Kornimate/medical-research-clean huggingface dataset:
zero-fluoroscopic navigation versus conventional fluoroscopic navigation for double-chamber pacemaker implantation

Conditions: Sick Sinus Syndrome; Complete Atrioventricular Block; High Degree Second Degree Atrioventricular Block (Disorder); Bradycardia

Summary: this study is intended to compare the feasibility, safety and efficacy of ensite-navx zero-fluoroscopic navigation system to conventional fluoroscopic x-ray approach as to performing double-chamber pacemaker implantation.

permanent pacemaker is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. fluoroscopy is the imaging modality routinely used for cardiac device implantation and electrophysiological procedures.due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel 3d mapping systems have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. ensite navx system can be used for cardiac imaging as a reliable and safe zero-fluoroscopy approach for implantation of single- or dual-chamber permanent pacemaker in patients. our method offered a choice for some special population of patient in whom radiation exposure need to be avoided or in the extreme circumstances when the x-ray machine is out-of-order.

Eligibility criteria:
inclusion criteria: * sick sinus syndrome * complete atrioventricular block * high degree second degree atrioventricular block * bradycardia exclusion criteria: * pacemaker replacement * severe structural cardiac malformations * severe cardiac enlargement * venous malformations

Keywords: fluoroscopy pacemaker three dimensional radiation imaging
demodex density, immune response and oxidative stress in rosacea patients

Conditions: Rosacea

Summary: aim of study is to determine reactive oxygen products and antioxidant capacity with rosacea patients; to measure metalloproteinase level and inflammatory markers of immune response and investigate their corelation with demodex infestation and also investigate the role of photoaging and sebum secretion in rosacea.

rosacea is a common and chronic inflammatory disease characterized by facial erythema, papule, pustule and telangiectasia. ultraviolet, demodex mite, oxidative stress and antioxidant system disorders are emphasized in increased inflammation seen in rosacea. the aim of our study was to evaluate the status of oxidative stress, matrix metalloproteinase (mmp) and inflammatory markers in systemic circulation, their relationship with demodex density and investigate the role of photoaging and sebum secretion in rosacea. forty patients with rosacea and age, gender and skin phenotype matched 40 healthy volunteers were enrolled in the study. reflectance confocal microscopy (rcm) was used to calculate facial demodex density. the number of demodex, follicle, the number of mite per follicle, the number of infested follicle and the number of mite per infested follicle were calculated with rcm. photoaging severity and facial sebum levels were also assessed. total oxidant capacity (toc), total antioxidant capacity (tac), oxidative stress index (osi), paraoxonase-1 (pon-1), aryl esterase (ares), myeloperoxidase (mpo), tumor necrosis factor-alpha (tnf-α), interleukin-1beta (il-1β), matrix metalloproteinase-1 (mmp-1) and matrix metalloproteinase-9 (mmp-9) levels in venous blood were measured.

Eligibility criteria:
inclusion criteria: * between the ages of 18-70 * no systemic illness * no other inflammatory dermatoses except for rosacea * no smoking * not using any topical, systemic treatment and sunblock at least a month for rosacea or other condition exclusion criteria: * systemic illness * other inflammatory dermatoses except for rosacea * smoking * using any topical, systemic treatment and sunblock for rosacea or other condition * type 4 rosacea patient (only ocular involvement)

Keywords: demodex oxidative stress reflectance confocal microscopy
observational study that will collect information on patients with urea cycle disorders (ucds)

Conditions: Urea Cycle Disorder

Summary: thrive is an observational study that will collect information on patients with ucds. thrive will follow enrolled participants for up to 10 years. as an observational study, enrolled patients will not be required to make any additional office visits or take any medicine outside of normal care.

ucds disproportionately affect children and females: depending on the severity of the defect, a ucd can manifest shortly after birth or later in life. this study will track long-term outcomes in ucd patients and effects of ammonia-scavenging agents on neuropsychological functions of ucd patients. this is a non-interventional, multi-center registry to be conducted in patients with ucds. investigators will prescribe treatments based on usual clinical practice, and there will be no restrictions on the use of commercially available medications. as an observational study, this study will not change the patient/ healthcare provider relationship, nor influence the healthcare provider's drug prescription or the therapeutic management of the patient. patients with ucds will be recruited and invited to attend a baseline visit. after eligible patients are enrolled, retrospective and baseline data will be collected. patients will be followed for up to 10 years, during which time they will be assessed by their healthcare provider. patients and healthcare provider will be asked to report episodes of hyperammonemic crisis, available ammonia values, and other information. study acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * confirmed or suspected diagnosis of ucd * signed informed consent/health insurance portability and accountability act (hipaa) authorization and medical records release exclusion criteria: * any other reason that, in the investigator's opinion, makes the patient unsuitable to participate in this study.

