Kornimate/medical-research-clean huggingface dataset:
efficacy and tolerability of sifrol® (pramipexole) in patients with advanced idiopathic parkinson's disease

Conditions: Parkinson Disease

Summary: assessment of daily maintenance dose of sifrol®, l-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability


Eligibility criteria:
inclusion criteria: * patients with advanced idiopathic parkinson's disease for whom combined treatment with sifrol and l-dopa was indicated exclusion criteria: * na
phase i/ii trial of velcade + chop-rituximab in untreated dlcbl or mantle cell nhl

Conditions: Non-Hodgkin's Lymphoma

Summary: primary objective: to determine the toxicity profile and maximum tolerated dose (mtd) of velcade when administered in combination with chop + rituximab to patients with previously untreated diffuse large b cell or mantle cell non-hodgkin's lymphoma (nhl) secondary objectives: to assess the response rate (overall and complete), event-free survival and overall survival with velcade and chop-r in patients with previously untreated diffuse large b cell or mantle cell lymphoma (phase ii component) treatment: standard chop chemotherapy administered every 21 days (full dose) for six cycles rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications) velcade is administered prior to rituximab and chop on day 1 of each cycle. the dose of velcade will be determined by the following dose escalation schedule: level dose/schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4

standard chop chemotherapy administered every 21 days (full dose) for six cycles rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications) velcade is administered prior to rituximab and chop on day 1 of each cycle. the dose of velcade will be determined by the following dose escalation schedule: once completed six cycles of therapy (\~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. patients who have disease progression will be contacted every 6 months until death to assess for survival status.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of diffuse large b cell or mantle cell non-hodgkin's lymphoma with characteristic immunophenotypic profiles. for mantle cell: cd5(+), cd19(+) or cd20(+), cyclin d1(+), cd23(-) and cd10(-). * patient has not received any prior anti-cancer therapy for lymphoma * tumor tissue confirmed to express the cd20 antigen * available frozen tumor tissue(rebiopsy if needed) * patient has measurable disease as defined by a tumor mass \> 1.5 cm * patient has stage ii, iii, or iv disease * age \> 18 years * absolute granulocyte count \> 1000 cells/mm3 * platelet count \> 50,000 cells/mm3 * creatinine \< 2.0 x uln * total bilirubin \< 2.0 x uln exclusion criteria: * known central nervous system (cns) involvement by lymphoma * known hiv disease * patient is pregnant or nursing * patient has had major surgery within the last 3 weeks * patient is receiving other investigational drugs * known peripheral neuropathy \> grade 2

Keywords: diffuse large b cell mantle cell lymphoma
study to compare the safety and pharmacokinetic characteristics of lbec0101 25mg with those of enbrel®

Conditions: Healthy

Summary: to compare the pharmacokinetic characteristic of lbec0101 25mg with active comparator, enbrel® 25mg.


Eligibility criteria:
inclusion criteria: * healthy males, 20 to 45 years of age the moment of screening * body mass index is between 18.0 and 30.0 kg/m exclusion criteria: * the tuberculosis patient of latent tuberculosis patient * hypersensitivity response to the test and comparator drugs
a phase ii randomized open label study of klh-2109 in patients with endometriosis

Conditions: Endometriosis

Summary: the purpose of this study is to evaluate the efficacy and safety of klh-2109 in patients with endometriosis.


Eligibility criteria:
inclusion criteria: * female patients with endometriosis exclusion criteria: * patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Keywords: gonadotropin-releasing hormone (gnrh) antagonist
deproteinization as a coadjuvant in dentin adhesion of noncarious cervical lesions

Conditions: Non-carious Cervical Lesions

Summary: this study will verify the effect of the application of a substance (10% sodium hypoclorite -naocl) in dentin on noncarious cervical lesions, with the aim of increasing the longevity of the restorations performed in this type of lesion. the hypothesis of the present study is that the application of deproteinization solution after acid etching does not influence the failure rate of the restorations.

the purpose of this study will be to evaluate the failure rates of composite restorations of non-carious cervical lesions (nccl) performed with or without the pre-treatment with 10% sodium hypochlorite (naocl) on etched dentin. a randomized controlled split-mouth and double blind clinical trial will be carried out. patients with at least two nccl will be selected. each patient will be received at least one pair of composite restorations (filtek z350/3m espe), bonded either with 2 techniques: control (acid etching + placebo solution for 60 seconds + adper single bond 2/3m espe) or experimental (acid etching + 10% naocl for 60 seconds + adper single bond 2). a calibrated examiner will be evaluated the restorations (baseline, 6-, 12-, 24- and 36-month) using the fdi criteria. the primary outcome is retention of the restoration.

