Kornimate/medical-research-clean huggingface dataset:
neoadjuvant chemotherapy for the treatment of resectable locally advanced colon cancer

Conditions: Colon Cancer

Summary: a randomized controlled clinical trial to compare the short and long outcomes of neoadjuvant chemotherapy with postoperative chemotherapy in patients with resectable locally advanced colon cancer

for resectable locally advanced colon cancer, the preferred treatment is colectomy with en bloc removal of the regional lymph nodes followed by chemotherapy of about 6 months. however, surgery may postpone the administration of chemotherapy due to postoperative complications such as anastomosis leakage, abdominal infection, thus leads to a poor survival. some scholars suggested that for patients with locally advanced colon cancer, chemotherapy given before surgery might shrink or downstage tumor, facilitate surgery and promote a better oncological outcome. whether adjuvant chemotherapy benefits these patients with better outcome still remains controversial. in this study, eligible patients will be randomly allocated to receive either adjuvant chemotherapy or not. for patients receiving adjuvant chemotherapy, surgery will be performed 3-4 weeks later. preoperative and postoperative chemotherapy will be given for a total of about 6 months. for patients receiving no preoperative chemotherapy, chemotherapy will be given for about 6 months postoperatively. the recommended chemotherapy regimes includes folfox, capeox, folfiri, capecitabine monotherapy. patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively.

Eligibility criteria:
inclusion criteria: * patients suitable for curative surgery between 18 to 80 years old; * american society of anesthesiologists(asa) grade i-iii; * pathological diagnosis of adenocarcinoma; * tumor located between the cecum and sigmoid colon; * enhanced ct scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is t3-t4 n0 or t any n+ (according to the national comprehensive cancer network(nccn) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis; * informed consent; * no preoperative chemoradiotherapy; * no history of familial adenomatous polyposis, ulcerative colitis or crohn's disease. exclusion criteria: * pregnant patient; * history of psychiatric disease; * use of systemic steroids; * simultaneous multiple primary colorectal cancer; * preoperative imaging examination results show: 1. distant metastasis; 2. unable to perform r0 resection; * postoperative pathology of t1-t2 n0; * history of any other malignant tumor in recent 5 years; * patients need emergency operation: mechanic ileus, perforation.

Keywords: locally advanced colon cancer neoadjuvant chemotherapy
effect of an e-learning intervention on knowledge, attitudes and beliefs of healthcare professionals managing low back pain.

Conditions: Knowledge, Attitudes, Practice; Low Back Pain; Physical Therapy; Physicians

Summary: the purpose of the current research project is to examine if the healthcare professionals (hcps) knowledge, attitudes, beliefs and behavior about the management of low back pain (lbp) patients changes following an e-learning intervention (experimental interactive e-learning versus traditional non-interactive e-learning)

the purpose of the current research project is to use an e-learning educational approach to implement guideline-adherent care in first line hcps. we aim to enhance the knowledge, attitudes, beliefs and behavior of hcps towards a biopsychosocial approach in the management of lbp patients. we will compare the effect of an interactive e-learning intervention (i.e. experimental intervention) to an e-learning intervention without interaction (i.e. traditional intervention). both interventions will be based on the most recent scientific literature regarding the management of lbp, but both the focus and the didactical approach will slightly differ between the interventions. we will use a mixed methods approach to gain an in-depth understanding of hcps behavior in clinical practice.

Eligibility criteria:
inclusion criteria: * to be an healthcare practitioner (general practitioner, physiotherapist, specialist physician, student in medicine including specialization, student in physiotherapy) * working or studying in belgium or france * being in possession of an internet connected device (e.g. computer, tablet or smartphone) with speaker

Keywords: distance education musculoskeletal pain guideline adherence first-line care
locally ablative therapy in oligo-progressive solid tumors (valorous)

Conditions: Breast Cancer; Oligoprogressive; Head and Neck Cancer; Sarcoma; Other Cancer

Summary: this is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. the primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.

this is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. the primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. participants will be assigned stereotactic ablative radiotherapy (sabr) or interventional radiology (ir) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.

