Kornimate/medical-research-clean huggingface dataset:
the effect of mandala application on anxiety level and caregiver burden in palliative care

Conditions: Palliative Care; Caregiver; Anxiety; Mandala; Caregiver Burden

Summary: the caregivers of palliative care patients can also be negatively affected during the palliative care process. especially family caregivers may experience difficulties in physical, social, economic, and psychological aspects. non-pharmacological approaches are utilized to cope with these difficulties. the mandala study is one of the non-pharmacological approaches and has been utilized to support patients and caregivers in various illnesses. mandala is a method that anyone can apply, based on coloring circular patterns. recent studies have reported that mandala contributes to improving psychological and physiological well-being. this study is designed in a randomized controlled design to examine the effects of mandala application on anxiety levels and caregiver burden in palliative care caregivers. caregivers who meet the inclusion and exclusion criteria will be randomly assigned to two groups using a computer program. both groups of caregivers will be administered an information form, the stai xt-1 state-trait anxiety inventory, and the zarit burden interview scale. then, the intervention group will be asked to apply mandala twice a week for 30 minutes for one month. after one month, the scales will be administered again. the caregivers in the control group will not receive any intervention, and after one month, the scales will be administered, and mandala application will be suggested. according to g power analysis, with a type i error (α) of 0.05 and a power (1-β) of 0.80, the minimum sample size that will meet the requirements is determined to be a total of 86 individuals (experimental: 43, control: 43). considering potential sample loss, the aim is to reach 45 participants in each group. the statistical analysis of the data will be performed using spss version 22.0. descriptive statistics such as frequency, median, standard deviation, mean, minimum, maximum, percentage, kolmogorov-smirnov test for normal distribution (n\>30), skewness, and kurtosis will be used for sociodemographic characteristics. correlation tests will be used for scale relationships, and anova, kruskal-wallis, t-test, or mann-whitney u test and post-hoc tests will be used for scale comparisons according to independent variables. the significance level will be accepted as p\<0.05.


Eligibility criteria:
inclusion criteria: * have reached the age of 18 * willingness to participate in the study * being able to read and write * having no problems in verbal communication * providing free care exclusion criteria: * providing paid care
documentation of continuous wheeze and cough dynamics in pediatric er sob patients

Conditions: Asthma; Bronchiolitis

Summary: phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.


Eligibility criteria:
inclusion criteria: * patient is admitted to the er with shortness of breath * patient management is according to standardized protocols used in hadassah mt. scopus pediatric emergency department including: * asthma management protocol * bronchiolitis management protocol * ages 0 - 15 * patient's parent/guardian is able to comprehend and give informed consent for participating in the study exclusion criteria: * patient has received any dose of inhaled bronchodilators in the hour prior to enrollment * patient has received oral or iv steroids in a time window of 30 minutes to 5 hours prior to enrollment * ventilated patients, while ventilated * chest skin lesions * cystic fibrosis * hemodynamic instability * patient's parent/guardian objects to the study protocol * concurrent participation in any other clinical study * physician objection
efficacy and safety of deb-bace combined with pd-1 inhibitors in stage ii/iii nsclc with standard treatment failure

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. all eligible patients were randomly assigned to deb-bace combined with pd-1 inhibitor (sindilizumab) treatment group (test group) and deb-bace treatment group (control group), to explore the efficacy and safety of combination therapy for stage ii/iii nsclc with standard treatment failure or intolerable patients.


Eligibility criteria:
inclusion criteria: * age more than 18 years old, no gender limit. * according to the diagnosis and treatment of primary lung cancer (2018 edition), non-small cell lung cancer (nsclc) was diagnosed by histopathology. * tumor node metastasis (tnm) staging is ii-iii. * according to the national comprehensive cancer network (nccn) guidelines, patients who had failed, refused, or were not suitable for standard treatment (surgery, chemoradiotherapy, targeted) after consultation. * eastern cooperative oncology group (ecog), performance status (ps) score ≤ 2. * estimated survival time is more than 3 months. * the patient has signed informed consent. exclusion criteria: * the patient has previously received interventional therapy \[iodine seed implantation, ablation, bronchial arterial chemoembolization (bace) therapy\], or received immunotherapy during the first-line standard treatment. * the patient is accompanied by other malignant tumors and had not been cured. * white blood cell \< 3×10\*9/l, absolute value of neutrophils \< 1.5×10\*9/l, neutrophil/lymphocyte ratio ≥ 3, platelet count \< 50×10\*9/l, hemoglobin concentration \< 90 g/l. * liver and kidney dysfunction (creatinine \> 176.8 μmol/l; aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \> 2 times the upper limit of normal). * uncorrectable coagulopathy or active hemoptysis. * patient with active infections requires antibiotic treatment. * patient has uncontrollable hypertension, diabetes, and cardiovascular disease with obvious symptoms. * allergy to contrast agents. * women with pregnancy or lactation.

