Kornimate/medical-research-clean huggingface dataset:
study of heparin prophylaxis of hereditary angioedema exacerbations

Conditions: Angioedema

Summary: objectives: i. determine the safety and efficacy of inhaled and subcutaneously administered heparin in the treatment of hereditary angioedema.

protocol outline: this is a randomized, double blind, placebo controlled, 3 way crossover study. all patients complete diary cards for the first month of the study in order to determine compliance in providing a daily record of symptoms and medication taken. all compliant patients receive subcutaneously injected heparin twice daily, inhaled heparin daily, or matched saline placebo in a random order. each of the three drug administration periods lasts 2 months, for a total of 6 months of treatment. patients who have a flare in disease activity that requires hospitalization are terminated from that drug administration period of the study. patients are followed biweekly during the first month and again at the end of the second month for each of the three 2 month drug administration periods. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * confirmed diagnosis of hereditary angioedema (hae) based upon c4 antigenic level, positive family history, and c1 inhibitor (c1inh) antigenic level (type i hae) or functional level (type ii hae) * functional c1 within normal levels if diagnosis of acquired c1inh is possible * negative family history will not exclude as long as patient meets all other criteria, has normal c1 level, and has no evidence of acquired c1inh deficiency * history of symptoms of hae including episodic swelling, abdominal pain, and/or respiratory difficulty * experiencing a minimum of 1-2 hae episodes within 6 weeks --prior/concurrent therapy-- * endocrine therapy: anabolic steroids allowed as long as dose has not been changed in at least 30 days * other: no concurrent and at least 1 week since prior aspirin, nonsteroidal antiinflammatory agents, dipyridamole, coumadin-like drugs, or any other medication having an effect on coagulation or platelets --patient characteristics-- * hematopoietic: no clinically significant history of hematologic disease * hepatic: no clinically significant history of hepatic disease * renal: no clinically significant history of renal disease * cardiovascular: no clinically significant history of cardiac disease or hypertension * pulmonary: no clinically significant history of pulmonary disease * other: no contraindication to the use of inhaled or subcutaneous heparin no drug allergy that would interfere with the study no clinically significant history of: malignancy diabetes mellitus neurologic disease immunologic disease bleeding disorder infirmity no history of drug abuse, alcoholism, psychosis, or other psychological/psychiatric disorder

Keywords: genetic diseases and dysmorphic syndromes hereditary angioedema rare disease
determinants of obtaining covid vaccination among health care workers

Conditions: COVID-19 Vaccination

Summary: despite the global preventive efforts (physical distancing, face, mask, travel constraints, and quarantine) to contain the infection, covid-19 is continuing with its devastating consequences on health, life, and economics. the world's hopes are attached to a successful preventive measure that is the vaccination which has proved its capability to stop infections and save lives over the years. world health organization (who) declared vaccination hesitancy as one of the top 10 obstacles for global health. multicentric study involved arab countries measure hesitancy of hcws toward vaccine, it reported the highest rates of hesitancy were among participants from the western regions of the arab world (egypt, morocco, tunisia, and algeria). this study aims to evaluate the attitude and the determinants of this attitude of hcws towards receiving or refusing to have their first dose of vaccination.


Eligibility criteria:
inclusion criteria: * all staff how are working in auh and offered to receive the first dose of astrazeneca \& sino pharm vaccine. exclusion criteria: * those who are not eligible to receive the vaccine * those who are not freely offered to receive the vaccine

Keywords: covid-19, vaccine, acceptance, attitude
food intake and epigenetic alteration in the spermatozoa of singletons and twins

Conditions: Fertility Issues; Nutrition, Healthy; Epigenetic Disorder; Overnutrition

Summary: the purpose of this study is to elucidate the role of acute dietary intake in male populations, and its impact on spermatozoa quality, integrity, content and epigenetic programming.

the feasst study has been designed to determine the impact of diet on the content, quality, and genetic programming of sperm. they are specifically interested in determining if a man's diet plays a role in influencing the health of his potential, future offspring through modifications of the sperm. previous research has highlighted that certain dietary patterns in fathers-to-be may lead to variable health outcome for their children. however, the specific effect of a man's diet has yet to be fully understood. this study will help understand the impact of a man's diet on semen quality and potential downstream implications for child health, to aid in the development of dietary guidelines for future fathers-to-be. for this study, male participants will be provided with two prescribed diets for three-week increments punctuated by a three month break. health information and biological samples such as blood, semen, and saliva will be collected from study participants throughout the five month period. the diets will consist of a 'processed diet', mimicking a traditional western dietary intake pattern and an 'unprocessed diet', based upon current dietary guidelines at quantities either adequate for the participants energetic needs or 500 calories in excess per day. patient information and samples will be collected before and after each dietary intervention. aspects of patient health examined at various time points include weight, body fat percentage, sperm quality, epigenetic sequencing, serum levels of metabolic parameters, and survey information surrounding health history, typical diet, physical activity patterns, and treatment adherence.