Eligibility criteria:
inclusion criteria: 1. must have one of the following histologically and/or biochemically confirmed genitourinary malignancies: 1. cohort a: breast malignancy 2. cohort b: gynecological malignancy 3. cohort c: head and neck malignancies 4. cohort d: sarcomas 5. cohort e: other solid malignancy specified in the protocol 2. provision of signed and dated informed consent form. 3. stated willingness to comply with all study procedures and availability for the duration of the study. 4. age ≥18 years at time of consent. 5. currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy. 6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[clinical benefit: treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\] 7. ≤ 5 progressing or new metastatic lesions. 8. all progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist. exclusion criteria: 1. medical comorbidities precluding locally ablative therapies. 2. history of treatment related toxicities that limit or prohibit application of locally ablative therapies. 3. progressing intracranial lesions.
study on blood pressure variability and frailty in the older people

Conditions: Hypertension; Old Age

Summary: observational prospective single-center, non-profit study. primary objective of the study: to determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (sbp) \<90 mmhg (or two episodes of daytime sbp \<90 mmhg, if mean 24 h sbp is \<125 mmhg) detected at ambulatory blood pressure monitoring (abpm) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)

observational prospective single-center, non-profit study. primary objective of the study: to determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (sbp) \<90 mmhg (or two episodes of daytime sbp \<90 mmhg, if mean 24 h sbp is \<125 mmhg) detected at ambulatory blood pressure monitoring (abpm) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events) secondary objectives of the study: * to examine the association between home blood pressure variability (bpv) and frailty, assessed using various tools for assessing frailty * to examine the association between short term bpv and adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events) * to determine the prevalence of hypotensive phenotype according to frailty status in hypertensive individuals.

Eligibility criteria:
inclusion criteria: * age ≥ 75 years * diagnosis of hypertension according to the criteria of the european society of cardiology guidelines \[williams 2018\] * consent of the patient (or legal representative) to participate in the study exclusion criteria: * refusal of the patient or his/her legal representative * life expectancy of less than 6 months

Keywords: blood pressure variability frailty
clavulanic acid (clav) and cocaine interaction safety study

Conditions: Cocaine Dependence; Cocaine Addiction; Cocaine Abuse; Cocaine-Related Disorders

Summary: the main purpose of this study is to determine if it is safe to use the study drug, clavulanic acid, in combination with cocaine. in this study, subjects will receive intravenous (i.v.) cocaine and the study drug, clavulanic acid. the safety of clavulanic acid is being studied so future studies can be done to find out if this drug is helpful in treating cocaine dependence. currently, there is no available medication treatment for cocaine dependence.

this is a prospective, placebo controlled inpatient crossover safety study of 3 doses (250 mg/day, 500 mg/day, 750 mg/day) of clav with an intravenous infusion of cocaine 40 mg. subjects will be non-treatment seeking experienced cocaine dependent adults, ages 18-65 (n=12 completers, 21 estimated to enroll). subjects will undergo a washout of the study drug for 5 half-lives between study drug administration sessions. the primary objective will be to determine whether there are clinically significant adverse interactions between clav (250 mg/day; 500 mg/day; 750 mg/day) and intravenously administered cocaine in healthy, non-treatment seeking adults with cocaine use disorder.

Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of mental disorders fifth edition criteria for cocaine use disorder, moderate to severe. * be a non-treatment seeking cocaine user. * if female and of childbearing potential, must have a negative pregnancy test within 48 hours of beginning the study and be willing to use acceptable contraception or be abstinent for 14 days prior to study, through the entire study and 30 days after study participation. exclusion criteria: * be seeking treatment for substance abuse. (for full inclusion/exclusion criteria or for more information, please contact the site directly.)

