Kornimate/medical-research-clean huggingface dataset:
pilot study of management of facial paralysis in the oncologic patient: nerve transfer techniques to improve facial function and quality of life

Conditions: Cancer; Head and Neck Cancer

Summary: the goal of this research study is to measure changes in patients' quality of life after surgeries that affect the facial nerve, including nerve transfer as treatment for facial paralysis.

primary objective: to evaluate the impact of facial nerve transfer techniques (fntt) on qol in head and neck cancer patients with facial paralysis. this study intends to measure the impact of fntt on qol utilizing a series of validated questionnaires which include: (i) facial clinimetric evaluation scale and facial disability index; (ii) sunnybrook facial grading system; and (iii) facial nerve grading scale 2.0. these instruments will be administered at baseline, after surgery, and at 6, 12, and 18 months post-operatively. secondary objective: to compare patient-reported outcomes and facial function scales for patients who undergo facial nerve transfer technique with a historical cohort of patients who did not undergo any dynamic nerve reconstruction procedures. the same assessment tools described in primary objective above will be utilized.

Eligibility criteria:
inclusion criteria: in order to be eligible to participate in the intervention group of this study, an individual must meet all of the following criteria: * provision of signed and dated informed consent form * aged 18 or greater * patient scheduled to undergo facial nerve transfer * stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study in order to be eligible to participate in the non-intervention historical control group of this study, an individual must meet all of the following criteria: * provision of signed and dated informed consent form * aged 18 or greater * previous facial surgery severing a facial nerve without graft or other form of dynamic facial nerve reconstruction within the last 5 years exclusion criteria: patients known to be pregnant
influence of resin cement composition on the longevity of intraradicular post of endodontically treated teeth

Conditions: MTA; Endodontically Treated Teeth; Resin Cement

Summary: the aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth. the composition of the resin cement (with and without mineral trioxide aggregate) will be evaluated. data will be collected, tabulated and submitted to statistical analysis.

endodontically treated teeth present an increased risk of fracture and are usually related to extensive carious processes or trauma that promote major coronary destruction. in such situations, it may be necessary to indicate intra-radicular retainers, such as fiberglass pins, to retain the restorative material. the aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth. the composition of the resin cement (with and without mineral trioxide aggregate) will be evaluated. twenty participants with at least two teeth with endodontic treatment with need intraradicular post cementation and confection of indirect dental crown (each participant) will be selected. the teeth will be randomly divided into 2 different groups according to resin cement composition (with and without mineral trioxide aggregate). data will be collected, tabulated and submitted to statistical analysis.

Eligibility criteria:
inclusion criteria: * healthy volunteers; * presence of at least two teeth with endodontc treatment; * presence of at least two teeth with indication of total crowns; * good oral hygiene. exclusion criteria: * dentures or orthodontics; * presence of periodontal disease * presence of parafunctional habits * presence of systemic disease * constant use of analgesic and or anti-inflammatory * allergic response to dental products
motivational interviewing to prevent suicide in high risk veterans

Conditions: Suicidal Ideation; Treatment Engagement

Summary: the purpose of study is to test the efficacy of an adaptation of motivational interviewing to address suicidal ideation (mi-si) on the severity of suicidal ideation in psychiatrically hospitalized veterans at high risk for suicide.

veterans who receive health care from the va are at elevated risk for suicide, and the number of veterans at high risk may be growing. although the months following discharge from psychiatric hospitalization are a period of acute risk for veterans, there is a dearth of empirically supported treatments tailored to psychiatric inpatients and no studies examining treatments for psychiatrically hospitalized veterans. this randomized controlled trial will test the efficacy of an adaptation of motivational interviewing to address suicidal ideation (mi-si) on the severity of suicidal ideation in psychiatrically hospitalized veterans at high risk for suicide. participants will be recruited from the acute psychiatric inpatient unit at the syracuse va medical center. to meet high-risk criteria, veterans must score over two on the scale for suicidal ideation (ssi), which is prospectively predictive of death by suicide. participants will complete a screening assessment to confirm eligibility and a baseline assessment of risk factors for suicide. they will be randomized to receive motivational interviewing to address suicidal ideation (mi-si) or a revised version (mi-si-r) plus treatment as usual (tau), or tau alone. the mi-si groups will receive two sessions of mi-si during hospitalization and one telephone booster session after discharge. participants in all conditions will be asked to complete telephone follow-up interviews at 1, 3, and 6 months after discharge. change in the severity of suicidal ideation will be measured using the ssi.

