Kornimate/medical-research-clean huggingface dataset:
decompressive craniectomy combined with hematoma removal to treat ich

Conditions: Intracranial Hemorrhages

Summary: decompressive craniectomy has been reported for the treatment of patients with intracerebral hemorrhage. but no prospective randomised controlled trials have yet been undertaken to confirm its effect.the purpose of the study is to determine whether decompressive craniectomy post hematoma removal surgery after intracerebral hemorrhage will reduce the chances of a person dying or surviving with a long term disability.

intracerebral hemorrhage (ich) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. about one third of people with ich die early after onset and the majority of survivors are left with major long-term disability. hematoma removal (hr) surgery is the primary treatment for ich which volume is more than 30ml. but whether decompressive craniectomy (dc) should be employed during the hr surgery still has considerable controversy. outcomes in this study will be measured at 3 months after surgery via a postal questionnaire including the glasgow outcome scale, modified rankin scale, and barthel index. two hundred patients will be recruited to the trial over 36 months. follow-up will take three months with analysis and reporting taking one year.

Eligibility criteria:
inclusion criteria: * evidence of a spontaneous lobar and basal ganglia ich on ct scan * patient within 72 hours of ictus * best score on the gcs of 5-13. * volume of hematoma between 30 and 100ml \[calculated using (a x b x c)/2 method\] * the history of hypertensive exclusion criteria: * clear evidence that the hemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation. * intraventricular hemorrhage of any sort * ich secondary to tumour or trauma. * if the hematological effects of any previous anticoagulants are not completely reversed.
comparison of treatment effect of chemotherapy with panitumumab to chemotherapy alone

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to evaluate the treatment effect of panitumumab plus folfiri compared to folfiri alone as second line therapy for metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * man or woman at least 18 years old * diagnosis of metastatic colorectal cancer (mcrc) * one and only one chemotherapy regimen for mcrc consisting of first-line 5-fu -based chemotherapy * radiologically documented disease progression per modified response evaluation criteria in solid tumors (recist) criteria during treatment or within 6 months of last dose of first-line chemotherapy * at least 1 uni-dimensionally measurable lesion of at least 20 mm per modified recist * eastern cooperative oncology group (ecog) status of 0, 1, or 2 * paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses * adequate hematologic, renal, and hepatic functions * negative pregnancy test within 72 hours of enrollment * other protocol-specified criteria may apply exclusion criteria: * history of or known presence of central nervous system (cns) metastases * history of another primary cancer within 5 years of randomization * prior irinotecan therapy * prior anti-epidermal growth factor receptor (egfr) antibody therapy or treatment with small molecule egfr inhibitors * any investigational agent or therapy within 30 days before randomization * known allergy or hypersensitivity to irinotecan, 5-fu or leucovorin * history of interstitial lung disease or evidence of interstitial lung disease on baseline chest computed tomography (ct) scan * active inflammatory bowel disease or other bowel disease causing chronic diarrhea * known positive tests for human immunodefiency virus (hiv), hepatitis c viris (hcv), acute or chronic active hepatitis b virus (hbv) * major surgery within 28 days of randomization or minor surgical procedure within 14 days of randomization * pregnant or breast-feeding * man or woman of child-bearing potential not consenting to use adequate contraceptive methods or abstinence during the course of the study and for 6 months after last study drug administration (women) or 1 month after last study drug administration (men) * other protocol-specified criteria may apply

Keywords: oncology cancer metastatic colorectal cancer egfr panitumumab clinical trial amgen
premedication to reduce discomfort with screening mammography

Conditions: Breast Pain

Summary: this study will explore the effect of pre-medication with acetaminophen, ibuprofen, and topical lidocaine gel (topicaine) on the perception of discomfort and overall satisfaction with the mammography experience. the research questions are: 1. what is the relationship between the use of acetaminophen, ibuprofen, and topicaine prior to screening mammography and the perception of discomfort during the procedure? 2. what is the relationship between perception of discomfort and overall satisfaction with the mammography experience? 3. what is the relationship between the perception of discomfort and plans for future mammograms? 4. what other factors are associated with the perception of discomfort and satisfaction?