Keywords: cocaine clavulanic acid
carbamazepine in severe liver disease due to alpha-1 antitrypsin deficiency

Conditions: Alpha-1-antitrypsin Deficiency; Liver Cirrhosis

Summary: the primary objective is to determine if the medication carbamazepine, can be used as a therapy for patients with severe liver disease due to alpha-1-antitrypsin deficiency .

the primary objective is to determine if carbamazepine therapy in patients with severe liver disease due to alpha-1-antitrypsin deficiency leads to a significant reduction in the hepatic accumulation of atz. the other objectives are: to determine whether carbamazepine treatment reduces hepatic fibrosis in alpha-1-antitrypsin deficient patients with severe liver disease. to determine whether carbamazepine treatment reduces portal pressure in alpha-1-antitrypsin deficient patients with severe liver disease. to determine whether carbamazepine treatment is safe and tolerated by patients with severe liver disease caused by alpha-1-deficiency. to determine whether carbamazepine treatment leads to stabilization in disease severity as measured by the meld scores.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 14 years to less than or equal to 80 years of age. * alpha-1-antitrypsin deficiency confirmed by zz or sz phenotype \& serum level * \< 83mg/dl. * hvpg greater than or equal to 10 mmhg unless collateral vessels are visualized via transvenous biopsy. exclusion criteria: * child pugh score greater than or equal to 12. serum total bilirubin \> 5 mg/dl. inr \> 2.2.

Keywords: carbamazepine (tegretol) use severe liver disease alpha-1-antitrypsin deficiency
efficacy of therapeutic exercise and pain neurophysiology education in temporomandibular disorders

Conditions: Temporomandibular Disorder

Summary: the aim of this study is to compare the effects in pain of two different treatments in pacients with temporomandibular disorders (tmd). one group will receive isolated therapeutic exercise (te) and the other will receive te combined with pain neurophysiology education (pne). the hypothesis of this study is that the pne+te group will obtain superior therapeutic results than an isolated te program.

objective: to evaluate the differences in pain intensity by performing isolated therapeutic exercise (te) versus performing the same exercise combined with pain neurophysiology education (pne) in patients with temporomandibular disorders (tmd). design: single-blind randomized controlled trial. setting: faculty of physical therapy of alcalá de henares. participants: subjects with tmd lasting more than 6 months (n= 36). interventions: participants will be randomly assigned to receive a te program consisting of stretching, coordination and strengthening exercises (n= 18) or the same te program in addition to a pne program (n= 18), performed in two sessions of 40 minutes in groups of 6 participants. the intervention will last 12 weeks, where all participants must complete the exercise program daily, one year later they will be evaluated again. main outcome measures: the primary outcome will be pain intensity through the visual analogue scale (vas) which will be completed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment. secondary outcome measures include pain-free mouth opening, craniofacial pain and disability inventory (cf-pdi), pain catastrophizing scale (pcs), tampa scale for kinesiophobia for temporomandibular disorders (tsk-11), pressure pain thresholds (ppt) and patient global impression of change (pgic). they will be recorded through blinded assessments performed by 2 physiotherapists at baseline, immediately after treatment, 4 and 12 weeks after treatment. student's t test will be used to determine differences between group interventions.

Eligibility criteria:
inclusion criteria: * over 18 years of age * limitation of mouth opening and/or jaw pain lasting more than 6 months * being able to understand the objective and carry out the study procedures * sign the informed consent. exclusion criteria: * suffer from any underlying disease * pain due to tumors or infections, metastases, osteoporosis, inflammatory arthritis or fractures * be receiving any other treatment for tmd or consuming some type of substance that alters muscle tone. * patients with myopathies, diseases of the peripheral nervous system, mental disorders diagnosed by a doctor * inability to collaborate * any other situation in which the evaluation could be altered.

Keywords: therapeutic exercise pain neurophysiology temporomandibular disorder
effect of radiation therapy among head and neck cancer patients on the inner ear function

Conditions: Head and Neck Cancer Patients Treated With Radiotherapy

Summary: aims: 1. to evaluate the effects of radiation therapy on the inner ear, among patients treated with radiation therapy for head and neck cancers using a wide battery of tests (audiometry and tympanometry, vhit, vemp, eng) ; 2. to correlate the mean total radiation dose to the cochlea with the effects on audiological and vestibular function


Eligibility criteria:
inclusion criteria: * females and males, age: ≥ 18 years old * patients diagnosed head and neck cancers, not treated previously * planned for radiation therapy in which the inner ear will be radiated exclusion criteria: * patients who were previously diagnosed with a vestibular disorder * previous middle or inner ear anomaly * failure to complete the whole course of radiation therapy * more than one course of radiation therapy * patients treated with concurrent ototoxic chemotherapy * pregnant women * patients who will not sign an informed consent form * helpless or incompetent patients
shenlingcao oral liquid for patients with stage ii or iiia nsclc

Conditions: Carcinoma, Non-Small-Cell Lung; Chemotherapy, Adjuvant

Summary: in this study, a pragmatic, open labelled, multi-center randomized controlled trial will be conducted. the study population are stage ii and iiia nsclc patients undergoing r0 resection and will be scheduled for adjuvant chemotherapy. potentially eligible patients will be screened by the research clinicians and requested to complete and sign a consent form before enrolment. eligible patients who consent to participate will be randomly assigned to the intervention group (patients receive conventional treatment and shenlingcao oral liquid) and the control group (patients only receive conventional treatment) designed dynamic stratified block randomized algorithm via a central randomization system for clinical research using 1:1 ratio. the intervention and control group will be enrolled before the first chemoradiation. non-allelic follow-up will be conducted in this study and terminated when the last enrolled patient follow up to 24 months. prospectively collected information from patients, including baseline, chemoradiation, use of shenlingcao oral liquid and the other complementary drugs, and various outcome measures (the questionnaire of eortc qlq, death, tumor recurrence, tumor metastasis, and chemotherapy-induced side effects of the blood system, etc.). follow-up points included: baseline (before giving chemotherapy), 2-3 days after each chemotherapy cycle, and 6,12,18,24,30,36 months after enrollment.


Eligibility criteria:
inclusion criteria: * age 18 or older; * pathological diagnosis of patients with stage ii, iii a primary nsclc; * r0 resection has been accepted; * received adjuvant chemotherapy or adjuvant chemotherapy for the first time after surgery; * informed consent has been signed. exclusion criteria: * incorporation of other malignant tumors (such as leukemia, liver cancer, etc.); * patients with unclear pathological types; * patients with unclear pathological staging; * preserved shenlingcao oral liquid before r0 resection surgery; * received immunotherapy or targeted therapy before r0 resection surgery; * radiotherapy and chemotherapy before r0 resection surgery.
stroke hyperglycemia insulin network effort (shine) trial

Conditions: Acute Ischemic Stroke; Diabetes; Hyperglycemia

Summary: the stroke hyperglycemia insulin network effort (shine) trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. the study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dl - 130 mg/dl) will be safe and result in improved 3 month outcome after stroke.

eligible subjects must be randomized within 12 hours of stroke symptom onset and either have type 2 diabetes and glucose concentrations of over 110 mg/dl or no history of diabetes and glucose concentrations of 150 mg/dl or higher on initial evaluation. the enrolling sites include the neurological emergencies treatment trials (nett) sites as well as non nett sites from all over the united states. the study evaluates the safety and efficacy of targeted glucose control (treatment group - iv insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dl.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. neuroimaging must be done to exclude intracranial hemorrhage (ich). 3. randomization must be within 12 hours after stroke symptom onset and treatment is recommended, but not required, to begin within 3 hours after hospital arrival. if time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal. 4. known history of type 2 diabetes mellitus and glucose \>110 mg/dl or admission blood glucose ≥150 mg/dl in those w/o known diabetes mellitus 5. baseline nihss score of 3-22 6. pre-stroke modified rankin scale score = 0 for patients with an nihss score of 3-7. pre-stroke modified rankin scale score = 0 or 1 for patients with an nihss score of 8-22. 7. able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). the approved consent form must be signed and dated in accordance with federal and institutional guidelines. exclusion criteria: 1. known history of type 1 diabetes mellitus 2. substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment 3. having received experimental therapy for the enrollment stroke. iv tpa (up to 4.5 hrs) or ia tpa are allowed as are ia therapies including use of fda cleared devices. non fda cleared devices are considered experimental and are excluded. 4. pregnant or breast-feeding at the time of study entry 5. other serious conditions that make the patient unlikely to survive 90 days 6. inability to follow the protocol or return for the 90 day follow up 7. renal dialysis (including hemo or peritoneal dialysis)

Keywords: stroke diabetes hyperglycemia