Kornimate/medical-research-clean huggingface dataset:
to assess the safety of avanafil in healthy and hepatically impaired male subjects.

Conditions: Erectile Dysfunction

Summary: the objective of this study is to assess the single dose pharmacokinetics of avanafil in subjects with hepatic impairment and in healthy control subjects.


Eligibility criteria:
inclusion criteria: * male subjects must be 21-75 years of age; inclusive. healthy control subjects (cohort 1) must be medically healthy with clinically insignificant screening results and hepatically impaired subjects (cohorts 2 and 3) must have mild or moderate hepatic impairment based on the child-pugh classification. exclusion criteria: * main exclusion criteria for healthy control subjects (cohort 1) include history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematologic, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the investigatorinvestigator; systolic blood pressure \ 160 mmhg; diastolic blood pressure \ 90 mmhg; allergy to or previous adverse events with pde5 inhibitors; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome p450 3a4 enzyme within 30 days of screening; use of any investigational drug within 30 days of screening; use of any prescription or over-the-counter drugs or herbal remedies within 14 days of screening; history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breath alcohol test; positive serology for hiv, hcv, hbsag; blood donation or significant blood loss within 56 days of dosing; plasma donation within 7 days of dosing. main exclusion criteria for hepatically impaired subjects (cohorts 2 and 3) include any significant concurrent medical condition or history of significant medical conditions other than hepatic impairment that may affect the interpretation of the data or which otherwise contraindicates participation in this study; acute exacerbation of or unstable hepatic disease, as indicated by worsening of clinical and/or laboratory signs of hepatic impairment, within the 2 weeks preceding study drug administration; history of esophageal variceal bleeding within past 6 months; history of bleeding or non-bleeding gastric varices; history of spontaneous bacterial peritonitis within the past 3 months; history of portosystemic surgical shunt; autoimmune liver disease; history of organ transplant; wilson's disease; diagnosis of cholestatic liver disease (e.g., primary biliary cirrhosis or primary sclerosing cholangitis); history of recent symptomatic cryoglobulinemia; alcoholic hepatitis, determined clinically or by histology; initiation of any new prescription or over the counter medications within 14 days before study drug administration and hemoglobin \< 9.0 g/dl, positive for afp.

Keywords: avanafil hepatic erectile dysfunction impairment
pivotal clinical study of endoscopic ablation for atrial fibrillation (af) in patients that have failed drugs

Conditions: Atrial Fibrillation

Summary: the purpose of the study is to compare two types of treatment for atrial fibrillation (af) that are designed to treat the symptoms of atrial fibrillation. the treatments being compared are: * a single catheter ablation procedure with the investigational eas, a visually-guided, light-energy catheter * standard drug therapy (antiarrhythmic drugs) to learn more about the cardiofocus enable investigational clinical study, please contact the study site closest to you. eligibility criteria persons with paroxysmal atrial fibrillation may be eligible for this study. other study eligibility criteria include: * 18 to 80 years of age * frequent episodes of af * failed at least 1 drug treatment for af (beta-blockers or standard aads) * other criteria


Eligibility criteria:
inclusion criteria: * 18 to 80 years old * paroxysmal atrial fibrillation (af) * frequent episodes of af * failed at least 1 drug treatment * others exclusion criteria: * others

Keywords: af paf paroxysmal atrial fibrillation ablation failed drugs
open label placebo to reduce prescription opioid use

Conditions: Acute Pain

Summary: the goal of the proposed study is to examine the efficacy of using an honest placebo to relieve pain for patients with an acute pain condition. people with acute pain will receive their standard dose of opioid medication for pain management. in addition, some people will be asked to take placebo pills, honestly described as placebos, as well. patients will answer a few short questions over the phone once per day for seven days about pain and opioid use. the investigators hypothesize that participants in the open label placebo group will take fewer opioids and have less pain than those in the treatment as usual group.

america is in the midst of an opioid epidemic. one of the reasons opioid addiction and overdose deaths have recently increased is that doctors are frequently prescribing opioid medication as a treatment for pain. if researchers can develop ways of increasing the pain-relief patients experience from a set amount of opioids, then doctors might ultimately be able to prescribe fewer opioid medications, which could help curb the opioid crisis. although "placebos," a medication whose benefit derives solely from positive psychological factors rather than pharmacological factors, are often disparaged in medicine, research suggests that placebos can actually help reduce pain. in fact, there is reason to think that placebos are effective even when a patient knows they are taking a placebo. the goal of the proposed study is to examine the efficacy of using an honest placebo to relieve pain for patients with an acute pain condition. people with acute pain in the emergency department, or patients undergoing hand/wrist surgery, will receive their standard dose of opioid medication for pain management. in addition, some people will be asked to take placebo pills, honestly described as placebos, as well. patients will answer a few short questions over the phone once per day for seven days regarding their pain, opioid use, and placebo use (only those assigned to take placebo pills).

Eligibility criteria:
inclusion * 18 years or older * english speaking * has a working smart-phone * able to provide informed consent * present for upper or lower extremity fracture (ed sample only) or for hand or wrist surgery (hand surgery sample only) * are expected to be prescribed opioids at discharge * are expected to be discharged from the emergency department (ed sample only) * intends to take 1 or more doses of opioid medication as prescribed exclusion * chronic opioid use * unlikely to follow-up (discretion of investigator and treating provider) * having been diagnosed with a psychotic disorder * having a current medical marijuana prescription * currently receiving worker's compensation or intending to apply for worker's compensation * history of opioid use disorder * allergy to opioid medication

Keywords: pain placebo analgesia opioid
stress management therapy in patients receiving chemotherapy for cancer

Conditions: Cancer; Psychological Stress; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: a stress-management program may improve quality of life and reduce anxiety and depression in patients receiving chemotherapy for cancer. purpose: this randomized clinical trial is studying how well stress management therapy works in patients receiving chemotherapy for cancer.

objectives: primary * determine if a self-administered stress management intervention is effective in improving quality of life and decreasing psychological distress (anxiety and depression) in hispanic and non-hispanic patients receiving cancer chemotherapy. secondary * determine if the degree of acculturation in hispanics influences the observed helpfulness of the intervention. outline: this is a randomized, multicenter study. patients are stratified according to participating center, use of psychotropic drugs (yes vs no), and ethnicity (hispanic vs non-hispanic). patients are randomized to 1 of 2 arms. * arm i (self-administered stress management training plus usual psychosocial care): patients receive a video dvd, audio cd, and brochure that provides information and instruction in 3 stress management training techniques (progressive muscle relaxation training and guided imagery, abdominal breathing, and coping skills training) to use during chemotherapy. patients also receive usual psychosocial care. * arm ii (usual psychosocial care only): patients receive usual psychosocial care. patients complete questionnaires to assess mood, quality of life, and other factors at baseline and before chemotherapy courses 2, 3, and 4. projected accrual: a total of 442 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * newly diagnosed with cancer * scheduled to receive a minimum of 4 cycles of intravenous chemotherapy * able and willing to give informed consent to participate exclusion criteria: * had intravenous chemotherapy prior to study entry * are scheduled to receive radiotherapy prior to the end of the fourth cycle * have severe depression or other severe psychiatric disorders

Keywords: psychosocial effects of cancer and its treatment unspecified adult solid tumor, protocol specific
poc study to evaluate the performance of the acuvid covid-19 rapid antigen saliva test

Conditions: COVID-19

Summary: the acuvid covid-19 rapid antigen saliva test is a lateral flow immunoassay to detect sars-cov-2 nucleocapsid antigens in human saliva specimens from individuals suspected of covid-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect. the acuvid covid-19 rapid antigen saliva test performance will be compared to a high sensitivity fda eua approved rt-pcr covid-19 test. nasopharyngeal (for rt-pcr) swab results will be collected from subjects by healthcare providers at clia waived covid-19 testing centers, and on the same day the subjects will also provide saliva samples which will be tested and interpreted by the healthcare providers. this prospective, observational, study will test up to 300 participants to establish the performance characteristics of the acuvid test on saliva specimens.


Eligibility criteria:
inclusion criteria: * participant is willing to sign verbal informed consent form. * age ≥12 and parents or legal guardians must consent as required by law. * participant is attending covid-19 testing centre to provide a nasopharyngeal swab sample. * participant is willing to provide a self-collected saliva sample. exclusion criteria: * participant has previously tested positive for covid-19 within the past 90 days.
distal protection combined with ptca in ami patients

Conditions: Coronary Artery Disease

Summary: the primary objective is to evaluate if use of the angioguard™ xp improves myocardial reperfusion after ptca as assessed by st segment resolution at the end of ptca.

this is a prospective, randomized, multicenter trial. patients will be randomized either to be treated by ptca only or in combination with the an-gioguard™ xp device. the patients will be followed for six-months post-procedure.

