Kornimate/medical-research-clean huggingface dataset:
ciprofol based on total intravenous anesthesia during pediatric laparoscopic surgery

Conditions: Pediatric Hernia; Laparoscopic Surgery; Appendicitis, Surgery

Summary: a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery.

ciprofol is a better alternative to surgical sedatives. the clinical application basis of ciprofol in pediatric anesthesia is still lacking. therefore, the investigators designed a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of all-through intravenous anesthesia in pediatric laparoscopic surgery. our main hypothesis is that in pediatric surgery, using ciprofol by intravenous anesthesia, the extubation time is no longer than that the propofol group.

Eligibility criteria:
inclusion criteria: * laparoscopic surgery under general anesthesia exclusion criteria: * known allergies to propofol and ciprofol, * mental retardation, cognitive and affective disorders, psychiatric or neurological disorders; * uncooperate with peripheral venipuncture and catheterization; * history of acute upper respiratory tract infection in the past 2 weeks; * with severe respiratory, circulation, liver and kidney insufficiency; * body mass index (bmi) of 30 kg/m² or 15 kg/m²; * known long-term use of sedative drugs; * asaⅲ grade or above; * recent participation in other clinical studies.

Keywords: ciprofol propofol total intravenous anesthesia children
a study to describe the characteristics, health care interventions and outcomes of patients with major bleedings in the presence of factor xa inhibitor treatment

Conditions: Major Bleeding

Summary: reverxal study aims to increase the understanding of the patient characteristics, bleeding presentation, health care interventions provided, and the clinical as well as self-reported health outcomes of patients with major bleeding in the presence of factor xa inhibitor treatment. the generation of insight on treatment approaches and associated outcomes in hospitalized patients with factor xa inhibitor-related major bleeds may inform clinical guidelines, health system decision making and streamline treatment pathways in this population.

reverxal is a multinational observational study incorporating 2 patient cohorts (historical and prospective) with major bleeds during factor xa inhibitor use. this study will be mainly descriptive in nature without any pre-specified statistical hypotheses. variables will be collected according to routine medical practice either through primary data collection directly from patients, or from secondary data collection via data extraction from electronic or paper medical records into electronic case report forms (ecrfs). patients will undergo clinical assessments and receive standard medical care as determined by their treating physicians. patients will not receive any experimental disease management intervention or experimental treatment because of their participation in the study. as part of routine care, study investigators will evaluate patients about their medical history, medication history, bleeding presentation, and any adverse event (ae) or severe adverse event (sae) experiences since the previous clinical visit and the related information. no additional or pre-defined site visits will be scheduled outside of the patient's routine clinical visits.

Eligibility criteria:
inclusion criteria: * aged ≥18 years on the index date * admitted to the hospital with an acute major bleeding or developed an acute bleeding while already in hospital * ongoing treatment with a factor xa inhibitor before the index date * provided signed and dated informed consent or able to obtain a waiver in addition, for cohort b: - administered reversal or replacement therapy exclusion criteria: * pregnant women * patients enrolled in any interventional trial that includes reversal/replacement agents in addition, for cohort b: * use of vitamin k antagonists, dabigatran, prothrombin complex concentrates or recombinant factor vii, or transfusion of whole blood or plasma within the preceding 7 days of the index event * as judged by the investigator, if it is deemed undesirable for the patient to participate in the study or participant is unlikely to comply with study procedures, and requirements * involvement in the planning and/or conduct of the study (applies to both astrazeneca staff and/or staff at the study site)

Keywords: real-world evidence factor xa inhibitor treatment reversal/replacement therapy
social reward and its effect on brain functions in psychotherapies for mid- and late-life depression

Conditions: Major Depressive Disorder

Summary: abnormalities in the positive valence system (pvs) are associated with depressive symptoms and reduced behavioral activation in mid- and late-life. this study will investigate the engagement of the pvs during exposure to social rewards, part of a novel streamlined psychotherapy for mid- and late-life depression. use of computational modeling will enable identification of neuroimaging and behavioral profiles associated with greater treatment response, and may guide future personalization of psychotherapy.


