Kornimate/medical-research-clean huggingface dataset:
adjuvant chemotherapy in high risk stage ii colon cancer

Conditions: Stage II Colon Cancer; Adjuvant Chemotherapy

Summary: * benefit of adjuvant chemotherapy after curative surgery for stage ii colon cancer is still debated. several high-risk features may help to stratify stage ii cancer patients into groups that will truly benefit from adjuvant chemotherapy. however, those factors are rather subjective, and no specific trial has been designed to answer the high-risk stage ii colon cancer question directly. * immunoscore® colon, an in vitro diagnostic test, which quantifies the density of cd3+ and cd8+ t lymphocyte populations in the center the tumor (ct) and its invasive margin (im) using immunohistochemistry and automated image analysis. immunoscore® has been extensively validated as a prognostic biomarker in early stage cc patients. this unique diagnostic assay measuring host immune response at the tumor site may inform the decision to administer adjuvant chemotherapy in resected stage ii and iii cc patients. * this randomized trial is studying how observation compares to adjuvant chemotherapy (investigator's choice) in stage ii colon cancer patients with high-risk features and high-immunoscore®. the trial would represent a unique opportunity to classify stage ii cc patients based on their tumor microenvironment with the aim to provide efficient patient stratification to improve clinical care.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years old 2. pathologically confirmed adenocarcinoma of the colon 3. complete resection of the primary tumor without gross or microscopic evidence of residual disease 4. histologically proven stage ii: t3-t4 n0 5. at least one of the following factors:t4 staging,number of examined lymph nodes \< 12,poor differentiation (except msi-h),lvi or pni,tumor perforation or occlusion 6. treatment within 7 weeks following surgery 7. ecog ps 0-1 8. no prior chemo, immuno or radiotherapy 9. patients must read, agree to, and sign a statement of informed consent prior to participation in this study. exclusion criteria 1. have a birth plan during the clinical trial; 2. severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (nyha 2-4), and arrhythmia requiring drugs intervention; 3. dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire; 4. subjects with ≥1 peripheral neuropathy according to ctcae v version 4.03; 5. allergy or hypersensitivity history of the drug or drug ingredient used in this test; 6. excluding other malignant tumors, cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or any other part of the carcinoma in situ; 7. have received any other test drug treatment or participated in another interventional clinical trial within 30 days of the screening period; 8. the investigator believes that it is not suitable for inclusion.

Keywords: stage ii colon cancer adjuvant chemotherapy high-risk factors high-immunoscore®
evaluating the effectiveness of intervention based on the model of occupational harmony in patients with crswd

Conditions: Circadian Rhythm Sleep-Wake Disorder

Summary: the goal of this clinical trial is to learn the effectiveness of an intervention based on the model of occupational harmony (mohar) in treating patients with circadian rhythm sleep-wake disorders (crswd). the main questions it aims to answer are: * does intervention based on the mohar can improve sleep quality in patients with crswd? * does intervention based on the mohar can improve the quality of life in patients with crswd? researchers will compare intervention based on the mohar to conventional treatment to see if the intervention works to treat crswd. participants will: * participate in an occupational therapy program for 6 weeks (including group therapy, individual treatment, and daily occupational tasks) * complete questionnaires at 1, 3, and 6 months after the program for follow-up


Eligibility criteria:
inclusion criteria: * ≥18 years of age * meet the diagnostic criteria for crswd * able to participate in research independently or with the assistance of a caregiver * participate voluntarily in the study and sign an informed consent form exclusion criteria: * unable to cooperate with the study process due to cognitive, sensory, and motor dysfunction * unable to skillfully use wearable monitoring devices or smartphones * diagnosed with mental disorders such as anxiety and depression * diagnosed with severe cardiac, liver, and kidney dysfunction and nervous system diseases * have cardiac pacemakers * being pregnant * participating in other clinical trials
hypothermia for encephalopathy in low income countries-feasibilty

Conditions: Neonatal Encephalopathy

Summary: whole body cooling improves survival with normal neurological outcome after neonatal encephalopathy in high-income countries. however, cooling equipments used in the high-income countries are expensive and unsuitable for wider use in low and middle-income countries (lmic). we had previously conducted a randomised controlled trial of whole body cooling using phase changing material in south india. although cooling was provided, there were wide temperature fluctuations. aim: to examine efficacy of the low technology cooling equipment (tecotherm-helix) in administering effective and stable whole body cooling in encephalopathic infants. methods: after informed parental consent (and ethical approvals), we will administer 72 hours of whole body cooling (rectal temperature 33 to 34c) to a total 50 encephalopathic infants (aged \<6 hours) admitted to the neonatal units at calicut medical college and madras medical college, over a six month period. to induce cooling, the infants will be kept on the cooling mattress. temperature will be continuously measured for 80 hours using a rectal probe connected to a digital data logger. the primary outcome will be the effective cooling time i.e. percentage of time (95% ci) for which the temperature remains between 33 to 340c during the intended cooling period.


