Kornimate/medical-research-clean huggingface dataset:
therapy with new oral anticoagulants

Conditions: Atrial Fibrillation; Non-valvular Atrial Fibrillation

Summary: the aim of the present registry is to characterize and follow patients prospectively and retrospectively with renal impairment who have been prescribed apixaban for the prevention of stroke in atrial fibrillation, with a comparison to the characteristics and outcomes associated with warfarin therapy in this population.

current guidelines for the management of patients with atrial fibrillation (af) recommend the use of novel oral anticoagulants (noacs) in patients with non-valvular af .renal dysfunction has been shown to be an independent predictor of stroke or systemic emboli, but the risk of bleeding with conventional warfarin therapy is also significantly increased.prevalence of renal dysfunction in patients with atrial fibrillation is high, with approximately 60% of patients having an estimated glomerular filtration rate (egfr) of ≤ 60 ml/min/bsa \[6\].noacs undergoing significant renal secretion such as dabigatran are not recommended for patients with severe renal impairment, and dose adjustment are indicated for patients with milder degrees of renal dysfunction.however, real-world information regarding the usage and outcomes associated with noac therapy in patients with renal dysfunction are limited. the investigators plan to prospectively and retrospectively collect data regarding the clinical settings, characteristics, and outcomes of patients with renal dysfunction who have been prescribed apixaban in israel, using a multicenter secure web-based registry.

Eligibility criteria:
inclusion criteria: * patients with renal dysfunction (egfr \<60 ml\\min\\bsa) who have an indication for treatment with an novel oral anticoagulant agent or vka * patients prescribed apixaban or warfarin at the enrollment center (patients enrolled in a 2:1 ratio) exclusion criteria: * valvular af or presence prosthetic valve * dialysis patients * contraindications noacs * hepatic dysfunction * cognitive impairment * clinical necessity to continue administration of potent inhibitors of both cyp3a4 and p-gp - including azole- antimycotics (e.g. ketoconazole, itraconazole) and hiv protease inhibitors (e.g. ritonavir)

Keywords: patients with atrial fibrillation (af) recommend the use of novel oral anticoagulants (noacs) in patients with non-valvular af
post-marketing follow-up of long-term type ureteral stent set

Conditions: Ureter Stricture; Hydronephrosis

Summary: ureteral stents have been widely used in many urological operations. although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by taiwan. the investigators have to propose the 5-year post-market survey report. though this observation study, the investigators can further understand the clinical safety and effectiveness of placing ureteral stents

ureteral stents have been widely used in many urological operations. the main purposes of placing ureteral stents include improvement of ureteral obstruction, protecting renal function and drainage of infection. although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by taiwan. thus, the investigators will conduct this post-marketing survey to observe and investigate the changes of ureteral stents, e.g. hydronephrosis, infection and stone formation. now this product has been approved by european medical device administration. the investigators have to propose the 5-year post-market survey report. though this observation study, the investigators can further understand the clinical safety and effectiveness of placing ureteral stents

Eligibility criteria:
inclusion criteria: 1. patients who used " bioteq" ureteral stent set (long-term type) in their treatments. 2. patients with complete basic parameters. exclusion criteria: 1. patients with any of the following conditions are excluded from this clinical study: patients with incomplete basic parameters. 2. the minorities, children and special populations

Keywords: ureter stricture hydronephrosis
to assess the utility of the point digit in a clinical take-home study

Conditions: Amputation; Traumatic, Hand

Summary: this study will allow us to assess whether the point digit confers functional and psychological benefit to persons with partial hand amputations in an unconstrained environment. the use of the point digit outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. this well-controlled trial (without randomization of subjects) will produce the first level ii-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 u.s. preventive services task force. furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.


Eligibility criteria:
inclusion criteria: * partial hand amputees with absence of index and/or middle fingers and presence of thumb. additional finger loss is acceptable if all other criterion are met. * fluent in english * individuals aged 18 or greater exclusion criteria: * significant cognitive deficits as determined upon clinical evaluation * significant neurological deficits as determined upon clinical evaluation * significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation * uncontrolled pain or phantom pain impacting full participation in the study as determined upon occupational therapist evaluation * serious uncontrolled medical problems as judged by the project therapist.
cocaine in parotid saliva, blood and urine - 4

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to establish the use of parotid saliva as a means of detecting and quantifying cocaine and its metabolites.


Eligibility criteria:
please contact site for information.