Eligibility criteria:
inclusion criteria: * male * 20 to 35 years old * bmi 18.5 to 30 * located within the copenhagen region * fluent in english and/or danish language * sperm concentration of \>15 mil/ml according to the who's criteria for semen quality * semen volume of \>1.5ml ml according to the who's criteria for semen quality * clinician approval for participation in study * obtained informed consent exclusion criteria: * self-reported history of serious or chronic illness * self-reported history of obesity * history of any food restrictions * history of allergies to any food products * history of disordered eating * record of current use of drugs, alcohol (\>14 units per week and/or chronic binge drinking), and/or tobacco/nicotine products within the past month * current use of prescription medication * engage in \> 200 minutes of vigorous aerobic exercise per week * currently actively trying to conceive a child * diagnosis of infertility or disease of the reproductive system * evidence of dysregulated metabolism, characterized by the occurrence of any one of the following: * waist circumference \>102 cm * blood pressure \> 130/85 mm hg
treatment for subjects with unresectable stage iii or stage iv melanoma

Conditions: Cancer; Melanoma

Summary: this is a randomized, double blind, placebo controlled, multicenter, phase ii study to compare the anti-tumor activity as measured by progression-free survival (pfs) and the tolerability of sorafenib in combination with dacarbazine (dtic) versus dtic in combination with placebo in subjects with unresectable stage iii or stage iv melanoma who have not received prior cytotoxic chemotherapy. a total of approximately 98 subjects will be randomized to receive dtic + sorafenib or dtic + placebo.


Eligibility criteria:
inclusion criteria: * patients who have a life expectancy of at least 12 weeks * patients with histologically or cytologically confirmed unresectable (stage iii) or metastatic (stage iv) melanoma * patients who have an ecog ps of 0, or 1 * measurable disease defined as at least one lesion that can be accurately and serially measured per the modified recist criteria exclusion criteria: * primary ocular or mucosal melanoma * previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (ta \[noninvasive papillary carcinoma\], tis \[carcinoma in situ: "flat tumor"\] \& t1 \[tumor invades subepithelial connective tissue\]) or any cancer curatively treated \< 3 years prior to study entry * history of cardiac disease * known history of human immunodeficiency virus (hiv) infection
evaluation of the clarifix™ cryotherapy device in subjects with chronic rhinitis

Conditions: Chronic Rhinitis

Summary: a multi-center, prospective, non-randomized, interventional clinical trial to assess the safety and effectiveness of the clarifix™ device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.


Eligibility criteria:
inclusion criteria: 1. subject is \>21 years of age 2. subject has moderate to severe symptoms of rhinorrhea (individual symptom rating of 2 or 3), mild to severe symptoms of congestion (individual symptom rating of 1, 2 or 3) and a minimum tnss score of 4 (out of 12) at the time of the treatment visit, which have been present for \> 6 months. 3. subject has had documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens or is willing to have one performed prior to study exit. 4. subject has been dissatisfied with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief by the subject's assessment. 5. subject has signed irb-approved informed consent form exclusion criteria: 1. subject has clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to septal deviation or perforation, nasal polyps, sinonasal tumor. 2. subject has had any prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose. 3. subject has active nasal or sinus infection. 4. subject has moderate to severe ocular symptoms. 5. subject has a history of nosebleeds in the past 3 months. 6. subject has a history of rhinitis medicamentosa. 7. subject has had prior head or neck irradiation 8. subject has active coagulation disorder or is receiving anti-coagulants which cannot be safely stopped for 4 weeks (excluding aspirin). 9. subject is pregnant. 10. subject is participating in another clinical research study. 11. subject has an allergy or intolerance to anesthetic agent. 12. subject has cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, raynaud's disease, and/or, open and/or infected wounds at or near the target tissue. 13. any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk.

Keywords: cryotherapy cryoablation
topical treatment of acute otitis media through tympanostomy tubes (aomt) and its effect on microbial flora

Conditions: Acute Otitis Media

Summary: the purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat acute otitis media through tympanostomy tubes (aomt) on selected bacterial species on the skin near the ear, in the nose, and in the throat.

pediatric patients with tympanostomy tubes were enrolled into one of two groups: 1) treatment, i.e., patients with signs of otic infection, to be treated with ciprodex; or 2) healthy, i.e., patients without signs of otic infection, to receive no treatment. microbiological specimens were collected from four areas (ear canal, skin, nose, throat) during three study visits (day 1, day 8, and day 42), and the specimens collected from the healthy group served as a comparison (control) group for identifying fluoroquinolone (fq) resistant bacterial strains.

