Kornimate/medical-research-clean huggingface dataset:
pilot, proof-of-concept study of sublingual tizanidine in children with chronic traumatic brain injury (tbi)

Conditions: Traumatic Brain Injury

Summary: nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve sleep and next-day functioning in cp (cerebral palsy) patients. it is hypothesized that this improvement in sleep efficiency (i.e.,fewer wake episodes, longer time asleep, etc.) with resulting improvement in quality-of-life (i.e.,improvements in next-day functioning, cognition and movement) may also be seen in a similar patient population, i.e., children with traumatic brain injury (tbi).

sublingual tizanidine, a novel test formulation of the known effective antispasticity agent, has been shown to have a unique pharmacokinetic profile \[(i.e., nearly twice the bioavailability/auc), but with little or no increase in peak plasma levels (cmax), as compared to oral tizanidine (zanaflex)\]. when administered nightly to cp (cerebral palsy) patients to more effectively reduce the muscle spasms that disrupt sleep, it was shown to improve sleep efficiency, decrease sleep fragmentation and improve the sleep cycle. this improvement in night-time sleep was translated into a potential improvement in next-day functioning (improvement in next-day measures of spasticity and movement). it is hypothesized that a similar type of improvement in sleep with consequent positive impact on next day improvement in spasticity, cognition and function, may also be manifest in a similar patient population, children with traumatic brain injury.

Eligibility criteria:
inclusion criteria: * males/females 8-18 years of age with documented history of tbi * documented loss of consciousness(loc) for more than 24 h, or initial gcs (glasgow coma score) lower than 8 * current spasticity that interferes with task performance * patient is able to cooperate and understand general explanations exclusion criteria: * history of allergy to tizanidine or any inactive component (including lactose intolerance) * use of other hypnotic medication within 3 days of baseline visit and during the study * botox therapy within 6 weeks of baseline, or use of baclofen pump during the trial * use of cyp1a2 inhibitors (ex. ciprofloxacin or fluvoxamine) for the duration of the study * female patients on oral contraceptives * significant abnormalities in clinical screening laboratory parameters (alt, ast, bilirubin\>2 x uln; creatinine\>2 mg/dl;wbc \<2300/mm3, platelets\<80,000/mm3) * taking of other medications that may adversely interfere with the actions of the study medication or outcome variables within 2 weeks of 5 half-lives of the baseline visit

Keywords: traumatic brain injury actigraphy spasticity, cognition and functioning
brimonidine eye drops for treatment of ocular graft-vs-host disease (ogvhd)

Conditions: Dry Eye; Ocular Graft vs Host Disease; Meibomian Gland Dysfunction

Summary: the objective of this study is to establish whether patients with dry eye disease (ded) are able to tolerate receiving brimonidine: 0.15% eye drops two times a day for twelve weeks (primary tolerability objective) and to investigate the preliminary efficacy of brimonidine 0.15% topical eye drop solution in treating meibomian gland dysfunction (mgd) (primary efficacy objective). meibomian gland dysfunction can happen with numerous conditions such as rosacea, sjögren's syndrome, and ogvhd. in order to limit the influence of differing etiologies on the outcome of this trial, the investigator has limited the screening to mgd that accompanies ogvhd.


Eligibility criteria:
inclusion criteria: 1. aged 18 years or older. 2. capable of giving informed consent and does provide informed consent. 3. diagnosis of meibomian gland disease 4. women must be post-menopausal ≥ 1 year, or surgically sterilized. if not, a negative urine pregnancy test is required within 7 days of the participant receiving first dose of study drug along with definite evidence of contraceptive use during the duration of the study. women of reproductive age should use a method of birth control that is acceptable to the participant and the study doctor. this may include oral contraceptive pills, birth control implants, barrier methods or abstinence. if a participant suspects pregnancy after being enrolled, another pregnancy test will be administered. if the test is positive, the participant will be discontinued from the study immediately. exclusion criteria: 1. allergic to brimonidine or any similar products, or excipients of brimonidine 2. currently receiving any brimonidine preparation as a part of glaucoma management 3. receiving or have received within 30 days any experimental systemic medication. 4. active ocular infection or ocular allergies. 5. any history of eyelid surgery or ocular surgery within the past 3 months. 6. corneal epithelial defect larger than 1 mm2 in either eye. 7. have active drug/alcohol dependence or abuse history. 8. vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.