Eligibility criteria:
inclusion criteria: * veteran status, * admitted to psychiatric inpatient unit, * age 18 and over, * english speaking, * able to understand the study and provide informed consent, * clinically cleared to participate by unit staff, * receive health care from a vha facility in upstate new york * at increased risk for suicide (scale for suicidal ideation \[ssi\] \> 2) exclusion criteria: * current psychosis, * current mania, * dementia, * prisoner status, * being inaccessible * being discharged from the unit less than 48 hours after being identified by study staff

Keywords: veterans motivational interviewing inpatients suicide, attempted
peritoneal dialysis in congestive heart failure

Conditions: Congestive Heart Failure

Summary: rationale: end-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. non-randomized observations showed peritoneal dialysis (pd) in these patients to improve clinically from nyha stadium iii-iv to as low as nyha stadium i-ii. a randomized trial is needed to test whether pd improves symptoms in this condition and to find an optimal scheme. objective: to improve symptomatology in severe chronic failure patients. study design: open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (extraneal®) with standard medical therapy.. study population: patients with chronic refractory left ventricular congestive heart failure (lvef \< 30%, older than 18 years). intervention: peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (extraneal®). main study parameters/endpoints: reduction in nyha classification of symptomatic congestive heart failure at 8 months after start of pd therapy. burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for chf-deterioration and death).


Eligibility criteria:
inclusion criteria: * age \> 18 years * refractory left ventricular congestive heart failure: lvef \< 30% * diminished renal function: egfr \< 60 ml/min * clinically volume overloaded (dyspnoea (nyha iii-iv), edema, and/or ascites) * hospitalization for chf during the last 6 months * patient is on optimal cardiologic medical therapy, which has been stable for more than 4 weeks * suitable for pd exclusion criteria: * hypotension (sbp \< 100 mmhg / map \< 70) mmhg * instable ap or recent (\< 6 months) myocardial infarction. * contraindications for pd (e.g. visual handicap, social) * liver failure * copd gold class iv * malignancy with life expectancy \< 2 years * non compliance * no informed consent * poor mental health

Keywords: congestive heart failure peritoneal dialysis symptomatic improvement renal function
trial to evaluate topical c-82 in a psoriasis plaque test

Conditions: Psoriasis

Summary: evaluate the effects of topical c-82 in a psoriasis plaque test.

the primary objective of this trial is to evaluate antipsoriatic efficacy of the c-82 topical gel compared with vehicle by measurement of the thickness of the echo lucent band (elb) of the psoriatic infiltrate using 20 mhz sonography. to gain additional information about possible efficacy the change of the test fields compared to untreated plaque will be clinically assessed by visual scoring.

Eligibility criteria:
inclusion criteria: * mild to moderate chronic stable plaque type psoriasis * plaques thickness of at least 200 µm * lesion(s) on the trunk or extremities (excluding palms/soles) * skin must be without disease findings exclusion criteria: * other skin disease * psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis * treatment with any locally acting medications (including anti-psoriatics like vitamin d analogues, dithranol) within 2 weeks preceding and during the trial * treatment with any systemic medications (including anti-psoriatics like corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (e.g. beta-blocker, anti-malarial drugs, lithium) or phototherapy/puva within 4 weeks preceding and during the trial * treatment with any biologics within 3 months preceding and during the trial * known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products (e.g. carbomere 940, propylene glycol) * drug or alcohol abuse * symptoms of a clinically significant illness within 4 preceding and during the trial * participation another clinical trial within 4 weeks of this clinical trial
a study of iw-6463 in healthy volunteers

Conditions: Other

Summary: stage 1: to assess the safety and tolerability of single-ascending-dose levels of iw-6463 tablets when administered orally to healthy subjects stage 2: to assess the safety and tolerability of multiple-ascending-dose levels of iw-6463 tablets administered orally to healthy subjects stage 3: to assess the safety and tolerability of a single dose of iw-6463 when administered to health subjects in fed vs fasted states and explore the effects of food on iw-6463 pharmacokinetics (pk)


Eligibility criteria:
inclusion criteria: * subject is an ambulatory adult between 18 and 64 years old at the screening visit with the exception of the elderly cohort, who must be 65 years or older at the screening visit. * subject is in good health and has no clinically significant findings on physical examination * women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 3 months after the final dose of study drug * men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 3 months after the final dose of study drug * other inclusion criteria per protocol exclusion criteria: * any active or unstable clinically significant medical condition * use of any prescribed or non-prescribed medication * other exclusion criteria per protocol
an exploratory study of ro4929097 in patients with recurrent or refractory non-small cell lung cancer

