Kornimate/medical-research-clean huggingface dataset:
therapy program for academic skills in children with intellectual disability

Conditions: Intellectual Disability, Mild; Educational Problems

Summary: the aim of this study is to investigate the effect of a physical and occupational therapy program on academic skills in a sample of egyptian children with intellectual disability. it also aims to provide a program based on physical and occupational therapy activities and techniques to develop children's basic abilities through play to make learning more enjoyable

this study hypothesis 1. there are statistically significant differences between the mean scores of the children of the experimental group in the pre and post measurements on the academic skills scale for children with mental disabilities and its sub-components in favor of the post measurement. 2. there are no statistically significant differences between the mean scores of the children of the experimental group in the post and follow-up measurements on the academic skills scale for children with mental disabilities and its sub-components. research question: what is the effect of a physical and occupational therapy program in improving academic skills (reading - writing - arithmetic) in a sample of children with mild intellectual disabilities? the study should include 20 children diagnosed with mild intellectual disability according to stanford binet scale 5th edition between the age of 8 to 10 years old from both sexes recruited from noor al-sabah association for the care and rehabilitation of people with intellectual disabilities from children with mild mental disabilities

Eligibility criteria:
inclusion criteria: 1. the child should be between 8 and 10 years of age of both sexes 2. the child should be of mild intellectual disabilities according to stanford binet scale 5th edition 3. the child should not be suffering from any apparent physical deformity in upper limbs, lower limbs or spine 4. the child should not suffer from any visual or auditory disorder exclusion criteria: 1. children out of age range 2. children with moderate or severe intellectual disabilities 3. children with physical deformities in upper limb, lower limb or spine 4. children suffering from visual or auditory disorders 5. children of parents who refuse to sign the consent form
evaluation of nebulization and positive expiratory pressure combination

Conditions: Cystic Fibrosis; Healthy Subjects

Summary: the purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination


Eligibility criteria:
inclusion criteria: * stable cystic fibrosis patients older than 16 y.o. * healthy subjects exclusion criteria: * kidney failure * no pregnancy
evaluating the role of inflammation in neonatal epileptogenesis

Conditions: Neonatal Seizure; Epilepsy; Seizures; Inflammatory Response

Summary: the purpose of this study evaluate the relationship between inflammation and epilepsy in neonates with seizures after birth.

seizures are a common symptom of neurologic dysfunction in the neonatal period, affecting more than 16,000 newborns in the united states per year. over 25% of neonates with acute symptomatic seizures develop post- neonatal epilepsy (pne), which is often resistant to medical therapies. there is a critical need to identify those patients most at risk for pne and understand the mechanisms by which early seizures increase the propensity for recurrent seizures, in hopes of identifying novel therapeutic targets in this population. there is increasing evidence for the role of neuro-inflammation in the development of epilepsy. levels of cytokines and micro-rna (mirna) may serve as markers of disease severity and have been implicated in epileptogenesis in animal models. the purpose of this study is to evaluate plasma cytokine and mirna levels after neonatal-onset acute symptomatic seizures and determine their association with acute seizure severity and pne.

Eligibility criteria:
for participants in the acute symptomatic seizure group: inclusion criteria: * neonates \<44 weeks corrected age at seizure onset * seizures due to acute brain injury * parent(s) who are english or spanish literate (with assistance of interpreter) exclusion criteria: * neonates at risk for adverse outcome independent of seizures and underlying brain injury * neonates with mild, temporary causes for seizures * newborns with neonatal-onset epilepsy syndromes * neonates who do not survive the initial hospital admission * neonates will not be excluded based on race, ethnicity, gender or gestational age for participants in the control group: inclusion criteria: * neonates that are born \> 37 weeks and \<44 weeks postmenstrual age at enrollment * consultation by the pediatric neurology inpatient service due neonatal paroxysmal events, with normal neurologic examination and ultimate diagnosis of non-epileptic spells on continuous video-eeg (ordered for clinical purposes, not for research) or consultation for hypoxic ischemic encephalopathy in neonates undergoing therapeutic hypothermia, with early exit from therapy owing to normal neurologic examination, normal continuous video-eeg and uncertain diagnosis of encephalopathy. * neonates requiring neurologic consultation for mild hypoxic-ischemic encephalopathy (hie) undergoing therapeutic hypothermia, with normal examination, ceeg, and neuroimaging upon rewarming.

Keywords: neonatal seizure inflammation cytokine micro-rna epilepsy eeg
shr - 1209 treatment efficacy and safety of the patients with hypercholesterolemia ⅲ period clinical research

Conditions: Primary Hypercholesterolemia

Summary: this study is ongoing to evaluate the efficacy and safety of shr-1209 in patients with hypercholesterolemia.


