Kornimate/medical-research-clean huggingface dataset:
maintenance treatment with liposomal doxorubicin (caelyx) in metastatic breast cancer patients

Conditions: Breast Neoplasms

Summary: this is a randomized, prospective and multicenter phase iv clinical trial, which has been designed as a phase iii study. one hundred fifty-four women (77 per treatment arm) will be recruited in the study.

the main variable is time to disease progression. all patients must be treated with first line of induction chemotherapy, consisting of doxorubicin 75 mg/m2, day 1 every 3 weeks, and docetaxel, 100 mg/m2, day 1 every 3 weeks. both drugs must be administered sequentially. patients previously treated with anthracyclines must receive 2 courses of doxorubicin and 4 courses of docetaxel. otherwise, patients will receive 3 courses of doxorubicin followed by 3 courses of docetaxel. patients with complete response, partial response or stable disease are eligible for 2001-01 study. the investigators assume that maintenance treatment with caelyx will increase mean time to progression from 10, 46 months (observation) to 17, 43 months. expected difference in mean time to progression is 6, 97 months (hazard ratio = 0.6). with an alpha error of 0.01 (unilateral) and power of 80%, 77 patients per arm are needed, 154 patients in total.

Eligibility criteria:
inclusion criteria: * written informed consent. * patients with metastatic breast cancer who have responded to a first line induction chemotherapy treatment. * age: at least 18 years old. * performance status eastern cooperative oncology group (ecog) scale 0, 1, 2. * normal cardiac function, confirmed by left ventricular ejection fraction (lvef). * hematology: leucocytes \>= 4 x 10\^9/l; neutrophils \>= 2.0 x 10\^9/l; platelets \>= 100 x 10\^9/l; hemoglobin \<= 10 g/dl. * hepatic function: total bilirubin \ 1.5 unl and alkaline phosphatase \> 2.5 unl are not eligible. * renal function: creatinine \ 45 ml/min. exclusion criteria: * pregnant or lactating patients. * previous cardiac dysfunction grade ii or higher as per new york heart association, along with congestive cardiac failure. * hypersensitivity to anthracyclines or cremophor®. * clinically significant hepatic dysfunction. * current uncontrolled infection. * mental confusion and lack of orientation. * any circumstance precluding an adequate follow-up. * radiotherapy in the previous 4 weeks. * any other concurrent neoplasm, except for basal cell carcinoma or in situ carcinoma. * symptomatic metastasis in the brain. * previous radiotherapy radiating a third of haematopoietic centres. * males.

Keywords: breast cancer metastases maintenance treatment
a non-interventional study in rheumatoid arthritis patients treated with tocilizumab (roactemra/actemra)

Conditions: Rheumatoid Arthritis

Summary: this multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. patients initiated on treatment with tocilizumab according to the licensed canadian product monograph recommendations will be followed for 12 months from the start of treatment.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe rheumatoid arthritis according to revised (1987) american college of rheumatology (acr) criteria * initiated on tocilizumab treatment by the treating physician in accordance with the canadian product monograph * informed consent to data being subject to computerized data processing * participant must fulfill the reimbursement criteria for treatment with tocilizumab under provincial or private health insurance coverage exclusion criteria: * received tocilizumab prior to enrolment visit * previously received tocilizumab in a clinical trial or for compassionate use * enrolled in an ongoing clinical trial and/or received treatment with any investigational agent within 4 weeks, or 5 half-lives of the investigational agent, whichever is longer, before starting treatment with tocilizumab * participation in another clinical trial or industry sponsored observational study * history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary sjörgen's syndrome
targeted-sequencing of ptc in different stages

Conditions: Exploratory Study

Summary: the prevalence of papillary thyroid micro-carcinoma (ptmc) increased rapidly in recent years but the design of treatment is controversial because a majority of them are indolent. therefore, to recognize which ptmc is of strong progressive potential which should be operated is very crucial. fine needle aspiration (fna) pre-surgery could obtain tumor cells which could be used in genetic analysis. to date, there is no specific way to evaluate the aggressive potential of a ptmc pre-surgery. so, the purpose of this proposal is to screen genetic mutations of the aggressive type of ptmc. the candidate did a whole exome sequencing on 3-3 pairs of ptcs and found some snps and indels in tp53、ttn、pdf. to further investigate those mutations, a target region sequencing will be done in 40 pairs tumor samples. and ultimately to find out which genetic event could contribute to strong aggressive potential of ptc. the mutations details would be design to test the fna and tissue sample to validate if the genetic testing based on fna is reliable. the gene test results would be evaluated with sonographic features to predict the potential of small thyroid carcinoma before surgery. this project won't aim to study the function and mechanism of specific genes but just screen them out. so, the fund would cover the fee of the whole study and this study is very likely to achieve the goal.


