Kornimate/medical-research-clean huggingface dataset:
a study of trastuzumab and pyrotinib in her2 positive locally advanced or metastatic urothelial carcinoma

Conditions: Carcinoma, Transitional Cell; HER-2 Gene Amplification

Summary: a open-label, single-arm, phase ii trial to study was designed to evaluate the effectiveness and safety of trastuzumab and pyrotinib in treating her2 positive patients who have previously treated, locally advanced, or metastatic urothelial carcinoma.


Eligibility criteria:
inclusion criteria: * sign the informed consent form * locally advanced or metastatic histologically confirmed transitional cell carcinoma of the urothelium, including the bladder, urethra, ureter, or renal pelvis * 18 years and older * her2 expression (3+ or 2+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization * relapsed from or failed at least one prior standard systemic chemotherapy regimen, including immunotherapy, her2 adc durgs, and chemothearpy containing cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine * at least 1 measurable lesion could be evaluated by recist v1.1 * performance status: ecog 0-1 * life expectancy more than 12 weeks * ejection fraction at least 50% (or lower limit of normal) by echocardiogram * good organ function: blood routine: hemoglobin ≥80g/l, neutrophil ≥1.5×10\^9/l, platelet ≥75×10\^9/l; renal function: creatinine≤1.5×upper limit of normal (unl) or creatinine clearance ≥50ml/min; liver function: total bilirubin (tbil)≤1.5×upper limit of normal (unl); alt≤2.5×unl, ast≤2.5×unl, alt≤5×unl and ast≤5×unl for patients with liver metastasis exclusion criteria: * have received trastuzumab or pyrotinib treatment in the past * known to have allergic reactions to any ingredients or excipients of experimental drugs * radiotherapy, rfa, interventional therapy or surgery were performed within 28 days before the first medication (except for previous diagnostic biopsy) * other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment * clinically significant ascites * brain metastasis or meningeal metastasis with neurological symptoms * diabetes was not controlled, defined as hba1c \> 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure \> 140 / 90 mmhg after antihypertensive drug * myocardial infarction, severe/unstable angina, new york heart association (nyha) class iii or iv congestive heart failure in the past 12 months * known to be infected with human immunodeficiency virus (hiv), have acquired immunodeficiency syndrome (aids) related diseases, have active hepatitis b or hepatitis c * pregnant or nursing * may increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results * there are other serious diseases that the researchers believe patients cannot be included in the study
metal-ceramic fixed partial dentures fabricated with laser sintering

Conditions: Survival, Prosthesis; Clinical Acceptability, Prosthesis

Summary: the aim of this retrospective clinical study was to evaluate the clinical acceptability of metal-ceramic fixed partial dentures (fpd) manufactured utilizing direct metal laser-sintering technology, taking into account the short-term, medium-term, and long-term outcomes. the federation dentaire international (fdi) world dental federation criteria were used to evaluate the esthetic, functional, and biological clinical acceptability of the patients who met the inclusion criteria

objectives: to evaluate the clinical success of laser sintered metal-ceramic restorations throughout several time periods, including the short, medium, and long term. materials and methods: participants who had 3-unit metal-ceramic fixed partial dentures fabricated by laser sintering in the mandibular posterior region between 2014 and 2021 were evaluated. the fdi criteria were used to evaluate the esthetic, functional, and biological clinical acceptability of the patients who met the inclusion criteria. the surface luster was assessed and given a score in the field of esthetic properties. the functional parameters were assessed and rated based on fracture, marginal adaptation, radiographic examination, contact point/food impaction, and patient satisfaction. the biological parameters assessed and rated included tooth vitality, periodontal response, mucosa, and oral health. following the examinations, each parameter was assigned a score ranging from 1 to 5. (1=clinically excellent/very good, 2=clinically good, 3=clinically satisfactory, 4=clinically unsatisfactory, 5=clinically poor) scoring between 1 and 3 was deemed clinically acceptable, whereas scoring 4 or 5 was deemed clinically unacceptable. descriptive statistical analysis was performed for all data.

