Kornimate/medical-research-clean huggingface dataset:
virtual reality application during cystoscopy

Conditions: Virtual Reality; Rigid Cystoscopy

Summary: this randomized controlled experimental study aimed to determine the effect of virtual reality glasses during cystoscopy on pain, anxiety and patient satisfaction.

patients in the intervention arm; in order to evaluate pain, anxiety and patient satisfaction regarding the cystoscopy procedure, the patient's pain level will be assessed with the visual analog scale 10 minutes before the procedure and the patient's anxiety level will be assessed with the state anxiety scale. patients will be asked to wear virtual reality glasses starting three minutes before the procedure and until the procedure is completed. the patient will be shown a video of nature scenes with the virtual reality glasses and will also be made to listen to the sounds of water and birds. routine institution procedures will be applied during the cystoscopy procedure. 10 minutes after the procedure, the patient's pain and satisfaction level will be assessed with the visual analog scale and the patient's anxiety level will be assessed with the state anxiety scale. patients in the control arm; to assess pain, anxiety, and patient satisfaction with the cystoscopy procedure, the patient's pain level will be assessed with the visual analog scale and the patient's anxiety level will be assessed with the state anxiety scale 10 minutes before the procedure. routine institution procedures will be applied during the cystoscopy procedure. 10 minutes after the procedure, the patient's pain and satisfaction levels will be assessed with the visual analog scale and the patient's anxiety level will be assessed with the state anxiety scale.

Eligibility criteria:
inclusion criteria: * 18 years of age and older, * first elective and rigid cystoscopy performed under local anesthesia, * no vision, hearing and perception problems, * open to communication and able to speak turkish, * patients who agree to participate in the study exclusion criteria: * contraindications for the procedure (lidocaine allergy, urinary tract infection, anatomical problems related to the urethra, etc.) * use of any analgesic or sedative medication at least 4 hours before cystoscopy patients who undergo manipulation such as j stent placement or removal and/or bladder biopsy.

Keywords: cystoscopy pain anxiety satisfaction virtual reality
apr-246 in combination with venetoclax and azacitidine in tp53-mutant myeloid malignancies

Conditions: Myeloid Malignancy

Summary: this clinical trial is a phase i, open-label, dose-finding and cohort expansion study to determine the safety and preliminary efficacy of apr-246 in combination with venetoclax and azacitidine in patients with myeloid malignancies.

this study will enroll adult male and female patients of age ≥ 18 years with documented diagnosis of aml, according to who classification, and documented tp53 mutation which is not benign or likely benign, who also meet the eligibility requirements of this protocol. the study will include a safety lead-in dose-finding portion followed by expansion portion. during the safety lead-in portion of the study, two cohorts will independently enroll patients following a 3 + 3 design. each cohort will enroll up to 6 patients. the expansion portion will begin once the recommended phase ii dose (rp2d) of apr-246 in combination with venetoclax and in combination with venetoclax and azacitidine have been determined in order to assess the antitumor activity of these combinations.

Eligibility criteria:
inclusion criteria: 1. signed informed consent and ability to comply with protocol requirements. 2. documented diagnosis of aml according to world health organization who) classification 3. adequate organ function as defined by the following laboratory values: 1. creatinine clearance \> 30 ml/min 2. total serum bilirubin \< 1.5 × uln 3. alanine aminotransferase (alt) and aspartate aminotransferase (ast) \< 3 × uln 4. age ≥18 years 5. at least one tp53 mutation 6. eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 7. projected life expectancy of ≥ 12 weeks. 8. negative serum or urine pregnancy test 9. females of childbearing potential and males with female partners of childbearing potential must be willing to use an effective form of contraception exclusion criteria: 1. prior treatment for tp53-mutant aml (\*dependent upon treatment arm assigned). 2. known history of hiv or active hepatitis b or active hepatitis c infection. 3. any of the following cardiac abnormalities: 1. myocardial infarction within six months prior to registration; 2. new york heart association class iii or iv heart failure or known left ventricular ejection fraction (lvef) \< 40%; 3. a history of familial long qt syndrome; 4. symptomatic atrial or ventricular arrhythmias 5. qtcf ≥ 470 msec, unless due to underlying bundle branch block and/or pacemaker and with approval of the medical monitor. 4. concomitant malignancies for which patients are receiving active therapy 5. known active cns involvement from aml. 6. malabsorption syndrome 7. pregnancy or lactation. 8. active uncontrolled systemic infection (viral, bacterial or fungal).
respiratory muscle strength in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: respiratory muscle strength, dyspnea perception, physical activity and quality of life measurements will be performed and groups will be compared in two groups consisting of patients with idiopathic pulmonary fibrosis referred to pulmonary rehabilitation clinic and healthy volunteers in similar age range.

the patients who have agreed to participate in the study from patients diagnosed with idiopathic pulmonary fibrosis referred to the center of pulmonary rehabilitation from the interstitial lung disease polyclinic will be included in the study. in addition, a healthy adult control group will be established from similar age groups. the two groups will be compared in terms of outcome measures.the study outcome measurements are maximum inspiratory/expiratory muscle strength , international physical activity questionaire, modified medical research council dyspnea scale, short form 36 quality of lide questionaire, fatigue severity scale, six minute walking test.

Eligibility criteria:
inclusion criteria: * between the ages of 18-70 * patients signing informed consent form * patients diagnosed with idiopathic pulmonary fibrosis. exclusion criteria: * patients who use steroids for less than 1 year * the patient does not want to participate in the study

Keywords: idiopathic pulmonary fibrosis respiratory muscle strength physical activity quality of life dyspnea fatigue severity exercise capacity
voriconazole trough plasma levels : genetic polymorphism, efficacy, safety in patients with hematologic malignancy

Conditions: Invasive Fungal Infection

Summary: multiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes. voriconazole is extensively metabolized by the human hepatic enzymes, primarily mediated by cyp2c19. the polymorphisms account for a relatively large portion of inter-individual variance observed in voriconazole plasma concentrations. however, there are limited data on the relationships between voriconazole blood levels and clinical outcomes or safety in asian populations. the purpose of this study is to investigate the relationships of voriconazole blood levels with genetic polymorphism, safety, and clinical outcomes in immunocompromised patients with invasive pulmonary aspergillosis.

the investigators are trying to establish that routine clinical practice for voriconazole therapeutic drug monitoring can improve the efficacy and safety outcomes. in korean patients with hematologic malignancy, the investigators also want to propose the optimal dosing guideline of voriconazole with different genetic polymorphisms.

Eligibility criteria:
inclusion criteria: all items below * male or female ≥ 15 years of age * immunocompromised patients with hematologic disorders * patients received voriconazole due to treat proven, probable invasive (pulmonary) aspergillosis exclusion criteria: * severe hepatic dysfunction (t.bil, ast, alt, alp \> 5 x upper normal limit) * who experienced hypersensitivity to azoles * pregnant women

Keywords: voriconazole invasive pulmonary aspergillosis hematologic malignancy therapeutic drug monitoring genetic polymorphism efficacy safety
post-marketing registry of inspiron sirolimus eluting coronary stent

Conditions: Coronary Artery Disease

Summary: post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and efficacy of inspiron sirolimus eluting coronary stent at the treatment of "real-world" patients.

up to 5.0000 patients with native coronary arteries lesions with diameter between 2.5 and 4.0 mm and 34 mm of length treated solely with the inspiron sirolimus eluting coronary stent. stent implantation should be performed according to the instructions for use and according to the local practice. it is recommended that ecg and cardiac enzymes are collected before and after procedure. dual anti-platelet therapy is recommended for at least 6 months after procedure. patients will be followed at 30 days, 1 and 2 years after procedure.

Eligibility criteria:
inclusion criteria: * alll patients that have been treated with the inspiron sirolimus eluting stent older and 18 years exclusion criteria: * safein vein or left internal mammary artery grafts

Keywords: stent, des, inspiron
covid 19 vaccine acceptance in egyptian pregnant women

Conditions: COVID-19

Summary: to determine vaccine acceptance and hesitancy attitudes toward coronavirus disease 2019 (covid-19) vaccines in egyptian pregnant women.

although 2 years passed since the covid 19 pandemic started, no specific treatment against the disease is available. according to who, more than two million deaths have been recorded worldwide . therefore, it is important to avoid infection. in the absence of an effective treatment for coronavirus disease 2019 (covid-19) non-pharmaceutical interventions are the only available methods of disease control. social distancing, face masks, and personal hygiene are the most effective precautions, but maintaining these actions is not practicable in the long term. as a result, vaccination becomes the most effective eradication method. (1,2) research into development of a vaccine for sars-cov-2 was undertaken immediately after the disease was identified.(3) the success of a vaccine depends not only on its efficacy, but also its acceptance. however, vaccine hesitancy has become an important threat to global health, which was pointed out by who in 2019.(4) several key factors behind vaccine hesitancy include fear or mistrust of the vaccine, underestimation of the value of the vaccine, and lack of access to the vaccine.(5) pregnant women are at increased risk of severe disease, icu admission, and ventilation when compared with non-pregnant patients of the same age.(6-8) therefore, pregnant women are classified as a high-risk population for covid-19 infection.(9) regarding this information, pregnant women have not been included in any covid-19 vaccine clinical trials to date.(10) even so, public health authorities, including the acog and the smfm recommend that covid-19 vaccines should be available for pregnant women if they prefer to be vaccinated.(11,12)