Keywords: brimonidine dry eye ogvhd mgd
differentiating the invasiveness of lung adenocarcinoma by dual energy ct parameter

Conditions: Adenocarcinoma of Lung

Summary: the core purpose of this study is to investigate whether the extracellular volume (ecv) fraction measured in delay phase by dual energy computed tomography (dect) can distinguish precancerous lesions from early-stage lung adenocarcinomas, which could assist clinical decision making for surgery operation indication and strategy.

although progression of lung adenocarcinoma (luad) depends on driver mutations, it is also affected by tumor microenvironment (tme), including vessels, immune cells and extracellular matrix (ecm). as major constituent of tme, ecm mediates interactions between cancer cells and stromal cells, promotes angiogenesis, epithelial-mesenchymal transition, causes metastasis and resistance to immune therapy. along with the progression of luad histologic stages, from atypical adenomatous hyperplasia (aah) and adenocarcinoma in situ (ais) to minimally invasive adenocarcinoma (mia), and finally to invasive adenocarcinoma (ia), the composition of the ecm changes a lot, which has some characterizations same as interstitial pulmonary fibrosis. hence, identifying the pathological ecm status may help differentiating the invasiveness of lung adenocarcinomas. based on the theory that in delay phase, the contrast medium is evenly distributed in the intravascular and extravascular-extracellular spaces and not entering the cell, extracellular volume (ecv) fraction is considered as a potential quantitative imaging parameter for ecm. it has been confirmed that ecv fraction is highly consistent with pathological fibrosis in cardiac and hepatic diseases. in other lesions with fibrosis such as pancreatic and thymic epithelial tumors, ecv fraction also has positive effects in malignancy prediction. it has been verified that ecv fraction is capable of differentiating lung cancer with benign lung lesions and classifying lung cancers into three subtypes. however, there has yet no study testified it as an invasion predictor. the core purpose of this study is to investigate whether ecv fraction can distinguish precancerous lesions from early-stage lung adenocarcinomas and compare it with other confirmed radiological features in prediction performance, which is clinically meaningful regarding optimal treatment selection and avoidance of unnecessary surgical procedures.

Eligibility criteria:
inclusion criteria: * patients older than 18 years old with pulmonary nodules (diameter≤3 cm). * pathologically confirmed as lung adenocarcinoma. * without history of other malignancies. * accurate hematocrit within 1 week before contrast enhanced dual energy ct examination. exclusion criteria: * with a history of allergy to iodine contrast agents and other reasons who are unable to complete the examination. * without histopathology of invasion stage, such as aah, ais, mia and iac. * history of chemotherapy, radiotherapy, or other anti-tumor therapy before contrast enhanced dual energy ct. * poor image quality. * contrast enhanced dual energy ct scans ≥ 4 weeks before surgery.

Keywords: ecv, invasion, lung adenocarcinoma, dect
decard: study of escitalopram in the prevention of depression in patients with acute coronary syndrome