Eligibility criteria:
inclusion criteria: * patients who treated between 2014 and 2021 by prosthodontists at cukurova university faculty of dentistry, department of prosthodontics. * patients who treated three-unit metal-ceramic fixed partial dentures due to mandibular posterior single tooth deficiency exclusion criteria: * patients with any non-vital abutment teeth * patients who have severe generalize periodontitis

Keywords: metal-ceramic restorations laser sintering
pharmacokinetic study of indinavir drug levels when boosted with ritonavir in thailand

Conditions: HIV Infection

Summary: this study looks at the ways indinavir drug levels, when boosted with ritonavir, may vary from patient to patient. the study population are hiv+ thai individuals.

this study will assess the inter-individual variability of indinavir drug levels, boosted with ritonavir, in thai patients. data will be collected in patients participating in the randomized study, "monitoring highly active antiretroviral therapy (haart) in hiv-infected patients in thailand (phpt-3)" (hsc 10668). the first 20 patents in phpt-3 will have steady-state pharmacokinetic sparse sampling performed at pre-dose, and 1, 2.5, 4 and 12 hours after drug intake 1 and 2 months after initiating idv/r 400/100 mg, twice daily. idv/r plasma concentrations will be determined by high performance liquid chromatography. this spare pk data will be pooled with indinavir concentration data collected within an intensive pharmacokinetic studies of idv/r \[cressey tr, et al 2005, jac, 55, p1041-44\]. population means and variances of indinavir and ritonavir pharmacokinetic parameters were estimated using non-linear mixed effects regression models (nonmem version vi). the validity of the final model was evaluated using a visual predictive check (vpc) and bootstrap re-sampling techniques.

Eligibility criteria:
inclusion criteria: * subjects enrolled in the parent study, "monitoring haart therapy in hiv-infected patients in thailand (phpt-3)" and agreeing to additional blood sampling and tests. exclusion criteria: * current active substance or alcohol abuse * active opportunistic infection * chronic malabsorption or diarrhea * other clinically significant disease * certain lab values (e.g. hemoglobin \< 8.0 mg/dl)

Keywords: indinavir, hiv, ritonavir, pharmacokinetics, thailand
home pelvic floor improvement trainer trial

Conditions: Pelvic Pain; Pelvic Floor Dysfunction; Voiding Dysfunction

Summary: this study will gauge the efficacy of a home biofeedback treatment device for pelvic floor dysfunction/voiding dysfunction and pelvic pain. investigators will test the utility of this device as a treatment alternative and/or temporary treatment for a patient's symptoms prior to or perhaps in lieu of their physical therapy appointment.

this study aims to determine if a special device can help children with pelvic floor problems. the pelvic floor issues under investigation include difficulty controlling urination and ongoing pain in the lower belly. the study will explore whether the device helps children gain better control over urination. it will also investigate if the device contributes to the reduction of pelvic pain experienced by children. furthermore, the study will analyze if the device leads to improvement in how the body functions during urination. the consistency with which children use the device and adhere to instructions will be monitored. finally, the study includes an assessment of whether children find the device acceptable for use.

Eligibility criteria:
inclusion criteria: * dysfunctional voiding symptoms without chronic pelvic pain. * chronic pelvic pain with or without dysfunctional voiding symptoms. * daytime enuresis, nocturnal enuresis, frequency, urgency, dysuria * 8 years - 18 years, no one under 8 and no one over 18. exclusion criteria: - has seen a physical therapist for traditional physical therapy of the pelvic floor due to urinary symptoms or chronic pelvic pain within the last 12 months. note: this would include patients who begin physical therapy for their pelvic floor outside of the study while enrolled in the study. -all patients with the following conditions: severe developmental delay such as cp or wheelchair bound, cannot eat by mouth, mechanical ventilation dependence, etc. * nonverbal or unable to effectively communicate needs and preferences. * within the voiding dysfunction group, a diagnosis of a congenital gu anomaly (bladder exstrophy, cloacal anomaly, spina bifida, etc.) * no initial medication usage will be excluded; however, if the patient begins a new medication or treatment regimen during the study, the patient will be excluded.

Keywords: voiding dysfunction pelvic floor dysfunction pelvic pain perineometer gamification
ketamine trial for the treatment of depression

Conditions: Unipolar Depression

Summary: this study is a randomized controlled trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.


