Kornimate/medical-research-clean huggingface dataset:
evaluation of pwi assisted by marshall ethanolization in ablation of persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this is a prospective, randomized controlled, single-blind, multi-center clinical trial study aiming to investigate whether the strategy of posterior wall isolation (pwi) assisted by vein of marshall ethanol infusion (vomei) could improve the success rate of persistent atrial fibrillation ablation.

a total of 260 participants with persistent af who undergo radiofrequency catheter ablation and received vomei + pvi will be randomized assigned to two groups at 1:1 ratio. group 1: vomei + pvi + linear ablation + pwi; group 2: vomei + pvi +linear ablation. the major endpoint (efficacy endpoint) is the recurrence of atrial tachyarrhythmias between 3-12 months during follow-up. the secondary endpoint (safety endpoint) is the occurrence of procedural complications.

Eligibility criteria:
inclusion criteria: 1. between 18-85 years old; 2. symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥1 week), and refractory to at least one antiarrhythmic drug; 3. prepared to undergo atrial fibrillation catheter ablation; 4. provide informed consent to participate in the study, comply with follow-up trials and evaluation procedures. exclusion criteria: 1. presence of acute conditions such as acute phase after myocardial infarction (within 3 months), acute heart failure or new onset of cerebral infarction within 3 months; 2. on the heart transplant list; 3. life expectancy less than 1 year; 4. with other bleeding disorders that cannot be treated with anticoagulation therapy; 5. with left atrial thrombus; 6. heart failure with nyha class iii-iv or lvef\<40%; 7. with uncontrolled malignant tumor; 8. obvious liver or kidney dysfunction (alt, ast levels more than 2 times the upper limit of normal, and/or ccr\<50%); 9. history of catheter radiofrequency ablation for atrial fibrillation or cardiac surgery; 10. women who are pregnant, breastfeeding, planning to become pregnant, or of childbearing age but not using reliable contraception.
sorin universal registry on aortic valve replacement

Conditions: Aortic Valve Disease; Aortic Stenosis

Summary: multi-center, international, prospective, non comparative, non randomized, open label. 5,000 patients to be enrolled approximately worldwide. the objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the sorin group aortic valve devices in accordance with the instructions for use (ifu). this observational global registry is intended to collect data without requiring any deviation from the standard of care and ifu in each participating center. the participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.

sure-avr objective is to collect post market safety and performance data collected along the procedure and the relevant follow-up with sorin group aortic valve devices in accordance with the ifu to further evidence the safety and efficacy in a post-approval environment. all current and future sorin group aortic valve devices that have obtained ce-mark or other local regulatory and/or commercial approvals may be included in the registry. during the duration of the registry,other aortic valve replacement products or current devices might receive modifications and might become commercial available. this registry allows extensions for the inclusion of new products. this observational global registry is intended to collect data without requiring any deviation from the standard of care and ifu in each participating center. the participating centers shall include those patients that have provided their informed consent to participate in this registry following the local applicable regulations. the data collection shall be performed as per the local standard of care and without exposing the patient to any additional risk to the treatment (s)he would normally receive. the registry is an open-ended project: * inclusions phase: open-ended * follow-up phase: annually throughout 5 years (7 and 10 years are optional). the study shall be completed after the 10-year follow-up of the last patient.

Eligibility criteria:
inclusion criteria: * all patients must provide written or oral informed consent to participate in the registry depending on the local regulations. * patients having received a sorin group aortic valve device in accordance with the ifu exclusion criteria: na

Keywords: biological aortic valves mechanical aortic valves aortic conduits sutureless aortic valve
vulvar scarring grading scale for lichen sclerosus

Conditions: Lichen Sclerosus; Lichen Sclerosus et Atrophicus

Summary: the study aims to validate a vulvar scarring grading scale for lichen sclerosus (ls).

utilizing the vulvar disorders registry, protocol #stu00001056, the research team seeks to analyze the medical record data, including standard of care vulvar photographs, of the vulvar ls population at northwestern memorial hospital (nmh) and the outpatient clinics of northwestern medicine (nm). these photographs will be used to develop a vulvar scarring grading scale for ls. the objective measurement of scarring severity in ls deidentified standard-of-care patient photographs will be correlated with clinical examination findings to assess validity of the grading scale. the development of an objective and standardized grading scale will assist with the longitudinal evaluation of individual disease, assessment of impact of therapy on scarring, and inform treatment modifications. further, objective grading of scarring would also provide the opportunity to search for potential correlation between qol scores and severity of clinical states in scarring dermatoses.

