Kornimate/medical-research-clean huggingface dataset:
rociletinib (co-1686) usa expanded access program

Conditions: Non-small Cell Lung Cancer

Summary: to provide access to rociletinib for patients with advanced or metastatic egfr-mutant nsclc who have been treated previously with egfr directed therapy and have evidence of a t790m mutation (t790m+).

this is an open-label, multi-center study in the us, which allows for expanded access to rociletinib for patients with advanced or metastatic, egfr-mutant t790m+ nsclc who were previously treated with at least one prior egfr tki therapy (≥2nd line). patients will receive oral rociletinib twice daily on study as long as they have clinical benefit and until they have access to fda-approved rociletinib.

Eligibility criteria:
key inclusion criteria: * unresectable locally advanced or metastatic nsclc with egfr activating mutation (excluding exon 20 insertion) and presence of the t790m mutation * prior treatment with an approved or experimental egfr-directed therapy * eastern cooperative oncology group (ecog) performance status 0-1 * adequate hematological and biological function * written informed consent on an institutional review board (irb)/independent ethics committee (iec)-approved icf before any study-specific evaluation key exclusion criteria: * eligibility for other enrolling clinical trials of rociletinib * leptomeningeal carcinomatosis or other untreated or symptomatic cns metastases (asymptomatic cns metastases allowed if clinically stable without requirement for steroid dose increase for at least 4 weeks) * history of prior interstitial lung disease * concurrent use of qt-prolonging medication * cardiac abnormalities: * clinically significant abnormal 12-lead ecg, qt interval corrected using fridericia's method (qtcf) \> 450 ms * inability to measure qt interval on ecg * personal or family history of long qt syndrome * implantable pacemaker or implantable cardioverter defibrillator * resting bradycardia \< 55 beats/min * presence of serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism, and other active malignancy associated with life expectancy of less than 1 year) * pregnant or breastfeeding females and male or female patients who refuse to use adequate contraception during the study and for 12 weeks after the last dose of rociletinib * any contraindication, allergy, or hypersensitivity to rociletinib or excipients
safety of phenylephrine for oral mucositis prevention

Conditions: Mucositis; Stomatitis

Summary: the purpose of this study is to determine if applying the drug phenylephrine to the inside of the mouth can be done safely and is tolerable to use in cancer patients receiving radiation to the sub-mandibular lymph nodes.


Eligibility criteria:
inclusion criteria: * cancer patients scheduled to receive at least 5 weeks of radiation therapy to the sub-mandibular lymph nodes * normal ecg * normal blood pressure exclusion criteria: * untreated cardiac disease * connective tissue disorders * open sores, wound, ulcerations to oral cavity * allergy to phenylephrine * know untreated hypertensin * abnormal ecg in past 6 months * taking prescription monoamine oxidase inhibitor (maoi) * are pregnant

Keywords: radiotherapy
selective laryngeal reinnervation for bilateral vocal fold paralysis

Conditions: Bilateral Vocal Cord Paralysis

Summary: this is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis.


Eligibility criteria:
inclusion criteria: * patients aged 18-70 * patients with bilateral vocal fold paralysis without any improvement for 6 months exclusion criteria: * patients with neck or chest radiation * patients with severe respiratory compromise * patients with cricoarytenoid ankylosis * patients with pacemakers * patients who are pregnant * patients with cochlear implant, or any nerve stimulator implants

Keywords: bilateral vocal fold paralysis tracheostomy dependency glottic airway obstruction stridor
ntms for negative symptom in schizophrenia

Conditions: Schizophrenia

Summary: this research aims to test the effectiveness of navigated transcranial magnetic stimulation (ntms) of left supramarginal gyrus for negative symptoms. in this double-blind, randomized controlled trial, patients will be assigned to active itbs experimental group or sham itbs group. treatment will last for 10 days, and data will be collected at baseline, 1 day and 1 month after treatment.

this research aims to test the effectiveness of navigated transcranial magnetic stimulation (ntms) for negative symptoms in patients with schizophrenia. in this double-blind, randomized controlled trial, patients will be assigned to active itbs experimental group or sham itbs group. by using the tms navigation system, the itbs will be targeted at the left supramarginal gyrus, and parameters are set to triplet 50hz bursts, repeat at 5hz, 2s seconds on and 8 seconds off, 1800 pulses per session, intensity of 90% resting motor threshold(rmt), total duration of 10 minutes.both group will receive ntms 5 times a day, total treatment for 10 days. measurements included a pretreatment measurement session, 10 days of ntms treatment, a post-treatment measurement, and a follow-up measurement 1 month after treatment. at baseline, data of demographic variables (such as sex, age, years of education, occupational status, social support) and disease characteristics (such as duration of illness, antipsychotic daily dose in chlorpromazine equivalents, family psychiatric history) will be collected.at baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7) , data of outcomes (such as positive and negative symptom scale (panss) score,negative symptoms(sans) score and other secondary outcomes) will be collected in order to test the effectiveness of ntms.

