Kornimate/medical-research-clean huggingface dataset:
prospective, single arm, single center study of duvelisib combined with chidamide in the treatment of newly diagnosed peripheral t-cell lymphoma (ptcl)

Conditions: Newly Diagnosed Peripheral T-cell Lymphoma

Summary: this is a prospective, single arm, single center study to evaluate the efficacy and safety of duvelisib combined with chidamide in the treatment of newly diagnosed peripheral t-cell lymphoma.

this is a prospective, single arm, single center study, including two phases. it plans to recruit36 patients with clinically diagnosed primary ptcl who will be treated with duvelisib and chidamide. in the first phase duvelisib is oral administration at a dose of 25mg twice a day, and every 4 weeks (28 days) was a cycle. next administration will be depend on whether the efficacy reaches cr in the second phase.

Eligibility criteria:
inclusion criteria: - 1.age: 18-70 years (contains boundary values 18 and 70); * 2.the newly diagnosed ptcl confirmed by histopathology is one of the following subtypes; a) angioimmunoblastic t-cell lymphoma (aitl); b) follicular t helper cell lymphoma (t-fhcl); including but not limited to the above two subtypes; * 3.ecog ≤ 3; * 4.at least one measurable or evaluable tumor lesion according to the lugano-2014 standard; * 5.expected survival ≥ 3 months; * 6.subjects fully understand and voluntarily participate in this study and sign informed consent; exclusion criteria: - 1.subjects who have previously received systemic treatment for lymphoma or currently undergoing anticancer treatment; * 2.subjects with central nervous system (cns) lymphoma or lymphoma involving cns; * 3.significant active heart disease within the past 6 months, including: new york heart association (nyha) class iii/iv congestive heart failure unstable angina pectoris or angina requiring surgical or medication intervention, and/or myocardial infarction; * 4.uncontrolled systemic fungal, bacterial, or viral infections (defined as persistent signs/symptoms related to infection that have not improved despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments); * 5.human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection and history of severe skin reaction; * 6.subjects with any other active malignant tumor at the time of screening, except for adequately treated cervical carcinoma in situ or breast cancer carcinoma in situ, skin basal-cell carcinoma or local skin squamous cell carcinoma; * 7.pregnant women, lactating women, patients who refused to take effective contraceptive measures during the study; * 8.any serious uncontrolled systemic disease; * 9.increasing the risk of the subject or interfering with the test results determined by the investigator;

Keywords: duvelisib chidamide peripheral t-cell lymphoma
safety and efficacy of sfpp in knee osteoarthritis

Conditions: Osteoarthritis Knee Pain

Summary: the objectives of this study are to demonstrate the non-inferiority of esflurbiprofen plaster (sfpp) 40 mg applied for 2 weeks to diclofenac gel, the comparator, in terms of efficacy in patients with knee osteoarthritis (oa) and to examine the safety of sfpp.


Eligibility criteria:
inclusion criteria: * patients who had unilateral knee pain and were classified as grade ii or iii according to kellgren-lawrence (kl) grading and whose non-assessed knee is not graded higher than the assessed knee based on x-ray in standing, weight-bearing extension position within 90 days before screening visit (1st visit) * patients whose knee pain on rising from the chair assessed by visual analogue scale (rvas) of the assessed knee meets all the following criteria for the level of pain; \< 80 mm at washout visit (2nd visit), ≥ 40 mm at baseline visit (3rd visit), worsening of ≥ 15 mm at baseline visit (3rd visit) compared with rvas at washout visit (2nd visit) as a result of discontinuation of use of nsaids exclusion criteria: * patients with complication of rheumatoid arthritis, history of knee surgery, malignant tumor, neuropsychiatric disease, or serious disease

Keywords: osteoarthritis knee pain
temporomandibular disorders knowledge, attitude, and practice in egypt

Conditions: Temporomandibular Disorder

Summary: primary objective: evaluate the level of knowledge, and attitude of dental practitioners in egypt. secondary objectives: 1. evaluate the need for continuing dental education in the field of tmd. 2. describe referral process practiced by dental practitioners. 3. describe the procedures practiced by the dental practitioners for diagnosis and management of tmd.

