Kornimate/medical-research-clean huggingface dataset:
longitudinal study of symptoms in colorectal cancer

Conditions: Colorectal Cancer

Summary: the goal of this research study is to learn more about the pain and/or other symptoms that patients may experience within five years from crc diagnosis. researchers also want to learn how genetic differences may affect the symptoms patients experience from cancer and cancer therapy.

if you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled visit. the questionnaires are designed to measure pain and other symptoms, your mood, and your quality of life. you will also give a tissue sample by inserting a cotton tipped swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about 1 minute at the most. completing the 5 questionnaires and the swab sample should take about 30 minutes. length of study: after you complete the questionnaires and the swab sample collection, your active participation in this study will be over. this is an investigational study. up to 500 patients will take part in this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. patients with colorectal cancer meeting one of the following criteria: 1. naive to oxaliplatin or to any microtubule stabilizing agents (e.g. taxol, abraxane, ixabepilone) but scheduled for combined oxaliplatine chemotherapy (longitudinal study cohort 1); or 2. during first 5 years from colorectal cancer diagnosis (cross-sectional study cohort). this second cohort may include patients with colorectal cancer from the original 12-month study (the longitudinal cohort), both those who completed the study and those who dropped out. it may also include new patients who did not participate in the longitudinal phase of the study. 2. patients \>= 18 years old. 3. patients who speak english or spanish. exclusion criteria: 1. cohort 1 patients with a neuropathy score of 1 or greater on the nci's common terminology criteria (ctcv3.0). 2. patients who do not understand the intent of the study. 3. cohort 1 patients unable to use the interactive voice response (ivr) system due to physical limitations (e.g., hearing impairment). 4. cohort 1 patients with a history of inflammatory bowel disease.

Keywords: colon cancer cancers of the colon and rectum oxaliplatin oxaliplatin chemotherapy inflammatory cytokines neurocognitive symptoms neuropsychiatric symptoms
high altitude cardiovascular research latin america population study

Conditions: Hypertension; Cardiovascular Risk Factor; Altitude Hypoxia; Altitude Sickness; Erythrocytosis; Sleep

Summary: high blood pressure (bp) is one of the principal cardiovascular risk factors. while bp levels and hypertension prevalence are well characterized in many populations, information on bp and on cardiovascular risk profile in high altitude inhabitants is limited and frequently contradictory, especially in the large highland populations of south america. the information on the effects of permanent high altitude exposure on cardiovascular variables including bp may be relevant in the light of the known bp-increasing effect of acute exposure to high altitude hypoxia. this information may have practical implications for millions of people living at elevated altitudes in asia, south america and africa. the inconclusive epidemiological evidence on bp and cardiovascular risk in high altitude dwellers may be the result of several factors, among them: 1) confounding by genetic and socio-economic factors; 2) imperfect methods of bp evaluation, in particular lack of data on ambulatory and home bp (both methods considered superior to conventional clinic bp in the assessment of exposure to high bp). on this background, the general aim of the study is to compare blood pressure levels and cardiovascular risk profile among population-based samples of subjects residing in peruvian communities living at different altitudes.


Eligibility criteria:
inclusion criteria: * adult (\>18 years) male and female subjects; * highlanders: permanence at high (\>2500 m) altitude; * lowlanders: permanence at low (\<1500 m) altitude; * written informed consent to participate in the study exclusion criteria: * lowlanders who over 3 months preceding inclusion in the study spent considerable (\> 7 consecutive days) amount of time at altitudes above 1500 m; * highlanders who over 3 months preceding inclusion in the study spent considerable (\>7 consecutive days) amount of time at altitudes below 2500 m; * subjects cognitively incapable of providing informed consent or responding to a questionnaire * physical disability that would prevent study assessments from being performed * active pulmonary tuberculosis * pregnancy

Keywords: ambulatory blood pressure monitoring echocardiography
acute control of chronic hypertension

Conditions: Preeclampsia With Severe Features; Chronic Hypertension in Obstetric Context

Summary: the purpose of this study is to understand if administration of a personalized dose of the anti-hypertensive medication, labetalol, based on patient's history of preexisting hypertension, will be more effective at controlling severe hypertension during pregnancy, compared to the current standard dosing.

the investigators seek to asses the effect of preexisting hypertension on the patient's response to treatment for severe hypertension in preeclampsia with severe features. the investigators hypothesize that successive administration of 40-60-80 mg of labetolol will reduce time to blood pressure control versus the standard dosing, 20-40-80 mg labetolol, recommended by the american college of obstetricians and gynecologists in 2015.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * gestational age ≥ 24 weeks * singleton gestation * chronic hypertension as defined as two elevated blood pressures (sbp ≥ 140mmhg and/or dbp ≥ 90mmhg) at least 4 hours apart before 20 weeks gestation exclusion criteria: * known allergic reaction to labetalol * persistent mild-moderate asthma (≥ 2 rescue inhaler uses per week in the previous month) * obstructive airway disease * bradycardia \< 70 beats/min * heart block \> 1st degree or history of heart failure

