Kornimate/medical-research-clean huggingface dataset:
pentosan polysulfate in treating patients with gastrointestinal disturbance caused by radiation therapy

Conditions: Diarrhea; Radiation Enteritis

Summary: rationale: pentosan polysulfate may be effective in treating side effects of radiation therapy to the abdomen or pelvis. it is not yet known whether pentosan polysulfate is more effective than no further therapy for treating gastrointestinal disturbance caused by previous radiation therapy. purpose: randomized phase iii trial to determine the effectiveness of pentosan polysulfate in treating patients who have inflammation of the rectum, diarrhea, or blood in stools caused by previous radiation therapy to the abdomen and pelvis.

objectives: i. evaluate the efficacy of pentosan polysulfate in patients with gastrointestinal tract sequelae after radiotherapy to the abdomen and pelvis. ii. determine the toxic effects of this drug in these patients. iii. determine the effect of this drug on symptoms and quality of life of these patients. outline: this is a randomized study. patients are randomized to 1 of 2 treatment arms. arm i: patients receive oral pentosan polysulfate three times a day for 2-6 months. arm ii: patients receive oral placebo three times a day for 2-6 months. both arms: patients may receive retreatment for two months if symptoms return and last for at least 2 weeks. quality of life is assessed before treatment, and at each follow up visit. patients are followed every 2 months for 6 months, then every 3 months for 18 months, then annually for 3 years. projected accrual: a total of 174 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: must have received prior radiotherapy to the abdomen and pelvis and now have radiation related gastrointestinal symptoms (which were not present before the radiotherapy and/or attributed to other causes) proctitis diarrhea melena (blood in stools) severity of symptoms classified as grade 1, 2, or 3 patient characteristics: age: any age performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: no bleeding ulcers no bleeding diathesis prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 1 month since prior chemotherapy no concurrent chemotherapy endocrine therapy: concurrent hormonal therapy for prostate cancer allowed radiotherapy: see disease characteristics at least 4 weeks since prior radiotherapy surgery: no prior bowel resection at least 3 weeks since prior surgery other: no concurrent anticoagulation therapy (except aspirin)

Keywords: radiation enteritis diarrhea
treatment of non-hodgkin's lymphoma with 90y-hll2 igg

Conditions: Non-Hodgkin's Lymphoma; Lymphoma, B-Cell

Summary: the purpose of this trial is to determine the safety of a 90y-radiolabeled, humanized (cdr-grafted) form of the ll2 monoclonal antibody in patients with non-hodgkin's lymphoma (nhl) at different dose levels.


Eligibility criteria:
inclusion: * histological or cytological diagnosis of b-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (all histological grades of nhl will be eligible for this trial.) * measureable via ct, with at least one lesion \> or = 1.5cm in one or both dimensions. (splenic tumors in absence of other tumors will not qualify.) * radiological studies (ie - ct) must be performed within 4 weeks prior to study start. * acceptable tumor burden that will allow adequate follow-up and evaluation. * less that 25% bone marrow involvement, determined by bone marrow biopsy. * must observe the following washout periods: at least 4 weeks beyond any major surgery. at least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity. at least 4 weeks beyond chemotherapy and/or immunotherapy. at least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria. * must have karnofsky score \>70% (or equivalent, ecog 0-2) with expected survival of at least 6 months. * serum creatinine \ or = 50ml/min. * serum bilirubin \< or = 2mg/dl. * hemoglobin \> or = 10 g/dl; wbc \> or = 3000/mm3; granulocyte count \> or = 150/mm3; platelet count \> or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study. * immunomedics elisa assay of hahll2 \< 100ng/ml for those with prior history of monoclonal antibody infusions. * cognizant informed consent.

Keywords: nhl recurrent b-cell lymphoma
prolonged air leak (pal) autologous blood patch intervention trial

Conditions: Lung Cancer

Summary: a postoperative autologous blood patch (abp) intervention trial for patients who underwent lung resection for cancer to examine its effectiveness in preventing a prolonged air leak. aim 1: to determine the safety and efficacy of autologous blood patch (abp) as a means to reduce the rate of prolonged air leak (pal) after lung cancer resection aim 2: to prospectively examine variation in morbidity and quality of life between patients with and without a pal

the plan for this trial is to establish the safety and efficacy of abp as a means of reducing pal following lung cancer resection. patients with an air leak on the morning of postoperative day 3 after elective lung resection for cancer will be randomized to abp on postoperative day 3 and day 4 (if an air leak remains present), or standard care (n=60 per arm). this will be a multi-institutional randomized, controlled trial open for enrollment at centers in the united states and canada. the study methods and design are compliant with the consolidated standards of reporting trials (consort). subjects will be consented on postoperative day 3, with autologous blood patch intervention occurring on day 3 or day 4. if subjects are randomized to the abp arm of the trial, they will receive 60-100 ml of autologous blood sterilely drawn from a peripheral vein and immediately instilled into the chest tube. subjects will then follow up either in clinic or via telephone to answer the questionnaire. if the subject is being seen in person, they will be handed a questionnaire form to complete. this form will be kept and stored as source documentation. if the patient is answering the questionnaire via telephone, the study team personnel will record their answers on the questionnaire form, indicating it was completed by the subject but recorded by study team personnel. a telephone encounter note will be recorded and stored as source with the completed questionnaire. follow up occurs at 30 days (+/-5 days) postoperatively.