to the best of our knowledge, no studies have been conducted to evaluate the knowledge, attitudes, and practices of egyptian dental practitioners regarding tmd. knowledge can be categorized into essential sections for assessment, including aetiology, diagnosis, and management. etiology and diagnosis are fundamental for providing effective management, which in turn reflects the quality of care received by patients. evaluating the kap of the gdps regarding tmd can be applied to assess areas of knowledge shortfall and correlation between levels of knowledge and attitudes with years of practice experience and specialty. this can also reflect how effective the training at the dental school, as well as the postgraduate training, has been in this context. besides, practice illustrates how practitioners apply their knowledge and attitudes to make appropriate patient diagnoses and management, as well as to describe the referral process

Eligibility criteria:
inclusion criteria: 1. gender: both males and females. 2. dentists practicing the profession in egypt 3. general practitioners or specialists exclusion criteria: 1-undergraduate students
the virtual better study

Conditions: Delivery Modality of BETTER Intervention

Summary: the focus of this project is to examine how delivering virtual care impacts health behaviour change for patients with chronic illnesses compared to in-person visits using a chronic disease prevention and screening (cdps) program called better (building on existing tools to improve chronic disease prevention and screening in primary care).

while the current pandemic has launched a likely irreversible transition towards increased utilization of virtual methods for delivery of healthcare, we have only a very superficial understanding of how this shift will affect health outcomes and equity of access to health services. several randomized trials comparing virtual to in-person delivery of health services have been completed, but none have examined the effect of interventions to address health behaviours, arguably one of the most challenging issues in healthcare and one that is most sensitive to the therapeutic relationship and modifiers to that relationship such as the mode of communication. the focus of this project is to examine how delivering virtual care impacts health behaviour change for patients with chronic illnesses compared to in-person visits using a chronic disease prevention and screening (cdps) program called better (building on existing tools to improve chronic disease prevention and screening in primary care).

Eligibility criteria:
inclusion criteria: * persons aged 40-70 * persons who are already booking a better prevention visit. exclusion criteria: * persons with the presence of a terminal illness * persons in active treatment (i.e., systemic and/or radiation therapy) for cancer. * persons who are unable to provide informed consent.

Keywords: chronic disease lifestyle screening physical activity diet
subjective and objective refraction in pseudophakic patients

Conditions: Pseudophakia

Summary: targeting of post-cataract refraction depends mainly on the prediction of the post-operative lens position, but also on the post-operative refraction itself. hence, aim of this study is to evaluate the agreement and variability of subjective refraction performed by two independent examiners, autorefraction, and wavefront aberrometry in pseudophakic patients after uneventful cataract surgery.

one of the main goals of modern cataract surgery, beside removing the cataractous lens, is to achieve the patient's desired post-operative refraction. targeting this post-operative refraction depends mainly on the prediction of the post-operative lens position and the post-operative refraction itself. reason for the contributing effect of post-operative refraction in the error-propagation analyses is that refraction in phakic patients was shown to have only moderate reproducibility. in the past, different studies evaluated refraction methods. however, there is no study that included reproducibility of subjective refraction in pseudophakic patients and compares it with objective refraction methods (autorefraction, wavefront aberrometry). 100 eyes of 100 patients, which underwent uneventful cataract surgery, will be included in the study. refraction of one eye of each patient will be tested using subjective refraction by two different examiners, autorefraction, and wavefront aberrometry at two separate occasions.

