Kornimate/medical-research-clean huggingface dataset:
ox bile- conjugated bile acids sodium in type ii diabetes mellitus

Conditions: Type 2 Diabetes Mellitus; Obese; Overweight

Summary: to study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum fgf-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with dpp4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.

this is a single-center, placebo-controlled, parallel-group, single dose, randomized, controlled trial. participants will receive 28 days (+/- 4 days) of treatment to study the effect of delayed (ileocolonic)-release ox bile extract 500 mg bid (twice daily) on insulin sensitivity, gastric emptying of liquids and solids (measured by scintigraphy) and weight loss i overweight and obese type 2 diabetic subjects. participants will be receiving therapy with dpp4 inhibitors alone or in combination with metformin. blood samples will be collected at defined times to measure glycemia, fgf-19 and incretins (glp-1 \[glucagon-like peptide-1\], oxm \[oxyntomodulin\], pyy 3-36 \[peptide yy\]) fasting levels and responses to the meal.

Eligibility criteria:
inclusion criteria: 1. overweight or obese subjects with bmi \> 30 kg/m2 with type 2 diabetes mellitus taking dpp4 inhibitors alone or in combination with metformin. 2. women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope. exclusion criteria: 1. structural of metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. 2. irritable bowel syndrome 3. bristol stool type classification 4-7 per bowel disease questionnaire. 4. subjects with other treatment for type 2 diabetes mellitus. 5. subjects with hba1c \> 8% 6. females who are pregnant or breastfeeding 7. concomitant use of appetite suppressants, orlistat, phentermine-topiramate er or lorcaserin. 8. subjects who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than type 2 diabetes mellitus), and unstable psychiatric disease. 9. subjects who have donated blood or plasma in the past 8 weeks. 10. subjects who have participated in another study within the past 30 days.
an organoid-based functional precision medicine trial in osteosarcoma

Conditions: Osteosarcoma

Summary: the purpose of this study is to examine if we can predict sensitivity of osteosarcoma to different chemotherapy agents using tissue cultures in the laboratory. we know that different chemotherapy agents can be used in the treatment, but not every sarcoma responds to them equally. it is important to understand if testing of the tissue obtained during a routine biopsy or surgery may be useful in selecting appropriate treatments. in addition, additional testing of the tumor, including genetic testing, will help us to understand osteosarcoma better.

investigators successfully established a miniaturized system that allows the setup of hundreds of wells and perform assays with minimal manipulation. the adapted geometry used to plate tumor cells in matrigel, to generate mini-rings around the rim of the wells. this is attained by plating single-cell suspensions obtained from a cell line or a surgical specimen pre-mixed with cold matrigel in a ring shape around the rim in 96-well plates. rings can be established using a single-well or multichannel pipette. cancer cell lines grown in mini-ring format give rise to organized tumor organoids that recapitulate features of the original histology. treatment protocols and readouts for the mini-ring approach have been optimized. seeding cells takes place on day 0, 2-3 days are allowed to establish organoids and it is followed by two consecutive daily drug treatments. the assay is flexible and can be easily adapted to single treatments followed by longer incubations, multiple consecutive recurring treatments, multi-drug combinations, or other screening strategies. assays were implemented to quantify drug response by measuring cell viability after staining of live organoids with specific dyes followed by imaging. the pipeline has been extended to sarcomas: the team characterized organoids established from over 120 sarcoma biopsies, resections, and metastasectomies. sarcoma organoids showed patient-specific growth characteristics and subtype-specific histopathology. organoid sensitivity correlated with diagnostic subtype, patient age at diagnosis, lesion type, prior treatment history, and disease trajectory for a subset of the compounds screened. organoid screening can provide information to facilitate optimal drug selection, avoid ineffective therapies, and mirror patient outcomes in sarcoma.

Eligibility criteria:
inclusion / exclusion criteria - group1: - patients without diagnosis of osteosarcoma and whose imaging studies are suggestive of osteosarcoma and who are planned to undergo biopsy or surgery for diagnostic purposes inclusion / exclusion criteria - group 2: - patients whose imaging studies are suggestive of metastatic osteosarcoma and who are planned to undergo biopsy or surgery for diagnostic purposes

Keywords: osteosarcoma
validation of hrm score for the gerd diagnosis

Conditions: Gastro Esophageal Reflux

Summary: the goal of this prospective study is to validate a high resolution manometry score to predict pathologic gerd in patients with reflux symptoms. the main question it aims to answer is: is it possible to predict gerd on high resolution manometry? participants will be asked to undergo high resolution manometry and ph-study

according to recent guidelines, high resolution manometry (hrm) has an ancillary role in the diagnosis of gastro-esophageal reflux disease (gerd). a recent multicenter study demonstrated the effectiveness of the straight leg raise (slr) maneuver in predicting gerd, thus increasing the diagnostic value of hrm in patients with suspected pathological reflux. hrm parameters associated with gerd include esophageal body hypomotility such as ineffective esophageal motility (iem), and esophagogastric junction (egj) metrics, particularly the egj contractile integral (egj-ci) that takes into consideration the presence or absence of a hiatal hernia (hh), and a hypotensive lower esophageal sphincter (les). the combination of these four parameters might help to predict or exclude true gerd in patients undergoing hrm with the suspicion of gerd. in this multicenter international prospective study, we aimed to build a score to predict pathological esophageal acid exposure time (aet\>6%).