Keywords: hypertension labetalol
a decade of sleeve gastrectomy: analysis of short and long-term outcome of 562 patients

Conditions: Morbid Obesity; Obesity; Diabetes; Dyslipidemia; Hypertension

Summary: obesity is a chronic disease and its treatment requires close follow-up to accurately assess the efficacy and durability of any treatment strategy. it is widely accepted that bariatric surgery patients require lifetime follow-up to assess for weight loss, co-morbidity changes, and nutritional deficiencies. the study objective was to ascertain efficacy of weight loss and complication rates in 562 consecutive cases of laparoscopic sleeve gastrectomy (lsg) in a single surgeon practice.

obesity is a major healthcare problem reaching epidemic proportion and affecting people of all age (1). the only treatment that proven effective option for a significant substantial long-term weight loss and that cures or durably improves comorbidities is still bariatric surgery (2, 3). because obesity is a chronic disease, it is widely accepted that to accurately assess the efficacy and durability of any type of bariatric surgery requires lifetime follow-up to assess for weight loss, co-morbidity changes, and nutritional deficiencies. despite initially performed as a first part of the staged procedures, the laparoscopic sleeve gastrectomy (lsg) has since introduced as a stand-alone bariatric operation associated with good, short and mid-term weight loss and satisfactory complication rates when conducted in experienced hands. although simplicity and the overall efficacy of the procedure supported by meta-analysis and systematic review (4, 5), there are still limited long-term outcome data (6). due to publication bias or multiple controversies regarding the technique of lsg, some of the available data may have underreported which has also been resulted in questioning the long-term weight loss efficacy of the procedure. although addressed by a recent consensus document,12 there are multiple controversies regarding the technique of lsg, and this may in part be what has led to the variable published results. the study objective was to assess the long-term (≥ 5 years) as well as short (1 to ≤ 3 years) and mid-term (\> 3 to \< 5 years) results in regard to the bmi change, resolution of co-morbidities and complications in 562 consecutive morbidly obese patients undergoing lsg as a primary procedure.

Eligibility criteria:
inclusion criteria: * underwent lsg for morbid obesity and related morbidities as a primary procedure exclusion criteria: * previous history of obesity surgery

Keywords: sleeve gastrectomy laparoscopy bariatric surgery obesity surgery metabolic surgery
platelet-rich plasma injections for persistent medial knee pain after total knee arthroplasty

Conditions: Knee Pain Chronic; Pes Anserinus Bursitis; Status-Post Total Knee Arthroplasty

Summary: this study will investigate the potential effects of platelet rich plasma for the treatment of persistent medial knee pain after total knee arthroplasty. all study participants will receive prp injections and will be followed up to see if any benefit in regards to pain and/or function is achieved.

this study aims to investigate the efficacy of platelet-rich plasma (prp) injections for the treatment of persistent medial knee pain after total knee arthroplasty (tka). the investigators hypothesize that prp injections will provide meaningful pain relief and improved functionality for patients suffering from post-tka residual pain. the incidence of residual pain after tka ranges between 10-34%. many of these patients can be effectively managed by physical therapy, orthotics, and pes anserine bursa corticosteroid injections. however, there remain a number of refractory cases that are frustrating for both the patient and physician. with the advent of interventional pain management, advanced interventions for this clinical problem have focused on selective nerve blocks and ablations targeting the infrapatellar branch of the saphenous nerve. more recently, attention has been paid to the role of patient biology and inflammatory mediators in the development of post-arthroplasty pain (including il-6 and crp). if individual patient biology is the foundation of post-tka pain, then biologic interventions aimed at restoring the balance of these mediators (such as prp), rather than ablative procedures, seems preferable. furthermore, while intra-operative prp has been studied for its effects on wound healing, blood loss, and post-operative pain control, no study has investigated its utility in treating residual medial knee pain after tka. all injections will be performed by the same board-certified sports medicine and musculoskeletal ultrasound physician. there will be no activity restrictions following the procedure. descriptive statistics will be used to report mean changes in outcome scores. data will be analyzed with a 2-sample t-test.