Conditions: Depression

Summary: objective: to evaluate the efficacy of preventive treatment with a selective serotonin reuptake inhibitor (ssri) (escitalopram) in the first year after acute coronary syndromes (acs). methods: 240 patients with acute coronary syndromes (st-elevation myocardial infarction \[stemi\]), non-stemi or unstable angina) will be enrolled within 8 weeks after acs and will be randomly assigned to treatment with escitalopram/placebo (5-20 mg) in 52 weeks. primary outcome measures are the diagnosis of depression and hds (hamilton depression scale). psychiatric measurements: scan (schedules for clinical assessment in neuropsychiatry), hds, has (hamilton anxiety rating scale), udvalg for kliniske undersogelser (uku) side effect rating scale, essi (enhancing recovery in coronary heart disease \[enrichd\] social support instrument), sf-36 (short form-36 health survey), scl-92 (symptom check list) and bdi (beck´s depression inventory). cardiological measurements are blood pressure, electrocardiography, echocardiography (left ventricular ejection fraction), heart rate variability and use of medicine. discussion: acs patients with mental illness are usually only diagnosed to a very small extent during admission in a cardiologic department. these patients mainly remain untreated with an increased risk of somatic comorbidity and mortality. therefore, it is in accordance with ethical principles to conduct a double blind, placebo-controlled study investigating the interface between anxiety, depression and acs. even in this blinded study, where one of the groups are treated with placebo, there will be a higher degree of treatment of depressive symptoms due to the low recognition of this problem. conclusion: the decard study is the first study evaluating the effect of prophylactic treatment of depression in patients with acs. the study will show if prophylactic treatment will improve cardiac prognosis.


Eligibility criteria:
inclusion criteria: * acs * randomization within 8 weeks form index hospitalization for acs * age \> 18 years * not pregnant * signed informed consent exclusion criteria: * current depression * use of antidepressants \< 4 weeks * previous intolerance to ssri * severe medical conditions * severe heart failure * alcohol or substance abuse * psychosis or dementia * current participation in other intervention trials * pregnancy and lactation * linguistic difficulties

Keywords: myocardial infarction
everolimus modulation of anti-tumor t cd4 immune responses

Conditions: Metastatic Renal Cancer

Summary: everolimus is an inhibitor of mammalian target of rapamycin, approved in patients with metastatic renal cell carcinoma. the objective of this study is to investigated the influence of everolimus immune modulation on antitumor efficacy .


Eligibility criteria:
inclusion criteria: * performance status ecog-who 0, 1 or 2 * metastatic renal cancer * patient candidate to everolimus treatment * signed written informed consent * fertile women with adequate contraception during the study and until 8 weeks after stopping treatment exclusion criteria: * patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed) * history of immune deficiency * hypersensitivity against rapamycin and derived * prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years * active autoimmune diseases, hiv, hepatitis c or b virus * patients with any medical or psychiatric condition or disease, * patients under guardianship, curatorship or under the protection of justice.
open label study for adults with pyoderma gangrenosum and inflammatory bowel disease

Conditions: Pyoderma Gangrenosum; Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease

Summary: subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (crohn's or ulcerative colitis) and pyoderma gangrenosum. this is a 6 month open label study of an intravenous (iv) medication. visits occur every 2 weeks initially, then every 1-2 months later in the study.


Eligibility criteria:
inclusion criteria: * must be ages 18-75 * must have both inflammatory bowel disease and moderate to severe pyoderma gangrenosum * must never have received infliximab for the treatment of pyoderma gangrenosum exclusion criteria: * have had any previous treatment with monoclonal antibodies other than infliximab used to treat ibd or antibody fragments. * have a history of serious infections
swiss sarcoma network: prediction model for patient selection in sarcoma care

Conditions: Sarcoma

Summary: the primary significance of this project is to perform a detailed analysis to assess the diagnostics, treatment and follow-up care, to develop a prediction model for future patient selection regarding various diagnostic and treatment procedures.

within the framework of interdisciplinary cooperation for a sarcoma problem, predictive and prognostic criteria will be developed that improve the treatment and particularly outcome. the outcome variables include patient characteristics, tumor types and characteristics, histology, management and treatment strategies as well as recurrence rate and overall survival.