Eligibility criteria:
inclusion criteria: * patients presenting at least two non-carious cervical lesions (ncl) in anterior, canine or pre-molars; * patients who had more than 20 teeth in the mouth; * patients who were at least 18 years of age at the time of treatment and capable to understand and sign the written informed consent; * ncl in the facial surface of the teeth with sometimes a small part extending interproximally; patients with good periodontal heath. exclusion criteria: * patients with smoking habits, practicing bruxism, severe systemic diseases, using active orthodontic treatment, malocclusion (angle class ii or class iii); * tooth with the ncl with the absent of antagonist; * ncl wear facets upper than 50% of the incisal/occlusion surface, as a result of tooth attrition; * presence of caries or restorations in the area to be treated; * full-mouth visible plaque index (vpi) or full-mouth gingival bleeding index upper than 20%, probing depth and clinical attachment loss values exceeding 4 mm with bleeding on probing; * unwillingness to return for follow-ups or refuse to participate.

Keywords: adhesive system controlled clinical trial dental restoration noncarious cervical lesions dental restoration failure sodium hypochlorite
telecoaching of people with type 2 diabetes in primary care

Conditions: Type 2 Diabetes Mellitus; Telenursing

Summary: the objective of the study is to analyze the effectiveness and the cost-effectiveness of telecoching in improving glyceamic control and other modifiable risk factors in patients with type 2 diabetes compared to usual care only.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes between 18 and 75 years old on the day of the selection exclusion criteria: * debilitating coexisting medical condition (e.g. dialysis, mental illness, cancer) * residents of long term care facilities * pregnancy * incapable of telephone communication in dutch

Keywords: type 2 diabetes mellitus telenursing rct economic analysis
mri brain (volumetry, fmri & mrs) in autism

Conditions: Autism Spectrum Disorder

Summary: to reach a feasible method for diagnosing autism spectrum disorder (asd) outcome measures: 1. primary (main): measurement of various brain structures, including the total brain volume, the volumes of specific brain regions (such as the amygdala, hippocampus, and cerebellum), and the thickness of the cortex. detection of other concurrent lesions, e.g. tuberous sclerosis 2. secondary (subsidiary): levels of various neurotransmitters, such as glutamate and gaba, and other metabolites, such as n-acetyl aspartate (naa), in specific regions of the brain assessing neural activity and connectivity in the brain in the resting state

autism spectrum disorder (asd) is a heterogeneous disorder (or collection of related disorders) of multifactorial etiology, and with a great range in severity of symptoms. asd affects approximately 1 in 166 children and is four times more prevalent in boys than in girls. core features of individuals with autism include 1) impairment in reciprocal social interactions; 2) verbal and nonverbal communication deficits; 3) repetitive and ritualized behaviors; and 4) a narrow range of interests. approximately 30% of individuals with asd manifest some degree of mental retardation. magnetic-resonance (mr) examination allows researchers and clinicians to noninvasively examine brain anatomy in vivo. structural mr examination is widely used to investigate brain morphology because of its high contrast sensitivity and spatial resolution, and because it entails no radiation exposure; the last feature is particularly important for children and adolescents. functional magnetic resonance imaging (fmri) has proven to be a useful tool to investigate aberrant neurobiological function in asds because of its excellent contrast properties, spatial resolution, and temporal resolution. fmri uses specialized pulse sequences to localize metabolic correlates of neural activity linked to relevant neurocognitive processes investigating brain network activity during the resting state has emerged as a new method that eliminates the caveats of task-based fmri studies the fmri signal is measured during the resting state and the data is analyzed based on a connectivity approach between subdivisions. to date, brain network activity during the resting state has been investigated in subjects with asd and typical development in numerous studies. overall, intrinsic connectivity between subdivisions of the brain is altered in patients with asd compared to controls. mrs's finding is that gamma oscillations are reduced in asd patients. gamma oscillations are generated by gabaergic neurons and are involved in sensory binding and higher cognitive functions.

Eligibility criteria:
inclusion criteria: * children clinically diagnosed with autism spectrum disorder. * males and females. * children with an iq of more than 70% exclusion criteria: * severe forms of asd. * children with iq less than 70%. * children with claustrophobia.

Keywords: mri brain in asd
a study of the efficacy and safety of two low-concentration atropine sulfate eye drops

Conditions: Myopia

Summary: a randomized, double-blind, placebo-controlled, multicenter, phase iii clinical study of the efficacy and safety of two low-concentration atropine sulfate eye drops in slowing the progression of myopia in children

primary objective is to evaluate the efficacy and safety of atropine sulfate eye drops versus placebo for 12 months in slowing the progression of myopia in children. the study was designed to enroll approximately 777 subjects. eligible subjects were randomly assigned to the placebo control group, lower dose atropine group and lower dose atropine group. subjects received the study medication in both eyes, 1 drop each time, once every night at bedtime. statistical analyses were performed with the use of sas software, version 9.4, without any specific description. all statistical tests were two-sided at a 0.05 level.