Eligibility criteria:
inclusion criteria: 1. person has had a total knee arthroplasty (total knee replacement) 2. has experienced persistent medial knee pain beyond six months after surgery 3. has the presumed diagnosis of pes anserine bursitis 4. no pain relief with conventional treatments such as arch supports (if one is flatfooted), nsaid's, and at least two local steroid injections exclusion criteria: 1. person has had a prior knee surgical procedure other than the total knee arthroplasty or an arthroscopic debridement procedure 2. evidence of knee instability, prosthetic loosening, knee infection, radiculopathy, or hip or back pain 3. personal history of chronic narcotic or recreational drug use, smoking, psychiatric disorders, or a total hip arthroplasty on the same side of the knee arthroplasty 4. body mass index (bmi) of greater than 35

Keywords: chronic knee pain status-post total knee arthroplasty platelet rich plasma
pediatric pilot study: irrigation and scrubbing in facial and scalp wounds

Conditions: Facial and Scalp Lacerations

Summary: most pediatric lacerations occur indoors and are considerably noncontaminated. wounds that occur outside of the house where dirt often enters the laceration, irrigation and scrubbing with soap has been proven effective at decreasing post-laceration infections. to date there are no pediatric prospective studies addressing a less aggressive approach to face and scalp wound preparation in pediatrics. we argue that wiping wounds with sterile gauze soaked in sterile saline will not increase infection rates as compared to our current practice. in our emergency departments, the current standard of care for all lacerations is aggressive wound preparation: irrigation and scrubbing. this occurs regardless if the wound is contaminated or not. research has proven that irrigation and scrubbing is unwarranted in adults with face and scalp lacerations. we want to perform a pilot/feasibility study comparing our two emergency campuses. one campus will serve as the control site, while the other will be the intervention site. in this pilot study, our goal is to demonstrate the feasibility of the intervention and provide data that a less aggressive approach to wound preparation is just as effective as our standard of care. we hope this project leads to further discussion about how we manage noncontaminated lacerations and provides a stepping-stone to a larger, appropriated powered study.


Eligibility criteria:
inclusion criteria: 1. facial and scalp wounds acquired by blunt trauma, 2. wounds incurring within a house or indoor gym, 3. all ages, 1 month to 20 years of age. scalp is defined as the skin covering the head. the face is the area anterior to the ears, below the chin and extending to the hairline of the forehead. wounds requiring deep sutures will also be included. exclusion criteria: 1. patients presenting with wounds that occur outdoors, 2. wounds greater than 12 hour old, 3. immunocompromised, malnourished or a diabetic, 4. intoxicated, 5. currently on antibiotics, 6. sickle cell anemia, 7. collagen vascular disease, 8. wounds requiring plastic surgery, 9. wounds from human or animal bites, 10. wounds not on the face or scalp, 11. patient's just discharged from the hospital within 72 hours, 12. wounds with foreign bodies or grossly contaminated, 13. no suture nurses are present or available to suture.
study of voy-101 in patients with advanced non-neovascular age-related macular degeneration

Conditions: Age-related Macular Degeneration; Geographic Atrophy

Summary: this safety study comprises a dose escalation study of voy-101, followed by a cohort of subjects randomized to the maximum tolerated dose arm, a lower dose arm, and control arm.

this is a prospective, multi-center safety phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (ivt) injection of three dose levels of voy-101 therapy in subjects with late-stage non-neovascular age-related macular degeneration (amd).

Eligibility criteria:
inclusion criteria: 1. are ≥50 years of age at the time of consent. 2. are willing and able to understand and provide written informed consent. 3. are willing and able to return for scheduled treatment and follow-up examinations. 4. are able to undergo etdrs bcdva testing and ophthalmic imaging. 5. well-demarcated ga secondary to amd in the absence of mnv and in the absence of history of mnv. 6. absence of signs of non-exudative mnv. 7. additional ocular inclusion criteria 8. meet certain genotype criteria for risk of amd. exclusion criteria: 1. are women of childbearing potential (wocbp) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study. 2. additional systemic, ocular, and genetic exclusion criteria.
study of ld013 in subjects with refractory or relapsed mesothelin -positive ovarian cancer

Conditions: Ovarian Cancer

Summary: early-stage clinical study of mesothelin-specific chimericantigen receptor t cells (ld013) in subjects with refractory or relapsed mesothelin-positive ovarian cancer

this is a single-arm, open, dose-increasing, and extended early-stage clinical study of mesothin-specific chimeric antigen receptor t cells (ld013) in patients with mesothelin-positive drug-resistant relapsed ovarian cancer. this study included two phases: dose escalation and extension.

Eligibility criteria:
inclusion criteria: fully understand and voluntarily sign informed consent. * aged at least 18 years old，female. * expected survival \> 12weeks. * eastern cooperative oncology group (ecog) score 0or1. * staining of mesothelin must be greater than 50% of the cells in the tumor tissue and with apparent expression in the membrane. tissue obtained for the biopsy must be ≤2year prior to enrollment for screening, not have been previously irradiated or exposed to chemotherapy. if unavailable, new tissue material from a recently obtained surgical or diagnostic biopsy is mandatory for this trial； exclusion criteria: * prior treatment with any cart therapy targeting any target. * subjects with severe mental disorders. * subjects with other malignant tumors. * patient is positive for syphilis, human immunodeficiency virus (hiv) , active hepatitis b (hbsag reactive) or hepatitis c (hcv rna (qualitative) is detected). * detectable clinically relevant central nervous system (cns) metastases and/or pathology such as epilepsy/seizure, brain ischemia/ hemorrhage, dementia, cerebellar disease, or autoimmune disease affecting central nervous system； * patients with ongoing or active infection. * subjects not appropriate to participate in this clinical study judged by investigators.
prevention of recurrence after thrombolysis in acute iliofemoral venous thrombosis (prais) study