Eligibility criteria:
inclusion criteria: * six months to less than 5 years of age at time of enrollment; * presence of bilateral, patent tympanostomy tubes; * otorrhea-free for at least 7 days following tympanostomy tube surgery (healthy group); * otorrhea up to and including 21 days in duration in at least one ear at visit 1 (treatment group); * willing to refrain from significant water immersion of both ears without the use of adequate ear protection during swimming, bathing, showering and other water-related activities; * read and sign informed consent (parent or guardian); * other protocol-defined inclusion criteria may apply. exclusion criteria: * ongoing/current therapy as described in protocol; * has received any treatment for current aomt episode (treatment group); * otorrhea greater than 21 days in duration immediately prior to day 1 visit (treatment group); * history of or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum); * current acute otitis externa (aoe), or malignant otitis externa (moe) or other conditions which could interfere with evaluation of the study drug; * known or suspected ear infection of fungal or mycobacterial origin (treatment group); * history or active herpes simplex, vaccina or varicella infections or overt viral infection of the tympanic membrane or the external canal; * prior otologic surgery, except that confined to the tympanic membrane, within one year of study entry; * diabetes; * any current known or suspected infection (other than aomt) requiring systemic antimicrobial therapy; * known or suspected allergy or hypersensitivity to quinolones; * other protocol-defined exclusion criteria may apply.

Keywords: ear tubes ear drainage ear infection ear drops tympanostomy tubes
mitomycin c with hyperthermia and intravesical mitomycin c to treat recurrent bladder cancer

Conditions: Transitional Cell Carcinoma of Bladder; Superficial Bladder Cancer

Summary: hypothesis: in selected patients external hyperthermia will be used in combination with intravesical mitomycin-c (mmc) to treat recurrent transitional cell carcinoma (tcc) of the bladder after local resection and standard adjuvant therapy and thus prevent or delay recurrence and the need for radical cystectomy.

it is well established that tumor cells are sensitive to heat and when combined with a chemotherapeutic agent, drug uptake and intracellular distribution of drug within malignant cells is improved due to increased cellular permeability. further, hyperthermia inhibits deoxyribonucleic acid (dna) repair as a result of increased reaction between dna and chemotherapy. by heating bladder tissue and accelerating the necessary series of reactions to link agents such as mitomycin c to cell dna, this effect may be optimized. depending on the extent of resection (and location, size, and depth of invasion of remaining tumor) after transurethral resection of the bladder tumor(turbt), recommended adjuvant therapy consists of intravesical chemotherapy. mmc has been studied at doses as high as 80 mg without producing significant or irreversible side effects. the most commonly used dose of mitomycin is 40 mg.2 this pilot study proposes to use mitomycin c at a dose of 40 mg in conjunction with deep hyperthermia to enhance the effect intravesical chemotherapy as second-line treatment of recurrent tcc (stage ta, t1, or tis) of the bladder after surgical resection and standard adjuvant therapy.

Eligibility criteria:
inclusion criteria: * non-muscle invasive transitional cell carcinoma (tcc) of the bladder (ta, t1, tis) recurrent after initial surgery and at least one round of adjuvant treatment (i.e. 6 weeks of intravesical biological therapy with bacillus calmette guerin (bcg) solution); or * an inability to tolerate bcg * age \> 18 * eastern cooperative oncology group(ecog) performance status 0-2 * laboratory tests performed within 14 days of study enrollment: * leukocytes ≥ 3,200, absolute neutrophil count ≥ 1,500, platelets ≥ 100,000 * hemoglobin ≥ 9.0 gm/dl, total bilirubin ≤ institution upper limit of normal \*(uln), asparate aminotransferase(ast) and alanine aminotransferase(alt) ≤ 2.5 times uln, alkaline phosphatase ≤ 2.5 times uln * creatinine ≤ 1.5 times uln * women of child bearing potential must have a negative pregnancy test * if post-menopausal - amenorrhea for ≥ 12 months exclusion criteria: * pregnancy or breastfeeding * muscle invasive disease (t2-t4) * prior radiation to the pelvis * peripheral neuropathy (any grade) * thrombocytopenia, coagulation disorder or an increase in bleeding tendency due to other causes * known bladder fistula * hypersensitive or idiosyncratic reaction to mitomycin-c or its components in the past
if chronic gallbladder diseases increase the incidence of pec

Conditions: Cholecystitis

Summary: this is a prospective, multi-centre trial conducts at 4 ercp centers in china designed to determine if chronic gallbladder diseases increase the incidence of post-endoscopic retrograde choledochopancreatography-choledocholithiasis (pec）

endoscopic retrograde choledochopancreatography(ercp) has the advantages of less injury and faster recovery for common bile duct stone patients. however, according to our retrospective study, ercp will has a mostly 10% possibility to get an acute purulent cholecystitis which often requires emergency intervention, when patients combined with chronic gallbladder diseases, such as chronic cholecystitis, asymptomatic gallstones, and gallbladder wall thickness, the incidence of pec will increase accordingly. the aim of this study is to observe if chronic gallbladder disease will increase the occurence of pec and develop a high-risk pec model.