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this study will evaluate the anti-tumour activity, safety and tolerability of ro4929097 as monotherapy in patients with recurrent or refractory non-small cell lung cancer. patients will receive oral doses of ro4929097 of 80mg (cohort 1) or recommended phase ii dose (cohort 2) on a 3 days on 4 days off schedule. anticipated time on study treatment is until disease progression or unacceptable toxicity. target sample size is \<50.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * stage iiib/iv recurrent or refractory non-small cell lung cancer * at most 2 lines of prior therapy in the metastatic setting (first line: platinum containing regimen and bevacizumab; second line: egfr-targeted therapy) * ecog performance status 0-2 * adequate liver, renal and bone marrow function exclusion criteria: * prior chemotherapy or radiotherapy \</= 4 weeks before first dose of study drug * history of other malignancy within the past 2 years, except for basal cell skin carcinoma or in situ cervical carcinoma * history of cns metastases or leptomeningeal metastases, except for clinically stable disease * serious cardiovascular illness
the relationship between fatigue and physical activity level in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a chronic, progressive and unpredictable disease of the central nervous system. in ms, various loss of strength, balance and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. these disorders lead to limitations in individual activities and participation. fatigue is as reported one of the most common first three symptoms among patients with ms and affects up to 80% of the patients. fatigue is defined as the lack of physical and/or mental energy. sometimes fatigue can reduce the quality of life by leaving other disorders behind. the most important effect of fatigue is that individuals reduce their physical activity levels. this can lead to the inactivity-related secondary problems being added to the findings of the disease. so the physical capacities of individuals may gradually decrease. in the literature, there are many studies showing that the level of physical activity of individuals with ms is lower than in healthy individuals. when the investigators analyze the studies that investigate the relation between fatigue and physical activity levels, it is seen that there is the single study about this subject in the literature. as a result, additional studies are needed to investigate the level of physical activity and the factors affecting it in individuals with ms. therefore, the investigators planned this study to investigate the relationship between fatigue and physical activity levels in patients with ms.

according to sample size calculation 37 diagnosed multiple sclerosis patients and 37 healthy individuals will be included.the demographic characteristics of the participants initially will be taken and expanded disability status scale score of those of ms will be recorded. then, fatigue severity and perception, physical activity level, balance, peripheral muscle strength, functional mobility, functional exercise capacity will be evaluated. primary outcomes are fatigue and physical activity level; secondary outcomes are balance, peripheral muscle strength, functional mobility, functional exercise capacity.

Eligibility criteria:
inclusion criteria: * 18-65 years of age * having a diagnosis of "multiple sclerosis" by a specialist physician * relapse free in the last 3 mounts * having an ambulatory status (expanded disability status scale score ≤ 6 ) * no diagnosis of depression exclusion criteria: * any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research

Keywords: multiple sclerosis fatigue physical activity exercise
tamadol wound infiltration in children under inguinal hernioplasty

Conditions: Children; Inguinal Hernia

Summary: tramadol is a centrally acting analgesic, is primarily indicated for the treatment of acute pain, moderate to severe. the hernioplasty in children is an outpatient procedure, and the possibility of postoperative analgesia with fewer systemic adverse effects such as nausea and vomiting make the tramadol infiltration a technique of interest. there is controversy about its effectiveness. the local effect of tramadol in hernioplasty was also studied by researchers with some better postoperative analgesia than with local anestetic . there are few studies with administration of tramadol for hernioplasty, which led to the interest in this study.

the primary objective of the study was to evaluate the analgesic effect of tramadol injected into the surgical incision in patients undergoing hernioplasty. the study is a prospective, comparative, double covered. the distribution of patients in the groups was randomly drawn prior to starting the project and the groups were identified in envelopes numbered 1-40. criteria for inclusion and exclusion after approval by the ethics committee of unifesp and signature of consent by those responsible, and the term of assent by patients over six years, 40 children of both sexes will be evaluated, aged between 3 and 12 years who underwent hernioplasty. children with bleeding disorders, using analgesic or sensitivity to any drug will be excluded. the patients will be randomly divided into one of two groups. patients in group 1 will receive local infiltration with 2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution and 20ml of 0.9% saline solution intravenously at the end of the surgical procedure patients in group 2 will receive 2 mg.kg-1 tramadol intravenously diluted in 20 ml of 0.9% saline solution and local infiltration with 5 ml of saline solution 0.9% at the end of the surgical procedure. all patients will undergo general anesthesia, and will receive additional analgesia with dipyrone and morphine as needed in post operative period.