breast cancer is prevalent, deadly, costly, and has low cure rates unless detected in its early stages. mammography is the key component to early detection, yet it remains underutilized due to cost, access, and factors such as fear of pain. multiple studies have shown that most women find mammography uncomfortable, even painful. yet, little research has been done to find methods to reduce mammography-related discomfort. in an unpublished master's thesis, this investigator found that women who expected discomfort \> 40 on a visual analog scale (vas) who were pre-medicated with 1000 mg of acetaminophen reported lower discomfort scores than those pre-medicated with placebo, but the sample size was too small to reach statistical significance. further study on the effects of pre-medication is needed. pain should not be associated with a potentially lifesaving procedure. a more comfortable and positive experience with mammography may increase the number of women who participate in regular mammography screening, and, thereby, increase early detection and reduce the mortality rate, costs, and emotional trauma associated with breast cancer.

Eligibility criteria:
inclusion criteria: * women scheduled for age-appropriate screening mammography at st. luke's breast cancer detection center * expect discomfort of 40 or greater on a scale of 0-100 * willing to arrive 1 hour early for appointment to enroll in study exclusion criteria: women who: * expect discomfort from their mammogram to be \< 40 on a scale of 0-100 * cannot understand or read english or who are unable to complete the consent process or questionnaire for reasons such as hearing impairment or other physical or mental disabilities * have a sensitivity or allergy to acetaminophen, ibuprofen, or lidocaine * have significant liver or kidney dysfunction * are breast-feeding * cannot arrive a minimum of 60 minutes earlier than their appointment time * have taken any pain relief medications within 24 hours of their mammogram appointment, including over-the-counter medications.

Keywords: mammogram pain discomfort breast pre-medication
predicting and addressing colonoscopy in safety net settings

Conditions: Colorectal Cancer

Summary: the prospective cohort study will evaluate the effectiveness of patient navigation in community health center settings. the investigators will collaborate with the advisory board, composed of key clinicians and patients, researchers, and policymakers, to establish a procedure to conduct and evaluate a patient navigation program that aims to increase rates of follow-up colonoscopy among diverse patient populations served by safety net clinics. phase 1 will be a milestone-driven planning process in which the investigators will validate the risk prediction model and apply the risk prediction model to stratify the patients and adapt patient navigation materials for the local context. phase ii will be a large-scale, patient randomized-controlled trial that will include 1200 patients at a large 34-clinic community health center in washington state.

the study will fulfill the following aims: aim 1: validate externally the predictive risk score using sea mar chc's robust data including 29,000 patients age-eligible for colorectal cancer screening; stratify patients according to risk of non-adherence to follow-up colonoscopy; and adapt patient navigation program for the local context. aim 2: assess the effectiveness, costs, and cost-effectiveness of a centralized, phone-based patient navigation program for follow-up colonoscopy receipt for patients at moderate risk or high risk for non-adherence. aim 3: assess differences in the intervention arms in secondary outcomes (e.g. time to colonoscopy receipt, no-show/canceled appointments, colonoscopy quality) and moderators of intervention effectiveness (e.g. probability level, intervention dose, and patient age, ethnicity, and sex)

Eligibility criteria:
inclusion criteria: * positive fit test exclusion criteria: * prior colorectal cancer * dialysis patient

Keywords: colorectal cancer screening cancer screening risk prediction model patient navigation colonoscopy
development of a biomarker of efficacy of vedolizumab (entyvio®) in patients with ulcerative colitis (detect)