Keywords: ucd buphenyl ravicti urea urea cycle disorder glycerol phenylbutyrate benzoate sodium phenylbutyrate ornithine transcarbamylase (otc) argininosuccinate synthetase (ass) argininosuccinate lyase (asl) carbamyl phosphate synthetase (cps) arginine citrulline ammonia
memantine monotherapy for executive dysfunction and adhd

Conditions: ADHD; Executive Function Deficits (EFD's)

Summary: this is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (memantine hc1, brand name namenda) in the treatment of executive function deficits (efds) in adults with attention deficit hyperactivity disorder (adhd). after screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks. the investigators hypothesize that memantine hydrochloride will prove to be an effective, safe, and well-tolerated agent for the treatment of efds in individuals with adhd interested in non-stimulant medications.


Eligibility criteria:
inclusion criteria: 1. male and female adults ages 18-45 years; 2. a diagnosis of dsm-iv \[78\] adhd-combined type 3. a score of at least 20 on the aisrs (a score of 20 in the aisrs identifies subjects with at least moderate severity of symptoms); 4. a brief-a global executive composite t-score of \>6; and 5. proficiency in english. - exclusion criteria: 1) pregnant or nursing females; 2) investigator and his/her immediate family (spouse, parent, child, grandparent, or grandchild); 3) any serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and hypertension), endocrinologic, neurologic, immunologic, or hematologic disease; 4) hypersensitivity to memantine; 5) multiple adverse drug reactions; 6) current or past history of seizures; 7) any history of a major psychiatric disorder including schizophrenia, psychosis, bipolar disorder (bpd), or autism spectrum disorder (asd); 8) meets dsm-iv criteria in the last month for major depression or any major anxiety disorder or has a hamilton rating scale for anxiety (ham-a) or hamilton rating scale for depression (ham-d) score greater than 14; 9) meets dsm-iv criteria for substance abuse or dependence in the last month or has a positive drug urine screen; 10) judged to be at serious suicidal risk; 11) use of any other concomitant medication with primarily central nervous system activity; or 12) iq \< 80. -

Keywords: adhd executive function deficits psychiatry psychopharmacology namenda
marker driven selection of patients for prostate biopsy and management

Conditions: PSA; Elevated PSA; Prostate Cancer

Summary: the purpose of this research study is to determine if the interpretation of multiparametric mri (mpmri) with an algorithm called habitat risk score (hrs) in combination with a panel of blood and urine biomarkers is more effective at detecting prostate cancer than standard of care interpretation of mpmri with the prostate imaging reporting and data system (pirads).


Eligibility criteria:
inclusion criteria: 1. male participant, aged 40-85 years. 2. in good general health as evidenced by medical history. 3. referred for a biopsy of the prostate for evaluation of prostate cancer due to elevated or increasing prostate-specific antigen (psa) or an abnormal digital rectal exam (dre). 4. participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers. exclusion criteria: 1. previous or current history of prostate cancer or treatment for prostate cancer. 2. previous history of pelvic radiation. 3. known allergic reactions to mri contrast or inability to undergo mri due to renal toxicity. 4. inability to undergo blood draw or biopsy of the prostate as per protocol. 5. prior mri guided biopsy of the prostate for prostate cancer evaluation. 6. previous prostate biopsy or prostate procedure within 6 months of enrollment within the trial. 7. standard contraindications to mri, such as allergies to contrast die, renal toxicity, ferromagnetic metal in body/eye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as ativan, may be attempted) will prevent eligibility and will be applied for all protocol-related mris. 8. patients with impaired decision-making capacity.
an investigational study to evaluate experimental medication bms-986165 in japanese participants with moderate-to-severe psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to investigate bms-986165 given to japanese participants with moderate-to-severe psoriasis.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: a. for participants with plaque psoriasis: i. stable plaque psoriasis for at least 6 months ii. moderate to severe disease iii. candidate for phototherapy or systemic therapy b. additional protocol-specified inclusion criteria apply for subjects with psoriatic arthritis, erythrodermic psoriasis, or generalized pustular psoriasis exclusion criteria: 1. guttate, inverse, or drug-induced psoriasis at screening or baseline 2. history of recent infection 3. prior exposure to bms-986165 other protocol defined inclusion/exclusion criteria could apply
evaluating genetic modifiers of cutaneous neurofibromas in adults with neurofibromatosis type 1

Conditions: Neurofibromatosis 1

Summary: the main goal of this protocol is to develop a well-phenotyped genetic biobank to identify genetic variants associated with the heterogeneous clinical presentations of neurofibromatosis type 1 (nf1). this will allow for improve understanding of nf1 pathogenesis and more personalized disease management. the investigators will conduct a gwas analysis to identify common genetic risk variants associated with the development of cutaneous neurofibromas.


