Kornimate/medical-research-clean huggingface dataset:
characterizing occupational therapy intervention for children with autism spectrum disorders

Conditions: Autism Spectrum Disorder

Summary: this pilot study aims to identify behavioral and neural measures of sensory processing and attention associated with routine occupational therapy intervention for children with autism spectrum disorders. specifically, the investigator will examine the impact of a child's level of engagement during therapy using standardized behavioral and electroencephalography (eeg) measures of sensory processing.

occupational therapy is one of the most frequently requested and highly utilized interventions for children with autism spectrum disorders (autism) and therapists have consistently reported using the sensory integration framework as a dominant theory guiding practice. a key component of sensory integration theory is the child's active engagement during therapy, which is assumed to improve neural function, behavior, and participation. however, no studies have examined the neural mechanisms associated with occupational therapy interventions among children with autism. this pilot feasibility study will examine behavioral and electroencephalography (eeg) measures of attention and sensory processing before and following 6-8 weeks of routine occupational therapy at community outpatient centers among 30 children with autism aged 6 - 13 years. the primary aim is to determine the feasibility, sensitivity, and validity of eeg measures of auditory processing as a response biomarker following routine occupational therapy intervention. another aim is to examine the contribution of a child's engagement during therapy as a key predictor of change using behavioral and eeg outcome measures. the occupational therapy intervention consists of one-hour weekly sessions of usual care at nationwide children's hospital outpatient centers. results from this grant will provide valuable proof-of-concept data establishing engagement during therapy as an active ingredient in occupational therapy intervention using neurophysiological and behavioral measures. these results will also establish the validity of eeg measures as sensitive to a child's level of engagement and neuroplastic changes following occupational therapy intervention.

Eligibility criteria:
inclusion criteria: for children with autism: * a medical diagnosis of autism * between 8 - 13 years * must be verbal * have normal or corrected vision/hearing * enrollment in the 8-week ot treatment plan with a therapist enrolled in the study. for typically developing children: • no history of neurological injuries, disabilities, and family history of mental health disorders on parent report exclusion criteria: * history of a definitive neurologic disorder including seizures (except for uncomplicated brief febrile seizures), tumor, severe head injury, stroke, lesion, or disease * presence of a severe chronic medical disorder * presence of a major visual impairment * history of alcohol/substance abuse or dependency.

Keywords: occupational therapy engagement autism spectrum disorders eeg/erp
internet-delivered cognitive behaviour therapy for adolescent depression

Conditions: Depression; Anxiety

Summary: the purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (cbt) is a feasible approach in the treatment of depressive symptoms and comorbid anxiety symptoms.

as above

Eligibility criteria:
inclusion criteria: * be between the ages of 15-19 years old * have symptoms of depression, major depression exclusion criteria: * suicidal ideation * alcohol addiction * other major primary psychiatric disorder * ongoing psychological treatment * recent (during last 4 weeks) change in psychiatric medication
pet/mr for rectal cancer treatment monitoring and surveillance

Conditions: Rectal Cancer; Cancer of the Rectum

Summary: the goal of pilot study is to assess the feasibility of fdg-pet/mri for monitoring rectal cancer disease status in the setting of rectal cancer non-operative management (nom). data from this study will be used to guide the design of future clinical trials involving fdg-pet/mri for rectal cancer nom.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * biopsy-proven rectal adenocarcinoma of the rectum with clinically suspected or previously known stage i-iiib (ct1-4, n0-2, m0) disease * anticipated or prior chemoradiation as part of an nom treatment strategy * ability to understand and willingness to sign an irb-approved written informed consent document exclusion criteria: * prior surgical resection of rectal cancer (endoscopic or tme) * contraindication to mri * comorbidities that would limit patient's ability to cooperate with a pet/mri examination (e.g. dementia, inability to follow commands, claustrophobia, tremors, requirement for oxygen by nasal cannula, etc...). * implanted devices or materials that may interfere with mri imaging or create significant artifact * pregnancy * contraindication to gadolinium contrast or fdg * end-stage renal disease
a multicomponent intervention program to prevent and reduce icu agitation and physical restraint use

Conditions: Agitation,Psychomotor

Summary: despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in dutch icus (20-25%). this study aims to determine the effectiveness of a person-centered multicomponent intervention (mci) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult icu patients.

applying physical restraints (pr) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated. nonetheless, pr are still used in approximately 20-25% of all patients during their intensive care unit (icu) stay in the netherlands. the aim of this study is to determine the effectiveness of a person-centered multicomponent intervention (mci) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints on short- and long-term outcomes and healthcare costs in (expected to become) agitated adult icu patients.