Eligibility criteria:
inclusion criteria: * patients who underwent elective wedge resection, segmentectomy, lobectomy, or bilobectomy for suspected non-small cell lung cancer * patients that have reviewed and signed the informed consent form, had an opportunity to ask questions, and consent to have their de-identified data included in the study * patients who have an air leak on the morning of postoperative day 3 * age ≥18 years old exclusion criteria: * patients who undergo pneumonectomy, sleeve lobectomy, chest wall or diaphragm resection, or bilateral procedures. * age \< 18 years old * women who are pregnant

Keywords: surgery prolonged air leak autologous blood patch lung
feasibility of high frequency qrs analysis in patients with acute myocardial infarction

Conditions: Myocardial Infarction

Summary: the primary objective of this study is to characterize the morphological patterns of high frequency qrs components (hfqrs) in patients with acute myocardial infarction (ami), including stemi and nstemi, compared to patients without ami.

chest pain is one of the leading reasons of hospital emergency department (ed) visits worldwide. in the us, approximately 6 million people annually undergo evaluation in the ed for acute chest pain. despite the wealth of knowledge available about acute coronary syndrome (acs), this condition continues to be among the most difficult to predict or diagnose. misdiagnoses may lead to discharge of patients with acs, who should have been admitted as well as costly unnecessary hospitalizations of patients who do not have acs. more than 2/3 of the patients with acs have unstable angina (ua) or non-st-elevation myocardial infarction (nstemi). conventional ecg has low sensitivity of less than 50% in diagnosing these conditions. as the initial ecg in the ed is often non-diagnostic in acs patients, the diagnosis of st-elevation myocardial infarction (stemi) during its early stages may also be difficult. analysis of high-frequency qrs components (hfqrs), which quantifies changes in the depolarization phase of the cardiac cycle, has been previously reported to be a sensitive method for detection of demand ischemia. preliminary studies have shown that hfqrs-derived indices can also identify supply ischemia caused by prolonged balloon occlusion, and transient ischemic episodes in patients with chest pain.

Eligibility criteria:
inclusion criteria: * age \> 40 years (men and women) * time from onset of chest pain ≤ 12h * ami confirmed by biomarkers * clinical or electrocardiographic evidence of ischemia during recording * signed an informed consent exclusion criteria: * prior mi * prior cabg * pre-excitation syndrome (e.g. wp) * atrial fibrillation or significant ventricular arrhythmia * bbb, intraventricular conduction delay or qrs duration \> 120 ms * implanted pacemaker or defibrillator * left-ventricular hypertrophy

Keywords: stemi nstemi acute ischemia non-invasive diagnosis elevated troponin
effects of limb ischemic postconditioning in young sicas

Conditions: Stroke

Summary: the purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis and the baseline characteristics of trial participants, as an open, randomized controlled, prospective controlled trial.

stroke is a common cardia-cerebrovascular disease with high morbidity, disability and mortality rate. and more and more young patients account for the increasing morbidity. among them, symptomatic intracranial atherosclerotic stenosis（sicas）is a major cause, especially in asians. currently, traditional therapeutic methods present reluctant achievements on reducing stroke recurrence and pose threat on patients'health because of invasive operation and severe side effects. therefore, other treatment methods are called for urgently. remote ischemic post-conditioning refers to local or distal ischemia treatment after the occurrence of cerebral ischemia. prior research has shown that repeatedly ischemic reperfusion have protective effect on lowering the occurrence rate of ischemic events of patients with carotid stenosis. however, in-depth research on cerebral protection and correlation with collateral circulation has not been proven in an open, definitive clinical trial. thus, the epic-sicas trial will provide important information on the protective effects of upper limb ischemic post-conditioning on collateral circulation after cerebral infarction. hopefully to present us a very meaningful way to improve the patient's quality of life.

