Kornimate/medical-research-clean huggingface dataset:
a study evaluating the safety and pharmacokinetics of abbv-075 in subjects with cancer

Conditions: Cancer; Breast Cancer; Non-Small Cell Lung Cancer; Acute Myeloid Leukemia (AML); Multiple Myeloma; Prostate Cancer; Small Cell Lung Cancer; Non-Hodgkins Lymphoma

Summary: this is a phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended phase 2 dose of abbv-075 at different monotherapy dosing schedules. in addition the study will evaluate the safety. tolerability and the pharmacokinetics of abbv-075 monotherapy or combination therapy in disease specific expansion cohorts.


Eligibility criteria:
inclusion criteria: 1. participant in the dose escalation cohorts must have histological confirmation of locally advanced or metastatic solid tumor that is either refractory after standard of care therapy for the disease or for which standard of care therapy or does not exist. 2. participants in the expansion cohorts must have histological confirmation of aml, multiple myeloma, breast cancer, nsclc, prostate cancer, sclc, or nhl that is either refractory after standard of care therapy or for which standard of care therapy does not exist. 3. participant must have an eastern cooperative oncology group (ecog) performance status of: 0 - 1 (dose escalation cohorts) or 0 - 2 (expansion cohorts) 4. participants in the dose escalation cohort must have a serum albumin of ≥ 3.2 g/dl at screening. 5. adequate bone marrow, renal, and hepatic function. 6. qtc interval \< 480 milliseconds (msec) on the baseline electrocardiogram. exclusion criteria: 1. participant has untreated brain or meningeal metastases. 2. participant has received anti-cancer therapy including chemotherapy, immunotherapy, biologic or any investigational therapy within a period of 21 days prior to study day 1. 3. participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis. 4. symptoms of gross hematuria or gross hemoptysis. 5. exhibits symptomatic or persistent, uncontrolled hypertension (bp \> or = to 140 and/or diastolic pressure of \> or = to 90 mm hg). 6. history of long qt syndrome. 7. peripheral neuropathy greater than or equal to grade 2.

Keywords: cancer bromodomain inhibitor
real-world study on the management of hematological toxicities associated with targeted therapies for breast cancer

Conditions: Hematological Toxicity; Targeted Therapy; Breast Cancer

Summary: this multicenter, real-world, observational study will retrospectively and prospectively collect real-world data related to the investigational drugs. we plan to observe 1000 patients and collect data on treatment cycles n and n+1 of the targeted therapies. retrospective data collection is based on existing patient diagnosis and treatment records, collecting information on patients who have completed two treatment cycles before january 1, 2024. prospective data collection is based on routine clinical treatment during the study period, collected until the end of the next cycle of treatment or early termination of the study. to observe the disease characteristics and management mode of hematological toxicity related to targeted therapies of breast cancer, and explore the possible related factors of hematological toxicity, such as age, disease subtype, cancer stage, targeted therapy regimens, etc. this study will respect the medication choices of researchers in the study, without specifying which medication to choose for treatment, dosage, mode of administration (including single drug, combination therapy, or sequential therapy), and duration of administration.


Eligibility criteria:
inclusion criteria: * · the patients signed the informed consent and voluntarily participated in the study. * a definite diagnosis of any type of breast cancer. * receiving or has completed targeted therapies. * investigator judged that the patient need to receive or had received treatment or prevention for ctit, cin or cra induced by targeted therapies. exclusion criteria: * · pregnant or lactating women. * failure to understand the study or to obtain informed consent. * the investigator determined other situations that are not suitable for inclusion.

Keywords: hematological toxicity targeted therapy breast cancer
fluid responsiveness using forehead sensor in children

Conditions: Hypovolemia

Summary: forehead sensor can predict the more accurate fluid responsiveness than finger sensor in children

the investigator hypothesized that the forehead sensor can predict the fluid responsiveness more accurate than the finger sensor in pediatric patients.