Keywords: non-small-cell lung cancer drug-eluting beads bronchial arterial chemoembolization pd-1 inhibitor advanced
understanding circadian responses to light in persons with mild cognitive impairment

Conditions: Mild Cognitive Impairment; Alzheimer Disease

Summary: the purpose of this research study is to investigate the relationship between light, the thickness of the pigment at the back of your eye, melatonin levels, and memory. the study will investigate whether changing light distribution pattern from "on-axis"' (i.e., directed along the eye's visual axis to the fovea) to "off-axis" (i.e., directed on the periphery of the eye's visual axis) impact melatonin suppression in 24 mild cognitive impairment participants and 24 healthy, age-matched controls.

eligible enrolled subjects will be exposed to 4 different lighting conditions in addition to one dark control condition. there will be 5 study session and each one will last for 90 minutes and will be separated by one week. subjects will collect 3 saliva samples, each one 30 minutes apart for melatonin levels during each study session.

Eligibility criteria:
inclusion criteria: * mild cognitive impairment * age matched healthy control * macular pigment density either \ 0.5 exclusion criteria: * extensive brain vascular disease * parkinson's disease * bipolar disorder * seasonal depression * diabetes * high blood pressure * obstructing cataracts * macular degeneration * diabetic retinopathy * use of melatonin supplements * use of beta blockers * use of sleep medications * use of antidepressant medication
av2 antiviral spray versus placebo in human papillomavirus cervix infections

Conditions: Genital Human Papilloma Virus Infection

Summary: this study aims to prove that, by a one-time topical spray on the cervix, av2-dm is an effective antiviral in reducing on short term (3 months) the human papillomavirus (hpv) infection. * primary endpoint: significant drop in viral load av2-dm versus placebo * secondary endpoint:the number of patients with adverse events


Eligibility criteria:
inclusion criteria: 1. women between 25 and 40 years 2. patient has been recently (up to 6 months) quantitatively (viral load) and qualitatively (hpv types) diagnosed with hpv. 3. ability and willingness to participate in the study. 4. subject agrees to refrain from using prescription or supplemental antiviral medications without obtaining permission of the treating doctor. 5. voluntary written informed consent. exclusion criteria: 1. subject has been vaccinated against hpv 2. interval between a delivery and t0 is less than 3 months 3. subject has a gynecologic surgical intervention between t0 and t1 4. subject is diagnosed hpv negative at t0 5. subject has a (adeno)carcinoma in situ. 6. females with child bearing potential who are not using a reliable, medically accepted method of birth control 7. pregnant or breast-feeding female, or women planning to become pregnant during the trial. 8. medical history of immunosuppression by radiotherapy, chemotherapy, immuno-modulatory drugs, or hiv. 9. participation to another clinical trial concerning hpv infections within 6 months before the application of av2-dm antiviral spray. 10. medical history of any severe diseases like hepatitis, renal or liver dysfunction, car-diovascular, gastrointestinal, malignant tumor(s), or psychiatric disorders etc., which might influence the assessments or conduct of the trial by the discretion of the investigator. 11. intake or application of antivirals or other prohibited concomitant medication within 30 days prior to application of av2, or patients who plan to take such drugs during the trial. 12. known or suspected allergic or adverse response to the investigational product av2-dm antiviral spray, it's components, olive oil or d-limonene. 13. inability to follow the study protocol.

Keywords: hpv cervix
a database study to estimate the risk of multiple sclerosis following vaccination with arepanrix™ in manitoba, canada

Conditions: Multiple Sclerosis

Summary: the purpose of this database study is to assess if arepanrix™ vaccination during the 2009 pandemic was associated with an increased risk of multiple sclerosis (ms) in manitoba, canada.

this observational, retrospective, propensity-score matched cohort study using the manitoba immunization monitoring system (mims) and the hospital, physician, and prescription claims databases of the manitoba health (mh) database system will assess if arepanrix™ vaccination during the 2009 pandemic was associated with an increased risk of multiple sclerosis (ms) and other demyelinating conditions not ultimately leading to a multiple sclerosis diagnosis in manitoba, canada. the data will be collected form the following linked databases: * manitoba health (mh) administrative databases * manitoba immunization monitoring system (mims) * manitoba health population registry (mhpr) * drug program information network (dpin) * hospital abstract database * the medical services database

