Kornimate/medical-research-clean huggingface dataset:
does lidocaine gel decrease pain perception in women undergoing diagnostic flexible cystoscopy

Conditions: Cystoscopy; Lidocaine; Pain Perception

Summary: this study is to determine if there is a clinically meaningful difference in pain perception for women during in-office diagnostic flexible cystoscopy when using lidocaine gel vs plain lubricant. this will be a double blinded randomized control trial.

the use of anesthetic lubricant during in-office flexible cystoscopy has been well studied men. pain during cystoscopy can lead to poor compliance and follow-up. very few studies challenging the use of anesthetic lubricant during cystoscopy have included women. those that have, only recruited a small number with insignificant findings. a meta-analysis reviewed four studies looking at the efficacy of lidocaine gel on pain relief during flexible cystoscopy in men. four hundred and eleven men underwent flexible cystoscopy with and without the use of lidocaine gel and those who received anesthetic gel were 1.7 times more likely not to experience moderate to severe pain than those who received placebo. the anatomy of the female and male urogenital tract differ. the female urethra is approximately 3cm in length while the male urethra averages 7 cm with an external and prostatic sphincter which is the location where the most discomfort is thought to occur. a randomized control trial of 144 women undergoing rigid cystoscopy and found that pain was decreased with lidocaine vs placebo, however other studies such found no difference in pain perception. the efficacy of lidocaine gel in women during flexible cystoscopy has not been studied. the use of lidocaine gel during diagnostic flexible cystoscopy in women is based on surgeon preference and experience, and use of either plain or anesthetic gel, is currently acceptable clinical practice. the morbidity and cost of local anesthesia associated with cystoscopy in women is unknown due to the lack of studies. the objective of this study is to determine if there is a clinically meaningful difference in pain perception in women during in-office diagnostic flexible cystoscopy when using lidocaine gel vs plain lubricant.

Eligibility criteria:
inclusion criteria: * need for in office diagnostic flexible cystoscopy exclusion criteria: * urethral stricture * simultaneous scheduling or performed additional procedure * current urinary tract infection * hypersensitivity to local anesthetic of amide type
s8947-9800-9911-0016a vitamin d insufficiency in determining prognosis in patients with newly diagnosed follicular lymphoma

Conditions: Lymphoma

Summary: rationale: studying samples of serum from patients with cancer in the laboratory may help doctors identify and learn more biomarkers related to cancer. it may also help doctors predict how well patients will respond to treatment. purpose: this research study is studying vitamin d insufficiency in determining prognosis in patients with newly diagnosed follicular lymphoma.

objectives: * to evaluate the role of pre-treatment serum 25(oh)d with regard to progression-free survival and objective response among patients with newly diagnosed follicular lymphoma, within the context of a uniformly treated and evaluated phase iii clinical trial in the modern therapeutic era. outline: this is a multicenter study. pre-treatment serum samples are analyzed for 25(oh)d levels to determine vitamin d sufficiency or insufficiency.

Eligibility criteria:
disease characteristics: * newly diagnosed cd20+ follicular lymphoma * enrolled on clinical trial swog-s0016, swog-9800, or swog-9911 * pre-treatment serum available through swog-8947 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: contiguous stage ii grade 1 follicular lymphoma contiguous stage ii grade 2 follicular lymphoma contiguous stage ii grade 3 follicular lymphoma noncontiguous stage ii grade 1 follicular lymphoma noncontiguous stage ii grade 2 follicular lymphoma noncontiguous stage ii grade 3 follicular lymphoma stage iii grade 1 follicular lymphoma stage iii grade 2 follicular lymphoma stage iii grade 3 follicular lymphoma stage iv grade 1 follicular lymphoma stage iv grade 2 follicular lymphoma stage iv grade 3 follicular lymphoma
rescue progesterone supplementation during frozen embryo transfer

