Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy, safety and immunogenicity of leucostim® versus neupogen® in breast cancer patients

Conditions: Breast Cancer

Summary: a study to compare the efficacy, safety and immunogenicity of leucostim® to those of neupogen® in patients with breast cancer intended to be treated with tac regimen as a myelosuppressive chemotherapy.

tac regimen (docetaxel, doxorubicin and cyclophosphamide) is recommended for the adjuvant treatment of breast cancer patients. the tac regimen is known to lead to significant hematological toxicity and induces febrile neutropenia with a rate \> 20%. the use of primary g-csf prophylaxis with the tac regimen is recommended by guidelines. e.g., by the european organisation for research and treatment of cancer as well as by the guideline on myeloid growth factors of the national comprehensive cancer network.6,7 this study is to compare the efficacy, safety and immunogenicity of leucostim® to those of neupogen® in patients with breast cancer intended to be treated with tac regimen as a myelosuppressive chemotherapy.

Eligibility criteria:
inclusion criteria: 1. willing to provide a written informed consent 2. men or women ≥ 18 and ≤ 70 years of age 3. histologically or cytologically confirmed breast cancer (stage ii to stage iv) 4. be scheduled to receive tac regimen as adjuvant therapy 5. subjects who meet the conditions at screening test as follows; * absolute neutrophil count (anc) ≥ 1,500/mm3 * platelet count ≥ 100,000/mm3 * ecog performance status : 0\~2 6. adequate renal function (creatinine ≤ 1.5 x uln at screening test) 7. adequate hepatic function at screening test (total bilirubin/ast/alt ≤ 1.5 x uln, alp ≤ 2.5 x uln at screening test) exclusion criteria: 1. prior chemotherapy experiences 2. prior bone marrow or stem cell transplantation 3. history of treatment with hematopoietic growth factors (e.g. g-csf, peg-g-csf, erythropoietin) 4. history of prior malignancy other than breast cancer or surgically cured malignancies within 5 years of informed consent date 5. participation in any other clinical study within 4 weeks of informed consent date or planning to simultaneously participate in another clinical study 6. currently receiving radiation therapy or having completed radiation therapy within 4 weeks of informed consent date 7. active infection which may require systemic antimicrobial or antiviral therapy during the study (e.g. anc ≥ 12,000/mm3 or body temperature \> 38.2 degrees c (100.8 degrees f)) 8. history of systemic antibiotic use within 72 hours prior to chemotherapy 9. history of hypersensitivity to the investigational product, components or similar products 10. hiv positive 11. pregnant or lactating women, or women of child-bearing potential who are not willing to follow a reliable and effective contraceptive measure during the course of the study and for at least one month after the completion of the study 12. any other cases that is considered by the investigator as an exclusion

Keywords: neutropenia
performance evaluation of dailies® total1™ in first time contact lens wearers

Conditions: Myopia

Summary: the purpose of this study was to evaluate the performance of dailies® total1™ in first time contact lens wearers.


Eligibility criteria:
inclusion criteria: * sign informed consent. * no previous contact lens experience or attempt to try contact lenses (neophyte). * willing to wear study lenses for at least 8 hours a day for at least 5 days a week. * use spectacle lenses for vision correction. * other protocol-defined inclusion criteria may apply. exclusion criteria: * 45 years or older. * prior wear experience with rigid or soft contact lenses. * systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study. * history of ocular surgery/trauma within the last six months. * pregnant or nursing women. * participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment. * other protocol-defined exclusion criteria may apply.

Keywords: dailies total1 alcon contact lens
oligos: impact of treatment on primary tumour in patients with newly diagnosed oligometastatic neoplasia of the prostate

Conditions: Oligometastatic Prostate Carcinoma

Summary: the proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to chaarted criteria. the aim of the study is the creation of a registry including patients with newly diagnosed ompca, belonging to the main urological centres in the triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (adt as monotherapy or in combination with docetaxel/androgen receptor signal inhibitors (arta)). the above criteria define 'high metastatic volume' disease with the following parameters * ≥ 4 bone metastases, including at least one outside the spine and pelvis * presence of visceral metastases consequently, patients included in the study should not have the above-mentioned characteristics.