Conditions: ULCERATIVE COLITIS

Summary: the main objective of this project is to demonstrate the feasability of an endomicroscopic biomarker of efficacy of vedolizumab and adalimumab, in ulcerative colitis (uc) by coupling vedolizumab to a fluorescent component, fitc (fluorescein isothiocyanate) , and adalimumab to rhodamine. this project should allow the development of a biomarker of therapeutic efficacy for vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while respecting manufacturing standards and good manufacturing procedures.

patients will be recruited before initiation of vedolizumab injections. the schedule for vedolizumab infusions will corresponding to the protocol follow-up visits (week 0, w2, w6, w14, w22), and flexible sigmoidoscopy appointments will be performed at week 0 and 22. for responder patients, the end of the study will occured two weeks after the last vedolizumab infusion (w24). at week 22, nonresponder patients to vedolizumab may be treated by adalimumab in the absence of contraindication and depending on the decision of the physician responsible for the patient. patients will be treated every two weeks during 8 weeks. the protocol follow up will end 2 weeks after the fourth adalimumab injection. during w0 and w22, colon biopsies will be collected. blood samples will be collected on w0, w2, w6, w14, w22 (and w30 for non responder).

Eligibility criteria:
inclusion criteria: * patients with moderate to severe uc defined by an overall mayo score ≥ 5 and an endoscopic sub-score ≥ 2 points and rectal bleeding score ≥ 1 point * extension \> 15 cm from the anal margin * requiring treatment with biotherapy and meeting the indications for the treatment * affiliated with a social security scheme exclusion criteria: * crohn's disease or unclassified colitis * severe acute colitis * requirement for immediate surgical treatment * previous treatment with vedolizumab or anti-tnf-α * contraindication to the use of vedolizumab or an anti-tnf-α agent * contraindication to the use of adalimumab * corticosteroid therapy \> 20 mg/day * corticosteroid therapy started within the previous two weeks * conventional immunosppressor started within the previous month * colonic dysplasia or known cancer * likelihood to refuse two rectosigmoidoscopies, performed eighteen weeks apart * pregnant or lactating women

Keywords: vedolizumab, confocal endomicroscopy biomarker ulcerative colitis
reproductive health survivorship care plan pilot

Conditions: Breast Cancer; Hot Flashes; Vaginal Dryness; Estrogen Deprivation Symptoms

Summary: most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. these late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal dryness), which are distressing in young breast cancer survivors (ybcs). the goal of this pilot study is to test the feasibility of a 4-week text message based intervention on hot flashes and vaginal dryness in ybcs. ybcs will be randomized in a 1:1 ratio to the intervention (text messages on hot flash and vaginal dryness management) and control arms. all participants will be prompted to provide daily hot flash frequency and severity via text messaging. the primary hypothesis is ybcs will have high rates of daily hot flash reporting via text messaging. secondarily, we will compare changes in hot flash frequency, hot flash severity and vagina dryness between the intervention and control arms.


Eligibility criteria:
inclusion criteria: * breast cancer * female * completed primary breast cancer treatment * age \<=45
rct: starr vs biofeedback

Conditions: Gastric Outlet Obstruction; Rectocele; Intussusception; Anismus

Summary: this study aimed to evaluate the safety and symptomatic outcomes achieved with stapled transanal rectal resection (starr) compared to biofeedback training in patients with obstructed defecation syndrome (ods).


Eligibility criteria:
inclusion criteria: 1. female patients \>18 years old 2. able to comprehend, follow, and provide written informed consent. 3. minimum ods score of seven at screening. 4. negative pregnancy test, by urine. 5. 'obstructed' defecation requiring straining/digitation as presenting lead symptom. 6. adequate external sphincter on rectal digital examination. 7. evidence of anterior rectocele and/or rectal intussusception on dynamic defecography. (note: dynamic defecography taken within 12 months will be acceptable) 8. willingness to comply with study requirements including follow-up visits exclusion criteria: evidence of external sphincter injury associated with incontinence. 1. enterocele at rest- requiring surgery. 2. faecal incontinence (soiling and faecal urgency is admissible). 3. any anterior defect, colpocele or cystocele requiring a combined surgical approach. 4. physical or psychological condition which would impair participation in the study. 5. participation in any other device or drug study within 90 days prior to enrollment. 6. planned participation in any other device study during the timeframe of this study. 7. general contraindication for surgery. 8. previous transanal surgery for ods. 9. immunocompromised subjects