Eligibility criteria:
inclusion criteria: * age 40 or older. * nf type 1 diagnosed using clinical criteria. * at least one neurofibroma present at time of enrollment. * patient able to read and understand consent form (or equivalent translation) and able to give consent. * patient able and willing to complete all study procedures.
bio|concept.biomonitor iii

Conditions: Atrial Fibrillation; Syncope; Tachyarrhythmia

Summary: the objective of the study is to confirm the safety and efficacy of the biomonitor iii system. furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the biomonitor iii will be assessed.


Eligibility criteria:
inclusion criteria: * patient is at high risk of developing a clinically important cardiac arrhythmia; or patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or patient is planned for af ablative procedure or has already undergone an af ablative procedure. * patient is able to understand the nature of study and has provided written informed consent. * patient is willing and able to perform all follow up visits at the study site. * patient is willing and able to use the cardiomessenger and accepts the biotronik home monitoring concept. exclusion criteria: * patients implanted with icd or pacemaker. * patient is pregnant or breast feeding. * patient is less than 18 years old. * patient is participating in another interventional clinical investigation * patient´s life-expectancy is less than 6 months.

Keywords: implantable cardiac monitor
optical coherence tomography guided c&d

Conditions: Basal Cell Carcinoma

Summary: the purpose of the study is to identify the presence of residual superficial and nodular basal cell carcinoma (bcc) status-post curettage and desiccation (c\&d) by using optical coherence tomography (oct).


Eligibility criteria:
inclusion criteria: * patients of any: age, gender, fitzpatrick skin type and ethnicity. * primary bcc of any type, except aggressive types that fit the criteria for mohs surgery * no prior treatment on the lesion within the last 3 months. * lesions anywhere except the head, neck and distal extremities. * willing and able to sign informed consent exclusion criteria: * aggressive bcc types. * recurrent tumors. * lesion treated within last 3 months. * lesions on head and neck (high risk areas) * lesions on distal extremities (thin epidermis not preferred for oct). * pregnant women. * patients less than 18 years old. * prisoners. * any other condition or circumstance that, in the opinion of the investigator, may compromise the subject's ability to comply with the study protocol

Keywords: superficial basal cell carcinoma nodular basal cell carcinoma
omega-6/omega-3 ratio and neural development in preterm infants.

Conditions: Impaired Psychomotor Development

Summary: it's known that docosahexaenoic acid dha and all polyunsaturated fatty acids pufa are important in neurodevelopment of term and preterm infants. this study tried to determine the utility of a balanced contribution of dha and arachidonic acid aa (omega-6/omega-3) in milk formula, with a ratio similar to that found in breastfeeding, equal to 2, in very premature infants less than 1500 grams and / or less than 32 weeks of gestational age. to evaluate values of fatty acids they have in blood and psychomotor development they achieve.

the study took place in a single-center; it is a prospective randomized study of preterm infants less than 1500 grams and/or less than 32 weeks gestational age, admitted to the neonatal intensive care unit in the university clinical hospital of santiago de compostela. they were recruited for a period of 14 months (from july 2010 to august 2011) and followed from birth until 2 years of life. 40 children were included and followed in the study. patients will be assigned randomly into two groups depending on the type of formula they are receiving. the group a of children will receive a formula supplemented with dha and ara with a relationship omega 6/omega 3 = 2. and group b will receive other formula with dha and ara, but with a ratio of 1/1. the classification of group a and b was made by simple random way; one birth in every group, continuously. implementation of breastfeeding will be promoted and will be fortified after 7 days of life, when the total amount of breast milk will be more than 1/2 of the total. when breastfeeding will be insufficient or nonexistent, special formulas for premature babies will be given during the follow-up of patients, will be measured: 1. - levels of fatty acids in blood in the first week of life, 3 months, 6 months and 12 months.the determination will be carried out in collaboration with the hospital de cruces, bilbao, spain. 2. - evaluation of psychomotor development by brunet-lezine scale at 2 years of corrected age.

Eligibility criteria:
inclusion criteria: living infants who were less than 1500 grams and/or less than 32 weeks gestational age, and whose parents accepted and subscribed the informed consent exclusion criteria: * preterm infants with any malformation or deformation. * extreme preterm infants with gestational age less than 25 weeks. * infants whose parents couldn't follow up their children in our study center. * preterm infants who had a severe intra ventricular hemorrhage (more than grade 2). * premature infants who had severe periventricular leukomalacia (more than grade 2) because the latest two conditions can affect neurodevelopment. * finally, we excluded neonates who don't need supplementary milk nutrition, i.e. children with breastfeeding only.