Eligibility criteria:
inclusion criteria: * diagnosis of new-onset prostate neoplasia (any risk category according to eau guidelines). * histological confirmation of disease by prostate biopsies. absence of neuroendocrine differentiation * low volume of metastatic disease defined according to chaarted study criteria (\< of 4 bone metastases, absence of visceral metastases) * patients without previous treatment of primary malignancy (e.g. previous radical prostatectomy, previous rt) * patients treated with systemic therapy (adt as monotherapy or in combination) for less than 6 months prior to enrolment * eastern cooperative oncology group (ecog) performance status 0-1 * patients eligible for local treatment of primary malignancy and concomitant systemic therapy * signature of informed consent exclusion criteria: * inability or unwillingness to give written informed consent * high volume metastatic disease defined according to charteed criteria * ecog performance status \> 1 * patients included in other clinical trials * contraindications to hormone/systemic therapy administration * previous treatment of primary tumour (rp, rt or other treatment of primary tumour)
postoperative adjuvant tace treatment in ck18 positive patients

Conditions: Postoperative Adjuvant TACE; Hepatocellular Carcinoma.

Summary: to evaluate and analyse the clinical effect and application value of postoperative adjuvant tace treatment in patients with different expression levels of ck18 using randomized controlled study and provide evidence for the necessity of postoperative adjuvant tace.


Eligibility criteria:
inclusion criteria: 1. via clinical diagnosis and confirm it is primary liver cancer 2. pathological evidence of hcc 3. estimate tumor can gain treatment of curing operation 4. no evidence for extrahepatic metestasis 5. liver function ：child-pugh a/b exclusion criteria: 1. reject to attend； 2. impossible to come to our hospital for physical examination regularly. 3. cancer epitome、seed focus、lymph node or distant metastasis 4. blood clotting function hindrance; 5, patients with other diseases which may affect the treatment mentioned.

Keywords: cell keratin 18
renal sympathetic denervation from the adventitia on hypertension

Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma

Summary: renal sympathetic denervation from the intima of renal arteries has become an important method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly located in the adventitia, and there is no report about renal sympathetic denervation from the renal adventitia. primary aldosteronism is an important factor of secondary hypertension, tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone, in some patients blood pressure control is still not desirable after resection of tumor aldosterone. this study intends to conduct renal sympathetic denervation ablation from the adventitia to observe its efficacy and safety on blood pressure of patients with primary aldosterone.

renal sympathetic denervation from the intima of renal arteries has become an important method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly located in the adventitia, and there is no report about renal sympathetic denervation from the renal adventitia. primary aldosteronism is an important factor of secondary hypertension, tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone, in some patients blood pressure control is still not desirable after resection of tumor aldosterone. this study intends to conduct renal sympathetic denervation ablation（rdn）from the adventitia to observe its efficacy and safety on blood pressure of patients with primary aldosterone.

Eligibility criteria:
inclusion criteria: 1. . renal artery diameter ≥4 mm and length ≥20 mm; 2. . 18 years old ≤ age ≤ 70 years old; 3. . specific diagnosis of adrenal adenoma and primary aldosteronism before the patients are enrolled in the study; 4. . clinic systolic blood pressure≥160 mmhg and/or diastolic blood pressure≥100 mmhg (patients with type 2 diabetes: clinic systolic blood pressure≥150 mmhg and/or diastolic blood pressure≥95 mmhg) . 5. . 24 hours ambulatory blood pressure (sbp/dbp)≥140 and/or 90 mmhg; 6. . estimated gfr (egfr)≥45 ml/min / 1.73 m2. exclusion criteria: 1. . renal artery abnormalities include: either side renal arterial blood flow mechanics or anatomical obvious stenosis (≥50% ); underwent renal artery balloon angioplasty or inserting a stent; renal artery anatomy apparently is unusual to insert catheter; 2. . cardiovascular instability includes: myocardial infarction in six months, unstable angina or cerebrovascular disease; thrombus or unstable plaques in the arteries with extensive atherosclerosis; hemodynamic apparently change in patients with heart valve disease; 3. . the patients with typeⅰdiabetes; 4. . other serious organic disease; 5. . participated in other clinical research.