Eligibility criteria:
inclusion criteria: 1. ages aged 50-85 \[stratified so that 50% are older than 65\] 2. diagnosis of unipolar major depressive disorder without psychotic features, determined by the scid 3. montgomery-åsberg depression rating scale (madrs) score ≥ 20. 4. mini mental status exam (mmse) ≤ 1 sd below the mean score for patient's age and education 5. off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks. 6. capacity to provide written consent for research assessment and treatment. exclusion criteria: 1. intent or plan to attempt suicide in the near future. 2. history or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia. 3. use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week. 4. neurological disorders (dementias, history of stroke, multiple sclerosis, parkinson's disease, epilepsy, etc.); cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses that may either influence brain systems of interest or ability to participate in the study. dr. alexopoulos or another research psychiatrist will review any medical illnesses that does not appear in the list above and determine whether it interferes with the study of positive valence system functions in depression. 5. contraindications to mri scanning including cardiac pacemaker, heart valve replacement, vascular stent, insulin pump, cochlear implant, any other metallic biomedical implant contraindicating to mri, and claustrophobia.

Keywords: late life depression psychotherapy mechanisms of action positive valence system social reward
a non-inferiority randomized controlled trial to evaluate promoting condom use among msm and transgender individuals in china

Conditions: Human Immunodeficiency Virus; Sexually Transmitted Diseases

Summary: this is a pragmatic, non-inferiority, randomized controlled trial comparing the effectiveness of two methods (crowdsourcing versus social marketing) for creating one-minute videos promoting condom use among msm and tg in china. crowdsourcing is the process of shifting individual tasks to a large group, often involving open contests and enabled through multisectoral partnerships.

crowdsourcing may be a powerful tool to spur the development of innovative videos to promote condom use among key populations such as men who have sex with men (msm) and transgender (tg) individuals. the purpose of this randomized controlled trial is to compare the effect of a crowdsourced video and a social marketing video on condom use among chinese msm and tg who report condomless anal sex during the past three months. the crowdsourced video was developed using an open contest, formal transparent judging, and several prizes. the hypothesis is that a crowdsourced video will not be inferior (within a margin of 10%) to a social marketing video in terms of condomless sex at three to four weeks (with an additional follow-up at three months) of watching the video.

Eligibility criteria:
inclusion criteria: * the target population for the condom use substudy is males, 16 years of age or older, who were born biologically male or are transgender, have had condomless sex in the past three months and are willing to provide their cell mobile number. exclusion criteria: * females

Keywords: health promotion crowdsourcing
chronic migraine epidemiology and outcomes study

Conditions: Migraine Disorders

Summary: this is a population internet-based study to characterize migraine clinical course and impact on family.


Eligibility criteria:
inclusion criteria: * history of migraine * u.s. member of survey panel * household member of study participant * ability to complete internet-based questionnaires exclusion criteria: * no access to internet
substrate metabolism and insulin sensitivity in patients with hyperprolactinemia before and after treatment

Conditions: Hyperprolactinemia; Insulin Resistance

Summary: the purpose of this study is to investigate the effects of chronic elevated levels of prolactin on metabolism and insulin sensitivity by studying patients with hyperprolactinemia before and after treatment.


Eligibility criteria:
inclusion criteria: * written consent * age between 18 and 70 * at diagnose a serum prolactin \> 200 microgram/l (10 u/l) exclusion criteria: * hypothyroidism * use of any medication * pregnancy

Keywords: prolactin insulin resistance glucose tolerance body composition substrate metabolism
intermittent preventive treatment of malaria in hiv-seropositive pregnant women in zambia

Conditions: Placental Malaria Infection; HIV Infections; Stillbirth; Prematurity; Neonatal Deaths

Summary: prevention of malaria in pregnancy is critical given the high incidence of malaria in zambia and its serious impact on both maternal and infant survival. intermittent presumptive treatment with sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing the risk of malaria in pregnancy. however, based on a study done in western kenya, hiv-infected pregnant women may need more frequent dosing of sp, i.e., on a monthly basis rather than the standard 2-dose regimen given during the second and third trimesters, as hiv appears to reduce the effectiveness of the sp drug combination. the goal of this study was to evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly sp dosing schedule in hiv-positive women.

primary objectives to compare the efficacy of ipt with monthly sp versus a two-dose regimen given once in the second and once in the third trimester in hiv-infected women on the: * prevalence of placental malaria infection * prevalence of maternal peripheral parasitemia secondary objectives to compare ipt with monthly sp versus a two-dose regimen given once in the second and once in the third trimester in hiv-infected women on: * birth weight, including the proportion of lbw infants * incidence of prematurity * neonatal and fetal death and third trimester stillbirth * incidence of neonatal jaundice * third trimester anemia * third trimester severe anemia * proportion of mothers who develop symptomatic malaria during the course of pregnancy