Eligibility criteria:
inclusion criteria: * patients seen at northwestern medicine department of dermatology and/or department of obstetrics and gynecology, who were seen by dr. bethanee schlosser, and/or other members of the vulvar mucosal specialty clinic team in any of their respective clinic settings and underwent complete mucocutaneous examination. * patients with histologically confirmed vulvar ls. exclusion criteria: * patients who refuse complete mucocutaneous examination. * patients who refuse recommended diagnostic procedures. * pregnant women or prisoners.
the effect of topical imipramine on pain and effectiveness of topical photodynamic therapy

Conditions: Imipramine; Photodynamic Therapy; Actinic Keratosis

Summary: the purpose of this study is testing the use of topical imipramine in combination with topical photodynamic therapy's (pdt) effect on pain following treatment. pdt is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis-aks) on their skin. these are both fda-approved treatments, but this study is evaluating their use in combination, which has not been evaluated in the past. the investigators have been doing studies using animals that suggest that imipramine might make the pdt less painful and might help it work better. in order to participate, the subject and their dermatologist have decided that they would benefit from pdt to treat their skin due to many ak precancerous lesions. please note that neither pdt nor imipramine are experimental treatments, but treating their skin with imipramine before pdt is a new approach.


Eligibility criteria:
inclusion criteria: * male or female ages 18 and older * skin type must be "fair", fitzpatrick type i to iii, due to the presence of actinic damage in this population. * subjects need to have a physician's order to receive pdt treatment on their face, scalp or forearms. * willing to participate and understand the informed consent document. * willing to avoid excess sun exposure/tanning beds to the area to be treated with pdt. exclusion criteria: * those currently taking any tricyclic antidepressants (tcas) * those currently taking any selective serotonin reuptake inhibitor (ssri) * those with porphyria * large tattoos in the treated areas * pregnancy or nursing * taking any oral or topical medications that could interfere with the pdt (appendix a) * active rashes in the area
evaluating e2007 (perampanel) in patients with painful diabetic neuropathy (pdn) or post-herpetic neuralgia (phn)

Conditions: Neuralgia

Summary: the purpose of this study is to evaluate the safety, tolerability and continued efficacy of perampanel in patients previously enrolled in double-blind, placebo-controlled studies for painful diabetic neuropathy (pdn) or post-herpetic neuralgia (phn).


Eligibility criteria:
inclusion criteria: each patient must meet all of the following criteria to be enrolled in this study: 1. met and continues to meet all inclusion and none of the exclusion criteria for the preceding pdn or phn study and received study drug or placebo under double-blind conditions. 2. completed the preceding double-blind study end of treatment (eot) visit no more than 12 weeks prior to baseline (visit 1) for the open-label study. the eligibility status of patients who do not enroll during this 12 week period will be evaluated on a case by case basis via discussion between the investigator and the sponsor. 3. males and females ≥18 years of age. female patients should be either of nonchildbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or intrauterine device \[iud\]) for at least 1 month before the baseline visit (visit 1) and for 1 month after the end of the study (visit 16). they must also have a negative pregnancy test at baseline (visit 1). female patients using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or iud) throughout the study. 4. provide written informed consent prior to entering the study and prior to undergoing any study-related procedures. 5. is reliable, willing, and able to cooperate with the study procedures. exclusion criteria: patients who meet the following criterion will be excluded from this study: 1. patients who discontinued early for any reason from the preceding double-blind study. 2. patients who have a clinically significant finding(s) that would make them unsuitable for the study in the opinion of the investigator or sponsor.

Keywords: neuralgia neuropathy
aortic stenosis: determinants and prognostic value of preoperative left ventricular remodeling after valvular replacement

Conditions: Aortic Valve Stenosis

Summary: aortic stenosis (as) is the most frequent valvulopathy in western countries. the prevalence of as is constantly increasing due to the aging of the population. although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of as, there is no medical treatment to slow or prevent its progression. the only treatment available is aortic valve replacement (avr) performed by surgery or by catheterization (tavi). as is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. associated with hypertrophy, myocardial fibrosis will gradually develop. despite interesting data, many unknowns persist and remain to be identified. the aim of the study is to characterize prospectively the left ventricular remodeling and assess its changes after avr and within 1 year in 500 patients using clinical, biological, echocardiographic and mri parameters.


