Kornimate/medical-research-clean huggingface dataset:
a 52-week, open-label extension study following a 6-week, double-blind, placebo- and active- controlled study (r076477-sch-303) to evaluate the safety and tolerability of paliperidone er in subjects with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of the study was an open label extension to a completed study that evaluated the efficacy and safety of 3 fixed dosages of extended release orosâ® paliperidone

this 52-week, open-label extension study followed a 6-week, double-blind, placebo- and active-controlled study (r076477-sch-303) and was conducted at 52 sites in 11 countries. the primary objective of the open-label extension was the long-term assessment of safety and tolerability of flexibly-dosed er oros® paliperidone. the secondary objective was the assessment of long-term efficacy expressed as a function of change in the total positive and negative syndrome scale (panss) score, effect on positive and negative symptoms of schizophrenia by means of change in panss factor scores, and personal and social functioning, overall functioning, and quality of life parameters as measured by personal and social performance scale (psp), clinical global impression scale - severity (cgi-s), and schizophrenia quality of life scale (sqls), respectively. subjects in the open-label phase received flexibly dosed er oros® paliperidone (3 mg to 12 mg/day) for 52 weeks

Eligibility criteria:
inclusion criteria: * subjects who had completed the double-blind phase or discontinued due to lack of efficacy after at least 21 days of treatment, who signed the informed consent for the open-label phase, and who the investigator agreed that open-label treatment was in the best interest of the subject, were eligible to participate in the open-label phase. exclusion criteria: * not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial, were pregnant, or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase

Keywords: schizophrenia paliperidone
mothers experience of pain following elective cesarean section. a qualitative study.

Conditions: Cesarean Section Complications

Summary: background and aim: in denmark, approx 56.000 babies are born every year, and approx 20% of them are born by cesarean sections. half of these cesarean sections are elective. previous studies have shown that many women experience severe pain in the days following the cesarean section, thus limiting their ability to care for their baby and recover. the danish national anesthesiological research network, cepra (collaboration for evidence based practice and research in anesthesia) is planning a national study on pain following elective cesarean sections. in order to assure that the investigators will be using actual patient-relevant outcomes in this large national study, the aim with this qualitative study is to obtain knowledge on how danish women experience pain, recovery and function following an elective cesarean section. methods: this is a qualitative study based on semi-structured telephone interviews with women 4-7 days after an elective cesarean section. the study will take place in three danish hospitals (kolding, copenhagen and hillerød). women aged 18 or above, scheduled for elective cesarean section, will be eligible for inclusion. women will be informed about the study, orally and in writing, at the pre-anesthesiological consultation, which is held a few days before the cesarean section. participation is completely voluntary. if they to participate, participants will sign a consent form. the investigators will include and interview participants until data saturation occurs. it is expected that 20-30 women should be included in total, evenly distributed at the three participating hospitals. interviews will be held by telephone, recorded digitally and transscribed verbatim. transscribed interviews will be coded for categories and themes using the nvivo software. data will be analysed using manifest content analysis. baseline characteristics will be handled with descriptive statistics. the primary outcome of the study is a thematic analysis of danish womens experience of pain, recovery and function following an elective cesarean section.


Eligibility criteria:
inclusion criteria: * women undergoing an elective cesarean section under spinal anesthesia * speaking/writing danish exclusion criteria: * cesarean section performed under general anesthesia

Keywords: postoperative pain postoperative function patient-relevant outcomes
virtual reality (vr) -directed brain gut behavioral treatment (bgbt) for inflammatory bowel disease (ibd) inpatients

Conditions: Inflammatory Bowel Diseases

Summary: the research is studying virtual reality (vr)-directed brain-gut behavioral therapy (bgbt) as a pain treatment option for hospitalized patients with inflammatory bowel disease (ibd). this study is being done to learn if vr-directed bgbt is feasible and acceptable for patients with ibd in addressing pain in the hospital setting. the study hypothesizes that: * at least 75% of enrolled participants will complete the vr-directed bgbt inpatient program * hospitalized patients with ibd will find vr-directed bgbt acceptable as a pain treatment option in the inpatient setting.


Eligibility criteria:
inclusion criteria: * patients with inflammatory bowel disease and self-reported pain * hospitalized for management of ibd (inpatient medicine services at michigan medicine) exclusion criteria: * patients that do not report pain * anticipated length of hospital stay is less than 72 hours * patients that have previously had a seizure, loss of awareness, or other symptoms linked to an epileptic condition * patients with binocular vision loss * patients with an uncontrolled cardiac condition such as an arrhythmia, coronary artery disease, or neurological/cerebrovascular disease. * patients that are currently pregnant

Keywords: virtual reality inpatient pain brain gut behavioral treatment
"air assisted"water injection colonoscopy in experienced endoscopists

Conditions: Colon Disease;; Rectal Disease

Summary: up to now, many studies has showed that compared with air insufflation colonoscopy, water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the patients,especially for training the beginners,the investigators conduct this study to preform the "air assisted" water injection colonoscopy in experienced endoscopists.

in order to further develop water skills and apply the water assisted colonoscopy technique more flexibly, the investigators designed this study.

