. 6. current use of monoamine oxidase inhibitor (mao-i) 7. hypersensitivity to drug class 8. narrow angle glaucoma 9. pheochromocytoma 10. severe cardiovascular disorders, i.e. patients with pre-existing conditions that would be expected to deteriorate if their heart rate or blood pressure were to increase in a clinically significant manner (e.g. 15-20 mmhg increase in blood pressure or 20 beats per minute in heart rate). 11. patients with uncontrolled hypertension. 12. patients with a history of symptomatic tachyarrhythmias. 13. presence of uncontrolled depression and suicidal ideation. -
stress, environment, and genetics in urban children with asthma

Conditions: Asthma; Lung Diseases

Summary: the purpose of this study is to evaluate the multiple mechanisms through which stress, physical environment, and genetic predisposition contribute to asthma in urban children.

background: the study design builds on the access study, a prospective pregnancy cohort study begun in 2003 of a cohort from birth to age four. the present study includes two new aims regarding the interaction of stress and genetic or environmental variables, reflecting a more comprehensive conceptualization of the multiple mechanisms by which stress can contribute to asthma. in addition, the current study proposes to follow the cohort until the age of three. design narrative: the study examines the role of psychosocial stressors in a systems biology framework considering multiple biologic pathways by which stress can contribute to asthma. the investigators will not only study the independent effect of stress on asthma/wheeze phenotypes in early childhood but also will consider stress as a modifier of physical environmental factors (allergens, cigarette smoking, and diesel-related air pollutants) and genetic predisposition on asthma risk. they will determine the independent effect of maternal stress (both prenatal and postnatal) on early childhood asthma phenotypes. they further hypothesize that multi-life stressors prevalent in disadvantaged populations can cumulatively influence immune system development and airway inflammation in early life, thus making the populations more susceptible to other environmental factors and genetic risk factors explaining, in part, observed asthma disparities associated with ses and race/ethnicity. they will take a multi-level approach, measuring both individual-level stress (negative life events, perceived stress, pregnancy anxiety) and community-level stress \[neighborhood disadvantage (e.g., percent of subjects living in poverty, percent unemployed), diminished social capital, and high crime/violence rates\]. they will also assess the influence of stress on the infant hormonal stress response and on t-helper cell differentiation as reflected in cytokine profiles and ige expression (a topic or pro inflammatory phenotype). additional physical environmental (indoor allergens, diesel-related air pollutants, tobacco smoke) and genetic factors will be assessed given their influence on the immune response and expression of early childhood asthma/wheeze. this interdisciplinary approach is unique because researchers are considering the context in which physical exposures and host susceptibility occur, analyzing their multiplicative joint effects and considering multiple biologic pathways, as such it is consistent with the nih roadmap objectives.

Eligibility criteria:
inclusion criteria: mothers aged 18 years or more at time of enrollment and speak english or spanish. exclusion criteria: none
fibrinogen concentrate (human) - efficacy and safety study

Conditions: Afibrinogenemia; Hypofibrinogenemia; Fibrinogen Deficiency

Summary: this is a multinational, multicenter, prospective, open-label historically controlled phase iiib non-inferiority clinical trial on the efficacy and safety of fibrinogen concentrate (human). it is estimated that 150-300 patients in the u.s. suffer from afibrinogenemia. substitution with cryoprecipitate or alternative treatments have limited safety and efficacy. the primary purpose of the study is to demonstrate the hemostatic efficacy of fibrinogen concentrate (human) by adequately controlling acute bleeding (spontaneous or after trauma) in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia). cryoprecipitate hemostatic efficacy data from a retrospective physician survey will be used as a historical control.


Eligibility criteria:
inclusion criteria: * documented congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia), expected to require treatment for bleeding * presenting with an episode of acute bleeding (either spontaneous or after trauma) not requiring surgery * provide informed consent exclusion criteria: * life expectancy \< 6 months * bleeding disorder other than congenital fibrinogen deficiency, but including dysfibrinogenemia * treatment with any investigational medicinal product (imp) in the 30 days prior to enrollment * treatment with any fibrinogen concentrate or other fibrinogen containing blood product in the 2 weeks prior to enrollment * treatment with any coagulation active drug (i.e., non-steroidal-antirheumatics, warfarin, cumarin derivates, platelet aggregation inhibitors) in 1 week prior to enrollment or as a planned or expected medication during the time period from day 1 until 24 hours after the last fch infusion * presence or history of hypersensitivity to fch * presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment * presence or history of arterial thrombosis within 1 year prior to enrollment * presence or history of hypersensitivity to human plasma proteins * presence or history of esophageal varicose bleeding * end stage liver disease (i.e., child pugh score b or c) * planned or expected surgery (i.e., for bleedings from aneurysm or splenic rupture) * pregnancy, or an intention to become pregnant during the study * currently breast-feeding, or with the intention of breast-feeding during the study * human immunodeficiency virus (hiv) positive * polytrauma, present or within 6 months prior to enrollment * suspicion of an anti-fibrinogen inhibitor as indicated by previous in-vivo recovery (ivr), if available (\< 0.5 (mg/dl)/(mg/kg)) * previous inclusion and treatment in the prospective part of the study * participation in any clinical study in the 30 days prior to enrollment

Keywords: congenital fibrinogen deficiency