Eligibility criteria:
inclusion criteria: * pediatric patients undergoing general anesthesia for neurosurgery, major abdominal surgery, and cardiac surgical procedures. exclusion criteria: * preoperative ejection fraction \<30% * underlying lung disease * cardiac arrhythmia
pain study of rectus muscle closure at cesarean delivery

Conditions: Pain

Summary: suture reapproximation of the rectus muscles at primary cesarean delivery is a common practice about which there are no data. some obstetricians believe that suture reapproximation of the rectus muscles increases post-operative pain, and it may decrease adhesions, yet there are no published data to support or refute these claims. the purpose of this study is to assess the effect of rectus muscle reapproximation at cesarean delivery and post-operative pain. we also plan to assess the impact of rectus muscle closure on adhesions as seen at repeat cesarean delivery.

there are more than 1 million cesarean deliveries performed annually in the united states, at a rate of 30.2% of all deliveries. data are limited regarding optimal surgical closure techniques to minimize adhesions at cesarean. adhesions are implicated in pelvic pain, infertility, difficult repeat surgery, and bowel obstruction. practice techniques regarding rectus muscle reapproximation vary widely, and there are no data regarding the impact of this step on pain, and some data suggesting a reduction in significant adhesions. given the frequency of cesarean deliveries, small changes in surgical technique may yield significant benefits. we hope to learn 1) whether suture reapproximation of the rectus muscles increases pain, and 2) the degree to which suture reapproximation of the rectus muscles alters adhesions when studied in a prospective, randomized trial. all patients undergoing primary cesarean delivery at lucile packard childrens hospital (lpch) will be offered the study. once consented, patients will be randomized to one of two standardized closure techniques at cesarean: two-layer uterine closure, peritoneal closure, fascial and skin closure, and either reapproximation of the rectus muscles with three-interrupted sutures, or non-closure. intra-operative and post-operative pain management will be standardized. subjects will undergo pain assessments while in-house on post-operative days 1 and 3, and at the standard post-partum clinic visit after 6 weeks. these assessments will require less than 5 minutes of the patient's time. patients will be shown a pain chart, and will be asked to rate their pain on a scale of 0 to 10 at rest. they will then stand up and rate their pain again. pain medication usage will also be assessed. the surgeons will know the groups to which the patients are randomized. the patients and those collecting data on pain scores will not. primary endpoint: combined opioid use and movement pain score (silverman integrated assessment-sia) 72 post-operative hours. secondary endpoint: surgical complications, maternal satisfaction with analgesia.

Eligibility criteria:
inclusion criteria: 37 weeks gestation primary cesarean american society of anesthesiologists (asa) class 1 or class 2 exclusion criteria: chronic analgesia use vertical skin incision at cesarean opioid or non-steroidal anti-inflammatory drugs (nsaid) allergy bmi \>40 labor
folfox6 as neoadjuvant chemotherapy in local advanced gastric cancer

Conditions: Gastric Cancer; Effects of Chemotherapy; Surgery

Summary: purpose: this aim of the study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with the modified folfox6(mfolfox6) regimen and its impact on survival on a series in local advanced gastric cancer patients. patients and methods: the study is a prospective non-randomized study. patients with histopathologically confirmed and locally advanced gastric cancer(t2-t4 or n+) are enrolled in the study. patients are given mfolfox6 scheme for 3 cycles.a radical gastrectomy and a d2 lymphadenectomy was will be scheduled 3-6 weeks after the completion of the preoperative chemotherapy. down-staging is assessed comparing pretreatment clinical staging with postoperative pathologic staging on patients who underwent radical surgery. tumor down-staging and the grade of pathologic response are included in a statistical correlation between tumor regression induced by mfolfox6 neoadjuvant chemotherapy and survival.the primary endpoint is 3-year overall survival, secondary endpoints are disease-free survival, r0 resection rate, toxicity and prediction of response.


Eligibility criteria:
inclusion criteria: eligibility criteria included histologically confirmed gastric cancer, the gastro-oesophageal junction(gej) may be involved, but the bulk of the tumour has to be in the stomach; age ≥18 years old, ecog performance status score ≤2, no prior chemotherapy, tnm stage of t2-t4 or positive regional lymph nodes by endoscopic ultrasound or computed tomography (ct), and adequate hematological, heart, liver and renal functions (alt and ast≤2.5 unl, total bilirubin ≤1.5 unl, and serum creatinine ≤1.5 unl). exclusion criteria: patients with second malignancies or evidence of severe or uncontrolled systemic disease were excluded.
mesalamine for uncomplicated diverticular disease: a randomized, double-blind, placebo-controlled study

Conditions: Colonic Diverticulosis

Summary: the purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.