Keywords: renal sympathetic denervation;hypertension
placenta accreta spectrum management: uterine preservation using jsica technique - retrospective cross-sectional study

Conditions: Placenta Accreta

Summary: the goal of this study is to present the jakarta surgical uterine conservation (jsica) technique and its perioperative outcomes in placenta accreta spectrum patients. participants are all patients undergoing standard hysterectomy or the jakarta surgical uterine conservation (jsica) technique. researchers will compare both groups to see if there are any differences in the perioperative outcomes.

this study uses data from cipto mangunkusumo general hospital's placenta accreta case register. this register includes all patients with a confirmed placenta accreta spectrum diagnosis. data collected includes demographic characteristics, risk factors, surgery characteristics, and perioperative outcomes. in this study, researchers would like to evaluate the perioperative outcomes of the jsica technique in comparison to a standard hysterectomy.

Eligibility criteria:
inclusion criteria for jsica: 1. focal accreta invasion ( \< 50% anterior wall) 2. anterior invasion 3. no parametrial or bladder invasion 4. residual tissue or healthy myometrium min 3 cm above the oui or cervix 5. good uterine contraction post-repair (with or without compression sutures) 6. hemodynamically stable exclusion criteria: -

Keywords: jsica technique placenta accreta uterine preservation
three different transdermal doses of rotigotine in subjects with idiopathic restless leg syndrome

Conditions: Restless Legs Syndrome

Summary: the primary objective of this trial is to demonstrate that rotigotine (spm 936) is efficacious in subjects with idiopathic restless leg syndrome (rls). additional objectives are to investigate the safety and tolerability of rotigotine. the primary variables are the absolute change from baseline in the international restless legs severity scale (irls) sum score and clinical global impression-global improvement (cgi) item 1 (severity of illness) score at the end of the maintenance period. subjects will be randomized to receive either placebo, 2.25, 4.5 or 6.75 mg/day rotigotine in a 1:1:1:1 (active:placebo) fashion. approximately 450 subjects will be enrolled in this trial, participating at approximately 50 sites. the maximum duration of the trial is approximately 8 months (3-week titration period, 6-month maintenance period, 7-day taper period, and 30-day safety follow-up period). subjects who complete the 6-month maintenance period will be eligible to participate in an open-label extension trial. subjects who do not complete the 6-month maintenance period or who choose not to participate in the open-label extension trial will complete a 3-day safety follow-up period. two different patch sizes will be used (5 and 10 cm2). active patches will contain either 2.25mg (5cm2) or 4.5mg (10cm2) of rotigotine.


Eligibility criteria:
inclusion criteria: * idiopathic rls exclusion criteria: * history of sleep disturbances

Keywords: idiopathic rls
comperasion the postoperative effect of low laser therapy and platelet rich fibrin on mandibular third molar surgery.

Conditions: Impacted Third Molar Tooth

Summary: the aim of this study was investigate the comparison of postoperative effects of low laser treatment and platelet-rich fibrin application on mandibular impacted third molar tooth extraction. the study included a total of 60 patients with impacted mandibular third molar. patients were evaluated in 4 randomly separated groups. in group 1, prf was applied to the tooth socket. in group 2, prf was applied to the tooth socket combined with low laser treatment extraorally to the extraction area for three days within surgery day in group 3, low laser treatment was applied to the extraorally to the extraction area for three days within surgery day. in group 4 (control group), tradional osteomy was made. the outcome variables were pain, swelling, the number of analgesics taken, and trismus. these variables were also assessed based on first, second, third, and seventh days following the operation. all of the 4 groups patients were prescribed an 875/125 mg amoxicillin/clavulanic acid tablet twice daily for five days.