Keywords: omega-3 omega-6
endoscopic biliary drainage in malignant high grade biliary stricture

Conditions: Malignant Biliary Stricture

Summary: biliary drainage is the mainstay of the palliative treatment in patients with inoperable malignant bile duct stricture. endoscopic retrograde cholangiopancreatography (ercp) is the cornerstone of biliary drainage method in these patients. however, ercp is sometime unsuccessful to perform because of the presence of the high grade biliary stricture, tumor invasion of duodenum and ampulla of vater and surgically altered gastrointestinal anatomy. endoscopic ultrasound (eus) guided biliary drainage has been emerged as an alternative procedure to traditional surgical bypass and percutaneous trans hepatic biliary drainage after failed ercp. there were few data to directly compare between ercp and eus guided biliary drainage and in patients with malignant high grade biliary stricture.

the aim of this study is comparing the efficacy and complications between ercp and eus guided biliary drainage in patients with malignant high grade biliary stricture. malignant high grade biliary stricture has not been well defined. the investigators define this malignant high grade biliary stricture using these arbitrary number include total bilirubin ≥ 15 mg/dl and or bile duct diameter ≥12 mm. based on the investigation's experience. the study will be divided patients with inoperable malignant high grade biliary stricture into 2 groups, group (a) will be undergone ercp with biliary stenting and group (b) will be undergone eus guided biliary drainage. if the assigned intervention is not successful, then patients will be crossed-over to the another intervention.

Eligibility criteria:
inclusion criteria: i) patients aged \> 18 years. ii) clinical, laboratory data, imaging and or histology suggestive of malignant distal bile duct strictures that occurs as a result of pancreatic adenocarcinoma, cholangiocarcinoma, ampullary carcinoma, duodenal carcinoma, gallbladder cancer and metastasis malignant bile duct obstruction iii) inoperability by tumor staging, medically unfit or patient wishes 1. distant metastasis 2. major vascular involvement (unreconstructible superior mesenteric vein/portal vein, superior mesenteric artery, common hepatic artery and celiac artery) 3. metastasis to lymphnode beyond the field or surgery iv) jaundice, total bilirubin ≥15 mg/dl and/ or common bile duct diameter ≥12 mm exclusion criteria: i) pregnancy ii) uncorrectable coagulopathy ( international normalized ratio ≥ 1.5 ) iii) thrombocytopenia (platelet count \< 50,000 ) iv) extremely poor general condition, ercp with stent insertion impossible for ethical reasons v) an extension of stricture to the main biliary confluent (hilum) or the existence of obstructive duodenal invasion vi) active suppurative cholangitis vi) surgically altered anatomy (i.e. billroth ii or roux-en-y reconstruction ) vii ) previous treatment with bile duct stent.

Keywords: ercp endoscopic ultrasound (eus) guided biliary drainage
airway responses following chlorine gas exposure

Conditions: Asthma; Lung Diseases

Summary: to determine lung airway responses following chlorine gas exposure.

design narrative: the specific aims of the study are to determine: (1) the effects of asthma with pre-existing airway hyper reactivity on the pulmonary function and airway reactivity and inflammation responses to chlorine; (2) the effects of chlorine concentration on the pulmonary function and airway reactivity and inflammation responses to chlorine; and (3) to assess the time dynamics of the pulmonary function and airway reactivity and inflammation responses to chlorine. it is hypothesized that both airway hyperactivity and higher chlorine concentration will result in larger changes in pulmonary function and airway reactivity and inflammation responses, and that these changes will have differential time courses following chlorine exposure. this study uses two controlled human exposure experiments, utilizing a single-blind, repeated-measures, and counter- balanced design. the two subject groups for both experiments will consist of 21 individuals with no airway hyperactivity, and 21 individuals with both asthma and airway hyperactivity. in experiment one, subjects are exposed for 15 minutes separately to each of: (1) chlorine at 0.4 ppm; (2) chlorine at 1.0 ppm; and (3) filtered air (control). pulmonary function and airway reactivity are measured immediately pre-exposure and 1 and 20 hours post-exposure. airway inflammation, as determined by cellular and biochemical components from sputum-induction, is measured 65 hours pre-exposure and 20 hours post-exposure. in experiments two, subjects are exposed for 15 minutes separately to each of: (1) chlorine (concentration determined from experiment one); (2) filtered air (control). pulmonary function and airway reactivity are measured immediately pre-exposure and at 3 and 72 hours post-exposure. sputum-induction is performed 65 hours pre-exposure and at 3 and 72 hours post-exposure. the results of this study will provide information on a major irritant chemical relevant to occupational environments. specially, the susceptibility of a large sub-population at increased risk, the dose-response effects, and the post-exposure time dynamics of the effects of chlorine gas will be determined. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria