Kornimate/medical-research-clean huggingface dataset:
digital dyadic family based intervention to improve sleep in children with odd and their parents: nitecapp sincc (pilot)

Conditions: Oppositional Defiant Disorder; Insomnia Chronic

Summary: in this proposal a brief web-based cognitive behavioral treatment for insomnia (cbt-i) for children with oppositional defiant disorder (odd) and their parents is iteratively adapted and tested for acceptability, feasibility, and preliminary efficacy.


Eligibility criteria:
inclusion criteria: 1. child ages 8-17 with odd (prior diagnosis) and insomnia 2. child and parent english proficiency. insomnia: 1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos 2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia 3. baseline diaries and actigraphy indicate \>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights exclusion criteria: 1. parent unable to provide informed consent or child unable to provide assent 2. family unwilling to accept random assignment 3. child/parent participation in another randomized research project 4. parent unable to complete forms or implement treatment procedures due to cognitive impairment 5. child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias) 6. child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin 7. child participation in non-pharmacological treatment (including cbt) for sleep outside current trial 8. parent report of inability to undergo holter monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts) 9. other conditions adversely affecting trial participation
gesture behavior and knowledge on low back pain among nurses

Conditions: Low Back Pain

Summary: the aim of the proposed study is to evaluate knowledge on low back pain and gesture behavior among nurses with low back pain using validated measures and compare the findings to those from nurses without back pain.

a controlled, cross-sectional study will be carried out with 100 nurses (50 with low back pain and 50 without low back pain). the following assessment measures will be employed: visual analogue scale (vas) for pain, gesture behavior test (gbt), low back pain knowledge questionnaire (lkq), roland morris questionnaire and the sf-36.

Eligibility criteria:
inclusion criteria: * non-specific chronic low back pain, * performance in the hospital sector (hospitals, emergency rooms and/or intensive care units, * hourly load of at least 6 hours per day, * low back pain on most days in the last three months, * pain greater than 3 cm in visual analog scale (vas). exclusion criteria: * dispute, * previous surgery of the spine, * pregnant.

Keywords: nurses low back pain gesture behavior knowlegde
the scleroderma biorepository and pathogenesis study (stop scleroderma)

Conditions: Scleroderma

Summary: the scleroderma biorepository and pathogenesis study (stop scleroderma) will help researchers use clinical data and human biospecimens to investigate why scleroderma patients develop certain complications from their disease. patients with confirmed scleroderma, raynauds or positive autoantibodies are invited to participate. this research may help us understand how to prevent and treat scleroderma and other diseases.


Eligibility criteria:
inclusion criteria: * age \>18 years * able to give informed consent. * diagnosed with scleroderma or with positive autoantibodies exclusion criteria: * \< 18 years old

Keywords: scleroderma biorepository
the pilot study of medical device-neuclare for patients with mild cognitive disorder and early dementia

Conditions: Dementia, Mild; Cognitive Disorder Mild

Summary: this clinical trial aims to explore the effectiveness and safety of cognitive function improvement of neuclare, a science medical device, for patients with mild cognitive impairment and early alzheimer's disease. through methods such as trail making test black \& white, attention questionnaire scale(aqs), neuropsychiatric inventory (npi), etc, cognitive function improvement before and after using neuclare will be evaluated.


Eligibility criteria:
inclusion criteria: * adults aged 55 to 90 * patients who meet "probable alzheimer's disease" and "diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv)" criteria for dementia * patients with cdr (clinical dementia rating) from 0.5 to 1 and mmse-ii over 18 * upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions exclusion criteria: * patient with pathological lesions in the brain identified by mri * patients with metabolic disorders such as thyroid dysfunction, hyperglycemia, hypoglycemia, liver or kidney dysfunction, and long-term use of drugs that will cause cognitive decline (e.g., anticholinergic drugs) * history of epileptic seizures or depression or psychiatric abnormalities or with visual acuity and fluctuations in cognitive decline * history of psychiatric disorder other than the inclusion criteria. * a person with a severe history of cancer/tuberculosis * a person who has or is taking psychiatric or peripheral/central nervous system drugs * a person who has contact dermatitis or sensitive skin abnormalities * patients with a high fever of 40 degrees or higher based on eardrum body temperature * a person whose bleeding is identified within the last 3 months due to a common procedure/surgery that may affect vital signs * a person who is unable to perform mri tests * pregnant women * patient with calcification in the brain identified by ct * patient with allergic to contrast agents such as definity or gadovist * other cases where the investigator judged that it is difficult to participate in the study;
can caudal dexmedetomidine prevents sevoflurane induced emergence agitation in children