Eligibility criteria:
inclusion criteria: * hrm and wireless ph-study or catheter ph-impedance study performed for persistent gerd symptoms off proton-pump inhibitor (ppi) within two weeks of each other, * slr maneuver performed at the end of hrm exclusion criteria: * body mass index (bmi) \>35 kg/m2 * prior esophageal surgery * paraesophageal hiatal hernia * eosinophilic esophagitis * scleroderma * esophageal achalasia

Keywords: high resolution manometry gastroesophageal reflux disease esophagogastric junction inta-abdominal pressure straight leg raise maneuver
continuation protocol to protocol bbco-001

Conditions: Muscular Dystrophy, Oculopharyngeal (OPMD)

Summary: this will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent control, parallel group study. patients completing protocol bbco-001 will be offered the opportunity to enter into this 12-month randomized withdrawal protocol.

this will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent control, parallel group study. patients completing protocol bbco-001 will be offered the opportunity to enter into this 12-month randomized withdrawal protocol. eligible patients will be randomized to one of the following treatment arms: * treatment arm 1: active treatment; continuation of 30 g iv cabaletta once a week over an additional 52 weeks. * treatment arm 2: no-treatment concurrent control; discontinuation of iv cabaletta and follow-up over 52 weeks. iv cabaletta will be administered once a week to patients in treatment arm 1. all patients, regardless of treatment arm allocation, will undergo the same safety and efficacy assessments during the monthly site visits.

Eligibility criteria:
inclusion criteria: 1. adult men and women who participated and completed study bbco-001 2. clinical and genetic diagnosis of opmd 3. able to provide written informed consent to participate in this study 4. able to understand the requirements of the study and willing to comply with the requirements of the study exclusion criteria: 1. pregnant or lactating 2. currently receiving anticoagulant treatment (e.g., warfarin) 3. any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety 4. known hypersensitivity to any ingredient in the cabaletta iv infusion 5. currently participating in another clinical trial (other than bbco-001) or have completed an interventional trial less than 30 days prior to the planned treatment start date
community oncology setting disease outcomes of sorafenib (nexavar) use in advanced renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: a retrospective medical record abstraction study of at least 200 advanced renal cell carcinoma patients treated in the following settings: * patients with advanced renal cell carcinoma treated with sorafenib (nexavar) as second-line therapy after sunitinib (sutent) or bevacizumab (avastin) for first-line therapy (about 100 patients) * patients with advanced renal cell carcinoma treated with sorafenib (nexavar) as first-line therapy followed by sunitinib (sutent) as second-line therapy (about 100 patients)

recently, a number of targeted agents have demonstrated single-agent activity in the treatment of advanced renal cell carcinoma. bevacizumab, a humanized monoclonal antibody directed against vegf, resulted in an improvement in median progression-free survival when compared to placebo in a prospective, randomized trial. more recently, the multitargeted agents sorafenib and sunitinib have been approved for use in the treatment of advanced renal cell carcinoma. both have proven superior to previous interferon and other standard treatment; however it is not clear how these drugs should be used in the treatment sequence. with roughly 80% of cancer patients receiving their oncology care in the community setting, we are proposing a review and evaluation of at least 200 advanced renal cell carcinoma patients.

Eligibility criteria:
inclusion criteria: * eligible patient cases are those that have received sorafenib (nexavar) as second-line therapy after sunitinib (sutent) or bevacizumab (avastin) for first-line therapy or those patients that were treated with sorafenib (nexavar) as first-line therapy followed by sunitinib (sutent) as secondline therapy.

Keywords: advanced renal cell carcinoma renal cancer renal cell sorafenib nexavar bevacizumab avastin sunitinib sutent
exercise training to improve ptsd symptoms and health in older veterans

Conditions: Post-traumatic Stress Disorder

Summary: posttraumatic stress disorder (ptsd) is prevalent among military veterans and is more than just a psychological condition; ptsd has profound negative impacts on health, function, and quality of life. older veterans are the largest patient population served by the veterans health administration (vha), and many have lived with ptsd for 40+ years. veterans with ptsd engage in low levels of physical activity and spend much of their time in sedentary activities, adding to their risk of physical disability. the benefits of exercise on mental health and physical well-being in older adults are well-substantiated, but the effects of exercise training on late-life ptsd symptoms is a new area of study. this study is designed to examine the effects of 6 months of supervised exercise training on ptsd symptoms and ptsd-related conditions (e.g., functional impairment, sleep) in 188 older veterans with ptsd.


