Kornimate/medical-research-clean huggingface dataset:
temsirolimus in recurrent primary central nervous system (cns) lymphoma

Conditions: Recurrent or Refractory Primary CNS Lymphoma

Summary: this is an open-label trial investigating the efficacy of temsirolimus in recurrent or refractory primary cns lymphoma (pcnsl) after initial chemotherapy with a high-dose methotrexate containing regimen. 37 patients are planned to be treated with weekly infusions of 25mg temsirolimus (first 3 patients) or 75mg temsirolimus (all other patients) up to a maximum of 12 months. the trial is designed in two stages, if less than one of the first 12 patients responds to treatment, the trial is stopped. in addition to efficacy, safety and penetration of temsirolimus into the cerebrospinal fluid will be investigated.


Eligibility criteria:
inclusion criteria: * primary cns lymphoma diagnosed histologically or by cerebrospinal fluid cytology; absence of systemic lymphoma manifestations * relapse or lymphoma progression after/during high-dose methotrexate containing first-line chemotherapy or alternative therapy in the case of contraindications against high-dose methotrexate * ecog performance score ≤ 2 * age ≥18 years and ≤ 75 years * life expectancy of at least 3 months * absence of active infection * negative hiv serology * adequate renal function (gfr \>30ml/h) * adequate bone marrow reserve (neutrophils \> 1500/µl, platelets \> 80,000/µl) * bilirubin \<1.5x upper limit of normal (uln), alt and ast \<3x uln * at least 3 weeks interval from prior cytostatic treatment * negative pregnancy test * patient accessible for treatment and follow-up * patient compliance * signed informed consent exclusion criteria: * secondary cns lymphoma * primary intraocular lymphoma * patient eligible for high-dose chemotherapy and autologous stem-cell transplantation * concurrent treatment within another clinical trial * concurrent other malignant disease * symptomatic congestive heart failure (≥nyha ii) * active or uncontrolled chronic infection * severe concomitant disease incompatible with study conduct * history of cerebral bleeding * concomitant treatment with strong cyp3a4/5-inductors or -inhibitors * premenopausal women without highly effective contraception (defined as pearl index \<1) * pregnant or lactating women * refusal to record and pass on pseudonymized disease and treatment related data as part of the treatment protocol * concurrent admission to a psychiatric institution by public order

Keywords: temsirolimus, primary cns lymphoma, pcnsl, salvage treatment
role of complete blood picture in predicting the etiology of extrahepatic cholestasis

Conditions: Extrahepatic Cholestasis

Summary: cases with extrahepatic cholestasis are common and faced during day to day clinical practice, however reaching the final etiology is sometimes challenging and needs investigations which are usually expensive, may carry hazards to the patients, or inaccessible so we are in need for a method which is easily available, affordable and safe for aiding in the differential diagnosis of extrahepatic cholestasis. our study aiming to evaluate the role of complete blood count in predicting the etiology of extrahepatic cholestasis.

extrahepatic cholestasis has various etiologies including benign causes (benign stricture, chronic pancreatitis, choledochal cyst, mirizzi syndrome, etc...), choledocholithiasis, malignant causes (cancer pancreas, gallbladder cancer, cholangiocarcinoma, etc....), parasitic infestations (fasciola hepatica, ascaris lumbricoides, etc......) and other causes. it is essential to detect the exact cause of extrahepatic cholestasis in order to determine treatment options. diagnosing such conditions depends on clinical examination, laboratory investigations, imaging studies, endoscopic procedures, biopsy and even surgical intervention. some of these investigations are expensive, not available, or carry risk to the patients. moreover non of them is accurate 100%. complete blood count is already available, easy to obtain, not invasive investigation. in these study we are trying to evaluate the role of complete blood count parameters namely rdw, mpv, pdw, pct, nlr, plr in the differential diagnosis of extrahepatic cholestasis.

Eligibility criteria:
inclusion criteria: * patients with extrahepatic cholestasis exclusion criteria: * age under 14 years * previous bilio-pancreatic interventions * hemoglobinopathy * splenomegaly * myeloproliferative disorders * diabetes mellitus * recent blood transfusion in less than one month

Keywords: extrahepatic cholestasis, cbc
clinical and radiographic evaluation of turmeric, thymus vulgaris, nigella sativa and aloe vera as pulpotomy medicaments in primary teeth

Conditions: Pulpitis - Irreversible

Summary: when caries reaches the pulp of the tooth, it has to be removed and replaced with a material. in this study im examining the clinical and radiographic signs and symptoms after using different natural materials in pulpotomized molars and compared to the formocresol.

patients who have irreversible pulpitis and need pulpotomy will be selected randomly from the out patient clinic. they will be assigned randomly to different study and control groups. pulpotomy will be performed in the second primary molar and 1 of the five materials will be put in the pulp chamber (aloe vera, nigella sativa, thymus vulgaris, turmeric and formocresol). it will be covered with a restoration and a stainless steel crown. patients follow up will be done after 1,3,6 and 12 months to assess clinical and radiographic signs and symptoms.