Conditions: Delayed Emergence From Anesthesia

Summary: emergence agitation (ea) is common phenomenon in pediatric patients undergoing general anesthesia by inhalation agents. the incidence of ea was reported to range from 18% to 80%. sevoflurane now is the inhalational anesthetic agent of choice for pediatrics, different strategies have been suggested to decrease the incidence and severity of ea. no gold standard technique for treating ea after sevoflurane anesthesia is currently available. the main question is can caudal dexmedetomidine be used for this purpose?

the purpose of this prospective comparative randomized clinical study will be to compare the effects of caudal dexmedetomidine on ea in children undergoing lower abdominal operations under general sevoflurane anesthesia. in addition, characteristics of anesthesia recovery and incidence of adverse effects will be compare. a total of (48) children aged 1-5 years old, the american society of anesthesiologists (asa) physical status classification system between i-ii of both sex who will be enrolled from april 2016 to april 2017 undergoing for lower abdominal surgeries will be included in the study. patients will be randomized by computer-generated random numbers in a double blinded fashion to get enrolled into 2 equal groups: group bd patients (n = 24) will be received single dose caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas group b patients (n = 24) will be received single dose caudal epidural analgesia with bupivacaine only. the dexmedetomidine used for this study will be prepared in a 1 ml syringe wrapped in aluminum foil by an investigator who will not be involved in the anesthesia process and another 1 ml syringe filled with saline will be prepared too.

Eligibility criteria:
inclusion criteria: * children aged 1-5 years old, * the american society of anesthesiologists (asa) physical status classification system between i-ii of both sex who will be enrolled from march 2015 to march 2016 undergoing for lower abdominal surgeries, e.g., hernia and perineal surgeries, e.g., undescended testis and hypospadius will be included in the study. exclusion criteria: * mental retardation, developmental delay, known allergy to any of the study drugs, congenital anomalies of spine, neurological or psychiatric illness that may be associated with improper communication, any signs of local infection in the sacrum region, any kind of cardiac conduction disorder, bleeding disorders, any previous cardiovascular disease and parental refusal.

Keywords: sevoflurane emergence agitation caudal dexmedetomidine
sperm production in kleinfelter syndrome patients after mesenchymal stem cell injection

Conditions: Klinefelter Syndrome; Azoospermia

Summary: klinefelter syndrome ks is caused by an additional x chromosome in males (47,xxy). clinical findings are nonspecific during childhood; thus, the diagnosis commonly is made during adolescence or adulthood in males who have small testes with hypergonadotropic hypogonadism and gynecomastia. virtually all men with klinefelter syndrome are infertile. approximately one in 1,000 boys is born with an additional x chromosome-47,xxy, the karyotype that causes klinefelter syndrome. this karyotype is detected at or before birth in 10 percent of affected boys, and it is found during adulthood in 25 percent of affected men. almost all men with a 47,xxy karyotype will be infertile; klinefelter syndrome accounts for 3 percent of male infertility. klinefelter syndrome is common in infertile men with oligospermia or azoospermia (5 to 10 percent). infertility in men with klinefelter syndrome is caused by a precipitous drop in sperm count. if sperm are present, cryopreservation is useful for future family planning with intracytoplasmic sperm injection, and if not, testicular sperm extraction may be pursued. although there have been multiple reports of successful fertilization by men with klinefelter syndrome. mesenchymal stem cell injection in testicular tubules and intra testicular artery using surgical microscope. the period for follow up last from three months to twelve months including semen analysis to detect sperm and hormonal profile .

the problem started with this kind of patinets when underwent multiple tese without sperm. the investigators try to inject ks patients with mesenchymal stem cells to stimulate testicular tissue for production of sperms. before injection the investigators measure:( fsh, lh, testosterone, prolactin, inhibin b, karyotyping, azoospermic factor, testicular size by ultrasound). three to twelf months after stem cell injection the investigators reevaluate patients by the same measure to demoenstarte any changes.

Eligibility criteria:
inclusion criteria: * kleinfelter syndrome * azoospermia * negative tese exclusion criteria: * absent testes

Keywords: stem cell kleinfelter syndrome azoospermia sterility infertility
a trail of drug-coated balloon treating below the knee arterial diseases

Conditions: Peripheral Artery Disease

Summary: this is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.

this trail is conducted in several centers all around china. 202 subjects with below the knee arterial stenosis or occlusion will be recruited and randomized, this trail compares the efficacy and safety of drug-coated balloon (zylox-tonbridge) with a similar balloon catheter producted by acotec. the subjects will be followed up when discharged /in 30 days/ 6 months.