Eligibility criteria:
inclusion criteria: * children of both sexes * aged between 3 and 12 years * underwent hernioplasty exclusion criteria: * children with bleeding disorders * using analgesic * sensitivity to any drug.

Keywords: tramadol children hernioplasty wound infiltration
renalof in the dissolution of renal calculi in patients with recurrent calcic lithiasis

Conditions: Recurrent Calcic Urolithiasis

Summary: the purpose of this study is to determine whether renalof administration promotes partial or total dissolution of urinary calculi and improves physicochemical parameters and metabolic activity in patients with recurrent calcic urolithiasis. the duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. the estimated number of patients to be recruited and randomized for the study is 110. ultrasonographic and humoral parameters will be assessed every 4 weeks.


Eligibility criteria:
inclusion criteria: * idiopathic calcic lithiasis * calculus size lesser than or equal to 2.0 cm (0.79 inches) * signed informed consent exclusion criteria: * calculus size greater than 2,0 cm (0.79 inches) * pregnancy * malignant neoplastic conditions * previous treatment for destruction of calculi in the urinary tract

Keywords: dietary supplement renalof recurrent calcic urolithiasis renal calculi
expression of bcrp in icteric patients

Conditions: Icterus

Summary: the expression of transporters involved in bile acid homeostasis is differentially regulated during obstructive cholestasis. bile acids are also substrates of the drug efflux transporter breast cancer resistance protein (bcrp) that is highly expressed in the human intestine. therefore we intend to analyze whether intestinal bcrp expression could be altered during cholestasis.

bcrp is capable of transport bile acids and may indicate that this transporter is involved in bile acid homeostasis. as an efflux pump, it could protect the enterocytes from potential toxic bile acid concentrations. during cholestasis, where the enterohepatic circulation is disrupted, there occurs an adaptive regulation of transporters for bile acids, bilirubin and cholesterol. these changes take place in liver, kidney, as well as in the intestine. using real-time rt-pcr analysis we determine bcrp mrna expression levels in duodenal tissue of healthy subjects and cholestatic patients. bcrp protein levels will be determined by immunohistochemistry. healthy subjects and cholestatic patients are enrolled in the study after giving informed consent. control subjects with an indication for a gastrointestinal tract endoscopy within a cancer-screening program and patients with obstructive cholestasis with an interventional endoscopic retrograde cholangiopancreatography (ercp) are included in this study. during endoscopy four biopsy specimens are obtained from the distal part of the duodenum. biopsies are immediately stored at -70°c until further processing.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of obstructive cholestasis (obstructive jaundice was defined on the basis of chemical parameters (bilirubin, g-glutamyltransferase, and alkaline phosphatase) and on imaging procedures (ultrasound and ercp) demonstrating a dilated bile duct system) * control subjects had an indication for a gastrointestinal tract endoscopy within a cancer-screening program exclusion criteria: -

Keywords: cholestasis bcrp multidrug resistance duodenum bile acids abcg2
efficacy of ferric carboxymaltose (ferinject®) in anemic patients anticipating pancreatoduodenectomy

Conditions: Pancreatic Cancer; Anemia

Summary: this phase ii study is to evaluate the safety and efficacy of ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.

primary objectives : perioperative transfusion rate (including preop, intraop, postop≦7 days). secondary objectives : postoperative complication, hospital stay, change of hematological parameters (hb, ferritin, transferrin saturation (tsat) change after ferinject® injection), adverse effect with ferinject® injection.

Eligibility criteria:
inclusion criteria: * ≥19 years old * anticipating pd * preoperative hb of female 7.0-11.9g/dl and male 7.0-12.9g/dl * signed written informed consent exclusion criteria: * a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient * hypersensitivity to any component of the formulation * active severe infection/inflammation * history of transfusion, erythropoietin, \>500 mg intravenous iron administration within 4 weeks prior to screening. * history of acquired iron overload. * mcv \> 95µm3 or tsat \> 35% * patients with preoperative hb\<7 g/dl * pregnancy or lactation * decreased renal function (defined as creatinine clearance \<50 l/min/1.73m2calculated by egfr(mdrd)) * chronic liver disease or increase of liver enzymes (alt, ast) \>5 times the upper limit of normal range

Keywords: ferric carboxymaltose ferinject® pancreatoduodenectomy