Eligibility criteria:
inclusion criteria: * diagnosis of diverticular disease with acute pain without serious complications * lower abdominal pain of moderate or severe intensity at least during the last 4 days before study inclusion exclusion criteria: * chronic inflammatory bowel disease * fever or other signs of serious complications.

Keywords: diverticular disease colonic diverticulosis mesalamine placebo randomized
oxidative stress and oxysterols profiling in patients with carotid revascularization

Conditions: Carotid Stenosis; Cardiovascular Disease; Atherosclerosis; Stroke

Summary: the combination of aspirin and dipyridamole, two antiplatelet drugs, is approved in italy for the secondary prevention of cerebral embolism in patients with carotid atherosclerosis. besides antiplatelet activity, dipyridamole has additional pharmacological action, including vasodilation and antioxidant properties. a role for oxidative stress has been suggested in acute cerebrovascular disease. in this study the investigators want to test the in vivo antioxidant activity of dipyridamole in patients who are candidate to take the drug under approved conditions of the italian drug regulation agency, i.e. secondary prevention of tia/stroke in patinets with carotid stenosis (\>= 70%). to test the hypothesis that dipyridamole acts as antioxidant in vivo, oxysterols (products of cholesterol autoxidation) and vitamin e are measured in plasma before and after 6 months therapy after carotid endoarterectomy. since dipyridamole is approved as combination preparation with aspirin, a control group of patients taking aspirin alone is enrolled. outcome measures: plasma biomarkers (oxysterols and vitamin e) change at two time points: baseline and 6-months therapy.

dipyridamole has been shown to act as potent antioxidant in vitro. the aim of the present study is to analyze if dipyridamole retains the antioxidant in vivo in man. the investigators identified a clinical setting where dipyridamole is approved for clinical use, i.e. secondary prevention of stroke, to test the hypothesis that dipyridamole given orally could affect circulating markers of oxidative stress, in particular reduction in oxysterols (autoxidation products of cholesterol) and increase in vitamin e concentration. methods. two arms are included in the study: a) dipyridamole plus aspirin (in italy the use of dipyridamole is approved in combination with aspirin); b) aspirin alone as comparison arm. patients eligible for endoarterectomy for the presence of carotid stenosis \>= 70% are randomized in the two arms. the study is open labeled for the patient and clinical investigators who have in charge the patinets . the study is blinded for the technicians performing biomarker assessment and investigators responsible for data analysis. blood is taken at baseline (before surgery) and after six months of treatment. oxysterol profiling and vitamin e are measured by isotope dilution gas chromatography and mass spectrometry.

Eligibility criteria:
inclusion criteria: * patients with carotid atherosclerosis eligible for carotid endoarterectomy (stenosis \>= 70%) with previous tia or stroke exclusion criteria: * congestive heart failure, chronic liver disease, chronic kidney disease (gfr \< 60%), cancer, use of antioxidant supplements in the previous 3 months, autoimmune diseases

Keywords: oxidative stress atherosclerosis carotid stenosis oxysterols vitamin e lipid peroxidation antioxidants aspirin dipyridamole
transsphincteric fistula management using lift and maf

Conditions: Perianal Fistula

Summary: a study that detect the most suitable surgical techniques for treating transsphincteric fistula

we compared between lift and maf in elderly with paf

Eligibility criteria:
inclusion criteria: * elderly persons with paf exclusion criteria: * recurrent fistula * associated autoimmune diseases

Keywords: perianal fistula,flap,ligation
de-escalation of ticagrelor in post ppci

