Kornimate/medical-research-clean huggingface dataset:
stereotactic body radiotherapy for head and neck tumors

Conditions: Squamous Cell Carcinoma of the Head and Neck; Nasopharyngeal Carcinoma; Salivary Gland Cancer; Head and Neck Sarcoma; Paraganglioma of Head and Neck; Chordoma of Head and Neck; Chondrosarcoma of Head and Neck; Angiofibroma of Head and Neck

Summary: this study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (sbrt) for the treatment of benign and malignant head and neck tumors.

this single site, non-randomized, prospective, phase iv study includes 3 patient groups to be treated with sbrt: * benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection * malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (residual disease group) * unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (primary rt group) data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities. follow up data will be collected during the patient's standard office visits. the anticipated duration of this study is 5 years.

Eligibility criteria:
inclusion criteria: * patient age \> 18 years * zubrod performance status of 0-3 * benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma * malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma * signed study-specific consent form exclusion criteria: * pregnant or lactating women, due to potential exposure of the fetus to rt and unknown effects of rt on lactating females * patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Keywords: stereotactic radiosurgery head and neck tumors squamous cell carcinoma of head and neck
camrelizumab combined with chemotherapy for recurrent or advanced cervical neuroendocrine carcinomas

Conditions: Chemotherapy; Anti-pd-1 Antibody; Cervical Neuroendocrine Carcinoma; Adverse Drug Event; Recurrent Cervical Carcinoma; Advanced Cervical Carcinoma; Objective Response Rate

Summary: recurrent or advanced cervical neuroendocrine carcinoma (nec) is refractory to multimodal treatment, even to extensive therapy. chemotherapy, consisting of platinum and etoposide, remains the main therapy for recurrent or advanced cervical nec. in addition, bevacizumab has shown progression-free benefits in recurrent or advanced cervical cancer. case report suggested anti-pd-1 antibody may have antitumor activities in nec. based on these evidences, a phase 2, single arm trial is conducted to explore the objective response rate (orr) of platinum/etoposide/bevacizumab/anti-pd-1 antibody (camrelizumab) for the treatment of recurrent or advanced cervical nec. this trial is to enroll 20 patients, who would accept 6 courses of platinum/etoposide/bevacizumab/camrelizumab. if the patient achieved complete or partial remission, a total period of 12 months bevacizumab/camrelizumab will be given as maintain therapy. the primary endpoint is orr. the second endpoints are severe adverse events according to criteria of common terminology criteria for adverse events (ctcae) and irecist guideline, and critical changes of laboratory testing.


Eligibility criteria:
inclusion criteria: * confirmed recurrent or advanced cervical neuroendocrine carcinoma * aged 18 years or older * no immunosuppressive disease * signed an approved informed consents * performance status of ecog 0-1 exclusion criteria: * not meeting all of the inclusion criteria
prospective, observational clinical investigation of the exos reformable brace

Conditions: Distal Radius Fracture

Summary: this is a prospective observational single cohort trial quantifying time to radiographic union (primary endpoint) and convenience, satisfaction, pain and resource requirements (secondary) for patients with non-operatively treated distal radius fractures managed with a thermoformable exos short-arm brace.

the trial will be a prospective trial of a convenience sample of skeletally mature patients with radiographically-confirmed distal radius fractures that can be managed without orif. the study population will be defined as all adult patients (\>18 years) with stable, non-displaced distal radius fractures. all patients will be independent in activities of daily living. patients will be screened as candidates for enrollment into the study and if the patient satisfies the inclusion/exclusion criteria, a clinical research coordinator or the study pi/copi will explain all essential elements of the clinical trial. if the patient agrees to participate, the study coordinator or pi/copi will obtain informed consent. the patient will still be followed clinically per the pi/copi's standard of care.

Eligibility criteria:
inclusion * age \> 18 years; * unilateral fracture of distal radius without misalignment (dorsal angulation \<10°, axial radial shortening \<5mm), \<2mm intraarticular stepoff; * independent in activities of daily living; * capable and willing of signing informed consent. exclusion * children under the age of 18; * fracture of the contralateral arm; * other fractures of the ipsilateral arm; * open fractures; * fractures that require reduction.
detecting absence seizures using eye tracking

Conditions: Epilepsy, Generalized; Absence Epilepsy; Absence Seizures; Seizures; Seizure Disorder

Summary: the goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. participants will wear an eye-tracker during a routine eeg.