Eligibility criteria:
inclusion criteria: * hiv-positive pregnant women between 16-28 weeks of gestation identified through vct * hiv-negative pregnant women between 16-28 weeks of gestation identified through vct * residence within the catchment area of the health facility * willing to deliver at the health facility * willing to agree to adhere to the requirements of study participation (including monthly anc visits and willing to allow all study procedures) * willing to provide written informed consent * aged 18 years and above exclusion criteria: * severe anemia (hb \< 6 g/dl) * history of allergic reactions to sulfa drugs * history of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section) * history or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization * any significant presenting illness that requires hospitalization * intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area * prior enrollment in the study or concurrent enrollment in another study

Keywords: malaria placental diseases birth complications plasmodium falciparum zambia hiv-seropositive hiv
an observational follow-up study of the incidence of cancer and mortality in patients from the seas (simvastatin and ezetimibe in aortic stenosis) trial (mk-0653a-043-10)

Conditions: Cancer

Summary: the purpose of this extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period in patients from the seas trial (2004_050, mk0653a-043; nct00092677).

the seas follow-up study is a 21 month extension to the base protocol (2004_050, mk0653a-043; nct00092677). the main objective of the extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period (from 04-march 2008 to 31-december 2009) in patients from the seas clinical trial. the sources of study data will include data collected from national cancer and death registries as well as data from the original clinical trial. no patient visits will occur. national cancer and death registries exist in 5 of the 7 countries that participated in the base seas trial. at the time of follow-up study initiation, accessing the registry data in ireland was not feasible due to local regulations and cancer and death registries did not exist in germany. as a result, data will be collected only for all seas patients known to be alive at the end of the base study originating from sweden, denmark, norway, finland, and the united kingdom.

Eligibility criteria:
inclusion criteria: * the cohort will include all patients from the five participating countries (sweden, denmark, norway, finland, and united kingdom) who were randomized into the seas base study and who were known to be alive at the end of the base study

Keywords: new incidence of cancer
emergency laparotomy and frailty study

Conditions: Emergencies; Frail Older Adult; Laparotomy

Summary: patients aged over 65 comprise more than half the emergency general surgical workload, however, available risk-prediction tools for such patients are extrapolated from younger cohorts. research suggests that high pre-operative frailty scores correlate with increased post-operative mortality and morbidity. validated frailty assessments may help identify high risk older emergency surgical patients, facilitating decision-making and informing patient choice. we propose the first prospective uk observational study assessing frailty as an independent predictor of outcome in the older surgical patient undergoing emergency laparotomy. prospective data collection of patients over 65 undergoing emergency laparotomy will be performed in 20 nhs trusts. pre-operative frailty scores will be evaluated using the rockwood frailty scale. primary outcome measure is 30-day mortality. secondary outcome measures are post-operative complications, altered independence status and length of stay. results will be disseminated at national/international surgical meetings and published in a peer-reviewed journal.

the elf steering committee will run this project as part of the north west research collaborative(nwrc), consisting of surgical trainees with a successful record of publishing credible research and establishing clinical trials. following ethical approval, data will be collected from nhs trusts throughout the uk. trained leads will facilitate data collection adhering to a study protocol and local clinical governance. patients over 65 undergoing emergency laparotomy will be identified prospectively over 3 months. demographics, time to surgical intervention, length of stay(los), pre- and post-admission independence, intermediate care stay, clavien-dindo post-operative complications, 30-day mortality and 30-day re-admission data will be collected on a secure database. pre-operative frailty will be assessed using the rockwood frailty scale. 500 patients are required for a statistically significant difference in primary outcome (30 day mortality). secondary outcome measures are complications, change in independence status and los. outcomes will be analysed to compare the impact of frailty.

Eligibility criteria:
inclusion criteria: * patients aged 65 years and older * admitted to emergency surgical departments * requiring an emergency laparotomy exclusion criteria: - patients less than 65 years old
telemedical interventional management in heart failure ii

Conditions: Chronic Heart Failure

Summary: superiority of additional remote patient management (rpm) in patients with chronic heart failure (chf) in comparison to usual care in terms of, e.g.: * days lost due to unplanned cardiovascular hospitalization or death * all-cause mortality * cardiovascular mortality * quality of life

the clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). all participants will continue to receive usual care from their general practitioner and specialist. all patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 750 of the patients will be randomly allocated to receive devices for remote patient management (rpm) which will measure various parameters on a daily basis (e.g. weight, blood pressure, heart rate). the devices are mobile and can be used at home or elsewhere.

