Kornimate/medical-research-clean huggingface dataset:
"family-centered" pediatric rehabilitation services in children with developmental disabilities

Conditions: Developmental Disabilities; Autistic Spectrum Disorder

Summary: developmental disability is a severe chronic disabled condition caused by mental or physical impairments. children with developmental disabilities may face life-long difficulties in motor functioning, self-care, condition, communication, and independent living. they often receive rehabilitation services to promote daily functions and participation in home, school, and community lives. "family-centered" service has been considered as "best practice" in pediatric rehabilitation. therapists encourage children with developmental disabilities and their parents to participate in decision making and implementing process of intervention, and provide intervention plan that best fit their family needs. research shows that for children with developmental disabilities, family-centered services can enhance children's development, decrease parenting stress, promote emotional wellness, and increase parental satisfaction to services. though the "family-centered" concept has been considered as relevant in pediatric rehabilitation, there are still difficulties, as well as a lack of evidence regarding its implementation in practice. reflecting the trend of family-centered medical care, the benefits of national health insurance in taiwan for early intervention outpatient care will emphasize on family-centered intervention. the range of benefits may include communication with parents, parental education, consultation and instructions for home programs. besides, outcomes of family-centered intervention will be treated as an important index for monitoring the quality of medical services. given that there is a lack of investigation regarding the family-centered pediatric rehabilitation, the purposes of this one-year research project are to investigate the implementation of family-centered pediatric rehabilitation for children with developmental disabilities and to identify related influencing factors. this study will provide empirical evidence for family-centered services in taiwan.


Eligibility criteria:
inclusion criteria: 1. children aged 2 to 12 years. 2. children with a primary diagnose or condition associated with developmental disabilities, including attention deficit hyperactivity disorder, autism, intellectual disability, down syndrome, learning disorders, cerebral palsy, and other developmental delay. 3. parents agree to participate in this study. exclusion criteria: 1. children with unstable physical conditions, such as cancer, having surgery within 3 months, infection, or other active medical conditions. 2. children with progressive disease (e.g. neuromuscular disease) or degenerative disorders (e.g. degenerative seizures).

Keywords: developmental disabilities family-centered services pediatric rehabilitation
phase i clinical study of qls-1304 in the treatment of patients with advanced malignant tumors

Conditions: Advanced Malignant Tumor

Summary: this study is a multi-center, open label, dose escalation/dose expansion phase i clinical trial aimed at evaluating the safety, tolerability, pk characteristics, and preliminary efficacy characteristics of qls1304 monotherapy in patients with advanced malignant solid tumors. this study was divided into two stages: dose escalation and dose expansion.


Eligibility criteria:
inclusion criteria: * volunteer to participate in this study, sign an informed consent form and have good compliance; * age ≥ 18 years old, male or female * ecog score: 0-1 * expected survival ≥ 12 weeks * local recurrent or metastatic advanced malignant solid tumor confirmed by histopathology or cytopathology; * failed to standard treatment or has no standard treatment scheme; * baseline presence of at least one evaluable lesion according to the recist v1.1; * the functional level of important organs is basically normal, meeting the requirements of the scheme * female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication; * female subjects with fertility must have a negative serum hcg test within 7 days before the first medication in the study, and must be in non lactation. * volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent exclusion criteria: * 1. subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug. * subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug. * subjects require long-term or high-dose use of non-steroidal drugs. * subjects have not recovered from adverse events (aes) caused by previous anti-tumor treatment to ≤ grade 1. * subjects have a known or suspected severe allergy to theinvestigational drug or any of its components subjects have other active malignant tumors within 5 years before the first use of the investigational drug. * subjects have brain metastases and/or carcinomatous meningitis or leptomeningeal disease. * subjects have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment. * subjects are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption. * subjects have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug. * subjects have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs.
fusion protein rhsa/gcsfclinical study on breast cancer patients

Conditions: Chemotherapy-induced Neutropenia; Cancer, Breast

Summary: the purpose of this study is to evaluate the tolerance and safety of the rhsa/gcsf in breast cancer patients with different doses and multiple injections. to observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple administration

this experiment adopts the method of multicenter, open, dose escalation study injection with recombinant human blood clean protein/granulocyte stimulating factor fusion protein after single and multiple doses of tolerance, security, and pharmacokinetic characteristics. breast cancer patients with reduced white blood cells after chemotherapy were selected as subjects of this study. the three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg respectively, each of which was studied by single and multiple doses. single dose of medicine, dose-climbing study.two doses of the drug, dose-climbing study