Eligibility criteria:
inclusion criteria: 1. age between 18 to 45 years old; 2. symptomatic intracranial atherosclerotic stenosis (sicas): cranial cta/mra/tcd/dsa confirm the diagnosis, patients got ischemic stroke or transient ischemic attack in the brain region supplied by the stenosis artery; 3. national institutes of health stroke scale(nihss) score 0-15 4. written informed consent was signed. exclusion criteria: 1. cerebral hemorrhage and other parts of the active bleeding disease; 2. severe aphasia, unable to express himself; 3. a history of brain tumor, brain trauma, cerebral embolism or other brain lesions; 4. severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction; 5. blood pressure\ 200 mmhg/110 mmhg after treatment; 6. dementia and mental illness; 7. using angiotensin-converting enzyme inhibitors; 8. a history of major surgery or trauma 4 weeks prior to admission; 9. without informed consent. elimination criteria： 1. patients with poor compliance，refuse to take regular treatment and examination; 2. patients' condition get exacerbated, with nihss score elevate for more than 4.

Keywords: stroke remote ischemic postconditioning symptomatic atherosclerotic intracranial arterial stenosis
effects of resistance and endurance training in pediatric cancer patients during intensive treatment phase

Conditions: Pediatric Oncology

Summary: the purpose of this study is to determine whether combined endurance and resistance training can improve muscle strength in children and adolescents with cancer during the intensive treatment phase.


Eligibility criteria:
inclusion criteria: * malignant tumor * medical treatment in the center for pediatrics, hematology, oncology and hemostaseology mainz (germany) * \> 3 years * signed informed consent exclusion criteria: * functional and/or cognitive limitations which limit performance during training * orthopedic condition which hinders to adequately participate in exercise training * heart failure (nyha iii-iv) * partial or global respiratory failure * symptomatic coronary disease * serious therapy-refractory hypertonia * sustainable thrombocytopenia \<10.000/µl, f. ex. therapy-refractory autoimmune thrombocytopenia * hereditary or acquired thrombocytopenia or coagulation disturbance * uncontrolled cerebral spasm * cns metastases * medical or psychological condition which does in the doctors opinion not allow participation in sport activity
study of two digital therapeutics for the treatment of experiential negative symptoms of schizophrenia

Conditions: Schizophrenia

Summary: this study evaluates the efficacy of two prescription digital therapeutics (pdt) in addition to standard of care (soc) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.

the purpose of the proposed study is to evaluate the efficacy and safety of two prescription digital therapeutics as an adjunct treatment to soc in participants 18 years of age or older diagnosed with experiential negative symptoms of schizophrenia.

Eligibility criteria:
inclusion criteria: a participant will be eligible for entry into the study if all of the following criteria are met: 1. has a primary diagnosis of schizophrenia. 2. is on a stable dose of antipsychotic medication(s). 3. has obtained an average score of ≥2 (moderate to severe) in at least two of the three cains-map domains (social, work, or recreational). exclusion criteria: a participant will not be eligible for study entry if any of the following criteria are met: 1. is currently treated with more than two antipsychotic medications (including more than two dosage forms). 2. meets dsm-5, for diagnoses not under investigation. 3. has participated in a ct-155 clinical study.

Keywords: prescription digital therapeutic (pdt) software as a medical device (samd) smartphone app schizophrenia negative symptoms
resect and discard approach to diminutive colonic polyps

Conditions: Benign Polyps of Large Intestine

Summary: resect and discard (rd) is a new paradigm for management of diminutive colorectal polyps wherein histology is determined by real-time endoscopic imaging; polyps are then resected and discarded rather than sent for histopathological review. the aims of this study were to compare the surveillance recommendations between rd and the standard of care where polyps are sent for histopathological review in a mixed setting of academic and community gastroenterologists and to evaluate the diagnostic performance of an rd program for management of diminutive polyps.

introduction: diminutive (≤5 mm) colorectal polyps are prevalent in the screening population but have low risk for harboring advanced villous or dysplastic components and for developing into colorectal cancer. "resect and discard" (rd) is a new paradigm for management of these diminutive polyps wherein histology is determined by real-time endoscopic imaging; polyps are then resected and discarded rather than sent for histopathological review. aim: the aim of this study were to compare the surveillance recommendations between rd and the standard of care where polyps are sent for histopathological review in a mixed setting of academic and community gastroenterologists and to evaluate the diagnostic performance of an rd program for management of diminutive polyps. methods: this is a prospective, observational study conducted in a single outpatient endoscopy center over 12 months. screening and surveillance colonoscopies were performed by four academic and two community gastroenterologists. all diminutive polyps (defined as ≤5 mm) were endoscopically imaged and histology predictions (adenoma vs. non-adenomatous polyp) were made using high-definition white light (hdwl) with/without narrow band imaging (nbi) at the discretion of the endoscopist. diagnostic performance and accordance of recommended surveillance intervals from endoscopic imaging were compared to histopathological review of the polyps.