Conditions: Ticagrelor

Summary: primary objective: to evaluate the efficacy and safety of de-escalation to lower dose ticagrelor (60 mg bid) plus aspirin (75 mg od) versus continuation of standard dose ticagrelor (90 mg bid) plus aspirin (75 mg od), 1 month after primary pci for stemi, in diabetic patients. secondary objectives: to compare tolerability and discontinuation of ticagrelor in both doses. to compare the 1ry safety \& efficacy endpoints in subgroups with different thrombotic/ischemic risk

\[15:42, 18/02/2023\] m taha: ticagrelor at a maintenance dose of 90 mg twice a day (bid) was shown to provide greater and more consistent platelet p2y12 inhibition than clopidogrel in patients with stable coronary artery disease (pa gurbal, kp bliden et al 2009) and acute coronary syndromes (acs) (rf storey, s husted et al 2007). the plato (platelet inhibition and patient outcomes) trial demonstrated the superior efficacy of ticagrelor, given at a maintenance dose of 90 mg bid, compared with clopidogrel for up to 1 year in patients with acs (l wallentin, rc becker et al 2009) \[15:42, 18/02/2023\] m taha: consequently, this regimen of ticagrelor is recommended in international guidelines as first-line therapy for up to 1 year following either non-st-segment elevation acs (p damman, aw van't hof et al 2017) or st-segment elevation myocardial infarction managed with primary percutaneous coronary intervention (pt o'gara, fg kushner et al 2013). in the pegasus-timi 54 trial, ticagrelor maintenance doses of 60 mg b.i.d and 90 mg b.i.d were clinically equally effective in stable patients more than 1 year after acute myocardial infarction (ami), with a better tolerability of treatment observed with the lower dose (bonaca mp, bhatt dl et al 2016). \[15:42, 18/02/2023\] m taha: n a pharmacokinetic \& pharmacodynamic substudy of the pegasus-timi 54 trial, ticagrelor 60 mg bid achieved high levels of peak and trough platelet inhibition in nearly all patients, similar to that with 90 mg bid, helping to explain the efficacy of the lower ticagrelor dose in the trial.1 most recently, in a pharmacodynamic randomized controlled study (electra), lowering ticagrelor maintenance dose to 60 mg b.i.d, on day 30 following acute mi, was shown to confer an adequate antiplatelet effect that is comparable to the standard maintenance dose of 90 mg b.i.d.2

Eligibility criteria:
inclusion criteria: diabetes mellitus. acute stemi. able to swallow tablets. exclusion criteria: patients presenting with stent thrombosis. hypersensitivity to ticagrelor and/or aspirin. active bleeding. arc-high bleeding risk status1. 2nd or 3rd degree av block. previous stent thrombosis on treatment with ticagrelor. pregnancy or lactation.

Keywords: post- ppci
dexmedetomidine supplemented intravenous analgesia in elderly after orthopedic surgery

Conditions: Elderly; Orthopedic Surgery; Analgesia; Dexmedetomidine; Postoperative Delirium; Long-term Outcome

Summary: delirium is common in the elderly after orthopedic surgery and is associated with worse outcomes. the investigators hypothesize that, for elderly patients after orthopedic surgery, dexmedetomidine supplemented intravenous analgesia can reduce the incidence of delirium and improve the long-term outcomes.

a growing number of elderly patients undergo orthopedic surgery each year. delirium is a common complication in these patients after surgery and is associated with worse outcomes, including prolonged hospital stay, poor functional recovery, decreased cognitive function, increased health care costs, and elevated mortality rate. previous studies showed that, for elderly patients admitted to the intensive care unit after non-cardiac surgery, low-dose dexmedetomidine infusion improved subjective sleep quality and reduced delirium early after surgery; it also increased survival up to 2 years and improved life quality in 3-year survivors. the investigators hypothesize that dexmedetomidine supplemented intravenous analgesia (in the form of patient-controlled analgesia) can also reduce delirium and improve long-term outcomes in elderly patients after orthopedic surgery.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years but \< 90 years; * scheduled to undergo total knee/hip replacement surgery, or spinal surgery; * planned to use patient-controlled intravenous analgesia (pcia) after surgery. exclusion criteria: * refuse to participate in this study; * preoperative history of schizophrenia, epilepsy, parkinsonism, or myasthenia gravis; * inability to communicate in the preoperative period because of coma, profound dementia or language barrier; * preoperative obstructive sleep apnea (diagnosed sleep apnea syndrome or a stop-bang score ≥3 combined with a serum bicarbonate ≥28 mmol/l); * sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker; * severe hepatic dysfunction (child-pugh class c); * severe renal dysfunction (requirement of renal replacement therapy before surgery); * american society of anesthesiologists physical status \>iv, or estimated survival ≤24 h.