Eligibility criteria:
inclusion criteria: * age 18-65. * diagnosed breast cancer，received chemotherapy. * ecog performance status 0 or 1. * anc≥1.5×10 9/l, plt≥100×10 9/l. no bone marrow metastasis,blood coagulation function normally, no hemorrhagic tendency. * leukocyte reduction occurred after chemotherapy,wbc≤3.0x109/l or anc≤1.5x109/l. * no obvious abnormal ecg examination. * cr，tbil, ast, alt≤1.5×uln，no serious underlying disease. * signed informed consent. exclusion criteria: * chemotherapy within past 4 weeks. * uncontrolled inflammatory disease,axillary temperature≥38℃. * merging other malignant tumor. * pregnancy or nursing status. * participation in another clinical trial with and investigational product within 3 months prior to study entry. * severe diabetes mellitus, or poor blood sugar controller. * allergic disease or allergic constitution. history of protein allergy. * history of drug addiction and alcoholism. * hematopoietic stem cell transplantation or organ transplantation. * received antibiotic treatment within 72 hours before chemotherapy. * long-term use of hormones or immunosuppressive agents. * severe mental or neurological disorders. * chronic disease of severe cardiac, kidney and liver. * other conditions that would be excluded from this study according to doctors'judgment.

Keywords: neutropenia chemotherapy rhsa/gcsf
physical activity in children with wolff-parkinson-white syndrome

Conditions: Wolff-Parkinson-White Syndrome

Summary: the aim of this study was to investigate the level of physical activity and its determinants in children with wpw.


Eligibility criteria:
inclusion criteria: * being between 7-18 years old * ensuring clinical stability in patients * no change in drug therapy, if any, that adversely affects clinical stability exclusion criteria: * neurological and/or genetic musculoskeletal disorders * diagnosed orthopaedic and cognitive problems that prevent the tests from being performed * history before 4 weeks of cardiac or other body system problems * the patient and/or his/her family does not want to be included in the study
trajectory of neuroinflammatory markers in cerebrospinal fluid prior to and after thoracic aortic surgery

Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction; Thoracic Aortic Aneurysm

Summary: observational prospective pilot study to analyze the trajectory of neuroinflammatory protein expression in cerebrospinal fluid (csf) in relation to systemic compartment in patients undergoing thoracic aortic surgery. the aim of this study is to identify and unravel the biochemical (neuroinflammatory) pathways involved in postoperative delirium. patient undergoing thoracic aortic surgery will have an external lumbar drain (eld) in situ on the day before surgery. this eld remains in place during and three days after surgery to reduce the risk on periprocedural spinal cord ischemia. paired measurements of csf and blood will be analyzed.

major (cardiovascular) surgery is frequently associated with cerebral dysfunction postoperatively. major surgical procedures account for substantial systemic inflammatory activation. interestingly, animal models have shown that surgery rather than anaesthetics trigger a neurocognitive decline. an increase of pro-inflammatory cytokines and activation of immune cells mediate this post operative cognitive decline. there is growing support that systemic inflammation can activate the innate immune system of the brain leading to inflammation in the brain ('neuroinflammation'). this neuroinflammation is suggested to play a pivotal role in postoperative delirium and postoperative cognitive decline due to surgery-related systemic inflammation. however little evidence is available on the extend of the neuroinflammation and which biochemical pathways are dysregulated in the brain after surgery. thoracic aortic surgery offers the unique opportunity to study the trajectory of protein expression in csf prior to and after surgery in a non-invasive matter. it is standard of care that an external lumbar drain (eld) is placed the day prior to surgery and this eld will remain in place during three postoperative days. to advance the understanding of the impact of major surgery to the brain, the investigators wish to study the trajectory of protein expression prior to and after thoracic aortic surgery.

Eligibility criteria:
inclusion criteria: * competent patients ≥ 18 years * patients who will undergo thoracic aortic surgery and will therefore receive an external lumbar drain as a standard of care procedure. exclusion criteria: * patients with meningitis/encephalitis/brain abscess within the last 6 months * patients with other neurological conditions: brain injury (acute stroke, brain trauma or cerebral haemorrhage) within the last 3 months, known brain tumours, neurodegenerative disease or known pre-existing cognitive impairment (to a degree that would be compatible with mild cognitive impairment or more). * brain or spinal surgery within the last 3 months * active infection \<2 weeks before surgery * patients who object against storage of their body material for scientific reasons
resting and stimulus-based paradigms to detect organized networks and predict emergence of consciousness

Conditions: Consciousness Disorder; Coma; Brain Injuries, Traumatic

Summary: the aim of this study is to assess the utility of advanced magnetic resonance imaging (mri) and electroencephalographic (eeg) technologies for predicting functional outcomes in patients with severe traumatic brain injury (tbi).