Eligibility criteria:
inclusion criteria: * the patient had no systemic diseases, no taken opioids for a long period, no current infections or acute pericoronitis, no smoke or drink alcohol, no pregnancy, the absence of allergy to penicillin and presence of penicillin allergy. exclusion criteria: * pericoronitis, no inflammation

Keywords: platelet rich fibrin comparison low laser therapy wisdom tooth
sleep-disordered breathing and perioperative atrial fibrillation in cardiac surgery

Conditions: Elective Coronary Artery Bypass Grafting (CABG) Surgery; Coronary Artery Disease; Sleep-disordered Breathing (SDB); Atrial Fibrillation

Summary: in patients undergoing elective coronary artery bypass grafting (cabg) surgery, coronary artery disease, sleep-disordered breathing (sdb), atrial fibrillation (af) perioperative atrial fibrillation and complications will be assessed. the primary objective is to determine, whether sdb patients have a higher rate of major adverse cardiac and cerebrovascular events (macce) within 30 days after surgery compared to those without sdb.


Eligibility criteria:
inclusion criteria: * patients undergoing elective cabg surgery at the department of cardiac and thoracic surgery, university hospital regensburg. * written informed consent exclusion criteria: * preoperative use of inotropes or intra aortic balloon pump * severe obstructive pulmonary disease * patients on oxygen therapy, nocturnal positive airway pressure support or mechanical ventilation
effect of oxytocin antagonists on implantation success rates of frozen-thawed embryo transfer

Conditions: Infertility, Female

Summary: uterine contraction has a negative impact on implantation and pregnancy rates. inhibition of oxytocin receptors decreases uterine contraction frequency both on pregnant and non-pregnant women. atosiban has been studied as an oxytocin antagonist to decrease uterine contraction frequency in order to increase implantation and pregnancy rates in assisted reproduction. previous studies have studied 37,5mg total dose which was used both before and during embryo transfer, and found atosiban to be effective in increasing implantation and pregnancy rates. we aim to use a single dose of 6,75mg atosiban before embryo transfer, in order to decrease the dose and cost and possibly introduce a simpler protocol. our study will also be the first randomized clinical study which investigates the effect of atosiban on frozen-thawed embryo transfer cycles.

inhibition of uterine contractions in order to increase implantation rates have been studied on several agents in the last two decades. beta-adrenergic agonists and non-steroidal anti-inflammatory drugs have been shown to have no benefit on implantation rates. vasopressin v1a and oxytocin receptor antagonist atosiban was first studied on premature labor patients and found to be effective. endometrium-originated oxytocin can possibly stimulate myometrium and have a negative impact on embryo implantation. inhibition of oxytocin receptors has been shown to reduce uterine contraction frequency in non-pregnant women. atosiban has been studied on assisted reproductive technologies in the last decade and has been shown to be effective on increasing implantation and clinical pregnancy rates. however, previous studies have used a 37,5 mg total dose of atosiban which was used both before and during embryo transfer. we aim to use a single and low dose of 6,75mg atosiban only before embryo transfer, which is simpler and cheaper and the medication given to patient is significantly lower. if we can demostrate the positive effect of our protocol, it can be suggested to be used routinely in all in vitro fertilization cycles. additionally, our study is an original study in terms of being the first randomized clinical trial studying the effect of atosiban on frozen-thawed embryo transfer cycles.