Eligibility criteria:
inclusion criteria: * patients diagnostic colonoscopy; * subjets able to provide informed consent exclusion criteria: * prior partial or complete colectomy; * patients who decline to participate; * patients with poor bowel preparation; * contraindications of the colonoscopy
the association between calretinin and the function of ganglion cells in hirschsprung disease

Conditions: Hirschsprung Disease; Ganglion; Hirschsprung Disease, Long-Segment; Hypoganglionosis

Summary: this study aims to compare the outcomes of patients with long segment hirschsprung disease or total colonic aganglionosis who had negative calretinin staining and positive ganglion cells on the proximal resection margins to those who had both positive findings.


Eligibility criteria:
inclusion criteria: * confirmed histopathological diagnosis of hirschsprung disease from january 1, 1990 to august 31, 2019 * long-segment hirschsprung disease (type a and b) * total colonic aganglionosis (tca) * surgery at chusj * tissue blocks of proximal resection margin available for pathological analysis * minimum 1 month of postoperative follow-up exclusion criteria: * short-segment hirschsprung disease (conventional form, rectosigmoid junction) * total colonic with small bowel aganglionosis (tcsa) * surgery done at another institution * early deaths * lost to follow-up * no documented post-operative outcome
study of hiv patients with undetectable viral load and abnormal lipids switching to atazanavir/ritonavir

Conditions: HIV Infections

Summary: patients with hiv who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (haart) regimen but with elevated non-hdl cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (nrtis).


Eligibility criteria:
inclusion criteria: * hiv positive * lpv/rtv-based haart for at least 6 months * hiv-1 rna less than 50c/ml (confirmed) * non-hdl higher than 160 mg/dl * cd4 of at least 50 cells/ml exclusion criteria: * use of lipid-lowering agents

Keywords: treatment experienced
a study of pcsk9 inhibitor ak102 in patients with heterozygous familial hypercholesterolemia (hefh)

Conditions: Heterozygous Familial Hypercholesterolemia

Summary: this is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of ak102 in patients with heterozygous familial hypercholesterolemia (hefh).the primary objective of this study is to evaluate the efficacy of ak102 in patients with hefh.


Eligibility criteria:
inclusion criteria: * subjects with heterozygous familial hypercholesterolemia diagnosed by genetic confirmation or clinical diagnosis criteria. * stable on pre-existing, lipid-lowering therapies (statins with or without ezetimibe) for at least 4 weeks with no planned medication or dose change for the duration of study participation. * fasting low-density lipoprotein cholesterol (ldl-c) ≥ 70 mg/dl in patients with history of atherosclerotic cardiovascular disease (ascvd) or fasting low-density lipoprotein cholesterol (ldl-c) ≥ 100 mg/dl in patients without history of atherosclerotic cardiovascular disease (ascvd). * fasting triglycerides ≤ 400 mg/dl. * body weight ≥ 40kg. key exclusion criteria: * subjects with homozygous fh (clinically or by genotyping). * receipt of ldl apheresis within 12 months prior to the first dose of investigational product. * receipt of lomitapide or mipomersen within 5 months prior to the first dose of investigational product. * prior use of pcsk9 inhibitors. * creatine kinase (ck) \>3 times of the upper limit of normal (uln). * aspartate aminotransferase (ast) ≥ 2 x uln. * estimated glomerular filtration rate (egfr)≤ 30 ml/min/1.73m\^2. * thyroid-stimulating hormone (tsh)\> 1.5 x uln or \<1 x lln. * type 1 diabetes, or type 2 diabetes that is or poorly controlled（hba1c\> 8.5%). * subjects with untreated or active chronic hepatitis b or active hepatitis c virus infections.

Keywords: hefh ldl-c
a comparison between glargine and detemir insulin in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study that when studies using our method of dosing adjustments driven by continuous glucose monitoring and because of the less variable glycemic effect of insulin detemir, insulin detemir treated subjects will spend a significantly greater time in the glucose target range than insulin glargine.