Eligibility criteria:
inclusion criteria: * minimum age: 21 years * cataract surgery (at least 8 weeks post-surgery) * written informed consent exclusion criteria: * complications during or after cataract surgery * ophthalmic diseases, that might interfere with measurements (macular degeneration, glaucoma, diabetic retinopathia) * ophthalmic surgery other than cataract surgery * clinically significant posterior capsule opacification

Keywords: subjective refraction autorefraction wavefront aberrometry
metabolic syndrome and obstructive sleep apnea

Conditions: Sleep Apnea; Metabolic Syndrome

Summary: background:metabolic syndrome is a disorder characterized by abdominal obesity,hypertension,increased triglycerides ,decreased hdl cholesterol and increased blood glucose. accumulating evidence strongly indicates that insulin resistance and an increased amount of abdominal fat are the pathogenic factors for the characteristics of metabolic syndrome. studies indicate that sleep apnea may be a manifestation of the metabolic syndrome. subjects and methods:this study was conducted in the pulmonology department at kasrelainy hospital. it included 80 patients who came to the sleep lab unit for polysomnography. each patient was subjected to full history taking including(sex,age,smoking history,presence of diabetes or hypertension),thorough clinical examination with emphasis on waist, neck\&hip circumference and blood pressure measurements,laboratory investigations including :lipid profile\& diabetic profile(hba1c).in addition to ess and stop bang score questionnaire.


Eligibility criteria:
inclusion criteria: * patients fulfilled the criteria of osa ( obstructive sleep apnea) in the form of symptoms suggestive of osa (daytime sleepiness/daytime fatigue/headache/snoring)and with ahi ( apnea-hyponea index) ≥5. exclusion criteria: 1. cerebro-vascular accident within the preceding 30 days. 2. patients on sedatives. 3. patients on anti-psychotics
adiponectin polymorphisms, insulin resistance, and pharmacokinetics in obesity

Conditions: Obesity

Summary: the primary objective of this study is to determine the influence of insulin resistance on drug metabolism and response in obese subjects. the investigators hypothesize that expression of adiponectin (a hormone secreted by fat tissue), and specific variants in the adiponectin gene can predict the insulin resistance and drug response among obese subjects.

the following study will hypothesizes that insulin resistance causes changes in drug metabolism, elimination, and effect. we will differentiate the insulin resistant phenotype amongst obese individuals on the basis of both laboratory (fasting insulin, triglycerides, fasting glucose) analysis, and quantitative and qualitative adiponectin expression. we will determine the effect of insulin resistance on the pharmacokinetics and pharmacodynamics of anesthetic induction agents and opioids, using propofol and fentanyl as examples.

Eligibility criteria:
inclusion criteria: * inclusion criteria include patients of adult age * american society of anesthesiologists class i, ii, or iii, and undergoing elective surgical procedures requiring general anesthesia * body mass index greater than 35 exclusion criteria: * patients with evidence of hepatic, renal, or cardiovascular dysfunction * history of difficult tracheal intubation, or adverse reaction to anesthesia shall be excluded from the study * patients taking prescribed or over-the-counter anxiolytics, narcotics, or sleeping aids, will also be excluded

Keywords: obesity insulin resistance
a study of erlotinib [tarceva] as monotherapy or intermittent dosing with docetaxel in patients with advanced or metastatic non-small cell lung cancer. (talisman)

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this randomized parallel group study will assess the efficacy and safety of erlotinib \[tarceva\], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. patients will be randomized to receive either tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus tarceva (150 mg/day orally, days 2-16 each cycle) followed by tarceva monotherapy. anticipated time on study treatment is until disease progression.


Eligibility criteria:
inclusion criteria: * male patients, \>/=18 years of age * former smoker (smoked \>/= 100 cigarettes in his lifetime and quit \>12 months before enrollment) * locally advanced (stage iiib), metastatic (stage iv) or recurrent squamous non-small cell lung cancer * prior platinum-based therapy for advanced nsclc * eastern cooperative oncology group (ecog) performance status 0-1 exclusion criteria: * uncontrolled symptomatic central nervous system (cns) metastases * prior therapy against epidermal growth factor receptor (egfr) * \>1 prior chemotherapy for advanced/metastatic nsclc * radiotherapy \<28 days prior to enrollment * history of melanoma at any time, or another malignancy in the last 5 years except for carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or surgically cured malignant neoplasias with a disease-free interval of \>5 years * not fully treated eye inflammation or infection, or predisposing conditions
a comparison of bms-232632 with efavirenz, each in combination with zidovudine-lamivudine