Eligibility criteria:
inclusion criteria: 1. child (female or male) aged 6 to 12 years. 2. myopia (ser of at least -0.50 d and no more myopic than -6.00 d) in each eye as measuredby cycloplegic autorefraction. 3. if present, astigmatism of ≤1.50 d in each eye as measured by cycloplegic autorefraction. 4. anisometropia ser of \< 1.50 d as measured by cycloplegic autorefraction. exclusion criteria: 1. have used other myopia control methods other than those used in this study, such as instruments (orthokeratology lenses, multifocal glasses, progressive glasses), drugs (atropine, etc.); only single vision glasses are allowed for myopia correction; 2. have used myopic control methods such as traditional chinese medicine, auricular acupuncture, massage, and reverse beat within 30 days before screening; 3. use of any local or systemic antimuscarinic/anticholinergic medication (e.g., atropine, scopolamine, tropicamide, phenamine, diphenhydramine, oxytropine, tricyclic antidepressant, etc.) within 21 days before screening; allowing for tests such as cycloplegic optometry;
ql1706 monotherapy or in combination with bevacizumab and xelox as first-line treatment of unresectable advanced or metastatic crc

Conditions: Colorectal Carcinoma

Summary: this is an open-label, muticenter phase ii study to evaluate the efficacy and safety of ql1706 monotherapy or in combination with bevacizumab and xelox as first-line treatment of unresectable advanced or metastatic crc.


Eligibility criteria:
inclusion criteria: * 1. subjects participate voluntarily and sign informed consent. * 2. age ≥ 18 and ≤ 80 years old, male or female. * 3. histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum. * 4. at least 1 measurable target lesion according to response evaluation in solid tumors (recist 1.1). exclusion criteria: * 1. diagnosed additional maliganancy within 5 years with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers. * 2. presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled). * 3. has active autoimmune disease that has required systemic treatment in past 2 years. * 4. significant cardiovascular disease.
pivotal response intervention minimal responders study

Conditions: Autism Spectrum Disorder With Impaired Functional Language

Summary: early intervention (ei) using naturalistic behavioural methods have shown benefits for the development of communication and other skills for young children with autism spectrum disorder. the publicly funded autism ei program in nova scotia (ns) is based on such a method, pivotal response treatment (prt), and pre-post studies indicate benefits for children and families. however, not all children benefit equally. in this study, the investigators test the efficacy of a brief parent-mediated intervention designed to prime responsivity to prt in children with a minimal responder profile derived from previous studies of the prt-based ei program.

investigators will enroll preschoolers with the minimal responder profile who are scheduled to begin the prt-based public ei program. consenting parents will be offered a virtual intervention in which they will be randomized to 1 of 2 arms to receive coaching in either (a) primer intervention, designed to target areas of weakness in the minimal responder profile, or (b) prt, the treatment model used in the ei program. coaching will take place on a virtual (video-conferencing) platform. each child's progress on treatment targets will be assessed in a single case experimental design (sced) using data from blind-coded video-recordings of parent-child play episodes using a standard set of toys. overall study effects will be based on aggregated data for an anticipated n of 20 participants assigned to each arm (4 sced series with 5 participants each contributing to each arm). the primary outcome is gains in children's social initiations (video-coded); the secondary outcome is gains in children's communication levels (multi-method assessment). mixed methods will be used to evaluate aspects of parents' experiences,

Eligibility criteria:
inclusion criteria: 1. upcoming enrollment in ns ei program for preschoolers with autism spectrum disorder (asd), based on confirmed or provisional asd diagnosis by a qualified clinician 2. significant delay in cognitive abilities (assessed formally by psychologist or estimated by psychologist or developmental pediatrician at time of diagnosis) 3. current spontaneous functional use of ≤ 10 words (clinician's observations; parent report using macarthur-bates communicative development inventory - words \& gestures (cdi-wg) 4. limited use of toys / objects (clinician's impression or parent's report with no contrary observation by clinician) 5. low levels of expressed positive affect (smiles, laughter) or limited positive and high negative affect (clinician's impression or parent's report with no contrary observation by clinician) exclusion criteria: 1. severe sensory or motor impairment in child 2. parent unable to complete consent process (and receive coaching) in english