Eligibility criteria:
inclusion criteria: 1. age \ 1.8, gestation \>36 weeks 2. need for resuscitation at birth and 5 minute apgar score \<6 (in born babies) or lack of cry by 5 minutes of age (for out-born babies) 3. evidence of encephalopathy on clinical examination exclusion criteria: * infants in moribound condition, where death is imminent * absent heart rate at 10 minute of age * major life threatening congenital malformation * lack of cooling equipment * lack of parental or physician consent

Keywords: encephalopathy, newborn, low and middle-income countries, hypothermia
anxiety levels before hemodialysis catheter insertion

Conditions: Anxiety Levels

Summary: determination of anxiety levels after verbal and video informing before hemodialysis catheter insertion

treatment options for end-stage renal patients are renal transplantation, peritoneal dialysis, or hemodialysis, and the majority of these patients live on hemodialysis dependent. the venous access route required for hemodialysis is provided by dialysis catheters until arterio-venous shunts are performed. the aim of this study was to determine the difference between verbal or video-related anxiety levels of patients with hemodialysis and determine which one is better before the hemodialysis procedure is performed.

Eligibility criteria:
inclusion criteria: * between the ages of 18 -65 * agree to participate ın the study * no need for emergency hemodialysis * no previously known psychiatric disorder * no history of hemodialysis before * no history of surgical procedures exclusion criteria: * refusing to participate ın the study * \ 65 years * need emergency dialysis * the presence of previously known psychiatric disorder * presence of dialysis and catheter * presence of a history of surgical procedure * lack of information and documents
prospective assessment of impact of personalized dosing of low-dose human chorionic gonadotropin (hcg) on in vitro fertilization (ivf) outcomes

Conditions: Infertility, Female

Summary: the purpose of the study is to determine the effect of tailoring dosage of low-dose hcg secondary to serum hcg levels during ivf ovarian stimulation on sustained implantation rates of preimplantation genetically tested euploid embryos.

the objective of this study is to conduct a double-blind prospective randomized control trial to determine if individualized hcg titration based on a patient's serum hcg level above or below the predetermined serum hcg level improves ivf outcomes, primarily sustained implantation rates. patients who fall below the desired serum hcg threshold will be randomized to either maintaining their current dose of low dose hcg or being increased.

Eligibility criteria:
inclusion criteria: 1. patients whose physicians plan to prescribe low-dose hcg for ovarian stimulation 2. age 18-46 3. negative serum hcg prior to start of coh 4. bmi \>18 and \<35 5. plan for ejaculated sperm use 6. plan for pgt testing with euploid embryo transfer exclusion criteria: 1. administration of low-dose hcg during frozen embryo transfer cycle 2. concomitant menopur administration during ovarian stimulation or during frozen embryo transfer cycle 3. bmi \ 35 4. age \ 46 5. presence of hydrosalpinxes that communicate with the endometrial cavity 6. diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), and persistent endometrial fluid 7. uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum) 8. male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable) 9. use of surgical procedures to obtain sperm 10. couples undergoing ivf for fertility preservation with no immediate plan for subsequent fet (embryo banking) 11. personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat) 12. declination of pgt testing
enhanced housing photoscreeners 2win and gocheckkids compared in burma and alaska

Conditions: Amblyopia; Anisometropia

Summary: "adaptica" (padova, italy) designed a fixed-distance, dark portable tube with power and remote control for the "2win: photoscreener. gocheckskids designed a flash-concentrating case for the iphone 7+ to more quickly achieve two-axis photoscreen. these devices were compared to confirmatory exams in children and young adults in a remote burma clinic and in an alaskan pediatric ophthalmology practice.