Eligibility criteria:
inclusion criteria: * chronic heart failure new york heart association (nyha) class ii or iii * echocardiographically determined left ventricular ejection fraction (lvef) ≤45% or \>45% + minimum 1 diuretic in permanent medicinal therapy * hospitalization due to decompensated hf within the last 12months before randomization * informed consent * depression score phq-9: \<10 exclusion criteria: * hospitalization within the last 7 days before randomization * implanted cardiac assist system * acute coronary syndrome within the last 7 days before randomization * high urgent listed for heart transplantation (htx) * planned revascularization, transcatheter aortic valve implantation (tavi), mitraclip and/or cardiac resynchronization therapy (crt)-implantation within the last 3 months before randomization * revascularization and/or crt-implantation within 28 days before randomization * known alcohol or drug abuse * terminal renal insufficiency with hemodialysis * impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate) * existence of any disease reducing life expectancy to less than 1 year * age \<18 years * pregnancy * participation in other treatment studies or remote patient management programmes (register studies possible)

Keywords: chronic heart failure chf
follow-up study of the alzheimer's disease anti-inflammatory prevention trial

Conditions: Alzheimer Disease; Dementia

Summary: the alzheimer's disease anti-inflammatory prevention trial - follow-up study (adapt-fs) will continue observations of the declared primary outcomes of the alzheimer's disease anti-inflammatory prevention trial (adapt) in the cohort previously established for that trial.

adapt was a multicenter, randomized, placebo-controlled trial designed to test the safety and efficacy of naproxen and celecoxib for the primary prevention of alzheimer's disease (ad) dementia and for attenuation of age related cognitive decline in persons over 70 years of age. the adapt treatments were stopped on 17 december, 2004, after the substantial majority of participants had been given treatments over an interval of one to three years. participants remained under observation until may, 2006, using double-masked methods of case identification that were identical to those of the original adapt protocol. results from the entire period of observations in adapt were ambiguous and suggested a need for additional longitudinal data to learn whether the dual-inhibitor nsaid naproxen can effect a long-term reduction in the occurrence of ad dementia. this adapt follow-up study (adapt-fs) is following-up the participants originally enrolled in adapt after a further interval of four years, thereby identifying additional individuals with ad dementia in each treatment assignment group, and then using time-dependent methods to estimate and contrast incidence rates by treatment assignment. the study is also extending prior observations on trajectory of cognitive performance on several psychometric measures, thus testing the hypothesis of differences in such trajectory by treatment assignment in adapt. adapt-fs is sponsored by the national institute on aging (nia) and is being conducted at the roskamp institute in tampa, fl; the veterans affairs puget sound health care system in seattle, wa; boston university school of medicine, in boston, ma; the johns hopkins medical institutions, in baltimore, md; sun health research institute, in phoenix, az; and the university of rochester, in rochester, ny.

Eligibility criteria:
inclusion criteria: * subjects must have been enrolled previously in the alzheimer's disease anti-inflammatory prevention trial (adapt). exclusion criteria: * individuals not previously enrolled in the adapt trial.

Keywords: naproxen celecoxib anti-inflammatory agents, non-steroidal
study of lyme neuroborreliosis

Conditions: Lyme Neuroborreliosis

Summary: the main purpose of this study is to determine whether four weeks treatment with oral doxycycline is as equally effective as three weeks treatment with intravenous ceftriaxone in patients with lyme neuroborreliosis. the other purpose is to improve laboratory diagnostics of lyme neuroborreliosis and further define the manifestations and epidemiology of the disease in finland.


Eligibility criteria:
inclusion criteria for definite lyme neuroborreliosis (criteria 1-3 or 1 and 4 fulfilled): 1. neurological symptoms suggestive of lnb without other obvious reasons 2. csf pleocytosis (\>4 leukocytes per mikrol) 3. intrathecal production of b. burgdorferi specific antibodies 4. detection of b. burgdorferi dna in central spinal fluid inclusion cirteria for possible lnb (criteria 1 and 2 or 3 fullfilled): 1. neurological symptoms suggestive of lnb wihtout other obvious reasons 2. production of b. burgdorferi spesific antibodies in serum 3. erythema migrans during the previous three months exclusion criteria: * pregnancy and breastfeeding * women planning to get pregnant in two months * age under 18 * handicapped persons * prisoners * use of any antibiotics two weeks before study treatments begins * allergy for tetracyclines or cephalosporins

Keywords: doxycycline ceftriaxone