Eligibility criteria:
inclusion criteria: 1. any male or female aged between 18 and 80 on the date of signing the informed consent; 2. diagnosed as hypercholesterolemia ; 3. fasting triglyceride was less than 5.6 mmol/l during screening: 4. understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent. exclusion criteria: 1. a history of the following diseases or treatments during the screening period: 1. known allergies to pcsk9 inhibitors or test drugs, or severe allergic reactions to other antibody drugs in the past; 2. participated in clinical studies of other drug interventions within the last 1 month (except for patients who failed in screening), or those who are within 5 half-lives of the drug before screening (whichever is longer); 2. any of the laboratory test indicators meets the following criteria: 1. alanine aminotransferase (alt) or aspartate aminotransferase (ast) was more than 3 times the upper limit of normal value (uln), and total bilirubin was more than 2 times uln during the screening period or at random; 2. the creatine kinase (ck) was more than 3 times of uln during the screening period or at random; 3. have used the following drugs: 1. pcsk9 inhibitors had been used in the previous 6 months; 2. continuous systemic corticosteroid therapy with doses exceeding or equivalent to 10mg of prednisone (oral or intravenous) within the previous 3 months was screened. 4. other circumstances: 1. women of reproductive age who are fertile but did not use contraception within 4 weeks before the screening period;women who are pregnant or breastfeeding;not agreed during the trial or at 24 weeks after the last dose 2. subjects who are considered by the investigator to have any unsuitable factors for participating in the study or who have poor compliance.
evaluation of the thyroid volume after radiofrequency ablation of thyroid nodules and recurrent thyroid

Conditions: Thyroid Nodule

Summary: thyroid nodules are among the common alterations of the thyroid. depending on the detection method the prevalence is between 20% and 50%, whereas the incidence increases with improvement of ultrasonic technology. the celonpro surge bipolar coagulation electrode operated with the compatible power control unit and compatible tube pump is indicated for ablation and coagulation of soft tissue, including thermal inactivation and/or volume reduction of locally defined tissue areas, such as tumors and metastases. the primary objective of the study is to assess the influence of radiofrequency ablation due to thyroid volume after 24 hours, 3 months, 6 months and 1 year.


Eligibility criteria:
inclusion criteria: * the patient must have given written (personally signed and dated) informed consent before completing any study-related procedures (i.e. any assessment or evaluation that would not have formed part of their normal medical care). * the patient must be aged 18yrs or older. * the patient must be able to understand, and be willing to comply with the requirements of the protocol * the patient is not pregnant * the patient has the diagnosis of benign thyroid nodules, struma diffusa, struma uninodosa, struma multinodosa, struma per magna, thyroidea nodosa or thyroidea multinodosa * the patient rejected surgery the patient rejected sole radioiodine therapy exclusion criteria: * malign nodules * pregnancy * pacemaker near the target issue (\<4cm) * nerve stimulating device * high fever * prosthesis for the inner ear

Keywords: thyroid nodule bipolar coagulation electrode radiofrequency ablation
prevalence and natural history of functional gastrointestinal disorders among at-risk infants.

Conditions: Functional Gastrointestinal Disorders; Gastroesophageal Reflux; Constipation - Functional; Diarrhea; Dyschezia; Colic, Infantile; Vomiting; Cyclical

Summary: the goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (fgid) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. the main questions it aims to answer are: * evaluate the prevalence of symptoms related to gastro-esophageal reflux (ger), of functional gastrointestinal disorders during the first 2 years of life * describe growth parameters during follow-up up to the corrected age of 2 years participants will be assessed clinically and with a structured questionnaire based on the rome iv criteria to describe fgid.

infants will undergo clinical assessment at 3, 6, 12, 24 months' corrected age at the local follow-up clinic. clinical examination, anthropometric measurement and data from a structured questionnaire to detect fgid will be performed. z-scores for weight, length and head circumference will be calculated according to the world health organization (who) standards. data from the questionnaires will be collected. clinical characteristics of patients and perinatal data will be collected and analyzed by appropriate statistical methods. the prevalence and characteristics of fgid in the study population will be compared to published data (mostly from term infants).

Eligibility criteria:
inclusion criteria: * infants with gestational age at birth \< 31 weeks * infants with gestational age at birth \< 37 weeks and major respiratory or neurologic morbidity * infants with history of perinatal asphyxia exclusion criteria: * lack of informed consent * diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)
desensitizing effect and tooth color change after using giomer-based varnish versus bioactive glass air polishing in treating cervical hypersensitive lesions

Conditions: Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG

Summary: this trial is test the dentin hypersenstivity using giomer based varnish versus bioactive glass air polishing system in patients with non-cervical lesions.

to investigate the clinical effectiveness of giomer based varnish versus bioactive glass air polishing system in the management of dentin hypersensitivity and tooth color change in the cervical lesions. p:patient/population: middle aged patients complaining of cervical dentin hypersensitivity. i: giomer varnish containing surface pre-reacted glass fillers. c: bio-active glass air polishing system: o:dentin hypersenstivity (primary outcome) was assessed by three different stimuli (evaporative , thermal and tactile) . o: color change (secondary outcome). t: baseline, t1, t2, t3. s:a randomized clinical trial.