Eligibility criteria:
inclusion criteria: * adult icu patients (aged ≥18) with an expected icu stay of \>24 hours * patients who are (expected to become) agitated within the first 14 days of their icu admission exclusion criteria: * contra indication for dexmedetomidine use (i.e., av-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known/suspected hypersensitivity); * neurological patients with an (expected risk of) increased intracranial pressure; * an intoxication as a result of drug abuse (e.g., ethanol, γ-hydroxybutyrate, opioids, benzodiazepines); * support with extracorporeal membrane oxygenation (ecmo); * difficult airway (e.g., a cormack and lehane laryngoscopy grade 4 view or a tumor causing airway obstruction); * a high risk of physical aggression towards healthcare professionals; * no consent for long term follow up in the monitor-ic study; * not able to read or understand the dutch language and no relatives able to assist; * enrolment in other sedation studies.

Keywords: icu agitation physical restraints non-pharmacologic interventions dexmedetomidine
study of the effect of four methods of cardiopulmonary resuscitation instruction on psychosocial response of parents with infants at risk of sudden death

Conditions: Pulmonary Hypertension; Bronchopulmonary Dysplasia; Respiratory Distress Syndrome

Summary: objectives: i. describe the psychosocial response of parents and caretakers who learn cardiopulmonary resuscitation (cpr) techniques for infants at high risk for respiratory or cardiac arrest. ii. compare the effect of 4 methods of cpr instruction on psychosocial response. iii. evaluate a psychological intervention based on social support theory designed to offset the potential adverse psychological outcomes of cpr instruction. iv. evaluate a self-paced cpr learning module using the principles of adult learning theory. v. document the level of cpr knowledge and skill retention over time. vi. document the frequency of cpr and its outcome following a witnessed respiratory or cardiac arrest.

protocol outline: parents of high-risk infants are randomly assigned to 1 of 4 groups; groups are alternated at each site and the sequence of groups at each site is randomly assigned. the first group receives a 90-minute, 1-person cardiopulmonary resuscitation (cpr) and obstructed airways management instruction. the second group receives the same instruction plus a 1-hour social support discussion. ongoing support is provided with weekly phone calls to assess caretaker status and answer questions regarding the infant's health. the third group learns cpr using a self-paced multimedia learning module. the control group receives the standard cpr instruction at hospital discharge. participants are followed at 2 weeks, then at 3 and 6 months.

Eligibility criteria:
protocol entry criteria: --population characteristics-- parent or caretaker with infant at risk for sudden death, i.e.: birth weight less than 2500 g abnormal pneumogram bronchopulmonary dysplasia respiratory distress syndrome primary pulmonary hypertension congenital cardiac abnormality home oxygen requirement asphyxia or hypoxia apnea of infancy documented episode of apnea or bradycardia sibling of sudden infant death syndrome victim substance-abusing mother literate in spanish or english no history of mental illness no contraindication to cardiopulmonary resuscitation instruction, e.g., arthritis or orthopedic injury no cardiopulmonary resuscitation instruction within 2 years

Keywords: bronchopulmonary dysplasia cardiovascular and respiratory diseases disease-related problem/condition educational needs hypertensive disorder neonatal disorders primary pulmonary hypertension rare disease respiratory distress syndrome
adherence improvement in glaucoma patients

Conditions: Glaucoma

Summary: the purpose of this study is to study the effect on intraocular pressure in glaucoma patients using the travalert dosing aid with or without the eyot drop guider and with or without additional patient education.


Eligibility criteria:
inclusion criteria: * diagnosis glaucoma or ocular hypertension * treatment with travoprost or travoprost/timolol exclusion criteria: * high risk of side effects expected from travoprost or travoprost/timolol * absolute inability to administer eye drops * difficulty in reading or speaking dutch

Keywords: glaucoma adherence
instant message-delivered early psychological intervention in stroke family caregivers

Conditions: Stroke; Caregiver Burden; Mobile Phone Use

Summary: psychological distress including depression and anxiety is a major component of caregiver stress, and its negative impact on caregivers' health and well-being has been established in the literature. a recent meta-analysis reported the prevalence of depression and anxiety in stroke caregivers as 40.2% and 21.4% respectively. an evidence profile report by the world health organization(who) has emphasised that psychological support is crucial in helping caregivers in the community to continue caring for individuals with long-term disabilities, such as stroke patients. therefore, early psychological intervention (epi) is crucial to improve the management and prognosis of an individual who are facing stressful events like caregiving. the main aim of this study is to prevent or alleviate the significant psychological consequences in carers resulting from stroke events in family members. internet-delivered cognitive-behavioural therapy (icbt) is delivered as an ecological momentary intervention (emi) to support the clients to engage in cognitive reframing and empower them with proper knowledge, skills and attitudes to make behavioural changes.