todate, most studies have compared insulin detemir and glargine to nph and not to each other. depending of their design, these studies have shown both insulins lower the fasting glucose, a1c, the incidence of hypoglycemia and are associated with less weight gain than nph. in the only direct comparison study of these two basal insulins, insulin detemir demonstrated significantly less day to day variation than glargine as measured by glucose infusion rated during an euglycemic clamp study. given the same incidence of hypoglycemia, this last study would suggest that insulin detemir treatment could achieve target glucose control more than glargine. we have used continuous glucose monitoring (cgms) extensively in our practice. cgms is arguably the most sensitive method for detecting differences in glycemic control in the outpatient setting and there by allowing fine adjustments in insulin treatment. when comparing insulin glargine to preprogrammable basal insulin as delivered by continuous subcutaneous infusion and using cgms, we have shown significantly better glucose control with continuous subcutaneous infusion, we have also developed a method of daily insulin dosage adjustments during a continuous cgms study from daily glucose tracings downloaded. this allows for an even more accurate basal insulin replacement per set glycemic goal. this protocol addresses a comparison of insulin glargine and insulin detemir for patients evaluated by cgms.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * currently on a basal insulin, that is, nph, glargine or detemir * capable of self monitoring glucose \>4/day * previously complaint with clinical recommendations * subject may be on oral antiglycemic medications but no change in treatment is permitted during study. exclusion criteria: * hb a1c \>9.0% * urinary ketosis * currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatine \>1.5 mg/dl) glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistance of another) * currently participating in another clinical trial * known or suspected allergy to insulin glargine or detemir * using other insulins, such as, bolus insulin or premixed insulin * sight or hearing impaired * pregnancy oor nursing of the intention of becoming pregnant or not using adequate contraceptive measures.

Keywords: type 2 diabetes continuous glucose monitoring basal insulin
prevalence of nnsh in a group of egyptian children aged 3-8 years old in giza governorate: a cross sectional study.

Conditions: Child Behavior

Summary: 1. prevalence of non-nutritive sucking habits (nnsh) in a group of egyptian children aged 3-8 years old in giza governorate. 2. assessment of factors associated with nnsh.

several studies have reported on the prevalence of non-nutritive sucking behaviors among infants and young children in different populations. non-nutritive sucking is regarded as a normal part of development, and early studies of its prevalence generally found that 70-90% of children had some history of a non-nutritive sucking habit. like these early studies, most recent studies have used retrospective methods to assess the prevalence of non-nutritive sucking habits. prolonged duration of non-nutritive sucking behaviors may have consequences in regard to the developing orofacial structures and occlusion. little is known as to why some children have sucking habits beyond the first 2 to 3 years of life. prevalence of nnsh and associated factors in egyptian children might be different.

Eligibility criteria:
inclusion criteria: * 3-8 years old children. * children free of systemic diseases. * positive patient/parents acceptance for participation in the study. * both sexes will be included. exclusion criteria: * disabled children. * children with cleft lip \& palate. * tmj disorders. * children undergoing orthodontic/orthopedic treatment. * participants who were exposed to thumb sucking prevention programs.
electronic health technology for assessment of physical activity and eating habits in children and adolescents who are overweight and those with obesity

Conditions: Overweight; Obesity

Summary: aims: during the last decades overweight/obesity has increased markedly. they are associated with a high risk for diabetes and death. effective intervention is mandatory. following participation in treatment programmes children/adolescents often fail to reach sufficient long-term weight reduction. the present trial aims to integrate telemedical support in therapy to improve long term outcome. methods: all children/adolescents with overweight/obesity were included (n=66,age 13.9±2.6 years, body mass index \[bmi\] 31.2±5.4kg/m², body mass index standard deviation score \[bmi-sds\] 2.41±0.6) admitted to our hospital 04-03/2009. to asses physical activity and eating habits electronic health technology was used (fraunhofer-institute). the system consists in a motion sensor integrated in a mobile phone(diatrace). the system analyses kind, intensity and duration of physical activity and eating habits.


Eligibility criteria:
inclusion criteria: * all children/adolescents with overweight/obesity were included admitted to our hospital

Keywords: differences between patients´ self-assessment and objective perception of physical activity and eating habits
hiv indicator diseases in hospital and primary care

Conditions: HIV Infections; Primary Health Care; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases, Viral; Herpes Zoster; Dermatitis, Seborrheic; Pneumonia; Infectious Mononucleosis; Psoriasis; Candida Infection; Lymphadenopathy; Uterine Cervical Dysplasia; Weight Loss; Diarrhea Chronic; Leukopenia; Thrombocytopenia; AIDS Defining Illness; HIV Indicator Condition

Summary: patients are frequently evaluated by physicians for medical work-up of hiv indicator conditions in hospital and in primary care at the general practitioner. testing for hiv is indicated with hiv indicator disorder but often omitted in clinical work-up. besides the fact that hiv testing is forgotten, there are other reasons such as an underestimation of the risk of hiv in the event of indicator disorders, stigma and difficulties in discussing the test with a patient. also and more relevant for primary care than for the hospital, practical challenges can exist for a patient to go to a laboratory, or costs are a hurdle. this project focuses on improving hiv indicator condition driven testing in different settings of the hiv epidemic, initially in the netherlands as low hiv prevalence setting followed by an assessment of its benefit in different international settings. a specific focus will also be on the rotterdam area in the netherlands which has a high prevalence of undiagnosed hiv in the netherlands. the ultimate aim is to decrease the number of undiagnosed hiv in populations, improve the 90-90-90 hiv cascade of care goals particularly its first pillar, and to help supporting the unaids goal to end hiv/aids