Eligibility criteria:
inclusion criteria: * patients aged from 4 to 7 years old * patients who are medically free * patients who have a restorable vital deep carious primary molar which is indicated for pulpotomy. * no clinical signs or symptoms as pain on percussion, tooth mobility, presence of sinus or fistula, history of swelling. * no radiographic signs of any periapical pathosis or signs of internal or external root resorption. exclusion criteria: * patients who have any medical condition. * teeth that are badly broken down, that cannot be restored. * presence of uncontrolled bleeding. * clinical evidence of non-vitality such as presence of an abscess or a sinus or premature mobility. * radiographic evidence of bone resorption, internal or external root resorption and periapical or interradicular radiolucency.
prevalence of sleep disordered breathing

Conditions: Unstable Angina; Acute Myocardial Infarction; Congestive Heart Failure

Summary: a novel technique in identifying unspecified sleep apnea has been developed. this technique uses signals typical acquired from a bedside monitor that is found in critical care environments. those signals are then processed by a sleep analysis algorithm to provide an apnoea hypopnea index (ahi) score. this study is intended to determine whether the prevalence of sleep disordered breathing identification among patients in a coronary care unit (ccu) using this novel approach is significantly different than using routine techniques.

this study will focus on inpatients diagnosed with coronary conditions. specific eligibility criteria will include: * unstable angina * acute myocardial infarction * congestive heart failure subjects enrolled in the study will be scored for sleep apnea using a novel approach designed by the sponsor. that score will not be used in the course of treatment. a follow-up call will determine whether the subject was identified for sleep disordered breathing during the hospital stay. a comparison will be done on the number of those identified with and without the use of the sleep scoring device.

Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 years at time of consent * written informed consent * patients admitted to the intensive care unit if able to remove oxygen * patients admitted to telemetry and step-down floor that will not require oxygen * primary diagnosis (any of the following) * un-stable angina * acute myocardial infarction * congestive heart failure exclusion criteria: * previously diagnosed sleep disordered breathing * inability to consent * pregnancy * intubation (no longer excluded after extubation) * oxygen therapy (no longer excluded after therapy ends) * end-stage renal disease * end-stage liver disease * terminal disorders other than cardiac * severe scoliosis * cervical spinal cord injuries * neuromuscular disorders * severe copd as defined by prescription of home oxygen therapy * other unsuitable circumstances
evaluate the effect of obicetrapib in patients with hefh on top of maximum tolerated lipid-modifying therapies.

Conditions: Dyslipidemias; High Cholesterol; Hypercholesterolemia; Familial Hypercholesterolemia; Lipid Metabolism Disorder; Metabolic Disease; Lipid Metabolism, Inborn Errors; Genetic Disease, Inborn; Hyperlipoproteinemias

Summary: this study will be a placebo-controlled, double-blind, randomized, phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib in participants with a history of heterozygous familial hypercholesterolemia (hefh).

this study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with hefh to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. the screening period for this study will take up to 14 days. afterwards, patients will be randomized to placebo or 10 mg obicetrapib for an 365-day treatment period. after the treatment period, participants will have an end-of-study follow-up visit.

Eligibility criteria:
inclusion criteria: * have a history of heterozygous familial hypercholesterolemia (hefh) by 1) genotyping (not a screening assessment), who criteria/dutch lipid clinical network criteria with a score of \> 8 points; and/or simon broome register diagnostic criteria for definite or possible familial hypercholesterolemia (fh) * maximally tolerated lipid modifying therapy for at least 8 weeks prior to screening such as: atv (40 or 80), or (ros 20 or 40 mg), ezetimide, bempedoic acid, pcsk9 targeted therapy for at least 4 doses * fasting serum ldl-c ≥70 mg/dl (≥1.80 mmol/l) exclusion criteria: * new york heart association class ii or iv heart failure or last known left ventricular ejection fraction \< 30%; * hospitalized for heart failure within 5 years prior to screening * major adverse cardiac event (mace) within 3 months prior to screening; * hba1c ≥10%, or fasting glucose * formal diagnosis of homozygous familial hypercholesterolemia (hofh) * uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmhg or diastolic blood pressure ≥100 mmhg prior to randomization

