Kornimate/medical-research-clean huggingface dataset:
trial of diphenhydramine for sleep in children with autism

Conditions: Autism; Autism Spectrum Disorder

Summary: the purpose of this study is to examine the effect of diphenhydramine on sleep in children and adolescents with autism spectrum disorder (asd). diphenhydramine is an anti-histaminergic agent with strong hypnotic properties. to accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of diphenhydramine on sleep physiology as assessed by polysomnography (psg), actigraphy, circadian rhythm, and clinical measures.


Eligibility criteria:
inclusion criteria: participants will meet the following * outpatients between 8 and 17 years of age at the time of consent * diagnostic and statistical manual, 5th edition (dsm-5) criteria for autism spectrum disorder (asd) on the basis of clinical evaluation, confirmed with the autism diagnostic interview-revised (adi-r) and the autism diagnostic observation schedule, 2nd ed (ados-2) * males and females * availability of polysomnography (psg) or actigraphy data * sleep disturbances as assessed using children's sleep habits questionnaire (cshq) with a score of 41 or higher * care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis * stable medications for at least 2 weeks, with the exception of prozac which is required to be stable for at least 4 weeks * no planned changes in psychosocial and biomedical interventions during the trial * willingness to provide additional saliva samples and participate in key study procedures (i.e.,safety measurements every visit, psg at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial). exclusion criteria: participants will be excluded if one or more of the following is met * active suicidal ideation or dsm-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder * active medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology) * evidence of a genetic mutation known to cause autism or intellectual disability (e.g., fragile x syndrome), metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism and chromosomal analysis * pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study) * individuals taking beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, melatonin and antihistamines * history of hypersensitivity to diphenhydramine * history of severe side effects from diphenhydramine * history of adequate trial of diphenhydramine * current use of any medications known to interact with diphenhydramine such as medications inhibiting cyp2d6 * taking anticholinergic agents (e.g., trihexyphenidyl, thioridazine).

Keywords: diphenhdramine sleep clinical trial autism
prevention of dental caries lesions with fluoride varnish in erupting first permanent molars

Conditions: Dental Caries

Summary: the aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. using as reference icdas criteria, when the success means that the surface maintain an icdas value 0 and failure that has change in icdas value 0 to 1. sample: the sample comprise 180 patients between 6-7 years old with high-risk of dental caries. study design: it proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(group a: every 6 month; group b: every 3 month; group c: positive control).


Eligibility criteria:
inclusion criteria: * informed consent from parents. * child assent * high risk of dental caries * at least one sound first permanent molar (icdas=0) exclusion criteria: * bad behaviour * any systemic condition, disability

Keywords: dental caries fluoride varnish preschool child prevention
web-based epilepsy education program for adolescents and parents

Conditions: Epilepsy

Summary: this study aims to develop a web-based epilepsy education program for adolescents with epilepsy and their parents and to evaluate the efficacy of eb-based epilepsy education program on health management.eb-based epilepsy education program has been proved to be a useful and reliable educational website for the development of knowledge, attitude, self-efficacy and e-health literacy of adolescents with epilepsy and their parents.

this study aims to develop a web-based epilepsy education program for adolescents with epilepsy and their parents and to evaluate the efficacy of web-based epilepsy education program on health management. this randomized controlled study was conducted with 69 adolescents with epilepsy aged between 9-18 and their parents (n=71) who were accepted to pediatric neurology policlinic of antalya training and research hospital of health science university between november 2017 and april 2018. the study sample was divided into two groups as study (35 adolescents, 37 parents) and control (34 adolescents, 34 parents) groups using simple randomization method. the web-based epilepsy training program which was developed during the preparation stage of the study was evaluated by 13 experts using the quality of criteria for consumer health information measurement instrument. the data collection materials (seizure self efficacy scale, e-health literacy scale, child attitude toward illness scale, website analysis and measurement inventory scale) were administered by the researcher to the adolescents and parents in both groups before applying eb-based epilepsy education program. following the administration of eb-based epilepsy education program to the initiative group, all participants were observed for three months. the data collection materials were reapplied to all the participants at the end of the third month. in addition, the adolescents and their parents in the study group were applied website analysis and measurement inventory measurement tool for the evaluation of usability of the site.