Eligibility criteria:
inclusion criteria: * primary family caregiver of first-ever stroke patient who has \<15 modified barthel index(mbi) scores (moderate disability); * caregiver of a stroke patient who has a hospital inpatient stay of ≥6 days and ≤21days; * aged ≥18; * able to read and communicate in chinese (cantonese or putonghua); * able to use mobile phone instant messaging function; and * phq-9 (depressive symptom) score ranging from 5 to 19 (note. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27) exclusion criteria: * caregiver of stroke patient who is admitted to intensive care unit; * professional medical personnel and/or professional carer; * diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants; * phq-9≥20 (we shall provide information on mental health services; if needed, we shall make the appropriate referrals); and * currently participating in any type of psychological intervention.

Keywords: cognitive-behavioural therapy ecological momentary intervention early psychological intervention
erector spinae plane versus interscalene blocks for shoulder surgery

Conditions: Anesthesia, Local; Phrenic Nerve Paralysis; Upper Extremity Injury; Shoulder Injury

Summary: the goal of this study is the evaluation of erector spinae plane (esp) blocks as an alternative to interscalene brachial plexus nerve blocks for rotator cuff repair and total shoulder arthroplasty procedures. currently, single shot interscalene nerve blocks are performed for rotator cuff repair surgeries, and interscalene nerve catheters are placed for total shoulder arthroplasty surgeries. erector spinae plane blocks are commonly used as part of the anesthetic plan for other surgeries, but less so for shoulder surgeries. the investigators would like to study whether an esp block can provide similar pain control compared to an interscalene nerve block, with less risk of upper extremity motor block and phrenic nerve block.


Eligibility criteria:
inclusion criteria: - all adult patients (18 years and over) scheduled for rotator cuff surgery or total shoulder arthroplasty surgery requiring a nerve block as part of their anesthetic care exclusion criteria: * concomitant life-threatening injuries and other concomitant injuries causing significant pain. * pregnancy, * any condition impairing patient's ability to consent to participation in study * an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder * infection in the vicinity of the block, and patient refusal.
neoadjuvant or adjuvant chemotherapy in patients with operable non-small-cell lung cancer

Conditions: Non-Small-Cell Lung Cancer

Summary: open-label multicenter randomized phase iii trial.

randomized trial of surgery with or without paclitaxel (taxol) plus carboplatin as neoadjuvant or adjuvant chemotherapy in patients with operable, non-small-cell lung cancer.

Eligibility criteria:
inclusion criteria: * the patients eligible for the study are those with a diagnosis, histologically or cytologically proven, of nsclc without metastases at stages ib, iia, iib and iiia (not n2) of the disease. patients with stage ia and tumor size \>2cm will be eligible as well. * patients aged \> 18 years. * tumor considered resectable by the attending surgeon. * the patient must have an ecog \*2 or karnofsky \>60%. * the patients need to have adequate hematological, renal and hepatic function defined as: absolute neutrophil counts (anc\*) \*1.5 x 109/l platelet counts \*100 x 109/l total bilirubin \*1.25 x upper limit of normal distribution serum creatinine \ 60 ml/min * anc = segmented neutrophils + banded neutrophils * the patients should have recovered from any serious surgical sequellae. * informed consent must be obtained from the patient in accordance with the requirements of the irb/ec. * if female, the patient must not be pregnant or breast-feeding. women of child bearing potential need to have a pregnancy test performed and to take appropriate contraceptive action during the period of the study. * operability criteria: lung function test will be performed so as to confirm a predictive postoperative value of fev-1 \>-800 ml, i.e. correct homeostasis. a carbon monoxide diffusion test is to be conducted and, when applicable, repeated following the induction treatment while taking into account the sensitivity of post-chemotherapy pulmonary toxicity detection. exclusion criteria: * patients who have previously been treated with chemotherapy and/or radiotherapy. * history of significant cardiovascular disease such as non-controlled hypertension, unstable angina or congestive heart failure even if these are controlled by medication. documented history of acute myocardial infarction in the previous year, ventricular arrhythmias that required medication or 2nd or 3rd atrial-ventricular blocks. * pre-existing sensory or motor neurotoxicity grade \>2 based on the who criteria. * active infection or other clinical state that could seriously reduce the patient's capacity to tolerate the treatment protocol, including previous allergic reactions to products containing cremophor (e.g. cyclosporin or vitamin k). * previous or concomitant malignant tumor (with the exception of in situ cervical carcinoma, baso-cellular carcinoma, squamous cell skin carcinoma or urothelial superficial carcinoma) which are considered potentially curable with oncological treatment and have a disease free survival (dfs) greater than 5 years excepting breast cancer, melanoma and hypernephroma * marked psychoses or senility

Keywords: natch lung operable nsclc surgery plus adjuvant therapy surgery plus neoadjuvant therapy
a clinical pharmacology study of ts-142 in patients with obstructive sleep apnea hypopnea.