Eligibility criteria:
inclusion criteria: * diagnosis of an hiv indicator conditions. exclusion criteria: * below 18 years of age * recent hiv test (\< 12 months, except for mononucleosis-like disease and stds)

Keywords: general practitioner, medical specialist, hiv indicator condition, hiv risk group, aids
effects of mindfulness practice on healthcare workers

Conditions: Psychological Burnout

Summary: this study aims to examine the effects of mindfulness practice administered using a mobile app on psychological health among health care workers in singapore.

research has shown that health workers are particularly at risk of experiencing heightened risks of burnout and psychological symptoms when dealing with a health pandemic, including the current covid-19 pandemic (lai et al., 2020; tan et al., 2020; wu et al., 2009). the increased risk reflects an urgent need to develop feasible psychological interventions to mitigate burnout and psychological symptoms among health workers. the present study aims to examine the effects of a brief mindfulness intervention delivered using a mobile application (headspace) on psychological functioning in the context of coping with the covid-19 pandemic in a sample of health workers in singapore. a total of 80 health workers will be recruited and randomly assigned to using a mindfulness practice app or a cognitive games app daily over a period of 21 days. they will be assessed at baseline, post-intervention, and at one-month follow-up on depressive symptoms, anxiety, stress, burnout, compassion fatigue, compassion satisfaction, post-traumatic stress symptoms, trait mindfulness, self-compassion, sleep quality, working memory, and fear of covid-19 infection. results of the study will have implications on developing cost-effective interventions to mitigate psychological symptoms among health workers in the context of heightened pandemic-related stress.

Eligibility criteria:
inclusion criteria: * aged between 21 and 60 * being a health care worker based in singapore * proficient in english * owns a smartphone (ios or android) with wi-fi or data access. exclusion criteria: -regular mindfulness practice, defined by practicing a minimum of two to three times a week for 10 to 15 minutes each time within the past six months.
confocal fluorescence microscopy of the human airways in diagnostics of lung transplantation

Conditions: Disorder Related to Lung Transplantation

Summary: bronchoscopy-guided tissue sampling is a central technique in many diseases including diagnosing and staging lung cancers, diagnosing interstitial lung diseases, and acute and/or chronic rejections following lung transplantation. confocal fluorescence microscopy is a novel technique used for real-time microscopic imaging of proximal and distal airways, microvessels, and inflammatory cells. we hypothesize that confocal fluorescence microscopy images of airways and alveolar structures during standard bronchoscopy could help recognize and classify the presence or absence of acute or chronic rejection in lung transplant recipients.

bronchoscopy-guided tissue sampling is a central technique in many diseases including diagnosing and staging lung cancers, diagnosing interstitial lung diseases, and acute and/or chronic rejections following lung transplantation. confocal fluorescence microscopy is a novel technique used for in vivo microscopic imaging of proximal and distal airways including bronchial and alveolar walls, microvessels, and inflammatory cells. we hypothesize that confocal fluorescence microscopy images of bronchiolar and alveolar structures during standard bronchoscopy could help recognize and classify the presence or absence of acute or chronic rejection in lung transplant recipients. the objectives and outcomes of this study are: 1. to assess the safety of confocal microscopy imaging in pediatric patients 2. to create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of acute and chronic rejections following lung transplantation 3. to determine the sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies 4. correlate confocal images to fev1 results 5. correlate with cxrs and/or ct images

Eligibility criteria:
inclusion criteria: * to be older than six years of age * to be undergoing surveillance or clinically indicated bronchoscopies with transbronchial biopsy as part of their routine care * to be willing and able to comply with study procedures and provide written informed consent/assent to participate in the study exclusion criteria: * to be unwilling to consent * to be unable to safely tolerate a bronchoscopic procedure * to have any contraindications to short-acting anesthetic agents * to have any contraindications to transbronchial biopsies

Keywords: acute rejection chronic rejection confocal microscopy
feasibility and effects of activity trackers among alcohol users receiving in-patient treatment for alcohol use disorder

Conditions: Substance-Related Disorders; Alcohol-Related Disorders; Alcohol Use Disorder (AUD)

Summary: the main objective is to assess the feasibility and effectiveness of using activity trackers to increase physical activity and improve the emotional state of people receiving an in-patient treatment for alcohol use disorder


Eligibility criteria:
inclusion criteria: * being 18 years old or older. * be undergoing inpatient treatment for alcohol use disorder. exclusion criteria: * finishing the treatment before 4 weeks.

Keywords: activity tracker alcohol use disorder physical activity treatment mental health