Eligibility criteria:
inclusion criteria: * veteran status * registered for care at durham va health care system (vahcs) * live within 50 miles of fitness facility * meet diagnostic criteria for ptsd as assessed by the caps-5 exclusion criteria: * history of any psychiatric disorder with severe psychotic features in the past 5 years (e.g., bipolar disorder, mania), as indicated by icd-10 codes f20-f29 (icd-9 category 298.9) * prominent suicidal ideation or hospitalization for suicidality in the previous 6 months * clinically significant: neurological disorder, systemic illness affecting central nervous system (cns) function, or history of seizure disorder in the past 5 years * uncontrolled diabetes defined as: * abnormal fasting plasma glucose 126 mg/dl, random plasma glucose 200 mg/dl * no active medications for diabetes management (metformin, insulin, etc.) * no clinical notes in the patient's electronic health record (ehr) indicating monitoring by primary care physician (pcp) or endo for diabetes management) * end stage liver disease or currently receiving dialysis * physical disabilities precluding use of exercise equipment (assistive mobility devices acceptable) * significant cognitive impairment or diagnosis of alzheimer's disease or dementia * hospitalization or er visit in the past 6 months for conditions contraindicated for exercise (cardiac event; physical trauma)

Keywords: physical performance veterans aged exercise hrqol
sb-705498 rectal pain study

Conditions: Irritable Colon

Summary: sb-705498 has demonstrated efficacy in several preclinical and human experimental pain models. this study will investigate the efficacy of sb-705498 in patients with rectal pain. this will be a double-blind, placebo-controlled, two-way crossover study. 21 patients with faecal urgency (group 1), and 21 patients with ibs (group 2) will complete this study.


Eligibility criteria:
inclusion criteria: * female/male aged 18-65. * women of child bearing potential must use an effective method of contraception * faecal urgency as defined by chan * ecg, which has no abnormalities * normal clinical labs * informed consent and understand protocol requirements * ibs subjects: has irritable bowel syndrome (ibs) as defined by rome ii criteria * rectal hyperalgesia exclusion criteria: * any clinical or biological abnormality found at screen (other than those related to the disease under investigation) * history of alcohol, substance or drug abuse * uncontrolled hypertension * a history or presence of cardiovascular risk factors * participation in a trial within 3 months before the start of the study * history of allergy * unable to withdraw from analgesic medications for their rectal hyperalgesia (opioid-dependent patients can be included if they are willing to withdraw from their opiate medication

Keywords: trpv1 antagonist fecal urgency rectal pain ibs
predictive value of fdg pet/ct, dwi and dce-mri scans for non-small cell lung cancer patients receiving chemotherapy

Conditions: Non-small Cell Lung Cancer

Summary: in this prospective study, the investigators will evaluate and compare the usefulness of functional and volumetric informations obtained by 18f-fdg pet and mri before and after the palliative chemotherapy with the aim of predicting tumor response and prognosis in patients with advanced non-small cell lung cancer (nsclc).

study cohort will undergo pet/ct and mri scans prior to chemotherapy and after the first chemotherapy cycle. mri scans include dce-mri and dwi. the following parameters will be calculated using these values: 1. metabolic parameters on fdg-pet a. suv change ratio (scr) = suvpost/suvpre b. mtv change ratio (vcr) = mtvpost/pre c. tlg change ratio = scr x vcr 2. perfusion parameters on dce-mri a. kep b. k-trans c. ve 3. diffusion parameters on dwi a. mean adc b. fdm

Eligibility criteria:
inclusion criteria: * histologically proven nsclc * newly diagnosed stage stage iv * participant is being considered for the chemotherapy with egfr tki as a first line therapy * at least one measurable primary or other intrathoracic lesion \>= 2cm, according to recist * performance status of 0 to 2 on the ecog scale * age 18 years or older * able to tolerable pet/ct and mri imaging required by protocol * able to give study-specific informed consent exclusion criteria: * pure bronchioloalveolar cell carcinoma histology * thoracic radiotherapy, lung surgery or chemotherapy within three months prior to inclusion in the study * poorly controlled diabetes * prior malignancy

Keywords: non-small cell lung cancer diffusion-weighted mri 18f-fdg pet treatment response prognosis
manual lymphatic drainage in chronic venous insufficiency: a randomized controlled trial

Conditions: Chronic Venous Insufficiency

Summary: the purpose of this study is to compare functional status and quality of life of a group of patients with chronic venous insufficiency treated with manual lymphatic drainage with a group not treated with manual lymphatic drainage. investigators hypothesized that manual lymphatic drainage can improve: * quality of life, * functional status, * calf muscle strength, * ankle range of motion, * edema, * severity of disease, * and symptoms.