seizures can be difficult to detect outside of the hospital even with careful observation by a caregiver. eeg is the best method that we have to detect seizures- but it is uncomfortable for long term use outside of the hospital. the goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. people participating in this study will have a routine eeg performed while an eye tracker measures eye movements. after the eeg is complete the researchers will compare the eye movements to the eeg to develop a software program that can detect seizures from eye movements.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form- per local irb 2. stated willingness to comply with all study procedures including the clicker test and availability for the duration of the study 3. male or female, aged 4-100 4. experience known typical absence seizures as defined by the ilae 2017 classification or referred to eeg lab for staring spell or concern for absence seizure a. this will allow for inclusion of children and adults across the entire spectrum of disease states including new diagnosis (medication naive), medication responsive and non-medication responsive 5. scheduled for clinical eeg observation exclusion criteria: 1. intolerant of wearing or unable to wear the eyeglasses 2. autism or other developmental disorder that the pi thinks will interfere with data collection 3. history of aggression that the pi thinks will interfere with data collection 4. history of not tolerating eeg that the pi thinks will interfere with data collection 5. unable to give consent (for individuals ≥ 18 years old) unless they have an adult with power of attorney to consent

Keywords: eye movements seizure detection
efficacy and safety of sr58611a in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: to evaluate the efficacy of a fixed dose of sr58611a(350 mg q12) compared to placebo in patients with majordepressive disorder (mdd) using escitalopram (10 mgqd) as positive control. the study is a multicenter, us and canadian, randomized, double-blind, 3-parallel-group, placebo- and escitalopram-controlled, phase iii study consisting of four segments (a, b, c and d). segment a is a 1-week, placebo, single-blind period. segment b is an 8-week, double-blind period. segment c is an optional 18-week double-blind extension period. segment d is a 1-week safety follow-up period after study drug discontinuation or early termination (during segment b or c).

to evaluate the efficacy of a fixed dose of sr58611a(350 mg q12) compared to placebo in patients with majordepressive disorder (mdd) using escitalopram (10 mgqd) as positive control. the present study is an 8-week, double-blind, placebo- and escitalopram-controlled, randomized, parallel-group study. a 1-week, placebo, single-blind period precedes the 8-week randomized treatment period and an optional 18-week, double-blind extension period follows the randomized treatment period. a safety follow up visit is scheduled 1 week after the acute and extension period, or early termination. escitalopram, a selective serotonin reuptake inhibitor (ssri), an approved treatment for mdd, is chosen as a positive control agent in this study. the dose of 10 mg is within the approved dose range with no need for dose adjustment in elderly patients. this trial is designed to formally compare the efficacy, safety, and tolerability of sr58611a to placebo. escitalopram is used as a positive control.

Eligibility criteria:
inclusion criteria: main inclusion criteria: * 1. out-patients, 18 year and older. * 2. major depressive disorder (mdd) with a recurrentmajor depressive episode (mde) according to dsmiv-tr criteria * 3. duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration. * 4. patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months. exclusion criteria: main exclusion criteria: * 1. patients at immediate risk for suicidal behavior * 2. patients with a mde with psychotic features, catatonic features, seasonal pattern or postpartum onset * 3. the duration of the current depressive episode is greater than 2 years * 4. patients whose current depressive episode is secondary to a general medical condition * 5. patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder * 6. patients who have received non-pharmacologic, somatic treatments for psychiatric disease * 7. patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening

Keywords: major depressive disorder depression major depressive episode antidepressive agents
perifosine in patients with relapsed/refractory waldenstrom's macroglobulinemia

Conditions: Waldenstrom's Macroglobulinemia

Summary: waldenström's macroglobulinemia (lymphoplasmacytic lymphoma, wm) remains incurable with limited therapeutic options and notably absent fda approved therapy with any wm indication. therefore, there is a need to identify new therapeutic agents for wm patients both in the upfront and relapsed/refractory setting. the purpose of this research study is to assess the efficacy of perifosine in patients with relapsed or refractory wm.