Eligibility criteria:
individuals will be eligible for enrolment on the basis of: * major depressive disorder for at least three months duration * an inadequate response to at least 2 adequate antidepressants * madrs ≥ 20 patients will be excluded on the basis of: * history of psychosis * history of bipolar disorder * any unstable medical or neurologic condition * any axis i disorder other than mdd judged to be primary presenting problem * planned major changes to psychotropic medication * significant risk of suicide * planned or probable use of ect * age under 16 years, or 16-17 years without parental consent * substance abuse or dependence in previous 6 months * any history of abuse of ketamine or phencyclidine * contraindication to the use of ketamine * planned use of ketamine * women of childbearing potential not taking reliable contraception * likely non-compliance with trial treatment * other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial
identification of the sensory level block to cold during epidural analgesia for labor: a cohort study to determine the influence of the direction of testing

Conditions: Labor Pain

Summary: assessment of the upper sensory block level during neuraxial analgesia for labor and delivery is an essential component of clinical management and patient safety. a variety of methods have been used for testing the sensory block such as cold, light touch, sharp touch or prick and transcutaneous electrical stimulation. in addition to the diversity of methods, the endpoints used by investigators have also been variable, considering total or partial responses as endpoints. not surprisingly, a variable sensory block level could be identified as a result of the different methods and types of question asked by the examiner. another complicating factor is the lack of standardization of the direction of the testing as it relates to anesthetized and non-anesthetized areas. this lack of standardization may result in a difference of several dermatomes in the level that two different assessors might record for the same patient. considering a clinical research scenario, it may be difficult to replicate results and implement clinical practices. the objective of this study is to determine the degree of agreement between two methods of assessing the sensory block level to cold in women receiving epidural analgesia for labor (anesthetized to non-anesthetized segments versus non-anesthetized to anesthetized segments).


Eligibility criteria:
inclusion criteria: * patients who request and have no contraindications to receive epidural analgesia * capable of understanding and signing the written informed consent * have no language barrier to respond to the level of sensory block assessment * have no conditions that could compromise their sensitivity to cold. exclusion criteria: * patients who refuse to sign consent * epidural analgesia is contraindicated

Keywords: epidural sensory block level dermatome
analgesic effect of erector spinae plane block for renal colic pain

Conditions: Renal Colic

Summary: plane blocks have become very popular in recent years with the introduction of ultrasonography into the regional anesthesia and algology practice. erector spinae plane (esp) block involves the injection of local anesthetics between erector spinae muscles and transverse process of vertebrae and can block the dorsal and ventral rami of thoracolumbar spinal nerves. the aim of this study was to evaluate the analgesic efficacy of the erector spine plane block for reno-ureteral colic.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic state i-ii patients exclusion criteria: * chronic pain * bleeding disorders * renal or hepatic insufficiency * patients on chronic non-steroidal anti-inflammatory medications
oral findings in a group of egyptian children with attention deficit hyperactivity disorder

Conditions: Oral Manifestations

Summary: attention-deficit/hyperactivity disorder is the most common childhood neuro-developmental disorder that is characterized by inattention, hyperactivity, and impulsivity. these symptoms last till adulthood in 65% of cases. adhd has been reported to have a worldwide prevalence of 5.3% and it is more common in boys than in girls (ghanizadeh 2008; serra-negra et al. 2012 and shooshtari et al. 2013) the symptoms of adhd are generally treated through behavioral therapy, with or without pharmacological intervention. medications prescribed are commonly divided into stimulant or non-stimulant drugs. the stimulant medications (such as methylphenidate and amphetamines) have been implicated in adverse oral effects, such as xerostomia and gingival enlargement. the current evidence is controversial regarding the severity and prevalence of dental caries, dental trauma, periodontal diseases, oral habits and tooth wear among patients with adhd (chau et al. 2017). in the arab world, few studies have been published on adhd. accordingly, in the arab society and egypt there are limited data regarding the oral findings of children with adhd. owing to the sparsity of these data, this study will be conducted to evaluate different oral characteristics of egyptian children with adhd.

due to lack of published studies about the oral findings of egyptian children with adhd, this study will be conducted to cover this point.

Eligibility criteria:
inclusion criteria: * - egyptian children 3-6 years old diagnosed with adhd. * patients taking medications for the treatment of adhd or not. * both male and female patients will be included. control group: a matched group of healthy children aged 3-6 years old. exclusion criteria: * - non-egyptian children. * patients having systemic disorders, such as cerebral palsy or down's syndrome. * patients complaining from any systemic disease

Keywords: oral findings oral characteristics oral health caries oral habits dental trauma adhd children
post market clinical follow-up study for microport profemur® preserve classic femoral stem

Conditions: Joint Diseases

Summary: sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its profemur® preserve classic femoral stem. this type of study is required by regulatory authorities for all devices that have been approved in europe (eu) to evaluate the medium and long-term clinical evidence. this study has been designed in accordance with meddev2.12/2 (european medical device vigilance system) rev2 and iso (international organization of standardization) 14155:2011 guidelines.