Conditions: HIV Infections

Summary: the purpose of this study is to compare the effectiveness of treatment with bms-232632 to that of efavirenz (efv) when both are used with zidovudine (zdv) and lamivudine (3tc).

this is a multinational, 2-arm study. patients in 1 arm receive bms-232632 plus efv placebo capsules. patients in the other arm receive efv plus bms-232632 placebo. both arms also receive a fixed dose of zdv-3tc.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * have a viral load of 2,000 or more copies/ml and a cd4 cell count of 100 or more cells/mm3 (or 75 or more cells/mm3 with no prior history of aids-defining diagnosis) within 2 weeks before randomization. * are at least 16 years old. * have signed consent of parent or guardian if under 18 years of age. * are willing to use effective barrier methods of birth control. * are available for follow-up for at least 52 weeks. exclusion criteria patients will not be eligible for this study if they: * have had anti-hiv treatment within 30 days before screening. * have a recently diagnosed hiv-related infection. * have any medical condition requiring treatment at enrollment. * have recently become hiv infected. * have acute hepatitis within 30 days of study entry. certain patients with chronic hepatitis will be eligible. * expect to need or have taken drugs with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months before study. expect to need methadone, ribavirin/interferons, neurotoxic drugs or drugs that affect cyp3a4. * abuse alcohol or drugs. * have severe diarrhea within 30 days before study entry. * are pregnant or breast-feeding. * have a history of hemophilia. * have a history of bilateral peripheral neuropathy. * cannot take medicines by mouth. * have any other conditions that the doctor thinks would interfere with the study.

Keywords: placebos drug therapy, combination zidovudine hiv protease inhibitors lamivudine rna, viral reverse transcriptase inhibitors anti-hiv agents viral load bms 232632 efavirenz
prediction study of complications after severe trauma

Conditions: Trauma; Sepsis; Multiple Organ Dysfunction Syndrome

Summary: the purpose of this study is to evaluate a clinically and economically most effective diagnostic algorithm for prediction of post-traumatic complications in a multicenter sample of severe trauma patients.

trauma is a major public health problem worldwide, ranking as the fourth leading cause of death. one of the most serious complications of major trauma is sepsis, which often induces sequential multiple organ dysfunction syndrome (mods). there were still no specific biomarkers to predict the susceptibility of complications and outcomes, which leading to the limited prevention methods and the high mortality rate of severe trauma patients. previous studies from our and other group have found some sepsis and mods predictors, including genetic polymorphisms, serum cytokines and cell-surface markers. the purposes of this multi-center observational study is to select biomarkers and evaluate a clinically and economically most effective diagnostic algorithm for prediction of complications in severe trauma patients.

Eligibility criteria:
inclusion criteria: * age\> 16 years old and \<65 years old * severe trauma patients (ais ≧3 or iss≧16) * admission within 48 hours after injury * given and signed informed consent exclusion criteria: * died within 48h after injury * being pregnant or lactating * chronic organ dysfunction comorbidities * long-term anticoagulant therapy before injury * presence of immunosuppression before injury

Keywords: trauma ; sepsis; multiple organ dysfunction syndrome; prediction; risk
dexmedetomidine addition to morphine in patients with metastatic cancer

Conditions: Refractory Pain; Metastatic Cancer

Summary: pain is a common symptom in patients nearing the end of life. its prevalence varies between 30 and 75%. nowadays, morphine is the most used molecule as first line treatment of moderate to severe pain. however, this molecule, considering its side effects, may contribute in part to the discomfort of these patients and may increase the pre-existing agitation or delirium. there is therefore a need to find new agents, other than morphine, for pain control at the end of life, without the limitations that the morphine molecule has. the author reviewed the literature on the role of dexmedetomidine in the treatment of refractory symptoms in palliative care, including pain. it is an agonist of the adrenergic alpha 2 receptor having a sedative, analgesic action and a morphine sparing effect demonstrated postoperatively. this study aims primarily at demonstrating that dexmedetomidine has a beneficial role in the treatment of pain in patients with metastatic cancer.