Keywords: elderly orthopedic surgery analgesia dexmedetomidine postoperative delirium long-term outcome
multi-plane hallux valgus correction with the phantom® nail

Conditions: Arthrodesis; Bunion; Hallux Valgus

Summary: the goal of this research study is to determine the change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st tmt joint with the phantom® intramedullary nail combined with a supinating reduction technique. the study hypothesis is that multi-planar correction can be achieved with the phantom® intramedullary nail.

each subject will undergo a lapidus arthrodesis combined with a supinating reduction technique. the subjects will undergo 3 weight-bearing cbct scans of their foot and ankle, one pre-arthrodesis, one two weeks post-arthrodesis, and one 12 weeks post-arthrodesis. these scans will be used to determine change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st tmt joint, change in angular/positional alignment of the 1st tmt joint using various measurements (1-2 ima, meary's angle, hva, maa, sesamoid position, and sesamoid frontal plane rotation), maintenance of correction of the 1st tmt joint, and union status. the subjects will also complete three surveys, the pain and satisfaction survey, the aofas hallux mtp-ip scale, and the faos foot and ankle survey, at the pre-operative visit, 2 week visit (post-op), 6 week visit (post-op), and 12 week visit (post-op). furthermore, the subjects will be asked about their willingness to undergo the procedure again at the 12 week visit (post-op). all of these scores will be considered in the secondary objectives. aside from the study activities listed above, all procedures, visits, and instructions for the subject are to follow the standard of care.

Eligibility criteria:
inclusion criteria: * the subject is at least 18 years of age at the time of screening. * the subject has been diagnosed with hallux valgus. * the subject has pain associated with hallux valgus. * the subject agrees to comply with the requirements of the study and complete the study measures. * the subject is willing and able to provide written informed consent. * the subject plans to undergo a lapidus arthrodesis procedure with a 3-hole phantom® intramedullary nail. exclusion criteria: * the subject is pregnant. * the subject has had previous surgery for hallux valgus on operative side. * the subject will require a structural graft in the 1st tmt joint. * the unshod foot in question is greater than 28 cm in length. * the subject is not expected to complete the study according to the investigation plan. * the subject has been deemed physiologically or psychologically inadequate by the enrolling physician. * the subject is a prisoner, unable to understand what participation in the study entails, mentally incompetent, a known abuser of alcohol and/or drugs, or anticipated to be non-compliant.

Keywords: bunion supinating reduction multi-plane lapidus arthrodesis intramedullary nail hallux valgus
study testing benefits of ursolic acid (ua) as a countermeasure to myopenia and insulin resistance in chronic spinal cord injury (sci)

Conditions: Spinal Cord Injuries; Tetraplegia; Paraplegia; Muscle Loss; Atrophy, Muscular; Insulin Resistance

Summary: this study will evaluate if ursolic acid supplementation may be effective in reducing muscle loss and improving blood sugar control in the sci community.


Eligibility criteria:
inclusion criteria: 1. male and female individuals with paraplegia having chronic (\> 1 year) motor-complete and incomplete (ais a/b/c) injuries from t2-t8 2. male and female individuals wi4.th chronic (\> 1 year) motor-complete and incomplete (ais a/b/c) injuries from c4-c7 exclusion criteria: 1. pregnant or planning to become pregnant 2. women who are breastfeeding
combination therapy for the treatment of bipolar disorders

Conditions: Bipolar Disorder

Summary: this study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.

early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders. these studies, however, do not include lithium-refractory subgroups, such as bipolar ii disorder patients. when the wide spectrum of bipolar disorders is considered, the lithium response rate decreases significantly. more broadly effective regimens are needed. participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium, divalproex, and lamotrigine for 7 months. symptoms of depression and mania will be assessed with scales and patient questionnaires.

Eligibility criteria:
inclusion criteria: * bipolar i or ii disorder * meet criteria for rapid cycling, defined as four or more episodes over the past 12 months * meet criteria for a major depressive episode exclusion criteria: * history of intolerability of lithium, divalproex, or lamotrigine

Keywords: depression