Eligibility criteria:
inclusion criteria: * adolescents without mental disability, * followed-up for at least six months with epilepsy diagnosis, * no chronic disease other than epilepsy, * no photosensitive epilepsy diagnosis, * internet access and use, and parents of these adolescents with internet access and use - were included in the study. exclusion criteria: * adolescents and parents who do not use the internet

Keywords: epilepsy web based education pediatric nursing parent adolescence
bioequivalency study of losartan potassium/hydrochlorothiazide 100 mg/25 mg tablet under fasted conditions

Conditions: Hypertension

Summary: the objective of this study was to prove the bioequivalence of losartan potassium/hydrochlorothiazide 100/25 mg tablet under fasted conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to losartan potassium hydrochlorothiazide or any comparable or similar product.
fecal microbiota transplantation in patients with multiple drug resistant klebsiella pneumoniae pneumonia

Conditions: Klebsiella Pneumoniae Pneumonia

Summary: multidrug-resistant klebsiella pneumoniae (mdr-kp) infections account for 10% of all nosocomial infections, and even with effective antibiotics, the mortality rate is as high as 50%. intestinal bacteria transplantation can not only treat intestinal diseases, but also inhibit the colonization and proliferation of drug-resistant bacteria. this study explored the therapeutic value of fecal microbiota transplantation in patients with mdr-kp pneumonia.

intervention study (controlled clinical study) : patients with multidrug-resistant klebsiella pneumoniae pneumonia were randomly assigned to the experimental group (conventional antibiotic treatment + fecal microbiota transplantation) and the control group (conventional antibiotic treatment); the clinical symptoms, inflammatory indexes, immune indexes, intestinal microecology, respiratory microecology and antibiotic resistance gene changes were compared between the two groups.

Eligibility criteria:
inclusion criteria: * age 18-75; * meet the diagnostic criteria for community-acquired pneumonia or hospital-acquired pneumonia; * the etiological results of sputum or alveolar lavage fluid suggested mdr-kp infection; * the patient or his family members voluntarily participated, collected alveolar lavage fluid and stool samples, agreed to perform fmt treatment, and signed the informed consent. exclusion criteria: * subjects with persistent bronchial asthma, severe pulmonary dysfunction, or inability to tolerate bronchoscopy; * patients with severe damage of intestinal barrier such as sepsis and digestive tract perforation due to various reasons; * those currently diagnosed with explosive colitis or toxic megacolon have gastroesophageal reflux disease or peptic ulcer; subjects taking probiotics within 6 months; * enteral nutrition patients who could not tolerate 50% of heat calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula and other reasons. * patients with obvious bleeding tendency, severe pulmonary hypertension, superior vena cava obstruction, and aortic aneurysm rupture risk; * patients with malignant hypertension, recent myocardial infarction (≤6 months), severe arrhythmia, and cardiac insufficiency; * suffering from malignant tumor diseases, congenital or acquired immune deficiency diseases, other systemic inflammatory response diseases; * those who have recently been treated with high-risk immunosuppressive/cytotoxic drugs, such as rituximab, doxorubicin, or steroid hormones (20mg/d ponisone or higher) for more than 4 weeks; * severe immunosuppression: adult neutrophils \<1 500/mm3, child neutrophils \<1 000/mm3; * pregnancy or lactation; * there is a mental disability or active mental illness that prevents informed consent; * conditions deemed unsuitable for study inclusion by other clinicians.

Keywords: fecal microbiota transplantation multiple drug resistant klebsiella pneumoniae pneumonia
eyeconic: qualification for cone-optogenetics

Conditions: Retinal Dystrophies

Summary: this study aims to prepare for the first-in-human clinical trial of cone optogenetics vision restoration. as a first step, this worldwide multicenter ocular imaging study (eyeconic study) is performed to identify eligible patients.

in a subset of patients with inherited retinal dystrophies (irds), cones lose their light-sensitive outer segments but remain alive in a dormant stage. this creates an opportunity to resensitize them through targeted optogenetic tools. however, the true proportion of low vision patients harboring dormant, non-functional cones, is currently unknown. the worldwide multicenter retrospective study (eyeconic) aims to estimate the proportion of low vision patients with remaining cone cell bodies for the first time.

Eligibility criteria:
inclusion criteria (patients): * diagnosis of generalized ird * low vision as defined as visual acuity worse or equal to 0.05 (or 20/400) in the study eye * availability of macular optical coherence tomography (oct) inclusion criteria (controls): * normal ophthalmic findings * availability of macular optical coherence tomography (oct) exclusion criteria (all): * other eye diseases with a significant effect on vision or retinal structure * extraocular disease affecting retinal structure such as neurodegenerative diseases

Keywords: cone-optogenetics rod-cone dystrophy cone-rod dystrophy generalized retinal dystrophies inherited retinal disease
diabetes prevention in clinical practice.

Conditions: Type 2 Diabetes

Summary: we randomize individuals with impaired glucose tolerance to one of three arms for degree of physical activity: 1. continue with your current life style; 2. ordinary life activities for increased physical activity; 3. scheduled group activities for changed behavior. the overall aim is to focus on change of physical activity and to keep other life style activities more or less unchanged (diet, smoking, etc) and the effect on metabolic variables.