Eligibility criteria:
inclusion criteria: * any painful patient with metastatic cancer * whatever type of pain: nociceptive, neuropathic, or mixed * age \> 18 and \<75 years * patient under analgesic tier iii treatment: with moderate to severe pain and not relieved by non-opioid conventional treatment * patient cooperating capable of responding to the pain assessment by providing a number from 0 to 10 at the vas * patient providing his explicit consent to participate in the study before inclusion (regardless of his inclusion in c or d group) * patients with systolic blood pressure (sbp) ≥ 100 mmhg and a diastolic blood pressure (dbp) ≥ 50 mmhg * patients with a heart rate ≥ 50/min exclusion criteria: * patient refusal to participate in the study or patient unable to give consent * age \ 75 years * comatose uncooperative patient unable to respond to the assessment of pain by vas * hypotensive patients with sbp \< 100 mmhg and dbp \< 60 mmhg or bradycardic with a heart rate \< 50/min * patient with a heart rhythm disorder, or a disorder of the atrial-ventricular conduction * patients under beta-blocker * patient with heart failure with an ejection fraction \< 40% * patient suffering from allergy or previous intolerance to morphine or dexmedetomidine * patient with renal impairment with a creatinine clearance \<3 0ml/min/1.73m2, or patient under hemodialysis or peritoneal dialysis. * patient with severe hepatic impairment with child-pugh score at c.
safety and efficacy of apixaban in severe renal impairment

Conditions: Renal Disease, End Stage; Anticoagulant-induced Bleeding

Summary: despite emergence of new anticoagulants over the last few years, patients with advanced chronic kidney disease still have limited options and are usually managed with warfarin after venous thromboembolism or diagnosis of atrial fibrillation. the use of all direct oral anticoagulants is not recommended in patients with creatinine clearance below 15 ml/min. apixaban has the lowest fraction of renal excretion (27%) and is sometimes used in patients with ckd v (gfr \< 15 ml/min/bsa) and end stage renal disease (esrd). until recently, data on apixaban use in this population were limited to pharmacodynamics as patients with severe renal impairment were excluded from clinical trials. in a 2016 study, it was found that esrd resulted in 36% increase in apixaban auc but no increase in cmax, and that hemodialysis had a limited impact on apixaban clearance.1 there are now data available on inpatient use of apixaban vs.coumadin in patients with creatinine clearance below 25 ml/min.2 there was no significant difference in bleeding events between the two groups but the study period was limited to a hospital admission and may not reflect bleeding risk of long-term anticoagulation. use of warfarin in patients on hemodialysis entails several disadvantages in this population. the need for inr monitoring adds clinic visits for patients that already spend a great portion of their time in healthcare facilities. numerous drug interactions, involving warfarin, complicate management of esrd patients that are often on many medications. the reduced risk of intracranial bleeding on apixaban, compared to warfarin, in the aristotle study, is an important consideration in patients that may already be at increased risk due other factors such as uremia and concurrent antiplatelet agents.

this is a retrospective cohort study. the investigators will use clinical looking glass (clg) to identify all adult patients with creatinine clearance \< 15 ml/min who were treated with apixaban or warfarin, for at least 1 month, between 3/1/2013 and 3/1/2017. the investigators will then review electronic charts in carecast and epic to gather data about bleeding and thrombotic events.primary outcome: clinically significant bleeding, per control of anticoagulation subcommittee criteria: 1) fatal bleed; 2) symptomatic bleed at anatomically critical sites such as intracranial, intraspinal, intraocular, or pericardial hemorrhage; 3)symptomatic noncritical bleeds resulting in transfusion of 2 units or more of red blood cells or drop in hemoglobin of at least 2.0 g/dl.4 secondary outcomes: venous thromboembolism, cerebrovascular accident, intracranial hemorrhage, bleeding related to hd access

Eligibility criteria:
inclusion criteria: * patients with creatinine clearance \<15 ml/min who are on anticoagulation with apixaban or warfarin. exclusion criteria: * patients without end stage renal disease who are not on anticoagulation with apixaban or warfarin.