Keywords: cocaine detection parotid saliva
effectiveness of balance exercise program for stroke patients with pusher syndrome

Conditions: Pusher Syndrome; Subacute Stroke

Summary: the objective of this study is to evaluate whether the application of two laser visual feedback exercises and core stability exercises can positively influence postural orientation and the perception of postural verticalization compared to conventional treatments, with the final goal of improving the balance in sitting and standing and the functionality in activities of daily living.

study designed as a randomized clinical trial. the total sample (n=16) will randomized into two groups: treatment vs. control. all of them suffering from subacute stroke and pusher syndrome. the study intervention will last 4 weeks. the control group will receive usual rehabilitation treatment for patients with stroke and pusher syndrome (60 minutes per day/5 days per week). the intervention group will receive usual rehabilitation treatment for patients with stroke and pusher syndrome (30 minutes per day/5 days per week) plus 30 minutes of therapy based on the specific protocol designed for the study. this protocol will consist of core stability exercises and visual feedback with lasers, both procedures will be alternated one day each. the evaluation of the intervention program will be based on the established objectives, assessing: 1) pushing intensity (controversial push scale (scp)), 2) laterality (burke scale (bls)), 3) balance (postural assessment scale for stroke patients (s-pass)), 4) patient functional capacity (barthel index), and 5) quality of life (newcastle stroke-specific quality of life measure (newsqol)). these variables will be evaluated baseline and post-intervention. additionally, scp, bls and s-pass will be assessed 15 days after starting treatment.

Eligibility criteria:
inclusion criteria: * patients ≥18 years admitted to an intermediate care unit after suffering from subacute stroke, for functional recovery. * diagnosis of ischemic or hemorrhagic stroke confirmed by magnetic resonance imaging (mri) or computed tomography (ct) scan. * pusher syndrome identified by the scale for contraversive pushing (scp) with a score of ≥2 and by burke lateropulsion scale (bls) with a value of ≥3. exclusion criteria: * patients with severe previous functional dependence (barthel index ≤60) * patients diagnosed with dementia gds-4 or previous severe cognitive impairment. * patients diagnosed with delirium. * patients diagnosed with wernicke's aphasia. * patients with a previous severe visual deficit that prevents them from continuing activity (retinopathy, cataracts, etc.) * patient with a history of other causes of balance impairment. * patients with orthopedic conditions that difficult the performance of the proposed rehabilitation treatment. * patients enrolled in other research studies.

Keywords: pusher syndrome core stability visual feedback postural control balance rehabilitation stroke
smoking status and body image in oral cancer patients

Conditions: Oral Cavity Cancer

Summary: primary objectives: 1. to characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures. 2. to examine the relationship between smoking status and body image in this sample of head and neck cancer patients. 3. to examine the influence of smoking status and body image on quality of life outcomes.

if you agree to take part in this study, researchers will first perform a test to check the level of carbon monoxide (co) in your blood. to do this test, you will be asked to blow into a cardboard tube attached to a machine. you will then be asked to fill out some questionnaires and complete a one-on-one interview. all of these things combined will take about an hour to complete. you will be asked basic questions such as your age, education level, and smoking history. you will also be asked questions about your mood, quality of life, and how you feel about your appearance. if you do not have surgery, your participation in this study will end after this visit. if you have surgery, you will be asked to come back for 2 more study visits, 1 month and 6 months after your surgery. during these evaluations, you will be asked once again to blow into the cardboard tube, fill out questionnaires, and a complete a one-on-one interview. each visit will last about an hour. you will again be asked questions about your smoking behaviors, mood, quality of life, and how you feel about your appearance. your participation in this study will be finished after the 6-month evaluation. this is an investigational study. about 75 people will take part in this research study. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. able to provide written informed consent to participate 3. diagnosis of head and neck malignancy involving an oral cavity site without previous treatment 4. current treatment plan includes surgical intervention 5. english speaking exclusion criteria: 1. previous treatment for malignancy in the head and neck region 2. significant preexisting facial disfigurement from a previous trauma or congenital defect 3. diagnosis of a serious mental illness involving formal thought disorder (e.g., schizophrenia) documented in medical record.