Eligibility criteria:
inclusion criteria: * malignant and intermediate and selected benign bone or soft tissue tumors, acc. to the who coding list of the ssn * female and male subjects of all ages exclusion criteria: * documented objection of subsequent use of personal health data

Keywords: sarcoma, epithelioid sarcoma, soft tissue sarcoma, spindle cell sarcoma, bone
study in women with severe diarrhea-predominant irritable bowel syndrome having failed conventional therapy

Conditions: Irritable Colon; Irritable Bowel Syndrome (IBS)

Summary: the purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have failed conventional therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with severe diarrhea-predominant irritable bowel syndrome (ibs). * failed conventional therapy. * willing to make daily calls on a touch-tone telephone. exclusion criteria: * history of or current chronic or severe constipation. * bloody diarrhea, abdominal pain with rectal bleeding. * thrombophlebitis. * abnormal thyroid stimulating hormone (tsh) value. * alcohol and/or substance abuse within past two years. * pregnant or lactating. * history/treatment of malignancy within past five years.

Keywords: prn diarrhea-predominant irritable bowel syndrome irritable bowel syndrome (ibs)
resistance exercise training during pregnancy: a randomized controlled trial

Conditions: Gestational Age; Birth Weight; Anaemia; Gestational Diabetes Mellitus; Type of Delivery

Summary: the investigators investigated the effects of a supervised maternal exercise training program (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health outcomes in a group of previously sedentary healthy women. a matched control group was assessed over the same time period. given the fact that most studies in the field have used aerobic exercises, here the investigators largely focused on very light resistance, toning exercises.


Eligibility criteria:
inclusion criteria: * sedentary (not exercising \>20 minutes on \>3 days per week) * with singleton * not at high risk for preterm delivery (no more than one previous preterm deliveries) * women planning to give birth in the same obstetrics hospital department (hospital severo ochoa, madrid, spain) exclusion criteria: * not being under medical follow-up throughout the entire pregnancy period were not included in the study * women having serious medical condition that prevent them from exercising safely
testing accountability in patient adherence

Conditions: Head And Neck Cancer

Summary: the goal of this research study is to look for factors that influence whether or not head and neck cancer patients follow the swallowing exercises that they are asked to perform while receiving radiation treatment.

head and neck cancer patients who receive radiation are at risk for permanent swallowing disorders. because of these potential problems, swallowing exercises are an important part of recovery. researchers want to learn what factors affect how well patients follow the swallowing schedule they are given, and what can be done to make it consistent. if you agree to take part in this study, you will have the following procedures performed. videotaped swallowing exercise: researchers will ask you to perform 3 swallowing exercises while being recorded by a video camera. the length of the taping session will be 3 minutes. afterward, you will fill out 3 questionnaires. the questionnaires will take about 10 minutes to complete. length of study: you will be asked to come in 1 time for this study. for the next 2 years, information may be collected from your medical record. this information will include the cancer stage, if the disease has gotten worse, any treatment you receive, and any side effects you experience. this information will help researchers learn how certain treatments affect patients and their risk for future disease. this is an investigational study. up to 225 patient will take part in this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases. 2. are stage ii-ivb for oropharyngeal and laryngeal 3. are stage i-ivb for hypopharyngeal and nasopharyngeal 4. at least 18 years of age 5. speak and read english 6. oriented to time, person, and place 7. have a zubrod performance status of 0 to 2 exclusion criteria: 1. have other cancer diagnoses, except non-melanoma skin cancer 2. had treatment for previous h \& n cancer or radiation to the head and neck 3. have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy) 4. have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)

Keywords: head and neck cancer nasopharyngeal cancer oropharyngeal cancer hypopharyngeal cancer laryngeal cancer primary cancer with cervical metastases swallowing exercises videotape videocamera m.d. anderson symptom inventory questionnaires surveys
peer support for young adult women with high breast cancer risk