Eligibility criteria:
inclusion criteria: * acute myocardial infarction \ 2 mm in at least 2 contiguous leads; * clinical indication of primary ptca; * de novo or restenotic lesions in native coronary vessel, single vessel treatment only; * target lesion stenosis is \> 80% (by visual estimation). exclusion criteria: * patient has unprotected left main coronary disease with \> 50% stenosis in case left coronary artery is treated; * patient has an ostial target lesion; * killip class \> 3.
a manufacturing transfer study comparing the bioequivalence of a single oral dose of claritin-d 12-hour extended release tablet from 2 different manufacturers under fasted conditions in healthy adult subjects

Conditions: Clinical Pharmacology

Summary: to evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for bayer healthcare llc by sag manufacturing, s.l.u. madrid, spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for bayer sa-nv by schering-plough labo nv heist (reference treatment) which is currently marketed in europe.


Eligibility criteria:
inclusion criteria: * healthy adult men or women * age 18 to 55 years inclusive * body mass index 18.5 to 30.0 kg/m\*2 inclusive exclusion criteria: * positive alcohol or drug screen at screening or on day -1 of each dosing period; * use of within 1 month before first study drug administration, systemic or topical medicines or substances which might affect the study objectives, any drug known to induce cytochrome p3a4/5 or p glycoprotein (e.g., rifampin, carbamazepine, st. john's wort); any drug known to inhibit cytochrome p3a4/5 or p glycoprotein (e.g., clarithromycin, chloramphenicol, ketoconazole); * history of hypersensitivity symptoms with the use of loratadine, desloratadine (clarinex), or pseudoephedrine; * females who are pregnant or lactating * known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids); * more than moderate alcohol consumption (\>40 g of alcohol regularly per day); * any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse; * loss of blood of 50 ml to 499 ml within 30 days of the first dose of trial treatment, or in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury)

Keywords: upper respiratory allergy symptoms including congestion
study of efficacy of a probiotic and postbiotic in overweight and obese individuals

Conditions: Obesity

Summary: the study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters.

investigation of the efficacy of probiotics as adjuvant in the management of overweight and obesity. specifically, in the reduction of abdominal/visceral adipose tissue.

Eligibility criteria:
inclusion criteria: male and female subjects from 18 to 65 years old. established diagnosis of overweight (bmi ≥ 25 and up to 34.9) waist circumference ≥ 102 cm for men waist circumference ≥ 88 cm for women signature of the informed consent letter. agreement to comply with the protocol and study restrictions exclusion criteria: diagnosed and pharmacologically-treated type 1 or type 2 diabetes subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease or chronic disease immunosuppression or ongoing therapy causing immunosuppression pharmacologically-treated (medication/supplements) hypertension or dyslipidaemia subjects consuming antibiotics in the previous 2 months subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period. history of chronic active inflammatory disorders history of bariatric surgery history of any chronic gastrointestinal disease (e.g. ibd). known hypersensitivity to any ingredients in the active or placebo products.
safety and efficacy of suprachoroidal tube shunt in patients with primary open and pseudoexfoliation glaucomas

Conditions: Glaucoma, Open-Angle; Suprachoroidal Space; Pseudo Exfoliation Syndrome

Summary: to assess safety and efficacy of a novel suprachoroidal silicone tube (sst) shunt for the treatment of primary open angle and exfoliative glaucomas.


Eligibility criteria:
inclusion criteria: * male or female subjects from 40 years up to 90 years old * diagnosis of primary open angle glaucoma (poag) and pseudo-exfoliative glaucoma * subject is able to understand and sign a written informed consent form * subject who underwent sst implantation and agreed to come for the cross-sectional follow-up exclusion criteria: * close angle forms of glaucoma * congenital or developmental glaucoma * pseudophakic with an anterior chamber intraocular lens (iol), iris fixed iol, or implantable contact lens (icl) * prior glaucoma procedures such as selective laser trabeculoplasty (slt), microinvasive glaucoma surgery (migs) or episcleral shunts * history of corneal transplant, corneal refractive surgery, corneal dystrophy, or corneal ectasia (such as either keratoconus or keratoglobus) in the study eye * chronic ocular inflammatory disease, or clinically significant ocular inflammation or infection (e.g., uveitis, iritis, iridocyclitis, retinitis). * any condition that, in the investigator´s opinion, can interfere with full participation in the study, including study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data.