photoscreening with follow up confirmatory exams for referred and passed interpretations were offered to children and young adults at a remote clinic in the karen state of eastern burma (myanmar). the clinic had intermittent 220 volt power generator, but no internet or cell phone coverage. consecutive patients in a "wifi-equipped" pediatric ophthalmology practice in anchorage, alaska had photoscreening before confirmatory examination. each patient had photoscreening with the "2win" photoscreener installed in the "kaleidos" housing. in anchorage, the devise was controled by the wireless tablet computer. in burma, however, despite a "wifi router" not connected to internet, the tablet computer would not connect to the 2win and therefore the "kaleidos" read-trap door was opened so the 2win could be activated and controlled manually. the" 2win" stored results on an "micro-sd" memory card which was eventually downloaded to computer. each patient also had photoscreening with gocheckkids (gck) on an "iphone 7 plus" using the enhanced, flash-concentrating cell-phone case. in anchorage, in addition to on-site smart-phone interpretation, images were uploaded to the central reading center for secondary interpretation. in burma, all images were retained on the smart phone and eventually uploaded for gocheckkids central secondary analysis after return to urban internet availability. in burma, a portable, light-wieght tent was used to provide a dim screening environment with less distraction. confirmatory exams were performed consistent with 2003 and 2013 american association for pediatric ophthalmology and strabismus (aapos) uniform guidelines. cycloplegic refractions were performed 20-40 minutes after cyclopentolate 1% instillation. visual acuity was checked with patched, surround "hotv" at 3 meters threshold with at least 3 of 4 optotypes correct. validation was performed with conventional 2 x 2 screen-exam matrix, and also with alaska blind child discovery (abcd) 3 x 3 matrix including inconclusive results (no instrument interpretation or unable to gain a reading) with inconclusive interpretations considered a referral.

Eligibility criteria:
inclusion criteria: * at least one eye exclusion criteria: * bilateral enucleation
safety and immunogenicity of meningococcal conjugate vaccine in healthy adults aged 19 to 55 years old

Conditions: Infection, Meningococcal

Summary: phase i study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of meningococcal (group a, c, w-135, and y)-crm197 conjugate vaccine


Eligibility criteria:
inclusion criteria: * subjects 19 to 55 years of age * written informed consent * available for all visits and telephone calls scheduled for the study exclusion criteria: * previous or suspected disease caused by n. meningitidis * household and/or intimate exposure to an individual with culture-proven n. meinigitidis infection within 60 days prior to screening * serious acute, chronic or progressive disease as determined by investigator * history of alcohol or substance abuse
study of intensive care units in india

Conditions: Critical Illness

Summary: there is scant data on the casemix and practices in indian intensive care units (icus). most of the available data comes from single centre studies. there is a dire need to have data from indian icus to reflect the vast spectrum of critical care illness, services and practices. indicaps planned to collect data of all patients in the icu on one particular day, and four such days spread throughout a one-year period were selected: the second wednesday of july and october this year, i.e. july 14 and october 13, 2010 and the second wednesday of january and april next year, i.e. january 12 and april 13, 2011. as many icus all over the country as possible were asked to participate. the investigators aimed to gather information about icus, patients in icus, the types and severity of illness, monitoring and therapeutic modalities used, types of infections,mortality rates, etc.

the following information will be analysed: case-mix, severity of illness, prevalence of infection, hemodynamic monitoring and therapy, mechanical ventilation practices, nutrition and outcome * seasonal and regional variations in the above * epidemiology and variations in antibiotic use * patterns of microorganisms and outcome * prevalence and outcome of specific tropical febrile illnesses, including malaria, dengue fever, leptospirosis, scrub typhus * prevalence and outcome of toxins and poisonings * relation of icu and hospital organizational issues to prevalence of infection and outcome * organisation of intensive care services * end of life - ethical decisions

Eligibility criteria:
inclusion criteria: * all patients present in the icu july 14, 2010, october 13, 2010, january 12, 2011 and april 13, 2011
physical training and cognitive activity on the mild cognitive impairment (mci) patient

Conditions: Mild Cognitive Impairment; Alzheimer's Disease

Summary: regular physical activity is now recognized as a key element of good physical and mental health and this all ages. main goal : evaluate the effectiveness of physical training associated with a cognitive training in improving the cognitive function of patients diagnosed with mild cognitive impairment (mci). design : controlled randomized monocentric and prospective study with clinical benefit for the patient with three groups : one physical training and cognitive exercise group, one physical training without cognitive exercise group and one control group. in agreement with the literature on the effects of physiological stress on cognitive performance, the investigators expect the best cognitive test scores in groups with exercise training compared with controls (35% versus 80% error), and better scores on the mmse, iald, depression scale, index of pittsburg sleep quality and quality of life questionnaire. furthermore the investigators hypothesize that this positive effect is greater in the physical training and cognitive exercise group compared with the physical training group only.