Eligibility criteria:
inclusion criteria: * the entire population of manitoba is considered for inclusion. exclusion criteria: * individuals less than or equal to 6 months of age; * having less than one year of insurance coverage before the enrolment period; * not registered with mh during the enrolment period; * physician or hospitalization records indicating a diagnosis of any demyelinating condition between 1971 (earliest year for which information is available) and the index date.
comparative efficacy and safety of fenoverine

Conditions: Irritable Bowel Syndrome

Summary: it is a randomized double-blind parallel phase iv study to compare fenoverine and trimebutine maleate in the efficacy and safety. study hypothesis: fenoverine is non-inferior to trimebutine maleate in its efficacy and safety.

for subjects with ibs, fenoverine and trimebutine will be administered orally for 8 weeks; fenoverine 100mg capsule three times a day and trimebutine 150mg tablet three times a day. because one is capsule and the other is tablet, double dummy design will be used. efficacy is evaluated at the end of 8 weeks and safety will be followed for 4 more weeks after the end of the scheduled medication.

Eligibility criteria:
inclusion criteria: * 18 years of age or older and 60 years of age or younger * diagnosed as irritable bowel syndrome using rome iii criteria * female subjects of child-bearing potential are confirmed to have a negative urine beta-hcg test within 7 days prior to administration of initial dose of investigational products. * female subjects of child-bearing potential must agree to use contraceptive measures during study period. exclusion criteria: * known allergy or hypersensitivity to investigational products or components of the formulation * past or current diagnosis of chronic liver disease (e.g., liver cirrhosis, acute hepatitis, alcoholic hepatitis, chronic alcohol abuse and hcc) * past or current diagnosis of myopathy * subject with serious renal disease * known medical condition assessed by investigators as inappropriate for the study * continuous use of nsaids, analgesics, steroids, or other immunosuppressants. * continuous use of hmg-coa reductase inhibitors or fibrates to lower blood lipid level * pregnant, lactating, or planning to be pregnant women * evidence of abuse of drugs or alcohol within 6 months prior to screening * participation in other clinical trials within 3 months prior to enrollment or elapse of less than 5 half lives of previous investigational product after last dose of it. * unable to submit informed consent or comply with the requirements of the study

Keywords: fenoverine irritable bowel syndrome abdominal pain bss
shape up somerville: eat smart play hard

Conditions: Childhood Obesity

Summary: community-based environmental approach to obesity prevention targeting first, second, and third grade students in somerville, ma.

this study will demonstrate using measures of effectiveness, the feasibility of partnering with the community to create, disseminate, implement and evaluate shape up somerville: eat smart. play hard., a community-based environmental change intervention to prevent obesity in culturally diverse, high-risk, early elementary school children. based on formative work with parents, children, teachers, school food service, school officials, and community members, a community-wide campaign will be developed with targeted environmental change strategies for early elementary school children within the before-, during-, and after-school environments reinforced by changes within the home and community to support behavioral action and maintenance. the intervention targeting children will bring the energy equation into balance by offering numerous physical activity options that total up to 125 kcals per day and by improving the composition of the food served and the dietary options, particularly snack foods, available throughout the day. this study will measure awareness and participation of the partners and residents within the community. in addition the temporal change in bmi z-score will be monitored internally in 700 somerville children and externally in 1000 control children from 2 demographically-matched communities for one year and will be compared to the change in bmi z-score in children participating in shape up somerville with children from control communities over the one-year intervention and for one year of follow up. if successful, somerville will serve as the model community that paves the way for cost-effective nationwide environmental action to prevent obesity at the community level.

Eligibility criteria:
inclusion criteria: * public school students in 1st, 2nd, and 3rd grade in somerville, ma exclusion criteria: * none

Keywords: childhood obesity community-based participatory research school intervention parental involvement
alternate-day buprenorphine administration. phase ii - 4

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to determine if two times a subject's daily maintenance dose will hold for 48 hours without changes in agonist and antagonist effects.


Eligibility criteria:
please contact site for information.
online interplay between deciding and acting with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the investigators aim to understand the interplay and neural structures involved with decision--making and movement for participants with mild cognitive impairment. rapidly deciding and acting becomes bottlenecked with mild cognitive impairment and alzheimer's, leading to detrimental outcomes such as falling and car crashes. the investigators work will have a tangible impact by discovering sensitive biomarkers to detect disease onset and pave the way for informed and effective neurorehabilitation.

mild cognitive impairment leads not only to impaired decision making, but also movement deficits that predict the development of alzheimer's disease. recent behavioral work has suggested a common mechanism that throttles the speed of both decisions and reaching movements, which is supported by converging neural evidence that finds an interac-tion between decision making and movement (motor) circuits. yet it remains unknown how the interplay between decision making and motor neural circuits becomes impaired and impedes rapid responses for those with mild cognitive impairment. here the investigators test the central hypothesis that there is an impaired interaction between decision making and motor neural circuits with mild cognitive impairment. first, the investigators will use human reaching experiments to establish that mild cognitive impairment disrupts the interplay of decision making and motor control. second, the investigators will use magnetic resonance elastography to elucidate whether brain stiffness in decision making and motor brain regions are related to altered movement behavior. the expected outcome is a mechanistic understanding of how impaired decision making and motor neural circuits impact movement for those with mild cognitive impairment.