Keywords: oral cavity cancer body image smoking appearance questionnaire interview
global and regional myocardial strain and power output in patients with single ventricles using novel mri techniques

Conditions: Fontan Procedure; Hypoplastic Left Heart Syndrome; Tricuspid Atresia; Double Inlet Left Ventricle

Summary: the investigators are beginning a clinical research study here at ucsf to learn more about how hearts with single ventricles work. the investigators hypothesize that myocardial strain , as measured by cardiac mri,in patients with single ventricles differs from normal hearts. this abnormality is associated with depressed cardiac power output and impaired exercise capacity. the study will utilize cardiac magnetic resonance imaging, exercise testing, and lung function testing to study how the single ventricle heart works so that in the future the investigators can improve how the investigators care for patients with this type of congenital heart disease. the research protocol involves: cardiac magnetic resonance imaging (mri of the heart), exercise tests, and lung function tests. some of these tests are routinely used to follow patients with single ventricles. some of these tests are part of the research protocol. if you agree to participate in this study, these tests will be performed at ucsf. the results of the routine tests will be shared with your doctor. participation will require approximately 30 additional minutes to the cardiac mri procedure to collect the research data. the exercise tests, and lung function tests time commitment will take about two hours.


Eligibility criteria:
inclusion criteria: * anatomy: the investigators will enroll 10 patients with single right ventricles status post fontan and 10 patients with single left ventricles status post fontan. * age range: 5 patients in each group will be between the ages of 10-18 years of age and 5 patients in each group will be older than 18 years of age. exclusion criteria: * study subjects will be excluded if there are any contraindications to mri including permanent pacemaker, icd, retained permanent wires, cerebral aneurysm clips, neurostimulators, insulin or infusion pumps, implanted drug infusion devices, bone growth/fusion stimulators, or cochlear implants. * in addition, patients with implanted hardware that may lead to inadequate imaging, such as steel coils or ventricular septal defect occluder devices, will be excluded. * finally, patients with developmental delay or physical limitations precluding cooperation with the mri or exercise test or patients with claustrophobia will be excluded. patients will be asked if there is any chance that they are pregnant. if they are possibly pregnant, they will be excluded.
study of the antidepressant efficacy of a combination herbal drug preparation (neurapas balance)

Conditions: Depressive Disorder

Summary: the efficacy and tolerability of neurapas® balance was compared against placebo in this single-centre, controlled, double-blind study in patients with a mild depressive episode. after a one-week placebo run-in phase to exclude placebo responders, patients were given the study medication (neurapas® balance or placebo) for 6 weeks in a dose of 3 x 2 tablets daily. the improvement in symptoms of depression was assessed on the basis of the internationally established hamilton depression scale 21. the self-rating depression scale (sds), the hamilton anxiety scale (ham-a), the clinical global impressions (cgi), quality of life questionnaire (sf-36) according to bullinger (german version) and a sleep questionnaire (sq) were used as further efficacy criteria.

the efficacy and tolerability of neurapas® balance was compared against placebo in this single-centre, controlled, double-blind study in patients with a mild depressive episode according to icd 10, f32.0 and f33.0. after a one-week, placebo run-in phase to exclude placebo responders, patients were given the study medication (neurapas® balance or placebo) for 6 weeks in a dose of 3 x 2 tablets daily. the study was conducted in accordance with the relevant requirements of the german medicines act (amg), the declaration of helsinki (48th general assembly, sommerset west, rep. of south africa, october 1996) and ich gcp guidelines. the improvement in symptoms of depression was assessed on the basis of the internationally established hamilton depression scale 21 (primary efficacy criterion). the self-rating depression scale (sds), the hamilton anxiety scale (ham-a), the clinical global impressions (cgi), quality of life questionnaire (sf-36) according to bullinger (german version) and a sleep questionnaire (sq) were used as secondary efficacy criteria.

Eligibility criteria:
inclusion criteria: * depressive symptoms of mild intensity, as defined in the international classification of mental disorders (icd 10), codes f32.0 (mild depressive episode) and f33.0 (recurrent depressive disorder, current episode mild) * sds index between 51 and 59 (this criterion was declared null and void on 21.02.02 in the 2nd amendment) * ham-d21 scores between 10 and 17 * between 18 and 70 years of age * duration of depression: not less than 4 weeks and not longer than 2 years * signed informed consent to take part in the clinical study after verbal and written information.

Keywords: depression hamd 21 anxiety hama hypericum valerian passionflower f32.0 f33.0
proof of concept trial of vamorolone in pediatric ulcerative colitis

Conditions: Pediatric Ulcerative Colitis

Summary: this is a phase i/ii, multi-center, open-label proof-of-concept study of vamorolone. twenty participants with a flare of mild or moderately active ulcerative colitis (defined as a pediatric ulcerative colitis activity index \[pucai\] 10-60) will be enrolled and receive vamorolone 6 mg/kg/day orally once daily for 8 weeks.