Conditions: Fertility Issues; Embryo Implantation; Frozen Embryo Transfer

Summary: endometrin is a progesterone supplement prescribed during in vitro fertilization (ivf) for preparation for embryo transfer. the usual dose of endometrin is 100 mg two to three times per day in the form of an effervescent tablet to be inserted vaginally. the purpose of this research project is to evaluate the dose response of the endometrin when determined based on the blood level of progesterone on the day of the fet. according to the literature, a predefined level of progesterone in the blood should be reached in order to have favorable conditions for pregnancy. the hypothesis being that a woman with low progesterone levels would benefit from a dose of endometrin of 600 mg (200 mg 3x/day) to decrease the risk of miscarriage and improve the chances of pregnancy. women with adequate progesterone levels according to the literature, would continue with the standard dose of progesterone prescribed at clinique ovo which is 300 mg (100 mg 3x/day). pibf (progesterone induced blocking factor) levels, a protein found in the blood that could also predict pregnancy outcomes in women using ivf will also be looked at.


Eligibility criteria:
inclusion criteria: * women 18-42 years of age * normal uterine cavity (according to treating physician) * fet substituted cycle prescribed * first or second cycle of fet * adequate endometrial pattern (triple layer) and thickness (\>7 mm) after adequate standard endometrial preparation in artificial cycle exclusion criteria: * any uterine abnormalities confirmed by treating physician making participant unable to proceed with fet * patients with personalized fet according to the endometrial receptivity assay tests * previous allergic reactions to progesterone or any of the ingredients of endometrin * severe hepatic dysfunction or disease * known or suspected breast cancer or genital tract cancer * known active arterial or venous thromboembolism or severe thrombophlebitis or cerebro-vascular disease, or a history of these events * diagnosed porphyria * undiagnosed abnormal vaginal bleeding * known missed abortion or ectopic pregnancy * recurrent pregnancy loss excluding biochemical pregnancies * hypersensitivity to acetylsalicylic acid (asa), salicylates, non-steroidal anti-inflammatory drugs (nsaids), analgesics, antipyretics or other ingredients in the product or component of the container * acute gastrointestinal ulcer, history of gastrointestinal ulcers and hemorrhagic diathesis * active or severe renal disease, or congestive heart failure * history of asthma induced by salicylates or other nsaids * use of methotrexate at doses of 15mg/week or more * glucose-6-phosphate dehydrogenase (g6pd) deficiency

Keywords: embryo frozen embryo transfer progesterone embryo implantation
impact of sonifilan on the quality of life in patients with cervical cancer during radiation or chemoradiation therapy

Conditions: Cervical Cancer

Summary: the impact of sonifilan on the quality of life in patients with cervical cancer during radiation or chemoradiation therapy 1. primary endpoint : quality of life 2. secondary endpoint : complications related to sonifilan, treatment effect of sonifilan

study design prospective randomized controlled trial study period protocol registration approval date - may/31/2016 study drug sonifilan(sizofiran) study population 1. cervical cancer figo stage ia2-iva patients will be participated. 2. squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma 3. age 20-75 year treatment fron the day of radiation therapy started, sonifilan 20mg, 1amp im/week for 8weeks concurrent therapy chemo \& radiation therapy 1. cisplatin 40mg/m2, day 1, 8, 15, 2, 29, 36 2. external whole pelvic irradiation 3000-3500 cgy / 6 fractions in high dose rate assessment 1. pre-study assessment (within 4weeks before participation) a medical history b informed consent c id number assignment d life quality assessment - fill out eortc qoq-c30, cx24, sf-36, fsfi e basic information collect 2. on-study assessment (during study) a complication check b life quality assessment - fill out eortc qoq-c30, cx24, sf-36, fsfi 3. post-study assessment (1week after study finished) a mri b pap smear c hpv test d life quality assessment - fill out eortc qoq-c30, cx24, sf-36, fsfi 4 follow-up assessment (every 3 month for 1 year) a pelvic exam b pap smear c hpv test d mri (if needed) e pet (if needed) f life quality assessment - fill out eortc qoq-c30, cx24, sf-36, fsfi 93, 6, 12, 24 month after study finished)

Eligibility criteria:
inclusion criteria: * cervical cancer figo stage ia2 - iva * histologic type : scc, adenocarcinoma, adenosquamous carcinoma * gog performance status 0-2 exclusion criteria: * past radiation therapy history * neuroendocrine carcinoma * concurrent other cancer * uncontrolled medical disease * ulcerative disease history * current pregnancy and lactation
single-port laparoscopy in children and adolescents

Conditions: Benign Ovarian Tumors

Summary: to compare the safety evaluation, efficacy evaluation, long-term aesthetics and psychological satisfaction of single-port and multiport laparoscopy for children and adolescents with bot in china.


Eligibility criteria:
inclusion criteria: * patients ≤18 years old * postoperative pathological diagnosis confirmed benign ovarian tumor * multi-hole laparoscopic or single-hole laparoscopic surgery * medical records and pathological data were complete and available exclusion criteria: * patients with malignant pathological diagnosis * patients undergoing open surgery * incomplete medical records or pathological data
gp vs pf as induction chemotherapy combined with ccrt for locoregionally advanced nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Nasopharyngeal Diseases; Head and Neck Neoplasm

Summary: the purpose of this study is to compare the survival and toxicity of gp (gemcitabine and cisplatin) vs. pf (cisplatin and fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (ccrt) for locoregionally advanced nasopharyngeal carcinoma( npc ) patients.

patients presented with non-keratinizing npc and stage t1-4n2-3/t4n0-1m0 are randomly assigned to receive gp (gemcitabine and cisplatin) or pf (cisplatin and fluorouracil) induction chemotherapy combined with concurrent chemoradiotherapy. patients in both arms receive radical radiotherapy, and cisplatin (100mg/m²) every three weeks for two cycles during radiotherapy. patients in the investigational arm receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. patients in the control arm receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. our primary endpoint is progress-free survival (pfs). secondary end points include distant metastasis-free survival (dmfs), overall survival (os), locoregional relapse-free survival (lrrfs), initial response rates after treatments, toxic effects and quality of life (qol).

Eligibility criteria:
inclusion criteria: * patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including who ii or iii * tumor staged as t1-4n2-3/t4n0-1m0（according to the 8th ajcc edition） * male and no pregnant female * age between 18-65 * adequate marrow: leucocyte count ≥4000/μl, hemoglobin ≥90g/l and platelet count ≥100000/μl * normal liver function test: alanine aminotransferase (alt)、aspartate aminotransferase (ast) \<2.0×upper limit of normal (uln) * adequate renal function: creatinine clearance ≥60 ml/min * satisfactory performance status: karnofsky scale (kps) ≥ 70 * without radiotherapy or chemotherapy * patients must give signed informed consent exclusion criteria: * evidence of relapse or distant metastasis * history of prior malignancy or previous treatment for npc * any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×uln), and emotional disturbance. * pregnancy or lactation

Keywords: gemcitabine cisplatin fluorouracil
brief transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (ptsd) in south africa

Conditions: Anxiety Disorders; Post-traumatic Stress Disorder

Summary: the purpose of this study is to examine the use of a brief transdiagnostic treatment for anxiety disorders and (post-traumatic stress disorder (ptsd) in south africa. the intervention will be delivered by non-specialist providers (e.g., nurses) in primary care clinics. the brief intervention group will be compared to an enhanced standard care control group.

post-traumatic stress disorder (ptsd) and anxiety disorders are highly prevalent and a leading cause of disability in low and middle-income countries (lmics). despite the development of evidence-based treatments (ebts), an overwhelming majority of those in need (i.e., 85%) in lmics do not receive treatment and, when they do, it is not empirically based. despite the clear need for ebts in lmics, there are three primary barriers associated with the implementation of ebts in these areas. these barriers include: (1) ebts tend to be single disorder focused only treating one disorder at a time, (2) they are long in duration (e.g., 12-16 treatment sessions to treat one disorder), and (3) they tend to be complex and require a high level of skill to administer. given the low availability of highly trained providers in lmics, using an approach that is brief, culturally congruent, and less complex than typical ebts is ideal for reducing these barriers. the current study aims to evaluate the use of a brief transdiagnostic treatment for anxiety disorders and ptsd (false safety behavior elimination treatment; f-set) in south african primary care clinics. the current study is a type 1 hybrid effectiveness-implementation trial assessing the effectiveness of the adapted brief transdiagnostic intervention and to explore facilitators and barriers to implementation. the adapted intervention is being compared to an enhanced standard care control condition.