Keywords: outlet obstruction rectocele
evaluation of cascade screening for elevated lipoprotein(a)

Conditions: Cardiovascular Diseases; Dyslipidemias; Hereditary Diseases

Summary: the aim of the current project is to evaluate the penetrance of elevated plasma lp(a) levels in patients with atherosclerotic coronary artery disease to their first- and second-degree biological relatives based on data from a clinical health care development project.

an elevated plasma level of lipoprotein(a) \[lp(a)\] is an independent and causative risk factor for atherosclerotic cardiovascular disease. the lp(a) plasma level is predominantly genetically determined via a complex hereditary pattern of the lpa gene, and remains relatively constant throughout an individual's entire life cycle. the relationship between plasma lp(a) and the risk for a cardiovascular event has been shown to be linear. cascade screening, i.e. screening of biological relatives of the first detected patient (index) with a disease in a family, is an effective approach to identify and diagnose new patients with hereditary diseases. the method has been shown to be cost-effective for the most common genetically caused dyslipidemia, familial hypercholesterolemia, but the knowledge if cascade screening would be an effective method to screen for elevated plasma lp(a) is not known. the aim of the current project is to evaluate the penetrance of elevated plasma lp(a) levels in patients with atherosclerotic coronary artery disease to their first- and second-degree biological relatives. the study will be based on results from a clinical health care development project in which patients who have had their plasma lp(a) measured in the clinical routine will be asked to participate in the project. the participating patients invite their relatives to participate in the cascade screening and to measure their plasma lp(a) levels. six swedish hospitals participate in the project and 750 patients with atherosclerotic coronary artery disease be included and divided into three strata according to their plasma lp(a) level (low \ 170 nmol/l). the indexes will in turn invite 1200 first- and second-degree relatives to have their plasma lp(a) measured. a scientific evaluation of the health care development project will be performed to study the penetrance of elevated plasma lp(a) levels in indexes to their relatives.

Eligibility criteria:
inclusion criteria * participation in the clinical health care development project * established atherosclerotic coronary artery disease exclusion criteria: * diagnosis of familial hypercholesterolemia * chronic kidney disease stadium ≥4

Keywords: lipoprotein(a) coronary artery disease cascade screening atherosclerotic cardiovascular disease
comparison of postoperative outcome of hepatectomy for living donors according to three different incision

Conditions: Healthy Donors for Liver Transplantation

Summary: living donor liver transplantation (ldlt) is an important option for patients with end-stage liver disease requiring liver transplantation. when performing ldlt, the safety and well being of donors is of the utmost importance. the conventional incision for donor hepatectomy is a right subcostal incision with a midline extension up to xiphoid. minimally invasive liver surgery throughout a single 10 cm upper midline incision without laparoscopic assistance has been widely applied and considered to be safe and effective. recently, laparoscopic and minimally invasive living donor hepatectomy via transverse incision has been suggested to reduce morbidity and the invasiveness of living donor hepatectomy. although minimally invasive approach has become the surgical method of choice for many transplant centers, little data on comparing the impact of all three different type incision in living liver donors. in our center, the investigators have adopted three different incision according to surgical teams. the investigators undertook this study with the aims of comparing the pain and quality of life of donors according to type of three different incisions and assessing any benefits to the donor due to the smaller midline incision during the early postoperative period.


Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiologists) physical status i-ii, * adult undergoing hepatectomy for living donors exclusion criteria: * known allergy to any of the drugs used in this study, * bleeding diathesis, * neurologic dysfunction (preexisting lower limb neurological deficit), * recent systemic or local infections, * history of drug use, or * under treatment with opioids because of chronic pain
comparing of the clinical outcome of periodontal accelerated osteogenic orthodontics with horizontal or vertical releasing incisions

Conditions: Malocclusion

Summary: the study aims to compare the effect of periodontal accelerated osteogenic orthodontics (paoo) with horizontal or vertical releasing incisions on operation time, healing, adverse effects, and effectiveness of bone augmentation. methods: a total of 22 patients requiring paoo surgery due to orthodontic treatment were enrolled in this trial, and randomly divided into test or control group, consisting of 11 subjects in each. the test group will receive paoo with horizontal extending incisions on both sides of the flap; while the control group will receive paoo with vertical releasing incisions; the two groups use the same surgical technic except for the incision design. outcome measures include: operation time, postoperative scar, radiographic data (alveolar height and alveolar ridge thickness), gingival thickness, etc. clinical evaluation will be performed at 1 week, 2 weeks, 3months, 6 months and 12 months after operation.


Eligibility criteria:
inclusion criteria: 1. patients aged between 18 and 40 years old, systemic healthy, undergoing or planning to undergo orthodontic treatment. 2. patients with a thin alveolar bone or with dehiscence and/or fenestration on the labial side of maxillary or mandibular front teeth area. 3. patients with expected tooth movement beyond the labial alveolar bone during orthodontic procedures. exclusion criteria: 1. smoker. 2. pregnant or lactating. 3. untreated periodontitis. 4. presence of \<2mm keratinized gingival width(kgw) or thin gingival phenotype (as defined by dental probe transparency.) 5. history of orthodontic and/or orthognathic treatment. 6. with systemic disease (diabetes, hypertension, heart disease, malignant tumor, severe mental illness, and other surgical contraindications.) 7. long-term medication (immunosuppressive drugs, bisphosphonates, etc.) 8. poor adherence to complete one-year follow-up.

Keywords: periodontal accelerated osteogenic orthodontics vertical releasing incision
effect of intermittent oro-esophageal tube feeding on dysphagic stroke survivors

Conditions: Stroke

Summary: the goal of this clinical trial is to explore clinical effect of intermittent oro-esophageal tube feeding in dysphagic stroke survivors. the main questions it aims to answer are: * can intermittent oro-esophageal tube feeding improve psychological status in dysphagic stroke survivors? * can intermittent oro-esophageal tube feeding improve social interaction in dysphagic stroke survivors? patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given intermittent oro-esophageal tube feeding as nutrition support and the control group will be given nasogastric tube. the study lasts 21 days for each patient. researchers will compare the social functioning scale, social support questionnaire, patients health questionnaire-9, general anxiety disorder-7 to see if the intermittent oro-esophageal tube feeding can help improve the symptom.

stroke is happening increasingly more. the goal of this clinical trial is to explore clinical effect of intermittent oro-esophageal tube feeding in dysphagic stroke survivors. the main questions it aims to answer are: * can intermittent oro-esophageal tube feeding improve psychological status in dysphagic stroke survivors? * can intermittent oro-esophageal tube feeding improve social interaction in dysphagic stroke survivors? patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given intermittent oro-esophageal tube feeding as nutrition support and the control group will be given nasogastric tube. the study lasts 21 days for each patient. researchers will compare the social functioning scale, social support questionnaire, patients health questionnaire-9, general anxiety disorder-7 to see if the intermittent oro-esophageal tube feeding can help improve the symptom.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * meeting the diagnostic criteria of stroke; * any degree of dysphagia at admission; * steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment. * transferred out within three weeks of hospitalization in the neurology department. exclusion criteria: * complicated with other neurological diseases; * damaged mucosa or incomplete structure in nasopharynx; * tracheostomy tube plugged; * unfeasible to the support of parenteral nutrition; * simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.