Keywords: obicetrapib brooklyn cholesteryl ester transfer protein (cetp) inhibitor heterozygous familial hypercholesterolemia (hefh) ldl-c
effect of mitomycin-c on the outcomes of patients receiving ahmed glaucoma valve implantation surgery

Conditions: Glaucoma

Summary: the goal of this clinical trial is to determine if the intraoperative application of mitomycin-c can enhance the outcomes of ahmed glaucoma valve (agv) implantation in treating refractory glaucoma. this study is conducted among adult patients diagnosed with refractory glaucoma, a condition characterized by uncontrolled intraocular pressure despite the use of maximum tolerated medical therapy and previous surgical interventions. the main questions it aims to answer are: does intraoperative mitomycin-c reduce postoperative intraocular pressure more effectively than surgery without it? does mitomycin-c reduce the occurrence of postoperative complications such as hypertensive phases? researchers will compare the experimental group receiving mitomycin-c during agv implantation to the control group undergoing agv implantation without mitomycin-c to see if the treatment leads to lower intraocular pressure and fewer surgical complications. participants will: * undergo baseline assessment including eye examination and measurement of intraocular pressure. * be randomly assigned to receive either the mitomycin-c treatment or no intervention during their scheduled agv implantation surgery. * attend follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months post-surgery to assess intraocular pressure, visual acuity, and any postoperative complications.


Eligibility criteria:
inclusion criteria: * diagnosis of primary open angle glaucoma (oag); including ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome * participant must be over 18 years of age * iop \> 16mmhg on at least two consecutive occasions separated by one month * two sighted eyes with visual acuity of 20/200 or better * informed consent from patient exclusion criteria: * diagnosis of secondary oag (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma * previous incisional glaucoma surgery * incisional glaucoma surgery scheduled within 1 year of intervention * corneal disease affecting visualization of anterior chamber of the eye * treatment or plan to treat with topical or systemic steroids * previous laser treatments (selective laser trabeculoplasty or argon laser trabeculoplasty) * other eye disorders or surgical procedures (ie retinal detachment) that may influence the results of glaucoma surgery.

Keywords: refractory glaucoma intraocular pressure ahmed glaucoma valve mitomycin-c glaucoma surgery
tap using dexmedetomidine and ropivacaine for cesarean section analgesia

Conditions: Multimodal Analgesia; Cesarean Section

Summary: to evaluate the effect of dexmedetomidine as an adjuvant of ropivacaine in the tap block on cesarean section parturients under multimodal analgesia, optimize the multimodal analgesia program for cesarean section, and guide perioperative analgesia managemen。this is a single center, double-blind, randomized clinical trial.


Eligibility criteria:
inclusion criteria: * 1) 37-42 weeks of gestation 2) plan cesarean section 3) receiving patient controlled intravenous analgesia 4) age\>18 years 5) asa（american society of anesthesiologists) grade i-iii 6) voluntary participation and informed consent exclusion criteria: * 1)the anesthesia method for cesarean section is general anesthesia or intraspinal anesthesia, and epidural administration is used 2) combined with other opioids during operation 3) high risk pregnancy (multiple pregnancy, in vitro pregnancy, etc.) or pregnancy related complications (hypertension, preeclampsia, chorioamnionitis, etc.) 4) times of previous cesarean section ≥ 3 5) bmi ≥ 50kg/m2 is not suitable for tap block 6) allergies or contraindications to the drugs involved in the study 7) combined with operations other than tubal ligation and ovariectomy 8) severe renal function impairment (scr\>176 µ mol/l and/or blood urea nitrogen\>17.9 mmol/l), severe liver function impairment (alt and/or aspartate aminotransferase exceed 3 times the upper limit of normal value) 9) increased risk of coagulation dysfunction or bleeding (plt\ 1.5) 10) history of chronic pain or opiate abuse 11) other clinical trials in the last three months

Keywords: dexmedetomidine transversus abdominis plane block
the leadless ii ide study for the aveir vr leadless pacemaker system

Conditions: Cardiac Rhythm Disorder; Bradycardia

Summary: prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the aveir lp system in a subject population indicated for a vvi(r) pacemaker.


