Kornimate/medical-research-clean huggingface dataset:
effect of benzalkonium chloride containing eye drops on the conjunctival bacterial flora of dry eye patients

Conditions: Dry Eye Syndromes

Summary: benzalkonium chloride (bac) is a preservative, which is a component of more than 70% of topical ophthalmic drugs. although bac is a preservative with an excellent antibacterial spectrum, it has also been shown to induce toxic effects to the ocular surface. several studies have indicated that bac may also have altering effects on the bacterial flora of the conjunctiva. since dry eye syndrome (des) is a very common and multifactorial disease of the ocular surface and the tear fluid resulting in tear film instability, inflammation of the ocular surface, symptoms of discomfort and visual impairment, there are many different preserved as well as preservative-free ophthalmic preparations of ocular lubricants for the treatment of des. unpublished data from our department shows differences between artificial tears for the treatment of des with and without bac in bacterial culture. therefore, the aim of this study is to investigate the effect of artificial tear eyedrops with and without bac on the conjunctival bacterial flora. for this 40 patients with mild or moderate dry eye syndrome with no use of artificial tears in the 4 weeks preceding the study will be recruited and treated either with the preservative-free "prosicca sine" eyedrops or the bac containing "prosicca" eyedrops for one month. conjunctival samples will be collected of one eye of each patient before and after the 1-month treatment period to compare the conjunctival bacterial flora of the two treatment groups.


Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 75 years. * signed and dated written informed consent. * history of dry eye syndrome for at least 3 months * tear break up time (but) ≤ 10 seconds or schirmer i test ≤ 10 mm and ≥ 2mm * normal ophthalmic findings except dry eye syndrome, ametropia \< 6 dpt. * recommended use of topical lubricants, but no administration of topical lubricants 4 weeks preceding the first study day. exclusion criteria: * history or presence of ocular disease judged by the investigator as incompatible with the study. * any other topical ocular treatment than the study medication in the 4 weeks preceding the first study day and during the treatment period. * wearing of contact lenses. * symptoms of a clinically relevant illness in the 3 weeks before the first study day. * participation in a clinical trial in the 3 weeks preceding the first study day. * pregnancy, lactation.
an observational study of gonal-f filled by mass pens in multifollicular stimulation prior to in-vitro fertilization (ivf) or intracytoplasmic sperm injection (icsi)

Conditions: Multifollicular Stimulation

Summary: this is a prospective, observational study in women using gonal-f filled-by-mass (fbm) in ovarian hyperstimulation as part of their in-vitro fertilization (ivf) or intracytoplasmic sperm injection (icsi) treatment at infertility clinics in korea. the purpose of this study is to assess gonal-f fbm in a practical setting encompassing all subject groups and local practices.

follicle stimulating hormone (fsh) is a complex hetero-dimeric glycoprotein used therapeutically to stimulate follicular development in the ovary. the technical advance of recombinant technology to manufacture fsh has resulted in a biochemically pure fsh preparation with high batch-to-batch consistency. the protein content can be reliably quantified in mass units by size exclusion high performance liquid chromatography. these developments have enabled recombinant human fsh follitropin alfa (gonal-f) to be filled and released in vials on the basis of mass with a variability of only ±2%. in one study, the fbm batches appeared to deliver a more consistent therapeutic effect than the filled-by-bioassay batches. in another randomized trial, self-administration and subjects' satisfaction were significantly higher in the pen device group than the conventional syringe group. local reactions at injection sites and pain were significantly higher in the conventional syringe group than in the pen device group. the authors concluded that the pen device of gonal-f is safe, convenient, and less painful, with more subject satisfaction than the conventional syringe form. this prospective, multicentric, observational study is planned in women using gonal-f fbm in ovarian hyperstimulation as part of their ivf/icsi treatment at infertility clinics in korea. subjects fulfilling the eligibility criteria shall be enrolled in a consecutive manner over a 9-month period (approximately 1500 subjects). objectives primary objective: * to assess the effectiveness gonal-f fbm secondary objectives: * to assess the safety and subject convenience of gonal-f fbm in a normal clinical practice over a period of 9 months

Eligibility criteria:
inclusion criteria: * women who are prescribed gonal-f fbm by their treating physician for their ivf/icsi treatment cycle will be eligible for this study exclusion criteria: * subjects who have hypersensitivity to follitropin alfa, fsh or to any of the excipients * subjects with tumors of the hypothalamus and pituitary gland * ovarian enlargement or cyst not due to polycystic ovarian disease * gynecological hemorrhages of unknown etiology * ovarian, uterine or mammary carcinoma * primary ovarian failure * malformations of sexual organs incompatible with pregnancy * fibroid tumors of the uterus incompatible with pregnancy