Eligibility criteria:
inclusion criteria: * subject has provided written informed consent/health insurance portability and accountability act (hipaa) authorization prior to any study-related procedures; * subject has current mild to moderately active ulcerative colitis, defined as a pucai score of 10-60. * subject is ≥ 4 years old and \<18 years old at the time of enrollment. * subject has had 1) a colonoscopy demonstrating endoscopic and histologic inflammation, and/or; 2) a fecal calprotectin \> 250 mcg/g, in the preceding 1 month. * subject is willing and able to comply with scheduled visits, study drug administration plan, and study procedures. * subject has not started a new immunomodulator or biologic in the preceding 2 months. * if subject is taking an immunomodulator and/or biologic, the dose has not been changed in the last 2 months * subject has a positive varicella igg titer, or history of at least 2 documented varicella vaccines exclusion criteria: * subject is currently being treated or has received previous treatment with oral or rectal glucocorticoids (including budesonide) in the past month * subject has an allergy or hypersensitivity to the study medication or to any of its constituents * subject has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow-up will be correctly completed or impair the assessment of study results, in the opinion of the investigator * subject is taking any other investigational drug currently or has taken any other investigational drug within 3 months prior to the start of study treatment * clinically significant abnormal biochemical and hematological parameters, including: * neutrophil count \< 1000 cells/mm3 * platelet count ≤ 130 cells/mm3 * creatinine ≥ 1.2 x the upper limit of normal * alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) ≥ 2x the upper limit of normal * conjugated bilirubin greater than 1.2. mg/dl * has active infection with enteric pathogens (including c. difficile) * has a positive ppd, quantiferon gold, or interferon-gamma assay * is pregnant or breast-feeding
comparative study of ceftaroline vs. vancomycin plus aztreonam in adult subjects with complicated skin infections

Conditions: Bacterial Infections

Summary: the purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

additional purpose of the study is to compare ceftaroline effectivity versus vancomycin plus aztreonam in the treatment of complicated skin infections in adults.

Eligibility criteria:
inclusion criteria: * skin and skin structure infection (sssi) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease. exclusion criteria: * prior treatment of current csssi with an antimicrobial. * failure of vancomycin or aztreonam as therapy for the current csssi, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

Keywords: abscess antibacterial antibiotic antimicrobial bacterial infection, skin ceftaroline ceftaroline acetate cellulitis cephalosporin complicated skin and skin structure infection csssi intravenous methicillin-resistant staphylococcus aureus (mrsa) ppi-0903 prodrug skin disease, bacterial skin infection staphylococcal skin infection staphylococcus aureus streptococcal skin infection surgical site infection tak-599
efficacy and safety of a 4% hydroquinone cream for the treatment of melasma

Conditions: Facial Melasma

Summary: to assess the ability of a new 4% hydroquinone formulation (melanoderm 4% crema) to reduce melasma on the face, using a split-face randomization design, evaluating the masi score from baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo. to assess the tolerance of a new 4% hydroquinone formulation (melanoderm 4% crema) on the face. to assess patients' satisfaction regarding melanoderm 4% crema after 8 weeks.


Eligibility criteria:
inclusion criteria: * adult women aged between 18-65 years old. * fitzpatrick phototypes i to iv. * presenting moderate to severe facial melasma facial, with a basal melasma area and severity index (masi index) between 10 and 20. * women of childbearing potential must use an adequate contraceptive method to avoid pregnancy and must have a negative pregnancy test in a maximum of 72 hours before receiving the trial treatment. * breastfeeding women will not be included in the study. * having given freely and expressly her informed consent. exclusion criteria: * those with any history of allergy or hypersensitivity to a cosmetic product, hydroquinone, or one of the ingredients of the investigational products. * fitzpatrick phototype v. * skin pigmentation diseases different to melasma. * evidence of active cancer disease or diagnosis of cancer in the last year. * those receiving any topical or oral treatment that could interfere with melasma. * pregnant or breastfeeding women, or those expecting to get pregnant during the study. * evidence or suspicion of low compliance with the study visits and procedures. * participation in other clinical trial simultaneously or in the previous 3 months.

Keywords: facial melasma