Eligibility criteria:
inclusion criteria: * age 18-85 years； * ≥70% diameter stenosis or occlusion in the target below-the-knee lesion； * rutherford category 3-6； * subjects are willing to sign informed consent； exclusion criteria: * planned major limb amputation within 30 days after the procedure; * in-stent stenosis in the target lesion; * severely calcified target lesions； * creatinine\>2.5mg/dl; * history of allergies to anesthetics, contrast agents； * subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint； * other circumstances judged by researchers that are not suitable for enrollment.
inflammatory biomarkers of pediatric pulmonary hypertension

Conditions: Hypertension, Pulmonary

Summary: to investigate if the inflammatory protein, high mobility group box 1 (hmgb1), along with other inflammatory mediators, is elevated in pediatric patients with congenital heart disease (chd) and pulmonary hypertension as compared to those with chd alone, or with healthy controls.


Eligibility criteria:
inclusion criteria: -patients of any age with congenital cardiac disease coming for catheterization of the right heart, or both the right and left heart. exclusion criteria: * active systemic infection * current active cancer * active cancer treatment * prior bone marrow transplant * prior solid organ transplant
cervical lidocaine for intrauterine device insertion pain

Conditions: Pain

Summary: the aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (iud) insertion. they will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just before intrauterine device insertion. anticipated pain scores will be assessed using a visual analog scale prior to insertion. using the same pain scale, patients will again be asked at the end of the procedure to rate their pain.

double blind randomized controlled trial. primary outcome: pain reported on visual analog scale (vas) intervention: 2% lidocaine gel at the tenaculum site and intracervical prior to intrauterine device placement

Eligibility criteria:
inclusion criteria: * age 18-45 yrs * selecting intrauterine device contraception * able and willing to consent exclusion criteria: * non-english speaking * current intrauterine device use * expulsion of intrauterine device within 2 weeks * allergy to lidocaine or water based lubricant

Keywords: intrauterine device pain lidocaine gel
communication training for caregivers in advanced care planning

Conditions: Primary Malignant Brain Tumors; Advanced Care Planning

Summary: the purpose of this research study is to develop and test a new communication training to help caregivers communicate more effectively with their loved ones and healthcare professionals about advanced care planning.


Eligibility criteria:
inclusion criteria: part 1: informal caregivers: * current self-reported informal cancer caregivers (ic) to a patient with a primary malignant brain tumor as per clinician judgment or as per emr * english fluency: self-report by participant identifying english as the preferred language for healthcare, and self-reported degree of fluency as speaking english "very well." * age ≥ 18 * has access to a computer or smartphone with a webcam and internet connection patients: * english-speaking as per emr * able to provide informed consent, a determination that will be made in assistance with the patient's medical team. part ii: informal caregivers: * current self-reported ic to an msk patient with a (1) primary malignant brain tumor or (2) leptomeningeal metastasis of a solid tumor, as per clinician judgment or as per emr. * english fluency: self-report by identifying english as the preferred language for healthcare, and self-reported degree of fluency as speaking english "very well." * age \>18 as per self report * access to a computer or smartphone with a webcam and internet connection as per self report exclusion criteria: * none

Keywords: communication training 19-398
environmental intervention to reduce allergens in urban schools and childhood asthma

Conditions: Asthma

Summary: the investigators aim to pilot the role of school based intervention consisting of enhanced integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.

by piloting this school based intervention, the investigators hope to learn from this study the best way to design and implement more cost and time efficient large-based school-based environmental interventions that may potentially help a community of children with asthma, allergic diseases, and its associated morbidity.

Eligibility criteria:
inclusion criteria: * grades k-8 with asthma attending sampling/intervention schools exclusion criteria: * moving schools
curcumin for the prevention of colon cancer

Conditions: Colorectal Cancer

Summary: rationale: chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. curcumin may be effective in preventing the development of colon cancer. purpose: phase i trial to determine the dose amount of curcumin that can be tolerated to help in preventing colon cancer in healthy men and women.

objectives: * determine the maximum tolerated dose (mtd) of curcumin as a chemopreventive agent of colon cancer in healthy subjects. * determine if tolerable doses of this agent in uniformly milled formulation capsules are bioavailable in these subjects. * determine the pharmacokinetics of this agent and two metabolites at the mtd and next lower escalated dose in these subjects. outline: this is a dose escalation study followed by a pharmacokinetic study. patients receive a single oral dose of curcumin followed by a standard fatty meal. cohorts of 3-6 patients receive escalating doses of curcumin until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which 2 of 6 patients experience dose limiting toxicities. once the mtd is determined, additional patients are accrued to receive curcumin in the pharmacokinetic phase of the study. patients are followed at 24, 36, 48, and 72 hours. projected accrual: a total of 3-24 patients will be accrued for the dose escalation phase and then 12 additional patients will be accrued for the pharmacokinetic phase of this study within 3 months.