Keywords: gonal-f multifollicular stimulation pregnancy ovarian hyperstimulation in vitro fertilization intracytoplasmic sperm injection infertility
comparison of allegra vs sapien transcatheter aortic valves in valve-in-valve indication

Conditions: Aortic Valve Stenosis; Structural Valve Deterioration

Summary: the vivall-2 study is a randomized trial to compare the self-expandable supra-annular allegra and the balloon-expandable intra-annular edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.

in the vivall.2 study, 104 patients with severely degenerated biological aortic surgical valve accepted for vave-in-valve procedure (transcatheter aortic valve implantation) will be randomized to be treated with the self-expandable supra-annular allegra or the balloon-expandable intra-annular edwards systems. the primary end-point will be trans-aortic mean gradient determined by trans-thoracic echocardiography at 30 days. the proportion of patients with moderate or severe prosthesis mismatch at 30 days will be a secondary end-.point. different countries will participate in the study.

Eligibility criteria:
inclusion criteria: patients meeting all the following criteria will be included: * patients aged ≥ 18 years. * severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area \< 1.0 cm2) and/or severe valve regurgitation. * the patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease. * heart team decision of viv procedure. * patient is willing to return at 30 days for tte and to be clinically contacted at 1 year. exclusion criteria: patients meeting, at least, 1 of the following criteria will be excluded: * patients who openly express their refusal to participate in the study. * female patients in gestational age. * presence or suspicious of biological aortic valve thrombosis. * known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated. * ongoing sepsis and/or suspicious or diagnosis of endocarditis. * patients whose life expectancy is \< 1 year due to non-cardiac comorbid conditions. * medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams. * true inner diameter of the prosthetic valve \> 27 mm. * transfemoral access inadequate to accommodate an 18f sheath. * patients included in other clinical trials (excluding registries).

Keywords: valve-in-valve aortic stenosis aortic regurgitation trans-catheter aortic valve degenerated aortic valve
collecting bone graft during spinal decompression and posterolateral lumbar fusion to better define bone making cells

Conditions: Pseudarthrosis After Fusion or Arthrodesis

Summary: the purpose of this study is to improve fusion (bony healing) techniques and improve patient recovery by identifying cells in your body that make bone. patients with spine problems often need surgeries that include fusion (bony healing) of vertebrae (bones in your back) together in order to hold the bones steady allowing them to heal together (fusion). if the vertebrae (back bones) fail to heal together, which occurs about 10-15% of the time, it can result in a slower recovery and may require revision (another) surgery. by using a small portion of the graft taken during surgery the investigators hope to define the cells that make bone most efficiently. this will help reduce the need for revision surgeries and improve patient recovery.

this study requests using your additional bone tissue (the extra tissue not needed after your back surgery is complete). this tissue will be measured for total volume (amount), labeled with your age, gender, date and time the tissue was removed (date and time of surgery), and taken to a lab for analysis. you will not be billed for the collection of your additional tissue or the lab analysis. all routine procedures (surgery and all follow-up care relating to your back surgery) will still be paid for by you or your insurance. once your extra tissue sample has been collected, measured, labeled, and sent to the lab for testing, no further participation is required from you in this research study. the investigators will use your sample in our research to enhance bone healing.

Eligibility criteria:
inclusion criteria: * patients electing to undergo spinal decompression with an instrumented posterolateral fusion exclusion criteria: * patients not undergoing spinal decompression with an instrumented posterolateral fusion

Keywords: fusion spine decompression pseudarthrosis bone harvest instrumented posterolateral fusion
neoadjuvant chemotherapy and radical surgery in stage iib cervical cancer

Conditions: Cervical Carcinoma Stage IIB

Summary: neoadjuvant chemotherapy (nact) and radical surgery (rs) may have a possible better outcome to concurrent chemoirradiation (ccrt) in stage iib cervical cancer. we try to verify such a hypothesis in terms of survival and treatment related morbidity.

patients with international federation of gynecology and obstetrics (figo) stage iib cervical cancer are eligible for our study. they will receive cisplatin based neoadjuvant chemotherapy (nact) 3 cycles followed by radical surgery (rs) (type iii to v radical hysterectomy plus systematic pelvic lymphadenectomy) (arm a) or external beam radiation (ebrt) with concurrent weekly platinum 40mg/m2 followed by brachyradiotherapy (arm b).

Eligibility criteria:
inclusion criteria: * patients with newly histologically confirmed cervical carcinoma * original clinical stage must be iib （figo 2009） * histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma * age between 18-65 * patients must give signed informed consent exclusion criteria: * the presence of uncontrolled life-threatening illness * receiving other ways of anti-cancer therapy * investigator consider the patients can't finish the whole study * with normal liver function test (alt、ast\>2.5×uln) * with normal renal function test (creatinine\>1.5×uln) * wbc\<4,000/mm3 or plt\<100,000/mm3

Keywords: cervical cancer, stage iib, neoadjuvant chemotherapy
evaluating the impact of quitting using executive function strategy training (quest) on smoking cessation in homeless young adult smokers

Conditions: Cigarette Smoking-Related Carcinoma

Summary: this clinical trial evaluates the impact of quitting using executive function strategy training (quest) on quitting smoking (cessation) in homeless young adult smokers with an acquired brain injury (abi). over 70% of youth and young adults experiencing homelessness (yyeh) smoke tobacco. more than half of yyeh who smoke have made at least one attempt to quit smoking but few use evidence-based methods to increase success. in addition, 9 out of 10 of these have an acquired brain injury which may have a negative impact on successful smoking cessation. quest may help homeless young adult smokers with an abi quit smoking.

primary objectives: i. gather data needed to build quest (quitting using executive function strategy training), an intervention to help youth and young adults (yyeh) with executive function dysregulation better 1) access evidence-based cessation; 2) adhere to processes of evidence-based treatment; and 3) address stress to prevent relapse. ii. establish the feasibility of collecting acquired brain injury (abi) status, and impact data sensitive to change over time (clinical and epigenetic), from yyeh tobacco users in community settings. exploratory objective: i. determine if 1) executive functioning 2) mild cognitive impairment and 3) epigenetic age \& other biomarkers of health risk measures are sensitive to difference by abi status among yyeh past week combustible tobacco users. outline: patients receive access to the ohio tobacco quitline, receive nicotine patches, gum, or lozenges for up to 8 weeks. patients also participate in tobacco cessation counseling sessions for 5 sessions over 8 weeks. patients additionally undergo cognitive assessment and nasal swab collection on study.

Eligibility criteria:
inclusion criteria: * 18-24 years old * utilizing star house ( a drop-in center for youth and young adults experiencing homelessness) services * use of combustible tobacco product in the last week * willing to quit smoking in the next 30 days * acquired brain injury (abi) (15 youth with and 15 without) * chats will be used to determine abi. ask "c", "h" and "a" of the chats tool. if yes to c or h and yes to a, that will be considered positive for abi * have access to a phone * willing to use phone for quitline (ql) services * willing to enroll in ohio tobacco quit line * willing to share ohio tobacco quit line portal data with researchers * willing to provide biospecimens (exhaled air and nasal samples) * conversational english skills
a phase i study of a novel tracer for positron emission tomography "pet" myocardial perfusion imaging "mpi"

Conditions: Coronary Artery Disease

Summary: \[11c\]-dimethyl-diphenyl ammonium (\[11c\]-dmdpa) - a phase i, open-label, safety and tolerability, radiation dosimetry, biodistribution, first-in-human study of a novel 11c-labeled tracer for positron emission tomography myocardial perfusion imaging


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.0 and 30.0 kg/m2 * good health * written informed consent exclusion criteria: * smokers * subject receiving medication * a blood transfusion in the 4 weeks prior to screening * positive alcohol blood test * subjects who suffer from claustrophobia * subjects who have had a clinically significant illness * subjects exposed to radiation within 12 months prior to screening
newborn screening assay of pompe's disease

Conditions: Pompe Disease

Summary: the purpose of this study is to test the feasibility of a newborn screen assay for pompe disease

dbs from newborn will be tested for acid alpha-glucosidase (gaa) activity. babies with low gaa activity will be confirmed for pompe disease.

Eligibility criteria:
inclusion criteria: * newborns receiving newborn screening in newborn screening center of national taiwan univeristy hospital * parents signed inform consent for this study exclusion criteria: -

Keywords: pompe disease alpha glucosidase deficiency
3d assessment of rv function in patients undergoing lvad implantation

Conditions: Heart Failure

Summary: this goal of this study is to analyze images of the right ventricle taken via 3d transesophageal echocardiography (tee) during left ventricular assist device (lvad) implantation.

there are two chambers in the heart known as ventricles which are responsible for pumping blood to both the lungs and the rest of the body. the right ventricle pumps blood to the lungs for oxygenation. the left ventricle then delivers this oxygenated blood to the organs in the body. when the left ventricle is damaged enough that it is not able to effectively pump blood then it may be necessary to assist it with a mechanical pump. this pump is called left ventricular assist device (lvad). left ventricular assist devices (lvads) improve quality of life and survival in patients with end stage heart failure. however, right ventricular (rv) failure is common in 20-50% of lvad recipients and is associated with perioperative complications. traditional two-dimensional ultrasound views of the right ventricle may not accurately depict how well or poorly the right ventricle is working. three-dimensional (3d) images can overcome the limitations of two-dimensional images and are becoming more commonplace. this goal of this study is to analyze images of the right ventricle taken via 3d transesophageal echocardiography (tee) during the lvad implantation to help predict which patients are at higher risk of right ventricular failure within 14 days of the procedure.