Conditions: Breast Cancer Risk

Summary: this trial will recruit young adult female relatives (yars) of male or female carriers of brca1/2. yars who consent to participate will be randomized to either a 3-session peer coach-led telephone counseling intervention or usual care navigation to peer support interventions provided by community organizations that support the hereditary cancer community. study aims are to 1) assess intervention effects on distress and decision making outcomes, including uptake of counseling for untested yars, 2) identify yars most likely to engage with and benefit from the intervention, 3) understand intervention mechanisms. participants will complete interviews at baseline, 1, 6, and 12 months.

germline (e.g., brca) mutation carriers have highly elevated odds of developing hereditary breast-ovarian cancer (hboc), as could their relatives. referral to genetic counseling is the standard of care for young, at-risk adult relatives (i.e., ages 18-39; herein "yars"). however, many female yars struggle to make decisions about familial hboc risk management, including whether and when to pursue genetic counseling, how to cope with stress and uncertainty about hboc, and how to navigate lifecycle events entwined with hboc threats (e.g., childbearing). prior work points to yars' strong desires to seek hboc risk information and emotional support beyond traditional genetic counseling-especially support from knowledgeable peers who can relate to their experiences and offer neutral grounding and objective guidance about coping strategies. peer support is a promising psychosocial cancer care approach that could fill this void. however, few evidence-based standards inform its practice as an adjunct to cancer genetic counseling. as genetic testing for hboc risk expands population-wide, new ways must be tested to reach, educate, and support yars to further reduce the cancer burden in communities of at-risk women. the 2-arm peace trial includes streamlined telephone counseling delivered by well-trained community peer coaches, with session content incorporating coping training for hboc stress reduction, and decision making and problem solving training about genetic counseling and hboc risk. trial participants are female yars (aged 21-30) randomized to an intervention or equated control condition, and followed for up to 12 months.

Eligibility criteria:
inclusion criteria: * there are two targets for recruitment with different eligibility criteria. index carriers: * men or women aged 18 or older with brca mutations with or without 2nd-tier multiplex panel genetic testing. index carriers will have received testing. yars: * female 1st-, 2nd- or 3rd-degree biological relatives of index carriers aged 21-30. exclusion criteria: * must be able to speak english or spanish and provide informed consent
use of harmonic in breast surgery

Conditions: Breast Cancer; Modified Radical Mastectomy

Summary: to compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (ebl), operating time, drain volume and drain days, seroma formation, surgical site infection and postoperative pain in adult females undergoing mrm at a tertiary care hospital. we hypothesized that harmonic yields better outcome than electrocautery dissection.

in this randomized controlled trial, adult females who underwent mrm between april 2010 and july 2011 were randomized to receive either intervention a (harmonic scalpel) or b (electrocautery). the procedure was standardized except elevation of flaps and axillary dissection, that was performed as per randomization. patients were followed up in clinic for four weeks. the outcomes were estimated blood loss (ebl), operating time, drain volume and drain days, complications (seroma, surgical site infection, hematoma and flap necrosis) and postoperative pain.

Eligibility criteria:
inclusion criteria: * adult females with biopsy proven breast cancer underwent mrm exclusion criteria: * simultaneous procedure (reconstruction, sentinel lymph node biopsy)

Keywords: breast cancer, harmonic scalpel, electrocautery, modified radical mastectomy, randomized controlled trial
treating to target for patients with hypertension

Conditions: Hypertension

Summary: patients with poorly controlled hypertension will have improved hypertensive control with telephone coaching and with telephone coaching combined with home-titration of medications.

patients with poorly controlled hypertension are randomized to a control arm which receives telephone coaching or an active arm which receives telephone coaching plus intensification of medications via telephone coaching with the coaches using treatment algorithms approved by the patients' physician. these patients' blood pressure control will be compared with usual care patients in a passive arm (chart review only).

Eligibility criteria:
inclusion criteria: * 2 blood pressure readings above 145/90. exclusion criteria: * cognitive impairment, * short life expectancy, * creatinine greater than 1.5, * inability to check blood pressures at home.