Conditions: Ileofemoral Deep Vein Thrombosis

Summary: the einstein program showed that oral rivaroxaban is effective and safe treatment for prevention of recurrent venous thrombosis and pulmonary embolism in deep vein thrombosis patients and fda approved the rivaroxaban for prevention and treatment of deep vein thrombosis (nov 2 2012). recently, catheter-directed thrombolysis can significantly reduce post-thrombotic syndrome, and more and more centers introduce catheter-directed thrombolysis to treat proximal (i.e, iliofemoral) dvt. however, the einstein program excluded patients with deep vein thrombosis if they had been treated with a vena cava filter or a fibrinolytic agent for the current episode of thrombosis. although catheter-directed thrombolysis (cdt) or pharmacomechanical thrombolysis has now been accepted as a treatment of choice in iliofemoral dvt, thrombolysis has an inherent risk of bleeding. therefore, patients who have completed cdt and have been stabilized at least 24 hours after thrombolysis will be included in this study. also, the investigators want to explore the efficacy and safety of rivaroxaban in patients with iliofemoral dvt after catheter-directed thrombolysis and/or a vena cava filter insertion and/or venous stent insertion and compare these outcomes with warfarin treatment alone. this study will be a pilot study to establish the safety and efficacy parameters for further studies.


Eligibility criteria:
inclusion criteria: * age 18-75 years * onset of symptoms within the past 21 days * objectively verified (by ct venography) deep vein thrombosis localized in the iliofemoral segment * complete catheter-directed thrombolysis and/or a vena cava and/or venous stent insertion * informed consent exclusion criteria: * incomplete catheter-directed thrombolysis * if patients received more than a single dose of a warfarin before randomization * contraindicating anticoagulant treatment * another indication for a warfarin * an estimated glomerular filtration rate by mdrd equation \<30ml/min * clinically significant liver disease (acute hepatitis, chronic active hepatitis, cirrhosis) * alanine aminotransferase \> 3-time higher than upper limit of the normal range * bacterial endocarditis * active bleeding or high risk of bleeding * pregnancy or breast-feeding * concomitant use of strong cytochrome p-450 3a4 inhibitors or inducers

Keywords: anticoagulation pharmacomechanical thrombolysis aspiration thrombectomy
expanded pk and pd of insulin glulisine versus insulin aspart in healthy volunteers

Conditions: Diabetes

Summary: the purpose of this study was to compare the pharmacodynamics (course of the blood glucose-lowering effect and duration of effect) and pharmacokinetics (course of the concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg of insulin glulisine and insulin aspart in a direct head-to-head comparison during two euglycemic glucose clamps in healthy subjects.

in a previous glucose clamp study with a head-to-head comparison of insulin glulisine and insulin lispro it was shown that the onset of metabolic action was significantly shorter with insulin glulisine than with insulin lispro (while the total metabolic effect was not different). these results were in line with a faster early insulin exposure of insulin glulisine compared to insulin lispro. the primary aim of this study was to investigate whether or not these favorable characteristics of insulin glulisine were also evident in the comparison against insulin aspart. this was the first clinical study realizing a head-to-head comparison between these two insulin analogs.

Eligibility criteria:
inclusion criteria: * overtly healthy males or females (women: contraception, pearl index \<1%) * between the ages of 18 and 65 years * body mass index of \<= 27 kg/m² * safety lab within reference range * normal blood pressure and heart rate * sufficient venous access * written informed consent approved by the ethical review board * hba1c and fasting plasma glucose in the normal range exclusion criteria: * investigative site personnel directly affiliated with this study and their immediate families or the sponsor´s employees * within 30 days of the initial dose of study drug had received treatment with a drug that had not received regulatory approval * known allergies to insulin or related compounds * regular treatment with any drug, both over-the-counter or prescribed * an abnormality in the 12-lead ecg increasing the risk for participation * history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs * significant active neuropsychiatric disease * regular use of drugs of abuse and or positive findings on urinary drug screening * evidence of hiv and/or positive antibodies 1 or 2 and or hiv1 antigen * evidence of hepatitis b and/or positive hepatitis c antibody * evidence of hepatitis b and/or positive hepatitis b surface antigen * women with a positive pregnancy test or breastfeeding women * blood donation more than 500 ml within the last 3 months

Keywords: diabetes