Kornimate/medical-research-clean huggingface dataset:
jenavalve as efs trial: pericardial tavr aortic stenosis study

Conditions: Aortic Valve Stenosis; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Summary: to collect information about treatment for severe aortic stenosis (as), which affects the aortic valve in the heart. aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. the preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

this study will examine the use of a tavr (transcatheter aortic valve replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. this less invasive surgical approach called tavr is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. in this study, tavr will be performed using the jenavalve pericardial tavr system.

Eligibility criteria:
inclusion criteria: * patient with severe degenerative native aortic stenosis (as). * patient at high risk for open surgical valve replacement * patient symptomatic according to nyha functional class ii or higher exclusion criteria: * congenital uni- or bicuspid aortic valve morphology * previous prosthetic aortic valve (bioprosthesis or mechanical) implant * endocarditis or other active infection * need for urgent or emergent tavr procedure for any reason * cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device

Keywords: valvular heart disease critical/severe aortic stenosis high risk symptomatic patients
fascial anthropometry in archery athletes

Conditions: Sports Physical Therapy

Summary: in archery, the body morphological and anthropometric characteristics of the prominent athletes change. it is important to examine facial anthropometry, especially since the athlete's equipment touches the facial area, and there are no studies on this subject. the aim of this study is to determine the relationship between facial anthropometric measurements and anthropometry-related parameters and sports performance in archery athletes.

within the scope of the study, a total of at least 60 athletes, between the ages of 9-18, who have been training archery at least twice a week for at least 2 years, who have not changed their bow category since it started, who do not have a temporomandibular joint problem, and who volunteer to participate in the study, will be recruited in equal numbers from each age category. within the scope of evaluation; demographic information and features regarding archery equipment will be recorded. within the scope of anthropometric measurements; adipose tissue measurements with skinfold; circumference measurements and length measurements with tape measure; diameter measurements with caliper; facial anthropometric measurements will be measured with a caliper/tape measure. formulary named "heath-carter anthropometric somatotype technique" to determine the body somatotypes of athletes; lateral photography for biomechanical evaluation of the craniocervical region; hand grip strength test for performance evaluation; corbin postural assessment scale will be used for posture evaluation. in order to determine the shooting performance, the athletes' actual competition scores in the last year will be recorded. medicine ball throwing test, upper extremity y balance test and closed kinetic chain upper extremity stability test will be used to evaluate upper extremity performance. for statistical analysis, normal distribution of parameters will be examined. to determine the relationship between shooting performance and stabilization and related parameters, pearson test will be used for normally distributed parameters and spearman correlation test will be used for non-normally distributed parameters.

Eligibility criteria:
inclusion criteria: * being between the ages of 9-18 years. * having been practicing archery at least twice a week for at least 2 years. * not having changed the bow category since it started. * fonseca anamnestic questionnaire result is between 0-15 points * volunteering to participate in the study exclusion criteria: * having had surgery involving the spine and upper extremities in the last year * scoliosis being diagnosed * having an orthopedic, neurological or musculoskeletal disease that involves the upper extremity and prevents shooting * having received orthodontic treatment * orthodontic surgery to have had * being actively involved in another sports branch for at least 1 year

Keywords: athletes anthropometry somatotypes archery posture athletic performance
al-38583 ophthalmic solution for allergic conjunctivitis associated inflammation

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to assess the safety and efficacy of al-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * presence of signs and symptoms of ocular inflammation in both eyes. * have a positive cac response at visit 1. * able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to visit 1, and for the duration of the study. * other protocol-defined inclusion criteria may apply. exclusion criteria: * have known history or presence of persistent dry eye syndrome. * presence of any ophthalmic abnormality that may affect the study outcomes. * have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study. * other protocol-defined exclusion criteria may apply.

Keywords: conjunctivitis conjunctival inflammation ocular allergies
differential effects of ergocalciferol and cholecalciferol therapies in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: this study is to research two questions. first, is vitamin d3 more effective than vitamin d2 in raising 25-hydroxyvitamin d \[25(oh)d\] levels in chronic kidney disease (ckd) patients? and secondly, what are the differential effects of vitamin d2 and vitamin d3 on other mineral metabolism parameters?

vitamin d helps form and strengthens bones by allowing the body to absorb calcium. vitamin d helps the immune system fight infection as well as helps keep muscles strong. without enough vitamin d, bones can become weak, thin and brittle. vitamin d is useful in people with various types of health issues. patients with ckd exhibit an unusually high rate of vitamin d deficiency, which may contribute to some of the poor clinical outcomes in this group. this study will randomize patients with ckd and low vitamin d levels to two groups; one group will be treated with vitamin d2 (ergocalciferol) and the other group will be treated with vitamin d3 (cholecalciferol). the purpose of this study is to compare the effects of the two different forms of vitamin d specifically in patients chronic kidney disease.

