Kornimate/medical-research-clean huggingface dataset:
radiotherapy concurrent with apatinib in advanced soft tissue and bone sarcomas of head and neck--rass study

Conditions: Soft Tissue and Bone Tumor; Head and Neck Cancer; Sarcoma

Summary: this is a non-randomized, phase ii, open label study of radiotherapy concurrent with apatinib mesylate after surgery in patients with advanced head and neck soft tissue and bone sarcomas. the primary purpose of this study is to evaluate the efficacy and safety of apatinib mesylate in patients with head and neck soft tissue and bone sarcomas.


Eligibility criteria:
inclusion criteria: 1. histologic diagnosis of head and neck soft tissue sarcoma (undifferentiated pleomorphic sarcoma, synovial sarcoma, alveolar soft part sarcoma, clear cell sarcoma, angiosarcoma, epithelioid hemangiosarcoma, solitary fibrous tumor and epithelioid sarcomas) or bone sarcoma (osteosarcoma/high grade bone sarcoma, ewing sarcoma or dedifferentiated chondrosarcoma) confirmed by central pathology review. 2. gross total resection, with invasive cancer seen on microscopic evaluation of the resection margin, or with gross tumor residual, or surgically unresectable and/or refuse surgery. 3. eastern cooperative oncology group (ecog) performance status of 0-1 4. adequate hepatic, renal, cardiac, and hematologic function. 5. patients must provide written informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up. exclusion criteria: 1. evidence of distant metastasis 2. prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5. presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia 6. suffered from grade ii or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including qt interval male ≥ 450 ms, female ≥ 470 ms). grade iii-iv cardiac insufficiency according to new york heart association (nyha) criteria or echocardiography check: left ventricular ejection fraction (lvef)\<50% 7. patients who have had prior allergic reaction to apatinib
postmarketing study of empliciti in korean patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: this study is a regulatory postmarketing surveillance study for empliciti with a representative sample of the overall korean multiple myeloma (mm) population.


Eligibility criteria:
inclusion criteria: * adult participants who have a confirmed diagnosis of multiple myeloma (mm) exclusion criteria: * participants who use empliciti for therapeutic indications which are not approved for empliciti combination therapy in korea * patients in whom treatment with empliciti (as clarified in the korean label) is contraindicated other protocol defined inclusion/exclusion criteria could apply
crossfit exercise to improve glucose control for overweight and obese adults

Conditions: Hyperglycemia

Summary: the purpose of this study was to examine the differences in glucose control, fitness, and body composition between a standard aerobic and resistance exercise training program and a shorter-duration, high-intensity crossfit training program in overweight and obese physically inactive adults. hypotheses: 1. both groups would improve glucose control, with the crossfit group improving significantly more than the aerobic and resistance training group. 2. both groups would improve fitness, with the crossfit group improving significantly more than the aerobic and resistance training group. 3. both groups would demonstrate decreases in body fat percentage and fat mass and increases in lean body mass, with the crossfit group improving significantly more than the aerobic and resistance training group.

overweight or obese participants will take part in an 8-week exercise intervention after clearance from a doctor, that is expected to improve glucose control, fitness (eurofit and peak aerobic capacity), and body composition (body fat percentage, fat mass, and lean body mass). after stratification by age and body mass index, participants will be randomized to either a standard aerobic and resistance training exercise program or a relatively higher intensity, shorter duration crossfit exercise program.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 25 - \< 40, physically inactive (i.e., not participating in any structured exercise programs for the past 2 months and not exceeding 30 total minutes of physical activity per week) exclusion criteria: * current smoker, pregnant, taking blood glucose altering medications, heart disease, type 1 or 2 diabetes mellitus, total cholesterol 200 mg/dl or higher

Keywords: exercise physical fitness body composition, beneficial
an evaluation of the daytime use of an investigational lubricant eye drop

Conditions: Dry Eye

Summary: the purpose of this study is to describe the subjective assessments of an investigational lubricant eye drop.


Eligibility criteria:
inclusion criteria: * documented diagnosis of dry eye * current use of refresh liquigel, genteal gel drops or refresh celluvisc at least twice daily exclusion criteria: * must not have worn contact lenses within 7 days preceding enrollment * must not have had punctal plugs inserted within 30 days preceding enrollment

Keywords: dry eye, artificial tears
the effect of vitamin c on quality of life of terminal cancer patients

Conditions: Vitamin C Deficiency

Summary: this study determines whether high dose vitamin c is effective for quality of life in terminal cancer patients.

the investigator's project is a single medical center, randomized double- blinded trial. the target group is terminal cancer patients at palliative care clinics. the experimental group will receive intravenous high-dose vitamin c 30 g in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. the control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. the primary outcome is the improvement of quality of life, measured by european organization for research and treatment of cancer (eortc). the secondary outcome is the survival analysis.the participants will be followed up weekly for 2 weeks, then bi-weekly for 6 months.

Eligibility criteria:
inclusion criteria: -terminal colon cancer patients without pleural effusions, who will not receive any curative radiotherapy or chemotherapy. exclusion criteria: * renal metastasis or obstructive uropathy by radiology * nephrotic syndrome * creatinine over 1.5mg/dl * urolithasis * under other folk therapy or vitamin infusion therapy * those who can't exercise the right of consent * those who can't answer the questionaires * glucose-6-phosphate dehydrogenase deficiency * severe lower leg edema or general edema

Keywords: vitamin c quality of life terminal cancer
a single dose of a marketed drug being studied for a new indication to treat surgical site infection following colorectal surgery as compared to a marketed drug approved for this indication (0826-039)

Conditions: Colorectal Surgery

Summary: the objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.

the duration of treatment is 1 day.

Eligibility criteria:
inclusion criteria: male or female patients 18 years of age scheduled to undergo elective colon or colorectal surgery by laparotomy must meet the following criteria: * surgery must be scheduled in advance. * there must be adequate time to complete preoperative bowel preparation
aneurysms and carotid artery block in newborns

Conditions: Cerebrovascular Disorder

Summary: this study will determine the risk of brain aneurysm (abnormal outpouching of a brain artery) in young adults who had their carotid artery tied off as an infant as part of the extracorporeal membrane oxygenation (ecmo) procedure. this procedure is sometimes performed on newborns with lung problems so that they can have oxygen brought to their blood outside the body. ecmo operates similar to a heart-lung machine. blood drained from the veins has the carbon dioxide removed and oxygen added. the oxygenated blood is then returned to the body through the arteries. people 18 to 25 years of age who underwent ecmo as an infant at the children's national medical center in washington, d.c., may be eligible for this study. participants undergo the following procedures: * medical history and physical and neurological examinations. * magnetic resonance imaging (mri) of the head and neck. mri uses a strong magnetic field and radio waves to obtain images of body organs and tissues. the subject lies in the scanner (a metal cylinder surrounded by a magnetic field) for about 90 minutes, lying still for up to 15 minutes at a time. during part of the procedure, a contrast dye is injected into a vein through a catheter (thin plastic tube) to enhance the images.

objective: to assess whether the hemodynamic stress of long-term common carotid artery occlusion can lead to cerebral aneurysm formation in young adults. study population: 100 adults 18-25 years of age who underwent common carotid artery (cca) occlusion as a neonate as part of the extracorporeal membrane oxygenation (ecmo) procedure performed in the setting of pulmonary insufficiency. design: patients who underwent cca occlusion as a neonate for ecmo at children's national medical center will be identified and contacted. the study will be explained and informed consent will be obtained. subjects will undergo outpatient evaluation to include history and physical, magnetic resonance angiography and magnetic resonance imaging of the head. outcome measures: * cerebrovascular anatomic anomalies such as cerebral aneurysms and persistent fetal circulation pathways, etc. * cerebral perfusion asymmetry on mri. * cerebral parenchymal abnormalities such as stroke.

Eligibility criteria:
* inclusion criteria: subjects must be 18-25 years of age. subjects had va ecmo as a neonate at children's national medical center. subjects must be in good health. subjects must provide informed, written consent for participation in this study. exclusion criteria: subjects with a history or evidence of mental retardation precluding a written consent unless this consent could be obtained from a legal guardian. subjects with a history of reaction to mr contrast media or who are unable to have an mri. subjects who underwent carotid artery reconstruction after neonatal ecmo. females who are pregnant or nursing.

Keywords: ecmo cerebral perfusion carotid artery aneurysm cerebral circulation common carotid artery occlusion
evaluation of galantamine in the treatment of alzheimer's disease

Conditions: Alzheimer Disease

Summary: galantamine is an experimental drug being evaluated in the united states for the treatment of alzheimer's disease. results from previous clinical trials suggest that galantamine may improve cognitive performance in individuals with alzheimer's disease. it is not a cure for alzheimer's disease. nerve cells in the brain responsible for memory and cognitive function communicate using a chemical called acetylcholine. research has shown that deterioration of cells that produce acetylcholine in the brain affects thought processes. galantamine is thought to work in two ways to increase the amount of acetylcholine available in the brain. it inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic receptors in the brain to release more acetylcholine.

after a 1-month single-blind run in phase, 910 subjects will be titrated, over a period of up to 8 weeks, to target doses of either: 0 (placebo); 24 mg/day galantamine; 16 mg/day galantamine; or 8 mg/day galantamine, in a 2:2:2:1 randomization ratio. double-blind treatment will continue for a total of 5 months. the change from baseline in adas-cog and civic-plus scores at month 5 will be the primary efficacy endpoints. tolerability will be evaluated based on adverse event reports, laboratory values, ecg, and vital signs with particular focus on the adverse event rates in the slower titration schedule for 24 mg/day. efficacy of 24 mg/day and 16 mg/day galantamine will be compared with that of placebo. information on the dose response relationship of galantamine will be evaluated.

Eligibility criteria:
inclusion criteria: * probable alzheimer's disease * mini-mental state examination (mmse) 10-22 and adas greater than or equal to 18 * alzheimer's disease assessment scale cognitive portion (adas-cog-11) score of at least 18 * opportunity for activities of daily living * caregiver * subjects who live with or have regular daily visits from a responsible caregiver (visit frequency: preferably daily but at least 5 days/week). this includes a friend or relative or paid personnel. the caregiver should be capable of assisting with the subject's medication, prepared to attend with the subject for assessments, and willing to provide information about the subject. exclusion criteria: * conditions that could confound diagnosis * neurodegenerative disorders * acute cerebral trauma * psychiatric disease * more than one infarct on ct/mri scans * history of alcohol or drug abuse * contradictions for a cholinominetic agent: seizures; ulcers; pulmonary conditions (including severe asthma); unstable angina; afib; bradycardia less than 50; and av block.

Keywords: alzheimer's disease cholinergic agents cholinergic agonists cholinesterase inhibitors
eicosapentaenoic free fatty acid and fecal calprotectin in inflammatory bowel diseases

Conditions: Ulcerative Colitis; Crohn's Disease

Summary: the aim of this study is to test eicosapentaenoic free fatty acid's effects on calprotectin levels in ibd patients in clinical remission. during the study fecal calprotectin levels will be measured every 3 months and clinical flares will be registered.


Eligibility criteria:
inclusion criteria: * age ranged between18 and 80 years. * patients with ulcerative colitis (diagnosed on the base of clinic, endoscopic and histologic criteria) in clinical remission (sccai = 0) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-asa, immunomodulators and/or biologics. * patients affected by crohn's disease (diagnosed on the base of clinic, endoscopic and histologic criteria) ) in clinical remission (cdai \< 150) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-asa, immunomodulators and/or biologics. * fecal calprotectin at baseline \> 150 μg/g. exclusion criteria: * patients affected by ulcerative colitis and crohn's disease respectively with a sccai ≥ 1 and a cdai ≥150. * patients on steroid therapy. * patients in therapy wih warfarin or other anticoagulants. * known or supposed ipersensitivity to eicosapentaenoic acid/omega 3. * women in fertile age which refuse to use contracceptives specified in the study (oral contraception, iud) and breastfeed women. * patients with severe clinical conditions which the investigator consider to controindicate patient partecipation at the study. * therapy modifications and/or assumption of sperimental therapies within three months before the study inclusion. * patients unable to follow protocol procedures and to sign the informate consent.
hip fractures treated with uncemented arthroplasties

Conditions: Femoral Neck Fractures

Summary: the aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties. the primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.

femoral neck fracture is a common cause of suffering and premature mortality among the elderly. riskfactors for femoral neck fractures are age, gender, osteoporosis and cognitive dysfunction. mortality and morbidity varies between undisplaced and displaced femoral neck fractures. different treatment options are available: reduction and internal fixation vs joint replacement (arthroplasty). the treatment of undisplaced femoral neck fractures is uncontroversial and consists of internal fixation with screws. the treatment of displaced, femoral neck fractures with internal fixation shows unacceptable results with complications rates leading to reoperation between 40-60%. treatment of these fractures with arthroplasties has therefore become the standard treatment in industrial countries. fixation of the femoral component with bone-cement is standard procedure in europe today. to avoid negative cardio-pulmonary events in patients with serious comorbidities and in very old and frail patients uncemented femoral components or internal fixation are used. these uncemented stems are mostly older design with poor track records. the use of modern, well-documented stems used in an osteoarthritis population for fracture patients has still to be tested.

Eligibility criteria:
inclusion criteria: * displaced fracture of the femoral neck * independent living * independent ambulation (with or without walking aids) exclusion criteria: * pathological fracture * severe dementia (defined as ≤3 in short portable mental questionnaire) preoperatively * preexisting ipsilateral hip disease * neurological disease (e.g. m. parkinson) * psychiatric disease which makes understanding or following instructions impossible * history of drug and alcohol abuse

Keywords: displaced femoral neck fractures treatment uncemented arthroplasty cemented arthroplasty
study on dmmet-01 versus metformin on improvement of metabolic control in naive type 2 diabetes patients

Conditions: Diabetes Type 2

Summary: the aim of this clinical trial is to compare the efficacy of dmmet-01 versus metformin hydrocloride on metabolic control in mexican type 2 diabetes patients without prior pharmacological treatment.