Eligibility criteria:
patients: inclusion criteria: * traumatic brain injury * glasgow coma scale score of 3-8 within 24 hours, unconfounded by sedation, paralysis, hypoxia, hypotension, hypothermia, or concurrent medical illness * clinical evidence of disorder of consciousness defined as coma, vs, or mcs exclusion criteria: * history of prior severe brain injury or dementia * emergence from mcs at time of initial crs-r assessment healthy subjects: exclusion criteria: history of brain injury or neurological disease, psychiatric disease, or any history of diabetes, high blood pressure, heart disease, or kidney disease
efficacy and safety of t-817ma in patients with mild to moderate alzheimer's disease (us202)

Conditions: Alzheimer's Disease

Summary: the primary objective is to evaluate the efficacy of t-817ma as measured by adas-cog and adcs-cgic. the secondary objectives are: * to evaluate the safety and tolerability of t-817ma measured by clinical safety laboratories, physical examinations, ecgs and solicitation of adverse events. * to evaluate the efficacy of t-817ma as measured by adcs-adl, faq, neuropsychiatric inventory (npi) and mini-mental state examination (mmse).


Eligibility criteria:
inclusion criteria: * male or female (post-menopausal or surgically sterile) * patients with mild to moderate alzheimer's disease who are receiving donepezil (aricept®) or rivastigmine transdermal system (exelon® patch), . memantine (namenda®) is allowed only when prescribed in combination with donepezil or rivastigmine transdermal system. * age 55 to 85 inclusive * patients must be living in the community * patients must have an eligible informant or study partner (caregiver) * patients and eligible informant or study partner (caregiver) must be able to read and understand english. * informed consent obtained from both the patient and the caregiver exclusion criteria: * patients with clinically significant cardiac, hepatic or renal impairment * patient have a dementia not of the alzheimer's type etc (according to the protocol) * patients who are taking any drug other than donepezil or rivastigmine transdermal system for alzheimer's disease, including olal rivastigmine (exelon®), galantamine (razadyne®)

Keywords: alzheimer's disease alzheimer's
elective coronary angiography and anxiety study

Conditions: Anxiety

Summary: anxiety will be assessed from two aspects, the somatic and emotional. angst aims to determine how anxiety correlates with psychological parameters (personality traits, coping strategies and depressive symptoms) and with the outcome of elective coronary angiography (ca).

this research is a prospective cross-section study of patients undergoing elective ca. research design will allow studying anxiety at four timepoints and its correlation with ca outcome and psychological parameters. this study will be conducted at the coronary care unit of the department of cardiology, general and teaching hospital celje, slovenia. data regarding prior to ca, during hospital stay and after discharge variables will be collected in order to control for confounding variables when testing the association between anxiety and psychological parameters. all the data needed for this study will be collected within one month from the patient enrollment in this study at four occasions: (1) 14 days prior ca - all patients will receive questionnaires by post, (2) on the day of the admission, 2-4 hours before ca, (3) 24 hours after ca, but prior to discharge and (4) 4-6 weeks after discharge. clinical and demographical data will be collected from medical records. data regarding anxiety and other psychological parameters will be assessed using standardized questionnaires. these will be sent to the patient together with covering letter providing instructions to complete the questionnaires 14 days prior ca without help of family members/friends. a month after ca, the questionnaires for anxiety and depressive symptoms will be sent to participants address with reply paid envelope provided. the republic of slovenia national medical ethics committee has approved this study.

Eligibility criteria:
inclusion criteria: * invited to elective ca because of suspected/unknown: coronary artery disease, valvular heart disease, heart failure etiology, unexplained arrhythmia, cardiomyopathy etiology; * written consent; * completed first set of questionnaires 14 days prior to coronary angiography exclusion criteria: * need for an urgent coronary angiography, * coronary angiography in last 6 months, * unable to provide written consent, * severe physical and/or mental disease/disability, * help needed in completing the questionnaires, * unsigned consent form, * incomplete first set of questionnaires 14 days prior to coronary angiography.