Eligibility criteria:
inclusion criteria: * participants diagnosed with a primary anxiety disorder (panic disorder, generalized anxiety disorder, social anxiety disorder, or obsessive-compulsive disorder) or post-traumatic stress disorder. exclusion criteria: * participants who are acutely suicidal, have severe alcohol of substance use disorder, or are engaged in another form of psychotherapy.
exercise and ectopic fat deposition

Conditions: Overweight

Summary: excess ectopic fat deposition is associated with development of cardiovascular and metabolic diseases. this study investigates how lifestyle interventions can have an effect on different sites of ectopic fat deposition and cardiovascular or metabolic factors. moreover, the clinical and economic value of exercise to supplement a hypocaloric diet is investigated. endocrinologists of the university hospital of antwerp, belgium, will be recruiting women during consultations. also, recruitment posters will be used in the university hospital of antwerp and the university of antwerp. potential participants meeting all a priori set inclusion and exclusion criteria will be randomized by minimization method to a hypocaloric diet group (usual care) or a group of hypocaloric diet combined with physical fitness training. both groups will undergo an intake procedure in which personal goals are set and barriers to changes in behavior will be discussed. ectopic fat deposition will be measured by imaging techniques after three and six months of intervention. based on the known relationship between ectopic fat and cardiovascular outcomes, the short term study results will then be extrapolated to an estimation of the reduction of cardiovascular events. the following clinical outcomes will be presented: change in ectopic fat in the abdomen (visceral fat), the liver (intra hepatic lipids), skeletal muscle (intra myocellular lipids), heart (epicardial fat) after a dietary or combined (diet+physical activity) intervention. the impact of supervised exercise in addition to diet will be expressed in projected healthcare costs and quality adjusted life years.

protocol of the study was published, hens et al. (physioscience 2017; 13: 80-87)

Eligibility criteria:
inclusion criteria: * participants should be willing to undergo a weight loss intervention and body weight must be stable during the past six months. * there will be no upper eligibility criterion for body mass index (bmi) but bmi should be at least 27 kg/m². exclusion criteria: * individuals who have a clinical history of type 2 diabetes, prediabetes (with use of medication), or hypothyroidism will be excluded. * when postmenopausal; premenopausal state will be verified by hormonal data (follicle-stimulation hormone (fsh) \ 20 pg/ml). * subjects will not be allowed when pregnancy is planned * when physical activity is not possible due to problems of the musculoskeletal system * when changes in medication (e.g. beta blockers) are advised by an endocrinologist. * when smoking * when drinking more than two alcoholic consumptions/day or binge drinking (self-reported) * when taking medication that influences body weight or metabolism (e.g. tricyclic antidepressants) * since all participants will undergo medical imaging, exclusion criteria related to mri and ct scans are also applicable.

Keywords: overweight ectopic fat exercise diet
the efficacy of aspirin combined with hydroxychloroquine treatment in high risk pregnancies for preeclampsia

Conditions: Preeclampsia

Summary: this study is prospective, single arm group ,open label, and multicenter trial (with two parallel-group \[hydroxychloroquine 200mg with aspirin 100mg or aspirin 100mg\])

this study is prospective, open label, and multicenter trial \[hydroxychloroquine 200mg with aspirin 100mg\] the study population consists of the singleton pregnancy at high risk for preeclampsia who had adverse pregnancy outcome (preeclampsia or fetal growth restriction or intrauterine fetal death) in previous pregnancy. after randomisation, participants are assigned to receive hydroxychloroquine 200mg with aspirin 100mg per day or aspirin 100mg per day. treatment is initiated between 12 and 22 weeks' gestation and stopped at 36 weeks' gestation. the medication adherence to dosing should be maintained at more than 80%.