Eligibility criteria:
inclusion criteria: * 1.clinical diagnosis of schizophrenia according to icd-11. * 2.confirmation of the diagnosis of schizophrenia using the scid-5-rv (dsm-5 structured clinical interview for dsm-5 disorders - research version). * 3.score more than 4 points on either item of negative symptoms (n1-n7). * 4.aged less than 60 years, course of disease less than 10 years. exclusion criteria: * 1.clinical diagnosis or scid-5-rv assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco). * 2.presence of severe or acute physical illnesses, including traumatic brain injury, intracranial space-occupying or infectious diseases, acute cardiovascular diseases, acute respiratory system diseases, acute hematological disorders, etc. * 3.presence of clearly defined genetic diseases, including tuberous sclerosis, multiple sclerosis, kleefstra syndrome, 22q11.2 deletion syndrome, prader-willi syndrome, klinefelter syndrome (47,xxy), etc. * 4.contraindication for mri examination or rtms, such as metal implantation in the body, epilepsy, cochlear implants, etc. * 5.severe risk of self-injury or suicide * 6.other conditions where the researchers find unsuitable for the treatment

Keywords: schizophrenia tms negative symptom
a phase ⅲ study of extended-release carvedilol sulfate for the treatment of heart failure

Conditions: Heart Failure

Summary: the aim of present study is to evaluate the efficacy and safety of extended-release carvedilol sulfate versus sustained-release metoprolol succinate in patients with mild or moderate chronic heart failure.


Eligibility criteria:
inclusion criteria: * males or females * aged from 18 to 75 years * new york heart association(nyha) classification ⅱ-ⅲ * at screening, subject has an lvef\<0.45 * have received optimal therapy with an angiotensin converting enzyme inhibitors or angiotensin receptor blocker for 4 weeks before enrollment * subjects with symptoms of stable heart failure do not need intravenous injection diuretics,cardiac inotropes or vasodilators * willing to provide written informed consent exclusion criteria: * current treatment on any class i or iii antiarrhythmic, except amiodarone or beta-blockers * current treatment on calcium antagonists except for long-acting dihydropyridine agents * have a history of acute coronary syndrome,cerebral apoplexy or transient ischemic attack with 3 months * have a history of cardio-vascular surgery or other vessel operations with 3 months * have a history of sustained ventricular tachycardia or ventricular fibrillation with 3 months * have a plan to receive coronary revascularization or heart transplantation * uncontrolled ventricular arrhythmias (not controlled with antiarrhythmic therapy or an implantable defibrillator) * subjects with uncorrected primary obstructive or severe regurgitative valvular disease，nondilated (restrictive) or hypertrophic cardiomyopathy * sitting systolic blood pressure≤90mmhg (based on an average of 3 readings) * current decompensated heart failure * second or third degree heart block，or sick sinus syndrome，a pacemaker is not placed * contraindication to vasodilators * have a history of cardiac resynchronization therapy or * have received cardioverter defibrillator or pacemaker with 1 month * resting heart rate\<50 beats per minute(based on the average of 3 readings) * elevated liver enzymes (alanine aminotransferase or aspartate aminotransferase levels greater than 3 times upper limit of normal) * serum creatinine levels greater than 2 times upper limit of normal * current clinical evidence of obstructive pulmonary disease (e.g., asthma or bronchitis) requiring inhaled or oral bronchodilator or steroid therapy * history of drug sensitivity or allergic reaction to alpha or beta-blockers * contraindication or intolerance to beta-blockers * pregnant or lactating women and women planning to become pregnant * has any systemic disease, including cancer, with reduced life expectancy (\<12 months) * use of an investigational drug within 30 days of enrollment * participation in an investigational device trial within 30 days of enrollment * known drug or alcohol abuse 1 year prior to enrollment * has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study * in the opinion of the investigator the subject is known to be noncompliant with prescribed medication regimen
efficacy study of pre-operative iph2201 in patients with squamous cell carcinoma of the oral cavity

Conditions: Squamous Cell Carcinoma of the Oral Cavity

Summary: the primary objective of this open label phase ib/ii trial is to evaluate the clinical and pharmacological activity of iph2201 as a single-agent in treatment-naïve pre-operative patients with operable squamous cell carcinoma of the oral cavity . 43 patients are planned to be enrolled. the first 6 patients will receive iph2201 at a dose of 4 mg/kg q2w x 4. subsequent patients will be treated at a dose of 10 mg/kg q2w x 4. standard loco-regional treatment with surgery followed by adjuvant therapy will be initiated after the last administration of iph2201.