Eligibility criteria:
inclusion criteria: * aortic stenosis * indication of aortic valve replacement (surgery or tavi) exclusion criteria: * rheumatismal or congenital aortic stenosis * aortic insufficiency (grade \>= 2/4) * associated valvulopathy (grade \>= 2/4) * myocardial infarction antecedent * severe renal failure * cardiac surgery (aorta abdominal) antecedent * complex congenital cardiopathy

Keywords: aortic valvular replacement aortic stenosis left ventricular remodeling biomarkers
rifaximin versus lactulose in renal failure

Conditions: Liver Cirrhosis; Renal Failure

Summary: the purpose of this study is to evaluate patients with cirrhosis of the liver and renal failure and determine if the administration of rifaximin as compared to lactulose is associated with less frequent and/or slower progression to severe hepatic encephalopathy. if one is associated with lower blood ammonia levels. and, if one is associated with lower breath hydrogen and methane levels.


Eligibility criteria:
inclusion criteria: * cirrhosis of liver of any etiology * progressive renal failure * stage 0-2 hepatic encephalopathy exclusion criteria: * pregnant women

Keywords: cirrhosis of liver and progressive renal failure
development and validation of a morbidity index for complications in minor and major abdominal surgery

Conditions: Postoperative Complications

Summary: the aim is to develop and validate a morbidity index for postoperative complications in patients undergoing visceral surgery.


Eligibility criteria:
inclusion criteria: * age: ≥ 18 years * capacity to act and no legal guardian * patients with any underlying disease admitted to the department of visceral and transplantation surgery of the university hospital of zurich with planned minor or major visceral surgery * german language as daily language. exclusion criteria: * patients with cognitive difficulties and diseases, which may yield unreliable answers * patients unable to read and write

Keywords: a self-administered questionnaire to collect data from patients, physicians and nurses about the severity of postoperative surgical complications. based on this questionnaire we will develop the morbidity index
multiple dose study of pf-04937319 in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; NIDDM

Summary: the purpose of this study is to characterize the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of pf-04937319 following multiple (14 days) escalating oral doses in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus who are taking metformin only. * treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 2 months. regimens may include once daily and twice daily dosing only. * male and/or female patients (females will be women of non childbearing potential) * body mass index (bmi) of 18.5 to 45.0 kg/m2; and a total body weight \>50 kg (110 lbs). * hba1c between 7.0% and 10.0%. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). patients who have chronic conditions other than t2dm (for example, hypercholesterolemia or hypertension) but are controlled by either diet or stable (for the last 2 months) doses of medications may be included as well (for example, a subject with hypercholesterolemia on appropriate treatment is eligible). * evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance less than 60 ml/min * any condition possibly affecting drug absorption (eg, gastrectomy) * history of stroke or transient ischemic attack or myocardial infarction within the past 6 months * history of coronary artery bypass graft or stent implantation. * clinically significant peripheral vascular disease (eg, manifested by claudication). * any history or clinical evidence of congestive heart failure, nyha classes ii to iv. * one or more self reported significant/severe/requiring treatment episodes of hypoglycemia within the last 3 months, or two or more self reported significant/severe/requiring treatment episodes of hypoglycaemia within the last 6 months. * current history of angina/unstable angina. * milk or soy allergy

Keywords: pharmacokinetics pk pharmacodynamics pd t2dm phase 1 type 2 diabetes mellitus safety and tolerability
post-authorization safety study on the long term safety of sonidegib in patients with locally advanced cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: collect real world safety data on the use of sonidegib in adult patients with labcc. document major safety parameters such as on treatment deaths, adverse events (aes)/ serious adverse events (saes) and discontinuation secondary to aes.

this is a non-interventional, multinational, multi-center post-authorization safety study (pass), to assess the safety of sonidegib administered in routine clinical practice in patients with labcc who are not amendable to curative surgery or radiation therapy. this study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a specific visit schedule. for this study, each enrolled patient will be followed up for 3 years after enrollment.

Eligibility criteria:
inclusion criteria: * written informed consent or equivalent document (e.g., written information) as per country regulation * patients aged 18 years or older with a diagnosis of labcc who are not amenable to curative surgery or radiation therapy * patients must be treated with sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted) * sonidegib treatment must be started either at the first visit for this study or prior to study entry. exclusion criteria: * patients treated with any hedgehog pathway inhibitor besides sonidegib within 3 months prior to study entry * patients currently enrolled in an interventional clinical trial * hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics (smpc) * pregnancy and breast-feeding * women of childbearing potential who do not comply with the odomzo pregnancy prevention programme (as defined in sections 4.4 and 4.6 of the approved smpc). * male patients who are unable to follow or comply with the required contraception measures (as defined in sections 4.4 and 4.6 of the approved smpc).