Eligibility criteria:
inclusion criteria: * participants complaining from dentin hypersensitivity. * middle aged patients. * good oral hygiene. exclusion criteria: * pregnant women. * patients with allergy to any material used in this study. * smoking patients will affect the oral hygiene and periodontal health. * patients taking anti-inflammatory drugs that will affect the perception of hypersensitivity. * systemically compromised patients. * smokers. * patients received desensitization treatment in the last 6 months
risk factors of preterm birth born in hospital：a prospective multicenter case-control study

Conditions: Risk Factors

Summary: the purpose of this study is to explore the perinatal risk factors of preterm birth in china.

preterm birth is a global scourge, and the leading cause of newborn deaths (babies in the first 4 weeks of life) and raised to the leading cause of death among children under 5 years of age, responsible for approximately 1 million deaths in 2015. in china, the prevalence of preterm increased from 4\~5% in 1990s to 7\~10% in 2010. preterm birth become a burden to both the family and society. therefore, the risk factors of preterm birth become the critical issue of both obstetrics and neonatology. more importantly, few multicenter prospective studies on risk factors of preterm birth included potential reasons such as maternal occupation, psychology condition and lifestyles during pregnancy were conducted in china. thus, the aim of our study is to explore the perinatal risk factors of preterm birth nowadays in china.

Eligibility criteria:
inclusion criteria: * live-born infants \>20weeks of gestational age exclusion criteria: * stillbirth

Keywords: premature birth; risk factors
do discounted vouchers for medical cannabis reduce opioid use in adults with pain

Conditions: Opioid Use; Marijuana; Chronic Pain

Summary: this study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. our study findings will have critically important implications to shape clinical care and medical cannabis policies.

this study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. releaf-v is a 4-arm blinded randomized controlled trial (rct) of 352 adults with (a) severe or chronic neuropathic or joint pain, (b) opioid analgesic use, and (c) active certification for medical cannabis. we will randomize participants to a discounted voucher for: 1) a placebo soft-gel capsule product, 2) high thc:low cbd soft-gel capsule product (4.3mg thc/0.7mg cbd), 3) equal thc:cbd soft-gel capsule product (2.5mg thc/2.5mg cbd), or 4) low thc:high cbd soft-gel capsule product (0.2mg thc/4.8mg cbd). over 14 weeks, participants will have 5 research visits in which data will be collected from questionnaires, and medical and prescription monitoring program (pmp) records. the primary independent variable will be randomization arm, and the primary outcome will be cumulative opioid analgesic dose.

Eligibility criteria:
inclusion criteria: 1. \>18 years old 2. english or spanish fluency 3. active certification for medical cannabis 4. intends to have a soft-gel capsule product dispensed at vireo health 5. medical cannabis qualifying conditions or complications of (a) chronic pain, or (b) pain that degrades health and functional capability as an alternative to opioid use or substance use disorder or (c) severe or chronic pain 6. joint or neuropathic pain 7. current severe pain 8. dispensed opioids analgesics within the last 60 days to maintain the integrity of the study, we do not disclose all inclusion criteria to potential participants. exclusion criteria: 1. inability to provide informed consent 2. inability to complete study visits over 14 weeks 3. terminal illness 4. current or prior psychotic disorder 5. current or prior buprenorphine or methadone treatment for opioid use disorder 6. nys medical marijuana prescriber does not approve changes to product and dosing recommendations listed on the participant's certification form 7. allergy to tapioca or coconut 8. currently pregnant, planning to become pregnant within the next 3 months, or breastfeeding 9. a condition that is considered by a pharmacist or medical provider to be a clinical contraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specific drug-drug interaction)

Keywords: opioid marijuana cannabis pain
castrate resistant prostate cancer enhertu therapy

Conditions: Prostate Cancer Metastatic; Prostate Cancer; CRPC

Summary: use of enhertu as a subsequent line of therapy in her2-positive metastatic castration-resistant prostate adenocarcinoma.

this phase ii clinical trial aims to evaluate the efficacy and safety of enhertu in her-2 positive mcrpc who have progressed on prior androgen deprivation therapy and novel hormonal agents, who are either not candidates for or have refused taxane based chemotherapy. led by dr. maneesh jain at the washington dc va, the open label multi center study will include 60 participants treated with enhertu. primary endpoints focus on objective response rates, while secondary measures include safety, progression-free survival, overall survival, and quality of life.