Eligibility criteria:
inclusion criteria: * age 18 and above * chronic kidney disease with an estimated glomerular filtration rate (gfr) between 15-60 ml/min (ckd stage iii-iv) * vitamin d insufficiency (25-hydroxyvitamin d level \< 30 ng/ml) that has not been treated with vitamin d replacement since the acquisition of this level exclusion criteria: * current treatment with cholestyramine * presence of gi disorders such as short bowel, history of gastrectomy, colectomy, gastric bypass, inflammatory bowel disease, celiac disease, disorders of fat absorption, chronic diarrhea. * liver cirrhosis * known current substance abuse * current treatment with immunosuppressant medications * presence of chronic infection * history of chronic inflammatory disease (i.e. - lupus, active rheumatoid arthritis, crohns disease) * currently receiving high-dose vitamin d replacement (avg dose of ≥ 3,000 u per day) or "active" vitamin d analogue (e.g., calcitriol, which is 1,25-dihydroxyvitamin vitamin d).

Keywords: chronic kidney disease vitamin d vitamin d2 vitamin d3
influence of pesticide exposure on the occurrence of hypospadias in newborns in picardie

Conditions: Hypospadias

Summary: we want to see if there is a relationship between exposure to pesticides and the occurrence of hypospade in picard newborn .

hypospadias is the most frequent malformation of the external genital organs in the male infant. incomplete virilization of the genital bud results in hypoplasia of the tissues on the ventral aspect of the penis, with an ectopic ureteral meatus, a curved penile shaft and an incompletely formed foreskin. the condition is generally isolated and the aetiology is unknown. the pathogenesis is complex and involves hormonal, genetic and environmental factors (which are probably interlinked). a doubling in the incidence of hypospadias over the last 15 years has emphasized the probable role of environment factors: in fact, certain exogenous compounds (collectively referred to as "endocrine disruptors" (eds)) may modify hormonal functions and thus exert harmful effects on the organism or its offspring. the male urethra develops between the 8th and 16th weeks of gestation in an androgen-dependence manner. in utero exposure of the foetus to eds may have a physiopathological role in the abnormal development of the male genital bud and thus in the development of hypospadia. these eds are present in many different substances, such as pesticides. many epidemiological studies have evidenced an increase in the incidence of hypospadias in children born to exposed parents. furthermore, animal studies have identified a certain number of compounds associated with hypospadias after in utero exposure. however, human foetal samples have very rarely been assayed in an attempt to measure the true level of impregnation (i.e. the dose received). at present, it is not possible to draw firm conclusions with regard to the true extent of a link between eds and the increased incidence of hypospadia. the "hypomeco" project is a prospective case-control study.

Eligibility criteria:
inclusion criteria: * male newborns * born after february 1st, 2011, in a maternity hospital/clinic in the picardie region exclusion criteria: * refusal to participate, * severe associated disorders * associated multiple malformation syndromes * patients not attending the consultation. * parents under the age of 18 * prison inmates

Keywords: hypospadias newborns pesticide picardie
control of iatrogenic endobronchial bleeding by tranexamic acid, adrenalin and hemagglutinase

Conditions: Iatrogenic Endobronchial Bleeding

Summary: a prospective national multi-center study will be conducted to evaluate the effectiveness of hemocoagulase in iatrogenic airway bleeding in a large class iii hospital, such as the second affiliated hospital of harbin medical university, the first affiliated hospital of nanchang university, and to compare it with topical epinephrine and tranexamic acid in a prospective double-blind cluster randomized controlled trial.


Eligibility criteria:
inclusion criteria: * during diagnostic bronchoscopy, patients with bronchial bleeding that was not successfully controlled with cold (4°c) saline (3 times within 60 seconds, 5ml each time). exclusion criteria: * 1: patients with contraindications for diagnostic flexible bronchoscopy. 2: coagulopathy (pv inr \>1.3). 3: thrombocytopenia (\<50x10\^9) or anemia (hgb \<80 g/l). 4: direct oral anticoagulant, low molecular weight heparin, or antiplatelet therapy. 5: thrombophilia, history of pulmonary embolism or deep vein thrombosis. 6: contraindications for the use of epinephrine in the bronchus. 7: coronary artery disease, cerebrovascular disease, history of rapid arrhythmias. 8: uncontrolled pulmonary hypertension. 9: cardiovascular decompensation. 10: severe hypoxia (pao2 \ =60%).