Eligibility criteria:
inclusion criteria: * histologically confirmed, primary, previously untreated, resectable squamous cell carcinoma of the oral cavity considered clinically and radiologically as intermediate or high risk, classified ii ( with large (≥ 3 cm and ≤ 4cm) ct2cn0cm0 tumors or any ct2cn0cm0 tumor invading neighboring structures) iii or iva according to the american joint committee on cancer * adequate liver and renal function exclusion criteria: * other malignancy * abnormal cardiac status * autoimmune disease * serious concurrent uncontrolled medical disorder * systemic treatment with corticosteroids or other immunosuppressive agents within 30 days prior to iph2201 first administration.
efficacy trial of life simulation game to routinize adolescent hiv testing

Conditions: Hiv

Summary: this study will aim to assess the acceptability, usability and efficacy of using state-of-the-art video game technology to increase hiv testing among adolescents and young adults (aya) ages 13-24. aya often lack awareness of their personal risk of contracting hiv and where to go for testing and care. this lack of awareness has contributed to poor uptake of hiv testing among aya despite engagement in high risk behaviors. the goal of this project is to harness this strong motivation to play games to increase hiv testing. previous games for behavior change have yielded early success for increasing target behaviors among their sample populations, yet research on increasing hiv testing among aya through gaming has been limited. this intervention builds on prior formative work and is designed to offer aya personally-tailored risk messages and supports their accessibility to hiv testing and prevention services through an innovative gaming approach that is sharable over social media with in-game rewards for sharing the game with peers. the specific aim of this study is to determine the efficacy of a life-simulation game in changing hiv testing, knowledge, and risk behaviors among aya at risk for hiv.


Eligibility criteria:
inclusion criteria: * age 13-24 * self-reported hiv negative or unknown status * self-reported ever sexually active * resident of the dc metropolitan region which includes the district of columbia, maryland and virginia for at least the next 6 months * is able to provide informed consent or assent * able to complete all study procedures in english * has own mobile phones and be willing to use them for the study.

Keywords: hiv prevention hiv testing mhealth pre-exposure prophylaxis (prep) adolescents interactive technology
efficacy of pregabalin in patients with radicular pain

Conditions: Neuropathy; Radicular, Lumbar, Lumbosacral; Failed Back Surgery Syndrome; Spinal Stenosis; Herniated Disc

Summary: the purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.

although the efficacy of pregabalin has been demonstrated in several pain states and it is approved by the fda for use in post herpetic neuralgia, diabetic neuropathy and fibromyalgia there are few studies of its efficacy in patients with radicular pain from herniated disc, spinal stenosis or failed back surgery syndrome. this study was conducted to evaluate the efficacy of pregabalin in these pain states.

Eligibility criteria:
inclusion criteria: 1. patients with pain in dermatomal distribution, in either cervical or lumbar region. 2. history of pain for more than 3 months. 3. history of herniated disc, spinal stenosis or failed back surgery. 4. a series of epidural steroid injections within the past 6 months. 5. presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia, allodynia, dysesthesia) in the affected dermatomes. 6. patients must be cognitively capable of completing the pain questionnaires. exclusion criteria: 1. patients below 18 or over 65 years of age. 2. patients with mostly axial spinal pain. 3. presence of significant motor deficits, and /or bowel and/or bladder dysfunction. 4. workmen's compensation or disability issues. 5. patients with chronic depression and on depression medications. 6. addiction and/or substance abuse issues. 7. patients using gabapentin or failure to respond to previous gabapentin use. 8. patients with known peripheral neuropathy (e.g. dpn, phn etc.). 9. known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and wheezing). 10. history of angioedema with pregabalin use. 11. patients with known renal insufficiency, diabetes, congestive heart failure, cardiac conduction abnormalities, and/or thrombocytopenia. 12. patients using ace-inhibitors and thiazolidinedione antidiabetic agents (avandia®, actos®). 13. pregnant patients.

Keywords: pregabalin radicular pain failed back surgery of greater than 3 months duration
laparoscopic-assisted surgery compared with open surgery in treating patients with colon cancer

Conditions: Colorectal Cancer

Summary: rationale: less invasive types of surgery may help reduce the number of side effects and improve recovery. it is not yet known which type of surgery is more effective for colon cancer. purpose: randomized phase iii trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.

objectives: * compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy. * compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients. * compare the differences in costs and cost effectiveness between these treatments in this patient population. * compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99) outline: this is a randomized, multicenter study. patients are stratified according to participating center, primary surgeon, site of primary tumor (right vs left vs sigmoid), and american society of anesthesiologists disease classification (i and ii vs iii). patients are randomized to one of two treatment arms. the extent of colon resection is identical for both arms.

Eligibility criteria:
disease characteristics: * clinical diagnosis of primary adenocarcinoma * involving a single colon segment: * right colon from the ileocecal valve up to and including the hepatic flexure * left colon from the splenic flexure to the junction of the sigmoid and descending colon * sigmoid colon between the descending colon and the rectum (at least 15 cm from the dentate) * diagnosis based on physical exam plus either a proctosigmoidoscopy and barium enema or a colonoscopy * no advanced local disease that renders laparoscopic resection impossible * no acutely obstructed or perforated colon cancer requiring urgent surgery * no transverse colon cancer (i.e., between distal hepatic flexure and proximal splenic flexure) * no stage iv disease * no rectal cancer (i.e., below the peritoneal reflection, lower edge of tumor less than 15 cm from dentate) * no american society of anesthesiologists iv/v disease classification * no associated gastrointestinal diseases (i.e., crohn's, chronic ulcerative colitis, or familial polyposis) that require additional extensive operative evaluation or intervention patient characteristics: age: * 18 and over other: * no other prior or concurrent malignancy within the past 5 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: surgery: * no prohibitive scars/adhesions from prior abdominal surgery other: * no concurrent investigational treatments or invasive diagnostic procedures within 30 days after surgery

Keywords: stage i colon cancer stage ii colon cancer stage iii colon cancer adenocarcinoma of the colon
reconstruction after abdominoperineal resection with robot-assisted harvest of vram flap

Conditions: Perineum; Wound; Postoperative Complications; Rectal Neoplasms; Rectus Abdominis Hernia; Prospective Studies; Wound Heal; Sexual Health

Summary: non-randomized study of robot-assisted perineal reconstruction with rectus abdominis muscle flap in patients operated with abdominoperineal resection for irradiated locally advanced rectal or anal cancer. operative time, complications, wound healing, pre- and postoperatively abdominal wall strength and patient related outcomes including sexual health will be registered.

inclusion criteria: patients \> 18 years of age operated with robotic-assisted abdominoperineal resection for irradiated locally advanced rectal or anal cancer where robotic-assisted perineal and/or vaginal reconstruction has been performed with a rectus abdominis muscle flap. methods up to 40 patients operated with robotic-assisted abdominoperineal resection with da vinci xi surgical system (intuitive surgical, sunnyvale, california, usa) and robotic-assisted reconstruction with a pedicled rectus muscle will be included in this prospective, non-randomized study. in addition to the standardized post-operative care for patients with locally advanced rectal or anal cancer as specified by national guidelines, patients will be offered study-specific follow-up visits at 1, 6 and 12 months. complications are recorded by the accordion severity grading system of surgical complications. patient related outcomes measures will be registered by using european organization for research and treatment of cancer quality of life questionnaire core 30 (eortc qlq-c30). sexual health will be registered by a subset of questions from european organization for research and treatment of cancer quality of life questionnaire sexual health (eortc qlq-sh22). primary endpoint: - perineal wound healing at 3 months secondary endpoints: * early (\ 30 days) complications * quality of life preoperatively and at 3- and 12 months postoperatively * sexual function preoperatively and at 3- and 12 months postoperatively * clinical evaluation of abdominal wall strength preoperatively, at 3- and 12 months postoperatively

Eligibility criteria:
inclusion criteria: * patients with rectal or anal cancer * scheduled for robot-assisted abdominoperineal resection * reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap exclusion criteria: * patients not eligible for robot-assisted procedure * rectus abdominis muscle not available for harvest * the expected wound defect is not suitable for reconstruction with rectus abdominis muscle flap

Keywords: rectus abdominis muscle flap reconstruction perineum
the comparison of comprehensive multi-disciplinary program and conventional care program on fragility fracture elderly

Conditions: Hip Fracture

Summary: fragility fractures are one of the commonest injuries among elderly people in hong kong and account for 12% of the disease burden in elderly aged 65 or above. a good management healthcare program and training helps elderly to restore full functional level and prevent re-fracture in the following 2 years after primary fracture, but hong kong lacks of such program. some reports from other countries pointed out a well-organized multi-disciplinary management programs are cost-effective to identify and treat osteoporosis, reduce the fracture rate, improve quality of life and raise awareness of fragility fracture. this study aims to compare the cost-effectiveness of multi-disciplinary management program with conventional care controls. the clinical effectiveness outcomes (re-fracture rate, fall rate, mortality, mobility, quality of life and specialist follow-up time) of the fragility hip fracture patients in new territories east receiving the proposed management program will be compared with those from kowloon central with usual care as controls. the findings will provide useful data for the policy maker to evaluate the current clinical service for fragility fracture patients and consider the implementation of new multi-disciplinary management program into our healthcare system.


Eligibility criteria:
inclusion criteria: * fragility hip fracture patients within age 65-90 exclusion criteria: * taking medication affecting bone metabolism or intensive exercise training; * those living in old age homes or anyone who is not able to comply with our program

Keywords: multi-disciplinary management program conventional care program balance ability quality of life