Eligibility criteria:
inclusion criteria: * patients who will receive thyroid resection exclusion criteria: * patients who has been radiologically treated

Keywords: thyroid
comparative evaluation of gabapentine and occlusal splint in the management of sleep bruxism

Conditions: Sleep Bruxism

Summary: sleep bruxism (sb) is defined as a "stereotyped movement disorder characterized by grinding or clenching of the teeth during sleep" usually associated with sleep arousal. it might lead to abrasive tooth wear, hypermobility of teeth, tooth hypersensitivity, hypertrophy of the masticatory muscles and pain in the masticatory muscles. diagnostic procedures include clinical evaluation, ambulatory monitoring sleep laboratory investigations and others. the clinical approach comprises the patient's history, orofacial examination, and tooth wear classification. there is no specific treatment for bruxism. management of sb comprises psychological, orodental and pharmacological strategies.orodental therapies, including soft vinyl mouth guards or stabilization bite splints, probably function more like protectors of the orofacial structures rather than actually diminishing bruxism.drug treatment of sleep bruxism is controversial since different treatment strategies have resulted in suppression or exacerbation of this condition. based on the current data, central primary efferents are the major drivers of bruxism. therefore centrally acting agents such as antiepileptic drugs which also affect the sleep structure, might be effective on sb. in a case report of bruxism, anxiety and tremor, the authors suggested that anti-convulsant gabapentine may be a useful treatment for patients with antidepressant-induced bruxism. however in the absence of definitive evidence, the appropiate treatment of sb is still a matter of debate. the objective of the present study was to compare the treatment efficacy of occlusal stabilization splint and gabapentine on sb, using polysomnographically determined outcome measures for the quantification of sleep bruxism.


Eligibility criteria:
inclusion criteria: * clinical and polysomnographic criteria of sleep bruxism according to the international classification of sleep disorders exclusion criteria: * loss of more than two teeth and having removable prosthesis * presence of a major malocclusion * using any medication with a known influence on sleep structure or sleep bruxism * being diagnosed with psychological or neurotic disorders.

Keywords: sleep bruxism gabapentine occlusal splint polysomnography
the financial and emotional impact of cleft palate

Conditions: Cleft Lip and Cleft Palate

Summary: cleft lip and/or palate (cl±p) is the most prevalent congenital craniofacial defect with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. these consequences have a long-term and negative impact on social integration and well-being. who highlights the significant financial costs, including morbidity, healthcare costs, emotional distress and social exclusion to patients, their families and society. the purpose of this study is to investigate the financial and emotional impact of cl±p based on the perceptions of children with cl±p and their parents/guardians followed by the interdisciplinary craniofacial teams of the university hospitals of leuven or ghent. participation in this study consists of completing questionnaires related to financial, social and well-being aspects using the cleft-q, parental stress scale and a financial impact questionnaire. the parents/guardians of the children aged 5 years always complete all questionnaires. the parents/guardians of the 12- and 18-year-old children complete the parental stress scale and a financial impact questionnaire. the children aged 18 complete the cleft-q themselves. questionnaires can be delivered online or on paper. the outcomes on the health-related qol of children with cleft and the pss are compared with the outcomes of 'healthy' children and their parents/guardians to ensure that the emotional impact is attributable to the cleft. in addition, children and their parents/guardians can participate in a semi-structured interview. during the interview appointment, the questionnaires can be completed on paper. potential participants will be told that the interview will be recorded and that all findings will be kept confidential. the actual interviews will take place at a location and time that is most convenient for the participants. participants do not need to come to uz gent or uz leuven for this. each interview will be recorded with a roland r-05 high quality audio recorder. after conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographic data. in addition, data regarding the type of cleft, diagnoses, observation sheets and consultation letters will be collected from the medical records of the children with cl±p. we also aim to investigate whether variations in these effects are observable based on the specific type of cleft. all participants will go through the same protocol regardless of recruitment through uz gent or uz leuven.