Eligibility criteria:
inclusion criteria: * diagnose of chronic venous insufficiency class c3-5 for clinical-etiological-anatomical-pathological classification (ceap). exclusion criteria: * severe cardiac insufficiency, * acute venous or arterial obstruction, * arterial insufficiency, renal insufficiency, * uncompensated thyroid dysfunction, * pregnancy, neoplastic pathology, * systemic or limb infection, * recent musculoskeletal injury in the lower limb, * peripheral neuropathy in the lower limb.

Keywords: venous insufficiency physical therapy techniques manual lymphatic drainage
men-10755 in treating patients with solid tumors

Conditions: Testicular Germ Cell Tumor; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of men-10755 in treating patients who have solid tumors.

objectives: i. determine the maximum tolerated dose of men-10755 in patients with solid tumors. ii. determine the qualitative and quantitative toxic effects of this drug and study the predictability, duration, intensity, onset, reversibility and dose relationship of the toxic effects in this patient population. iii. propose a safe dose for phase ii study. iv. study the pharmacokinetics of this drug at different dose levels in this patient population. v. document any possible antitumor activity of this drug in this patient population. outline: this is a dose escalation study. patients receive men-10755 iv over 15 minutes on days 1, 8, and 15. treatment continues every 4 weeks, or upon recovery of toxicity, whichever comes later. treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression. cohorts of 3-6 patients receive escalating doses of men-10755 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. patients are followed for at least 3 weeks. projected accrual: a total of 30 patients will be accrued for this study over 12 months.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed solid tumor that is not amenable to standard therapy measurable or evaluable disease no brain involvement or leptomeningeal disease patient characteristics: age: 18 and over performance status: who 0-2 life expectancy: at least 3 months hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl liver function tests no greater than 2 times upper limit of normal (uln) (no greater than 5 times uln if liver metastases present) renal: creatinine no greater than 1.4 mg/dl creatinine clearance at least 60 ml/min cardiovascular: lvef at least 50% (by muga) other: not pregnant or nursing fertile patients must use effective contraception no active infections no other nonmalignant disease that precludes study no history of alcoholism, drug addiction, or psychotic disorders prior concurrent therapy: biologic therapy: at least 4 weeks since prior immunotherapy chemotherapy: at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, and high dose carboplatin) no other concurrent antitumor drugs endocrine therapy: no concurrent corticosteroids radiotherapy: at least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) no concurrent radiotherapy surgery: not specified other: no prior anthracyclines or anthracenediones no other concurrent investigational drugs

Keywords: unspecified adult solid tumor, protocol specific testicular embryonal carcinoma and yolk sac tumor
trial testing ftorafur (uft) associated with neoadjuvant radiotherapy versus radiotherapy alone in rectal adenocarcinoma

Conditions: Rectal Cancer; Stage II/III; T3 or T4 (Only Anal Extension) Rectal Cancer; N0-2; M0

Summary: rationale: drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. oral 5-fluorouracil is more convenient for ambulatory patients. giving uft (tegafur and uracil) with radiation therapy before surgery may shrink the tumor so it can be removed. purpose: this phase iii trial is studying how well giving uft with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.

adenocarcinoma of the rectum stage ii/stage iii rectal cancer (if t4 only anal extension eligible) drug: uft procedure: chemotherapy procedure: conventional surgery procedure: neoadjuvant therapy procedure: radiation therapy procedure: radiosensitization procedure: surgery

Eligibility criteria:
disease characteristics: * histologically confirmed invasive adenocarcinoma of the rectum , m0, lower side \< 10 cm from anal verge * t3 or t4 disease (t4 exclusive anal extension ) patient characteristics: performance status * ecog 0-2 or * zubrod 0-2 life expectancy * not specified hematopoietic * absolute neutrophil count \> 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 hepatic * bilirubin \< x2 unl renal * creatinine \< 150 µmol/l gastrointestinal * no history of inflammatory bowel disease * no history of difficulty or inability to take or absorb oral medications neurologic * not specified other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * no history of psychiatric conditions or diminished mental capacity that would preclude study compliance or giving informed consent prior concurrent therapy: chemotherapy * no prior chemotherapy radiotherapy * no prior radiotherapy to the pelvis other * no other concurrent investigational drugs * no other concurrent anticancer treatment

Keywords: rectal cancer neoadjuvant therapy uft radiochemotherapy