Eligibility criteria:
inclusion criteria: * patients were included if diminutive polyps (defined as ≤5 mm) were identified at colonoscopy. exclusion criteria: * indication other than screening or surveillance * no diminutive polyps were found * an optical or histopathological diagnosis of the diminutive polyp could not be made * the polyp was resected but not retrieved for histopathology * a synchronous colorectal cancer was identified at the time of the colonoscopy * polyposis syndrome * inflammatory bowel disease * colonoscopies not complete to cecum * fair or poor bowel preparation

Keywords: colorectal polyps resect and discard endoscopic prediction histological diagnosis narrow band imaging
five-plus year follow-up of smart randomized controlled trial

Conditions: Chronic Low Back Pain

Summary: the objective of this study is to evaluate long-term ongoing effectiveness of the intracept intraosseous nerve ablation system for the treatment of chronic low back pain.

this is a prospective multi-center, nonintervention, observational, single arm post market data collection of the 5+ year effectiveness and satisfaction outcome for the smart trial population.

Eligibility criteria:
inclusion criteria: * lbp at least 6 months from original smart trial * rf ablation arm from smart trial exclusion criteria: -control arm subjects from smart trial
functional luminal imaging probe (flip) topography use in patients with scleroderma and trouble swallowing

Conditions: Scleroderma; Dysphagia; GERD - Gastro-Esophageal Reflux Disease

Summary: flip topography has been fda cleared to evaluate a variety of esophageal conditions, but has never been evaluated in patients with scleroderma. the investigators hope to evaluate this technology in patients who have scleroderma and various esophageal symptoms, and compare to non-scleroderma patients.

in patients with treatment refractory reflux disease, dysphagia (trouble swallowing) or other symptoms possibly attributed to the esophagus, the standard protocol is generally to first do an upper endoscopy to evaluate for abnormalities. if this is normal the next step is often to do esophageal manometry to measure esophageal muscle contractions, along with a ph/impedance study in certain clinical situations. if these are normal, then the the disorder is thought to be functional (no clear biological pathology). however, it is believed that flip (functional luminal imaging probe) technology may pick up additional disorders of the esophagus missed by standard esophageal manometry, leading to different treatments in certain cases. additionally, flip technology offers a different approach to classifying motility disorders of the esophagus. flip is a technology that measures distensibility and diameter of the esophagus during endoscopy by inflating a balloon in the esophagus. it has previously been used to aid in the diagnosis and provide more information regarding gastroesophageal reflux disease, achalasia, and eosinophilic esophagitis. it has also been used pre and post fundoplication and myotomy to assess adequacy of these procedure. more recently a group at northwestern has developed a modification of this procedure called flip topography. the basic principles are the same, but this technique measures the reaction of the esophagus to distension, providing additional information. a recent study of flip topography looked at 145 patients referred for dysphagia (trouble swallowing). all patients had both standard manometry and flip topography. 25% of patients in the study had a normal manometry, offering no measurable explanation of their symptoms. of these patients, half had an abnormal flip topography, and additional treatments were offered in certain situations. flip topography has also been evaluated in patients with eosinophilic esophagitis, though numbers are small. currently, the flip topography device has been fda cleared for esophageal distensibility testing. it has never been evaluated specifically in patients with scleroderma.

Eligibility criteria:
inclusion criteria: * must have a clinical indication for upper endoscopy (recruiting patients both with scleroderma and without) exclusion criteria: * not healthy enough to undergo an upper endoscopy * mass, stricture, ring, or web present on upper endoscopy * history of esophageal cancer * history of esophageal surgery
prevalence of hba1c in women with pcos

Conditions: Polycystic Ovarian Syndrome; Pelvic Endometriosis; Insulin Resistance; Non-insulin Dependent Diabetes Mellitus; Tubal Obstruction

Summary: women with pcos have been observed to be potential diabetics.recently,american diabetes association has suggested screening of women with pcos for hba1c.

in view of recent suggestion of american diabetes association(ada)to screen women with pcos for hba1c,we intend to study its prevalence in all categories of obesity in women with pcos. women with pcos by rotterdam criteria will be screened for insulin resistance by using different techniques or tests. further, the sensitivity and specificity of hba1c will be compared with sensitivity and specificity of other insulin resistance markers such as ogtt, free androgen index, free testosterone, fasting insulin to glucose ratio, homa-ir and homa-b-cell.

Eligibility criteria:
inclusion criteria: 1. bmi of 25-35 kg/mt2 2. atleast three of the rotterdam criteria for diagnosis of pcos. 3. subjects with well stabilized thyroid,if they had documented evidence of previousthyroid disorder. exclusion criteria: 1. subjects with documented diagnosis of metabolic syndrome. 2. subjects with laparocopic and histopathologic diagnosis of endometriosis. 3subjects with primary hyperprolectineamia. 4.subjects with basal fsh \>/=15miu/ml. 5.subjects with continuously elevated 17-0h-p.

Keywords: pcos hba1c insulin resistance ogtt homa-ir homa-b-cell