Eligibility criteria:
inclusion criteria: 1. impaired glucose tolerance 2. age: 20-85yrs exclusion criteria: 1. type2 diabetes 2. significant disease making life style changes unlikely to happen 3. unable to communicate in swedish

Keywords: diabetes insulin resistance exercise
snow properties and its modeling for studying gas exchange under the simulated avalanche snow

Conditions: Accident Caused by Snow Avalanche

Summary: the aim of the study is to investigate respiratory parameters of a person in the simulated avalanche snow and consequent use of the measured data for development of a mathematical-physical model of breathing during increasing hypercapnia in the avalanche.

the study is a part of a university research project aimed at studying physiological conditions and development of breathing parameters of a person breathing in the simulated avalanche snow. presence of an air pocket and its size play an important role in survival of victims buried in the avalanche snow. even small air pockets facilitate breathing, yet they do not provide a significant amount of fresh air for breathing. the investigators hypothesize that the size of the air pocket significantly affects the airflow resistance and work of breathing. the aim of the study is to investigate the effect of the air pocket volume on gas exchange and work of breathing in subjects breathing into the simulated avalanche snow.

Eligibility criteria:
inclusion criteria: * healthy and fit volunteers, classified as the american society of anesthesiologists class i * without a smoking history exclusion criteria: * tiffeneau index less than 0.70 * any cardiovascular or respiratory condition

Keywords: snow avalanche hypercapnia work of breathing
the effects of gabapentin premedication on neurosurgery

Conditions: Cerebral Tumor

Summary: the study is to observe the effects of gabapentin premedication on postoperative pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are randomized into groups gabapentin(gg) or placebo(gp). patients are given gabapentin or placebo orally the night before operation day and 2hours before surgery,respectively.the investigators hypothesized that lower incidence of postoperative pain,vomiting and nausea be observed in gg than gp.

this is a random, double-blind study. in gg, patients are given gabapentin 600mg orally at the night and 2hours before surgery, respectively. in pg, vitamine pills are given instead.total intravenous anesthesia is applied for all patients. 1hour, 2hours,1day, 2days, 3months and 6months after surgery, patients are evaluated for pain (vas) and incidence of ponv. in addition,glasgow score, ramsay score and other gabapentin-related effects, such as somnolence,dizzy or dry mouth are also observed.the incidence of persistent pain and neuropathic pain was assessed at the 3-mo and 6-mo postoperative evaluation.

Eligibility criteria:
inclusion criteria: * 18-65 years old, asa physical status i or ii, bmi\<30 * scheduled for elective craniotomy * cooperative and given informed consent in person exclusion criteria: * history of mental or psychiatric disorders * pregnant or lactating female * history of systemic malignant tumor or diabetes * previously treated with this protocol or participated in another experimental study within previous 30 days * suspected history of allergic reaction or intolerance to gabapentin or other anesthetic agents in this study * history of alcohol abuse and/or drug abuse within previous one year

Keywords: gabapentin postoperative pain vomiting nausea
observational study describing conditions for intensification of insulin therapy in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this observational study is to determine diabetes control improvement, during the third month of follow-up after insulin intensification to at least 3 daily insulin injections, in assessing the proportion of uncontrolled fasting and postprandial glycaemia values recorded on a diary.


Eligibility criteria:
inclusion criteria: * type 2 diabetes patients * treatment with two insulin daily injections and needing insulin intensification regimen to at least three daily injections * hba1c greater than or equal to 8.0% exclusion criteria: * patients not performing glycaemia self-measurements * secondary diabetes * requirement of or use of an insulin pump * treatment with corticoids
assessing frailty and its impacts on patients facing major gi surgery

Conditions: Bowel Cancer

Summary: the study team will look at 3 new tests that will make it easier to measure frailty in patients awaiting surgery for cancer and compare them against standard clinical measures of frailty in a pilot study. the expected outcome is that evidence will be collated in order to apply for a major grant to look at improving the care of frail patients with cancer in the future.

over 40% of patients with bowel cancer are over the age of 75. in older patients, rates of ill health and frailty are high, with frailty found in 6 in 10 patients over the age of 90. surgery is the main treatment for bowel cancer, but the risks of surgery are higher in older people especially if they are frail. the main features of frailty are weight loss, lack of energy, weakness, slow walking speed and low activity levels. frailty is a condition linked to an increased risk of death and major complications after surgery. as a result, older and frailer patients are often refused surgery for their cancer. if we could identify frailty more reliably before surgery, we could offer patients better counselling about the surgical risks and benefits. we could also offer treatments that might improve their fitness, making the surgery safer (pre-operative exercise, better post-operative support). surgeons are not very good at measuring frailty because the clinical tests for it are complicated and take a long time to complete.