perifosine is a drug that in particular inhibits akt thought to be important for initiation and progression of malignancies, specifically in lymphomas. in laboratory experiments of wm and lymphoma cell lines, perifosine has shown to have cytotoxic and anti-proliferative activity as a single agent. this drug has been used in clinical research studies of other types of cancers including soft tissue sarcomas, head and neck cancers and prostate cancer. this study uses a two-stage design to evaluate efficacy of perifosine based on overall response (or). the null and alternative or rates are 20% and 40%. if 4 or more patients enrolled in the stage one cohort (n=17 patients) achieve or than accrual will proceed to stage two (n=20 patients). if fewer than 10 ors are observed then the regimen will be considered ineffective.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * must have received prior therapy for their wm and have relapsed or refractory wm. any number of prior therapies is acceptable * measurable disease, defined as presence of immunoglobulin m paraprotein with a minimum igm level of equal to or greater than 2 times the uln and over 10% of lymphoplasmacytic cells in bone marrow * ecog performance status 0,1, or 2 * laboratory values as described in the protocol * life expectancy of greater than 12 weeks exclusion criteria: * uncontrolled infection * other active malignancies * cns involvement * cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration. * other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational * pregnant or nursing women * known to be hiv positive * radiation therapy less than 2 weeks prior to registration

Keywords: relapsed waldenstrom's macroglobulinemia refractory waldenstrom's macroglobulinemia wm perifosine
clinical validation of a urinary exosome gene signature in men presenting for suspicion of prostate cancer

Conditions: Prostate Cancer

Summary: validate a non-dre exosome gene expression test, with an npv \>/= 90% certainty, will exclude the presence of high gleason grade/ score (\>/=7) prostate cancer in a prostate needle biopsy.

the purpose of this multi-center clinical study is to determine the association of an exosome urine test score with the presence of high gleason grade / score (gs\>/=7) prostate cancer on a prostate needle biopsy and validate the assay's performance characteristics in men presenting to their urologist with or without a previous negative biopsy, and recommended for an initial or subsequent biopsy. the results of this study are to support the use of this assay as a laboratory developed test. a secondary objective is to develop an assay that accurately predicts the presence of any gleason grade prostate cancer in men at risk for prostate cancer.

Eligibility criteria:
inclusion criteria: 1. male, \>50 years of age with a clinical suspicion for prostate cancer based in part on an elevated psa (limit range: 2.0 - 20 ng/ ml), and or suspicious dre, with or without the clinical history of a single prior negative biopsy, and who have been recommended for a repeat and or first time biopsy. 2. the subject must be able to comprehend and sign an approved informed consent form and other applicable study documents. exclusion criteria: 1. use of medications or hormones that are known to affect serum psa levels within 3-6 months of study enrollment. 2. clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment. 3. history of prostate cancer. 4. history of invasive treatments for benign prostatic hypertrophy (bph) or lower urinary track symptoms within 6 months of study enrollment. 5. medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion or results of this trial, or constitutes an unacceptable risk to the subject. 6. participation in pharmaceutical or treatment related clinical study within 6 months of study enrollment. exception: trials for non-prostate conditions may be acceptable, with approval by the investigator and sponsor. 7. no known hepatitis (all types) and/or hiv documented in patient's medical record. 8. patients with history of concurrent renal/bladder tumors within 6 months of study enrollment.

Keywords: prostate cancer gleason grade prostatic neoplasms
effects of oropharyngeal exercises on patients with primary snore, mild and moderate obstructive

Conditions: Primary Snore, Obstructive Sleep Apnea (Mild and Moderate).

Summary: randomized study of patients with primary snore, mild and moderate obstructive sleep apnea. protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator, breathing exercise and nasal lavage. the objectives are study the effects of therapy on oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on snore and quality of sleep using pharyngeal critical pressure, magnetic resonance, negative expiratory pressure and snore analyses. hypothesis that the therapy group (oropharyngeal exercises) will have more modifications compared to the control group.

this is randomized study with multiple primary endpoints. in december 2012 the study also started collecting tongue strength and endurance (iopi). because not all patients are able to perform all evaluations, the publications will be divided and presented according to the completion of the required number of patients for each primary endpoint.

Eligibility criteria:
inclusion criteria: subjects with primary snore, mild and moderate obstructive sleep apnea exclusion criteria: bmi \> or = 40, craniofacial malformations, smokers, pregnant women, edentulous, total dental prostheses, use of hypnotic medications, stroke, neuromuscular dystrophy, coronary artery disease, chronic heart failure, chronic obstructive pulmonary disease, severe nasal obstructive disease, pharyngeal surgery,already made some kind of treatment for obstructive sleep apnea.

Keywords: oropharyngeal exercises, obstructive sleep apnea, speech therapy, magnetic resonance, pcrit, negative expiratory pressure, snore
aripiprazole for schizophrenia outpatients completing bms clinical trials

Conditions: Schizophrenia

Summary: the purpose of this study is to provide aripiprazole to schizophrenic outpatients and community treated patients who are currently receiving aripiprazole therapy on another bms sponsored clinical trial.