Keywords: migs suprachoroidal space glaucoma, open-angle suprachoroidal silicone tube suprachoroidal shunt glaucoma shunt
probiotic (visbiome) for gulf war illness

Conditions: Gulf War Illness

Summary: the overall objective is to determine whether visbiome will improve 1. intestinal symptoms of irritable bowel syndrome (ibs) and 2. non-intestinal symptoms (fatigue, joint pain, insomnia, general stiffness and headache) associated with ibs. all of these symptoms are part of the gulf war (gw) illness.

specific aims: aim # 1: determine the efficacy of visbiome on ibs symptoms in gw veterans. hypothesis: treatment with visbiome compared to placebo will improve global and individual symptoms of ibs aim #2 determine the efficacy visbiome in reducing non-intestinal symptoms of ibs (fatigue, joint pain, insomnia, general stiffness and headache). hypothesis: treatment with visbiome compared to placebo will improve non-intestinal symptoms of ibs in gw veterans. aim #3 determine whether changes in gut flora and plasma cytokines correlate with treatment response in gw veterans

Eligibility criteria:
inclusion criteria: 1. first gw veterans, men and women age 35-75 years, 2. rome iii criteria for ibs and two or more of the non-intestinal symptoms (chronic-once a week or more often-fatigue, joint pains, insomnia, general stiffness, and headache) 3. symptoms of \> 6 months duration, 4. no significant findings on physical examination, complete blood count (cbc) and clinical chemistry panel. 5. normal gross appearance of the colonic mucosa other than erythema and polyps 6. negative tissue transglutaminase (ttg) for celiac disease, 7. normal thyroid function. 8. veterans with psychological disorders will not be excluded but will be identified for sub-group analysis. 9. stable medication regimen for more than a month exclusion criteria: 1. current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease 2. history of/or presence of systemic malignancy (patients with skin and other cancers in remission for more than 5 years are allowed in the study 3. clinically significant chronic disease: hiv, cardiac, pulmonary, hepatic or renal dysfunction. 4. presence of giardia antigen, and clostridium difficile toxin in stool, 5. abnormal blood test for thyroid stimulating hormone, tissue transglutaminase antibody 6. current effects of drug or alcohol abuse 7. investigator perception of patient's inability to comply with study protocol 8. recent change in gastrointestinal medications 9. use of any antibiotic in the last 1 months 10. positive pregnancy test 11. subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study.

Keywords: gwi ibs irritable bowel syndrome gulf war illness probiotics
the tricure first in human trial

Conditions: Tricuspid Regurgitation

Summary: the objective of this first in human study is to gain early clinical insight into the safety profile and performance of the topaz transcatheter tricuspid valve replacement (ttvr) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

the tricares topaz prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.

Eligibility criteria:
inclusion criteria: * subject of age \>18 years. * subject with severe symptomatic tricuspid regurgitation presenting following conditions: 1. tr severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or 2. symptoms requiring use of diuretics. * subject presenting with new york heart association class nyha ≥ii. * subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a heart team decision. exclusion criteria: * subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months. * subject undergoing cardiac interventions within 30 days prior to index procedure. * subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis. * subject who had previous tricuspid valve replacement or repair and a device is still in situ.
durolane versus phosphate buffered saline (pbs) in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of the study is to determine whether a single intra-articular injection of durolane 4.5 ml is superior to a single injection of pbs 4.5 ml for the relief of joint pain in patients with osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≤ 35 kg/m2 * symptomatic osteoarthritis (oa) of the knee * k l severity grade 1 or 2 * if bilateral oa, contralateral knee k l severity grade 0 or 1 exclusion criteria: * has clinically apparent tense effusion of the index knee * has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months * has any painful orthopedic disorders of the back or hip * has a joint disorder other than osteoarthritis in the index knee

Keywords: double-blind randomized intraarticular injection hyaluronic acid placebo knee osteoarthritis
incarceration risk factors in inguinal hernia.

Conditions: Incarcerated Inguinal Hernia; Strangulated Inguinal Hernia; Inguinal Hernia

Summary: it is known that strangulation or necrosis of the intestine within the hernia sac of inguinal hernia increases mortality and morbidity in patients. however, the risks of incarceration in hernias have not been fully revealed.to better understand the factors associated with incarceration in inguinal hernia, the investigators will examine patients who will apply to our clinic for inguinal hernia and undergo elective and emergency inguinal hernia surgery.

a prospective study will be conducted for 2 years, involving all adult patients who have applied to the general surgery outpatient clinic of bakırköy dr sadi konuk training and research hospital, diagnosed with inguinal hernia, and who have applied to the emergency diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.

Eligibility criteria:
inclusion criteria: * ages between 18-80 * primary and recurrent inguinal hernias * incarcerated / strangulated inguinal hernias exclusion criteria: * younger than 18, older than 80 * pregnancy * mental retardation