Keywords: autism spectrum disorder limited verbal ability early intervention parent-mediated intervention
correlation between computer tomography angiography and d-dimer level for the diagnosis of pulmonary embolism

Conditions: D-Dimer as an Early Detector of Pulmonary Embolism

Summary: a blood sample was taken before starting the patients on any thrombolytic treatment. the positivity threshold for d-dimer was above 250 ng/ml. ctpa was performed after performing blood sampling. patients with confirmed pulmonary embolisms were admitted to icu for continued monitoring of vitals, consciousness level, and signs of tissue perfusion. signs of shock or hemodynamic instability should be observed regularly. patients were managed in the icu with anticoagulants by parenteral use. the most commonly used items were heparin, either unfractionated (ufh) or low-molecular-weight heparin (lmwh).d-dimer levels can leverage to detect pe. d-dimer levels can help in guiding the option of ctpa and the initiation of treatment for patients with suspected pe.

a blood sample was taken before starting the patients on any thrombolytic treatment. the positivity threshold for d-dimer was above 250 ng/ml. ctpa was performed after performing blood sampling. patients with confirmed pulmonary embolisms were admitted to icu for continued monitoring of vitals, consciousness level, and signs of tissue perfusion. signs of shock or hemodynamic instability should be observed regularly. patients were managed in the icu with anticoagulants by parenteral use. the most commonly used items were heparin, either unfractionated (ufh) or low-molecular-weight heparin (lmwh).presenting symptoms were mainly dyspnea, chest pain or discomfort, cough, and shortness of breath. twenty-four patients of the total number of cases were positive for ctpa while four patients were negative for pe by ctpa. embolism was detected in the anterior, posterior, medial, and lateral basal segmental branches of the right lung, the lateral, posterior, and anterior basal segmental branches of the left lung, and the posterior segmental branch of the left lung. the d-dimer test and ctpa both provided similarly accurate pe diagnoses with no significant differences between them. there were 28 patients total, 3 of those patients had d-dimer levels below the cut-off value of 250 ng/ml, whereas the remaining 25 had d-dimer levels over the diagnostic threshold. those with a positive ctpa diagnosis of pe had greater levels of d dimers than those with a negative ctpa diagnosis of pe. plasma d-dimer concentration did not correlate with the cross-sectional diameter of the blocked pulmonary vessel.d-dimer levels can leverage to detect pe. d-dimer levels can help in guiding the option of ctpa and the initiation of treatment for patients with suspected pe.

Eligibility criteria:
inclusion criteria: acute chest pain, dyspnea, tachypnea, and suspicion of pe - exclusion criteria:the history of pe, the administration of anticoagulant medication before blood sampling, an allergic response to the ctpa contrast agent, impaired hepatic function or renal function, inability to cooperate during examinations, and an absence of relevant medical records for analyses -

Keywords: d-dimer, pulmonary, embolism, ctpa.
saline versus lactated ringer's solution: the solar fluid trial

Conditions: Postoperative Complications

Summary: perioperative volumes of saline cause a mild acidosis compared with buffered fluids. on the other hand, saline administration maintains plasma osmolality and better repletes vascular volume which is an important goal of perioperative fluid administration. currently, there is no convincing evidence that either saline or buffered solutions are preferable. consequently, both types of fluid remain in common use at the clinic and worldwide. there has never been a large trial of perioperative saline and balanced salt solutions comparing the incidence of major complications including acute kidney injury. the investigators primary objective is thus to determine the relative safety of perioperative saline and lactated ringer's solution. specifically, the investigators propose to test the: 1. primary hypothesis that a composite of major in-hospital postoperative complications is lower in patients given lactated ringer's solution compared to normal saline. 2. secondary hypothesis that acute kidney injury, measured by akin criteria, is lower in patients given lactated ringer's solution compared to normal saline. the acquisition cost of saline and lactated ringer's solutions is similar in the united states. (curiously, buffered solutions are far more expensive than saline in great britain.) but to the extent that one fluid or the other provokes more complications, cost of care may be increased with that fluid selection. cost may also be increased by the need for additional electrolyte monitoring and electrolyte replacement. the investigators will therefore secondarily conduct an economic evaluation to determine the relative incremental hospital cost of each fluid. to the extent that one fluid or the other reduces cost (assuming similar complication rates), the clinic will be able to reduce cost by specifying the appropriate fluid without impairing quality. evidence that one fluid or the other causes few complications would be a strong quality indicator that the clinic should standardize perioperative fluid selection.


Eligibility criteria:
inclusion criteria: * patients having colorectal or similar surgery * patients having orthopedic or similar surgery * patients 18 years and older exclusion criteria: * patients under 18 years of age