Keywords: flexible bronchoscopy diagnostic flexible bronchoscopy hemocoagulase tranexamic acid adrenalin
soft tissue graft over immediately placed dental implant in maxillary molar socket

Conditions: Dental Diseases

Summary: compare between free tissue graft of buccal pad of fat bfp and free palatal gingival tissue graft for primary soft tissue closure over immediately placed dental implant

buccal pad of fat bfp and free palatal gingival tissue graft over immediately placed dental implant

Eligibility criteria:
inclusion criteria: * class one molar extraction socket exclusion criteria: * pregnant females psychiatric problems
comparative pharmacokinetics and pharmacodynamics of synthetic nicotine

Conditions: Nicotine Dependence; Nicotine Vaping

Summary: in a crossover study, experienced electronic cigarette users will vape 3 different forms of nicotine: natural (derived from tobacco), synthetic, or a 50:50 mixture of both natural and synthetic. the investigators will compare nicotine metabolism, cardiovascular effects, patterns of self-administration, and participants' feelings of craving/withdrawal and enjoyment.


Eligibility criteria:
inclusion criteria: * healthy on the basis of medical history and limited physical examination. * current regular user of e-cigarettes (≥ 15 days in the past 30 days) exclusion criteria: * • medications * use of medications that are inducers of nicotine metabolizing enzyme cyp2a6 (example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs). * use of sympatholytic medications for cardiovascular conditions including hypertension (example: beta and alpha-blockers). * concurrent use of nicotine-containing medications (example: nicotine patch, lozenge, gum). * any stimulant medications (example: adderall) generally given for adhd treatment. • pregnancy * pregnancy (self-reported and urine pregnancy test) * breastfeeding (determined by self-report) * women of childbearing potential must be using an acceptable method of contraception * inability to read and write in english * a known propylene glycol/vegetable glycerin allergy * uncomfortable with getting blood drawn

Keywords: nicotine pharmacokinetics nicotine pharmacodynamics vaping e-cigarettes
comparison of weight loss programs for individuals with severe obesity

Conditions: Obesity; Weight Loss

Summary: the purpose of this study is to evaluate the effectiveness of a technology-based system (the body media fit system) for enhancing weight loss in severely obese individuals (bmi: ≥ 40 kg/m2). the investigators will compare two 6-month interventions: 1) a standard behavioral weight loss program (sbt) and 2) a standard behavioral weight loss program plus the use of the body media fit system (sbt+fit). the body media® fit system is a novel weight loss tool consisting of an armband that measures energy expenditure, a digital display watch that provides "real time" physical activity and energy expenditure feedback, and access to a system website which allows individuals to track their food intake and set exercise and dietary goals. we will examine differences in physical activity, weight loss, and program adherence between groups.


Eligibility criteria:
inclusion criteria: * age 21-55 * body mass index (bmi) ≥40kg/m2 (or no more than 440 lbs) exclusion criteria: * recent weight loss (≥ 10 pounds within the past 6 months) * currently pregnant, pregnant within the last 6 months, or planning on becoming pregnant in the next 6 months. * presence of any condition that would limit exercise participation (assessed by the physical activity readiness questionnaire (par-q)). * a history of myocardial infarction or other heart-related surgeries. * currently enrolled in a commercial weight loss program. * a recent (\< 1 year) diagnosis or hospitalization for a psychological condition or history of psychosis (e.g. - schizophrenia, bipolar, eating disorder) * diagnosed with cancer within the past year or currently undergoing cancer treatment. * currently taking weight loss medications. * currently do not have daily access to a computer or internet. * individuals with diabetes

Keywords: obesity weight loss exercise intervention studies
improved diagnosis of ovarian cancer

Conditions: Ovarian Neoplasms; Ovarian Cancer; Ovarian Cysts; Adnexal Mass; Adnexal Lesion; Adnexal Carcinoma; Adnexal Neoplasm

Summary: after implementation of systematic image description of adnexal masses, we aim to improve and evaluate our use of available imaging methods and biomarkers for classifying adnexal masses and distinguishing between benign and malignant adnexal masses in the hands of clinicians in central denmark region. secondarily, we want to improve our management of adnexal masses by evaluating the complications and longitudinal changes in conservatively managed adnexal masses. data is registered prospectively but analyzed retrospectively.

imaging methods include ultrasonography (us) by varied observers, magnetic resonance imaging (mri) and positron emission tomography-computed tomography (pet-ct). imaging criteria are based on recommendations by the international ovarian tumor analysis (iota) group. educational efforts in iota terminology and systematic description at ultrasonography may support quality in the diagnostic process. patients will be diagnosed and treated according to national and regional guidelines by the local clinicians. the project has been evaluated by the ethical committee in the central denmark region prior to initiation. the aim of the power calculation for estimation of sample size is to be able to detect a difference in sensitivity from 75% to 90% at a threshold of 200 for risk of malignancy index (rmi) and 10% for assessment of different neoplasia of the adnexa (adnex) model and two-step-strategy / the ovarian-adnexal reporting and data system (o-rads). to detect a difference in sensitivity (90% for adnex and two-step-strategy vs 75% for rmi at a specificity of 80%) at least 103 cases of malignancy should be included (calculated by using paired proportions).