Eligibility criteria:
inclusion criteria: * ercp patients with gallbladder in situ exclusion criteria: * acute cholecystitis before surgery * gallbladder has been removed * gastrointestinal reconstruction * unwillingness or inability to consent for the study * unstable vital signs coagulation dysfunction (inr\>1.5) * low peripheral blood platelet count (\<50×10 \^9 / l) or using anti-coagulation drugs * preoperative coexistent diseases: acute pancreatitis, gi tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock biliary- duodenal fistula confirmed during ercp * pregnant women or breastfeeding

Keywords: ercp acute purulent cholecystitis bile duct stone post-ercp-choledocholithiasis pec
restylane® for the treatment of tear trough deformity

Conditions: Tear Trough Eyelid Deformity

Summary: the aim of this study is to investigate the effectiveness and tolerability of restylane® for correction of tear trough deformity, using various injection techniques.


Eligibility criteria:
inclusion criteria: 1. female; 2. age of 18 years or greater; 3. indication for treatment of bilateral tear trough deformity; 4. symmetry of tear trough deformity at baseline; 5. subjects who understood and signed the informed consent form (icf) when entering the study, before performing any investigational procedure. exclusion criteria: 1. prior (\<1 year) or planning to undergo any surgery in the corporal area of interest for study; 2. any type of comorbidity or clinical condition that, at investigator's discretion, could interfere with study assessments; 3. diabetes mellitus type 1 or type 2; 4. autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments; 5. using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors; 6. initiated use of hormones or change in dose of hormonal replacement therapy within 3 months; 7. pregnant or breastfeeding, or wishes to get pregnant within the next 12 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential); 8. restylane® should not be used in any person who has hypersensitivity to any of the components of the product; 9. active skin inflammation or infection in or near the treatment area; 10. possessing any of the contraindications for use of restylane®; 11. septal fat herniation; 12. severe elastosis (e.g., dermatochalasis); 13. use of vitamin e, gingko biloba, aspirin or non-steroidal anti-inflammatory drugs (nsaids) within 1 week of treatment. 14. use of tear trough injections in the last 12 months. 15. use of anterior midface injections in the last 12 months.
telemedicine to enhance adherence to cpap therapy in patients with osas

Conditions: Obstructive Sleep Apnea Syndrome

Summary: we hypothesize that the use of telemedicine combined with support interventions by short messages, telephone calls and ambulatory visits to control cpap treatment during the first month improves adherence and reduces unresolved side effects of therapy. the primary objective of an osas treatment program is to successfully implement indicated cpap in the highest possible proportion of patients in order to lower the proportion of untreated osas in the population. on an individual basis, it has been shown that a longer duration of cpap use is associated with better outcomes in terms of daytime functioning and in the control of metabolic and blood pressure effects of cpap. for our study, we have therefore decided to use 2 co-primary endpoints, taking into account both aspects of adherence mentioned. cardiovascular complications are a major concern in osas patients. effective cpap treatment has been shown to reduce surrogate measures of cardiovascular risk. we hypothesize that intensified efforts for cpap adherence with telemedicine has a positive impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of treatment.


Eligibility criteria:
inclusion criteria: * symptomatic osas patients with an ahi and an oxygen desaturation index (odi) of \>5/h in polysomnography (psg) consenting to start longterm cpap treatment. exclusion criteria: * age \<18 years * unable to communicate in german, english, french or italian * alcohol consumption \> 4 units \>4 times a week * acute manifestation of psychiatric diseases * life expectancy of \< 6 months for any reason * surgical obesity treatment planned within the next 6 months * predominantly central sleep apnea and cheyne stokes respiration

Keywords: osas cpap adherence telemedicine
pilot randomised controlled trial of posturing following surgery for full-thickness macular hole

Conditions: Full Thickness Macular Hole

Summary: this is a pilot randomised controlled trial (rct) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery.


Eligibility criteria:
inclusion criteria: * full thickness macular hole * \>16 years old exclusion criteria: * any history of previous intraocular surgery (including cataract surgery) * history of ocular trauma * history of visual loss greater than 1 year