Eligibility criteria:
inclusion criteria: 1. has previously undergone or currently has been determined to undergo a primary tha with the study component mpo profemur® preserve classic stem combined with any type of polyethylene or ceramic acetabular shells, acetabular liners and femoral heads. 2. has previously undergone or currently has been determined to undergo a primary tha for any of the following: * non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; * inflammatory degenerative joint disease such as rheumatoid arthritis; * correction of functional deformity 3. willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit. 4. previously implanted subjects must be enrolled within 3 years (+ 6 months) of their primary tha implantation. exclusion criteria: 1. skeletally immature (less than 21 years of age) at time of implantation 2. has or had an overt infection at the time of implantation 3. has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation 4. has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation 5. has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable 6. has or had neuropathic joints 7. has or had hepatitis or hiv infection 8. has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing 9. has or had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques 10. currently enrolled in another clinical investigation which could affect the endpoints of this protocol 11. has or had documented substance abuse issues 12. has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study 13. currently incarcerated or has impending incarceration 14. has a medical condition, as judged by the investigator, that would interfere with the subject's ability to comply with the requirements of the protocol
recovery of impairments early after stroke

Conditions: Stroke

Summary: upper limb recovery after stroke is highly predictable early after stroke. nijland et al. showed that based on two simple clinical bedside tests - 'shoulder abduction' and 'finger extension' (the so called 'safe model' \[stinear et al., 2012\]) - measured within the first 72 hours after stroke, \~87% of the patients could be correctly classified as either regaining or not regaining some dexterity (recoverers or nonrecoverers, respectively) (nijland et al., 2010). this kind of information regarding the patients' functional prognosis allows proper discharge planning, setting realistic rehabilitation goals, and adequate patient information. however, the length of hospital stay after stroke has been decreasing. therefore, knowledge is needed regarding the ability to make an accurate first prediction within the first 24 hours after stroke onset while using simple clinical bedside assessments. this would facilitate an earlier triage and with that, an accelerated and smooth transition of patients within the stroke care continuum. in addition, a first prediction within 24 hours poststroke has the potential to decrease health care expenses, as length of hospital stay after an acute stroke is \~30% of the total costs (i.e., direct and indirect costs) associated with stroke (roger et al., 2012; fattore et al., 2012). the primary objective of arise is to determine the ability of the behavioral biometric impairments 'shoulder abduction' and 'finger extension' measured \<24 hours poststroke to predict outcome of upper limb capacity 3 months after stroke. the secondary aim is to investigate the the added value of other simple clinical bedside tests for predicting outcome of upper limb capacity 3 months poststroke. arise is a prospective longitudinal observational cohort study of 40 first-ever ischemic stroke patients, who will be assessed \<24 hours, 7 days and 3 months after stroke onset.


Eligibility criteria:
inclusion criteria: * first-ever unilateral ischemic stroke in the middle cerebral artery territory \<48 hours, confirmed by mri-dwi and/or ct * age 18 years or older * able to follow one-staged commands * nihss arm score ≥1 * informed consent after participants' information exclusion criteria: * modified rankin scale score \>2 before stroke * neurological or other diseases affecting the upper limb(s) before stroke * intravenous line in the upper limb(s) which limits assessment * contra-indications on ethical grounds * expected or known non-compliance to participate in the observational study, severe drug or/and alcohol abuse

Keywords: upper extremity cohort studies prognosis
safety & effectiveness study of the hydrus microstent for lowering iop in glaucoma patients undergoing cataract surgery (horizon)

Conditions: Primary Open Angle Glaucoma

Summary: this clinical trial is a prospective, randomized, controlled, multicenter, study. after informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (iop) value. clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. at the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (iop taken in the morning, mid-day, and afternoon in the same day) iop evaluation. annual follow up will occur up to 5 years. the primary effectiveness endpoint is a decrease in diurnal iop from baseline compared to the 24 months diurnal iop following medication washout.


Eligibility criteria:
inclusion criteria: * an operable age-related cataract * a diagnosis of poag treated with 1 to 4 hypotensive medications * medicated iop ≤ 31 mmhg * diurnal iop ≥ 22 mmhg and ≤ 34 mmhg exclusion criteria: * congenital or developmental glaucoma * previous argon laser trabeculoplasty * ab-interno or ab-externo device implanted in or through schlemm's canal * use of oral hypotensive medication for glaucoma for treatment of fellow eye

Keywords: glaucoma poag cataract