Eligibility criteria:
disease characteristics: * healthy men and women age 18 and over patient characteristics: age: * 18 and over performance status: * not specified life expectancy: * not specified hematopoietic: * wbc greater than 4,000/mm3 * hemoglobin greater than 12 g/dl * platelet count greater than 120,000/mm3 hepatic: * alt/ast less than 1.5 times upper limit of normal (uln) * alkaline phosphatase less than 1.5 times uln * bilirubin less than 1.5 mg/dl renal: * creatinine less than 1.7 mg/dl other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior cancer except surgically resected basal cell or squamous cell skin cancer * no history of peptic ulcer disease, gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors * no history of unreliability or noncompliance (missing pretreatment appointment more than twice) prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * at least 14 days since prior steroids radiotherapy: * not specified surgery: * not specified other: * at least 14 days since prior curcumin (turmeric) rich foods * at least 14 days since prior nonsteroidal antiinflammatory drugs (nsaids) * no chronic medications (i.e., daily for more than 28 days) except for oral contraceptives * no concurrent coumadin or other anticoagulants

Keywords: colon cancer
phosphorous magnetic resonance spectroscopy of heart

Conditions: Left Ventricular Dysfunction

Summary: heart needs constant supply of energy to continue working. phosphorus magnetic resonance spectroscopy allows us to measure energy produced in the heart. the purpose of this study is to determine if the energy production is reduced in failing heart.

we will use non-invasive phosphorus magnetic resonance spectroscopy technique to measure creatine kinase (ck) flux in failing heart. the studies will be done on siemens 3.0t human system. we will recruit subjects with lv dysfunction due to prior anterior wall myocardial infarction.

Eligibility criteria:
inclusion criteria: * individuals with left ventricular dysfunction exclusion criteria: * age \< 18, pregnant, history of excessive alcohol use, or any condition (e.g. claustrophobia, a pacemaker) that would prevent him/her from completing the magnetic resonance spectroscopy study
pain in america: a randomized controlled trial

Conditions: Orthopaedic Related Pain (Musculoskeletal Pain)

Summary: each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. but little evidence exists about orthopaedic patient understanding of the common methods of managing musculoskeletal pain. therefore, it is our aim to determine which discussion method best improves patient comprehension of common methods of managing pain.


Eligibility criteria:
inclusion criteria: * patients who are new to a discussion about the common methods of managing musculoskeletal pain, over the age of 18, native english speakers exclusion criteria: * patient with a previous orthopaedic surgery or musculoskeletal pain consultation, patients without the capacity to give consent, chronic narcotic users. patients with a severe mental, visual, auditory or tactile impairment.
back beliefs among the general population

Conditions: Low Back Pain

Summary: in the current study we aim to evaluate the effects of a short educational video on improving the belief that "the back is fragile and needs to be protected" among the german speaking swiss general population. we hypothesize that a short video education program can positively change the assessed back belief among the german speaking general population of switzerland. to evaluate the outcomes, we will use the 10-item version of the back pain attitude questionnaire (back-paq). the primary outcome is the second question of the back-paq-10 ("you could injure your back if you are not careful"). the secondary outcome of this study is the total score of the back-paq-10. the design of the present study is a two-group randomized controlled trial, with one intervention and one control group in a 1:1 allocation.

this study will be conducted in collaboration with hesav (haute ecole de sante vaud). the research group at the hesav has developed an educational website in 2020, called "www.infomaldedos.ch". the website aims to educate people on low back pain, and common unhelpful beliefs about the back - primarily targeting the belief about the fragility of the back and the need for its protection - are addressed. in the current study we are going to translate the above-mentioned website to the german language. furthermore, we are going to assess the quality and applicability of a short video intervention among the general population, using one of the videos from the website. participants will be recruited through social media and emails. a link will be created to the questionnaire and the educational video with limesurvey. a 'randomizer' built-in function will be used to blindly split people into intervention or control group. the link will be spread on social media platforms and through email. to induce a snowball sampling method, all participants will be asked to send the link further. the length of the video intervention is 3 minutes. in the video, health care professionals, such as a psychologist, a medical doctor, a professor, and physiotherapist interviewed by a scientist explains the burden of lbp, how unhelpful beliefs affect treatment outcome, difficulties in the management of lbp and the optimal way of treating lbp. the scientist then inquires a representative patient about their own experiences of the management of lbp. at the end of the video the scientist encourages people to exercise despite lbp by performing various movements. the control group will receive a neutral video about the back, selected from youtube.

Eligibility criteria:
inclusion criteria: * age \>18 years exclusion criteria: * professionals and students with prior knowledge on the topic of interest such as physiotherapists, osteopaths, and chiropractors.

Keywords: nonspecific low back pain back beliefs education