Conditions: Patients with Mild Obstructive Sleep Apnea Hypopnea

Summary: a study to evaluate the respiratory safety of ts-142 in patients with mild obstructive sleep apnea hypopnea.


Eligibility criteria:
inclusion criteria: * japanese male and female, age 20 years or older at the time of informed consent * patients who meet the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for obstructive sleep apnea hypopnea * other protocol defined inclusion criteria could apply exclusion criteria: subjects who meet any of the following criteria will be excluded from this study: * patients who meet the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria excepting obstructive sleep apnea hypopnea and insomnia disorder * patients who have clinically significant respiratory dysfunction (bronchiectasis, emphysema, asthma, etc.) other than obstructive sleep apnea hypopnea * patients with percutaneous arterial oxygen saturation (spo2) \<94% by pulse oximetry at visit 1 * other protocol defined exclusion criteria could apply
magnezixkids study

Conditions: Magnesium-based; Bioresrobable Implants; Pediatric Elbow Fractures; Osteosynthesis; Childhood; Magnezix; Elbow Fracture

Summary: the overall objective of the study is to describe the outcomes of osteosyn-thesis with magnesium based screws in children with a primary or second-ary (within 7 days from trauma) dislocated fracture of the epicondyles ul-naris or condylus radialis, and to compare them with outcomes of conven-tional osteosynthesis using steel screws. if our results suggest non-inferiority of osteosynthesis with magnesium-based screws, the procedure could be tested formally in a subsequent full-size study.


Eligibility criteria:
inclusion criteria: * primary or secondary (within 7 days from trauma) dislocated fracture of the epicondyles ulnaris or condylus radialis (indication for operative treatment according to international standard: dislocation of more than 2 mm in condylus radials fractures and more than 5 mm in epicondylus ulnas fractures ) * age 3-15 years * informed consent as documented by signature exclusion criteria: * - open fractures or complex multi fragment fractures that require dif-ferent osteosynthetic procedures than screw fixation * severe local accompanying injury (injury to nerves/vessels) * polytrauma patients * fracture age \> 7 days * preexisting ipsilateral elbow fracture * relevant comorbidities, which have influence on fracture and wound healing * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or the legal representatives * previous enrolment into the current study * enrolment of the investigator's family members and other dependent persons * any of the following applicable absolute and relative contraindica-tions listed in the magnezix® cbs and csc 4.8 mm instruction for use : absolute contraindications: * insufficient or avascular bone mass for anchorage of the implant, ex-cept osteochondral fractures and dissecates * confirmation or suspected septic infectious surgical site * application in the area of the epiphyseal plates relative contraindications: * acute sepsis * alcohol, nicotine and/or drug abuse * epilepsy * poor skin/soft tissue conditions * uncooperative patient or patient with restricted intellectual capacity * no options for adequate postoperative treatment (e.g. temporary strain relief)
probiotic intervention for acute stress

Conditions: Stress

Summary: efficacy of probiotics on acute stress


Eligibility criteria:
inclusion criteria: * 19-35 years * smbq-score ≥3.75 * understand swedish in spoken and written terms * willing and able to give written informed consent for participating in the study * intake of probiotics within two weeks prior to the start of the study exclusion criteria: * bmi\> 30 * pregnant * antibiotic treatment in the last three months * known disease (diabetes, pulmonary or cardiovascular disease, celiac disease, thyroid problems, gastrointestinal disease) or mental illness * use of psychotropic drugs, beta blockers, asthma or rheumatoid arthritis drugs, steroid drugs or local steroid treatment
optimized treatment of peginterferon alfa 2a/2b in treatment experienced patients with hbv related liver fibrosis

Conditions: Hepatitis B; Liver Fibrosis

Summary: compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis b surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. we design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment experienced patients with hbv related liver fibrosis.

compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis b surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. but there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with hbv related liver fibrosis. we design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment experienced patients with hbv related liver fibrosis.

Eligibility criteria:
inclusion criteria: 1. positive hepatitis b surface antigen or hepatitis b virus dna \> 0.5 year; 2. age from 18 to 55 years old; 3. fibrosis lever of f1 to f3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan; 4. portal vein diameter ≤ 12 mm from liver ultrasound; 5. receiving treatment of nucleoside/nucleotide analogues at the past one year; 6. normal liver function; 7. undetectable hepatitis b virus dna. exclusion criteria: 1. decompensated cirrhosis, hepatocellular carcinoma or other malignancy; 2. pregnancy or lactation; 3. other active liver diseases； 4. human immunodeficiency virus infection or congenital immune deficiency diseases; 5. severe diabetes, autoimmune diseases; 6. other important organ dysfunctions; 7. patients can not follow-up; 8. investigator considering inappropriate.

Keywords: hepatitis b virus peginterferon alfa liver fibrosis