Eligibility criteria:
inclusion criteria: * pregnant women at any gestational age exclusion criteria: * covid 19 suspicious patients at time of survey. * patients refusing survey * obstetric emergency.
a comparison of one-site and two-site peribulbar anaesthesia for cataract surgery at kaduna, nigeria

Conditions: Anaesthesia; Cataract

Summary: the aim of the study was to compare the efficacy and safety of single injection peribulbar anaesthesia against the classic double injection technique. this was a double blind randomized controlled trial involving two groups of consenting, adult nigerian subjects with operable age-related cataract. an anaesthetic nurse who allocated the subjects to the two groups administered all the injections. the same surgeon operated on all the subjects while the principal investigator and a research assistant measured the outcome variables. all others were blinded as to subject allocation.


Eligibility criteria:
inclusion criteria: * age 50 years and above * diagnosed with uncomplicated senile cataract * visual acuity of \<3/60 exclusion criteria: * impaired mental status * difficulty in speaking * known allergy to amide-type local anaesthetic agents and/ or hyaluronidase * previous surgery in the same eye * glaucoma * impaired ocular motility * eyelid abnormalities * patients with only one eye

Keywords: ophthalmic surgery, peribulbar local anaesthesia
safety and efficacy study of topical cantharidin for the treatment of molluscum contagiosum

Conditions: Molluscum Contagiosum

Summary: the purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids

this was a double-blind, placebo-controlled trial. participants were recruited from the pediatric dermatology clinic at montefiore medical center. one hundred eligible participants were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with occlusion, placebo, or placebo with occlusion. treatments were applied at weeks 0 and 3 (blinded phase). at week 6, all participants were treated with open-label, topical cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label phase).

Eligibility criteria:
inclusion criteria: * 2-17years * healthy * \<50 molluscum contagiosum lesions exclusion criteria: * immunosuppressed * oral corticosteroids * sexually active/pregnant
prediction of hepatocellular carcinoma recurrence after curative treatment by longitudinal monitoring mrd based on ctdna

Conditions: Hepatocellular Carcinoma Resectable

Summary: this study will conduct a prospective cohort study to verify the predictive value of ctdna-mrd longitudinal monitoring model in predicting postoperative recurrence, verify whether ctdna-mrd longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.

the recurrence rate of hepatocellular carcinoma after curative treatment is high, and the minimal residual disease(mrd) in patients is the major cause of liver cancer recurrence, and the mrd is an important basis for the decision of adjuvant therapy after curative treatment. previous studies have confirmed that circulating tumor dna(ctdna)-mrd monitoring model can accurately predict the recurrence of hepatocellular carcinoma patients. it was also found in retrospective analysis that tumor free survival was significantly prolonged after ctdna-positive treatment for hepatocellular carcinoma after resection. this study will conduct a prospective cohort study to verify the predictive value of ctdna-mrd longitudinal monitoring model in predicting postoperative recurrence, verify whether ctdna-mrd longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.this study is to verify the predictive value of ctdna-mrd longitudinal monitoring model in predicting postoperative recurrence.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18-75 years; 2. preoperative imaging examination diagnosed hepatocellular carcinoma (bclc) stage 0 / stage a/stage b, eligible for radical surgery; 3. ecog physical status score is 0-1; 4. child-pugh score is 5-6 points (level a); 5. not received any anti-tumor therapy; 6. laboratory tests were at normal levels within 7 days before enrollment. exclusion criteria: 1. patient can't provide blood samples for ctdna testing; 2. patient with two or more types of tumors at the same time; 3. non-primary liver lesions; 4. pregnant or lactating women; 5. patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma; 6. patient with serious heart disease; 7. other conditions deemed unsuitable for inclusion by the researcher.
beta-blocker evaluation in survival trial (best)

Conditions: Cardiovascular Diseases; Heart Diseases; Heart Failure, Congestive; Heart Failure

Summary: to determine if addition of a beta-blocker to standard therapy in class iii and class iv heart failure patients reduced total mortality.