Eligibility criteria:
inclusion criteria: * currently receiving aripiprazole at time of screening * men and women ages 18 to 70 exclusion criteria: * all patients previously discontinued from an aripiprazole study for any reason * active alcohol or substance abuse * patients who represent a significant risk of committing suicide * patients with clinically significant abnormal laboratory test results, vital signs or ecg findings
black star - magnetic stent removal in transplant patients

Conditions: Kidney Failure, Chronic; End Stage Renal Failure With Renal Transplant

Summary: this is a pilot, single-centre, feasibility study to assess the feasibility issues and collect preliminary clinical data for the design of future randomized controlled trial to evaluate the feasibility and patient comfort of magnetic retrieval device removal of ureteral stent in transplant patients.

to curtail the pain and discomfort during cystoscopic stent removal and in order to improve patient's quality of life, a newly developed ureteral stent with a small magnet at its distal end and a customized magnetic retrieval catheter is recently used in europe. the product is black-star® with a retrieval device by urotech (achenmühle, germany). the magnetic blackstar stent is a ureteral stent with a small magnet fixed with a string at the distal loop. the placement of stent is similar as routinely done on a guidewire, the only difference is to include the magnetic piece over the guidewire. to remove the stent a customized catheter with a magnetic tiemann tip is used. the catheter is inserted after urethral application of a standard lubricant and removed with the stent after coming in contact with the stent's magnet. the stent comes in various sizes and is currently being used in europe. the studies have concluded fast and easy retrieval of stent without requirement of cystoscopy and decreased patient discomfort.

Eligibility criteria:
inclusion criteria: 1. patients at least 18 years of age and capable of giving informed consent 2. patients scheduled for deceased donor renal transplant surgery exclusion criteria: 1) patients undergoing live donor renal transplant

Keywords: renal transplant magnetic ureteral stent black-star®
low dose interscalene and infraclavicular block for humerus surgery

Conditions: Humerus Fracture

Summary: combining interscalene block with infraclavicular block for humerus surgery provides a unique surgical anaesthesia and postoperative analgesia.

interscalene block provides effective surgical anaesthesia for shoulder and proximal arm surgery. however, sometimes it can be inadequate for distal arm surgery. combining infraclavicular block with interscalene block may provide a successful surgical anaesthesia for humerus surgery.

Eligibility criteria:
inclusion criteria: * patients accepting peripheral nerve block technique for humerus surgery * unilateral orthopedic humerus surgery * 18 years of age or older exclusion criteria: * patients refused peripheral nerve block * non-cooperate patients * neuropathy of any etiology in the affected extremity

Keywords: interscalene infraclavicular humerus surgery
prediction of mortality in patients waiting for liver transplantation through brain magnetic resonance imaging

Conditions: End Stage Liver Disease; Hepatic Encephalopathy

Summary: the purpose of this study is to determine whether hepatic encephalopathy, measured through magnetic resonance imaging, electroencephalogram and neuropsychological evaluation adds prognostic information to patients who are waiting for liver transplantation. if this model improves mortality prediction this might be used in the future for organ allocation.

the only current definitive treatment for end-stage liver disease is transplantation. due to the scarcity of organs available, the correct prioritization of patients for liver transplantation has a crucial importance. nowadays, patients are ranked according to severity of liver disease, measured by the meld score. this index is only derived from objective measures (serum concentration of bilirubin, creatinine and inr). hepatic encephalopathy (he) is a serious and progressive disorder in patients with end-stage liver disease. the severity of he has prognostic implications in those waiting for liver transplantation. however, the prognosis of he is independent and not correlated to the meld score. hepatic encephalopathy triggers multiple changes in brain magnetic resonance imaging (mri) providing an objective way to evaluate it. also electroencephalogram and neuropsychological evaluation might increase mortality prediction. adding the information provided by mri, electroencephalogram and neuropsychological evaluation to the meld score model might increase the prediction of mortality. increase mortality's prediction has a fundamental importance because in organ allocation. we will evaluate the predictive value of these variables in predicting mortality of those patients waiting for liver transplantation.

Eligibility criteria:
inclusion criteria: * man or woman over 18 years old * listed in liver transplantation waiting line * patient able and willing to participate in the evaluations of this study exclusion criteria: * acute liver failure * serious structural brain anomalies * condition or situation in which, in the opinion of the investigator, put the patient at significant risk

Keywords: liver disease hepatic encephalopathy meld liver transplantation