Keywords: locally advanced basal cell carcinoma labcc
study of fluoxetine in adults with autistic disorder

Conditions: Autistic Disorder

Summary: this is a study to determine the effect of fluoxetine in the treatment of adult autism and on functional ability and behavior associated with autism. evidence suggests abnormal serotonin function in autism. fluoxetine is a selective inhibitor of the serotonin transporter.

eligible patients will undergo comprehensive evaluation. informants familiar with the patient will also provide information. patients will be randomized to receive treatment or placebo. during the 12-week treatment there will be weekly monitoring for the first 4 weeks and biweekly monitoring for the next 8 weeks. the drug dosage will be increased each week as tolerated by the patient. serum levels of fluoxetine and norfluoxetine will be documented at week 12. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
inclusion criteria: * meets dsm-iv and adi criteria for autistic disorder * patients must use effective contraception * negative pregnancy test * clinical global impression-severity scale for autistic disorder (cgi-ad) score of 4 exclusion criteria: * pregnant or nursing * prior or concurrent history of mental disorders, including schizophrenia, schizoaffective disorder, organic mental disorders, or bipolar disorders * concurrent depression determined by dsm-iv diagnosis * serious suicidal risk * active seizure disorder within the past 2 years * clinically significant or unstable medical illness, including hematopoietic or cardiovascular disease * any organic or systemic disease * any geographical condition that would preclude study compliance * prior or concurrent gastrointestinal, liver, or kidney disease * any other concurrent condition that interferes with the absorption, distribution, metabolism, or excretion of drugs * prior or concurrent cerebrovascular disease or brain trauma * prior or concurrent clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism * prior or concurrent malignancy * clinically significant abnormalities on ekg, laboratory tests, or physical exam * requirement for ect or any other psychotropic medication * inability to tolerate taper from psychoactive medication * history of hypersensitivity or severe side effects associated with the use of fluoxitine or other serotonin reuptake inhibitors * treatment with any drug known to have a well-defined potential for toxicity to a major organ within the past 30 days * concurrent terfenadine (seldane) or astemizole (hismanal) * prior treatment with fluoxetine of 40 mg/day for 6 weeks * prior electroconvulsive therapy within the past 3 months * prior investigational drug use within the past 30 days * prior monoamine oxidase inhibitor use within the past 14 days * prior long-acting phenothiazines within the past 6 weeks * prior psychotropic drugs within the past 7 days * prior fluoxetine within the past 6 weeks * requirement for any therapeutic intervention that would confound study evaluation

Keywords: adult, autism
incidence of phantom limb pain and method of anesthesia after lower extremity amputation

Conditions: Phantom Limb Pain

Summary: phantom limb pain (pain originating from where an amputated limb once was) is a common occurrence after lower extremity amputations, with some sources noting incidence to be as high as 60-80% six months after surgery. this pain can eventually subside, however, cases have been reported of incidence 10 years after surgery. this pain is not only physically detrimental, but can also be psychologically detrimental after a difficult to accept change in the body. prior studies have been performed using regional anesthetic techniques (including spinals and epidurals) and different medications to attempt to reduce the incidence of phantom limb pain, however, the data have been mostly inconclusive. of interest, prior studies have not addressed peripheral nerve blocks, a method of anesthesia/analgesia more commonly employed for amputations recently. the purpose of our retrospective study is to look at the incidence of phantom limb pain at our institution over a two year period to determine if peripheral nerve blocks result in a significantly reduced incidence compared to other techniques (spinal, epidural, general anesthesia only). in addition, there is little data on relation of reason for amputation and presence of preoperative neuropathy and incidence of phantom pain. as secondary endpoints, the investigators wish to investigate if certain reasons for amputation (trauma, peripheral vascular disease, diabetes, and others) and/or neuropathy lead to a higher incidence of phantom limb pain. the results of this study could impact future management of patients who are to receive amputations and may lead to further prospective studies on the topics involved.


Eligibility criteria:
inclusion criteria: * patients who receive lower extremity amputation exclusion criteria: * death or incapacitating medical condition since surgery