background: controlled and uncontrolled studies suggested that beta-blockade improves ventricular function in congestive heart failure. several trials suggested that beta-blockers may also reduce mortality. in the beta-blocker heart attack trial, patients with a history of heart failure had less cardiac and sudden-death mortality than those who did not. patients with a low ejection fraction in the cardiac arrhythmia suppression trial who were treated with beta-blockade also had a reduction in mortality. the metoprolol in dilated cardiomyopathy trial randomized patients with dilated cardiomyopathies to treatment with metoprolol or placebo. there was a trend toward reduction in a morbidity and mortality endpoint in patients treated with metoprolol, but this was due entirely to a reduction in the need for cardiac transplantation. thus, despite a reasonable theoretical basis and suggestive clinical studies, the concept that beta-blockers reduced mortality in congestive heart failure patients was unproved. design narrative: randomized, double-blind, multicenter. patients were assigned to standard therapy plus the addition of a beta-blocker (bucindolol) versus a placebo. the primary endpoint was total mortality. a radionuclide ventriculogram was performed within 60 days of randomization. history, physical examination, clinical laboratory studies, chest x-ray, electrocardiogram, and plasma norepinephrine levels were obtained within 14 days of randomization. patients were stratified by hospital, congestive heart failure etiology, ejection fraction, and gender, and were assigned to a treatment group by an adaptive balancing scheme ("biased coin" randomization). patients were randomized to either placebo plus standard congestive heart failure treatment or to the beta-blocker plus standard congestive heart failure treatment and followed for a minimum of 18 months. the over three year recruitment period began in may 1995 at the first 35 sites. an additional 55 sites began recruitment on august 14, 1995. recruitment ended in december, 1998 with the enrollment of 2,708 patients.

Eligibility criteria:
men and women, ages 18 and over. patients had compensated congestive heart failure due to idiopathic dilated cardiomyopathy or coronary disease with ejection fraction less than or equal to 0.35, were in the new york heart association functional class iii or iv, and were taking an angiotensin-converting enzyme inhibitor, digitalis, and if needed, a diuretic. patients with a specific indication for, or contraindication to, beta-blockade were excluded.
a study to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo

Conditions: NonSegmental Vitiligo

Summary: the purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% bsa on the face, ≥ 0.5 f-vasi, ≥ 3% bsa on nonfacial areas, ≥ 3 t-vasi. * total body vitiligo area does not exceed 10% bsa. * pigmented hair within some of the areas of vitiligo on the face. * must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. * for sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child from screening through 30 days after the last application of study cream. exclusion criteria: * diagnosis of other forms of vitiligo (eg, segmental). * other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor). * any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments. * prior or current use of depigmentation treatments (eg, monobenzone). * any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * use of protocol-defined treatments within the indicated washout period before baseline. * current or previous use of jak inhibitors, systemic or topical. * protocol-defined clinically significant abnormal laboratory values at screening. * bmi-for-age \< 5th percentile or ≥ 85th percentile according to the cdc bmi percentile calculator for child and teen. * pregnant or lactating participants or those considering pregnancy during the period of their study participation. * in the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations. * living with anyone participating in any current incyte-sponsored ruxolitinib cream study. * employees of the sponsor or investigator or are otherwise dependents of them. * known allergy or reaction to any component of the study cream formulation. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: nonsegmental vitiligo pediatric
evaluation of prochymal® for treatment-refractory moderate-to-severe crohn's disease

Conditions: Crohn's Disease

Summary: to provide open-label re-treatment with prochymal to subjects enrolled in companion protocol 603 to evaluate the safety in subjects with active crohn's disease who are resistant to standard crohn's disease therapies.

subjects will receive infusions of prochymal on day 42, day 84, and day 126 after initial infusion of prochymal in protocol 603. each infusion will contain 200 million cells. as subjects will be required to be in protocol 603 during the entire duration of their participation in protocol 611, all concomitant medication and safety information will be monitored by protocol 603 and the combination of data from the two protocols

Eligibility criteria:
inclusion criteria: * subject must have qualified for, enrolled in, and provided written informed consent form (icf) and authorization for use and disclosure of protected health information (phi) for protocol 603 after the august 3, 2010. * subject successfully completed all screening assessments in protocol 603 as required by protocol 603. * subject successfully completed the full course of each of the four infusions of investigational agent on days 0, 3, 7, and 14 of protocol 603 after august 3, 2010. * subject must enroll in protocol 611 on or before the 45th day after first infusion in protocol 603. * subject must provide written icf and authorization for use and disclosure of phi for protocol 611. exclusion criteria: * subject is unwilling or unable to adhere to requirements of protocol 611. * subject had confirmed respiratory distress during a prochymal infusion in any prior prochymal study. * subject had a serious adverse event in any previous prochymal study that was deemed by the principal investigator of that study to be possibly or probably related to prochymal and also that was within 48 h after a prochymal infusion.

Keywords: crohn's disease adult stem cell therapy inflammation of the gastrointestinal tract