Eligibility criteria:
patients with an adnexal mass observed at ultrasonography.
efficacy study of telbivudine in chronic hepatitis b patients

Conditions: Chronic Hepatitis B; Roadmap Concept in Chronic Hepatitis B Treatment; 24-week PCR Negativity of Telbivudine; PCR Negativity at 52 and 104 Week; HBeAg Seroconversion Rate at 52 and 104 Week

Summary: this study is designed to support the optimal use of telbivudine by providing data to refine our understanding of telbivudine efficacy and resistance in real life clinical setting in patients with chronic hepatitis b with defined baseline characteristics and 24-week pcr negativity.

this study will be multicenter, open-label and observational data collection of patients on telbivudine who meet baseline characteristics defined as the majority of patients seen in the clinic setting. data collection will take place after enrollment, at week 12, 24, 52, 76 and 104 for efficacy assessments. in patients who discontinue observational drug earlier, clinical information would be kept following for assessment as well. study purpose: this study is designed to evaluate the efficacy of telbivudine in real-life clinical settings with the use of the roadmap concept in chronic hepatitis b treatment. objectives: primary: to observe telbivudine's 2-year efficacy in real-world clinical setting of achieving hbv-dna \< 60 iu/ml and hbeag seroconversion rate in patients with defined baseline characteristics and 24-week treatment pcr negativity as previously reported in globe study's sub-analysis. secondary: 1. to observe the treatment outcomes. 2. to validate the result of super-responder trial. 3. to validate the roadmap concept. population: the study population will consist of a representative group of 500 chronic hepatitis b patients with detectable hbsag for more than 6 months who need telbivudine therapy based on investigators' judgment in 16 medical centers located in taiwan.

Eligibility criteria:
inclusion criteria: * male or female 18 to 65 years of age * documented chronic hepatitis b defined by all of following: 1. clinical history compatible with compensated chronic hepatitis b 2. detectable serum hepatitis b surface antigen (hbsag)\> 6 months and at the screening visit. exclusion criteria: * pregnant or nursing * co-infection with hepatitis c virus (hcv) or hiv * clinical or imaging diagnosis of cirrhosis * evidence of decreased renal function of creatinine \>(=)2x uln
improving medication adherence among underserved patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study evaluates a mobile phone-delivered intervention, called reach (rapid education/encouragement and communications for health), in supporting adults with type 2 diabetes in their self-management relative to a control group. the goal of this study is to determine if individually tailored content (based on the information-motivation-behavioral skills model) delivered to the participant via text messages can improve the participant's glycemic control and adherence to diabetes medications. we will test whether our intervention improves adherence-related information, motivation, and behavioral skills and whether improving these mechanisms drives improvements in adherence and, in turn, glycemic control.


Eligibility criteria:
inclusion criteria: * adults aged 18 years and older * individuals who have received a diagnosis for type 2 diabetes mellitus * enrolled as a patient at a participating community health center * individuals currently being treated with oral and/or injectable diabetes medications exclusion criteria: * non-english speakers * individuals who report they do not have a cell phone * individuals unwilling and/or not able to provide written informed consent * individuals with unintelligible speech (e.g., dysarthria) * individuals with a severe hearing or visual impairment * individuals who report a caregiver administers their diabetes medications individuals who fail the cognitive screener administered during the baseline survey * individuals who cannot receive, read, and respond to a text after instruction from a trained research assistant * individuals whose most recent (within 12 months) hba1c value was 6.8% or greater
predicting inflammatory skin disease response to il-23 blockade

Conditions: Psoriasis Vulgaris

Summary: this study examines the effect of il-23 blockade with tildrakizumab on the immune cells of psoriatic skin lesions.

this is a one-arm, open-label study to examine the effect of tildrakizumab. tildrakizumab is a fda-approved medication for the treatment of cutaneous psoriasis. this study will examine how tildrakizumab affects immune cells within psoriatic skin lesions. fifteen subjects with moderate to severe psoriasis will be enrolled. biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict tildrakizumab treatment response.

Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age at clinic visit. * documentation of moderate-severe psoriasis or atypical psoriasis. * written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. exclusion criteria: * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data * tuberculosis, active serious infection, active systemic malignancy, * received a systemic medication for psoriasis within 3 months of study screening