Eligibility criteria:
inclusion criteria: 1. age 45 - 90 years 2. perfect or corrected vision 3. ability to reach 4. neurotypical age-matched control participants - no history of neurological disorders or injury. 5. mild cognitive impairment participants - clinical diagnosis of amnestic mild cognitive impairment. exclusion criteria: 1. any injury or condition that impacts reaching 2. traumatic brain injury, such as concussion, in the last 6 months. 3. neurotypical age-matched control participants: modified telephone interview for cognitive status (tics-m) score \< 34 4. mild cognitive impairment participants: modified telephone interview for cognitive status (tics-m) score \> 34 5. mild cognitive impairment participants: mini-mental state examination second edition (mmse-2) score \< 21.

Keywords: reaching brain decisions
fecal microbiota transplantation in cirrhosis

Conditions: Cirrhosis, Liver

Summary: patients with cirrhosis were recruitted and divided into cintrol group and fmt group. patients in fmt group were carried by fecal microbiota transplantation, and biochemical indexes, intestinal flora and intestinal hif expression were observed before and after fmt respectively.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of cirrhotic * aged 18-80 years. * must be able to cooperate with treatment exclusion criteria: * patients with severe cardiac, pulmonary and renal dysfunction; * patients with severe hypertension and cerebrovascular accidents; * patients with liver cancer or active infection are in the active stage of hepatic encephalopathy or gastrointestinal bleeding; * prothrombin activity ≤40%, platelet count \< 50\*10\^9/l; * patients with intellectual and language disorders and mental disorders; * probiotics with antibiotic and drug grade were used within 3 months prior to sampling; * there are prehepatic or posthepatic portal hypertension reasons; * drug history: anticoagulant therapy, use of antiplatelet drugs, and current use of beta blockers, statins or interferon (ifn) treatment; * peptic colon examination contraindications, such as intestinal perforation, intestinal obstruction, etc. * other researchers believe that patients should not be included in the group.

Keywords: cirrhosis；fecal microbiota transplantation
cardiac stem/progenitor cell infusion in univentricular physiology (apollon trial)

Conditions: Hypoplastic Left Heart Syndrome; Single Ventricle

Summary: the purpose of this study is to evaluate the efficacy and safety of intracoronary injection of jrm-001 after reconstructive surgery in pediatric patients with functional single ventricle


Eligibility criteria:
inclusion criteria: * functional single ventricle patient with heart failure who is scheduled for stage 2 (glenn) or stage 3 (fontan) surgery * ef(%) by echocardiography ≤ 55% * able to obtain written informed consent of participation in the study by a parent of the patient exclusion criteria: * known medical history of cardiogenic shock * lethal, uncontrollable arrhythmia * complication of coronary artery disease * eisenmenger syndrome * complication of brain dysfunction due to circulatory failure * malignant neoplasm * complication of severe neurologic disorder * severe pulmonary embolism or pulmonary hypertension * severe renal failure * multiple organ failure * active infection (including endocarditis) * sepsis * active hemorrhagic disease (e.g. gastrointestinal bleeding, injury) * known history of hypersensitivity to anti-infective drugs * inability to complete the protocol treatment and baseline to follow-up examinations

Keywords: cardiac stem/progenitor cells autologous cell therapy functional single ventricle congenital heart disease
safety and efficacy of exc 001 in subjects who have participated in prior studies of exc 001

Conditions: Reduction in Severity of Skin Scarring

Summary: the purpose of this study is to provide subjects who participated in prior studies of exc 001 the opportunity to have their hypertrophic scars surgically revised and treated with exc 001.


Eligibility criteria:
inclusion criteria: * healthy adults who have participated in previous studies of exc 001. * healthy adults who have chosen to have their scars revised. exclusion criteria: * currently pregnant or pregnant during the 6 months prior to inclusion in the study, or breast feeding. * participation in another clinical trial within 30 days prior to the start of the study.

Keywords: skin scarring cicatrix hypertrophic scar hypertrophic scar prevention