Eligibility criteria:
inclusion criteria: * ages eligible for study: 40 to 60 years * with type 2 diabetes evolution \< 5 years without pharmacological treatment 1 month prior to the screening * fasting glucose = 130-200 mg/dl * hba1c of 7% to 9% * blood pressure \< 140/80 mmhg * ability to communicate and meet the requirements of the study * signed written informed consent before to conducting any study * body mass index (bmi) of 25 kg/m2 to 35 kg/m2 exclusion criteria: * suspected or confirmed pregnancy * nursing * inability to secure the non-pregnant during the study duration * hypersensitivity to any biguanides * use of an investigational drug within 30 days prior to the screening * liver failure, heart failure, kidney failure or thyroid disease * periods of acute or chronic diarrhea or vomiting * chronic hepatic disease * total cholesterol \>300 mg/dl * triglycerides \>400 mg/dl

Keywords: type 2 diabetes monotherapy antidiabetics metformin
high flow nasal cannula for obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this study compare the efficacy of high flow nasal cannula with nasal continuous positive airway pressure. all of participants will be randomized to receive one night high flow nasal cannula therapy and another night for nasal continuous positive airway pressure.

obstructive sleep apnea-hypopnea syndrome (osahs) is a common medical condition. nasal continuous positive airway pressure (cpap) is mainstay of treatment for osahs, but cpap has some limitations. patient who has bulbar dysfunction and poor consciousness are contraindications for cpap. they are also not suitable for other therapy. there are still large number of patients could not accept cpap. alternative treatment method transnasal high flow was developed and previous study showed moderately reduce respiratory event. it is deliver 20 l/minute constant room air by nasal cannula. because the technical limitation, the maximal flow rate is also 20 l/minute and it limit the effectiveness. recently, new high flow nasal cannula(hfnc) is developed. this hfnc has already widely been used for respiratory disease. it can deliver air flow up to 60 l/mins. it is also can maintain high humidifier and adequate temperature. the every 10 l/min air flow could generate approximately 1 cmh2o positive end expiratory pressure (peep). the higher air flow could generate more high peep and may have better effect than previous hfnc, but there are no study to evaluate the efficacy in osahs patient. thus, the purpose of our study is to compare the efficacy of hfnc with standard cpap therapy. all of the participants were randomized into two groups for minimized first night effects. all of them would receive one-night hfnc therapy and another night for cpap titration under psg monitoring. the duration between these two treatments was approximately one week apart. the first group underwent cpap titration on the first night and hfnc titration on the second night. conversely, the second group was subjected to hfnc on the first night and cpap titration on the second night. all of the participants were asked and recorded their side effects following completion of an hfnc or cpap.

Eligibility criteria:
inclusion criteria: * apnea hypopnea index greater than 5 times per hour * age greater than 18 years old. exclusion criteria: * central sleep apnea * hypoventilation syndrome * chronic obstructive airway disease * receive soft palate surgery or used an oral appliance * intolerance to transnasal high flow or cpap * pregnant women * unstable hemodynamic state * eastern cooperative oncology group performance status higher than grade 2

Keywords: continuous positive airway pressure high flow nasal cannula
prospective assessment of hpv associated anogenital pathology in female patients and female partners of patients with confirmed hpv associated oropharyngeal carcinoma, pap-op study

Conditions: Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

Summary: this study evaluates how often women with throat (oropharyngeal) cancer or who have a partner with oropharyngeal cancer get anogenital infections with high risk, potentially cancer-causing types of human papilloma virus (hpv).

primary objectives: i. prospectively determine the incidence of anogenital infection with high-risk hpv serotypes and hpv-associated anogenital lesions in female patients with newly diagnosed hpv(+)opscc and female partners of patients with hpv(+)opscc, and compare this with retrospective review of exams and paps obtained during routine well woman checks in rochester mn. ii. to determine the risk of requiring additional procedures or treatments secondary to these diagnoses. iii. to determine the sexual health and well-being among patients and partners with hpv(+)opscc. iv. to develop standardized patient education and recommendations for referral and screening for this patient population. v. measure patient satisfaction with study education and anogenital pathology screening process via internal questionnaire. outline: this is an observational study. participants complete surveys, watch an educational video on hpv vaccination and undergo collection of blood and saliva samples on study. patients also undergo cervical screening per standard of care and may receive a referral to gynecology if not up to date on anogenital screening.

Eligibility criteria:
inclusion criteria: * \* female patients with diagnosed hpv(+)opscc seen at the mayo clinic, rochester * age ≥ 18 * female partners of mayo clinic patients with diagnosed hpv(+)opscc * patient has given permission to give his/her blood/saliva sample for research testing * ability to complete questionnaire(s) by themselves or with assistance exclusion criteria: * \* hpv(-) opscc * unable to provide informed consent * unwilling to attend screening visit at mayo clinic site, if indicated * unwilling/unable to complete surveys electronically