Eligibility criteria:
inclusion criteria: * diagnosed patient mci (mild cognitive impairment) * elderly from 40 to 75 years old * mmse upper to 22 * affiliated or beneficiary of a national insurance scheme * medical capacity to the physical proposed activity (filling of the conditions of the medical certificate of not contraindication in the sport) exclusion criteria: * the placed persons under guardianship, under protection of justice, * the private persons of freedom (administrative or judicial) * nobody already participating in a clinical trial

Keywords: mci
trial of a distal targeting system for cephalomedullary nails as part of surgical repair of hip and femoral shaft fractures

Conditions: Hip Fractures; Femoral Shaft Fractures

Summary: this study will be a prospective, case - control trial looking at the use of a previously fda approved device made by stryker, a distal targeting system that eases the distal targeting of screws in cephalomedullary nails in hip and femoral shaft fractures. patients who consent to participate in the study will either be in the control or device arm of the study depending on their surgeon.

surgeries conducted by dr. konda or dr. leucht will be done using the device technique, surgeries completed by dr. egol or dr. tejwani will be done without the device, "free hand" technique. each arm of the study will contain 29 patients. patients who consent to participation will be enrolled in the study and placed in the correct arm based on who their surgeon is. demographic and injury data will be collected. intra-operatively, control patients will receive the soc procedure. device arm patients will have the distal targeting device used in their procedure, but the implant, will not be different than soc.

Eligibility criteria:
inclusion criteria: * the patient must be greater than or equal to 18 years of age. * the patient must have sustained a hip or femur fracture that is indicated for cephalomedullary nailing as the primary and definitive treatment measure. * the patient must be medically cleared for operative fixation of their fracture. exclusion criteria: * the patient does not meet all of the inclusion criteria.
prognostic value of the marker p63 in adenocarcinoma of lung, breast, and pancreas

Conditions: Lung Adenocarcinoma; Breast Adenocarcinoma; Pancreatic Ductal Adenocarcinoma

Summary: the p63 gene is a recently discovered member of the p53 family located at chromosome 3q27many studies have reported that overexpression of p63 can mimic p53 activities by binding dna, activating transcription, and inducing apoptosis. various studies proved p63 as a marker of basal cells in normal salivary glands, breast, prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies. still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast carcinoma, and no study has described the correlation of p63 with pancreatic ductal adenocarcinoma. in the current study, we aim to evaluate the prognostic value of the expression of p63 in the lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. we will achieve this aim by collecting clinical data retrospectively from the patients' medical records as well as assessing the histological sections and performing immunohistochemical staining for p63.


Eligibility criteria:
inclusion criteria: * patients who were treated at our institution for lung adenocarcinoma, breast adenocarcinoma, or pancreatic ductal adenocarcinoma. * available histopathological diagnosis of the malignancy. exclusion criteria: * patients with inoperable tumors. * patients with second primary tumor. * patients with pathological blocks not enough for future slicing.

Keywords: prognostic markers,pancreatic ductal adenocarcinoma
coolsculpting the upper arm study

Conditions: Body Fat Disorder

Summary: evaluate the safety and efficacy of the zeltiq coolsculpting system using a specialized surface applicator for non-invasive subcutaneous fat reduction in the upper arm.

this multi-center trial will evaluate the zeltiq coolsculpting treatment to perform treatments in the upper arm for the reduction subcutaneous fat reduction.

Eligibility criteria:
inclusion criteria * male or female subjects \> 22 years of age and \< 65 years of age. * subject has clearly visible fat sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment. * no weight change exceeding 5% in the preceding month. * subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study. * subject has read and signed the study written informed consent form. exclusion criteria * history of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment. * history of prior surgery in the arms. * known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria. * known history of raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. * history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. * history of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities. * currently taking or has taken diet pills or weight control supplements within the past month. * any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation. * active implanted device such as a pacemaker, defibrillator, or drug delivery system. * pregnant or intending to become pregnant in the next 5 months. * lactating or has been lactating in the past 6 months. * unable or unwilling to comply with the study requirements. * currently enrolled in a clinical study of any other unapproved investigational drug or device. any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
a study of aleglitazar in type 2 diabetes patients with moderate renal impairment

Conditions: Diabetes Mellitus Type 2

Summary: this multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. in addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. the target sample size is 200-400 patients.


Eligibility criteria:
inclusion criteria: * adult patients \>/= 18 years of age * diabetes mellitus, type 2 * moderately impaired kidney function * drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening * bmi 25-35 exclusion criteria: * current or previous treatment with a thiazolidinedione * current or previous treatment with insulin * treatment with fibrates \<3 months prior to screening * history of renal disease other than diabetic nephropathy