Keywords: anxiety coronary angiography
resolution endoclips vs epinephrine injection and heater probe

Conditions: Peptic Ulcer Hemorrhage

Summary: to compare the efficacy of a novel endoscopic clipping device(resolution clip™) and conventional epinephrine injection and heater probe thermocoagulation in control of peptic ulcer bleeding and prevention of recurrent bleeding

the mortality of peptic ulcer bleeding remains high despite advances in endoscopy and medical therapy. endoscopic therapy effectively controls peptic ulcer bleeding and substantially reduces recurrent bleeding. however, the best endoscopic therapy is still unclear. the current standard of therapy is injection with diluted epinephrine and heater probe (3.2mm) thermo-coagulation. however, it may be associated with complications such as precipitation of myocardial ischemia or heater probe perforation. endoscopic clipping is an emerging modality of endoscopic treatment, it mimics the use of surgical ligature on bleeding artery. endo-clipping has the theoretical advantage over injection and heater probe in that the tissue reaction or damage will be much milder. resolution clip™ is a newly developed endo-clipping device. it is superior to older generations of endo-clips in that it allows repeated closures and re-opening of clip so as to facilitate accurate deployment onto bleeding artery to ensure its optimal placement for hemostasis. consecutive patients with endoscopically confirmed bleeding peptic ulcer will be invited to participate in this double-blind, randomised trial, which compares the efficacy of resolution clip and conventional dual endoscopic therapy. patients will be compared for 30-day treatment failure rate.

Eligibility criteria:
inclusion criteria: * age \>16 , can obtain written consent * ulcers that require endoscopic therapy with srh: forrest i a, ib, ii a and ii b exclusion criteria: * moribund patients with terminal malignancy * pregnancy * intercurrent ulcer complication that prevents treatment and surgery becomes mandatory such as bulbar stenosis and ulcer perforation

Keywords: bleeding peptic ulcer endoscopic treatment
percutaneous image guided video-assisted thoracic surgery (vats) resection of lung lesions

Conditions: Lung Cancer

Summary: this is a phase ii protocol to determine the safety and feasibility of intraoperative ct fluoroscopy guidance for lung resection for small nodules.

this is a phase ii protocol to determine the safety and feasibility of image guided ct marking for resection of small lung nodules. this is relevant because many such nodules are hard to localize for minimally invasive lung resection. it is hoped that this technology using fluoro ct capability available now in most operating room will improve safety and reliability of thoracic surgery.

Eligibility criteria:
inclusion criteria: * peripheral lung nodules \< 3cm in size * surgical candidate exclusion criteria: * non surgical candidate

Keywords: lung nodule lung cancer lung mass
special investigation for long term use of tolterodine (regulatory post marketing commitment plan).

Conditions: Urinary Bladder, Overactive

Summary: the objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the lpd (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

all the patients whom an investigator prescribes the first detrusitol® capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: * patients need to be administered detrusitol® capsule in order to be enrolled in the surveillance. exclusion criteria: * patients not administered detrusitol® capsule.
individualized chemotherapy based on brca1 and rrm1 mrna for advanced non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: gemcitabine, docetaxel, cpt-11 and cisplatin are effective in 1st line treatment of advanced non-small cell lung cancer (nsclc). platinum-based doublets including gemcitabine, docetaxel or cpt-11 are standard 1st regimens. brca1 and rrm1 expression levels are reported to be associated with sensitivity of the tumor cells to cytotoxic agents. some phase ii or iii trials did prove feasibility of customized chemotherapy based upon expression levels of one or two biomarkers in the nsclc patients. the investigators think customized chemotherapy may further improve efficacy of chemotherapy in advanced nsclc. but there is no randomised trial to compare efficacy of standard chemotherapy with individualized chemotherapy in this setting. so, the investigators plan to initiate this phase ii trial to compare efficacy between standard chemotherapy of gemcitabine/cisplatin versus customized chemotherapy in chemonaive nsclc patients.

primary end point:orr secondary end point:pfs,os,safety,qol,etc.

Eligibility criteria:
inclusion criteria: 1. written informed consent, 2. histologically confirmed stage m1a or m1b nsclc, 3. aged over 18 years old, 4. measurable disease, 5. life expectancy of at least 12 weeks, 6. no prior chemotherapy or target therapy, 7. no brain metastases or spinal cord compression, 8. less than 10% body weight loss, 9. ecog performance status 0-2, 10. adequate vital organ function (haematological, renal, hepatic, etc). 11. enough tissue for detection of brca1 and rrm1 expression. exclusion criteria: 1. prior systemic cytotoxic chemotherapy or egfr tki therapy, 2. positive pregnancy test, 3. another active malignancy, other than superficial basal cell and squamous cell or carcinoma in situ of the cervix, within the last 5 years, 4. patients with brain metastases or spinal cord compression, 5. allergy to gemcitabine, cisplatin, docetaxel, cpt-11, 6. any unstable systemic disease including active infection, 7. no enough tissue for detection of brca1 and rrm1

Keywords: chemotherapy individual therapy rrm1 brca1