Eligibility criteria:
inclusion criteria: * pathologically confirmed adenocarcinoma of the prostate * diagnosis of mcrpc * documented progression on androgen deprivation and novel hormonal agents, with or without progression on taxane containing regimen * ongoing adt to maintain serum testosterone levels below 50 ng/dl * formalin fixed paraffin embedded tumor tissue for her2 immunohistochemistry * life expectancy 6 months * ecog 0 or 1 * lvef at least 50% * adequate blood clotting function * adequate organ and bone marrow function * adequate renal function * adequate hepatic function exclusion criteria: * history of interstitial lung disease or pneumonitis requiring steroids * significant coronary vascular disease * previous exposure to her2 targeted therapy

Keywords: prostate cancer metastatic prostate cancer enhertu her2 positive trastuzumab deruxtecan crpc phase 2
nephropathy in type 2 diabetes and cardio-renal events

Conditions: Diabetic Nephropathy

Summary: the nid-2 study, a multicentric study (21 centres enrolled), was planned in two phases: phase 1(observational study, completed in september 2005): after the identification of a type-2 diabetic population with typical diabetic nephropathy (dn), to study of the rate of renal and cardiovascular events during a middle term follow-up. phase 2(interventional study, started in october 2005): after randomization in two groups, a group (intervention group) is treated with an intensive multifactorial intervention whose aim is to reduce morbidity and mortality due to diabetic complications. the other group (control group) continues the conventional therapy . to avoid bias in the treatment in each center, the randomization was performed for centre.

the same patients that completed the first phase of the nid-2 study (observation) were enrolled for the phase 2 of the study (intervention).

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients * albumin extraction rate (aer= \>30 mg/die (micro- or macro-albuminuric ranges) in at least two determinations in the last six months * diabetic retinopathy * patients followed in the outpatients clinic for at least 12 months exclusion criteria: * type 1 diabetic patients * \<40 years old

Keywords: type 2 diabetes nephropathy cardiovascular (cv) events
cardiovascular risk stratification in patients with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea; Obesity

Summary: the purpose of this study is: 1. to determine the frequency of cardiovascular diseases in patients with osa, obese, overweight, and lean (bmi\<25) 2. to analyze the cpap treatment over the clinical evolution of osa patients 3. to determine if osa is a independent predictor of cardiovascular risk

obstructive sleep apnea (osa) is a condition with important cardiovascular repercussions. however, the association between osa, cardiovascular diseases, and obesity has not been totally clarified. we hypothesized that the cardiovascular consequences of osa are due to obesity.

Eligibility criteria:
inclusion criteria: * men and women with osa (apnea-hypopnea index higher than 5 events/hour) exclusion criteria: * body mass index higher than 40
chronic pain after cardiothoracic surgery

Conditions: Chronic Pain; Thoracic; Chronic Pain Syndrome

Summary: this is a prospective cohort study to estimate prevalence of chronic pain after cardiothoracic surgery

this is a prospective cohort study of all patients undergo cardiothoracic elective surgery in cipto mangunkusumo hospital using general anesthesia. patients with emergency surgery, history of psychologic and neurologic disease which cannot reliably state their pain score, cannot communicate well, and disagree to follow the research will be exempted. the pain score will be recorded one week after surgery during walk-in consultation, followed by 3 months and 6 months after surgery via telecommunication.

Eligibility criteria:
inclusion criteria: * patients undergo elective sternotomy and/or thoracotomy using general anesthesia * patients agree to follow the study exclusion criteria: * patients undergo emergency sternotomy or thoracotomy * patients with pyschological and neurological disorder, that it is not reliable to determine the pain intensity * patients who cannot communicate * patients disagree to follow the study

Keywords: chronic pain thoracotomy sternotomy cardiothoracic surgery
randomized trial of fulvestrant with or without dasatinib in men and postmenopausal women who have hormone receptor-positive advanced breast cancer previously treated with an aromatase inhibitor

Conditions: Advanced Breast Cancer

Summary: the purpose of this study is to find out what effect the combination of fulvestrant (faslodex) and dasatinib (sprycel) has on advanced breast cancer compared to fulvestrant alone.


Eligibility criteria:
for more information regarding bristol-myers squibb (bms) clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * histologically confirmed hormone receptor positive (hr+) \[(estrogen receptor (er+) and/or progesterone receptors(pgr+)\] breast cancer according to immunohistochemistry (ihc) * measureable or evaluable-only disease * human epidermal growth factor receptor 2+ (her2+) or her2- breast cancer * males and females ≥18 years of age * females are post menopausal or surgically sterile * recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that has progressed: (a) during or within 12 months after completion of adjuvant aromatase inhibitor (ai) treatment or (b) during ai treatment in advanced setting (metastatic therapy) exclusion criteria: * pregnant or breast feeding * \>1 chemotherapy regimen for advanced disease * pleural or pericardial effusion * serious cardiac condition