Eligibility criteria:
inclusion criteria: * patients will be eligible to be included in the study if they receive either a left-sided: 1. heartmate iii (thoratec, pleasanton, ca) 2. heartware hvad (heartware, oakville ca) 3. levitronix centrimag (levitronix llc, waltham, ma) lvad. exclusion criteria: * patients will be excluded if:: 1. hemodynamic data needed to calculate papi or comprehensive echocardiographic images are missing 2. additional procedures affecting cardiac geometry and/or hemodynamic measurements, such as tricuspid, mitral, and/or aortic valve repair/replacement, were performed at the time of lvad implantation 3. sternal closure at the end of the procedure is not possible 4. rv mechanical support was introduced concurrently with lvad implantation 5. inadequate image quality required to obtain a 3d protocol 6. known contraindication to tee 7. unexpected inability to advance probe into the mid-esophagus

Keywords: right ventricular function left ventricular assist device 3d transesophageal echocardiography
the role of patient expectations in traumatic orthopedic outcomes-teftom eurasia

Conditions: Tibia Fracture (Isolated); Ankle Fracture (Isolated)

Summary: design: prediction trial, up to 10 sites in asia and europe goal: to better understand the "success" or "failure" after orthopedic trauma surgery by developing a model that can be applied clinically as a user-friendly "baseline" questionnaire - capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome and to validate a novel outcomes measure (tom). primary aim: to assess the psychometric properties of predictive validity, internal consistency and reproducibility of the trauma expectation factor (tef) in the eurasian population. secondary aim: to assess the psychometric properties of criterion validity, internal consistency,reproducibility, and sensitivity to change of the tom in the eurasian population. key questions related to patient and surgeon expectations: * how different, or similar, are patient and surgeon expectations? * do expectations change over time? * do patient expectations predict outcomes in validated measures use today?


Eligibility criteria:
inclusion criteria: * isolated ankle or distal tibia fracture * scheduled for and undergoing one of the following surgeries for their fracture: * open fracture and internal fixation (orif) * external fixation (ef) * ef followed by orif * 18 years of age or older * understand and read country national language at elementary level * able to understand the purpose of the clinical trial, * able and willing to conduct all follow-up visits * signed informed consent exclusion criteria: * subject has previously undergone internal fixation surgery for this ankle/distal tibia fracture. * subject has disease entity, or condition that precludes likelihood of bony union (e.g., metastatic cancer, metabolic bone disease). * subject has severe dementia or other severe mental health problem that may preclude him/her from completing study questionnaires. * subject is participating in other competing clinical research that may interfere with participation in this research. * subject is unlikely to attend study related follow-up visits. * subject has poly-trauma (more than one organ system compromised) * subject has additional fracture(s) other than ankle fracture * subject is a prisoner * fracture occurred more than 28 days before surgery

Keywords: validation study outcome measures patient outcomes assessment patient expectations physician patient relationship
safety study of sublingual immunotherapy tablets of house dust mite allergen extracts in adolescents

Conditions: Allergic Rhinitis Due to House Dust Mite

Summary: the purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (hdm) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.


Eligibility criteria:
inclusion criteria: * written informed consent from patient and parent(s)/legal representative. * male or female patient from 12 to 17 years. * diagnosed rhinitis with medical history consistent with hdm-induced allergic rhinitis for at least 1 year before visit 1 * positive skin prick test to house dust mites(hdm)and hdm-specific ige serum value ≥ 0.7 kunit/l. * concommittant controlled asthma allowed up to gina 1 or 2 treatment step * spirometry with best fev1 \> 80% of predicted fev1. exclusion criteria: * patient with a nasal or oral disease that could interfere with the safety assessments * patient has undergone recent nasal surgery * patient with asthma receiving therapy consistent with gina (global initiative for asthama) treatment step 3, 4, or 5. * patient with partially controlled or uncontrolled asthma * patient with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of this study. * female patient pregnant or breast-feeding/lactating. * female patient of childbearing potential planning a pregnancy during this trial or not using a medically accepted contraceptive method. * patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (maois). * patient who received allergy specific immunotherapy for house dust mites for more than 1 month in the 5 years before screening or who is currently receiving immunotherapy with any allergen. * patient with a history of anaphylaxis * patient having participated in any clinical study within the 12 weeks before visit 1

Keywords: house dust mite allergic rhinitis phase i house dust mite allergen extract