Eligibility criteria:
inclusion criteria: 1. male or female. 2. aged 70 years and over. 3. patients with a diagnosis of primary operable colorectal cancer where treatment includes a planned curative surgical procedure. 4. about to undergo elective surgery for cancer. 5. mental capacity to consent. exclusion criteria: 1. patients with unresectable cancer. 2. patients presenting as an emergency. 3. patients who are having chemotherapy or radiotherapy before their surgery.
clinical application of lutetium [177lu]-catalase in tumor radionuclide therapy

Conditions: Advanced Malignant Neoplasm

Summary: the purpose of this study is to evaluate the retention in tumour and distribution behavior of \[lu-177\]-catalase after intratumoral injection,and preliminary evaluation the efficacy and safety of \[lu-177\]-catalase.

after being informed about the study and potential risks, all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. at day1, patients who meet the eligibility requirements will be intratumoral injection the \[lu-177\]-catalase.the efficacy evaluation will be conducted at one month p.i., whether to continue intratumoral injection the \[lu-177\]-catalase, depending on the patient's efficacy and safety results.

Eligibility criteria:
inclusion criteria: 1. male or female patients, aged 18-70 years; ecog score 0 or 1; 2. patients with advanced malignant tumors, such as liver cancer, ovarian cancer, prostate cancer, and so on, clearly diagnosed by pathology and/or cytology; 3. patients with advanced solid tumors who have failed or cannot tolerate standard treatment; 4. expected survival of more than 3 months; 5. according to the solid tumor efficacy evaluation criteria , the patient had at least one measurable or evaluable tumor lesion with the longest diameter ≥10 mm at baseline (in the case of lymph nodes, the short diameter ≥15 mm). this lesion is suitable for intratumoral injection (the length of the lesion is at least 1 cm or equal). 6. blood routine and liver and kidney function meet the following criteria: blood routine: wbc≥4.0×109l or neutrophil ≥1.5×109l, plt≥100×109/l, hb≥90g/l; pt or aptt≤1.5uln; liver and kidney function: t-bil≤1.5×ult(upper limit of normal),alt/ast≤2.5uln or ≤5×ult(subjects with liver metastasis), alp≤2.5uln(alp≤ 4.5uln if there is bone metastasis or liver metastasis); bun≤1.5×ult, scr≤1.5×ult; 7. women must use effective contraception during the study period and for 6 months after the study (effective contraception means sterilization, intrauterine hormone devices, condoms, contraceptives/pills, abstinence or partner vasectomy, etc.); men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period; 8. can understand and voluntarily sign informed consent, compliance is good the exclusion criteria: 1. severe abnormal liver and kidney function; 2. pregnant, pregnant and lactating women; 3. can not lie flat for half an hour; 4. refuse to join the clinical investigator; 5. suffering from claustrophobia or other mental illness; 6. other conditions deemed unsuitable for participation in the trial by the investigator
effect of virtual reality on cognitive skills

Conditions: Virtual Reality

Summary: the aim of this study is to investigate the effects of virtual reality (vr) intervention on cognitive skills in children with attention deficit hyperactivity disorder (adhd).

the study was designed as a randomized controlled trial. a simple randomization method will be used to randomly assign individuals to two groups (intervention and control groups). a simple randomization method will be used where the intervention and control group papers are selected from a sealed envelope. following the initial assessment of each participant, one of the papers labeled "intervention" or "control" will be randomly selected. this decision will determine whether the individual will be assigned to the intervention or control group. the study will be conducted at hacettepe university. the intervention group will receive occupational therapy (ot) for 30 minutes once a week for 8 weeks and will play a virtual reality (vr) game with the sony playstation 2 eye toy system for 20 minutes. both the intervention and control groups will receive occupational therapy for only 30 minutes once a week for 8 weeks. the dynamic occupational therapy cognitive assessment (dotca-ch) will be administered before and after the intervention to assess children's cognitive functions.

Eligibility criteria:
inclusion criteria: * being between the ages of 7-12, having diagnosed with adhd by a child psychiatrist in accordance with the dsm-5 diagnostic criteria, having stabilized medications used for adhd, being open to communication, and being able to understand and follow instructions at a basic level exclusion criteria: * having any neurological, orthopedic or psychiatric diagnosis in addition to adhd diagnosis, having undergone any surgical intervention in the last 3 months, being inadequate in understanding visual and auditory commands, and having a visual or hearing impairment.

Keywords: attention deficit and hyperactivity disorder cognitive functions motor skills virtual reality