Eligibility criteria:
inclusion criteria: * presence of a cleft (lip and) palate * age of 5, 12 or 18 years exclusion criteria: - no specific exclusion criteria

Keywords: cleft lip and palate emotional burden financial burden questionnaires perceptions interviews
study of trimethoprim/sulfamethoxazole as pcp prophylaxis in ctd patients

Conditions: Pneumonia, Pneumocystis; Prevention & Control

Summary: evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as pneumocystis carinii pneumonia (pcp) prophylaxis in patients with connective tissue diseases (ctd) treated with high-dose glucocorticoids and immunosuppressive agents. open-labeled, randomized, prospective single-center clinical trial. observation period of 12 weeks.


Eligibility criteria:
inclusion criteria: * age 18-65 years with informed consent * sle, sjögren syndrome, polymyositis or dermatomyositis, defined by consensus classification criteria * concomitant high dose glucocorticoid, defined as \>1mg/kg/d prednisone or equivalent * concomitant cyclophosphamide, cyclosporine or mycophenolate mofetil exclusion criteria: * pregnant or lactating * wbc\< 4×10\^9/l，plt\<100×10\^9/l * serum alt or ast \> 2 times upper limit of normal * serum creatinine \> 1.5 mg/dl * severe hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease * active infection, including hiv, hcv, hbv, tuberculosis or pcp * concomitant antibiotics other than trimethoprim/sulfamethoxazole * patient with malignancy * drug allergy, especially trimethoprim/sulfamethoxazole

Keywords: pneumocystis carinii pneumonia prophylaxis trimethoprim/sulfamethoxazole
composur: study to understand the performance of vibegron in participants with overactive bladder (oab)

Conditions: Overactive Bladder

Summary: this study will evaluate the treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with vibegron for the treatment of oab in the context of real-world clinical practice.


Eligibility criteria:
inclusion criteria: * diagnosis of overactive bladder (oab) with or without urgency urinary incontinence * symptoms of oab for at least 3 months prior to the baseline visit * willing and able to complete electronic patient-reported outcomes questionnaires monthly for a minimum of 1 year * previous exposure to anticholinergics or mirabegron monotherapy and/or mirabegron plus solifenacin combination therapy prior to initiation of vibegron exclusion criteria: * any contraindication to the use of vibegron per the united states label * history of oab treatment with botulinum toxin a; sacral neuromodulation; percutaneous tibial nerve stimulation; external beam radiation therapy; urinary stents within the last 6 months; pelvic or lower urinary tract surgery within the last 6 months; and urethral catheterizations within the last 3 months prior to the baseline visit * history of mixed incontinence where stress incontinence is the predominant form (as determined by the investigator) * participants at risk of urinary retention (as determined by the investigator) * neurologic conditions associated with oab symptoms, e.g., multiple sclerosis * pregnant or breastfeeding or plans to do so during the study * use of vibegron prior to the baseline visit either prescribed or in a previous vibegron clinical trial where the participant was on vibegron * anyone who, at the discretion of the investigator, is not suitable for treatment with a beta 3 agonist for oab for any reason

Keywords: vibegron urinary bladder, overactive beta-3 adrenergic receptor (β3-ar) agonists urge urinary incontinence oab
stapler reinforcement patches compared to standard staplers in gastrojejunostomy

Conditions: Gastric Cancer; Gastrostomy; Anastomotic Leakage; Postoperative Complications

Summary: this is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.

this study compares stapler reinforcement patches with standard staplers in gastrojejunostomy to reduce postoperative complications. it aims to demonstrate the effectiveness and safety of these patches in preventing anastomotic leakage and other related complications.

Eligibility criteria:
inclusion criteria: * age between 18 and 85 years. * pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or subtotal gastrectomy. * ecog performance status of 0 or 1. * asa (american society of anesthesiologists) classification of i-iii. * voluntary signed informed consent from the participant or their legal representative. exclusion criteria: * evidence of potential distant metastasis found preoperatively. * history of other malignancies diagnosed within the past 5 years, or any malignancy treated with chemotherapy or radiotherapy. * significant contraindications for surgery (e.g., severe liver or kidney dysfunction). * participation in any other clinical trial within the last 6 months. * participants or their legal representatives unwilling to sign the informed consent or comply with the study protocol.

Keywords: stapler reinforcement patch gastrojejunostomy randomized controlled trial surgical outcomes complication prevention
clinical performance of two reusable silicone hydrogel contact lenses

Conditions: Refractive Errors

Summary: the purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

in this crossover study, subjects will wear each study lens type for approximately 14 days and attend 7 scheduled visits. the expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).