Eligibility criteria:
inclusion criteria: 1. subject must have one of the clinical indications before device implant in adherence with medicare, acc/aha/hrs/esc single chamber pacing guidelines including: * chronic and/or permanent atrial fibrillation with 2° or 3° av or bifascicular bundle branch block (bbb block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or * normal sinus rhythm with 2° or 3° av or bbb block and a low level of physical activity or short expected lifespan (but at least one year); or * sinus bradycardia with infrequent pauses or unexplained syncope with ep findings; and 2. subject is ≥18 years of age; and 3. subject has a life expectancy of at least one year; and 4. subject is not enrolled in another clinical investigation; and 5. subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and 6. subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by the irb/ec; and 7. subject is not pregnant and does not plan to get pregnant during the course of the study. exclusion criteria: 1. subject has known pacemaker syndrome, has retrograde va conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or 2. subject is allergic or hypersensitive to \< 1 mg of dexamethasone sodium phosphate (dsp); 3. subject has a mechanical tricuspid valve prosthesis; or 4. subject has a pre-existing endocardial pacing or defibrillation leads; or 5. subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy (crt) device; or 6. subject has an implanted vena cava filter; or 7. subject has evidence of thrombosis in one of the veins used for access during the procedure; or 8. subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or 9. subject has an implanted leadless cardiac pacemaker or 10. subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators).

Keywords: bradycardia pacemaker leadless
effect of tacrolimus formulation on neurological side effects in older kidney transplant recipients

Conditions: Kidney Transplant; Complications; Toxicity; Drug Toxicity; Neurotoxicity

Summary: previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.

the investigators will conduct a single-center, prospective, open-label, randomized study to evaluate the difference in neurocognitive side effects between envarsus and immediate release tacrolimus. eligible patients will be enrolled within 8 weeks post-transplantation. they will be administered a baseline panel of neurocognitive tests. they will then be randomized to either continue on immediate release tacrolimus or envarsus. 6 weeks after randomization, the neurocognitive tests will be repeated.

Eligibility criteria:
inclusion criteria: 1. recipient of a kidney transplant 2. age 60 or greater at the time of transplant 3. kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant 4. have ir tacrolimus as maintenance therapy 5. have bmi \< 35 at time of transplant 6. achieve therapeutic tacrolimus level within 4 weeks post-transplant exclusion criteria: 1. recipient of a simultaneous non-kidney transplant (pancreas) 2. had an episode of rejection before study enrollment 3. had a tia/cva after transplantation and before study enrollment 4. had a neurologic injury after transplantation and before study enrollment 5. blindness 6. have an mtor inhibitor as maintenance therapy 7. nonadherence, as determined by a trough level less than 7 ng/ml after achieving therapeutic level with no other rationale for sub-therapeutic levels. 8. adults unable to consent 9. pregnant women 10. prisoners

Keywords: elderly neurotoxicity calcineurin inhibitors tacrolimus
effect of web-based training with thyroidectomy patients

Conditions: Thyroidectomy; Education; General Surgery; Patient

Summary: this study evaluates the effect of an internet website, created by the nurse for the purpose of internet-based training related to perioperative period, on the anxiety and postoperative recovery measures (length of hospitalization, first oral feeding time, first mobilization time, first defecation time, first gas release, pain, nausea, vomiting, re-admission) of thyroidectomy patients. for this, while the experimental group will educate via the internet, the control group will take rutin care.

today, due to changing guidelines, current approaches, and new paradigms, the approach to thyroid surgery has become more sensitive and selective. besides, thyroid surgery has increased due to the increase in thyroid cancer and early detection of thyroid nodules. in a comprehensive study conducted by the thyroid cancer association with 2398 patients in 35 countries, it is found that 92.6% of the patients did not receive psychological support, 84.1% did not receive institutional information, and 63.0% did not receive written information about the disease or treatment. thyroidectomy patients are known to experience postoperative complications and symptoms such as hypocalcemia, hoarseness, dysphagia, drowsiness, or restricted neck/shoulder movement. therefore, informing thyroidectomy patients about the surgical process will facilitate the management of the process. in addition to this, due to the increasing use of the internet with the developing technology, the behaviors of the patients searching for information from the internet are increasing day by day. it has been found that the rate of searching for health information from the internet is 68-72% in the world. under this scope, this study will evaluate the effect of the web-based training on with thyroidectomy patients

Eligibility criteria:
inclusion criteria: * older than 18 years and old, * had planned surgery, * speaks and understands turkish, * are literate, * learned to have surgery at least one day before surgery, * had first thyroidectomy, * had total bilateral thyroidectomy, * had internet connection at home or phone and * had computer tablet or smartphone. exclusion criteria: * are mentally handicapped, * are visual, hearing and speech impaired and * had psychiatric illness