Eligibility criteria:
inclusion criteria: 1. the singleton pregnant women aged from 19 to 50 years 2. includes at least one factors of the below ① history of preeclampsia ② history of fetal growth restriction ③ history of intrauterine fetal death 3. women who have agreed to enroll in the study and given their informed consent exclusion criteria: 1. indication to a treatment according to the severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease and malignancy (however, the participation of the trial is allowed by the investigator based on medically necessary.) 2. previous inclusion in other intervention study within 3 months of screening (except for non-interventional observational studies) 3. major malformation of the fetus is diagnosed at 11-13 weeks of gestation 4. elevated blood concentrations of creatinine more than double the normal value 5. elevated blood concentrations of liver transaminases (ast(got) or alt(gpt)) more than three times the normal value 6. conditions related with aspirin treatment * previous exposure within 28 days of screening * previous nsaid exposure within 28 days of screening * bleeding disorder (von willebrand's disease, peptic ulceration) * hypersensitivity to aspirin 7. conditions related with hydroxychloroquine treatment * previous exposure within 28 days of screening * hypersensitivity to hydroxychloroquine and 4-aminoquinoline compounds * maculopathy * medications that has potential for visual disturbance * women who have potential for changes in the retina or visual impairment by 4-aminoquinoline compounds * galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption * prolonged qt interval on ekg (congenital or acquired) or the risk factors of qt prolongation (heart failure, arrhythmia, myocardial ischemia) * low level of potassium in the blood * low level of magnesium in the blood 8. not suitable for participant based on medical evidence by investigator
effects of therapeutic doses of acetaminophen in moderate drinkers

Conditions: Moderate Alcohol Consumption (1-3 Drinks Per Day)

Summary: the study objective was to evaluate the safety of ten consecutive days of therapeutic acetaminophen dosing in moderate alcohol consumers. the main outcome was liver injury (measured by an increase in mean serum alt or ast levels). patients were randomly assigned to 10 days of acetaminophen or placebo. blood tests were measured at baseline, day 4 and day 11 to look for injury. we hypothesized that there would be no difference in liver enzymes between the two groups.


Eligibility criteria:
inclusion criteria adult volunteers of age 21 years or older, regardless of ethnicity or gender, who provided written consent and met all three of the following criteria of a moderate alcohol consumer: 1. average baseline ethanol consumption of at least one alcoholic beverage per day before enrollment for the past two months. the estimate of ethanol intake was based on the average intake over seven days. for example, a person who ingested no alcohol on sunday, monday, tuesday or wednesday, two drinks on thursday and four drinks on friday and saturday would be calculated as 10 drinks/7days = 1.4 drinks/day. the average alcoholic beverage contains 15 grams of alcohol(9). 2. average baseline ethanol consumption of no more than three alcoholic beverages (\> 45 grams of alcohol) per day, calculated as a weekly average over the preceding two months. 3. at least one alcohol-containing drink within the last 48 hours exclusion criteria subjects were excluded from the study at baseline if any of the following were evident at baseline: 1. serum acetaminophen level greater than 20 mcg/ml 2. serum ast or alt levels greater than 50 iu/l 3. if female, positive for b-hcg 4. clinically intoxicated, psychiatrically impaired or unable to give informed consent 5. known hypersensitivity to acetaminophen 6. history of ingesting more than four grams of acetaminophen per day for any of the four days preceding study enrollment 7. alcoholic patients as defined by those who consume on average more than three alcoholic beverages daily 8. currently enrolled in another trial or had been enrolled in another trial in the preceding three months

Keywords: acetaminophen alcohol liver injury
egg quality assessment

Conditions: Infertility (IVF Patients); Ovarian Aging; IVF

Summary: the goal of this observational study is to learn about egg physiology in humans. the main question it aims to answer is if there is an association between egg physiology and egg quality. discarded, unfertilised eggs and follicular fluid collected during routine egg retrieval from participants undergoing in vitro fertilisation (ivf) as part of their regular medical care along with information from participants' electronic medical records will be collected and analysed.


Eligibility criteria:
inclusion criteria: * undergoing in vitro fertilisation treatment or egg freezing exclusion criteria: * no discarded, unfertilised eggs for collection