Eligibility criteria:
key inclusion criteria: * successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months. * best corrected visual acuity of 20/25 snellen (0.10 logmar) or better in each eye. * willing to stop wearing habitual contact lenses for the duration of study participation. * other protocol-specified inclusion criteria may apply. key exclusion criteria: * any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator. * any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator. * habitual wear of aohp contact lenses. * habitual wear of any daily disposable contact lenses. * other protocol-specified exclusion criteria may apply.

Keywords: myopia
assessment of skills and behaviors in children with down syndrome

Conditions: Down Syndrome

Summary: parents of children with down syndrome can help in describing children's abilities and behavior. most of the studies evaluating parents of children with down syndrome and other intellectual disabilities have focused on parental stress and coping; additionally, most research has evaluated the perspectives of mothers rather than fathers. for this reason, in this study we aims to evaluate skills and behaviors in children with down syndrome through the perception of parents.


Eligibility criteria:
inclusion criteria: * down syndrome childrens * age between 0 and 3 years exclusion criteria: * other physical or functional impairment that limits the performance of evaluation
effectiveness of ergonomics training and exercise in esports players

Conditions: Musculoskeletal Diseases; Musculoskeletal Pain

Summary: the aim of this study is to investigate the effectiveness of ergonomics training and exercise in e-sports players.

after detailed information about the study is given to the individuals to be included in the study, individuals who voluntarily agree to participate in the study will sign an informed consent form. participants will be divided into 2 groups consisting of equal numbers of individuals. the groups were called control group and exercise group. all participants will be given ergonomics training. in addition to the exercise group, exercise training will be given for 8 weeks, 3 days a week and 45 minutes a day. sociodemographic information form, arm, shoulder and hand problems questionnaire (dash), neck disability questionnaire (ndi), rapid upper extremity assessment (rula) and pittsburgh sleep quality index (psqi) will be used as evaluation scales. evaluations will be made at the beginning and end of the study. will be done once.

Eligibility criteria:
inclusion criteria: * those who signed the voluntary consent form * having actively participated in e-sports organizations and tournaments within 16 months * not having a chronic disease that will affect the musculoskeletal system * not having any health problems that prevent him from exercising and not having had a surgical operation in the last 6 months. exclusion criteria: * players under 18 years of age * have a chronic disease that affects the musculoskeletal system * having had a surgical operation in the last 6 months that would prevent him from being interested in e-sports games
clinical study of the mirabilis high-intensity focused ultrasound system for non-invasive treatment of uterine fibroids

Conditions: Uterine Fibroids (Leiomyomas)

Summary: the mirabilis high-intensity focused ultrasound (hifu) treatment system delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine fibroids. the purpose of this clinical study is to assess the initial safety and performance of the mirabilis hifu treatment system for transabdominal treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy following treatment with the device or who are seeking relief from fibroid-related symptoms.


Eligibility criteria:
inclusion criteria: * female * age 18-55 years * patients seeking relief from uterine fibroid related symptoms, including those scheduled to undergo abdominal hysterectomy due to benign pathology * patients able and willing to provide informed consent exclusion criteria: * visible scar within the hifu beam path that cannot be avoided * known or suspected abdominal adhesions between the anterior uterine serosa and the abdominal wall * currently pregnant or desire to become pregnant in the future * pelvic malignancy * pelvic congenital malformation * acute pelvic infection * otherwise determined by a physician to be inappropriate for the study

Keywords: uterine fibroids leiomyomas high-intensity focused ultrasound ablation ultrasonography
the use of a fully automated pulsating support system (curocell® a4 cx20) in pressure ulcer prevention and treatment

Conditions: Pressure Ulcer; Pressure Injury; Pressure Sore; Pressure Ulcer, Buttock

Summary: pressure ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. they represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 20 community patients. international guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. it has been acknowledged that a significant proportion of pressure ulcers are avoidable. the prevalence of pressure ulcers is 1 of the 4 common harms recorded in the uk nhs safety thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.


Eligibility criteria:
inclusion criteria: * at risk of pressure ulcer development based on a braden score ≤ 17 or pressure ulcer category iii or iv * bedbound or chair bound * aged ≥ 65 exclusion criteria: * short-stay residents (expected length of stay ≤14 days) * end of life care * medical contraindication for patient repositioning/turning

Keywords: support surface elderly nursing home prevention treatment