Eligibility criteria:
inclusion criteria: * infertile women applied to assisted reproduction clinic * follicle stimulating hormone \< 12 * body mass index \< 25 * patients whom antagonist protocol will be used * patients whom at least 2 good-quality embryos obtained * patients who are volunteer exclusion criteria: * severe male factor (sperm concentration \<5 m/ml, progressive sperm motility \<%10) * uterine anomaly * hydrosalphynx * difficult embryo transfer * patients who previously had a diagnosis of endometriosis and / or adenomyosis * endocrine problems (hypothyroidism, hyperthyroidism, hyperprolactinemia, premature ovarian insufficiency) * having more than 3 in vitro fertilization failure * refusing to participate

Keywords: in vitro fertilization atosiban embryo transfer oxytocin antagonist
effect of therapeutic light on sleep, circadian rhythm, and global function in women with alzheimer's

Conditions: Alzheimer's Disease

Summary: determine effect and duration of effect of timed therapeutic light compared to control light on parameters of circadian rhythmicity, physiologic plasticity, sleep, and global function in women with alzheimer's disease.

the impact of disturbed sleep on cognition and functional domains is vitally important to study in order to increase our understanding of alzheimer's disease (ad) phenomenology. research has shown that the severity of sleep disturbance and dementia advance in parallel and possibly in a manner amenable to therapeutic intervention. in ad, sleep disruption is characterized by changes in sleep architecture. it is our contention that neuropathology specific to ad alters the circadian system at the suprachiasmatic nucleus (scn). environmental light is the most powerful regulator of this circadian system,4,5 and is known to have a significant regulatory effect on pineal melatonin synthesis and secretion via the scn and multisynaptic pathways downstream from the scn. this study will explore further the efficacy of a particular type of therapeutic light intervention in regulating the circadian system in ad, using data analytic methods capable of detecting changes at multiple time scales. our central hypothesis is that properly-timed light exposure in individuals with ad will synchronize disorganized circadian and sleep-wake rhythms and improve functional plasticity \[approximate entropy (apen), fractal dimension (fd)\], thereby resulting in increased sleep efficiency (se), reductions in sleep fragmentation (sf), reduced excessive daytime sleepiness (eds) and dementia-related behaviors, and improvements in cognition and other daytime behaviors. women are nearly twice as likely as men to develop ad due to longer life expectance and emerging evidence. in light of this increased risk and also to enhance other aspects of biological uniformity in our study, this project will investigate women with ad.

Eligibility criteria:
inclusion criteria: 1. baseline sleep efficiency index \< .85 2. mini-mental state exam-2 standard version (mmse-2:sv) score of 0-20 3. be medically stable exclusion criteria: 1. received light treatment in last 3 months 2. are totally blind in both eyes, have photosensitivity or photophobia, parkinsons disease, known untreated sleep apnea or other sleep disorders, seizure disorder, bipolar, schizophrenia, are actively receiving chemotherapy or radiation therapy for cancer.
post-treatment novmalized urodynamiz findings as the golden standard of objective cure for female overactive bladder patients receiving antimuscarinic drug

Conditions: Overactive Bladder Syndrome

Summary: post-treatment novmalized urodynamiz findings as the golden standard of objective cure for female overactive bladder patients receiving antimuscarinic drug and its conelations with voiding diary, king's health quentionaire, overactive bladder sympton scores and patient perception of bladder condition.


Eligibility criteria:
inclusion criteria: * female patients within 18 years old to 99 years old with overactive bladder syndrome exclusion criteria: * unwilling or unable to perform testing procedure

Keywords: overactive bladder syndrome derusor overactivity urodynamic studies bladder oversensitivity
effects of abdominal binders and tens on puerperium period after cesarean section

Conditions: Cesarean Section; Complications, Wound, Dehiscence

Summary: to determine the combined effects of abdominal binders and tens on post-operative pain, distress and constipation in puerperium period after cesarean section


Eligibility criteria:
inclusion criteria: * participants on early puerperium period having constipation and willing to participate. * primigravida * body mass index (bmi) less than 30 kg/m2 exclusion criteria: * laxatives-induced patients * history of chronic constipation * post cesarean abdominal suture infection. * people with chronic diseases, and who underwent non-routine or additional surgical procedures, such as hysterectomy, tubal ligation, and classical uterine incision. * participants with inability to tolerate the binder. * participants who show unwillingness to participate in the study

Keywords: cesarean section constipation post-operative pain puerperium tens